hackint0sh/New-Dataset huggingface dataset:
One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first. conditions: Coronary Artery Disease conditions: Coronary Disease conditions: Myocardial Ischemia conditions: Heart Diseases conditions: Arteriosclerosis conditions: Cardiovascular Diseases conditions: Chronic Total Occlusion conditions: Chronic Total Occlusion of Coronary Artery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: Sapphire 3 Coronary Dilatation Catheter measure: Number of Participants With Device Procedural Success measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) measure: Number of Deaths (Cardiac and Non-Cardiac) measure: Number of Participants With Myocardial Infarctions (MI) measure: Number of Participants With Target Lesion Revascularization (TLR) measure: Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) measure: Number of Participants With Absence of Sapphire 3 Study Balloon Rupture measure: Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA) measure: Number of Participants With Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358495 id: REB24-0253 briefTitle: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-07-30 date: 2024-04-10 date: 2024-04-15 name: University of Calgary class: OTHER name: Hotchkiss Brain Institute, University of Calgary briefSummary: Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders). conditions: Insomnia conditions: Sleep Disturbance conditions: Depressive Symptoms conditions: Anxiety Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes assessor will be blinded to participants' assigned condition. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia name: Active Control measure: Insomnia Severity Index measure: Pittsburgh Sleep Quality Index measure: Internalizing Symptoms Subscale of the Youth Self-Report measure: Sleep Logs - Total sleep time measure: Sleep Logs - Onset latency measure: Sleep Logs - Wake after sleep onset measure: Sleep Logs - Sleep efficiency sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06358482 id: ORAL1 briefTitle: Electric Toothbrush Efficacy in Preventing Dental Plaque Development acronym: E-TOOTH overallStatus: RECRUITING date: 2023-01-30 date: 2024-04-30 date: 2024-07-30 date: 2024-04-10 date: 2024-04-15 name: Riccardo Polosa class: OTHER briefSummary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology. conditions: Dental Plaque conditions: Calculus, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: oscillating toothbrush name: standard manual toothbrush measure: fluorescence intensity of at least 30% (ΔR30) measure: the fluorescence intensity of at least 120% (ΔR120) measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: ADDENDO status: RECRUITING city: Catania zip: 95100 country: Italy lat: 37.49223 lon: 15.07041 hasResults: False
nctId: NCT06358469 id: VU2 briefTitle: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision acronym: STRIVE overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2030-06-30 date: 2031-11-30 date: 2024-04-10 date: 2024-04-10 name: Canadian Cancer Trials Group class: NETWORK name: Australia New Zealand Gynaecological Oncology Group briefSummary: This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach? conditions: Vulvar Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 249 type: ESTIMATED name: Surgery name: Active Surveillance measure: Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival measure: HPV-I and HPV-A VSCC cohorts: Overall-survival measure: HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358456 id: 20-928 briefTitle: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices overallStatus: COMPLETED date: 2020-11-20 date: 2022-04-22 date: 2022-04-22 date: 2024-04-10 date: 2024-04-10 name: University Clinic Frankfurt class: OTHER briefSummary: The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
This is relevant because high quality measurements improve the postoperative outcome after cataract surgery. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one arm for each diagnostic device (three in total) primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The investigator and patient knew which device they were tested on count: 145 type: ACTUAL name: Artificial tear name: No artificial tears measure: Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? measure: Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) measure: If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Goethe University Hospital city: Frankfurt state: Hesse zip: 60590 country: Germany lat: 50.11552 lon: 8.68417 hasResults: False
nctId: NCT06358443 id: PF-Jarlsberg/IIIB briefTitle: The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia acronym: PF-JB3 overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-18 date: 2025-02-23 date: 2024-04-10 date: 2024-04-10 name: Meddoc class: OTHER name: Tine briefSummary: Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).
Sample size: At least 16 patients will be included conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One armed observational study primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Jarlsberg cheese measure: Bone Mineral Density measure: Bone Turnover Markers measure: Osteocalcin measure: Vitamin K2 sex: ALL maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358430 id: 2023-1017 id: NCI-2024-03107 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-01-18 date: 2029-01-18 date: 2024-04-10 date: 2024-04-10 name: M.D. Anderson Cancer Center class: OTHER name: Bellicum Pharmaceuticals, Inc. briefSummary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC. conditions: Colorectal Cancer conditions: Minimal Residual Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Fludarabine Phosphate name: Cyclophosphamide name: Cetuximab name: TROP2-CAR-NK Cells name: Rimiducid (AP1903) name: Lymphodepleting Chemotherapy measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Maria Pia Morelli, MD, PhD role: CONTACT phone: 713-745-1297 name: Maria Pia Morelli, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
nctId: NCT06358417 id: 2024P000873 briefTitle: CHW Intervention to Improve Nutrition Security of Patients With Hypertension acronym: HeartWell overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-01-31 date: 2027-05-01 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER briefSummary: The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. conditions: Hypertension conditions: Nutrition, Healthy conditions: Food Insecurity conditions: Community Health Worker studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Nutrition-enhanced CHW name: Basic CHW measure: Feasiblity measure: Feasibility of CHW nutrition intervention (intervention arm only) measure: Acceptability (intervention arm only) measure: Diet quality measure: Blood pressure sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358404 id: 2024P000615 briefTitle: Developing a Peer Support Intervention for Depression in SCD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-10 date: 2024-04-10 name: Massachusetts General Hospital class: OTHER name: National Institutes of Health (NIH) briefSummary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline. conditions: Subjective Cognitive Decline conditions: Depression in Old Age studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: PeersCOG measure: Feasibility of Intervention measure: Acceptability of Intervention measure: Fidelity of Intervention sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358391 id: TS-RF system briefTitle: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-10 date: 2024-04-16 name: Starmed class: INDUSTRY name: Helptrial briefSummary: The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device. conditions: Arrhythmias, Cardiac conditions: Atrial Fibrillation conditions: Heart Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: TS-RF Transseptal Needle name: BRK Transseptal Needle measure: First-pass TSP Success Rate (percent) measure: TSP Time (Second) measure: Fluoroscopy Time (Second) for TSP measure: Needle cross-over between the study and control groups measure: Intra-TSP procedural device-associated complications measure: Changes in patient's quality of life measure: Complications measure: Intra-TSP procedural Adverse Events measure: Overall Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358378 id: 995 briefTitle: Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-10 date: 2024-04-10 name: Sligo General Hospital class: OTHER briefSummary: Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.
Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.
There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Aktiia SA Bracelet measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements measure: Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state measure: Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis measure: Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices measure: User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices measure: Proportion of recruited patients who provide at least 5 daytime cuffless blood pressure readings per day measure: Proportion of total measurements taken which can be paired (i.e. taken within 1-hour of a measurement from the other device) measure: Proportion of missing data from activity diaries measure: Proportion of recruited patients who provide at least 3 paired blood pressure readings for 3 consecutive days sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
nctId: NCT06358365 id: AQP-DCL-026 briefTitle: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients overallStatus: COMPLETED date: 2023-03-29 date: 2023-11-02 date: 2023-11-07 date: 2024-04-10 date: 2024-04-10 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin. conditions: Acute Kidney Failure conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: The AquaPass System measure: Differences in weight gain over the long interdialytic period measure: Device related Adverse Events measure: Changes in NT-proBNP measure: Changes in Blood Urea Nitrogen measure: Effect on Quality of Life measure: Affect on Ultrafiltration Rates after the long inter dialytic gap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nazareth Hospital EMMS city: Nazareth state: Al Wadi Al Jawani 1611 zip: 16100 country: Israel lat: 32.69925 lon: 35.30483 hasResults: False
nctId: NCT06358352 id: M18080921 briefTitle: Clinical and Radiographic Assessment of PRF Versus Lutein Placement overallStatus: COMPLETED date: 2021-10-01 date: 2022-02-01 date: 2023-05-01 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months conditions: Osteogenesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Lutein / Zeaxanthin name: Platelet rich fibrin measure: bone formation sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: faculty of dentistry,Mansoura university city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False