hackint0sh/New-Dataset huggingface dataset:
Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group). conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Virtual Interview Training (VIT) name: Services-as-usual measure: Competitive Employment based on self-report employment surveys measure: Change in Job Interview Skills from Mock Interview Rating Scale (MIRS) measure: Change in Job Interview Skills from Measure of Job Interview Skills (MOJO-iSkills) measure: Time to Employment measure: Vocational Index Score measure: Vocational Index Score measure: Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA) measure: Change in Interview Motivation measure: Change in Social Responsiveness using the Social Responsiveness Scale 2nd version (SRS-2) measure: Change in Job Search Behavior using the Job Search Behavior Scale (JSBS) measure: Change in Work Readiness using the Work Readiness Scale (WRS) measure: Change in Work Motivation using the Work Motivation Scale (WMS) measure: Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) measure: Change in Interview Knowledge sex: ALL minimumAge: 16 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: The San Diego State University city: San Diego state: California zip: 92182 country: United States lat: 32.71533 lon: -117.15726 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Disability Network Wayne County city: Detroit state: Michigan zip: 48235 country: United States lat: 42.33143 lon: -83.04575 facility: Lincoln Park city: Lincoln Park state: Michigan zip: 48146 country: United States lat: 42.25059 lon: -83.17854 hasResults: False
nctId: NCT06291220 id: M24-291 id: 2023-507637-19 type: OTHER domain: EU CT briefTitle: A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2029-07-21 date: 2029-07-21 date: 2024-03-04 date: 2024-03-04 name: AbbVie class: INDUSTRY briefSummary: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.
ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.
Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Obinutuzumab name: ABBV-453 measure: Part A and B: Percentage of Participants With Adverse Events (AEs) measure: Part A: Maximum Administered Dose (MAD) of ABBV-453 measure: Part A: Maximum Tolerated Dose (MTD) of ABBV-453 measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453 measure: Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453 measure: Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453 measure: Part A and B: Overall Response Rate (ORR) measure: Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better measure: Part A and B: Complete response rate (CRR) measure: Part A and B: Duration of Complete Response (DOCR) measure: Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi measure: Part A and B: Progression-free survival (PFS) measure: Part A and B: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06291207 id: AD-224P3 briefTitle: A Study to Evaluate the Efficacy and Safety of AD-224 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-04 date: 2024-03-06 name: Addpharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-224 conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: AD-224A name: AD-224B name: AD-224C name: Placebo of AD-224A name: Placebo of AD-224B name: Placebo of AD-224C measure: Change rate of MSSBP sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06291194 id: 22DE30902 briefTitle: Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients overallStatus: RECRUITING date: 2023-11-10 date: 2024-05 date: 2024-05 date: 2024-03-04 date: 2024-04-08 name: AJU Pharm Co., Ltd. class: INDUSTRY name: GL Pharm Tech Corporation briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 396 type: ESTIMATED name: AJU-S56 5% name: Placebo Group(Vehicle) measure: Total corneal staining score (TCSS) measure: LGCSS measure: TFBUT sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AJU Pharm Co., Ltd. status: RECRUITING city: Seoul country: Korea, Republic of name: JUNGMIN LEE role: CONTACT phone: +82-02-2630-0700 email: ajuf13001@ajupharm.co.kr lat: 37.566 lon: 126.9784 hasResults: False
nctId: NCT06291181 id: Soh-Med-24-01-05MD briefTitle: Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-03-04 date: 2024-03-04 name: Sohag University class: OTHER briefSummary: Staphylococcus aureus is an important pathogen causing a wide spectrum of infections . The organism usually colonizes the skin and mucous of humans and several animal species. Multiple body sites can be colonized in humans, however, the anterior nares of the nose are the most frequent carriage site for S. aureus. Other sites for carriage include the skin, perineum, and pharynx . It has been shown that there is an increased prevalence of staphylococcus infections, which may be attributed to its carriage in anterior nares and hands of health care workers and patients .
Antibiotic resistance associated with S.aureus infections is a great concern for the clinicians to prevent spread of infections. Methicillin was commonly used for these infections before the emergence of MRSA which is developed due to irrational use of antibiotics, prolonged hospital stay, nasal and hand carriage in health care staff. Also vancomycin, linezolid and mupirocin are used in treating infections,as well as decolonization of carriers .
Linezolid resistance is mediated by, mutations in the 23S rRNA gene, altering the drug-binding site, and/or the 50S ribosomal proteins L3, L4 and L22, impairing linezolid binding;,Oracquisition of the primarily plasmid-encoded genes cfr, encoding a methyltransferase, or optrA, encoding an ABC transporter, or the cfr homologues cfr(B) and cfr(C).
There are 2 classes of virulence factors regulated by agr. The first class includes virulence factors implicated in attachment to the host and immune evasion, whereas the second class contains genes engaged in the production of exoproteins related to invasion and toxin production . The activation of the agr system switches the bacterium from an adhesive, colonizing commensal into an invasive and aggressive pathogen(Roux A et al; 2009).
Major virulence factors in S. aureus, exfoliative toxins (ETs), toxic shock syndrome toxin (TSST-1), and staphylococcal enterotoxins (SEs) are involved in host colonization, invasion of damaged skin and mucus, gastrointestinal infection, and prevarication of host defense mechanisms. Indeed, agr operon including agrA, agrB, agrC, and agrD genes regulate over 70 genes in S. aureus 23 of which control its pathogenicity and invasive infections .
Moreover, S. aureus can be stratified into 4 different groups (agr I, agr II, agr III, and agr IV) according to the sequences of agrC (auto inducing peptide) and agrD (cyclic AIP) genes. It is stated that agr types are different in their properties and prevalence in various geographical areas thus, identification of predominant types in each region may well be functional . conditions: Staphylococcus Aureus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 265 type: ACTUAL name: antibiotic sensitivity test measure: resistence of staphylococci to mupirocin and linezolid antibiotics sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
nctId: NCT06291168 id: CMT002 briefTitle: Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain acronym: CTESMYCLBP overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-06-01 date: 2024-03-04 date: 2024-03-04 name: SEFA HAKTAN HATIK class: OTHER briefSummary: The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain. conditions: Low Back Pain conditions: Spinal Manipulation conditions: Yoga studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 60 participants will be divided into three groups. These groups will be randomly divided into three groups as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). Exercise programs will be performed under the supervision of a physiotherapist. Chiropractic manipulation will be applied to the lumbar region and sacroiliac joint in the side lying position. Data will be analyzed in SPSS 29.0 IBM program. Kruskal-Wallis H test will be used for difference analysis between groups, Kruskal-Wallis H test will be used for comparisons between groups by taking the differences between measurement times and the significance level will be determined as p\<0.05. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) name: Yoga-Based Exercise Program name: Conventional Exercises measure: Numeric Rating Scale (NRS) measure: Roland-Morris Disability Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: Range of Motion (ROM) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06291155 id: HUM00222335 briefTitle: Renal Mechanism of SGLT2 Inhibition overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-06-30 date: 2024-03-04 date: 2024-03-04 name: University of Michigan class: OTHER name: University of Colorado, Denver name: Renal Pre-Competitive Consortium (RPC3) briefSummary: The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.
Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples. conditions: Type 2 Diabetes conditions: Diabetic Kidney Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, non-randomized mechanistic trial of an FDA-approved drug primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: SGLT2 inhibitor measure: Glomerular basement membrane (GBM) width and mesangial expansion measure: Kidney Transcript Changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Chrysta C Lienczewski, BS role: CONTACT phone: 734-615-5021 email: boridley@umich.edu name: Markus Bitzer, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
nctId: NCT06291142 id: R129030 id: IRAS 315004 type: OTHER domain: IRAS briefTitle: Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot overallStatus: ENROLLING_BY_INVITATION date: 2023-11-22 date: 2024-09 date: 2025-03 date: 2024-03-04 date: 2024-03-08 name: University of Manchester class: OTHER name: National Institute for Health Research, United Kingdom name: Royal Bolton Hospital NHS Foundation Trust name: Alder Hey Children's NHS Foundation Trust name: University Hospitals of Morecambe Bay NHS Trust name: Stockport NHS Foundation Trust name: Medway NHS Foundation Trust name: Northern Care Alliance NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust briefSummary: The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:
Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report. conditions: Systemic Sclerosis conditions: Raynaud Phenomenon studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Observation - Nailfold capillaroscopy measure: Pilot Image Acquisition measure: Qualitative Feedback measure: Skin tone sub-study data set sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Care Alliance NHS Foundation Trust city: Salford zip: M6 8HD country: United Kingdom lat: 53.48771 lon: -2.29042 hasResults: False
nctId: NCT06291129 id: CAAE: 61347422.4.0000.5626 briefTitle: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-30 date: 2023-10-30 date: 2024-10-30 date: 2024-03-04 date: 2024-03-04 name: Universidade Federal Fluminense class: OTHER briefSummary: Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test. conditions: Gingivitis conditions: Periodontal Diseases conditions: Diabetes conditions: Diabetes Mellitus, Type 1 conditions: Malocclusion conditions: Malocclusion in Children studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Periodontal therapy measure: Bleeding on probing sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidade Federal Fluminense city: Nova Friburgo state: Rio De Janeiro zip: 28625650 country: Brazil lat: -22.28194 lon: -42.53111 hasResults: False
nctId: NCT06291116 id: 2022/0345/HP briefTitle: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease acronym: ETERNAL-PKD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2029-05-01 date: 2029-05-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.
Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).
This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact. conditions: Kidney Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: standard care + rotigotine at 4 mg/24h for 24 months. name: standard care for 24 months. measure: Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
nctId: NCT06291103 id: 2022/0342/HP briefTitle: Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) acronym: BELA-M-R overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2031-03-01 date: 2031-03-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, we published a retrospective multicenter study within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, we did not observe any effect of standard of care treatment in active sABMR. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. They concluded the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, we propose to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.