hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06319989 id: IRB202301905 briefTitle: The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients. overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2026-03-25 date: 2026-09-30 date: 2024-03-20 date: 2024-04-16 name: University of Florida class: OTHER briefSummary: Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, parallel study to assess the efficacy of biplane ultrasound-guided caudal epidural anesthesia in pediatric patients. primaryPurpose: OTHER masking: NONE maskingDescription: The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound. count: 281 type: ESTIMATED name: Biplane Ultrasound name: Single plane ultrasound measure: First puncture success measure: Number of Needle redirections measure: Duration of epidural measure: Postoperative analgesic use sex: MALE minimumAge: 4 Months maximumAge: 10 Years stdAges: CHILD hasResults: False
nctId: NCT06319976 id: P.T.REC/012/004883 briefTitle: Effect of Rotator Cuff Training on Hand Grip in Adults overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-10-30 date: 2024-12-30 date: 2024-03-20 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: Purpose of the study:
* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index. conditions: Hand Grasp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: open chain exercises for rotator cuff muscles name: Advices for postural correction measure: Hand grip strength measure: Hand grip static endurance measure: Hand grip dynamic endurance measure: Upper limb function sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
nctId: NCT06319963 id: Lenti-HPV-07-CT01 briefTitle: A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-12 date: 2024-03-20 date: 2024-03-20 name: Theravectys S.A. class: INDUSTRY briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).
After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year. conditions: HPV-Related Cervical Carcinoma conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1/2a, open label, multicenter, dose-escalation and dose expansion trial to assess the safety, tolerability, and preliminary efficacy of Lenti-HPV-07 to participants with HPV associated oropharyngeal squamous cell cancer or cervical cancer. Three dose strengths will be investigated: a low, midlevel, and high dose. Lenti HPV-07 will be administered as either 2 × intramuscular (IM) injections to participants in arm A (recurrent or metastatic stage, refractory to previous treatments) or as a single IM injection to participants in Arm B (newly diagnosed with locally advanced HPV+ cancer never treated). Eligible participants in Arm B will receive only 1 injection of Lenti-HPV-07 prior to the initiation of their standard of care (SoC) therapy. After 18 participants in either arm have been treated in the escalation phase and have completed the 14 day DLT period, the Safety Review Committee and Sponsor will determine the OBD for use in the dose expansion phase. primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Two IM injections Lenti-HPV-07 name: One IM injection Lenti-HPV-07 measure: Safety and Tolerability measure: OBD measure: Immunogenicity measure: PD-L1 expression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida Cancer Specialists (from Sarah Canon research Institute) city: Orlando state: Florida zip: 32827 country: United States name: Cesar Augusto Perez Batista, MD role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 hasResults: False
nctId: NCT06319950 id: 20240229 briefTitle: High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-30 date: 2026-12-30 date: 2024-03-20 date: 2024-03-20 name: Taizhou Hospital class: OTHER briefSummary: The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis. conditions: Lung Cancer, Nonsmall Cell studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 255 type: ESTIMATED name: Furmonertinib name: Osimertinib measure: progression free survival(PFS) measure: objective response rate(ORR) measure: Intracranial objective Response Rate(iORR) measure: Intracranial progression free survival(iPFS) measure: overal survival time(OS) measure: Disease control rate(DCR) measure: Intracranial disease control rate(iDCR) measure: Depth of response (DepOR) measure: Depth of intracranial response(iDepOR) measure: Time to intracranial remission(iTTR) measure: Duration of response(DoR) measure: Duration of intracranial response(iDoR) measure: Rate of improvement in neural function measure: Health-related quality of life measure: Adverse events measure: Dynamic changes of ct-DNA sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06319937 id: OA2023 briefTitle: Muscle Architecture in Knee Osteoarthritis overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2025-09-01 date: 2024-03-20 date: 2024-03-20 name: Hacettepe University class: OTHER briefSummary: Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.
Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy). conditions: Knee Osteoarthritis conditions: Foot Deformities conditions: Muscle Weakness conditions: Kinesiophobia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Ultrasound measure: Muscle thickness measure: Pennation angle measure: Fat thickness measure: Stair climbing test measure: Sit-stand test sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06319924 id: XIMEPEG-RL briefTitle: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy acronym: XIMEPEG-RL overallStatus: COMPLETED date: 2020-02-01 date: 2021-05-31 date: 2022-09-15 date: 2024-03-20 date: 2024-03-20 name: Hospital St. Joseph, Marseille, France class: OTHER briefSummary: Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.
Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments. conditions: Colorectal Cancer conditions: Colonoscopy conditions: Bowel Preparation Solution studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 601 type: ACTUAL name: Simethicone combined with Macrogol 4000 (PEG) measure: Assess the quality of the bowel preparation assessed by Bubble scale measure: Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS) measure: Colonoscope removal time measure: The frequency of adverse events (AEs) measure: volume of bowel preparation ingested measure: Caecal intubation rate sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique des Cèdres, Ramsay Santé, city: Cornebarrieu zip: 31700 country: France lat: 43.64895 lon: 1.32407 facility: Polyclinique Louis Pasteur, city: Essey-les-Nancy zip: 54280 country: France lat: 48.70179 lon: 6.22425 facility: Saint Joseph Hospital city: Marseille zip: 13008 country: France lat: 43.29551 lon: 5.38958 facility: 5. Clinique Ambroise Paré city: Toulouse zip: 31082 country: France lat: 43.60426 lon: 1.44367 facility: Pole Santé des Haberges city: Vesoul zip: 70000 country: France lat: 47.63333 lon: 6.16667 hasResults: False
nctId: NCT06319911 id: AETOS 2022.04 briefTitle: AETOS Shoulder System overallStatus: RECRUITING date: 2024-03-31 date: 2027-08-30 date: 2030-08-30 date: 2024-03-20 date: 2024-03-20 name: Smith & Nephew, Inc. class: INDUSTRY briefSummary: The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization conditions: Shoulder Osteoarthritis conditions: Shoulder Arthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED name: AETOS measure: Implant Survivorship measure: Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years measure: Radiographic Assessment - Glenoid Migration/Subsidence measure: Radiographic Assessment - Glenoid Radiolucency measure: Radiographic Assessment - Humeral Radiolucency measure: Radiographic Assessment - Humeral Migration/Subsidence measure: Radiographic Assessment - Humeral Head Centeredness measure: Radiographic Assessment - Bone Remodeling measure: Radiographic Assessment - Glenohumeral Subluxation measure: Radiographic Assessment - Device Condition: Anatomic measure: Radiographic Assessment - Device Condition: Reverse measure: American Shoulder and Elbow Score (ASES) measure: Constant Murley Score measure: Simple Shoulder Test (SST) measure: Single Assessment Numeric Evaluation (SANE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: California Pacific Orthopedics status: RECRUITING city: San Francisco state: California zip: 94118 country: United States name: Katie Sheehi role: CONTACT phone: 415-668-8010 email: ksheehi@calpacortho.com name: James Kelly, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Western Orthopaedics status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80210 country: United States name: Libby Mauter role: CONTACT phone: 303-321-1333 email: lmauter@western-ortho.com name: Armand Hatzidakis role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: Hughston Foundation status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909 country: United States name: Cholly Minton role: CONTACT phone: 706-494-3330 email: cminton@hughston.com name: Brent Ponce role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Center for Orthopedics and Neurosurgical Care status: RECRUITING city: Bend state: Oregon zip: 97701 country: United States name: Cody Manriquez role: CONTACT phone: 541-420-0774 email: codymanriquez@gmail.com name: Scott Jacobson, MD role: PRINCIPAL_INVESTIGATOR lat: 44.05817 lon: -121.31531 facility: Rothman Institute status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Brooke Olin role: CONTACT phone: 267-516-9393 name: Matthew Ramsey, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
nctId: NCT06319898 id: IRB00110787 briefTitle: Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder acronym: RELAX overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-02 date: 2024-03-20 date: 2024-03-20 name: Wake Forest University Health Sciences class: OTHER briefSummary: Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population.
The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline. conditions: Anxiety conditions: Pain conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Lavender aromatherapy sticker measure: Mean change in Visual Analog Scale (VAS) Anxiety Scores measure: Visual Analog Scale (VAS) Pain during the chemodenervation procedure measure: Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout measure: Patient satisfaction with their procedure experience Scores sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Megan Tarr, MD role: CONTACT phone: 704-304-1160 email: megan.tarr@atriumhealth.org lat: 36.09986 lon: -80.24422 hasResults: False
nctId: NCT06319885 id: SDU project nr. 3110386 id: ID: 158341 type: OTHER_GRANT domain: Trygfonden briefTitle: Text Messaging to Reduce High-risk Alcohol Use Among Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-04 date: 2024-03-20 date: 2024-03-20 name: University of Southern Denmark class: OTHER name: Anette Søgaard Nielsen, PhD name: Kjeld Andersen, PhD name: Angelina Mellentin, PhD name: Alexis Kuerbis briefSummary: High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment. conditions: Hazardous Alcohol Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Text messaging measure: High-risk alcohol use (yes/no) measure: WHOQOL-Bref (The World Health Organization Quality of Life Brief Version ) measure: OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS) measure: Drinker Inventory of Consequences (DrInC-2R) measure: Frequency of alcohol use measure: Amount of alcohol use measure: Heavy drinking days measure: User evaluation (tailor-made) measure: PHQ-9 (Patient Health Questionnaire-9 ) sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06319872 id: STUDY00009118 briefTitle: The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-03-20 date: 2024-03-20 name: University of Rochester class: OTHER briefSummary: Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder. conditions: Alcohol Use Disorder conditions: Retinal Dystrophies conditions: Age-Related Macular Degeneration conditions: Retinitis Pigmentosa conditions: Stargardt Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Oral disulfiram measure: mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS measure: mean change in total contrast sensitivity score using Pelli-Robson charts measure: mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment measure: mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) measure: mean change in fundus autofluorescence (FAF) measure: number of participants with retinal anatomy changes assessed using fundus photos measure: mean change in visual field perimetry using full-field stimulus test measure: mean change in isopter constriction using Goldmann visual field measure: mean change in size of scotomas using Goldmann visual field measure: mean change in cone and rod latency assessed using Full field electroretinogram (ffERG) measure: mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG) measure: mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG) measure: mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG) measure: mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flaum Eye Institute, University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States name: Gary Gagarinas role: CONTACT email: gary_gagarinas@urmc.rochestere.edu name: Alex Levin, MD role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 hasResults: False
nctId: NCT06319859 id: N-72-2024 briefTitle: Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-20 date: 2024-03-20 name: Cairo University class: OTHER briefSummary: This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Morphine name: Placebo measure: Time to first analgesic requirement measure: Nalbuphine consumption measure: Postoperative pain measure: The incidence of other adverse effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kasr Alaini hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False