hackint0sh/New-Dataset huggingface dataset:
iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways. conditions: Prostate Cancer conditions: Prostate Adenocarcinoma conditions: Prostate Neoplasm conditions: Prostatic Neoplasm conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 25 type: ESTIMATED name: observational study measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano status: RECRUITING city: Milan country: Italy name: giancarlo albo, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06292884 id: IMAGINER CREATINE briefTitle: Optical Imaging as a Tool for Monitoring Brain Function in Creatine Deficiency Syndromes overallStatus: RECRUITING date: 2023-10-06 date: 2025-06-15 date: 2025-12-15 date: 2024-03-05 date: 2024-03-05 name: IRCCS Fondazione Stella Maris class: OTHER briefSummary: The objective of this project is to explore the potential of functional near-infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Creatine Deficiency Syndromes (CDS), a group of rare neurodevelopmental disorders. Among these disorders, effective treatments are lacking for two. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With gene therapy trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. This project seeks to address this gap by assessing the prognostic reliability of both resting and task-evoked fNIRS. Arousal of participants will be also assessed through the measure of spontaneous heart rate (HR) fluctuations. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with CDS; 2. to collect pilot data on individuals with CDS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. conditions: Creatine Deficiency, X-linked conditions: Creatine Deficiency Syndrome Due to Gamt Deficiency studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Resting-state functional connectivity measure: Amplitude of sensory-evoked hemodynamic responses measure: Correlation between neurophysiology endpoints and the response on neuropsychological scale. sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Pisa zip: 56128 country: Italy name: Roberta Battini, MD role: CONTACT phone: +39 050886282 email: roberta.battini@fsm.unipi.it name: Laura Baroncelli, PhD role: CONTACT phone: +39 050886233 email: laura.baroncelli@fsm.unipi.it name: Elena Scaffei, MD role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
nctId: NCT06292871 id: 2023/2712 briefTitle: The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-05 date: 2024-03-05 date: 2024-03-05 name: KK Women's and Children's Hospital class: OTHER_GOV name: Singapore Institute of Technology briefSummary: To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,
iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM. conditions: Gestational Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will employ a randomized controlled trial design, with GDM patients from KKH randomly assigned to either the intervention or control group. Randomization will be conducted via the electronic randomization list. primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Additional GDM management through social media name: Usual care measure: Acceptance levels measure: Satisfaction levels measure: Engagement levels measure: Appropriateness levels measure: Feasibility levels measure: Emotional wellbeing measure: Blood glucose levels measure: Proportion of participants with optimal blood glucose control measure: Confidence levels measure: Meal skipping measure: Proportion of participants with cigarette smoking measure: Proportion of participants with alcohol intake measure: Gestational weight gain rate measure: Proportion of participants with inappropriate weight gain measure: Motivational levels measure: Proportion of participants with induced labour measure: Proportion of participants with caesarean delivery measure: Birth weight measure: Birth length measure: Head circumference measure: Birth size-for-gestational age measure: Gestational length at birth measure: Proportion of participants with preterm delivery measure: Neonatal apgar score measure: Proportion of participants delivering healthy live birth sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
nctId: NCT06292858 id: IMB071703-101 briefTitle: Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2023-02-24 date: 2025-04 date: 2025-08 date: 2024-03-05 date: 2024-03-05 name: Beijng Immunoah Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors conditions: Recurrent or Metastatic, Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: IMB071703 injection measure: Incidence of adverse events/serious adverse event related with IMB071703 injection measure: Dose-limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection measure: Maximum measured plasma concentration (Cmax) of IMB071703 injection. measure: Time to maximum plasma concentration (Tmax) of IMB071703 injection. measure: Half-life (T1/2) of IMB071703 injection. measure: Immunogenicity profile of IMB071703 injection. measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oncology, Shanghai East Hospital, Tongji University status: RECRUITING city: Shanghai state: Shanghai zip: 200120 country: China name: Ye Guo, Doctor role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06292845 id: 11272 briefTitle: Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents acronym: SprayDye overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-12-01 date: 2027-12-01 date: 2024-03-05 date: 2024-03-05 name: Erasmus Medical Center class: OTHER briefSummary: This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Topical application of a fluorescent imaging agent measure: Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices. measure: Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology measure: Difference in tumor-to-background ratio (TBR) between different imaging time windows measure: The concordance between the presence of tumor cells and fluorescence signal measure: Depth of the fluorescence signal on 4-μm tissue slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus University Medical Center city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
nctId: NCT06292832 id: MSR/AZAST/AIP029/22/222/8/2023 briefTitle: Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-09-10 date: 2024-09-10 date: 2024-03-05 date: 2024-03-05 name: Al-Azhar University class: OTHER briefSummary: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. conditions: Cesarean Section Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Ultrasound-guided pain block name: Ultrasound Machine measure: postoperative time to rescue analgesia requirement sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Al-Azhar University city: Assiut country: Egypt name: Warda Ali role: CONTACT phone: 010300020456 email: warda2001@hotmail.com lat: 27.18096 lon: 31.18368 hasResults: False
nctId: NCT06292819 id: CMUH112-REC2-214 briefTitle: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-05 date: 2024-03-05 name: China Medical University Hospital class: OTHER briefSummary: The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events. conditions: Photobiomodulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Bright light name: Near-infrared light name: Bright light+ near-infrared light measure: Actigraphy-derived sleep indicators measure: Dim-light melatonin onset measure: Sleep quality measure: Emotional state measure: Daytime sleepiness sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06292806 id: 001-2024 briefTitle: Inhibin B/AFC Ratio for Ovarian Response overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-20 date: 2025-12-31 date: 2024-03-05 date: 2024-03-05 name: Insemine Humen Reproduction Centre class: NETWORK briefSummary: Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.
A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality. conditions: IVF conditions: Infertility, Female conditions: Ovulation Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 144 type: ESTIMATED name: FSH-R measure: serum Inhibin B levels measure: serum Anti Mullerian Hormone levels sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
nctId: NCT06292793 id: STUDY00004696 briefTitle: Cyclical Sighing for Pain overallStatus: COMPLETED date: 2023-12-13 date: 2024-02-26 date: 2024-02-26 date: 2024-03-05 date: 2024-03-05 name: Florida State University class: OTHER briefSummary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 81 type: ACTUAL name: Pain Coping Information name: Cyclical Sighing measure: Change in Pain Unpleasantness Numeric Rating Scale measure: Change in Pain Intensity Numeric Rating Scale measure: Change in Anxiety Numeric Rating Scale measure: Change in Depression Numeric Rating Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tallahassee Orthopedic Clinic (TOC) city: Tallahassee state: Florida zip: 32308 country: United States lat: 30.43826 lon: -84.28073 hasResults: False
nctId: NCT06292780 id: R5458-ONC-2274 id: 2023-507809-34-00 type: OTHER domain: EUCT Number briefTitle: A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) acronym: LINKER-AL2 overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-08-26 date: 2035-02-26 date: 2024-03-05 date: 2024-03-05 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab ("study drug").
* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects) conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Note: Participants enrolled in Phase 2 will be randomized 1:1 primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: Linvoseltamab measure: Incidence of dose-limiting toxicity (DLTs) measure: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) measure: Achievement of hematologic CR, as determined by the IRC measure: Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC measure: Achievement of overall hematologic response (PR or better), as determined by the IRC measure: Time to initial hematologic response measure: Time to best hematologic response measure: Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC measure: Hematologic progression-free survival (PFS) measure: Incidence of death measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Incidence of adverse events of special interest (AESIs) measure: Severity of AESIs measure: Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2 measure: Incidence of TEAEs in dose regimen 1 vs 2 measure: Severity of TEAEs in dose regimen 1 vs 2 measure: Incidence of SAEs in dose regimen 1 vs 2 measure: Severity of SAEs in dose regimen 1 vs 2 measure: Incidence of AESIs in dose regimen 1 vs 2 measure: Severity of AESIs in dose regimen 1 vs 2 measure: Time from treatment initiation to hematologic disease progression as determined by the IRC measure: Time from treatment initiation to cardiac deterioration, as determined by the IRC measure: Time from treatment initiation to kidney deterioration as determined by the IRC measure: Time from treatment initiation to death as determined by the IRC measure: Time from initiation of treatment to date of death from any cause measure: Achievement of renal response in participants with renal involvement at baseline, as determined by IRC measure: Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC measure: Time to first renal response in participants with renal involvement at baseline measure: Time to first cardiac response in participants with cardiac involvement at baseline measure: Linvoseltamab concentration in serum over time measure: Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time measure: Titers of ADAs to linvoseltamab over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06292767 id: 2023/462 briefTitle: Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-01-15 date: 2025-04-25 date: 2024-03-05 date: 2024-03-05 name: TC Erciyes University class: OTHER briefSummary: During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications. conditions: Postoperative Pulmonary Atelectasis conditions: Pneumothorax conditions: Pneumonia conditions: Ards conditions: Respiratory Failure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: mechanical power calculation measure: mechanical power measure: mechanical power sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06292754 id: 2023.211 briefTitle: Rotator Cuff Repair With Magnesium Pin overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-12 date: 2024-03-05 date: 2024-03-05 name: Chinese University of Hong Kong class: OTHER briefSummary: Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes. conditions: Arthroscopic Rotator Cuff Repair studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: magnesium pin in additional to the suture anchor name: routine suture anchor measure: Imaging Examinations measure: Cofield classification measure: Sugaya Score measure: Goutallier Classification measure: Height measurement measure: Weight measurement measure: BMI measurement measure: Shoulder flexibility (range of motion) measure: Shoulder muscle strength measure: Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index measure: Constant-Murley Score measure: Visual Analogue Scale (VAS) measure: Adverse events measure: C-reactive protein measurement measure: Calcium (Ca) measurement measure: Magnesium (Mg) measurement measure: Phosphorous (P) measurement measure: Creatinine (Cr) measurement measure: Urea measurement measure: Alanine transaminase (ALT) measurement measure: Aspartate aminotransferase (AST) measurement measure: Total protein (TP) measurement measure: Albumin (ALB) measurement measure: Globulin (GLB) measurement sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False