hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06302439, orgStudyIdInfo id: INZ701-007, briefTitle: PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2034-05, completionDateStruct date: 2034-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Inozyme Pharma, class: INDUSTRY, collaborators name: GACI Global, descriptionModule briefSummary: The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease., conditionsModule conditions: Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency, conditions: ATP-Binding Cassette Subfamily C Member 6 Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention for this observational study, outcomesModule primaryOutcomes measure: Characterization of the natural history of ENPP1 Deficiency and the infantile-onset form of ABCC6 Deficiency longitudinally, primaryOutcomes measure: Assessment of Patient Functional changes through a validated Patient Reported Outcomes (PROs) tool, primaryOutcomes measure: Assessment of Health-Related Quality-of-Life (HRQoL) changes through validated Patient Reported Outcomes (PROs) tools, primaryOutcomes measure: Measurement of inorganic phosphate (PPi) levels in patients' venous blood, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06302400, orgStudyIdInfo id: RS-IC04, briefTitle: Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma, acronym: RHEPaiR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Terumo Europe N.V., descriptionModule briefSummary: The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:* What is the safety and toxicity profile of the 166-Holmium microspheres?* Is the device effective in treating HCC?Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:* A Computed Tomography (CT) scan* A Magnetic Resonance Imaging (MRI) scan* Blood tests* Quality of life questionnairesBefore receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: 166Holmium microspheres (QuiremSpheres®), outcomesModule primaryOutcomes measure: The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0., secondaryOutcomes measure: The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, zip: W12 0HS, country: United Kingdom, contacts name: Rohini Sharma, Professor, role: CONTACT, phone: 02033133720, email: r.sharma@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06302387, orgStudyIdInfo id: BEC-LSMU(R)-27, briefTitle: Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2020-04-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Harvard Medical School (HMS and HSDM), class: OTHER, descriptionModule briefSummary: This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are., conditionsModule conditions: Soft Tissue Augmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The interventional study model for this trial is a two-arm, double-blind, randomized, prospective controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double-blind, where neither the patients nor the clinicians responsible for treatment know the specific treatment modality, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Acellular Dermal Matrix, interventions name: Soft Tissue Expansion using Tenting Technique, outcomesModule primaryOutcomes measure: Crestal Bone Levels, secondaryOutcomes measure: Vertical soft tissue thickness, secondaryOutcomes measure: PPD, secondaryOutcomes measure: BOP, secondaryOutcomes measure: PI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VIC Clinic, city: Vilnius, zip: 01362, country: Lithuania, geoPoint lat: 54.68916, lon: 25.2798, hasResults: False
protocolSection identificationModule nctId: NCT06302348, orgStudyIdInfo id: PTC923-PKU-401, briefTitle: A Study of Sepiapterin in Participants With Phenylketonuria (PKU), acronym: EPIPHENY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2031-02-28, completionDateStruct date: 2031-02-28, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: PTC Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood., conditionsModule conditions: Phenylketonuria, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Sepiapterin, outcomesModule primaryOutcomes measure: Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Weschler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score, primaryOutcomes measure: Mean Change From Baseline in FSIQ Weschler Intelligence Scale for Children - Fifth Edition (WISC-V) Score, secondaryOutcomes measure: Change From Baseline in Phenylketonuria-Quality of Life (PKU-QOL) Questionnaire Score, secondaryOutcomes measure: Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Score, secondaryOutcomes measure: Mean Change From Baseline in FSIQ (WPPSI-IV) Score, secondaryOutcomes measure: Mean Change From Baseline in FSIQ (WISC-V) Score, secondaryOutcomes measure: Change From Baseline in Mean Blood Phe Levels, eligibilityModule sex: ALL, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Indiana University, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Susan Romie, role: CONTACT, contacts name: Melissa Lah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
protocolSection identificationModule nctId: NCT06302335, orgStudyIdInfo id: 2022-0442, briefTitle: Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hospital de Clinicas de Porto Alegre, class: OTHER, descriptionModule briefSummary: Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil., conditionsModule conditions: Surgical Site Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants will not know what kind of substance will be used during the surgery., whoMasked: PARTICIPANT, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-iodine, interventions name: Saline solution, outcomesModule primaryOutcomes measure: Surgical site infection, secondaryOutcomes measure: Intracavitary surgical infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de Clinicas de Porto Alegre, status: RECRUITING, city: Porto Alegre, state: RS, zip: 90.035-903, country: Brazil, contacts name: Daniel C Damin, role: CONTACT, phone: +5551996020442, email: damin@terra.com.br, geoPoint lat: -30.03306, lon: -51.23, hasResults: False
protocolSection identificationModule nctId: NCT06302322, orgStudyIdInfo id: 158200-07-512-149, briefTitle: Long-term Follow up of Mucosal Tissue Height Influence on Peri-implant Bone Levels., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-07, primaryCompletionDateStruct date: 2022-08-15, completionDateStruct date: 2022-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Harvard Medical School (HMS and HSDM), class: OTHER, descriptionModule briefSummary: Our study looks into how the thickness of the gum tissue affects the health of the bone around dental implants over ten years. We include 59 people and divide them into three groups based on their gum tissue thickness. Some have naturally thin gums, some have thin gums that were made thicker with a special procedure, and some already had thick gums. We try to find out if having thicker gums, whether naturally or through enhancement, can help keep the bone around dental implants healthy in the long run., conditionsModule conditions: Edentulous Alveolar Ridge, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: Thin Tissues, interventions name: Thick Tissues, interventions name: Surgically augmented thin tissues, outcomesModule primaryOutcomes measure: Crestal Bone Levels, secondaryOutcomes measure: PPD, secondaryOutcomes measure: BOP, secondaryOutcomes measure: PI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VIC Clinic, city: Vilnius, zip: 01362, country: Lithuania, geoPoint lat: 54.68916, lon: 25.2798, hasResults: False
protocolSection identificationModule nctId: NCT06302309, orgStudyIdInfo id: NL85217.091.23, briefTitle: Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease, acronym: TACKLING-FOG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease., conditionsModule conditions: Freezing of Gait, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded., enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psychological intervention, outcomesModule primaryOutcomes measure: % time frozen during a personalized gait trajectory, secondaryOutcomes measure: subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale, secondaryOutcomes measure: Heart Rate Variability, secondaryOutcomes measure: The Parkinson Anxiety Scale (PAS), secondaryOutcomes measure: Gait-Specific Attention Profile, secondaryOutcomes measure: he Updated Perceived Control over Falling Scale (UP-COF), secondaryOutcomes measure: New Freezing of Gait Questionnaire, secondaryOutcomes measure: The Parkinson's Disease Questionnaire, secondaryOutcomes measure: The Rosenberg self-esteem score, secondaryOutcomes measure: Perceived Stress Scale, otherOutcomes measure: Montreal Cognitive Assessment, otherOutcomes measure: Unified Parkinson's Disease Rating Scale Part III, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06302296, orgStudyIdInfo id: Hama University/, briefTitle: Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hama University, class: OTHER, descriptionModule briefSummary: One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize., conditionsModule conditions: Tooth Mobility, conditions: Injectable Platelet-rich Fibrin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: injectable form of PRF, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Leveling and alignment maxillary incisors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fadi Jnaid, status: RECRUITING, city: Hama, country: Syrian Arab Republic, contacts name: Fadi Jnaid, Associate Professor, role: CONTACT, email: Drfadijnaid@gmail.com, contacts name: PhD, role: CONTACT, phone: 0988499015, geoPoint lat: 35.13179, lon: 36.75783, hasResults: False
protocolSection identificationModule nctId: NCT06302283, orgStudyIdInfo id: 114/23-EP, briefTitle: Collateral Effects of Pandemics - Care for Informal Caregivers, acronym: COLLPAN-3A, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: Wuerzburg University Hospital, collaborators name: Johannes Gutenberg University Mainz, collaborators name: Universitätsklinikum Hamburg-Eppendorf, descriptionModule briefSummary: The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics., conditionsModule conditions: Bereavement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Bereavement burden, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Depression, primaryOutcomes measure: Caregiving burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bonn, city: Bonn, zip: 53127, country: Germany, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False
protocolSection identificationModule nctId: NCT06302270, orgStudyIdInfo id: K2024-0507, briefTitle: CFTR Modulators in Pregnancy and Postpartum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2034-01-31, completionDateStruct date: 2039-01-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Karolinska Institutet, descriptionModule briefSummary: Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Health effects in the newborn infant, eligibilityModule sex: ALL, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Stockholm CF center, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Terezia Pinzikova, MD, PhD, role: CONTACT, phone: +46 8 123 80000, email: jenny.svedenkrans@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06302244, orgStudyIdInfo id: R-21075263, briefTitle: Multimodal Neuromonitoring in Acute Brain Injury, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2017-03-27, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.The individual studies are detailed below:, conditionsModule conditions: Acute Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, outcomesModule primaryOutcomes measure: Correlation between systemic glucose and microdialysis glucose, primaryOutcomes measure: Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg)., primaryOutcomes measure: Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure., primaryOutcomes measure: The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening, primaryOutcomes measure: The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg)., secondaryOutcomes measure: Functional outcome at six months, secondaryOutcomes measure: Mortality at six months, secondaryOutcomes measure: Length of stay in the ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False