hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06307808, orgStudyIdInfo id: Vitamin, briefTitle: Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination, acronym: VITAMIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, collaborators name: National Agency for Research on AIDS and Viral Hepatitis (ANRS), descriptionModule briefSummary: Solid Organ Transplantation (SOT) is made possible by the use of a lifelong immunosuppressive treatment. This treatment limits the response of the immune system, enabling long-term survival of the transplanted organ, but also leading to weaker anti-infectious responses.In this study, we will compare the response to a booster Hepatitis B vaccination (HBV) in SOT patients, either after kidney or liver transplantation. We will also compare the immune response depending on the immunosuppressive treatment.In order to provide a detailed picture of the immune response, we will investigate the usual serological response (anti-HBs antibodies), but also the cellular memory (both T and B) using ELISpot assays and flow-cytometry, over a 6 months period following booster vaccination., conditionsModule conditions: HBV, conditions: Kidney Transplantation, conditions: Liver Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus, interventions name: Belatacept, outcomesModule primaryOutcomes measure: Titer of anti-HBs ELISA antibody, secondaryOutcomes measure: Number of anti-HBs memory B cells, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grenoble University Hospital, city: Grenoble, state: Aura, zip: 38043, country: France, contacts name: Pr Thomas Jouve, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False
protocolSection identificationModule nctId: NCT06307756, orgStudyIdInfo id: SayıNo:521, briefTitle: The Effect of Music on Maternal Stress and Milk Amount, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Adiyaman University, class: OTHER, descriptionModule briefSummary: Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk., conditionsModule conditions: Amount of Breast Milk, conditions: Maternal Anxiety Level, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Music group, outcomesModule primaryOutcomes measure: amount of breast milk measured at the same time every day, secondaryOutcomes measure: State Anxiety Inventory, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi, status: RECRUITING, city: Diyarbakır, country: Turkey, contacts name: Özlem Sıdıka Kartal, role: CONTACT, phone: +90 05534452828, email: ozlem.kartal.002.@gmail.com, geoPoint lat: 37.91363, lon: 40.21721, hasResults: False
protocolSection identificationModule nctId: NCT06307730, orgStudyIdInfo id: CHSD_0033_GERIATRIE, briefTitle: Application of the Recommendations of the SPLIF (French Society of Infectious Pathology) in a Geriatric Population on the Duration of Treatment for Bacterial Pneumonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Saint-Denis, class: OTHER, descriptionModule briefSummary: Pneumopathy is the leading cause of death from infectious disease in the elderly. Prior to 2021, the recommended duration of antibiotic therapy for pneumonia, in adults, was 7 days.Two theses have shown that these recommendations were poorly applied in geriatric services. Indeed, the duration of treatment exceeded 7 days, and less than 30% of antibiotic antibiotic treatments were re-evaluated at 72 hours.In 2021, the SPLIF ( published new recommendations reducing this duration to 5 days in the event of clinical improvement observed on the 3rd day of treatment. These new recommendations are based on studies, in which the average age of participants was 65 years. However, the average age of patients in geriatric short-stay departments is 84.7 years.In addition, the geriatric population is characterized by immunosenescence, pulmonary vulnerability and undernutrition, raising questions about the validity of these recommendations in the geriatric population.The investigators offer a monocentric, retrospective, observational study of the geriatric hospital Casanova to assess the application of SPLIF recommendations in the geriatric population., conditionsModule conditions: Pneumonia, Bacterial, conditions: Pneumopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, outcomesModule primaryOutcomes measure: Sex, primaryOutcomes measure: Age, primaryOutcomes measure: Weight, primaryOutcomes measure: Phone Number, primaryOutcomes measure: Origins, primaryOutcomes measure: Autonomy in daily life's score before hospitalisation, primaryOutcomes measure: Charlson's morbidity score, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hopitalier de Saint-Denis, city: Saint-Denis, state: Seine Saint Denis, zip: 93200, country: France, geoPoint lat: 48.93326, lon: 2.36666, hasResults: False
protocolSection identificationModule nctId: NCT06307717, orgStudyIdInfo id: PLAGH-DA-002, briefTitle: Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2021-10-31, completionDateStruct date: 2022-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, collaborators name: Beijing Tsinghua Changgeng Hospital, collaborators name: Peking University First Hospital, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, collaborators name: Xiangya Hospital of Central South University, collaborators name: Beijing Anzhen Hospital, collaborators name: Central South University, collaborators name: Peking University People's Hospital, collaborators name: Zhejiang University, collaborators name: Fudan University, collaborators name: Sun Yat-sen University, collaborators name: Wuhan Union Hospital, China, collaborators name: China-Japan Friendship Hospital, collaborators name: The Affiliated Hospital Of Guizhou Medical University, collaborators name: First Affiliated Hospital of Xinjiang Medical University, collaborators name: First Affiliated Hospital of Guangxi Medical University, collaborators name: Taihe Hospital, descriptionModule briefSummary: This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients., conditionsModule conditions: Cohort Studies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8000, type: ACTUAL, armsInterventionsModule interventions name: volatile anaesthetic (sevoflurane, isoflurane, desflurane), outcomesModule primaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06307704, orgStudyIdInfo id: LUSPEEPORRPC, briefTitle: Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nazmy Edward Seif, class: OTHER, descriptionModule briefSummary: There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).Preventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.Bedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.The aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications., conditionsModule conditions: Prostate Cancer, conditions: Urinary Bladder Cancer, conditions: Surgery, conditions: Positive End Expiratory Pressure, conditions: Lung Ultrasound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Lung Ultrasound - guided Stepwise PEEP, interventions name: Standard Ventilation Protocol, outcomesModule primaryOutcomes measure: Post-operative lung consolidation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University Hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Mustafa E Mohamed, MD, role: CONTACT, phone: 01140806330, phoneExt: +2, email: mustafaemam931@gmail.com, contacts name: Nazmy S Mikhael, MD, role: CONTACT, phone: 01227400808, phoneExt: +2, email: nazmy.edwar.seif@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06307678, orgStudyIdInfo id: AtaturkU-DHF-MS-01, briefTitle: Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-07, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2023-12-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions., conditionsModule conditions: Periapical; Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: outcome assessments have performed by a investigator who was blinded to groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Calcium Hydroxide, interventions name: Calcium Silicate, outcomesModule primaryOutcomes measure: preoperative and postoperative levels of RANKL/OPG ratio, primaryOutcomes measure: preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio, primaryOutcomes measure: preoperative and postoperative levels of TNF alpha ratio, primaryOutcomes measure: preoperative and postoperative levels of TGF beta ratio, secondaryOutcomes measure: dependent variables (sex, age, teeth number, smoking habit), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ataturk University, city: Erzurum, zip: 25240, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
protocolSection identificationModule nctId: NCT06307665, orgStudyIdInfo id: D6934C00001, briefTitle: Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma, acronym: ACADIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-10-13, completionDateStruct date: 2027-10-13, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The purpose of this study is to compare the budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI) administered as needed on severe asthma exacerbations in adolescent participants aged 12 to \< 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: BDA MDI, interventions name: AS MDI, outcomesModule primaryOutcomes measure: Annualized rate of severe asthma exacerbations (AAER), secondaryOutcomes measure: Time to first (TTF) severe asthma exacerbation, secondaryOutcomes measure: Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma, secondaryOutcomes measure: Number of participants with adverse events (AEs) and severe adverse events (SAEs), secondaryOutcomes measure: Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast), secondaryOutcomes measure: Area under plasma concentration-time curve from time 0 to infinity (AUCinf), secondaryOutcomes measure: Time to reach maximum concentration following drug administration (Tmax), secondaryOutcomes measure: Time to reach maximum concentration following drug administration (Tlast), secondaryOutcomes measure: Terminal elimination half-life (t½λz), secondaryOutcomes measure: Terminal elimination rate constant (λz), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution based on the terminal phase (Vz/F), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Research Site, city: White Marsh, state: Maryland, zip: 21162, country: United States, geoPoint lat: 39.38372, lon: -76.43218, hasResults: False
protocolSection identificationModule nctId: NCT06307639, orgStudyIdInfo id: MYMSwifee, briefTitle: Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples., conditionsModule conditions: Male Infertility Due to Azoospermia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE)., outcomesModule primaryOutcomes measure: Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis., primaryOutcomes measure: Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06307626, orgStudyIdInfo id: ARGX-113-2309, secondaryIdInfos id: 2023-509198-22-00, type: CTIS, briefTitle: A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.After an up to 28-day screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively. Study drug will be administered subcutaneously during the 24-week double-blinded treatment period (DBTP). At the end of the DBTP (week 24), proptosis responders will enter a follow-up observational period (52 weeks) to assess the safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy. Proptosis nonresponders and participants who have proptosis relapse during the 52-week follow-up observational period will receive open-label treatment with efgartigimod PH20 SC for up to 24 weeks., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod PH20 SC, interventions name: Placebo PH20 SC, outcomesModule primaryOutcomes measure: Percentage of participants who were proptosis responders, secondaryOutcomes measure: Change in proptosis measurement in the study eye from baseline, secondaryOutcomes measure: Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline, secondaryOutcomes measure: Percentage of participants with a resolution of diplopia (responders), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Research, status: RECRUITING, city: Boynton Beach, state: Florida, zip: 33437, country: United States, contacts name: Sirtaz S. Sibia, MD, role: CONTACT, phone: 857-350-4834, email: clinicaltrials@argenx.com, geoPoint lat: 26.52535, lon: -80.06643, hasResults: False