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protocolSection identificationModule nctId: NCT06357559, orgStudyIdInfo id: OCTA in Myopic CNV, briefTitle: OCTA Changes in Choroidal Neovascularization in High Myopia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.., conditionsModule conditions: Myopic Choroidal Neovascularisation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: OCTA, outcomesModule primaryOutcomes measure: Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357546, orgStudyIdInfo id: RECHMPL23_0411, secondaryIdInfos id: 2023-A02424-41, type: OTHER, domain: N° ID-RCB, briefTitle: Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section, acronym: C2S, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery., conditionsModule conditions: Pregnant Women, conditions: Cesarean Section, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomization list by blocks of random size and stratified by center, by scarred uterus (with or without scar) and Body Mass Index (BMI) at the start of pregnancy (\<30 and ≥30), will be established by a methodologist independent of the study. Patients will be randomized into each group at a ratio of 1:1., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The care provider carrying out the heterocatheterization will be blinded to the participant's randomization group., whoMasked: CARE_PROVIDER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Spontaneous urination during the hour before caesarean section., interventions name: Systematic bladder catherization during caesarean section., outcomesModule primaryOutcomes measure: Necessity of heterocatheterization within 24 hours following the cesarean section., primaryOutcomes measure: Experience of childbirth, primaryOutcomes measure: Duration of preoperative preparation, primaryOutcomes measure: Operating time, primaryOutcomes measure: Duration of post-operative hospitalization, primaryOutcomes measure: Time to resume ambulation, primaryOutcomes measure: First urination, primaryOutcomes measure: Pain during the first urination or the first heterocatheterization, primaryOutcomes measure: Discomfort during the first urination or the first heterocatheterization, primaryOutcomes measure: Additional prescription for painkillers, primaryOutcomes measure: Urinary infection detection, primaryOutcomes measure: Occurrence of surgical difficulties, primaryOutcomes measure: Occurrence of operative complications, primaryOutcomes measure: Amount of bleeding, primaryOutcomes measure: Presence of symptoms suggestive of a urinary infection, primaryOutcomes measure: Presence of functional signs (dysuria, incontinence, delayed bleeding or others), primaryOutcomes measure: Time before resuming spontaneous urination, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montpellier University Hospital, city: Montpellier, zip: 34295, country: France, contacts name: Martha DURAES, MD, role: CONTACT, phone: +334.67.33.65.32, email: [email protected], contacts name: Martha DURAES, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Florent FUCHS, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Nîmes University Hospital, city: Nîmes, zip: 30029, country: France, contacts name: Audrey LAMOUROUX, MD, role: CONTACT, email: [email protected], contacts name: Audrey LAMOUROUX, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vincent LETOUZEY, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, hasResults: False
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protocolSection identificationModule nctId: NCT06357533, orgStudyIdInfo id: D7632C00001, briefTitle: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations, acronym: TROPION-Lung10, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2030-05-24, completionDateStruct date: 2030-05-24, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations., conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Open-label, sponsor-blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 675, type: ESTIMATED, armsInterventionsModule interventions name: Datopotamab Deruxtecan, interventions name: Rilvegostomig, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) in TROP2 biomarker positive participants., primaryOutcomes measure: Overall Survival (OS) in TROP2 biomarker positive participants., secondaryOutcomes measure: Progression-Free Survival (PFS) in the intent-to-treat (ITT) population., secondaryOutcomes measure: Overall Survival (OS) in the intent-to-treat (ITT) population., secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab., secondaryOutcomes measure: Pharmacokinetics (PK), secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Second Progression-Free Survival (PFS2)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Clayton, zip: 3168, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Research Site, city: Melbourne, zip: 3000, country: Australia, geoPoint lat: -37.814, lon: 144.96332, locations facility: Research Site, city: South Brisbane, zip: QL 4101, country: Australia, geoPoint lat: -27.48034, lon: 153.02049, locations facility: Research Site, city: Innsbruck, zip: 6020, country: Austria, geoPoint lat: 47.26266, lon: 11.39454, locations facility: Research Site, city: Krems, zip: 3500, country: Austria, geoPoint lat: 48.40921, lon: 15.61415, locations facility: Research Site, city: Linz, zip: 4020, country: Austria, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Research Site, city: Rankweil, zip: 6830, country: Austria, geoPoint lat: 47.27108, lon: 9.64308, locations facility: Research Site, city: Wien, zip: 1140, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Wien, zip: 1210, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Research Site, city: Rio de Janeiro, zip: 22211-230, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Research Site, city: Vancouver, state: British Columbia, zip: VSZ 4E6, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, locations facility: Research Site, city: Winnipeg, state: Manitoba, zip: R3E 0V9, country: Canada, geoPoint lat: 49.8844, lon: -97.14704, locations facility: Research Site, city: London, state: Ontario, zip: N6A 4L6, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, city: Newmarket, state: Ontario, zip: L3Y 2P9, country: Canada, geoPoint lat: 44.05011, lon: -79.46631, locations facility: Research Site, city: Oshawa, state: Ontario, zip: L1G 2B9, country: Canada, geoPoint lat: 43.90012, lon: -78.84957, locations facility: Research Site, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, city: Lévis, state: Quebec, zip: G6V 0B8, country: Canada, geoPoint lat: 46.80326, lon: -71.17793, locations facility: Research Site, city: Montreal, state: Quebec, zip: H3T 1E2, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Rimouski, state: Quebec, zip: G5L 5T1, country: Canada, geoPoint lat: 48.44879, lon: -68.52396, locations facility: Research Site, city: Trois-Rivieres, state: Quebec, zip: G8Z 3R9, country: Canada, geoPoint lat: 46.34515, lon: -72.5477, locations facility: Research Site, city: Chicoutimi, zip: G7H 5H6, country: Canada, geoPoint lat: 48.41963, lon: -71.06369, locations facility: Research Site, city: Gauting, zip: 82131, country: Germany, geoPoint lat: 48.06919, lon: 11.37703, locations facility: Research Site, city: Budapest, zip: 1121, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Research Site, city: Gyula, zip: 5700, country: Hungary, geoPoint lat: 46.65, lon: 21.28333, locations facility: Research Site, city: Győr, zip: 9024, country: Hungary, geoPoint lat: 47.68333, lon: 17.63512, locations facility: Research Site, city: Kecskemét, zip: 6000, country: Hungary, geoPoint lat: 46.90618, lon: 19.69128, locations facility: Research Site, city: Salgótarján, zip: 3100, country: Hungary, geoPoint lat: 48.09872, lon: 19.80303, locations facility: Research Site, city: Szekszárd, zip: 7100, country: Hungary, geoPoint lat: 46.35014, lon: 18.70905, locations facility: Research Site, city: Székesfehérvár, zip: 8000, country: Hungary, geoPoint lat: 47.18995, lon: 18.41034, locations facility: Research Site, city: Törökbálint, zip: 2045, country: Hungary, geoPoint lat: 47.42931, lon: 18.91356, locations facility: Research Site, city: Bergamo, zip: 24125, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Research Site, city: Genoa, zip: 16132, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Research Site, city: Milano, zip: 20141, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, city: Milano, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, city: Monza, zip: 20052, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, locations facility: Research Site, city: Padova, zip: 35128, country: Italy, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Research Site, city: Pavia, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Research Site, city: Ravenna, zip: 48100, country: Italy, geoPoint lat: 44.41344, lon: 12.20121, locations facility: Research Site, city: Roma, zip: 00128, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Research Site, city: Rozzano, zip: 20089, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Research Site, city: Kawasaki-shi, zip: 216-8511, country: Japan, geoPoint lat: 35.52056, lon: 139.71722, locations facility: Research Site, city: Nagoya-shi, zip: 460-0001, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Research Site, city: Sagamihara-shi, zip: 252-0375, country: Japan, geoPoint lat: 35.54899, lon: 139.26064, locations facility: Research Site, city: Sapporo-shi, zip: 003-0804, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Research Site, city: Takatsuki-shi, zip: 569-8686, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Research Site, city: Tokushima-shi, zip: 770-8503, country: Japan, geoPoint lat: 34.06667, lon: 134.56667, locations facility: Research Site, city: Utsunomiya-shi, zip: 320-0834, country: Japan, geoPoint lat: 36.56667, lon: 139.88333, locations facility: Research Site, city: Changwon, zip: 51353, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Research Site, city: Incheon, zip: 21565, country: Korea, Republic of, geoPoint lat: 37.45646, lon: 126.70515, locations facility: Research Site, city: Seongnam-si, zip: 13496, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Research Site, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Suwon-si, zip: 16499, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, locations facility: Research Site, city: Suwon, zip: 16247, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, locations facility: Research Site, city: Olsztyn, zip: 10-357, country: Poland, geoPoint lat: 53.77995, lon: 20.49416, locations facility: Research Site, city: Poznań, zip: 60-569, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Research Site, city: Warszawa, zip: 01-138, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Research Site, city: Barcelona, zip: 08003, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, city: Jerez de la Frontera, zip: 11407, country: Spain, geoPoint lat: 36.68645, lon: -6.13606, locations facility: Research Site, city: Reus,Tarragona, zip: 43204, country: Spain, locations facility: Research Site, city: Salamanca, zip: 37007, country: Spain, geoPoint lat: 40.96882, lon: -5.66388, locations facility: Research Site, city: Kaohsiung, zip: 80756, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, city: New Taipei, zip: 220, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, locations facility: Research Site, city: Taichung, zip: 40447, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Research Site, city: Tainan, zip: 704, country: Taiwan, geoPoint lat: 22.99083, lon: 120.21333, locations facility: Research Site, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 112, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: TAIWAN, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, locations facility: Research Site, city: Adapazarı, zip: 54100, country: Turkey, geoPoint lat: 40.78056, lon: 30.40333, locations facility: Research Site, city: Ankara, zip: 06560, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, city: Ankara, zip: 6200, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, city: Antalya, zip: 07070, country: Turkey, geoPoint lat: 36.90812, lon: 30.69556, locations facility: Research Site, city: Diyarbakir, zip: 21280, country: Turkey, geoPoint lat: 37.91363, lon: 40.21721, locations facility: Research Site, city: Istanbul, zip: 34030, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Research Site, city: Istanbul, zip: 34890, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Research Site, city: Inverness, zip: IV2 3UJ, country: United Kingdom, geoPoint lat: 57.47908, lon: -4.22398, locations facility: Research Site, city: London, zip: SE1 9RT, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, city: London, zip: SW10 9NH, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, city: London, zip: SW17 0QT, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, city: Truro, zip: TR1 3LJ, country: United Kingdom, geoPoint lat: 50.26526, lon: -5.05436, hasResults: False
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protocolSection identificationModule nctId: NCT06357520, orgStudyIdInfo id: D6970C00005, briefTitle: A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-06-06, completionDateStruct date: 2024-06-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the effect of itraconazole on the pharmacokinetic (PK) of baxdrostat., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Baxdrostat, interventions name: Itraconazole, outcomesModule primaryOutcomes measure: Area Under Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf), primaryOutcomes measure: Maximum Observed Plasma Drug Concentration (Cmax), secondaryOutcomes measure: Extrapolated Area Under The Curve From Tlast to Infinity (AUCextr), secondaryOutcomes measure: Area Under Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Apparent Total Body Clearance (CL/F), secondaryOutcomes measure: Apparent Volume Of Distribution Based On The Terminal Phase (Vz/F), secondaryOutcomes measure: Terminal Elimination Half-life (t1/2λz), secondaryOutcomes measure: Terminal Rate Constant (λz), secondaryOutcomes measure: Mean Residence Time (MRTinf), secondaryOutcomes measure: Time To Reach Maximum Observed Concentration (tmax), secondaryOutcomes measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on Maximum Plasma Concentration (RCmax), secondaryOutcomes measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUClast (RAUClast), secondaryOutcomes measure: Ratio of Baxdrostat (Baxdrostat + Itraconazole) to Baxdrostat (Alone) Based on AUCinf (RAUCinf), secondaryOutcomes measure: Number of Participants with Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Brooklyn, state: Maryland, zip: 21225, country: United States, geoPoint lat: 39.23039, lon: -76.60219, hasResults: False
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protocolSection identificationModule nctId: NCT06357507, orgStudyIdInfo id: hayam hamdy, briefTitle: Molecular Characterization of Moraxella Catarrhalis From Pneumonic Children at Pediatric Assiut University Hospital, acronym: Mcatarrhalis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: moraxella catarrhalis is responsible for respiratory tract infection in children and adults with streptococcus pneumonia and haemophilus influenza.Moraxella catarrhalis is gram negative diplococci, non-motile and non spore bearing bacteria. Until, 1995 it was considered as a non pathogenic respiratory tract flora.This bacteria is an important pathogen and a common cause of both upper and lower respiratory tract infections, pneumonia, sinusitis and conjunctivitis in infants, children and in elderly patients. In adults, M. catarrhalis also causes chronic obstructive pulmonary disease (COPD) and pneumonia. However, it is associated with a number of respiratory infections affecting both children and adults, including laryngitis, bronchitis and pneumonia ., conditionsModule conditions: Respiratory Tract Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, outcomesModule primaryOutcomes measure: isolation of moraxella catarrhalis, secondaryOutcomes measure: detection of virulence genes of moraxella catarrhalis, secondaryOutcomes measure: detetion of antibiotic resistance, eligibilityModule sex: ALL, minimumAge: 1 Month, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06357494, orgStudyIdInfo id: Thyroid Doppler in Graves', briefTitle: Assessment of Thyroid Doppler Ultrasound in Followup of Pediatric Graves' Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2027-04-05, completionDateStruct date: 2028-04-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: All cases of the study will be diagnosed as Graves' by History, examination, laboratory (FT3, FT4, TSH \& TRAbs), X-ray on left wrist for bone age, neck grey scale ultrasonography for thyroid gland size, shape, echotexture, vascularity and nodule characters if present with TIRAD score calculation.Then Color flow doppler ultrasound will be done to asses thyroid volume, number of vessels per square cm and inferior thyroid artery peak systolic velocity, end diastolic velocity and resistive index. Patients then will receive carbimazole antithyroid drug at dose 0.25-0.5 mg/kg/day PO \& the dose will be titrated according to thyroid function test after 4-6 weeks.Beta-adrenergic blockade will be added to all symptomatic cases. Regular follow up will be done every month of first 3 months of diagnosis and then every 3 months for 2 years by clinical and thyroid function test to asses response, compliance, complications, drug side effects, remission and relapses.Doppler ultrasound will be done at 0, 12 and 24 months., conditionsModule conditions: Doppler Ultrasound in Follow up of Graves' Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, outcomesModule primaryOutcomes measure: To make follow up of graves disease easier and improve patients adherence to treatment and follow up plan., secondaryOutcomes measure: better control of disease in our patients, less complications, less mortality and better prognosis., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357481, orgStudyIdInfo id: SaglikBilimleriU-22-122, briefTitle: Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth, acronym: Endodontics, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-26, primaryCompletionDateStruct date: 2023-01-30, completionDateStruct date: 2024-01-28, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests., conditionsModule conditions: Post-operative Pain, conditions: Retreatment, conditions: Symptomatic Periapical Periodontitis, conditions: Endodontic Disease, conditions: Asymptomatic Periapical Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eighty patients who needed endodontic retreatment were assingned to 2 groups according to symptomatic or asymptomatic teeth and 4 subgroups with rotary and resiprocal files., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Endodontic Retreatment, outcomesModule primaryOutcomes measure: Post-operative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 67 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hüseyin Gürkan Güneç, city: Istanbul, state: Uskudar, zip: 34450, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06357468, orgStudyIdInfo id: UKGEB003, briefTitle: Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women With Vaginal Births in Difference Between Physician-led and Midwife-led Birth, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Martin-Luther-Universität Halle-Wittenberg, class: OTHER, descriptionModule briefSummary: The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births, conditionsModule conditions: Pain, Labor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: midwife-led births in low risk women in pregnancy, outcomesModule primaryOutcomes measure: Pain perception, secondaryOutcomes measure: Satisfaction with pain therapy, secondaryOutcomes measure: Pain perception in women with perineal tear grade III, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Halle, status: RECRUITING, city: Halle, state: Saxony Anhalt, zip: 06120, country: Germany, contacts name: Marcus Riemer, MD, role: CONTACT, phone: 03455573946, email: [email protected], geoPoint lat: 51.48159, lon: 11.97948, hasResults: False
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protocolSection identificationModule nctId: NCT06357455, orgStudyIdInfo id: Platelet CellSaver Liver trnsp, briefTitle: Platelet Count and Function After Usage of Two Different Cell Saver Devices During Liver Transplant Surgery, acronym: PLFLTS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Eduardo Schiffer, class: OTHER, collaborators name: University Hospital, Geneva, collaborators name: Insel Gruppe AG, University Hospital Bern, descriptionModule briefSummary: Intraoperative cell salvage is commonly used in surgeries that carry a major hemorrhagic risk to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation status after these types of surgeries, especially liver transplantation.There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are re-transfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the liver transplant surgery population.The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function., conditionsModule conditions: Liver Transplant, conditions: Hemorrhage, Surgical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cell Salvage Autotransfusion: SAME™ device, interventions name: Cell Salvage Autotransfusion: Autolog™ device, outcomesModule primaryOutcomes measure: Platelet number, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Platelet function, secondaryOutcomes measure: Blood plasma albumin level, secondaryOutcomes measure: Blood hemoglobin level, secondaryOutcomes measure: Blood lactate level, secondaryOutcomes measure: Free hemoglobin level, secondaryOutcomes measure: Anti-Xa activity, secondaryOutcomes measure: Number of allogeneic blood products used, secondaryOutcomes measure: Number of coagulation concentrates used, secondaryOutcomes measure: Amount of autologous blood at the end of the liver transplantation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Geneva University Hospitals, city: Geneva, zip: 1211, country: Switzerland, contacts name: Eduardo Schiffer, MD, role: CONTACT, email: [email protected], contacts name: Tony Mouawad, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False
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protocolSection identificationModule nctId: NCT06357442, orgStudyIdInfo id: 23-2305, briefTitle: Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.The main questions it aims to answer are:Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapyAim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesteroneAim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesteroneParticipants will be asked to:* Get two pelvic ultrasounds* Fill out two surveys* Continue their current hormone replacement therapy* Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups., conditionsModule conditions: Primary Ovarian Insufficiency, conditions: Hypogonadotropic Hypogonadism, conditions: Hormone Replacement Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Mean change in endometrial thickness after 6 months of progesterone therapy, secondaryOutcomes measure: Measure the mean endometrial thickness on estrogen replacement therapy, otherOutcomes measure: Satisfaction of progesterone replacement therapy, otherOutcomes measure: Bleeding patterns on progesterone replacement therapy, otherOutcomes measure: Side effects of progesterone replacement therapy, otherOutcomes measure: Adherence to progesterone replacement therapy, otherOutcomes measure: Rate of enrollment and attrition, otherOutcomes measure: Number of patients willing to be randomized in future trial, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357429, orgStudyIdInfo id: 171002100, briefTitle: Evaluation of the Effect of the LI4 Cold Application, acronym: LI4, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-23, primaryCompletionDateStruct date: 2022-11-18, completionDateStruct date: 2022-11-18, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduce/eliminate pain, nausea and anxiety in postoperative patients. The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward. The study was completed with 80 individuals constituting the experimental group (n=40) and the control group (n=40). Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention. Follow-up was performed before cold application, immediately after cold application, 30 minutes after the end of cold application, 1 hour and 2 hours after the end of cold application., conditionsModule conditions: Pain, conditions: Nausea, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Cold Application, outcomesModule primaryOutcomes measure: Pain Level, primaryOutcomes measure: Nausea Level, primaryOutcomes measure: Anxiety Level, primaryOutcomes measure: Sensory characteristics, intensity and impact of pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saglik Bilimleri University, city: Istanbul, state: Uskudar, zip: 34674, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06357416, orgStudyIdInfo id: CCR5573, briefTitle: The Man Van Project, acronym: MV, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-13, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Royal Marsden NHS Foundation Trust, class: OTHER, collaborators name: RM Partners West London Cancer Alliance, collaborators name: Institute of Cancer Research, United Kingdom, collaborators name: Imperial College London, descriptionModule briefSummary: National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor.The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project.Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important).The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider.Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer.The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways.We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van.The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer., conditionsModule conditions: Prostate Cancer, conditions: Urologic Cancer, conditions: Urologic Diseases, conditions: Bladder Cancer, conditions: Diabetes, conditions: Hypertension, conditions: Mental Health Issue, conditions: Alcoholism, conditions: Smoking, conditions: Renal Cancer, conditions: Testis Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: MV-POCT Sub-study, interventions name: Main Man Van Group Sub-study, interventions name: MV-QualQ Sub-study, interventions name: MV-PRS Sub-study, interventions name: MV-DNA and MV-UctDNA Sub-study, interventions name: Man Van patients, outcomesModule primaryOutcomes measure: Cancer detection rates, primaryOutcomes measure: Detection rates of other diseases, eligibilityModule sex: MALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Marsden Hospital NHS Foundation Trust, status: RECRUITING, city: London, zip: SW3 6JJ, country: United Kingdom, contacts name: Ann Gandolfi, role: CONTACT, phone: 02086613903, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06357403, orgStudyIdInfo id: AntiXa-ICU 1881/2023, briefTitle: Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients, acronym: AntiXa-ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:* What is the association between antiXa and VTE?* What is the association between antiXa and symptomatic, respectively incidental, VTE?* How is pharmacological anticoagulation with enoxaparin related to measured antiXa?* What is the association between antiXa and bleeding complications.* What is the incidence of venous thromboembolism in patients treated at an intensive care unit?* How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital., conditionsModule conditions: Thrombosis, conditions: Pulmonary Embolism, conditions: Enoxaparin, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1300, type: ESTIMATED, armsInterventionsModule interventions name: Anti-factor Xa activity calibrated for enoxaparin, outcomesModule primaryOutcomes measure: Number of patients with new-onset venous thromboembolism, secondaryOutcomes measure: Number of patients with new-onset upper extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset lower extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset central vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset symptomatic upper extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset symptomatic lower extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset incidental upper extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset incidental lower extremity deep vein thrombosis, secondaryOutcomes measure: Number of patients with new-onset pulmonary embolism, secondaryOutcomes measure: Number of patients with new-onset symptomatic pulmonary embolism, secondaryOutcomes measure: Number of patients with new-onset incidental pulmonary embolism, secondaryOutcomes measure: Number of patients with venous thromboembolism, secondaryOutcomes measure: Number of patients with deep vein thrombosis, secondaryOutcomes measure: Number of patients with pulmonary embolism, secondaryOutcomes measure: Number of patients with new-onset venous thromboembolism, secondaryOutcomes measure: Number of days with any bleeding, secondaryOutcomes measure: Number of days with major and/or fatal bleeding, secondaryOutcomes measure: Number of red blood cell concentrates administered, secondaryOutcomes measure: Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered, secondaryOutcomes measure: Length of stay in the intensive care unit, secondaryOutcomes measure: Length of stay in the hospital, secondaryOutcomes measure: Death, secondaryOutcomes measure: Days alive and out of the intensive care unit, secondaryOutcomes measure: Days alive and out of the hospital, secondaryOutcomes measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value, secondaryOutcomes measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357390, orgStudyIdInfo id: 202106174RINB, briefTitle: Physiologic and Clinical Effect of High-flow Oxygen Therapy in Tracheostomized Patients With Prolonged Mechanical Ventilation Undergoing Weaning Trials, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-07, primaryCompletionDateStruct date: 2022-07-25, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: This study is aimed at patients who have been admitted to the respiratory care center of this hospital who meet the PMV conditions (defined as continuous use of the ventilator for at least ten days) who are about to receive the ventilator out of training. After obtaining the explanatory consent, they will undergo continuous complete Before and after spontaneous breathing training, collect various relevant physiological data of lung volume and ventilation perfusion distribution, and analyze and predict the correlation of ventilator detachment., conditionsModule conditions: High Flow Oxygen Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, outcomesModule primaryOutcomes measure: ventilation perfusion distribution measurement, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06357377, orgStudyIdInfo id: NEO100-03, briefTitle: A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Neonc Technologies, Inc., class: INDUSTRY, descriptionModule briefSummary: This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid)., conditionsModule conditions: Pediatric Tumor of CNS, conditions: Pediatric Tumor of Brain, conditions: Diffuse Midline Glioma, H3 K27M-Mutant, conditions: Pediatric Tumor of Brain Stem, conditions: Pineocytoma, conditions: Choroid Plexus Carcinoma, Childhood, conditions: Spinal Cord Tumor, conditions: High Grade Glioma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: NEO100, outcomesModule primaryOutcomes measure: Nature and severity of adverse events, secondaryOutcomes measure: Identify the maximum tolerated dose (MTD) of NEO100, secondaryOutcomes measure: Determine the recommended Phase 2 dose (RP2D) of NEO100, secondaryOutcomes measure: Measurement of NEO100 and its metabolite perillic acid in brain tumor tissue, secondaryOutcomes measure: Blood brain barrier penetration, secondaryOutcomes measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by Peak Plasma Concentration, secondaryOutcomes measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by the Time to Peak Plasma Concentration, secondaryOutcomes measure: Characterize the pharmacokinetics (PK) of NEO100 as measured by Area Under the Curve, secondaryOutcomes measure: To assess efficacy of NEO100 based on objective response rate (ORR)., secondaryOutcomes measure: To assess efficacy of NEO100 based on progression free survival (PFS)., secondaryOutcomes measure: To assess efficacy of NEO100 based on overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357364, orgStudyIdInfo id: CBT_Procrastination_Neuro, briefTitle: Neural Changes Following Cognitive Behavior Therapy for Procrastination, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2026-01-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Nencki Institute of Experimental Biology of the Polish Academy of Sciences, class: OTHER_GOV, collaborators name: SWPS University of Social Sciences and Humanities, collaborators name: Institute of Psychology, Polish Academy of Sciences, descriptionModule briefSummary: The aim of this study is to compare the efficacy of and the neural changes following two cognitive behavior therapy (CBT) protocols for procrastination with a wait-list control group. The interventions will be delivered online in group settings. Both protocols include identical psychoeducation and cognitive modules aiming at identification and modification of dysfunctional automatic thoughts related to procrastination but will differ in the behavioral modules. The behavioral module in the first protocol is focused on timely beginning and realistic planning. The second protocol implements working time restriction. The wait-list control group will receive one of the CBT protocols after a waiting period that will last as long as the CBT intervention and the assessments performed directly after treatment. It is assumed that the interventions will be superior to the wait-list control. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior to and after the interventions (or waiting period in the wait-list group) and after 6 months in the two active condition groups. Additionally, neuroimaging measurements will be conducted before and after the interventions (or waiting period in the wait-list group). Approximately half of the participants will undergo functional Magnetic Resonance Imaging (fMRI), and another half will undergo electroencephalography (EEG). Both methods are aimed at exploring neural correlates of the expected improvements in participants' self-regulation abilities., conditionsModule conditions: Procrastination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A researcher not having direct contact with participants will create a script generating random sequence using a computer random sequence generator (Matlab). Randomization will take place at an individual level, stratified by age, gender and procrastination severity (block randomization). Participants will be randomized into three groups with an allocation ratio of 1:1:1.Pairs of experienced psychotherapists trained in one of the therapy protocols will deliver the interventions in an online group setting., whoMasked: PARTICIPANT, enrollmentInfo count: 276, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation and cognitive modules, interventions name: Behavioral module: Starting on Time and Planning Realistically, interventions name: Behavioral module: Working Time Restriction, outcomesModule primaryOutcomes measure: Change in Polish version of the Pure Procrastination Scale (PPS), primaryOutcomes measure: Change in Polish version of the Aitken Procrastination Inventory (API), secondaryOutcomes measure: Change in Polish version of the Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in Polish version of the Generalized Anxiety Disorder Questionnaire-7 (GAD-7), secondaryOutcomes measure: Percentage of completion of a particular project that the participant decided to work on during the training (e.g. a thesis, an essay, a report)., otherOutcomes measure: Change in Polish version of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Short Form (SPSRQ-SF), otherOutcomes measure: Change in Polish version of the Multidimensional-Multiattributional Causality Scale (MMCS), otherOutcomes measure: Change in Polish version of the Performance Failure Appraisal Inventory (PFAI), otherOutcomes measure: Change in Polish version of the Difficulties in Emotion Regulation questionnaire (DERS), otherOutcomes measure: Change in Polish version of the Motivation Diagnostic Test (MDT), otherOutcomes measure: Change in Polish version of the Zimbardo Time Perspective Inventory, otherOutcomes measure: Change in Polish version of the Metacognitive Beliefs about Procrastination Questionnaire (MBPQ), otherOutcomes measure: Change in Polish version of the Impulsivity Scale (UPPS-P), otherOutcomes measure: Change in Polish version of the Self-control Scale (NAS-50), otherOutcomes measure: Change in Polish version of the Procrastination Diagnostic Criteria Questionnaires (PDCQ), otherOutcomes measure: Change in Polish version of Positive and Negative Affect Schedule (PANAS) in relation to a project that the participant decided to work on during the training (e.g. a thesis, an essay, a report), otherOutcomes measure: Polish version of the Group Session Rating Scale (GSRS), otherOutcomes measure: Several items concerning homework compliance (cf. Kazantzis et al., 2005)., otherOutcomes measure: Polish version of the Credibility Expectancy Questionnaire (CEQ), otherOutcomes measure: Polish version of the Negative Effects Questionnaire (NEQ), otherOutcomes measure: Polish version of the Client Satisfaction Questionnaire (CSQ), otherOutcomes measure: fMRI measurements, otherOutcomes measure: Electroencephalography (EEG) measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nencki Institute of Experimental Biology, Polish Academy of Sciences, status: RECRUITING, city: Warsaw, zip: 02-093, country: Poland, contacts name: Marek Wypych, Phd, DSc, role: CONTACT, email: [email protected], geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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protocolSection identificationModule nctId: NCT06357351, orgStudyIdInfo id: VISTA in gingival recession, briefTitle: Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification., conditionsModule conditions: Gingival Recession, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: vestibular incision sub periosteal tunnel access ( VISTA) technique., outcomesModule primaryOutcomes measure: Measuring the recession width in millimeter, primaryOutcomes measure: Measuring the recession depth in millimeter, primaryOutcomes measure: Measuring the width of keratinized gingiva in millimeter, primaryOutcomes measure: Mean of root coverage, secondaryOutcomes measure: Measuring the probing depth, secondaryOutcomes measure: Measuring the plaque index, secondaryOutcomes measure: Measuring the gingival index, secondaryOutcomes measure: Clinical attachment level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mansoura university, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06357338, orgStudyIdInfo id: Soh-Med-24-03-15MS, briefTitle: Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Marwa Mahmoud Hassan, class: OTHER, collaborators name: Qena Oncology Center, descriptionModule briefSummary: Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma, conditionsModule conditions: Invasive Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: role of c-MYC in breast cancer, eligibilityModule sex: FEMALE, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06357325, orgStudyIdInfo id: E-74555795-050.01.04-52290, briefTitle: 2023 Problems Faced by Women Earthquake Survivors in Kahramanmaraş, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-22, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Maltepe University, class: OTHER, descriptionModule briefSummary: Objective:This study was conducted to evaluate the opinions of earthquake victims about the problems affecting women's health physically and psychosocially after the 2023 Kahramanmaraş earthquake.Method:The study was designed in a qualitative type (semi-structured). The population of the study consisted of women affected by the 2023 Kahramanmaraş-Pazarcık earthquake. 15 women were interviewed., conditionsModule conditions: Psychosocial Problem, conditions: Nurse-Patient Relations, conditions: Disaster; Personality, conditions: Gender, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: a qualitative study., outcomesModule primaryOutcomes measure: Personal Information Form, primaryOutcomes measure: A semi-structured interview form, primaryOutcomes measure: consists of questions about changes experienced after the earthquake, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ozeninam, city: Istanbul, state: Maltepe, zip: 34857, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06357312, orgStudyIdInfo id: 2023/11P, briefTitle: Influence of Static Distal Locking of a Short Proximal Femoral Nail, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Elda University Hospital, class: OTHER, descriptionModule briefSummary: Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw., conditionsModule conditions: Hip Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, comparative, randomized and double-blind study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinding of the patient included in the study and the investigator evaluating the results, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: hip trochanteric nail, outcomesModule primaryOutcomes measure: Evaluation of functional status using the Barthel index, secondaryOutcomes measure: Postoperative mechanical complications, secondaryOutcomes measure: Parker mobility scale, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elda University Hospital, status: RECRUITING, city: Elda, state: Comunidad Valenciana, zip: 03600, country: Spain, contacts name: FRANCISCO ANTONIO MIRALLES MUÑOZ, role: CONTACT, phone: 651552115, email: [email protected], geoPoint lat: 38.47783, lon: -0.79157, hasResults: False
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protocolSection identificationModule nctId: NCT06357299, orgStudyIdInfo id: Pro00115060, briefTitle: Assessing Better Bottles for Babies, acronym: AB3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain., conditionsModule conditions: Pediatric Obesity, conditions: Weight Gain Trajectory, conditions: Infant Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 factorial design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Small Bottle Size, interventions name: Standard Bottle Size, interventions name: Clear Bottle, interventions name: Opaque Bottle, outcomesModule primaryOutcomes measure: Conditional weight gain z-score changes (CWGz), secondaryOutcomes measure: Formula volume per feed, secondaryOutcomes measure: Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS), eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357286, orgStudyIdInfo id: IRB0148156, briefTitle: Income Volatility and Mental Health, Pilot Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cornell University, class: OTHER, descriptionModule briefSummary: Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. Our research is the first to assess the causal effects of predictable and unpredictable income instability on the psychological and physical health of the poor. It will advance the scientific knowledge on the effects of economic instability as well as our understanding of health disparities., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Work opportunities, outcomesModule primaryOutcomes measure: Depression, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357273, orgStudyIdInfo id: WhiteTeaAY, briefTitle: The Effect of White Tea Consumption on Obesity, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Recep Tayyip Erdogan University, class: OTHER, descriptionModule briefSummary: Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients., conditionsModule conditions: Obesity, conditions: Obesity; Endocrine, conditions: Obesity Adult Onset, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Weight loss, primaryOutcomes measure: Waist Circumference, primaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Tumor Necrosis Factor - alpha, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Low-Density Lipoprotein cholesterol, secondaryOutcomes measure: High-Density Lipoprotein cholesterol, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Recep Tayyip Erdogan University, city: Rize, zip: 53100, country: Turkey, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False
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protocolSection identificationModule nctId: NCT06357260, orgStudyIdInfo id: Shifa OMR, briefTitle: Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Postgraduate Institute of Dental Sciences Rohtak, class: OTHER, descriptionModule briefSummary: Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated., conditionsModule conditions: Trigeminal Neuralgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Pregabalin and Carbamazepine, interventions name: Carbamazepine, outcomesModule primaryOutcomes measure: VAS score, primaryOutcomes measure: Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory, secondaryOutcomes measure: Patient Global Impression of change(PGI), secondaryOutcomes measure: mean dose of carbamazepine, secondaryOutcomes measure: Liverpool scale, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PGIDS, city: Rohtak, state: Haryana, zip: 124001, country: India, contacts name: DR. Lavina Arya, MDS, role: CONTACT, phone: 09212795285, email: [email protected], contacts name: Dr. Ambika Gupta, MDS, role: CONTACT, phone: 09315903300, email: [email protected], contacts name: Shifa Akhtar, MDS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.89447, lon: 76.58917, hasResults: False
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protocolSection identificationModule nctId: NCT06357247, orgStudyIdInfo id: HM20027093, briefTitle: The Effect of SRS on Hemiplegia in Stroke Survivors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Sensory Threshold, interventions name: Nine Hole Peg Test, interventions name: Semmes Weinstein Monofilament Assessment, outcomesModule primaryOutcomes measure: Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients, secondaryOutcomes measure: Optimal level of stochastic resonance vibration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Commonwealth University, status: RECRUITING, city: Richmond, state: Virginia, zip: 232398, country: United States, contacts name: Virginia Chu, role: CONTACT, phone: 804-828-1564, email: [email protected], geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06357234, orgStudyIdInfo id: APRE-2023, briefTitle: Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: IWK Health Centre, class: OTHER, descriptionModule briefSummary: This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine)., conditionsModule conditions: Spinal Fusion, conditions: Nausea and Vomiting, Postoperative, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized double-blind placebo controlled study, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Treatment arm of participants will be masked until data collection is complete., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Aprepitant, interventions name: Placebo, outcomesModule primaryOutcomes measure: Anti-Nausea Rescue Medication, secondaryOutcomes measure: Anti-nausea rescue medication administered by post-operative day, secondaryOutcomes measure: Emesis (Yes/No), secondaryOutcomes measure: Baxter Retching Faces score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Headache (yes/no), secondaryOutcomes measure: Flatus (yes/no), secondaryOutcomes measure: Bowel Motility (yes/no), secondaryOutcomes measure: Sensation of Itch, secondaryOutcomes measure: Treatment of emergent adverse events, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357221, orgStudyIdInfo id: GLI.04.US.SL.035, briefTitle: A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Galderma R&D, class: INDUSTRY, descriptionModule briefSummary: Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Evaluations of the regimen's efficacy will be conducted at 2 weeks, 4 weeks, and 8 weeks post-baseline., conditionsModule conditions: Plaque Psoriasis, conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cetaphil, outcomesModule primaryOutcomes measure: Change in psoriatic Body Surface Area compared to baseline, primaryOutcomes measure: Change in target lesion severity compared to baseline, primaryOutcomes measure: Change of Physician Global Assessment compared to baseline, primaryOutcomes measure: Change in skin quality measured by macroscopic imaging, primaryOutcomes measure: Subject treatment satisfaction, primaryOutcomes measure: Incidence of psoratic irritation [tolerability assessment], secondaryOutcomes measure: Subject Quality of Life Satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southeast Dermatology Specialists, LLC, status: NOT_YET_RECRUITING, city: Columbus, state: Georgia, zip: 31904, country: United States, contacts name: George F Hougeir, MD, role: CONTACT, phone: 706-568-2700, email: [email protected], contacts name: Moriah Hibbard, role: CONTACT, email: [email protected], contacts name: George F Hougeir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Southeast Dermatology Specialists, LLC, status: NOT_YET_RECRUITING, city: Douglasville, state: Georgia, zip: 30135, country: United States, contacts name: George F Hougeir, MD, role: CONTACT, phone: 678-702-3376, email: [email protected], contacts name: Moriah Hibbard, role: CONTACT, email: [email protected], contacts name: George F Hougeir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.7515, lon: -84.74771, locations facility: Dermatology Consulting Services, status: RECRUITING, city: High Point, state: North Carolina, zip: 27262, country: United States, contacts name: Zoe D Draelos, MD, role: CONTACT, phone: 336-841-2040, email: [email protected], contacts name: Crystal Williams, role: CONTACT, email: [email protected], contacts name: Zoe D Draelos, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.95569, lon: -80.00532, hasResults: False
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protocolSection identificationModule nctId: NCT06357208, orgStudyIdInfo id: 23-AOI-06, secondaryIdInfos id: 2023-A02687-38, type: OTHER, domain: ANSM, briefTitle: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM, acronym: BHBB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: we propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control, conditionsModule conditions: Reproductive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Breathing Control and Retention, outcomesModule primaryOutcomes measure: Rate of stressed patients, secondaryOutcomes measure: STAI Y-A (anxiety state) scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu de Nice, city: Nice, zip: 06003, country: France, contacts name: Valérie BENOIT, role: CONTACT, phone: 0492034702, email: [email protected], contacts name: marion causeret, role: CONTACT, phone: 0492034702, email: [email protected], contacts name: Valérie BENOIT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06357195, orgStudyIdInfo id: 2024H0075, briefTitle: DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?, conditionsModule conditions: Emergency Psychiatric, conditions: Cognition Disorder, conditions: Movement Disorders, conditions: Antipsychotics and Neuroleptics Toxicity, conditions: Dementia With Lewy Bodies, conditions: Alteration in Mental Status, conditions: Behavior, conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Antipsychotic/Benzodiazepine, primaryOutcomes measure: Clinical Indication, secondaryOutcomes measure: Length of Stay, secondaryOutcomes measure: Disposition, secondaryOutcomes measure: Code Status, eligibilityModule sex: ALL, minimumAge: 54 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357182, orgStudyIdInfo id: STUDY00026136, secondaryIdInfos id: NCI-2024-01262, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00026136, type: OTHER, domain: OHSU Knight Cancer Institute, briefTitle: Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2026-03-08, completionDateStruct date: 2026-05-29, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: OHSU Knight Cancer Institute, class: OTHER, collaborators name: Oregon Health and Science University, collaborators name: Oryzon Genomics S.A., descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome/Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The treatment plan starts with a 7 day monotherapy lead-in (Cycle 0 \[C0\]) and then proceeds to combination therapy in 28 day cycles. Disease will be assessed pre-treatment (Screening/Baseline), at the end of monotherapy, in C1 (and C2, if response is not observed in C1), and at the end of alternating cycles, thereafter. A disease assessment will also be conducted within 30 days of the last dose of IADA. Participants that do not achieve response after up to 2 cycles of the triplet regimen will be taken off treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Azacitidine, interventions name: Biospecimen Collection, interventions name: Bone Marrow Biopsy, interventions name: Echocardiography, interventions name: Iadademstat, interventions name: Multigated Acquisition Scan, interventions name: Questionnaire Administration, interventions name: Venetoclax, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels, secondaryOutcomes measure: Percentage of efficacy-evaluable participants achieving composite complete remission (cCR), secondaryOutcomes measure: Percentage of efficacy-evaluable participants achieving an overall response (ORR), secondaryOutcomes measure: Incidence of treatment-emergent grade ≥ 3 adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHSU Knight Cancer Institute, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Curtis A. Lachowiez, role: CONTACT, phone: 503-494-5058, email: [email protected], contacts name: Curtis A. Lachowiez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06357169, orgStudyIdInfo id: Venus Glow, briefTitle: Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-13, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2024-01-13, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared., conditionsModule conditions: Lichen Planopilaris of Scalp, conditions: Alopecia Areata, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Venus Glow, outcomesModule primaryOutcomes measure: scalp microbiome composition, secondaryOutcomes measure: scalp health, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False
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protocolSection identificationModule nctId: NCT06357156, orgStudyIdInfo id: ORAD-621, briefTitle: Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.* Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).* Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.* The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).* CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.* radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.* The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.* Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee, Kim et al, 2014).Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III• Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).After collecting the whole data, statistically will be correlated to the age and gender., conditionsModule conditions: Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 222, type: ESTIMATED, armsInterventionsModule interventions name: CBCT, outcomesModule primaryOutcomes measure: Effect of gender on the mean height of basal bone in the symphysial area, secondaryOutcomes measure: Effect of gender on quantity of the bone in symphysial area: *depth of the bone *width of the bone, secondaryOutcomes measure: Effect of gender on topography of the bone in symphysial area, secondaryOutcomes measure: Effect of age on quantity of the bone in the symphysial area, secondaryOutcomes measure: Effect of age on topography of the bone in symphysial area, secondaryOutcomes measure: Prevalence of mandibular incisive canal, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357143, orgStudyIdInfo id: REMOVE, briefTitle: Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Malaga, class: OTHER, descriptionModule briefSummary: The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients., conditionsModule conditions: Shoulder Fractures, conditions: Prosthesis User, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: REMOVE, interventions name: CONTROL, outcomesModule primaryOutcomes measure: Functionality, secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Kinematics, secondaryOutcomes measure: Strength, secondaryOutcomes measure: Range of movement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06357130, orgStudyIdInfo id: CHUBX 2023/75, briefTitle: Gynaecological Care for Transgender People in France in 2024., acronym: GyneTrans, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people., conditionsModule conditions: Transgender Management Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Percentage of people aware of gynaecological recommendations., secondaryOutcomes measure: Percentage of people aware of cancer risks, secondaryOutcomes measure: Percentage of people aware of contraception in transgender male population, secondaryOutcomes measure: Percentage of people aware of fertility and the impact of hormone treatments, secondaryOutcomes measure: Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Haut-Lévêque, city: Pessac, zip: 33604, country: France, contacts name: Virginie GROUTHIER, MD, role: CONTACT, phone: 05.57.65.60.78, phoneExt: +33, email: [email protected], contacts name: Clara GUINARD, role: CONTACT, phone: 05.57.65.60.78, phoneExt: +33, email: [email protected], geoPoint lat: 44.81011, lon: -0.64129, hasResults: False
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protocolSection identificationModule nctId: NCT06357117, orgStudyIdInfo id: A01263, briefTitle: Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-04-13, primaryCompletionDateStruct date: 2021-12-22, completionDateStruct date: 2021-12-22, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Tsinghua Chang Gung Hospital, class: OTHER, descriptionModule briefSummary: The extent of intrahepatic infiltration of perihilar cholangiocarcinoma (PHCC) remains unclear. This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research. This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy. A whole-mount digital liver pathology system (WDLPS) for hepatectomy specimens greater than 10 × 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC., conditionsModule conditions: Perihilar Cholangiocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 62, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Relapse-free survival (RFS)., secondaryOutcomes measure: Overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 44 Years, maximumAge: 81 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tsinghua Chang Gung Hospital, city: Beijing, state: Beijing, zip: 102218, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06357104, orgStudyIdInfo id: SCI-CT-0001, briefTitle: Detoxification From the Lipid Tract, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-03-14, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Pachankis, Yang I., M.D., class: INDIV, collaborators name: First Affiliated Hospital of Chongqing Medical University, descriptionModule briefSummary: Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study., conditionsModule conditions: COVID-19 Vaccine Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: electroencephalogram biofeedback, interventions name: electrical brain stimulation, interventions name: ultra-low frequency transcranial magnetic stimulation, interventions name: Sertraline Hydrochloride, interventions name: Clonazepam, interventions name: Alprazolam, interventions name: Metoprolol, interventions name: Olanzapine, interventions name: Pravastatin Sodium 20 MG, interventions name: Sacubitril Valsartan Sodium Hydrate, outcomesModule primaryOutcomes measure: Changes in Leukocyte and Components' Quantities, primaryOutcomes measure: Changes in Leukocyte Components' Ratios, primaryOutcomes measure: Quantity Changes in Megakaryocyte-Erythroid Progenitor, primaryOutcomes measure: Changes in Hemoglobin Distribution, primaryOutcomes measure: Changes in Mean Corpuscular Hemoglobin, primaryOutcomes measure: Changes in Hematocrit, primaryOutcomes measure: Changes in Plateletcrit, primaryOutcomes measure: Red cell Distribution Width Coefficient of Variation, primaryOutcomes measure: Changes in Particulate Matter Sizes, primaryOutcomes measure: Changes in Total Lipid Quantities, primaryOutcomes measure: Changes in Apolipoproteina, primaryOutcomes measure: Changes in Lipoprotein (a), secondaryOutcomes measure: Blood Pressure Changes, secondaryOutcomes measure: Heart Rate Changes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Residential Address, city: Chongqing, state: Chongqing, zip: 402762, country: China, geoPoint lat: 29.56278, lon: 106.55278, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2024-03-07, uploadDate: 2024-03-15T00:02, filename: Prot_ICF_000.pdf, size: 479591, hasResults: False
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protocolSection identificationModule nctId: NCT06357091, orgStudyIdInfo id: 1097/2023 ACL-Shark Screw®, briefTitle: ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-06-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Bezirkskrankenhaus Schwaz, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery.the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low, conditionsModule conditions: Anterior Cruciate Ligament Rupture, conditions: Anterior Cruciate Ligament Reconstruction, conditions: Anterior Cruciate Ligament Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: ACL reconstruction with Shark Screw ACL®, interventions name: ACL reconstruction with biocomposite screw (Mecta), outcomesModule primaryOutcomes measure: bone tunnel widening will be measured by CT and/or MRI and measured in mm, secondaryOutcomes measure: International Knee Documentation Committee (IKDC) Scores, secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores, secondaryOutcomes measure: Lysholm Knee Score, secondaryOutcomes measure: Tegner Activity Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H., city: Schwaz, state: Tirol, zip: 6130, country: Austria, contacts name: Alexander Rofner-Moretti, MD, role: CONTACT, phone: +435242, phoneExt: 600, email: [email protected], contacts name: Markus Reichkendler, MD, role: CONTACT, phone: +435242, phoneExt: 600, email: [email protected], geoPoint lat: 47.35169, lon: 11.71014, locations facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H, city: Schwaz, state: Tirol, zip: 6130, country: Austria, contacts name: Alexander Rofner-Moretti, MD, role: CONTACT, phone: +435242600, email: [email protected], contacts name: Markus Reichkendler, MD, role: CONTACT, phone: +435242600, email: [email protected], contacts name: Alexander Rofner-Moretti, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Markus Reichkendler, MD, role: SUB_INVESTIGATOR, contacts name: Boris Tirala, MD, role: SUB_INVESTIGATOR, contacts name: Martin Wallner, MD, role: SUB_INVESTIGATOR, contacts name: Lukas Pöhl, MD, role: SUB_INVESTIGATOR, contacts name: Samuel Dolling, MD, role: SUB_INVESTIGATOR, contacts name: Edith Reches, MD, role: SUB_INVESTIGATOR, contacts name: Clemens Lottersberger, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.35169, lon: 11.71014, hasResults: False
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protocolSection identificationModule nctId: NCT06357078, orgStudyIdInfo id: AmasyaU-NU-679, briefTitle: Art Therapy and Caregivers Stress, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Amasya University, class: OTHER, descriptionModule briefSummary: This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service., conditionsModule conditions: Caregiver Stress Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Art Therapy, outcomesModule primaryOutcomes measure: Distress Thermometer, primaryOutcomes measure: The State Anxiety Inventory, primaryOutcomes measure: Personal Well-Being Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neşe Uysal, status: RECRUITING, city: Amasya, zip: 0500, country: Turkey, contacts name: Neşe Uysal, role: CONTACT, phone: (90)3582181767, email: [email protected], geoPoint lat: 40.65333, lon: 35.83306, hasResults: False
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protocolSection identificationModule nctId: NCT06357065, orgStudyIdInfo id: UCatolicaMaule, secondaryIdInfos id: 11240343, type: OTHER_GRANT, domain: ANID Chile, briefTitle: Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project, acronym: MOV-ES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-20, completionDateStruct date: 2026-12-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Universidad Católica del Maule, class: OTHER, descriptionModule briefSummary: The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions.Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial.Expected results: This project will give rise to the following master\'s and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency., conditionsModule conditions: Physical Inactivity in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study design, setting: This is a cluster randomized field trial aimed to evaluate the previously tested MOV-ES intervention.Population: First year of high school students in a city in south-central Chile. Three secondary schools in the urban area of Talca (1 public, 1 private subsidized, and 1 private non-subsidized) with at least three classes per school year will be randomly selected. This methodological option was adopted because, in Chile, school administration is associated with the socioeconomic level of families., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Randomization and blinding procedures: We invited 6 first-year high school classes to participate and, using a computer-generated procedure, will be randomized to the IG and to CG. The participants will be informed of the result of randomization after they agreed to participate in the study. The nature of the intervention makes its blinding infeasible., whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Active transport educational program based on the ecological model, outcomesModule primaryOutcomes measure: Body composition change (fat mass) by bioimpedance at 16 weeks, primaryOutcomes measure: Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks, primaryOutcomes measure: Changes in Executive Function (inhibition) at 16 weeks, primaryOutcomes measure: Changes in Executive Function (cognitive flexibility) at 16 weeks, primaryOutcomes measure: Changes in executive function (working memory) at 16 weeks, secondaryOutcomes measure: Change from Anthropometric measurements at 16 weeks, secondaryOutcomes measure: Changes in objective physical activity at 16 week, secondaryOutcomes measure: Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks, secondaryOutcomes measure: Change from Physical Fitness (lower body strength) at 16 weeks, secondaryOutcomes measure: Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks, secondaryOutcomes measure: Change from mental health (depression) at 16 weeks, secondaryOutcomes measure: Change from mental health (Anxiety) at 16 weeks, secondaryOutcomes measure: Change from mental health (Stress) at 16 weeks, secondaryOutcomes measure: Changes in overall academic performance once the intervention is completed, secondaryOutcomes measure: Changes in health-related quality of life at 16 weeks, secondaryOutcomes measure: Changes in the Perception of urban environmental characteristics at 16 weeks, secondaryOutcomes measure: Changes in physical activity barriers at 16 weeks, secondaryOutcomes measure: Changes in adherence to physical activity at 16 weeks, secondaryOutcomes measure: Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks., otherOutcomes measure: Sociodemographic evaluations of parents, otherOutcomes measure: Parents' perception of urban environmental characteristics, otherOutcomes measure: Parents' perception of physical fitness, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06357052, orgStudyIdInfo id: 2701, briefTitle: The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), acronym: LINA, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-19, primaryCompletionDateStruct date: 2022-04-30, completionDateStruct date: 2022-11-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation., conditionsModule conditions: NAFLD, conditions: Urinary Lithiasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico A.Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06357039, orgStudyIdInfo id: 09.2023.422, secondaryIdInfos id: 2220124, type: OTHER_GRANT, domain: Scientific and Technological Research Council of Türkiye (TÜBİTAK), secondaryIdInfos id: 1065371, type: OTHER_GRANT, domain: Small and Medium Enterprises Development Organization (KOSGEB), briefTitle: Validation Study of Sleep Tracking Devices, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-21, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2023-07-17, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: PNAPS Health Informatics and Space Technologies Inc., class: OTHER, collaborators name: Analog Devices, descriptionModule briefSummary: In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years., conditionsModule conditions: Sleep, conditions: Sleep Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 305, type: ACTUAL, armsInterventionsModule interventions name: Sleep tracking device, outcomesModule primaryOutcomes measure: Sleep Stages Classification Accuracy, primaryOutcomes measure: Interoception analysis from PPG data collected from facial skin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pnaps Health Informatics and Space Technologies Inc, city: Istanbul, state: Başıbüyük, Maltepe, zip: 34854, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-03-09, uploadDate: 2024-04-04T08:32, filename: Prot_000.pdf, size: 55944, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-03-09, uploadDate: 2024-04-04T04:55, filename: ICF_001.pdf, size: 78393, hasResults: False
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protocolSection identificationModule nctId: NCT06357026, orgStudyIdInfo id: Phitys I -2024, briefTitle: Phitys I™ Percutaneous Left Ventricular Assist System Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shanghai NewMed Medical Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Phigine Medical Technology Co., Ltd., descriptionModule briefSummary: The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous Ventricular Assist System（Phigine Medical）, interventions name: intra-aortic balloon pump (IABP), outcomesModule primaryOutcomes measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE), secondaryOutcomes measure: Incidence of death, secondaryOutcomes measure: Incidence of myocardial infarction, secondaryOutcomes measure: Incidence of stroke, secondaryOutcomes measure: Incidence of target vessel revascularization, secondaryOutcomes measure: Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia, secondaryOutcomes measure: Incidence of acute kidney injury, secondaryOutcomes measure: Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion, secondaryOutcomes measure: Incidence of increasing in aortic insufficiency by more than one grade, secondaryOutcomes measure: Incidence of severe hypotension, secondaryOutcomes measure: Incidence of failure to achieve angiographic success, secondaryOutcomes measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE), secondaryOutcomes measure: Hemodynamic support success rate during PCI procedure, secondaryOutcomes measure: Technical success rate, secondaryOutcomes measure: Procedural success rate, secondaryOutcomes measure: Change in LVEF compared to baseline, secondaryOutcomes measure: Improvement in cardiac function, secondaryOutcomes measure: Evaluation of Experimental device performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Hospital of Jilin University, city: Jilin, state: Changchun, country: China, contacts name: Bin Liu, role: CONTACT, geoPoint lat: 43.85083, lon: 126.56028, locations facility: The First Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, country: China, contacts name: Yue Li, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Henan Provincial Chest Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Yiqiang Yuan, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Renmin Hospital of Wuhan University, city: Wuhan, state: Hubei, country: China, contacts name: Hong Jiang, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Second Xiangya Hospital of Central South University, city: Changsha, state: Hunan, country: China, contacts name: Shenghua Zhou, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: General Hospital of Northern Theater Command, city: Shenyang, state: Liaoning, country: China, contacts name: Yaling Han, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, city: Shanghai, state: Shanghai, country: China, contacts name: Li Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, country: China, contacts name: Mao Chen, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06357013, orgStudyIdInfo id: 2023-40, briefTitle: Postoperative Analgesia in Bilateral Knee Arthroplasties, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Kocaeli City Hospital, class: OTHER_GOV, descriptionModule briefSummary: To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period., conditionsModule conditions: Knee Arthroplasty, Total, conditions: Peripheral Nerve Block, conditions: Pain, Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral Suprainguinal fascia iliaca compartment block, interventions name: Local infiltration analgesia, outcomesModule primaryOutcomes measure: Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli City Hospital, city: Kocaeli, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
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protocolSection identificationModule nctId: NCT06357000, orgStudyIdInfo id: Time from PCI to surgery, briefTitle: Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-01, primaryCompletionDateStruct date: 2018-12-31, completionDateStruct date: 2018-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database., conditionsModule conditions: Coronary Artery Disease, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3621, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Occurence of Bleeding, secondaryOutcomes measure: Occurence of Spontaneous myocardial infarction, secondaryOutcomes measure: Occurence of Repeat revascularization, secondaryOutcomes measure: Occurence of Cancer recurrence, secondaryOutcomes measure: Occurence of All cause death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06356987, orgStudyIdInfo id: 0002, briefTitle: Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children, acronym: Herniotomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: All patients of age 6 month to 12 years with inguinal hernia were included in study.Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis, and postoperative complications, conditionsModule conditions: Inguinal Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 66 patients with inguinal hernia were randomly divided into two groups (A and B), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: 66 patients (33 patients in each group) of laparoscopic extraperitoneal closure and open herniotomy each, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Herniotomy, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: Recurrence, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Muhammad Sharif, city: Lahore, state: Punjab, zip: 53711, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06356974, orgStudyIdInfo id: STROgHAT, briefTitle: Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT), acronym: STROgHAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Drugs for Neglected Diseases, class: OTHER, collaborators name: Institute of Tropical Medicine, Belgium, collaborators name: Institut de Recherche pour le Developpement, collaborators name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, collaborators name: Ministry of Public Health, Democratic Republic of the Congo, descriptionModule briefSummary: This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period.The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative., conditionsModule conditions: Human African Trypanosomiasis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: one-arm, open label, non-randomized, multicentre, phase IIIb study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Treatment of seropositive individuals (positive serology test, but parasitology not confirmed), outcomesModule primaryOutcomes measure: Interruption of transmission of T.b. gambiense, primaryOutcomes measure: Assessment of safety, secondaryOutcomes measure: Economic evaluation, secondaryOutcomes measure: assessment of the performance of several diagnostic tests, eligibilityModule sex: ALL, minimumAge: 11 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356961, orgStudyIdInfo id: 2022Z4BB82, secondaryIdInfos id: 2022Z4BB82, type: OTHER_GRANT, domain: Decreto Direttoriale n. 901 SH4(MUR-PRIN 2022), briefTitle: Routine Outcome Monitoring and Feedback Informed Therapy in Italy, acronym: FIT-ITALY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-10-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Bergamo, class: OTHER, collaborators name: University of Palermo, collaborators name: Politecnico di Milano, collaborators name: Leiden University, collaborators name: University of Ottawa, collaborators name: University of Sheffield, collaborators name: Brigham Young University, descriptionModule briefSummary: The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/).Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables., conditionsModule conditions: Feedback, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training, interventions name: Feedback and ROM (basic), outcomesModule primaryOutcomes measure: Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months), primaryOutcomes measure: Clinical Outcomes in Routine Evaluation-10 (Change in Session by session), primaryOutcomes measure: Working Alliance Inventory-Short Revised-Client (Change in session by session), secondaryOutcomes measure: Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes, secondaryOutcomes measure: Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bergamo (DSUS), city: Bergamo, state: Ita (bg), zip: 24125, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
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protocolSection identificationModule nctId: NCT06356948, orgStudyIdInfo id: H23-02918, briefTitle: Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study., acronym: RateTXA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2027-07-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, descriptionModule briefSummary: Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, randomized, double-blind, non-inferiority trial.Arm 1: Intravenous infusion of TXA 1g (10 mL) administered over 1 minute. Arm 2: Intravenous infusion of TXA 1g (10 mL) administered over 10 minutes, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic Acid (TXA), outcomesModule primaryOutcomes measure: Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups., secondaryOutcomes measure: Incidence of nausea, secondaryOutcomes measure: Incidence of vomiting, secondaryOutcomes measure: Incidence of hypotension, secondaryOutcomes measure: Incidence of hypertension, secondaryOutcomes measure: Incidence of central nervous system side effects, eligibilityModule sex: FEMALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BC Women's Hospital, status: RECRUITING, city: Vancouver, state: British Columbia, zip: V6H3N1, country: Canada, contacts name: Aislynn Sharrock, BA (Hons.), role: CONTACT, phone: 604-875-2158, phoneExt: 6335, email: [email protected], contacts name: Anton Chau, MD MMSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Simon Wydall, MBBS MSc, role: SUB_INVESTIGATOR, contacts name: Juliana Barrera, MD MSc, role: SUB_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, hasResults: False
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protocolSection identificationModule nctId: NCT06356935, orgStudyIdInfo id: HP2024, briefTitle: Effects of Heavy-load Resistance Training, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-17, primaryCompletionDateStruct date: 2023-08-03, completionDateStruct date: 2023-08-03, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: Team Denmark, descriptionModule briefSummary: The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON)., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: RT, interventions name: CON, outcomesModule primaryOutcomes measure: Explosive muscle strength, primaryOutcomes measure: Acceleration capacity, primaryOutcomes measure: Agility performance, primaryOutcomes measure: Jump ability, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Southern Denmark, city: Odense, zip: 5230, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False
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protocolSection identificationModule nctId: NCT06356922, orgStudyIdInfo id: RC20_0123, briefTitle: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia., acronym: PENTILULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2027-05-15, completionDateStruct date: 2027-05-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study., conditionsModule conditions: Acute Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Experimental drug [177Lu]Lu-PentixaTher, outcomesModule primaryOutcomes measure: Safety of RLT using one injection of [177Lu]Lu-PentixaTher, primaryOutcomes measure: Tolerance, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Complete response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Leukemia-free survival, secondaryOutcomes measure: Minimal residual disease, secondaryOutcomes measure: Whole-body biodistribution, secondaryOutcomes measure: Serum uptake, secondaryOutcomes measure: Radiation dosimetry, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Renal safety, secondaryOutcomes measure: Correlation between different cytokines and toxicity, secondaryOutcomes measure: Factors associated response, secondaryOutcomes measure: Exploratory outcome measure = Identification of biological biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Bordeaux, city: Bordeaux, state: Gironde, zip: 33604, country: France, contacts name: DUMAS Pierre-Yves, role: CONTACT, contacts name: [email protected], role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU de Nantes, city: Nantes, state: Loire-Atlantique, zip: 44000, country: France, contacts name: Patrice CHEVALLIER, role: CONTACT, phone: 00332 40 08 39 94, email: [email protected], geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU d'Angers, city: Angers, state: Maine Et Loire, zip: 49100, country: France, contacts name: HUNAULT Mathilde, role: CONTACT, email: [email protected], geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU de Clermont-Ferrand, city: Clermont-Ferrand, state: Puy De Dôme, zip: 63000, country: France, contacts name: MOLUCON Cécile, role: CONTACT, email: [email protected], geoPoint lat: 45.77966, lon: 3.08628, hasResults: False
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protocolSection identificationModule nctId: NCT06356909, orgStudyIdInfo id: SUPREMEneo, briefTitle: Study of PREMEdication Before Laryngoscopy in Neonates in France, acronym: SUPREMEneo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-04-07, completionDateStruct date: 2024-04-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal Creteil, class: OTHER, descriptionModule briefSummary: This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety), conditionsModule conditions: Neonatal Respiratory Distress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Survey of sedo-analgesia practices before laryngoscopy, outcomesModule primaryOutcomes measure: Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement, secondaryOutcomes measure: Molecules used for sedo-analgesia, secondaryOutcomes measure: Cumulative doses of sedo-analgesia used, secondaryOutcomes measure: Questionnaire for the operator describing reasons for non-compliance with best practice guidelines, secondaryOutcomes measure: Numeric rating scale for pain (by operator and assistant), secondaryOutcomes measure: TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment), secondaryOutcomes measure: Side effects related to the premedication, eligibilityModule sex: ALL, minimumAge: 20 Weeks, maximumAge: 44 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Intercommunal de Creteil, status: RECRUITING, city: Creteil, zip: 94000, country: France, contacts name: Manon TAUZIN, MD, role: CONTACT, phone: 0157023458, email: [email protected], geoPoint lat: 48.78333, lon: 2.46667, hasResults: False
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protocolSection identificationModule nctId: NCT06356896, orgStudyIdInfo id: 2023/034, briefTitle: The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery., conditionsModule conditions: Coronary Artery, conditions: Anxiety, conditions: Symptom, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Single (Participant) Single Blinded, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: diaphragmatic breathing exercise, outcomesModule primaryOutcomes measure: cardiovascular surgery symptom inventory, secondaryOutcomes measure: richards champbell sleep quality scale, otherOutcomes measure: state anxiety inventory, otherOutcomes measure: Personal information form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Konya City Hospital, status: RECRUITING, city: Konya, state: Karatay, zip: 42020, country: Turkey, contacts name: Serap SAYAR, PhD, role: CONTACT, phone: 05059102994, email: [email protected], contacts name: Havva Nur YALICI, Nurse, role: CONTACT, phone: 05413386593, email: [email protected], geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06356883, orgStudyIdInfo id: 2024-4938, briefTitle: Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, descriptionModule briefSummary: The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC).Putting together these data will allow to correlate clinical and radiological response to QOL and NC., conditionsModule conditions: Glioblastoma Multiforme, conditions: Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: IA Carboplatin + IA Caelyx, interventions name: IA Carboplatin + IA Etoposide Phosphate, outcomesModule primaryOutcomes measure: Tumor Response on MRI using the RANO Criteria, primaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Median overall survival, secondaryOutcomes measure: Treatment-related toxicity, secondaryOutcomes measure: Per treatment quality of life assessment, secondaryOutcomes measure: Incidence of treatment related Neurocognitive decline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHUS, status: RECRUITING, city: Sherbrooke, state: Quebec, zip: J1H 5N4, country: Canada, contacts name: David Fortin, MD, role: CONTACT, phone: 819-346-1110, phoneExt: 13895, email: [email protected], contacts name: Marie-Andrée Roy, Nurse, role: CONTACT, phone: 819-346-1110, phoneExt: 13895, email: [email protected], geoPoint lat: 45.40008, lon: -71.89908, hasResults: False
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protocolSection identificationModule nctId: NCT06356870, orgStudyIdInfo id: BUE, briefTitle: Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone., acronym: BMAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting, conditionsModule conditions: Alveolar Cleft Grafting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: BMAC MIXED WITH ALLOGRAFT, interventions name: Cancellous bone from anterior iliac crest, outcomesModule primaryOutcomes measure: bone density, secondaryOutcomes measure: Bone gain, secondaryOutcomes measure: Postoperative donor site morbidity, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06356857, orgStudyIdInfo id: H-23070312, briefTitle: Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging, acronym: Heart-Wave, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peter Hovind, class: OTHER, descriptionModule briefSummary: This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI., conditionsModule conditions: Myocardial Blood Flow, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Myocardial perfusion imaging (MPI) using [O15]H2O-PET-CT, outcomesModule primaryOutcomes measure: [O15]H2O-PET-MPI variability and repeatability coefficient estimated from 20 patients having [O15]H2O-PET-MPI done twice, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bispebjerg Hospital, city: Copenhagen, state: RegionH, zip: 2400, country: Denmark, contacts name: Laila Seidelin, MD, role: CONTACT, phone: +4520353008, email: [email protected], contacts name: Martin Krakauer, MD, Phd., role: CONTACT, email: [email protected], contacts name: Laila Seidelin, MD, role: SUB_INVESTIGATOR, contacts name: Martin Krakauer, MD, P.hd, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06356844, orgStudyIdInfo id: 27.02.2023-E.142568, briefTitle: The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months.The primary outcome measure will be changes in protruded/extruded disc size assessed via MRI, with secondary outcomes including pain levels measured by the Numeric Rating Scale (NRS) and serum cytokine levels (IL-6, IL-17, IL-1 beta, TNF-alpha) over the study period.Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain., conditionsModule conditions: Low Back Pain, conditions: Inflammatory Response, conditions: Lumbar Disc Herniation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Resolvin supplement, outcomesModule primaryOutcomes measure: changes in protruded/extruded disc size, secondaryOutcomes measure: Pain intensity score, secondaryOutcomes measure: Cytokine markers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aylin Ceren Şanlı, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Aylin C Sanli, Asist Dr, role: CONTACT, phone: +0905496522412, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, locations facility: Aylin Ceren, status: COMPLETED, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06356831, orgStudyIdInfo id: Endomecryo, briefTitle: National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis, acronym: Endomercyo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal Creteil, class: OTHER, descriptionModule briefSummary: National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team, conditionsModule conditions: Endometriosis, conditions: Cryotherapy Effect, conditions: Surgical, conditions: Radiology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: creation of a national registry for the removal of nodules by cryoablation or surgery for parietal endometriosis, secondaryOutcomes measure: Characterize the epidemiology of parietal endometriosis nodules, secondaryOutcomes measure: Characterize the epidemiology of parietal endometriosis nodules, secondaryOutcomes measure: To assess the impact of hormone treatment on parietal endometriosis, secondaryOutcomes measure: Assess the demographic distribution of parietal endometriosis, secondaryOutcomes measure: Evaluate pre- and post-treatment imaging characteristics of parietal endometriosis, secondaryOutcomes measure: Evaluate the aesthetic impact of the treatments, secondaryOutcomes measure: Assess the complication rate between the two groups, secondaryOutcomes measure: Assess the Severity of Complications according to Society (SIR) of Interventional Radiology or Cardiovascular and Interventional Radiological Society of Europe ( CIRSE) for Radiologists, secondaryOutcomes measure: Assess the Severity of Complications according to Clavien Dindo for the surgeon, secondaryOutcomes measure: Assess the recidivism rate at 3 years, secondaryOutcomes measure: Assess the quality of life between the two groups with PGIC-7 questionnaire, secondaryOutcomes measure: Assess the quality of life between the two groups with asses EHP-5 questionnaire, secondaryOutcomes measure: Assess the quality of life between the two groups with asses EVA questionnaire, secondaryOutcomes measure: Evaluate signal and morphology changes on imaging MRI of parietal endometriosis nodules after cryoablation treatment, secondaryOutcomes measure: Evaluate signal and morphology changes on ultrasound imaging of parietal endometriosis nodules after cryoablation treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Tivoli, city: Bordeaux, country: France, contacts name: Horace ROMAN, role: CONTACT, email: [email protected], geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU bordeaux, city: Bordeau, country: France, geoPoint lat: 48.32158, lon: 3.20107, locations facility: CHU Clermont Ferrand, city: Clermont-Ferrand, country: France, contacts name: Benoit Chauveau, role: CONTACT, email: [email protected], contacts name: Michel CANIS, role: CONTACT, email: [email protected], geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHI Creteil, city: Créteil, country: France, contacts name: Leo RAZAKAMANANTSOA, role: CONTACT, email: [email protected], contacts name: Yann SALHI, role: CONTACT, email: [email protected], geoPoint lat: 48.78333, lon: 2.46667, locations facility: CHU de Lyon, city: Lyon, country: France, contacts name: Ana GJORGJIEVSKA-DELOV, role: CONTACT, email: [email protected], contacts name: Gautier CHENE, role: CONTACT, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, locations facility: APHP Marseille, city: Marseill, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, country: France, contacts name: Cécile VERHEYDEN, role: CONTACT, email: [email protected], contacts name: Claire VINCENS, role: CONTACT, email: [email protected], geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Nime, city: Nîmes, zip: 30000, country: France, geoPoint lat: 43.83333, lon: 4.35, locations facility: AP-HP - Tenon, city: Paris, country: France, contacts name: Milan NAJDAW, role: CONTACT, email: [email protected], contacts name: Yohann DABI, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: AP-HP Hôpital Européen Georges Pompidou, city: Paris, country: France, contacts name: Tom BOEKEN, role: CONTACT, email: [email protected], contacts name: Henri AZAIS, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Cochin-Port Royal, city: Paris, country: France, contacts name: Maxime BARAT, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Strasbourg, city: Strasbourg, country: France, contacts name: Afshin GANGI, role: CONTACT, email: [email protected], contacts name: Emilie FALLER, role: CONTACT, email: [email protected], geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU Toulouse, city: Toulouse, country: France, contacts name: Marie FARUCH, role: CONTACT, email: [email protected], contacts name: Elodie CHANTALAT, role: CONTACT, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, locations facility: CH Valencienne, city: Valenciennes, country: France, contacts name: Thibault POCLET, role: CONTACT, email: [email protected], contacts name: Vassili FAGUE, role: CONTACT, email: [email protected], geoPoint lat: 50.35, lon: 3.53333, hasResults: False
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protocolSection identificationModule nctId: NCT06356818, orgStudyIdInfo id: E-74555795-050.04-941155, briefTitle: Comparison of Virtual Reality and Motor Imagery Applications in Patients With Ankle Instability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: In this study, the effects of different treatment methods for ankle instability patients are being compared aiming to find the optimal treatment. Via comparing virtual reality, motor imagery, and classic rehabilitation programs to clarify their effects on ankle static and dynamic balance, proprioception, range of motion, muscle strength, pain, function and patient satisfaction., conditionsModule conditions: Ankle Sprains, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: three groups with a conventional therapy control group., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Conventional physiotherapy program, interventions name: Virtual reality (VR), interventions name: Motor imagery (MI), outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: Pressure Pain Threshold (PPT), primaryOutcomes measure: Star Excursion Balance Test (SEBT), primaryOutcomes measure: Single Leg Balance Test (SLBT), primaryOutcomes measure: Joint position sense (JPS), primaryOutcomes measure: Range of Motion (ROM), primaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Cumberland ankle instability questionnaire (CAIT), secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul University-Cerrahpasa (IUC), city: Istanbul, country: Turkey, contacts name: Doaa HAKAM, PT, role: CONTACT, phone: +905345456224, email: [email protected], contacts name: YILDIZ AKBABA, Assoc. Prof., role: CONTACT, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06356805, orgStudyIdInfo id: rTMS in Fibromyalgia, briefTitle: rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia, acronym: rTMS, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, collaborators name: Tanta University, descriptionModule briefSummary: the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale., conditionsModule conditions: Treatment Resistant Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: repetitive transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ), secondaryOutcomes measure: 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months), secondaryOutcomes measure: Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT],, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Eman Khedr, city: Assiut, zip: 11517, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06356792, orgStudyIdInfo id: Obstetrics outcome in Abortion, briefTitle: Obstetrics, Prenatal Outcomes in Recurrent Miscarriage, acronym: OBPORPL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2025-03-21, completionDateStruct date: 2025-03-21, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come, conditionsModule conditions: Recurrent Miscarriage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 102, type: ESTIMATED, outcomesModule primaryOutcomes measure: If there's relation between recurrent abortion and having a medical disorder during current pregnancy, eligibilityModule sex: FEMALE, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut University, status: RECRUITING, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06356779, orgStudyIdInfo id: H-23066725, briefTitle: Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease, acronym: OLIGO-DK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2035-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Gitte Fredberg Persson MD PhD, class: OTHER, descriptionModule briefSummary: This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities., conditionsModule conditions: Oligometastatic Disease, conditions: Metastases, conditions: Ablation Techniques, conditions: Radiotherapy, conditions: Stereotactic Radiation, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Local ablative therapy (LAT), outcomesModule primaryOutcomes measure: Time to failure of local ablative therapy (LAT) strategy, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Time to widespread progression, secondaryOutcomes measure: Freedom from systemic treatment, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to progression, secondaryOutcomes measure: Time to local progression, secondaryOutcomes measure: Local lesion control rate at 1- and 3-years post-local ablative therapy, secondaryOutcomes measure: Time to distant progression, secondaryOutcomes measure: Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity, secondaryOutcomes measure: Harms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital Rigshospitalet, status: NOT_YET_RECRUITING, city: Copenhagen, state: Capital Region Of Denmark, zip: 2100, country: Denmark, contacts name: Mette Pøhl, MD PhD, role: CONTACT, contacts name: Mette Pøhl, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maja Maraldo, MD PhD, role: SUB_INVESTIGATOR, contacts name: Morten Suppli, MD PhD, role: SUB_INVESTIGATOR, contacts name: Rene H Petersen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Hans-Christian Pommergaard, MD PhD, role: SUB_INVESTIGATOR, contacts name: Søren Møller, MD PhD, role: SUB_INVESTIGATOR, contacts name: Michael Achiam, MD PhD, role: SUB_INVESTIGATOR, contacts name: Mikkel Rosendahl, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Copenhagen University Hospital Herlev and Gentofte, status: RECRUITING, city: Herlev, state: Capital Region Of Denmark, zip: 2730, country: Denmark, contacts name: Michael RT Laursen, MD, role: CONTACT, phone: +453868 9202, email: [email protected], contacts name: Mette Felter, MD PhD, role: SUB_INVESTIGATOR, contacts name: Henriette Lindberg, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eva Serup-Hansen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Sebastian Krog, MD, role: SUB_INVESTIGATOR, contacts name: Jesper Palshof, MD PhD, role: SUB_INVESTIGATOR, contacts name: Bodil Engelmann, MD PhD, role: SUB_INVESTIGATOR, contacts name: Eva Ellebæk, MD PhD, role: SUB_INVESTIGATOR, contacts name: Lisbet Hölmich, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Hillerød Hospital, status: NOT_YET_RECRUITING, city: Hillerød, state: Capital Region Of Denmark, zip: 3400, country: Denmark, contacts name: Maria Lendorf, role: CONTACT, contacts name: Maria Lendorf, MD PD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.92791, lon: 12.30081, locations facility: Aarhus University Hospital, status: NOT_YET_RECRUITING, city: Aarhus, state: Central Denmark Region, zip: 8200, country: Denmark, contacts name: Mette Marie Fode, MD PhD, role: CONTACT, email: [email protected], contacts name: Mette Marie Fode, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Azza Khalil, MD PhD, role: SUB_INVESTIGATOR, contacts name: Thomas Decker Christensen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Ole Graumann, MD PhD, role: SUB_INVESTIGATOR, contacts name: Jørgen Bjerggaard Jensen, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Gødstrup Hospital, status: NOT_YET_RECRUITING, city: Herning, state: Central Denmark Region, zip: 7400, country: Denmark, contacts name: Trine Øllegaard, role: CONTACT, contacts name: Trine Øllegaard, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.13932, lon: 8.97378, locations facility: Danish Center for Particle Therapy, status: NOT_YET_RECRUITING, city: Aarhus, state: Central Region Denmark, zip: 8200, country: Denmark, contacts name: Britte Weber, MD PhD, role: CONTACT, contacts name: Britta Weber, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Aalborg University Hospital, status: NOT_YET_RECRUITING, city: Aalborg, state: Northern Region Of Denmark, zip: 9000, country: Denmark, contacts name: Jimmy Søndergaard, MD PhD, role: CONTACT, contacts name: Laurids Ø Poulsen, MD PhD, role: CONTACT, contacts name: Jimmi Søndergaard, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laurids Ø Poulsen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Hella Sand, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 57.048, lon: 9.9187, locations facility: Odense University Hospital, status: NOT_YET_RECRUITING, city: Odense, state: Southern Denmark Region, zip: 5000, country: Denmark, contacts name: Tine Schytte, MD PhD, role: CONTACT, contacts name: Tine Schytte, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jørgen Johansen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Christina Nyborg, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Sønderborg Hospital, status: NOT_YET_RECRUITING, city: Sønderborg, state: Southern Denmark Region, zip: 6400, country: Denmark, geoPoint lat: 54.90896, lon: 9.78924, locations facility: Vejle Hospital, status: NOT_YET_RECRUITING, city: Vejle, state: Southern Denmark Region, zip: 7100, country: Denmark, contacts name: Charlotte Kristiansen, MD, role: CONTACT, contacts name: Charlotte Kristiansen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lars Fokdal, MD PhD, role: SUB_INVESTIGATOR, contacts name: Lise Bentzen, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.70927, lon: 9.5357, locations facility: Zealand University Hospital, Roskilde and Næstved, status: NOT_YET_RECRUITING, city: Roskilde, state: Zealand Region, zip: 4000, country: Denmark, contacts name: Julie Gehl, MD DMSc, role: CONTACT, contacts name: Julie Gehl, MD DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False
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protocolSection identificationModule nctId: NCT06356766, orgStudyIdInfo id: 30.01.2024/009, briefTitle: Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-10-08, completionDateStruct date: 2025-04-08, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed., conditionsModule conditions: Zone 2 Flexor Tendon Injuries of the Hand, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation, interventions name: Face-to-face rehabilitation, outcomesModule primaryOutcomes measure: Range of Motion, secondaryOutcomes measure: DASH, secondaryOutcomes measure: Pain of the affected hand, secondaryOutcomes measure: Muscle Strength, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06356753, orgStudyIdInfo id: RC19_0203, briefTitle: EndoxOmics : Exposome, Endometriosis and Fertility, acronym: EndoxOmics, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-01, primaryCompletionDateStruct date: 2021-03-31, completionDateStruct date: 2021-03-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: For several years, the effects of environmental pollution on human health have been a growing concern for the scientific community and public authorities. Among the many known chemical contaminants, persistent organic pollutants (POPs) are of particular concern because of their properties as endocrine disrupters, bioaccumulation and biomagnification. The associations between environmental pollutants, endometriosis and infertility remains poorly understood. The objective of this exploratory non interventional monocentric study conducted in the University Hospital of Nantes, is to identify endogenous molecular profiles associated with endometriosis and related infertility. This project implements an exploratory approach combining exposure and metabolomics approaches based on high-resolution mass spectrometry to identify exposure and metabolomics profiles associated with infertility, and biomarkers for potential prognostic application., conditionsModule conditions: Endometriosis, conditions: Infertility, Female, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 87, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identify endogenous molecular profiles of patients with infertile endometriosis, secondaryOutcomes measure: Characterize the internal chemical exposure profiles and metabolomic profiles in the different groups., secondaryOutcomes measure: Compare the distribution of contaminant concentration levels and metabolomic profiles according to the media measured., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nantes University Hospital, city: Nantes, state: Loire-Atlantique, zip: 44093, country: France, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False
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protocolSection identificationModule nctId: NCT06356740, orgStudyIdInfo id: 69HCL22_0878, secondaryIdInfos id: 2023-508611-22-00, type: CTIS, briefTitle: Efficacy and Tolerance of Abacavir/Lamivudine Treatment in Patients With Systemic Lupus Erythematosus, acronym: PENCIL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2028-11-01, completionDateStruct date: 2029-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Systemic lupus (SL) is a rare chronic autoimmune disease characterized by the production of autoantibodies directed against nuclear antigens, particularly native double-stranded deoxyribonucleic acid (DNA), and excessive production of antiviral cytokines: type I interferons, particularly interferon alpha (IFN-α). IFN-α production results from the excessive detection of nucleic acids (DNA or Ribonucleic Acid (RNA)) by endosomal or intracytoplasmic receptors that are capable of inducing interferon production. The precise mechanisms of cytoplasmic sensor activation remain unknown; however, recent work in the field of interferonopathies suggests a role for human endogenous retroviruses (HERVs). HERVs are remnants of ancient infections caused by exogenous retroviruses integrated into the genome during evolution and represent 8% of the human genome.Several studies have suggested a role for HERVs in the development and maintenance of an excessive immune response in lupus patients and other autoimmune diseases by affecting the type I interferons (I IFN) signalling pathway.To date, none of the approved immunosuppressive drugs for Systemic Lupus Erythematosus (SLE) have been shown to be effective in the background treatment of SL or in preventing relapse. Consequently, there is an urgent need to identify new molecules and therapeutic avenues for disease-modifying therapies.In this study, an innovative therapeutic strategy using a combination of nucleoside reverse transcriptase inhibitors (NRTIs), abacavir/lamivudine, is proposed to treat SLE. Thus, we propose a pilot Phase II, randomized, open-label study using NRTIs in patients with SL in remission or with low clinical activity, and evaluating a biological endpoint (IFN signature), which is a direct proxy for the drug's expected effect.The main objective is to compare the addition of Abacavir/Lamivudine (Add-on) to standard care for 6 months, on the value of the interferon (IFN) transcriptomic signature of patients with systemic lupus with low activity as defined by the Lupus Low Disease Activity State (LLDAS)., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-label randomized, controlled study with 2 parallel arms (Add-on treatment versus standard of care treatment), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, interventions name: Treatment :Abacavir 600 mg/lamivudine 300 mg, interventions name: Lupus Impact Tracker questionnaire, outcomesModule primaryOutcomes measure: Absolute variation in interferon signature (IFN), secondaryOutcomes measure: percentage of patients maintaining LLDAS criteria, secondaryOutcomes measure: number of relapses, secondaryOutcomes measure: anti-native double-stranded DNA quantification, secondaryOutcomes measure: anti-extractable nuclear antigens (anti-ENA) quantification, secondaryOutcomes measure: interferon-α production quantification, secondaryOutcomes measure: Number of successful patients, secondaryOutcomes measure: Cumulative dose of intravenous (IV) corticosteroids, secondaryOutcomes measure: Lupus Impact Tracker questionnaire score, secondaryOutcomes measure: number of missed treatment, secondaryOutcomes measure: number of adverse event (AE), secondaryOutcomes measure: number of serious adverse event (SAE), secondaryOutcomes measure: HERVs transcription quantification, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Groupe Hospitalier Pellegrin-CHU de Bordeaux, city: Bordeaux, zip: 33076, country: France, contacts name: Christophe RICHEZ, MD, PhD, role: CONTACT, phone: 05 56 79 56 79, phoneExt: +33, email: [email protected], contacts name: Christophe RICHEZ, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hôpital Femme-Mère-Enfant (HCL), city: Bron, zip: 69677, country: France, contacts name: Alexandre BELOT, MD, PhD, role: CONTACT, phone: 04 27 85 61 26, phoneExt: +33, email: [email protected], contacts name: Alexandre BELOT, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied, city: Clermont-Ferrand, zip: 63003, country: France, contacts name: Marc ANDRE, MD, PhD, role: CONTACT, phone: 0473751440, phoneExt: +33, email: [email protected], contacts name: Marc ANDRE, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Nord de Grenoble - Albert Michallon, city: Grenoble, zip: 38043, country: France, contacts name: Laurence BOUILLET, MD, PhD, role: CONTACT, phone: 04 76 76 76 40, phoneExt: +33, email: [email protected], contacts name: Laurence BOUILLET, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Hôpital Claude Huriez, city: Lille, zip: 59037, country: France, contacts name: Éric HACHULLA, MD, PhD, role: CONTACT, phone: 03 20 44 56 50, phoneExt: +33, email: [email protected], contacts name: Éric HACHULLA, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Hôpital de la Croix-Rousse (HCL), city: Lyon, zip: 69004, country: France, contacts name: Yvan JAMILLOUX, MD, PhD, role: CONTACT, phone: 0426732636, phoneExt: +33, email: [email protected], contacts name: Yvan JAMILLOUX, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Edouard Herriot (HCL), city: Lyon, zip: 69437, country: France, contacts name: Thomas BARBA, MD, role: CONTACT, phone: 0472119583, phoneExt: +33, email: [email protected], contacts name: Thomas BARBA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Necker-Enfants malades, city: Paris, zip: 75015, country: France, contacts name: Brigitte BADER-MEUNIER, MD, role: CONTACT, phone: 0144494332, phoneExt: +33, email: [email protected], contacts name: Brigitte BADER-MEUNIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Pitié-Salpêtrière, city: Paris, zip: 75651, country: France, contacts name: Zahir AMOURA, MD, PhD, role: CONTACT, phone: 01 42 17 80 01, phoneExt: +33, email: [email protected], contacts name: Zahir AMOURA, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Lyon Sud (HCL), city: Pierre-Bénite, zip: 69310, country: France, contacts name: Mael Richard, MD, role: CONTACT, phone: 0478861352, phoneExt: +33, email: [email protected], contacts name: Mael Richard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.7009, lon: 4.82511, locations facility: CHU de Saint-Etienne - Hôpital Nord, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Martin KILLIAN, MD, PhD, role: CONTACT, phone: 04 77 82 91 79, phoneExt: +33, email: [email protected], contacts name: Martin KILLIAN, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, hasResults: False
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protocolSection identificationModule nctId: NCT06356727, orgStudyIdInfo id: 121CET-MICROREV-DCM, briefTitle: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling, acronym: MICROREV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2030-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Universitaria Integrata Verona, class: OTHER, collaborators name: Abbott Medical Devices, descriptionModule briefSummary: Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance., conditionsModule conditions: Heart Failure, conditions: Left Ventricular Dysfunction, conditions: Idiopathic Dilated Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective multicenter single-arm experimental study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with new diagnoses of dilated cardiomyopathy and clinical indication for coronary angiography. Following this, a multiparametric imaging study with transthoracic echo cardiography will be performed. 12 months after the optimization of medical therapy, the patient will receive a clinical, laboratory and instrumental re-evaluation of transthoracic cardiac color Doppler. The primary endpoint is the recovery of left ventricular function on cardiac imaging. Follow up will continue up to 5 years from enrollment through telephone contacts, outpatient visits and review of clinical data., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Thermodilution based assessment of coronary microcirculation, outcomesModule primaryOutcomes measure: Rate of Left ventricular reverse remodeling (LVRR), secondaryOutcomes measure: Adverse clinical events, secondaryOutcomes measure: Rate of LVRR at cardiac magnetic resonance, secondaryOutcomes measure: Changes in functional capacity at cardiopulmonary exercise test, secondaryOutcomes measure: Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling., secondaryOutcomes measure: Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Universitaria di Ferrara, status: NOT_YET_RECRUITING, city: Ferrara, country: Italy, contacts name: Gianluca Campo, role: CONTACT, contacts name: Elisabetta Tonet, role: CONTACT, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, country: Italy, contacts name: Italo Porto, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele, status: NOT_YET_RECRUITING, city: Milan, country: Italy, contacts name: Matteo Montorfano, role: CONTACT, contacts name: Marco Ancona, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Galeazzi di Sant'Ambrogio IRCCS, status: NOT_YET_RECRUITING, city: Milan, country: Italy, contacts name: Giovanni Monizzi, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: University of Naples Federico II, status: NOT_YET_RECRUITING, city: Naples, country: Italy, contacts name: Giovanni Esposito, role: CONTACT, contacts name: Luigi Di Serafino, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: NOT_YET_RECRUITING, city: Roma, country: Italy, contacts name: Cristina Aurigemma, role: CONTACT, contacts name: Francesco Burzotta, role: CONTACT, contacts name: Antonio M Leone, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Sant'Andrea, status: NOT_YET_RECRUITING, city: Rome, country: Italy, contacts name: Emanuele Barbato, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, status: NOT_YET_RECRUITING, city: Torino, country: Italy, contacts name: Fabrizio D'Ascenzo, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Azienda Ospedaliera Universitaria di Verona, status: RECRUITING, city: Verona, zip: 37126, country: Italy, contacts name: Flavio Ribichini, role: CONTACT, phone: 0039 0458122320, email: [email protected], geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
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protocolSection identificationModule nctId: NCT06356714, orgStudyIdInfo id: 13914704179, briefTitle: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens for the Treatment of Potentially Hazardous Colorectal Cancer SD Status, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sun Jing, class: OTHER, descriptionModule briefSummary: Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world., conditionsModule conditions: Colorectal Cancer, conditions: Colorectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Nocardia Rubra Cell Wall Skeleton in Combination With Prior Second- or Third-line Regimens, outcomesModule primaryOutcomes measure: Progression-free survival(PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective remission rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Incidence and extent of major security incidents, secondaryOutcomes measure: Quality of Life Score (QoL) for tumor patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356701, orgStudyIdInfo id: dongyandl, briefTitle: Tumor Nutritional Therapy in the First-line Treatment of Stage IV NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Dalian Medical University, class: OTHER, descriptionModule briefSummary: A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations, conditionsModule conditions: Long-Term Effects Secondary to Cancer Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cancer nutritional treatment regimen (Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, Ganoderma Spore Oil Soft Capsules), outcomesModule primaryOutcomes measure: PFS, primaryOutcomes measure: Assessment of global disorders in patients with cancer, primaryOutcomes measure: ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DongYan, status: RECRUITING, city: Dalian City, state: Liaoning, zip: 116000, country: China, contacts name: DongYan Dong, role: CONTACT, phone: 18098876750, email: [email protected], hasResults: False
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protocolSection identificationModule nctId: NCT06356688, orgStudyIdInfo id: 13914704178, briefTitle: A Clinical Study on the Efficacy and Safety of Paclitaxel Polymer Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-06-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sun Jing, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (cadonilimab) in combination with platinum-containing chemotherapy (paclitaxel polymer micelles combined with cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with cadonilimab combined with chemotherapy., conditionsModule conditions: Locally Advanced Esophageal Squamous Cell Carcinoma, conditions: Neoadjuvant Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: paclitaxel polymer micelles and cisplatin combined with Camrelizumab, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: paclitaxel polymer micelles and cisplatin combined with Cadonilimab, outcomesModule primaryOutcomes measure: Pathological complete response (pCR) rates, secondaryOutcomes measure: Objective Rate of Effectiveness (ORR), secondaryOutcomes measure: R0 Removal Rate, secondaryOutcomes measure: 2-year overall survival rate, secondaryOutcomes measure: 2-year disease free survival rate, secondaryOutcomes measure: major pathological response (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356675, orgStudyIdInfo id: A single-arm pilot, briefTitle: A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-07-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes., conditionsModule conditions: Advanced NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Anlotinib, outcomesModule primaryOutcomes measure: objective response rate, secondaryOutcomes measure: progression free survival time, secondaryOutcomes measure: over survival time, secondaryOutcomes measure: disease control rate, secondaryOutcomes measure: safety including any grade adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356662, orgStudyIdInfo id: KY-2023-198, briefTitle: Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tenofovir Disoproxil Fumarate, outcomesModule primaryOutcomes measure: UPDRS III（Unified Parkinson's Disease Rating Scale part 3）, secondaryOutcomes measure: Non-Motor Symptom Scale（NMSS）, secondaryOutcomes measure: creatinine(μmoI/L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guohua Zhao, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Zhao Guohua, Doctor, role: CONTACT, phone: +86 13777812308, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06356649, orgStudyIdInfo id: ESOGU2, briefTitle: Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, descriptionModule briefSummary: Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications., conditionsModule conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 199, type: ACTUAL, armsInterventionsModule interventions name: extubation, outcomesModule primaryOutcomes measure: Complications developing during recovery-extubation, secondaryOutcomes measure: hemodynamic changes, secondaryOutcomes measure: hemodynamic data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskisehir Osmangazi University Medical Faculty, city: Eskisehir, state: Odunpazarı, zip: 26040, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False
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protocolSection identificationModule nctId: NCT06356636, orgStudyIdInfo id: P1216/2022, briefTitle: Impact of the Financial Inclusion Improves Sanitation and Health, acronym: FINISH, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Amref Health Africa, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene.Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits., conditionsModule conditions: Health Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants are divided into two or more groups, with each group receiving a different intervention or a control condition. The outcomes of each group are compared at the end of the study to assess the effectiveness of the intervention., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, maskingDescription: to be updated, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1090, type: ESTIMATED, armsInterventionsModule interventions name: Financial Inclusion Improves Sanitation and Health, outcomesModule primaryOutcomes measure: Health outcome, measured as, Proportion of households with diarrhoea occurrence in children under five years, and social outcome measured as proportion of households whose children missed school due to diarrhoea occurrence, eligibilityModule sex: ALL, minimumAge: 0 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Homa Bay county, status: RECRUITING, city: Homa Bay, country: Kenya, contacts name: Martin Dr Muchangi, PhD, role: CONTACT, phone: 0721453712, email: [email protected], geoPoint lat: -0.52731, lon: 34.45714, hasResults: False
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protocolSection identificationModule nctId: NCT06356623, orgStudyIdInfo id: SHDC2202020401, briefTitle: A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2024-08-05, completionDateStruct date: 2024-08-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice., conditionsModule conditions: Nausea and Vomiting, Postoperative, conditions: Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 476, type: ESTIMATED, armsInterventionsModule interventions name: 1, outcomesModule primaryOutcomes measure: Postoperative nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356610, orgStudyIdInfo id: ALCS-REG-23-08-HT, briefTitle: Pharmacokinetic and Subjective Effects of Heated Tobacco Products, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Altria Client Services LLC, class: INDUSTRY, collaborators name: Celerion, descriptionModule briefSummary: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6)., conditionsModule conditions: Tobacco Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK and subjective effects of HTPs (2 menthol varieties, Products A and B; 2 tobacco flavor varieties, Products C and D). The study will include participants' UBCC (Product F) and a nicotine gum (Product E) as high and low abuse liability reference products. Sponsor will prepare the randomization schedule. On Day -1 participants will be randomized at 1:1:1:1:1:1 ratio into 1 of 6 sequences as listed below. At least 60 participants will be randomized to ensure approximately 48 completed participants, with approximately 24 menthol and 24 non-menthol cigarette smokers. Participants will be stratified by sex and cigarette type for each of the sequences. A 6x6 Latin Square with the following sequences will be used for the randomization: Sequence 1 = ABFCED Sequence 2 = BCADFE Sequence 3 = CDBEAF Sequence 4 = DECFBA Sequence 5 = EFDACB Sequence 6 = FAEBDC., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Study participants will know when they are using their UBCC (usual brand combustible cigarette) and the nicotine gum. However, participants will not be informed of which Ploom® HTS (heated tobacco stick) product they are using. Participants will not see the stick or device packaging., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Test Product A, interventions name: Test Product B, interventions name: Test Product C, interventions name: Test Product D, interventions name: Reference Product E, interventions name: Reference Product F, outcomesModule primaryOutcomes measure: Plasma Nicotine Concentration Pharmacokinetic (PK) Measurement, primaryOutcomes measure: Product Liking of Heated Tobacco Products (HTP), primaryOutcomes measure: Tobacco Nicotine Withdrawal Questionnaire, primaryOutcomes measure: Direct Effects of Product Questionnaire, primaryOutcomes measure: Use the Product Again Questionnaire, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire (mCEQ) - Cigarette, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire - HTP, primaryOutcomes measure: Modified Cigarette Evaluation Questionnaire-NRT, primaryOutcomes measure: Product Use for HTP-Units Dispensed, primaryOutcomes measure: Product Use for UBCC-Units Dispensed, primaryOutcomes measure: Product Use for Nicotine Gum-Units Dispensed, primaryOutcomes measure: Product Use for HTP-Puff Count, primaryOutcomes measure: Product Use for UBCC-Puff Count, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-HTP, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-UBCC, primaryOutcomes measure: Physiological Heart Rate (HR) Assessment-Nicotine Gum, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alliance for Multispecialty Research, LLC, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts name: Mark Adams, MD, role: CONTACT, phone: 859-264-8999, email: [email protected], geoPoint lat: 37.98869, lon: -84.47772, locations facility: QPS Bio-Kinetic, status: RECRUITING, city: Springfield, state: Missouri, zip: 65802, country: United States, contacts name: Donald W Burkindine, DO, role: CONTACT, phone: 417-893-6161, email: [email protected], geoPoint lat: 37.21533, lon: -93.29824, locations facility: Alliance for Multispecialty Research, LLC, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: William Smith, MD, role: CONTACT, phone: 865-305-9100, email: [email protected], geoPoint lat: 35.96064, lon: -83.92074, hasResults: False
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protocolSection identificationModule nctId: NCT06356597, orgStudyIdInfo id: KY2024-004-A, briefTitle: Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2027-12-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Jing-yuan Fang, MD, Ph. D, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab with Fruquintinib, Metronidazole, outcomesModule primaryOutcomes measure: objective response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai First People's Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Qi Li, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Ninth People's Hospital, status: NOT_YET_RECRUITING, city: Shanghai, country: China, contacts name: Yanjie Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06356584, orgStudyIdInfo id: SDZLEC2024-078-01, briefTitle: Sintilimab Combined With Fruquintinib/Regorafenib ± Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shandong Cancer Hospital and Institute, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. Despite advancements in first- and second-line treatments, third-line therapies for advanced CRC remain limited, emphasizing the need for novel strategies. This prospective study evaluates the efficacy of combined therapy involving Sintilimab, Fruquintinib/Regorafenib, and radiotherapy in advanced CRC. The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases, each receiving tailored treatment protocols. The primary objectives are to assess progression-free survival (PFS), overall survival (OS), and treatment response rates. Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes. The rationale for this study stems from the intricate interplay between immunotherapy, targeted therapy, and radiotherapy in CRC management. Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy, necessitating a comprehensive approach integrating multiple treatment modalities. Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has shown promise in controlling liver tumors and modulating the tumor microenvironment, potentially enhancing immunotherapy responses. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach. The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics, ultimately improving clinical outcomes in this challenging disease setting., conditionsModule conditions: Colorectal Cancer, conditions: Immunotherapy, conditions: Radiotherapy, conditions: Targeted Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 141, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinbo Yue, status: RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Jin Bo Yue, role: CONTACT, phone: 0531-67626442, phoneExt: 0531-67626442, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06356571, orgStudyIdInfo id: LPS18183, secondaryIdInfos id: U1111-1298-7348, type: OTHER, domain: WHO ICTRP, briefTitle: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma, acronym: SubQSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-11, primaryCompletionDateStruct date: 2027-01-08, completionDateStruct date: 2027-07-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy., conditionsModule conditions: Plasma Cell Myeloma Refractory, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Isatuximab SC-OBDS, interventions name: Montelukast, interventions name: Dexamethasone, interventions name: Acetaminophen, interventions name: Diphenhydramine, interventions name: Methylprednisolone, interventions name: Carfilzomib, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Number of participants with infusion reactions (IRs), secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable), secondaryOutcomes measure: Number of participants with injection site reactions (ISRs), secondaryOutcomes measure: CR or better, secondaryOutcomes measure: VGPR or better, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Time to first response (TT1R), secondaryOutcomes measure: Time to best response (TTBR), secondaryOutcomes measure: Patient experience and Satisfaction Questionnaire v2 (PESQ v2), secondaryOutcomes measure: Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants, secondaryOutcomes measure: Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants, secondaryOutcomes measure: Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356558, orgStudyIdInfo id: IRB-300010279, secondaryIdInfos id: R01CA271303, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA271303, briefTitle: Adapting Enhanced Recovery Programs for Low Health Literacy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-05, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: Low health literacy patients are a vulnerable population at high-risk for surgical disparities including longer hospital stays, more complications, and more readmissions. This study will adapt enhanced recovery programs (ERPs) to low health literacy patients with a multilevel, health literacy-based implementation strategy (called VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) to improve ERP fidelity and thereby outcomes. In the final aim of this project (Specific Aim 3), the VISACT intervention will be tested in a pilot trial. Findings from this study will lay the foundation for a multi-institutional stepped-wedge trial and establish key principles for adapting interventions to eliminate disparities., conditionsModule conditions: Surgery, conditions: Health Knowledge, Attitudes, Practice, conditions: Colorectal Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This pilot study will be a pre-post trial of the intervention (VISACT - VISuAl aids, Coach providers in communication, and Train organizations in health literacy) at 2 sites. This design was selected because the intervention is an implementation strategy and it will not be possible to randomize patients to a non-intervention arm once the VISACT is delivered to a facility. All patients, providers, and organizational units will be subject to downstream effects of VISACT once implemented., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Educational intervention (VISACT), outcomesModule primaryOutcomes measure: Reach - the primary outcome will be to assess the reach of the intervention (VISACT) on patients and providers., secondaryOutcomes measure: Efficacy - Length-of-stay of index surgical hospitalization, secondaryOutcomes measure: Adoption - Completion rate of the intervention (VISACT) by participants per month, secondaryOutcomes measure: Implementation - Fidelity rate of patients with components of the Enhanced Recovery Program, secondaryOutcomes measure: Maintenance - Long-term adoption rate of the intervention (VISACT) per year, secondaryOutcomes measure: Efficacy - Readmission rate, secondaryOutcomes measure: Efficacy - Complications rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356545, orgStudyIdInfo id: OMICS_CODE_01, briefTitle: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Fudan University, class: OTHER, descriptionModule briefSummary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model., conditionsModule conditions: Diarrhea Infantile, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Clinical phenotype of congenital diarrhea and enteropathy in China, secondaryOutcomes measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features, secondaryOutcomes measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 3 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356532, orgStudyIdInfo id: 202312197544, briefTitle: the Intensive Care Unit Diary for Liver Transplant Recipients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: the purpose of this study is to assess the effectiveness of the intensive care unit diary for intensive care unit liver transplant recipients., conditionsModule conditions: Liver Transplant Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants in the control group received the routine care including communication and companionship provided by the nurses of the intensive care unit.The participants in the intervention group received the intensive care unit diary writing and reading. Participants are required to write at least one sentence daily. The primary writers will be the patients themselves, and in cases where patients are unable to write, their family members will write on their behalf. After completion, the diary will be handed over to the patients to review its contents for at least 10 minutes before bedtime, allowing them to write down their immediate reflections and thoughts on when they read. This process will continue until the 14th day post-operation., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Outcomes Assessor is blinded to the group assignments of the patients. She is tasked with collecting the measured outcomes from the patients. Data collection will be conducted by co-principal investigator of the research team. She will distribute the questionnaires at enrollment, and on the 7th and 14th days post-operation. Once notified by the researchers, data collector will distribute and collect the questionnaires. Upon completion, the questionnaires will be sealed in envelopes by the data collectors., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: intensive care unit diary, outcomesModule primaryOutcomes measure: change from baseline in depression on the Depression-Anxiety-Stress scale at post operation day 7 and day 14, primaryOutcomes measure: change from baseline in anxiety on the Depression-Anxiety-Stress scale at post operation day 7 and day 14, primaryOutcomes measure: change from baseline in stress on the Depression-Anxiety-Stress scale at post operation day 7 and day 14, primaryOutcomes measure: change from baseline in sense of coherence on the Sense of Coherence Scale at post operation day 7 and day 14, primaryOutcomes measure: change from baseline in emotional stress on the Brief Symptom Rating Scale at post operation day 7 and day 14, secondaryOutcomes measure: change from baseline in delirium on the intensive care delirium screening checklist at post operation day 1 and day 14, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356519, orgStudyIdInfo id: YOUNGBC-29, briefTitle: Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab Govitecan, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Biyun Wang, role: CONTACT, phone: 18017312387, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06356506, orgStudyIdInfo id: 2022-P2-338-01, briefTitle: A Study on Factors of Biochemical Response in Autoimmune Hepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2034-05-01, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up., conditionsModule conditions: Autoimmune Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 630, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Alanine aminotransferase (ALT) recovery, primaryOutcomes measure: Aspartate transaminase (AST) recovery, primaryOutcomes measure: Immunoglobulin G (IgG) recovery, primaryOutcomes measure: Death, primaryOutcomes measure: Liver transplantaiton, primaryOutcomes measure: Progression to hepatocellular carcinoma (HCC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06356493, orgStudyIdInfo id: OBIIA CMNT, briefTitle: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-02, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Tunis University, class: OTHER, descriptionModule briefSummary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders., conditionsModule conditions: Hemorrhage, conditions: Placenta Accreta Spectrum, conditions: Cesarean Section Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries, interventions name: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries, outcomesModule primaryOutcomes measure: calculated blood loss, primaryOutcomes measure: Transfusion peroperatively, primaryOutcomes measure: Duration of surgery, primaryOutcomes measure: Postoperative hospital stay, primaryOutcomes measure: Postoperative transfer to the intensive care unit, secondaryOutcomes measure: Morbidity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Haithem Aloui, city: Manouba, state: Nabeul, zip: 2010, country: Tunisia, geoPoint lat: 36.80803, lon: 10.09721, locations facility: Haithem Aloui, city: Tunis, state: Nabeul, zip: 2010, country: Tunisia, geoPoint lat: 36.81897, lon: 10.16579, hasResults: False
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protocolSection identificationModule nctId: NCT06356480, orgStudyIdInfo id: 266, briefTitle: 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dr. Muhammad Naeem, class: OTHER, descriptionModule briefSummary: Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds, conditionsModule conditions: Granulation of Chronic Diabetic Wounds, conditions: Diabetic Wounds, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: 1% Acetic acid dressing, outcomesModule primaryOutcomes measure: Early epithelialization and granulation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pak Emirates military hospital, city: Rawalpindi, state: Punjab, country: Pakistan, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
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protocolSection identificationModule nctId: NCT06356467, orgStudyIdInfo id: FARINET, briefTitle: Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs, acronym: FARINET, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated., conditionsModule conditions: Neuroendocrine Tumors, conditions: GEP-NET, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, outcomesModule primaryOutcomes measure: Global Progression Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS OSpedale San Raffaele, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06356454, orgStudyIdInfo id: KAPCON-CR, briefTitle: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-02, primaryCompletionDateStruct date: 2025-06-02, completionDateStruct date: 2025-12-02, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD)., conditionsModule conditions: Physician's Role, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease, outcomesModule primaryOutcomes measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease, eligibilityModule sex: ALL, minimumAge: 32 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356441, orgStudyIdInfo id: B2024-039-01, briefTitle: Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation., conditionsModule conditions: Artificial Intelligence Supported Image Reviewing, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10400, type: ESTIMATED, armsInterventionsModule interventions name: AI, outcomesModule primaryOutcomes measure: sensitivity, secondaryOutcomes measure: specificity, secondaryOutcomes measure: positive predictive value, secondaryOutcomes measure: negative predictive value, secondaryOutcomes measure: total time of interpretation for all the MR images, secondaryOutcomes measure: the rate of discussion with a third radiologist, secondaryOutcomes measure: the detection rate of local recurrence in the AI-supported reading group, secondaryOutcomes measure: the sensitivity in the subgroups of different rT-stage, secondaryOutcomes measure: the incidence of cases whose recurrent risks and contours cannot be provided by the AI model, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Fang-Yun Xie, role: CONTACT, phone: +8602087342926, email: [email protected], contacts name: Pu-Yun OuYang, role: CONTACT, phone: +8602087342926, email: [email protected], contacts name: Fang-Yun Xie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06356428, orgStudyIdInfo id: KARYÖN-DR, briefTitle: Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2025-05-13, completionDateStruct date: 2025-08-13, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties., conditionsModule conditions: Physician's Role, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Physcian Attitudes toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R), outcomesModule primaryOutcomes measure: Physician Attitudes toward Cardiac Rehabilitation and Referral (PACRR)-Revised Scale Score, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356415, orgStudyIdInfo id: Dex Dex in infraclavicular, briefTitle: Infraclavicular Brachial Plexus Block With Bupivacaine Alone or With Both Dexmedetomidine and Dexamethasone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Suez Canal University, class: OTHER, descriptionModule briefSummary: Upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. Many medications have been investigated to extend and enhance long-acting local anesthetics' (LA) analgesic effects. Currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. In general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects., conditionsModule conditions: Upper Extremity Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The sealed-envelope technique will be used. An assistant who is not involved in patient care will make and combine bupivacaine, whether it contains adjuvants or not. Thus, all patients, operators, and outcome assessors remain blinded to the nature of the perineural adjuvant, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine injection, interventions name: Bupivacaine+ Dexamethasone+ Dexmedetomidine, outcomesModule primaryOutcomes measure: Onset of sensory block, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06356402, orgStudyIdInfo id: 8510224SMCPD, briefTitle: An Investigation of the Efficacy of OHEM for Improving Oral Hygiene in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ziauddin University, class: OTHER, collaborators name: Universiti Sains Malaysia, descriptionModule briefSummary: This pilot study evaluates the feasibility of conducting a larger Randomized Controlled Trial to compare three oral health education delivery methods to a control group. Except for the control group, mothers in the three intervention groups will receive the same oral health education based on the OHEM module but differ in the delivery methods, namely lecture, exhibition, and demonstration. All groups will receive a booklet and oral hygiene kits and be instructed to educate their children at home. Pre- and post-intervention assessments include the satisfaction of participants, the researchers' evaluation and cost of the trial, oral hygiene status, and the knowledge of the parents and children., conditionsModule conditions: Dental Plaque, conditions: Gingivitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 540, type: ESTIMATED, armsInterventionsModule interventions name: Oral Health Educational Module for Mothers (OHEM) lecture, interventions name: Oral Health Educational Module for Mothers (OHEM) exhibition, interventions name: Oral Health Educational Module for Mothers (OHEM) demonstration, outcomesModule primaryOutcomes measure: Satisfaction of participants:, primaryOutcomes measure: Recruitment and participation of participants in the study, primaryOutcomes measure: Cost of the trial, secondaryOutcomes measure: Dental plaque scores, secondaryOutcomes measure: Gingival scores, secondaryOutcomes measure: Oral health KAP scores, secondaryOutcomes measure: Oral health behaviors, secondaryOutcomes measure: Oral health-related quality of life using Oral health impact profile-14, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Primary Healthcare Center Gulshan-e-Sikandarabad Shireen Jinnah Colony, city: Karachi, country: Pakistan, contacts name: Sidra Mohiuddin, MDS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06356389, orgStudyIdInfo id: JX11502MA-Ib-II, briefTitle: A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-02, primaryCompletionDateStruct date: 2022-12-27, completionDateStruct date: 2023-01-28, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Zhejiang Jingxin Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Mental Health Center, descriptionModule briefSummary: A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia, conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double-Blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: JX11502MA, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 28, secondaryOutcomes measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Day 28, secondaryOutcomes measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Day 28, secondaryOutcomes measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: Css_min, secondaryOutcomes measure: Css_max, secondaryOutcomes measure: Css_av, secondaryOutcomes measure: AUC0-t,ss, secondaryOutcomes measure: AUC0-∞,ss, secondaryOutcomes measure: AUCtau,ss, secondaryOutcomes measure: t1/2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, state: Shanghai, zip: 201109, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06356376, orgStudyIdInfo id: UAarhus_AGK_MNG_2, briefTitle: The Effects of Pain and Pain Relief on Peripheral Nerve Excitability, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Lundbeck Foundation, descriptionModule briefSummary: This study will assess changes in nerve excitability of C-fibers, and changes in sympathetic or parasympathetic tone, when the subject experiences pain and pain relief.The investigators will continuously measure blood pressure, heart rate, respiration rate, gastric motility, sympathetic skin response and C-fiber excitability while using thermal stimuli before and after an analgesic., conditionsModule conditions: Analgesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Heat Stimulation, outcomesModule primaryOutcomes measure: C-fiber excitability, secondaryOutcomes measure: Action potential duration (ms), secondaryOutcomes measure: Action potential amplitude (V), secondaryOutcomes measure: Heart-rate variability (ms), secondaryOutcomes measure: Blood pressure variability (mmHg), secondaryOutcomes measure: Sympathetic Skin Response (V), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danish Pain Research Center, status: RECRUITING, city: Aarhus N, zip: 8200, country: Denmark, contacts name: Alexander G Kristensen, MD,PhD, role: CONTACT, phone: +45 93 52 28 64, email: [email protected], geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06356363, orgStudyIdInfo id: 2023_RIPH_005_OncoPREMs, briefTitle: Development of a Questionnaire on Patients' Perception of Their Oncology Care Pathway (Onco-PREMs), acronym: OncoPREMs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Institut Jean-Godinot, class: OTHER, collaborators name: Université de Reims Champagne-Ardenne, descriptionModule briefSummary: Healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes.PREMs (Patient Reported Experience Measures) are used to assess how patients feel about their experience of care. PREMs enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes.In oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. While a few initiatives have emerged in the field of PREMs, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: Psychometric validation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356350, orgStudyIdInfo id: IUC_jia_scoliosis_gait, briefTitle: Exercise Programs on Gait in Children With Scoliosis Diagnosed JIA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA., conditionsModule conditions: Scoliosis Idiopathic, conditions: Juvenile Idiopathic Arthritis, conditions: Gait, Frontal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Conventional exercises, interventions name: 3D exercises, outcomesModule primaryOutcomes measure: ATR, primaryOutcomes measure: Cobb angle, primaryOutcomes measure: Maximum Loading, primaryOutcomes measure: Center of mass displacement, primaryOutcomes measure: Walking speed, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul University-Cerrahpasa, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Gökçe Leblebici, role: CONTACT, phone: 05397395718, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06356337, orgStudyIdInfo id: STUDY-22-01199, briefTitle: A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested., conditionsModule conditions: Alzheimer's Disease, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Light goggles, interventions name: Orange glasses, outcomesModule primaryOutcomes measure: Saliva samples for melatonin levels, secondaryOutcomes measure: Light exposure using the Speck, secondaryOutcomes measure: Sleep time using actigraphy, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Light and Health Research Center, status: RECRUITING, city: Menands, state: New York, zip: 12204, country: United States, contacts name: Barbara Plitnick, role: CONTACT, phone: 518-242-4603, email: [email protected], contacts name: Mariana Figueiro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.69202, lon: -73.72456, hasResults: False
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protocolSection identificationModule nctId: NCT06356324, orgStudyIdInfo id: 2021-13347, briefTitle: The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-18, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, descriptionModule briefSummary: This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events.The key questions that are to be answered are:1. Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?, conditionsModule conditions: Anxiety, conditions: Intraoperative Hypertension, conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants assigned to one of three groups: music listening, tv viewing, or control (waiting with ambient noise), primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 650, type: ACTUAL, armsInterventionsModule interventions name: Music Intervention, interventions name: Television Intervention, outcomesModule primaryOutcomes measure: Intraoperative hypertensive event, secondaryOutcomes measure: Change in VAS-A measurements for Anxiety, secondaryOutcomes measure: Change in Heart Rate measurements for Anxiety, secondaryOutcomes measure: Change in Blood pressure measurements for Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center, city: New York, state: New York, zip: 10467, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06356311, orgStudyIdInfo id: 2870-015, secondaryIdInfos id: 2023-505423-31, type: REGISTRY, domain: EU CT, secondaryIdInfos id: U1111-1291-7109, type: OTHER, domain: UTN, secondaryIdInfos id: MK-2870-015, type: OTHER, domain: Merck Id, briefTitle: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-01-04, completionDateStruct date: 2028-05-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS)., conditionsModule conditions: Gastroesophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab tirumotecan, interventions name: Trifluridine-Tipiracil, interventions name: Irinotecan, interventions name: Paclitaxel, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of Participants Who Discontinue Study Intervention Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356298, orgStudyIdInfo id: MCHH_004, briefTitle: Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Maternal and Child Health Hospital of Hubei Province, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA., conditionsModule conditions: Anesthesia Intubation Complication, conditions: Airway, conditions: Adenotonsillectomy, conditions: Children, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Airway Management: Flexible Reinforced Laryngeal Mask Airway, interventions name: Airway Management: Endotracheal Tube, outcomesModule primaryOutcomes measure: Peak airway pressure, primaryOutcomes measure: Petco2, primaryOutcomes measure: Ventilation leakage or not, secondaryOutcomes measure: Mean arterial pressure (MAP), secondaryOutcomes measure: Heart rate (HR), secondaryOutcomes measure: Recovery time, secondaryOutcomes measure: Extubation time, secondaryOutcomes measure: Dosage of anesthetic, secondaryOutcomes measure: Success of FLMA or ETT, secondaryOutcomes measure: Surgeon satisfaction, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Maternal and Child Health Hospital of Hubei Province, city: Wuhan, state: Hubei, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06356285, orgStudyIdInfo id: 6995049, briefTitle: Testing New Ways to Name Antimicrobial Resistance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: The Behavioural Insights Team, descriptionModule briefSummary: This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future. It is known that current ways to name this don't resonate well with the public, and the study team have worked with members of the public through focus groups and community workshops to develop new ways of describing this in a process of co-design. This study aims to test four different ways of presenting this potential crisis to the public, some of which are new communication strategies designed by the public themselves, to evaluate which are the most memorable and investigate the impact on behaviour change.Adults aged over 18, living in the United Kingdom, who have already signed up to a market panel research company will be eligible to participate in this study.Participants will be invited to complete a short online survey (this should take around five minutes), advertised to them by the market research panel they have already signed up to. This survey is completely anonymous, and contains some multiple-choice questions, and some that require a short free text response. At the start of the survey one of the four ways to name AMR will be presented to participants in the form of a poster.This study aims to result in an improved understanding regarding the general public's understanding of antibiotic use and investigate the impact of communication on behaviour change. The data from this study may be used to inform future public health campaigns on this topic and improve the use of antibiotics.This study will be conducted online using the Predictiv platform, an online platform built by the Behavioural Insights Team. The study is being run in collaboration between the Behavioural Insights Team and the Institute of Global Health Innovation at Imperial College London.Is it anticipated that the survey will open in April 2024 and be open until recruitment of 4000 participants is complete. This is expected to take 4-6 weeks., conditionsModule conditions: Antimicrobial Resistance, conditions: Attitude to Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study has been designed as a four-armed online randomised control trial (RCT). This will be conducted using Predictiv, an online platform for running behavioural experiments built by the Behavioural Insights Team The 4,000 participants will be randomised in a 1:1:1:1 ratio to one of four trial arms., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will be blinded to the study arm that they have been assigned to., whoMasked: PARTICIPANT, enrollmentInfo count: 4000, type: ESTIMATED, armsInterventionsModule interventions name: Presentation of Antimicrobial Resistance, outcomesModule primaryOutcomes measure: Attitudes towards Antimicrobial Resistance (Sentiment), secondaryOutcomes measure: Comprehension, secondaryOutcomes measure: Intent, secondaryOutcomes measure: Recall, otherOutcomes measure: Impact on population sub-groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06356272, orgStudyIdInfo id: 19-006036, secondaryIdInfos id: NCI-2024-00965, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19-006036, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Oropharynx (OPX) Biomarker Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-11-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this research is to identify a biomarker that is exists when human papillomavirus (HPV) mediated oropharyngeal squamous cell carcinoma is present and does not exist when HPV mediated oropharyngeal squamous cell carcinoma is absent., conditionsModule conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, conditions: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, conditions: Metastatic Oropharyngeal Squamous Cell Carcinoma, conditions: Oropharyngeal Squamous Cell Carcinoma, conditions: Recurrent Oropharyngeal Squamous Cell Carcinoma, conditions: Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, conditions: Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Change in biomarkers, primaryOutcomes measure: Oncologic outcomes associated with biomarkers, primaryOutcomes measure: Genetic alterations, primaryOutcomes measure: Immunologic biomarkers for predicting progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Diane Vogen, role: CONTACT, phone: 507-266-1247, email: [email protected], contacts name: Kathryn M. Van Abel, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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