hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06276348, orgStudyIdInfo id: 20226892, briefTitle: Newborn Genomic Sequencing Pilot Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Rady Pediatric Genomics & Systems Medicine Institute, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?* What are the potential issues related to implementing DWGS in this population?Enrolled newborns will have a blood sample taken and will receive three tests:* DWGS* BeginNGS* WES, conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group, multiple interventions. All enrollees receive all interventions., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Whole genome sequencing, interventions name: BeginNGS test, interventions name: WES, outcomesModule primaryOutcomes measure: Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS., secondaryOutcomes measure: Proportion of enrolled infants who are identified with a genetic disease by BeginNGS., secondaryOutcomes measure: Proportion of enrolled infants who are identified with a genetic disease by WES., secondaryOutcomes measure: Proportion of enrolled infants who have a positive standard NBS test., secondaryOutcomes measure: Proportion of parents approached who agree to participate in the study., secondaryOutcomes measure: Parental reasons for refusal., secondaryOutcomes measure: Time from sample arriving in lab to return of DWGS results., secondaryOutcomes measure: Time from birth to return of DWGS results., secondaryOutcomes measure: Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS., eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 10 Days, stdAges: CHILD, contactsLocationsModule locations facility: Rady Children's Hospital San Diego, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06276322, orgStudyIdInfo id: HU-FTR-SZK-01, briefTitle: Assessment of All Spine Segments ın Individuals With Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Low back pain group and healthy group, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Low back pain group, interventions name: Healthy group, outcomesModule primaryOutcomes measure: Evaluation of the kinematics of the all spine during walking, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Standing from Sitting, primaryOutcomes measure: Evaluation of the kinematics of the all spine during Climbing Step, secondaryOutcomes measure: Spine Normal Joint Movement evaluation, secondaryOutcomes measure: Pain intensity: Visual Analog Scale, secondaryOutcomes measure: Oswestry Disability Index, secondaryOutcomes measure: Fear of movement: Tampa Kinesiophobia Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe university, status: RECRUITING, city: Ankara, state: Altındağ, zip: 06050, country: Turkey, contacts name: Sümeyye Zehra Güler, MSc, role: CONTACT, phone: 5079320390, phoneExt: +90, email: zhrkzlk1906@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06276296, orgStudyIdInfo id: 0001, briefTitle: Heart Rate Variability After Ablation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Vascular surgery, University hospital Královské Vinohrady, Prague, descriptionModule briefSummary: Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Holter EKG - 1 day before ablation, interventions name: Radiofrequency ablation, interventions name: Pulsed field ablation, interventions name: Holter EKG - 1 month after ablation, outcomesModule primaryOutcomes measure: Mean RR interval (ms), primaryOutcomes measure: SDNN (ms), primaryOutcomes measure: RMSSD (ms), primaryOutcomes measure: pNN50 (%), primaryOutcomes measure: peak frequency (Hz), primaryOutcomes measure: power (ms2), primaryOutcomes measure: LF/HF ratio, primaryOutcomes measure: SD1 (ms), primaryOutcomes measure: SD2 (ms), primaryOutcomes measure: SD2/SD1, primaryOutcomes measure: ApEn, primaryOutcomes measure: Correlation dimension, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady, status: RECRUITING, city: Prague, zip: 10034, country: Czechia, contacts name: Jana Vesela, Ing.,Ph.D., role: CONTACT, phone: +420267162714, email: janca.zd@gmail.com, contacts name: Pavel Osmancik, MD,Ph.D., role: CONTACT, phone: +420267162714, email: pavel.osmancik@fmail.com, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
protocolSection identificationModule nctId: NCT06276283, orgStudyIdInfo id: DZ2022E0006, briefTitle: DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Dizal Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: DZD9008 plus Bevacizumab, outcomesModule primaryOutcomes measure: Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs., secondaryOutcomes measure: Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Lu, Dr, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06276270, orgStudyIdInfo id: PT-MUC-1_05-21, briefTitle: Multi-centre, Open-label, First-in-man Study With Mucopad HA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Contipro Pharma a.s., class: OTHER, descriptionModule briefSummary: The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results., conditionsModule conditions: Oral Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mucopad HA, outcomesModule primaryOutcomes measure: Resolution of mucositis symptoms since completion of radiotherapy, secondaryOutcomes measure: - Pain management (VAS scale), secondaryOutcomes measure: Development of xerostomy, secondaryOutcomes measure: Subjective evaluation on scale 1-5 of the treatment by investigator/ patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Masarykův onkologický ústav, Klinika radiační onkologie, status: RECRUITING, city: Brno, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Tomáš Novotný, role: CONTACT, phone: +420543131103, email: novotny@mou.cz, geoPoint lat: 49.19522, lon: 16.60796, locations facility: FN Hradec Králové Klinika onkologie a radioterapie, status: RECRUITING, city: Hradec Králové, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Milan Vošmik, role: CONTACT, phone: +420495832316, email: milan.vosmik@fnhk.cz, geoPoint lat: 50.20923, lon: 15.83277, locations facility: Fakultní nemocnice Ostrava, Klinika onkologická, status: RECRUITING, city: Ostrava, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Jana Jackaninová, role: CONTACT, phone: +420597371111, email: jana.jackaninova@fno.cz, geoPoint lat: 49.83465, lon: 18.28204, locations facility: Etická komise FN Bulovka, status: RECRUITING, city: Praha, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Petra Holečková, role: CONTACT, phone: +420266084516, email: petra.holeckova@bulovka.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN, status: RECRUITING, city: Praha, state: Česká Republika, zip: 56401, country: Czechia, contacts name: Radka Lohynská, role: CONTACT, phone: +420261083890, email: radka.lohynska@ftn.cz, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
protocolSection identificationModule nctId: NCT06276257, orgStudyIdInfo id: 2024-7301, briefTitle: Paravertebral Block for Mastectomy With Immediate Reconstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: CHU de Quebec-Universite Laval, class: OTHER, descriptionModule briefSummary: Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Paravertebral block, interventions name: Usual analgesia, outcomesModule primaryOutcomes measure: Evaluation of postoperative pain using the BPI, secondaryOutcomes measure: Total use of opioids received intraoperatively., secondaryOutcomes measure: Use of non-opioid analgesia intraoperatively, secondaryOutcomes measure: Total dose of opioids received in the PACU, secondaryOutcomes measure: Time before first opioid, secondaryOutcomes measure: Total opioids consumed in the 48 hours following surgery, secondaryOutcomes measure: Chronic pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06276218, orgStudyIdInfo id: PSU, briefTitle: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace., conditionsModule conditions: Clavicle Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Clavicular brace, outcomesModule primaryOutcomes measure: DASH, secondaryOutcomes measure: Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla University, status: RECRUITING, city: Songkla, state: Hatyai, zip: 90110, country: Thailand, contacts name: Thanachai Klongsangsorn, role: CONTACT, phone: +66991964733, email: poom_thanachai@hotmail.com, geoPoint lat: 7.19882, lon: 100.5951, hasResults: False
protocolSection identificationModule nctId: NCT06276205, orgStudyIdInfo id: 1037/RC/KEMU, briefTitle: Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism, acronym: ViDaLLiT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.The main question it aims to answer is:• whether adding Vitamin D to standard therapy has any additional benefitsParticipants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them, conditionsModule conditions: Hypothyroidism Primary, conditions: Lipid Disorder, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D, interventions name: Levothyroxin, outcomesModule primaryOutcomes measure: Decline in Total Cholesterol, primaryOutcomes measure: Decline in LDL, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Edward Medical University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: AP Endocrinology, role: CONTACT, phone: +923004683473, email: sidrah.lodhi@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06276192, orgStudyIdInfo id: 2023-01882-01, briefTitle: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care, acronym: diSAID, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-03-26, completionDateStruct date: 2028-03-26, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Region Östergötland, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.The main question this clinical trial aims to answer are:- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?, conditionsModule conditions: Subacromial Pain Syndrome, conditions: Shoulder Pain, conditions: Rotator Cuff Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Non-Inferiority Randomised Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Digital Physiotherapy (diSAID), interventions name: Traditional Physiotherapy, outcomesModule primaryOutcomes measure: Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI), secondaryOutcomes measure: Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS), secondaryOutcomes measure: Mean change in pain Self-Efficacy, secondaryOutcomes measure: Mean change of self-reported rating of improvement, secondaryOutcomes measure: Mean change of health-related quality of life, otherOutcomes measure: Patients treatment expectancies, otherOutcomes measure: Patients self-reported rating of pain sensitivity, otherOutcomes measure: Costs and cost-effectiveness direct and indirect, otherOutcomes measure: Impact on the environment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Petersson, city: Linköping, zip: SE 58191, country: Sweden, contacts name: Anna Petersson, PhD student, role: CONTACT, phone: +46101031053, email: anna.h.petersson@regionostergotland.se, contacts name: Teresa Holmgren, PhD, role: CONTACT, phone: +46101034158, email: Teresa.Holmgren@regionostergotland.se, contacts name: Hanna Björnsson Hallgren, Associate Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Jenny Samuelsson, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False