Datasets:
hackint0sh
/
Text-Clinical-Records

Dataset card Data Studio Files Community
text
stringlengths
0
197k
Schematically, after recognition of the MHC-peptide complex by the TCR, the T lymphocyte response is modulated by several activating or inhibiting co-stimulatory signals (or "checkpoints"). The balance of these different signals determines whether the T lymphocyte (LT) is activated, resulting in the destruction of the target cell, or whether the T lymphocyte is inhibited (anergy), inducing immune tolerance. By hijacking this system through the expression of inhibitory checkpoints on its surface, the tumour cell is able to evade the effector immune response (1). Monoclonal antibodies (mAbs) directed against inhibitory co-stimulatory molecules such as Programmed-cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) or their ligand Programmed-cell death ligand 1 (PD-L1) have been developed to restore effective anti-tumour immunity. These ICIs have led to a major improvement in the prognosis of certain cancers, notably melanoma and non-small cell lung cancer.
However, the efficacy of ICIs varies from one cancer to another. In addition to the expression of PDL1 by the tumour and/or immune cells, and the mutational load, one of the primary factors predicting response to immunotherapy mentioned in several studies is microsatellite instability (MSI). conditions: Colorectal Cancer Metastatic conditions: Microsatellite Instability-High Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 600 type: ESTIMATED measure: Identification of predictive factors of resistance to pembrolizumab immunotherapy in first-line treatment of unresectable mRCC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ch - Centre Hospitalier de La Côte Basque status: NOT_YET_RECRUITING city: Bayonne CEDEX zip: 64100 country: France name: Franck AUDEMAR, Dr role: CONTACT phone: +33 5 59 44 37 22 email: [email protected] name: Anne GUILNGAR, Dr role: CONTACT phone: +33 5 59 44 37 22 email: [email protected] name: Franck AUDEMAR, Dr role: PRINCIPAL_INVESTIGATOR lat: 43.48333 lon: -1.48333 facility: Ch - Ch Beauvais status: NOT_YET_RECRUITING city: Beauvais country: France name: Fayçal HOCINE role: CONTACT phone: 03 44 11 23 09 email: [email protected] ; [email protected] lat: 49.43333 lon: 2.08333 facility: CH Jean Minjoz status: NOT_YET_RECRUITING city: Besançon zip: 25030 country: France name: Stéfano KIM, Dr role: CONTACT email: [email protected] lat: 47.24878 lon: 6.01815 facility: Polyclinique Saint Privat status: RECRUITING city: Boujan-sur-Libron zip: 34760 country: France name: Michaël HUMMELSBERGER, Dr role: CONTACT email: [email protected] lat: 43.36996 lon: 3.24759 facility: Ch - Duchenne status: NOT_YET_RECRUITING city: Boulogne-sur-Mer country: France name: Vincent BOURGEOIS role: CONTACT phone: 06 84 88 43 37 email: [email protected] name: Vincent BOURGEOIS role: PRINCIPAL_INVESTIGATOR lat: 50.71667 lon: 1.61667 facility: Ch - Centre Hospitalier Metropole Savoie status: NOT_YET_RECRUITING city: Chambéry CEDEX zip: 73011 country: France name: Olivier BERTHELET, Dr role: CONTACT phone: 0479965087 email: [email protected] name: Tarik HABET, Arc Étude role: CONTACT phone: 0479965910 email: [email protected] name: Olivier BERTHELET, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.56667 lon: 5.93333 facility: Ch - Centre Hospitalier de Cholet status: NOT_YET_RECRUITING city: Cholet zip: 49300 country: France name: You-Heng LAM, Dr role: CONTACT phone: 02 41 49 66 79 email: [email protected] name: Laura VALLEE, Arc Étude role: CONTACT phone: 02 41 49 69 91 email: [email protected] name: You-Heng LAM, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: -0.88333 facility: CH - Compiegne status: NOT_YET_RECRUITING city: Compiègne country: France name: Virginie SEBBAGH role: CONTACT phone: 0344236278 email: [email protected] name: Virginie SEBBAGH role: PRINCIPAL_INVESTIGATOR lat: 49.41794 lon: 2.82606 facility: Ch - Chd Vendée status: NOT_YET_RECRUITING city: La Roche-sur-Yon zip: 85925 country: France name: Margot LALY, Dr role: CONTACT phone: +33 2 51 44 61 68 email: [email protected] name: Paul GIROT, Dr role: CONTACT phone: +33 2 51 44 61 68 email: [email protected] name: Margot LALY, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: CH - Louis Pasteur status: NOT_YET_RECRUITING city: Le Coudray country: France name: Sylvie APRELON role: CONTACT phone: 0237303030 email: [email protected] lat: 48.42115 lon: 1.50057 facility: Centre Hospitalier Regional et Universitaire de Lille status: RECRUITING city: Lille zip: 59037 country: France name: ANTONY TURPIN, MD role: CONTACT phone: 0320445461 lat: 50.63297 lon: 3.05858 facility: CH Saint Joseph - Saint Luc status: NOT_YET_RECRUITING city: Lyon zip: 69365 country: France name: Denis PERE VERGE, Dr role: CONTACT email: [email protected]; [email protected] lat: 45.74848 lon: 4.84669 facility: Caluire et Cuire - Infirmerie Protestante de Lyon status: NOT_YET_RECRUITING city: Lyon country: France name: Johannes HARTWIG role: CONTACT email: [email protected] name: Johannes HARTWIG role: PRINCIPAL_INVESTIGATOR name: David TAVAN role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Ch - Hôpital Saint Joseph status: NOT_YET_RECRUITING city: Marseille zip: 13285 country: France name: Hervé PERRIER, Dr role: CONTACT phone: 0491808211 email: [email protected] name: Christelle BASTHISTE-PELE, Dr role: CONTACT phone: 0491808203 email: [email protected] name: Hervé PERRIER, Dr role: PRINCIPAL_INVESTIGATOR name: Christelle BASTHISTE-PELE, Dr role: SUB_INVESTIGATOR name: Patrick BEAURAIN, Dr role: SUB_INVESTIGATOR name: Hélène BRUNETEAU, Dr role: SUB_INVESTIGATOR name: Aurélie CAMOIN, Dr role: SUB_INVESTIGATOR name: Annick CHICOUENE-BRUNELLE, Dr role: SUB_INVESTIGATOR name: Christophe LAPLACE, Dr role: SUB_INVESTIGATOR name: Nadjet SAADALLAH-BOUCHEMOT, Dr role: SUB_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: CH Saint Joseph status: NOT_YET_RECRUITING city: Marseille country: France name: Hervé PERRIER role: CONTACT email: [email protected]; [email protected] name: Hervé PERRIER role: PRINCIPAL_INVESTIGATOR name: Xavier ADHOUTE role: SUB_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Centre Hospitalier status: NOT_YET_RECRUITING city: Mulhouse zip: 68070 country: France name: D. B. Vedrenne, MD role: CONTACT phone: 33-3-8964-7049 lat: 47.75 lon: 7.33333 facility: CHR D'Orleans - Hopital de la Source status: NOT_YET_RECRUITING city: Orleans zip: 45100 country: France name: Jean-Paul Lagasse role: CONTACT phone: 33-02-3651-4704 lat: 47.90289 lon: 1.90389 facility: Prive - Institut Montsouris status: RECRUITING city: Paris country: France name: Raphael COLLE role: CONTACT phone: 0156616035 email: [email protected] name: Emilie SOULARUE role: CONTACT phone: 0633312811 email: [email protected] name: Christophe LOUVET role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Ch - Centre Hospitalier de Soisson status: NOT_YET_RECRUITING city: Soissons CEDEX zip: 02209 country: France name: Sarah MONTEMBAULT, Dr role: CONTACT phone: 0326966859 email: [email protected] name: Valérie PANIS, Arc Étude role: CONTACT phone: 0322824002 email: [email protected] name: Sarah MONTEMBAULT, Dr role: PRINCIPAL_INVESTIGATOR lat: 49.38167 lon: 3.32361 facility: CH - Gustave Dron status: NOT_YET_RECRUITING city: Tourcoing country: France name: Loïc LEBELLEC role: CONTACT phone: 0320694488 email: [email protected] name: Floriane RICHA role: CONTACT phone: 0320694949 email: [email protected] name: Loïc LEBELLEC role: PRINCIPAL_INVESTIGATOR lat: 50.72391 lon: 3.16117 hasResults: False
<|newrecord|> nctId: NCT06353841 id: 2023/435 briefTitle: Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children overallStatus: RECRUITING date: 2023-05-03 date: 2024-05-01 date: 2024-12-31 date: 2024-04-09 date: 2024-04-09 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children. conditions: Functional Constipation conditions: Therapeutic Touch conditions: Infants conditions: Children conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The data analyst will be blinded to the procedure and results of randomization, group allocation, and intervention. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Therapeutic Touch measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Primary Results Follow-up Form measure: Bristol Stool Scale sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: [email protected] name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False
<|newrecord|> nctId: NCT06353828 id: ICBD-UC-01 briefTitle: Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-04-01 date: 2025-04-01 date: 2024-04-09 date: 2024-04-09 name: CannaMore Biotechs class: INDUSTRY briefSummary: Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.
Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: CBD, synthetic form name: Placebo measure: Change from baseline in Full Mayo Score measure: Change in Partial Mayo Score measure: Change in patient reported outcome (PRO-UC) measure: Change in endoscopic Mayo subscore in distal 15 cm of anus measure: Change in the length of the inflamed colon sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Meir Medical Center city: Kfar Saba country: Israel lat: 32.175 lon: 34.90694 hasResults: False
<|newrecord|> nctId: NCT06353815 id: anaesthetic efficacy briefTitle: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-02 date: 2025-06 date: 2024-04-09 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars conditions: Restorative Dental Treatment by Buccal Infiltration Anaesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 44 type: ESTIMATED name: 4% articaine infiltration measure: Success of local anesthesia measure: Child behavior during treatment sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06353802 id: P.T.REC/012/004963 briefTitle: Relationship Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-01 date: 2024-04 date: 2024-05 date: 2024-04-09 date: 2024-04-09 name: Cairo University class: OTHER briefSummary: to investigate the correlation between chronic non-specific neck pain and lumbar reposition sense. conditions: Chronic Non-specific Neck Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 67 type: ACTUAL name: Chronic non-specific neck pain and lumbar reposition sense measure: Correlation Between Chronic Non-Specific Neck Pain And Lumbar Reposition Sense Using iPhone inclinometer app sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Physical Therapy College Cairo University city: Giza zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
<|newrecord|> nctId: NCT06353789 id: RoADPain Clinical Study briefTitle: Adolescent Dysmenorrhoea as a Risk Factor for Chronic Pain: Clinical Cohort Study acronym: RoADPain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-09 date: 2024-04-09 name: University of Oxford class: OTHER name: University of Exeter name: University of York name: Endometriosis UK briefSummary: This study aims to understand whether changes in a variety of body systems which are seen in adult women with period pain are also seen in adolescents in the first few years of having periods. This information will help us to understand 1) how quickly any changes occur, informing clinical practice, and 2) how period pain might lead to other types of chronic pain, potentially allowing development of preventative strategies. conditions: Dysmenorrhea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 132 type: ESTIMATED measure: Quantitative Sensory Testing (QST) measure: Heart rate (HR) measure: Change in heart rate measure: Bladder sensitivity to filling measure: Volume voided at maximum tolerance measure: Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan) measure: Area under the curve (AUC) of single day salivary cortisol profile measure: Change of pressure pain threshold (PPT) measure: fMRI scan sex: FEMALE minimumAge: 11 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06353776 id: 02052023 briefTitle: MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface overallStatus: COMPLETED date: 2023-05-03 date: 2023-10-31 date: 2023-10-31 date: 2024-04-09 date: 2024-04-09 name: University Tunis El Manar class: OTHER briefSummary: MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface. conditions: Conjunctiva conditions: Cornea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ACTUAL name: conjunctival biopsy after micropulse transscleral laser therapy measure: conjunctival inflammation or fibrosis measure: intraocular pression measure: ocular surface disease index score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed Taher Maamouri Hospital city: Nabeul zip: 8000 country: Tunisia lat: 36.45606 lon: 10.73763 hasResults: False
<|newrecord|> nctId: NCT06353763 id: CV briefTitle: Design, Implementation, and Evaluation of Virtual Reality in the Nursing Curriculum overallStatus: COMPLETED date: 2022-02-24 date: 2022-05-30 date: 2022-06-30 date: 2024-04-09 date: 2024-04-09 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: The aim of the study is to determine the effectiveness of an immersive virtual reality learning programme for nursing students, based on virtual glasses, in acquiring the competence (knowledge, skills and attitudes) to care for patients with pressure ulcers, and to compare it with the traditional teaching method.
The design was an exploratory randomised controlled trial. The variables used to measure effectiveness were competence and its attributes: knowledge assessment by a multiple-choice test (Pressure Ulcer Knowledge Assessment Tool, Pukat 2.0 instrument), skill performance by direct observation of procedural skills (simulated cases with standardised patients) and satisfaction and usability assessment (Usefulness, Satisfaction and Ease of Use Questionnaire). conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Participants were blinded in their group assignment. whoMasked: PARTICIPANT count: 127 type: ACTUAL name: Immersive virtual reality learning program measure: Knowledge measure: Skill performance measure: Usefulness, Satisfaction, and Ease of Use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Navarra city: Pamplona state: Navarra country: Spain lat: 42.81687 lon: -1.64323 hasResults: False
<|newrecord|> nctId: NCT06353750 id: 331039 briefTitle: Intracellular Magnesium and Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-02-28 date: 2026-04-25 date: 2024-04-09 date: 2024-04-09 name: University of Oxford class: OTHER name: British Heart Foundation name: Oxford University Hospitals NHS Trust briefSummary: Low magnesium levels are surprisingly common in those with a heart condition known as HFpEF, where the heart pumps well but is too rigid to fill properly with blood. While routine blood tests can check magnesium levels, they don't tell us how much magnesium is actually inside the heart and muscle cells, where it's vital for energy and overall function. Our research aims to get a clearer picture by looking directly at the magnesium inside these cells and understanding its role in the body's energy production and usage. We're also interested in how magnesium levels affect symptoms and the body's handling of sugar. We're using advanced medical imaging techniques, like heart magnetic resonance imaging (MRI) and other heart and muscle function tests, at rest and when the heart is working hard to help answer these questions. We'll compare the magnesium levels inside the cells before and after giving a supplement of magnesium to see if this can make a difference in how the heart and muscles work. conditions: Heart Failure With Preserved Ejection Fraction conditions: Hypomagnesemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: Magnesium supplement measure: Myocardial/ skeletal muscle metabolism and energetics at rest and stress. measure: Serum versus intracellular magnesium concentration measure: Cardiac function measure: Skeletal muscle performance measure: Symptoms measure: Insulin sensitivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oxford Centre for Magnetic Resonance (OCMR) city: Oxford zip: OX3 9DU country: United Kingdom name: Jennifer L Holland, BMBS role: CONTACT email: [email protected] name: Oliver Rider, BM BCh role: CONTACT email: [email protected] lat: 51.75222 lon: -1.25596 hasResults: False
<|newrecord|> nctId: NCT06353737 id: CTO 4489 briefTitle: Looking for Asymptomatic Mpox in a Population at High Risk acronym: LAMP overallStatus: RECRUITING date: 2024-04-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-09 date: 2024-04-18 name: Unity Health Toronto class: OTHER briefSummary: Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature. conditions: Mpox (Monkeypox) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 450 type: ESTIMATED measure: Asymptomatic prevalence measure: Symptomatic prevalence measure: Mpox seropositivity measure: Characteristics measure: Characteristics of seropositivity sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unity Health Toronto status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Reva Persaud role: CONTACT phone: 416-360-4000 phoneExt: 77105 email: [email protected] name: Darrell HS Tan role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<|newrecord|> nctId: NCT06353724 id: RP2218 briefTitle: Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent acronym: stent overallStatus: COMPLETED date: 2019-10-14 date: 2020-10-01 date: 2021-01-01 date: 2024-04-09 date: 2024-04-09 name: Tanta University class: OTHER briefSummary: The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues, salivary PH. The main question it aims to answer are: Does the difference in manufacturing method affect on Healthy tissues, salivary PH.
Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared
* Group A: OPRS was constructed according to the conventional technique.
* Group B: OPRS was constructed digitally using CAD /CAM technology. to evaluate Dosimetric analysis to quantify the radiation dose in OARs, PH of saliva measurement and Mucositis assessment. conditions: Radiotherapy Side Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 16 type: ACTUAL name: conventional oral positioning stent were used during radiation planning and the PTV will be defined and contoured in computed tomography pre irradiation planning name: Digital positioning stent measure: Dosimetric analysis measure: PH of saliva measurement: measure: Mucositis assessment: sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry city: Tanta state: Gharbia zip: 31527 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False
<|newrecord|> nctId: NCT06353711 id: IRB-23-0746 id: R34MH129782 type: NIH link: https://reporter.nih.gov/quickSearch/R34MH129782 briefTitle: CA-LINC Black Youth Suicide Detection and Intervention Study acronym: CA-LINC overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-03 date: 2025-05 date: 2024-04-09 date: 2024-04-10 name: University of North Carolina, Charlotte class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34).
CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards.
CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study. conditions: Suicide conditions: Suicide Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ESTIMATED name: CA-LINC Intervention name: Treatment as Usual measure: Change in Suicide Ideation measure: Change in Suicide Behaviors measure: Treatment Acceptability measure: Change in Therapeutic Alliance measure: Change in Cultural Humility measure: Change in Family Relationships measure: Change in Engagement Behaviors sex: ALL minimumAge: 14 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: The University of North Carolina at Charlotte city: Charlotte state: North Carolina zip: 28223 country: United States name: Sonyia Richardson, PhD role: CONTACT phone: 704-687-7935 email: [email protected] name: Sonyia C Richardson, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False
<|newrecord|> nctId: NCT06353698 id: Nnftri briefTitle: Fasting Mimicking Diet With Chemotherapy in Patients With Leukemia overallStatus: RECRUITING date: 2023-07-02 date: 2024-04-01 date: 2024-05-01 date: 2024-04-09 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: The goal of this clinical trial is to investigate The effect of fasting mimicking diet with chemotherapy on the number of blasts and platelets and quality of life in patients with acute lymphoid leukemia and acute myeloid leukemia. conditions: Fasting Mimicking Diet conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: fasting mimicking diet measure: Blast cell count measure: Quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azita Hekmatdoost status: RECRUITING city: Tehran state: Middle East zip: 19835 country: Iran, Islamic Republic of name: Azita Hekmatdoost, MD, PhD role: CONTACT phone: +989123065084 email: [email protected] lat: 35.69439 lon: 51.42151 facility: Ehsan Hejazi status: RECRUITING city: Tehran zip: 19839-63113 country: Iran, Islamic Republic of name: Ehsan Hejazi, PhD role: CONTACT phone: 00989121530775 email: [email protected] lat: 35.69439 lon: 51.42151 hasResults: False
<|newrecord|> nctId: NCT06353685 id: neo-CHART-HNC briefTitle: De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCR/MPR. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-19 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The prognosis of locally advanced oral squamous cell carcinoma(OSCC ) is poor, and there are still many problems to be solved in the current treatment paradigm. Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC. For patients who achieve pCR and MPR after neoadjuvant therapy and surgery, it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy. Neoadjuvant therapy is an ideal predictor of radiosensitivity. In theory, neoadjuvant therapy can eliminate microscopic lesions, thereby reducing the dose and volume of irradiation.
Continuous hyperfractionated accelerated radiotherapy (CHART, based on hyperfractionated radiotherapy, increasing daily or weekly treatments and shortening the total treatment duration, but reducing the total dose), is to give a higher dose of radiation to tumor tissue in a shorter period of time, so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells. It is beneficial to improve the local control rate of tumor, control the acute injury of normal tissue and the yield acceptable late treatment-related complications. The specific protocol was as follows: high-risk CTV area (CTV1), 45Gy in total, fraction dose of 1.5Gy, twice a day, bioequivalent dose (BED) of 51.75Gy; Low-risk CTV area(CTV2), 39Gy in total , fraction dose of 1.3Gy, twice a day, BED of 44.07Gy; A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks. conditions: De-escalated Radiotherapy; Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 103 type: ESTIMATED name: Continuous, hyperfractionated, accelerated radiotherapy(CHART) measure: 2-year PFS measure: 2-year OS sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06353672 id: RLR-01 briefTitle: A Study to Evaluate Safety and Feasibility of Robotic Liver Resection overallStatus: RECRUITING date: 2020-12-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-09 date: 2024-04-09 name: Zhejiang University class: OTHER briefSummary: The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries.
This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR. conditions: Liver Diseases conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: Robotic liver resection measure: Postoperative complications measure: Postoperative hospital stay measure: Postoperative unplanned reoperation measure: Unplanned readmission sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310003 country: China name: Tingbo Liang, MD,PHD role: CONTACT phone: 086-571-87236688 email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False
<|newrecord|> nctId: NCT06353659 id: M2024077 briefTitle: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-06-30 date: 2026-06-30 date: 2024-04-09 date: 2024-04-09 name: Peking University Third Hospital class: OTHER briefSummary: The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury. conditions: Intensive Care Unit conditions: Acute Kidney Injury conditions: Ultrasound studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Contrast-enhanced Ultrasound measure: Acute kidney injury (according to KDIGO 2012 criteria) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06353646 id: XKY-C-004 briefTitle: XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2026-12 date: 2024-04-09 date: 2024-04-09 name: Wu Wenming class: OTHER name: NeoCura briefSummary: This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: XH001 name: Ipilimumab Injection name: Chemotherapy measure: DFS measure: 1-year DFS rate measure: MFS measure: OS measure: Elispot measure: Adverse Event measure: ctDNA measure: CA19-9 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06353633 id: AHekmatdoost briefTitle: The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-10-20 date: 2024-12-25 date: 2024-04-09 date: 2024-04-09 name: National Nutrition and Food Technology Institute class: OTHER briefSummary: In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: formula name: exclusion diet measure: PCDAI measure: CRP measure: ESR measure: FC measure: Alb measure: Arm Circumferance measure: BMI measure: Height measure: weight sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06353620 id: 1018 briefTitle: Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy overallStatus: RECRUITING date: 2024-02-13 date: 2024-03-18 date: 2027-02-28 date: 2024-04-09 date: 2024-04-09 name: IRCCS Eugenio Medea class: OTHER briefSummary: Recent studies have shown that the aperiodic part of the signal (neuronal avalanches) of electroencephalography (EEG) contains important information about the dynamics of neuronal networks. Indeed, this has helped to identify functionally altered areas in patients with temporal epilepsy by simply using the resting EEG signal. Furthermore, it has been seen that the propagation of neuronal avalanches (VNs) correlates with the morphological organization of the cerebral cortex. Therefore, NAs represent a measure with direct utility for studying functional reorganization pre and post drug/surgical treatment. In addition, the aperiodic portion of the signal may represent a noninvasive measure of the excitation/inhibition relationship, which is known of being altered both in epilepsy and in some rare neurodevelopmental syndromes (example: Angelman and Dup15q) conditions: Epilepsy conditions: Angelman Syndrome conditions: Dup15q Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED name: High Density EEG recording name: Rey Complex Figure Test measure: Differences in the network coherence values in theta and alpha band after treatment measure: Stability of the alpha frequency band in the EEG activity measure: Correlation of neural excitation and memory performance sex: ALL minimumAge: 6 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS E.Medea status: RECRUITING city: Conegliano state: Treviso zip: 31015 country: Italy name: Duma Gian Marco, PhD role: CONTACT phone: +39 0438414248 email: [email protected] lat: 45.88805 lon: 12.30201 hasResults: False
<|newrecord|> nctId: NCT06353607 id: 2023-02267; kt23Berdajs briefTitle: Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm. overallStatus: RECRUITING date: 2024-04-08 date: 2028-12-31 date: 2028-12-31 date: 2024-04-09 date: 2024-04-22 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection. conditions: Acute Aortic Dissection conditions: Thoracic Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 730 type: ESTIMATED measure: Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease. measure: Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology. measure: To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD. measure: To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Denis Berdajs, Prof. Dr. role: CONTACT phone: 0041 61 328 71 80 email: [email protected] name: Islam Salikhanov, Dr. role: CONTACT phone: 0041 61 26 53225 email: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False
<|newrecord|> nctId: NCT06353594 id: COPERNICAN TRIAL briefTitle: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI acronym: COPERNICAN overallStatus: RECRUITING date: 2024-03-11 date: 2026-09 date: 2035-09 date: 2024-04-09 date: 2024-04-09 name: Jorge Sanz Sanchez class: OTHER briefSummary: The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:
* Study group: reduced stent PCI strategy (DCB-based)
* Control group: conventional PCI strategy (DES-based). conditions: ST Elevation Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1272 type: ESTIMATED name: Primary PCI measure: Target lesion failure (TLF) measure: Incidence of all-cause death measure: Incidence of myocardial infarction measure: Incidence of cardiovascular death measure: Incidence of target lesion revascularization measure: Incidence of stent thrombosis measure: Incidence of acute vessel closure measure: Incidence of stroke measure: Incidence of acute kidney injury measure: Incidence of bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Y Politecnico La Fe status: RECRUITING city: Valencia state: Comunidad Valenciana country: Spain name: Jorge Sanz Sánchez, PI role: CONTACT lat: 39.46975 lon: -0.37739 facility: Consorcio Hospitalario Provincial de Castellon status: NOT_YET_RECRUITING city: Castelló country: Spain name: David Tejada Ponce, PI role: CONTACT lat: 41.01149 lon: 0.84856 facility: Hospital General Universitario de Elche status: NOT_YET_RECRUITING city: Elche country: Spain name: Paula Tejedor Viñuela, PI role: CONTACT lat: 38.26218 lon: -0.70107 facility: Hospital Universitari de Bellvitge status: NOT_YET_RECRUITING city: Hospitalet de Llobregat country: Spain name: Neus Salvatella Giralt, PI role: CONTACT lat: 41.35967 lon: 2.10028 facility: Hospital Universitario 12 de Octubre status: NOT_YET_RECRUITING city: Madrid country: Spain name: Fernando Sarnago Cebada, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario de La Princesa status: NOT_YET_RECRUITING city: Madrid country: Spain name: Fernando Rivero Crespo, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Madrid country: Spain name: Juan F Oteo Domínguez, PI role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Regional de Malaga status: NOT_YET_RECRUITING city: Málaga country: Spain name: Cristobal Urbano Carrillo, PI role: CONTACT lat: 36.72016 lon: -4.42034 facility: Hospital Universitario de Navarra status: NOT_YET_RECRUITING city: Pamplona country: Spain name: Guillermo Sánchez Elvira, PI role: CONTACT lat: 42.81687 lon: -1.64323 facility: Hospital Universitario Virgen Del Rocio status: NOT_YET_RECRUITING city: Sevilla country: Spain name: José Díaz Fernández, PI role: CONTACT lat: 37.38283 lon: -5.97317 facility: Hospital Universitari Joan Xxiii de Tarragona status: NOT_YET_RECRUITING city: Tarragona country: Spain name: Mauricio Torres Sánchez, PI role: CONTACT lat: 41.11667 lon: 1.25 facility: Consorcio Hospital General Universitario de Valencia status: RECRUITING city: Valencia country: Spain name: Eva Rumiz González, PI role: CONTACT lat: 39.46975 lon: -0.37739 facility: Hospital Clinico Universitario de Valladolid status: NOT_YET_RECRUITING city: Valladolid country: Spain name: Ignacio J Amat Santos, PI role: CONTACT lat: 41.65518 lon: -4.72372 facility: Hospital Clinico Universitario Lozano Blesa status: NOT_YET_RECRUITING city: Zaragoza country: Spain name: Antonela Lukic Otanovic, PI role: CONTACT lat: 41.65606 lon: -0.87734 facility: Hospital Universitario Miguel Servet status: NOT_YET_RECRUITING city: Zaragoza country: Spain name: Georgina A Fuertes Ferre role: CONTACT lat: 41.65606 lon: -0.87734 hasResults: False
<|newrecord|> nctId: NCT06353581 id: 4-2021-0924 briefTitle: Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-16 date: 2024-05-08 date: 2024-05-08 date: 2024-04-09 date: 2024-04-09 name: Yonsei University class: OTHER briefSummary: Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy. conditions: Locally Advanced Pancreatic Cancer conditions: Metastatic Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 78 type: ACTUAL name: Neulapeg name: Control measure: Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) measure: development of neutropenic fever (febrile neutropenia) measure: relative dose intensity measure: quality of life assessed according to EORTC QLQ-C30 measure: Number of patients experiencing Adverse events (AEs) measure: objective response rate measure: Progression-free survival measure: Overall survival measure: Change in blood cytokine concentrations measure: G-CSF induced bone pain as assessed by questionnaires sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06353568 id: 5.888.210 briefTitle: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2027-10-30 date: 2027-12-30 date: 2024-04-09 date: 2024-04-09 name: University of Nove de Julho class: OTHER briefSummary: This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life). conditions: Diabetic Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over 60 days, and will receive therapeutic education.
The Control Group will use a non-therapeutic LED boot (placebo) for 6 minutes once daily for 60 days and will also receive therapeutic education.
Participants will be assessed at the beginning of the study (baseline) and after 30 days (clinical examination) and 60 days (clinical examination, assessment of Peripheral neuropathy, assessment of peripheral artery disease, blood and urine tests, and quality of life evaluation). primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: * 1 physician-researcher who will conduct all initial evaluations and follow-up examinations (excluding Doppler ultrasound, Ankle-Brachial Index - ABI, and Toe-Brachial Index - TBI), without knowledge of the subjects' allocation, and will administer the Informed Consent Form (ICF).
* 1 Vascular surgeon researcher who will perform Doppler ultrasound, Ankle-Brachial Index (ABI), and Toe-Brachial Index (TBI) measurements during the initial assessment and follow-up examinations, without knowledge of the subjects' allocation.
* 1 Nurse researcher who will retrieve the allocation envelope and provide the appropriate PBM equipment (active or placebo), as well as provide recommendations for its use at home.
* 1 Researcher, who will not participate in any assessments, will prepare randomization and envelopes to ensure allocation confidentiality.
* 2 physician residents who will provide daily contact for device usage control, guidance, addressing inquiries, etc. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Photobiomodulation name: Simulation of Photobiomodulation name: Therapeutic education measure: Ulcer Incidence measure: Ulcer Incidence measure: Ulcer Incidence measure: Tactile sensitivity with Semmes-Weinstein monofilament measure: Tactile sensitivity with Semmes-Weinstein monofilament measure: Vibratory sensitivity measure: Vibratory sensitivity measure: Assessment of Achilles reflex measure: Assessment of Achilles reflex measure: Neuropathy Symptom Score (NSS) measure: Neuropathy Symptom Score (NSS) measure: Neuropathic Impairment Score (NIS) measure: Neuropathic Impairment Score (NIS) measure: Evaluation of the degree of ischemia measure: Evaluation of the degree of ischemia measure: Systolic peak velocity measure: Systolic peak velocity measure: Resistance Index measure: Resistance Index measure: Waveform pattern measure: Waveform pattern measure: Evaluation of claudication measure: Evaluation of claudication measure: Thermography measure: Thermography measure: Quality of Life Assessment measure: Quality of Life Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06353555 id: PUMCH-20240311 briefTitle: Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage overallStatus: RECRUITING date: 2023-10-11 date: 2025-06-01 date: 2025-12-31 date: 2024-04-09 date: 2024-04-09 name: Peking Union Medical College Hospital class: OTHER briefSummary: Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.
Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.
As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.
The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.
This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism. conditions: Intracerebral Hemorrhage conditions: Low T3 Syndrome conditions: Neurocritical Care conditions: Hormone Replacement Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Euthyrox name: Euthyrox measure: blood pressure measure: cerebral blood flow dynamics measure: Whether to use vasoactive vasopressors measure: neurological function measure: Days of the patients received intensive care measure: Mechanical ventilation time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking union medical college hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Junji Wei role: CONTACT phone: +8615801056698 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06353542 id: HCB/2023/1206 id: PI23/01856 type: OTHER domain: Institut d'Investigacions Biomèdiques August Pi i Sunyer briefTitle: Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS) acronym: BEGAS overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-03 date: 2026-09 date: 2024-04-09 date: 2024-04-09 name: Hospital Clinic of Barcelona class: OTHER briefSummary: Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care.
Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP).
The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist.
In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis.
This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them.
Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 500 type: ESTIMATED name: Software analysis name: Ophthalmologist examination measure: Diagnostic agreement between the AI software and the ophthalmic examination measure: Health-Related Quality of Life (HRQoL) measure: Demographics measure: Intraocular pressure measure: Optical coherence tomography (OCT) measure: Visual field measure: Cost-effective analysis of both screening methods measure: Risk score with parameters associated with positive screening of glaucoma sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic - ICOF city: Barcelona zip: 08028 country: Spain name: Nestor Ventura Abreu, MD, PhD role: CONTACT phone: +34932275400 phoneExt: 9336 email: [email protected] name: Marta Pazos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<|newrecord|> nctId: NCT06353529 id: 17065 briefTitle: Sphenopalatine Ganglion Block for Postop Pain Management acronym: SPGB overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-09 date: 2024-04-09 name: Hamilton Health Sciences Corporation class: OTHER briefSummary: To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. The aim is to improve patient outcomes and reduce the need for pain medication after surgery. conditions: Pituitary conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution name: Placebo measure: Post-operative pain score measure: Post-operative bleeding measure: Post-operative complications measure: Analgesic requirement measure: Length of stay sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hamilton General Hospital city: Hamilton state: Ontario zip: L8L 2X2 country: Canada name: Dr. Kesava Reddy, MD role: CONTACT phone: 905-521-2100 email: [email protected] name: Ms. Jessy Moore, MSc role: CONTACT phone: 289-686-8827 email: [email protected] lat: 43.25011 lon: -79.84963 hasResults: False
<|newrecord|> nctId: NCT06353516 id: 2310-117-126 briefTitle: The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients overallStatus: RECRUITING date: 2024-02-14 date: 2024-09 date: 2024-12 date: 2024-04-09 date: 2024-04-09 name: Chung-Ang University Gwangmyeong Hospital class: OTHER name: National Research Foundation of Korea briefSummary: The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:
* \[Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?\]
* \[Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?\] Participants will be anesthetized with different categories of anesthetics.
* Intravenous anesthetics
* Inhalation gas anesthetics conditions: Postoperative Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: This study is a double-blinded randomized controlled trial. The group assignment is conducted by the pre-generated random number table. The participant, investigator and the outcome assessor are blinded to the group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Propofol name: Sevoflurane measure: Concentration of serum S100B levels measure: Incidence of Delirium measure: Incidence of Postoperative Cognitive Dysfunction measure: Concentration of serum albumin measure: Concentration of serum CRP measure: Concentration of serum IL6 levels measure: Concentration of serum TNFα levels measure: Concentration of cerebrospinal fluid (CSF) albumin sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung-Ang University Gwangmyeong Hospital status: RECRUITING city: Gwangmyeong state: Gyeonggi-do zip: 14353 country: Korea, Republic of name: Wongook Wi, M.D. role: CONTACT phone: 02-2222-1553 email: [email protected] hasResults: False
<|newrecord|> nctId: NCT06353503 id: KAZ briefTitle: Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment. overallStatus: RECRUITING date: 2024-04-02 date: 2024-09-27 date: 2024-09-27 date: 2024-04-09 date: 2024-04-09 name: abdulmajeed hammadi class: INDUSTRY briefSummary: A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia. conditions: Anterior Cruciate Ligament Tear studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single armed study open label primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: autologous bone marrow aspirate concentrate measure: Functional recovery by clinical assessments of the ACL and overall knee joint stability. measure: magnetic resonance imaging of the knee joint sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Ministry of Health status: RECRUITING city: Baghdad zip: 964 country: Iraq name: thamer A alrubaie, MD role: CONTACT phone: +9647700009294 email: [email protected] lat: 33.34058 lon: 44.40088 hasResults: False
<|newrecord|> nctId: NCT06353490 id: Geon-111001 briefTitle: The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers overallStatus: ACTIVE_NOT_RECRUITING date: 2022-08-12 date: 2023-11-08 date: 2024-08-11 date: 2024-04-09 date: 2024-04-09 name: Geon Corporation class: INDUSTRY briefSummary: Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.
The main objectives of this study are:
1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
2. To verify the consistency of repeated measurements of investigational devices. conditions: Febrile conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: Infrared Forehead Thermometer (GE-TF03) name: Infrared Ear Thermometer (GE-TE06) name: Electronic Thermometer (MT-B321FB) name: Electronic Thermometer (MT-B231) measure: Clinical Bias measure: Limits of Agreement measure: Clinical Repeatability sex: ALL maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hsinchu MacKay Memorial Hospital city: Hsinchu country: Taiwan lat: 24.80361 lon: 120.96861 facility: HsinChu Municipal MacKay Memorial Hospital city: Hsinchu country: Taiwan lat: 24.80361 lon: 120.96861 hasResults: False
<|newrecord|> nctId: NCT06353477 id: EOU 2019-10 briefTitle: Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option overallStatus: COMPLETED date: 2019-06-01 date: 2022-06-01 date: 2023-01-01 date: 2024-04-09 date: 2024-04-09 name: Eskisehir Osmangazi University class: OTHER name: Abdi Ibrahim Ilac San. ve Tic A.S. briefSummary: This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children. conditions: Hand, Foot, and Mouth Disease studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: EPs® 7630 is an extract from the roots of Pelargonium sidoides, drug-extract ratio 1 : 8-10, extraction solvent ethanol 11% (w/w). The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route \[Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children \>12 years of age)\] for 7 days and (ii) group 2 (control group) did not receive any herbal medication. The medication was administered orally, at least 30 minutes before or after meals. Patients in both groups were prescribed paracetamol (10 mg/kg/dose, 4 times a day, maximum 4,000 mg/day.) as an antipyretic agent. Temperature measurement was made at home and in the hospital via the axillary route. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ACTUAL name: EPs® 7630 measure: the patient's fever status, restlessness, inappetence, and sleeplessness scores sex: ALL minimumAge: 1 Year maximumAge: 10 Years stdAges: CHILD facility: Istinye University Medicine Faculty Hospital city: Esenyurt state: İstanbul zip: 34517 country: Turkey lat: 41.02697 lon: 28.67732 hasResults: False
<|newrecord|> nctId: NCT06353464 id: 2306009984 briefTitle: A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation acronym: OPBIM overallStatus: RECRUITING date: 2023-10-04 date: 2025-09 date: 2025-09 date: 2024-04-09 date: 2024-04-09 name: Drexel University class: OTHER briefSummary: This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: individuals consume two distinct preloads at separate sessions primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants consume two preloads one at each visit, but are not informed which preload is being consumed on which test visit. count: 80 type: ESTIMATED name: Ensure and Water measure: Grams of pizza consumed measure: Baseline medial prefrontal cortex oxygenated hemoglobin measure: Baseline lateral prefrontal cortex oxygenated hemoglobin measure: medial prefrontal cortex Oxygenated hemoglobin concentration measure: lateral prefrontal cortex Oxygenated hemoglobin concentration measure: medial prefrontal cortex Time to Peak Light Intensity measure: lateral prefrontal cortex Time to Peak Light Intensity measure: Preload Oxygenated Hemoglobin Difference sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Drexel University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Principal Investigator, PhD RD role: CONTACT phone: 267-359-6287 email: [email protected] lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06353451 id: EK GZ 67/2021-2024 briefTitle: Digital Detox Study: A Randomized Controlled Trial overallStatus: COMPLETED date: 2023-10-23 date: 2024-01-21 date: 2024-01-21 date: 2024-04-09 date: 2024-04-09 name: Danube University Krems class: OTHER briefSummary: The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students.
After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).
Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI).
The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline. conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, non blinded, randomized controlled trial primaryPurpose: PREVENTION masking: NONE count: 111 type: ACTUAL name: Digital Detox measure: Depressive Symptoms measure: Stress measure: Sleep Quality measure: Well-being measure: Problematic smartphone use measure: Body Appreciation measure: Anxiety Symptoms measure: Eating Disorder measure: Physical Activity measure: Heart rate variability (HRV) measure: Resting Heart Rate (RHR) measure: Screen time sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: Danube University Krems city: Krems state: Lower Austria zip: 3500 country: Austria lat: 48.40921 lon: 15.61415 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-08 uploadDate: 2024-03-26T06:01 filename: Prot_SAP_000.pdf size: 251127 hasResults: False