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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.
Actively Recruiting
Researchers are evaluating metabolic improvements in people diagnosed with Alzheimers Disease through a dietary supplement called CMA2, which includes N-acetyl-L-cysteine, L-carnitine-L-tartrate, nicotinamide, and L-serine. This Phase 3, randomized, double-blinded, placebo-controlled study involves about 676 participants and is conducted at multiple clinical sites in Turkey. The study aims to understand how these supplements affect cognition and daily living activities in Alzheimers patients. Participants will be randomly assigned to take either CMA2 or a placebo twice daily for 26 weeks. The supplement is given as a soluble powder with a strawberry flavor, taken after breakfast and dinner. The first dose is given at the clinic with a two-hour observation for allergic reactions. Those who cannot tolerate the supplement will be withdrawn. The study includes four clinic visits screening, start of treatment, mid-treatment at 13 weeks, and end of treatment at 26 weeks. Monthly phone calls will check medication use, health status, and any side effects. During the study, participants will undergo tests including cognitive assessments ADAS-Cog, MMSE, daily living activity scales ADCS-ADL, and blood sample collections for advanced analyses. Optional samples of saliva, feces, and cerebrospinal fluid may be collected for further research. Researchers will monitor safety through various blood tests and vital signs. The main outcome measured is the change in cognitive function by the ADAS-Cog score over the 26 weeks.
Actively Recruiting
Healthy Volunteer
Researchers are investigating dental caries and oral hygiene status in children aged 7 to 12 years who have specific learning disabilities SLD and comparing their dental health with healthy children. The study aims to understand differences in tooth decay and oral hygiene habits between these two groups. Children diagnosed with SLD will be compared to healthy children without psychiatric diagnoses. Both groups will undergo detailed dental exams measuring decay experience dmftDMFT, caries severity ICDAS II, plaque levels, and gum health Gingival Index. Questionnaires will also assess oral hygiene routines, dietary habits, and parental supervision during tooth brushing. Participants will attend a single clinical examination where all dental assessments will be done. Researchers will collect information on plaque and gum health, tooth decay, and oral hygiene practices using questionnaires. The study will measure these outcomes at one point in time to better understand dental health differences in children with and without specific learning disabilities.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating how consuming acidic drinks like lemon juice and apple cider vinegar with starchy foods affects blood sugar levels and feelings of fullness in healthy adults aged 18 to 35. The study aims to understand whether these drinks can slow the rise in blood sugar after meals, compare their effectiveness, and assess if different amounts change their impact. This research focuses on practical dietary choices that might help manage blood sugar and support metabolic health. Participants will consume white bread in the morning on an empty stomach alongside one of several drinks plain water, water with either 50 g or 100 g of lemon juice, or water with 10 g or 20 g of apple cider vinegar. Each participant will have a one-week break between tests. The study uses a randomized design to compare the different acidic beverages and doses. During each test day, participants will have their blood sugar measured at regular intervals for three hours after eating. They will also report their feelings of fullness using a simple scale. Researchers will track post-meal blood glucose levels, including peak levels and total glucose response over time. The study includes measures of appetite and glucose increase rate to evaluate how these drinks affect digestion and satiety.
Actively Recruiting
Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.
Actively Recruiting
Healthy Volunteer
This research aims to assess how effective toothbrushing education is at helping children aged 7 to 12 years with specific learning disabilities SLD remove dental plaque. It also compares their plaque removal skills with those of healthy children. The study focuses on improving oral hygiene habits and reducing plaque, a key factor in dental diseases, using a structured education approach tailored to children with learning challenges. Participants receive standardized toothbrushing education involving visual cards and videos based on the Modified Bass technique. This includes practical instructions, mirror-assisted self-modeling, and parent involvement. Standard toothbrushes and toothpaste are provided, and plaque removal is measured using plaque-disclosing agents, intraoral photos taken before and after brushing, and quantitative analysis software. The study lasts for two weeks with follow-up assessments. During the two-week period, children brush their teeth under parental supervision using the taught method. Assessments at the start and end include Plaque Index, Gingival Index, plaque disclosure, and photo-based plaque analysis to evaluate improvements. The studys findings aim to help develop personalized oral hygiene education for children with SLD and support advanced plaque analysis techniques in pediatric dentistry.
Actively Recruiting
Healthy Volunteer
This research aims to compare levels of specific salivary biomarkersIL-6, MMP-8, MMP-9, and TIMP-1between healthy children and children with active dental caries. The study focuses on understanding the role of inflammation and tissue breakdown in caries progression and evaluates how 5% sodium fluoride NaF varnish and 2% chlorhexidine CHX affect these biomarkers in caries prevention among children aged 6 to 8 years. Participants are divided into four groups one receiving 5% NaF varnish, another receiving 2% CHX followed by 5% NaF varnish, a group receiving standard oral hygiene education, and a control group of caries-free children with no intervention. Applications involve drying teeth, applying varnish or solution with specific timings, and parental instructions to limit water and hard food intake for an hour post-application. Saliva samples are collected at baseline, 30 minutes after application, and after one month, with the control group sampled only once at baseline. Children and their parents provide informed consent, and samples are processed and stored under controlled conditions. Researchers measure changes in the salivary biomarkers using approved ELISA kits, with data analyzed statistically to assess differences between groups and over time. The study includes clinical assessments, oral hygiene education, and follow-up saliva collections, aiming to link biomarker changes to clinical findings over the study period ending in June 2027.