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Found 10 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Age: 18Years +All GendersPhase 3
229 locations
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Actively Recruiting

Researchers are evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

Age: 18Years +All GendersPhase 3
259 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan I-DXd in adults with various recurrent or metastatic solid tumors. These tumor types include endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 IHC 0 breast cancer, cutaneous melanoma, and neuroendocrine carcinoma. The study includes multiple phases to assess treatment effects and safety in these diverse groups. Participants receive I-DXd via intravenous infusion, typically dosed at 12 milligrams per kilogram, except in hepatocellular carcinoma where the dose is determined separately. The study is divided into three parts Stage 1, Stage 2, and an optional Stage 3 expansion for endometrial cancer, depending on safety and efficacy results. Each participant starts at Stage 1 and may continue to Stage 2 based on observed data. The hepatocellular carcinoma group includes a safety run-in phase to evaluate tolerability. Participants engage in regular assessments including imaging scans to measure tumor response and disease progression. Researchers monitor treatment-related side effects and collect blood samples to study how the drug behaves in the body over time. The studys main goal is to measure the objective response rate up to about 60 months after the first dose. Safety evaluations continue during treatment and for 47 days after the last dose. Participants may remain in the study for up to five years to track long-term outcomes and overall survival.

Age: 18Years +All GendersPhase 1Phase 2
120 locations
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Actively Recruiting

Researchers are evaluating the safety and efficacy of nemtabrutinib in adults with various blood cancers, including chronic lymphocytic leukemia CLL, small lymphocytic lymphoma SLL, Richters transformation, marginal zone lymphoma MZL, mantle cell lymphoma MCL, follicular lymphoma FL, and Waldenstrms macroglobulinemia WM. The study is a phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC, designed to explore how well nemtabrutinib works and its safety profile in these hematologic malignancies. The study has two parts Part 1 focuses on dose escalation and confirmation to identify the recommended phase 2 dose, while Part 2 involves cohort expansion across eight disease-specific groups. Participants take nemtabrutinib tablets orally once daily until their disease progresses or they stop treatment. This approach allows researchers to assess responses across different types of blood cancer and treatment histories. Participants will be involved in regular assessments including monitoring for adverse events, evaluating response rates using established criteria for each disease type, and biomarker analysis from biopsies or bone marrow samples. Safety and response will be tracked over several months, up to about five to six years. The study also monitors drug levels in the body and collects detailed data on how participants tolerate the treatment during this period.

Age: 18Years +All GendersPhase 2
120 locations
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Actively Recruiting

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.

Age: 18Years +All GendersPhase 3
215 locations
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Actively Recruiting

Researchers are studying patients aged 12 to 85 who experience dizziness and balance problems due to peripheral vestibular hypofunction. The study aims to explore the relationship between the degree of vestibular hypofunction and the results of various vestibular and balance tests applied in a clinical setting. This investigation is sponsored by Istanbul Medipol University Hospital and involves diagnostic assessments rather than treatment interventions. Participants will undergo evaluations including demographic forms covering personal and clinical information, vestibular tests, and balance tests. Diagnosis is confirmed by videonystagmography VNG following an ENT physicians decision, and the degree of hypofunction will be recorded. The study includes tests such as the Unterberger Test, Dynamic Visual Acuity, Head Thrust Test, Timed Balance Tests, and questionnaires like the Dizziness Handicap Inventory and Tampa Kinesiophobia Scale. Throughout the approximately two-month study period, participants will complete these assessments at regular intervals. Researchers will collect and analyze data on balance and vestibular function to determine any correlations with hypofunction levels. Safety monitoring is not specifically mentioned, but participants are evaluated in a clinical setting, and their participation includes completing forms and performance tests to assess their condition comprehensively.

Age: 12Years - 85YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are studying the Turkish version of the General Sleep Disturbance Scale GSDS-T to evaluate its validity and reliability in patients with multiple sclerosis MS. The GSDS-T assesses difficulties falling asleep, waking during sleep, overall sleep quality, and daytime alertness. Although the scale has been validated in Turkish stroke patients, this study aims to confirm its accuracy specifically for MS patients. This observational study involves 126 participants diagnosed with MS. The GSDS-T, consisting of 21 questions, will be administered along with the Pittsburgh Sleep Quality Index PSQI, a validated Turkish tool for assessing sleep quality. To measure test-retest reliability, these scales will be repeated after 15 days. Participants will complete the sleep disturbance and sleep quality assessments at baseline and again two weeks later. The study monitors and compares these results to evaluate the GSDS-Ts consistency and accuracy in this population. The total participation timeline includes the initial assessment and a follow-up after 15 days to review changes or stability in responses.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

Researchers are comparing the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone for people with metastatic non-small cell lung cancer NSCLC who have high PD-L1 expression 50% or more. The study aims to see if the combination improves overall survival compared to pembrolizumab by itself. This is a Phase 3 clinical trial focusing on first-line treatment in this patient group. Participants receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone. Sacituzumab tirumotecan is given by intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, while pembrolizumab is given by intravenous infusion every 6 weeks for up to 18 cycles. Supportive medications such as diphenhydramine, acetaminophen, dexamethasone, and H2 antagonists are used before some infusions to manage side effects. Participants who complete the first pembrolizumab course and show disease progression may be eligible for additional pembrolizumab cycles. Throughout the trial, participants will have regular assessments including scans and evaluations to measure overall survival and other outcomes such as progression-free survival, tumor response, and quality of life. Researchers will also monitor symptoms like cough, chest pain, and breathing difficulties. Safety is closely followed over up to approximately 77 months, with detailed data collected on adverse events and treatment discontinuation. The total participation duration can last several years depending on individual progress and treatment response.

Age: 18Years +All GendersPhase 3
220 locations
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Actively Recruiting

This trial investigates the efficacy and safety of inavolisib combined with fulvestrant in adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have previously been treated with a cyclin-dependent kinase inhibitor. The study compares two different doses of inavolisib given with fulvestrant in this specific group of patients to assess treatment outcomes. Participants receive oral inavolisib tablets alongside intramuscular injections of fulvestrant. The study is randomized and open-label, with two experimental groups receiving different doses of inavolisib plus fulvestrant. Treatment and assessments continue for up to approximately two years to evaluate various outcomes. During the study, participants will undergo regular assessments including tumor response evaluations, safety monitoring for adverse events, and patient-reported outcomes on treatment side effects and quality of life. Researchers will track objective response rates, duration and time to response, progression-free survival, treatment discontinuations due to side effects, and symptom changes over time. The total participation may last up to five years, including follow-up assessments after primary treatment completion.

Age: 18Years +All GendersPhase 2
31 locations
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Actively Recruiting

Researchers are evaluating the Turkish version of the Situational Vertigo Questionnaire SVQ to determine its validity and reliability for assessing dizziness symptoms often triggered by visual or environmental factors in people with vestibular conditions. The study is designed as a methodological scale adaptation and psychometric evaluation involving adults aged 18 and older who experience situational dizziness and can read Turkish. The Turkish adaptation process involves a detailed back-and-forth translation method to ensure linguistic and cultural accuracy. After developing a preliminary Turkish version, a pilot test with 20 participants will assess clarity, followed by revisions as needed. The final version will be used in a larger group to evaluate its psychometric properties. Participants will complete the SVQ along with other assessments such as the Dizziness Handicap Inventory DHI, Vertigo Symptom Scale VSS, and a Visual Analog Scale VAS for satisfaction. A subgroup will retake the SVQ after 7-14 days to assess test-retest reliability. Participants will provide written consent and complete surveys on their dizziness symptoms and related factors like medical history and daily activities. Researchers will collect detailed sociodemographic and clinical data to support analysis. No invasive procedures are involved. The main outcome measure is the SVQ score at baseline and follow-up, with secondary measures including DHI and VSS scores. Data confidentiality will be maintained, and findings are expected to support clinical evaluations by providing a reliable dizziness assessment tool in Turkish.

Age: 18Years +All Genders
1 location