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Found 11 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating metastatic colorectal cancer mCRC patients who have a specific genetic change called the BRAFV600E mutation. This rare subtype of mCRC often shows poor response to current treatments and has a generally poor outlook. The study aims to collect detailed clinical data and biological samples to better understand this condition, including how patients respond to treatments and what factors predict their survival. It focuses on real-world treatment outcomes and biological markers that might influence therapy choices and resistance. Participants will provide blood samples at multiple times during their treatment, including before and during the first three treatment cycles, at 3 and 6 months after starting each treatment line, and when disease progression occurs following certain therapies. The study gathers up to 390 mL of blood per participant over time to analyze circulating tumor DNA and immune environment factors. This observational approach will help researchers identify biomarkers related to treatment response and disease progression. During the study, participants clinical progress and survival will be tracked for up to five years. Researchers will review overall survival from diagnosis to death and assess how prognostic markers relate to progression-free survival and response to treatments. The study involves collecting tumor tissue samples and blood tests, along with routine follow-up visits. All data collected will contribute to understanding BRAFV600E mCRC and improving future treatment strategies.

Age: 18Years +All GendersPhase Not Applicable
45 locations
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Actively Recruiting

This research aims to describe the clinical, histological, and radiological features of rare primary liver cancers. It focuses on collecting tumor and blood samples to better understand these cancers and to evaluate how well treatments used in real-world practice work, with the goal of identifying the best treatment sequences. The study serves as a foundation for future research to find new molecular and imaging biomarkers that could improve diagnosis and prognosis. The study is observational and retrospective, meaning it reviews past cases from multiple centers in France. It collects biological samples and clinical data from patients diagnosed with rare primary liver cancers after January 2018. The study evaluates treatments patients have received in clinical practice without assigning any new treatments or interventions. Participants data, including clinical characteristics, tumor biology, and imaging, will be reviewed for up to five years from diagnosis. Researchers will measure outcomes such as recurrence-free survival for patients without metastases, progression-free survival for those with metastases, and overall survival. The study includes both living patients who consent to participate and deceased patients, aiming to gather comprehensive information to support future translational studies.

Age: 18Years +All Genders
40 locations
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Actively Recruiting

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Age: 12Years +All Genders
116 locations
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Actively Recruiting

Researchers are studying the drug Deucravacitinib in children and adolescents aged 4 to under 18 years who have moderate to severe plaque psoriasis. The study aims to evaluate the drug levels, efficacy, and safety of Deucravacitinib in this population. It includes two age groups Cohort 1 for ages 12 to under 18 years and Cohort 2 for ages 4 to under 12 years. The study is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Bristol-Myers Squibb. The study consists of two parts for each cohort. Part A will assess the drug levels of Deucravacitinib to select two dose levels for Part B. Part B will then evaluate the efficacy and safety of these two dose levels. There is also a 5-year long-term extension period to observe the long-term safety and tolerability of Deucravacitinib in participants who completed Parts A or B. Participants will undergo assessments including measuring drug concentrations at steady state, improvement in psoriasis severity using PASI and sPGA scores, and monitoring of adverse events over time. Growth and sexual maturation will be tracked through body weight, height, and Tanner staging. Safety labs and other clinical tests will also be conducted up to 52 weeks, with longer-term monitoring for some outcomes extending up to 316 weeks.

Age: 4Years - 18YearsAll GendersPhase 3
63 locations
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Actively Recruiting

Researchers are evaluating the safety and effects of Abrocitinib in adults with moderate to severe atopic dermatitis, a long-lasting skin condition that causes inflammation, redness, and irritation. This observational study aims to understand how Abrocitinib works in real-life clinical settings for patients aged 18 and older who do not have other medical conditions that would prevent them from taking the medication. All participants will take Abrocitinib as a daily tablet and may also use medicated topical treatments for their condition. The study lasts 24 months, during which participants will be monitored regularly. They will visit the study clinic approximately five times, about once every 4 to 6 months, to report their experiences and health status while using the medication. Throughout the study, researchers will assess participants using various measures such as skin condition scores, itching severity scales, and sleep quality assessments. They will also track treatment adherence, any changes in medication dosage, and any side effects. The main outcome focuses on the proportion of patients achieving clear or almost clear skin after 16 weeks, with ongoing evaluations through 24 months to monitor safety and effectiveness.

Age: 18Years +All Genders
30 locations
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Actively Recruiting

Researchers are studying the biological effects and monitoring methods of chronic nitrous oxide abuse, which can cause neurological problems such as combined sclerosis of the spinal cord. Patients may experience walking difficulties, abnormal sensations, and in severe cases may require a wheelchair. There have also been reports of thrombosis linked to nitrous oxide use. Traditional tests measuring nitrous oxide levels in blood or urine are not reliable due to the gass short half-life, so other markers like vitamin B12 and homocysteine are being evaluated. The underlying causes of these clinical effects are not yet fully understood. The study observes two groups of nitrous oxide users those hospitalized with clinical symptoms assessed by neurological evaluation using the Peripheral Neuropathy Disability score or thrombotic events, and those without clinical symptoms seen during routine medical consultations. Participants undergo blood collections for biological analysis, with samples preserved for further study. This is an observational study without experimental treatment. Participants will have blood tests at the start and at intervals up to six months to measure markers related to nitrous oxide use and clinical outcomes. Researchers will also assess nitrous oxide consumption through self-reporting and estimation, alongside the severity of related clinical signs. The main outcome is the change in blood markers over about one year. The study includes people aged 14 to 65 who currently or formerly use nitrous oxide and have social insurance coverage.

Age: 14Years - 65YearsAll Genders
8 locations
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Actively Recruiting

Researchers are evaluating the effects of caffeine on cognitive decline in people with Alzheimers disease at early to moderate stages, characterized by a Mini-Mental State Examination MMSE score between 16 and 24. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to study the 30-week impact of caffeine treatment on cognition. The study addresses the potential benefits and risks of caffeine, considering its complex effects on the central nervous system, including possible anxiety and insomnia at high doses, which may be more pronounced in Alzheimers patients. Participants begin with a 3-week dose escalation period, followed by a 27-week treatment phase. The caffeine group receives capsules starting at 100 mg, titrated up by 100 mg increments to a target dose of 400 mg per day divided into two doses, while the placebo group undergoes a similar regimen with placebo capsules. After the treatment period, caffeine is tapered off using the same negative titration. Both groups follow a low caffeine diet before and during the study. During the study, participants undergo regular assessments of cognitive function using the Neuropsychological Test Battery NTB scores at 30 weeks and six weeks after treatment ends to observe any lasting effects. Additional evaluations include MMSE scores, attention tests, sleepiness scales, daily living activities, quality of life, caregiver burden, clinical global impression, and safety monitoring of heart rate and blood pressure. Blood samples will measure caffeine and its derivatives. The study involves caregivers living with the patient and lasts for at least 36 weeks from randomization.

Age: 50Years +All GendersPhase 3
17 locations
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Actively Recruiting

Researchers are evaluating elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive ER and human epidermal growth factor receptor 2-negative HER2- breast cancer who have a relapse detected by circulating tumor DNA ctDNA. This international, multi-center, randomized, open-label phase III trial focuses on patients without distant metastasis who show ctDNA positivity during screening. The study aims to assess whether elacestrant can improve outcomes over the current standard endocrine treatments. The study consists of two phases. First, during the ctDNA screening phase, patients on standard adjuvant endocrine therapy will have plasma samples collected every six months for about 5.7 years to detect ctDNA. Patients who test positive will undergo imaging to confirm no distant metastasis and then be randomized 11 to either continue their current endocrine therapy or receive elacestrant 400 mg orally once daily. Treatment duration depends on prior endocrine therapy length, lasting between 2 to 6 years. Intensive follow-up with ctDNA testing and imaging occurs for up to 3 years after randomization. Participants will be monitored closely with blood tests for ctDNA at weeks 4, 16, and every 16 weeks thereafter, along with yearly mammograms, bone scans, and CT scans every 16 weeks to detect metastases or recurrences. Safety, quality of life, and overall survival are assessed throughout, with follow-up continuing until three years after the last patient enrolls. The primary outcome measured is distant metastasis-free survival at 6.25 years after the first randomization.

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

Researchers are evaluating the effects of American ginseng combined with vitamin C from Camu Camu berries on fatigue in patients treated for localized breast or gynecological cancer. This multicenter randomized trial aims to assess the safety and efficacy of the dietary supplement Qiseng in improving cancer-related fatigue. The study is randomized, double-blind, and placebo-controlled, led by the Centre Francois Baclesse. Participants receive either Qiseng, containing 200 mg of P. quinquefolius extract 30 mg ginsenosides plus 30 mg vitamin C, or a placebo made of microgranules without active extracts. Both groups take 2 capsules daily for 8 weeks. The trial includes detailed monitoring of fatigue and other quality-of-life aspects during and after treatment. During the study, participants will have their fatigue levels assessed after 1 week and 4 weeks following the 8-week treatment. Researchers will also evaluate other fatigue dimensions, treatment-related side effects, quality of life, anxiety, cognitive function, physical activity, sleep quality, and treatment acceptability at multiple timepoints. The study spans approximately 12 weeks with close follow-up for safety and outcome measurement.

Age: 18Years +FEMALEPhase Not Applicable
10 locations
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Actively Recruiting

Researchers are studying patients with metastatic colorectal cancer to identify clinical and biological factors that predict how well fruquintinib works in real-world settings. The study aims to confirm survival and safety results seen in previous trials and to better understand treatment outcomes, especially in older patients aged 70 and above, who have been underrepresented in earlier research. This cohort is designed to optimize treatment pathways by pinpointing patients who may benefit most from fruquintinib. Participants will receive fruquintinib, an oral drug that targets specific blood vessel growth receptors, given as 5 mg daily for 21 days followed by a 7-day break. This cycle repeats until the cancer progresses, unacceptable side effects occur, the patient dies, or the patient chooses to stop treatment. The study includes patients treated under compassionate use or after marketing authorization in France, integrating routine clinical practice data. During the study, participants will be monitored for overall survival up to one year after starting treatment, which is the main outcome measured. Additional monitoring includes progression-free survival within the same timeframe. The study involves collecting biological samples like circulating tumor DNA and tumor tissue blocks. Safety, survival, and treatment response data will be gathered to support understanding of fruquintinibs effects in everyday clinical use. The study is expected to continue until the end of 2031.

Age: 18Years +All GendersPhase Not Applicable
83 locations

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