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Found 20 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
C

Actively Recruiting

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months 5 years. The study allows prior use of CDK46 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patients randomization.

Age: 18Years - 130YearsAll GendersPhase 3
711 locations
A

Actively Recruiting

Researchers are studying patients with community-acquired pneumonia who need oxygen therapy due to acute respiratory distress and low blood oxygen levels. This research aims to see if placing patients in a prone position lying face down while they receive nasal high flow oxygen can reduce the need for intubation and improve outcomes. The study particularly excludes patients with COVID-19 and focuses on non-COVID pneumonia cases. Participants will be randomly assigned to one of two groups. One group will be encouraged and assisted to lie in the prone position for at least 8 hours per day in multiple sessions, aiming for up to 16 hours if tolerated. The other group will receive usual care with nasal high flow oxygen therapy but no prone positioning. Both groups will have oxygen levels monitored and care adjusted to maintain target oxygen saturation. During the study, patients will be observed for intubation rates within 28 days, comfort levels during prone positioning, oxygenation changes, time to escalation of breathing support, and overall outcomes including mortality up to 90 days. Safety measures like skin and infection monitoring will also be recorded. Quality of life will be assessed at 90 days and 5 years, with nursing workload tracked within the first day after randomization.

Age: 18Years +All GendersPhase Not Applicable
38 locations
B

Actively Recruiting

Atrial fibrillation AF is a common heart rhythm disorder linked to a significant number of strokes, especially in people over 65. This research aims to explore the genetic causes and blood clotting processes related to AF and stroke by creating a biological database. Understanding these genetic factors may help identify new targets for treatments. Participants are grouped based on their AF and stroke history, age, and specific medical procedures. Blood samples are collected to obtain DNA and plasma for genetic studies. The study includes patients with AF with or without stroke, those undergoing certain heart procedures, people over 80 without AF, and individuals with early stroke or transient ischemic attack but no AF. During the study, blood samples are collected and stored for quality analysis up to seven years. Clinical data collection accompanies the biological sampling. Researchers will evaluate the quality and preservation of these samples to support genetic research. Participation involves providing blood samples and medical history information, with ongoing monitoring of sample integrity.

Age: 18Years +All Genders
5 locations
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Actively Recruiting

This research aims to reduce extubation failure in critically ill patients with acute brain injuries who have impaired consciousness. These patients often require mechanical ventilation with tracheal intubation, and after their acute neurological condition is treated, doctors need to carefully wean them off ventilators to avoid complications like pneumonia. Current guidelines for ventilator weaning do not include brain-injured patients with impaired consciousness, so this study evaluates a simple clinical score to help decide when to safely remove the breathing tube. Participants will be assigned by random clusters of intensive care units to receive either usual care or care guided by the extubation readiness clinical score. After a successful spontaneous breathing trial, clinicians in the intervention group will use the score based on swallowing, gag reflex, cough, and consciousness level to decide on extubation. If the score is above 9, extubation should proceed. Those in the usual care group will follow standard ICU ventilator weaning protocols. The study uses a stepped wedge cluster randomized design. During the study, patients are assessed daily for readiness to breathe without the ventilator. Researchers will monitor extubation failure from the time of extubation up to five days later. They will also track other outcomes such as time to extubation, duration of mechanical ventilation, reintubation rates, pneumonia occurrence, hospital stay length, and neurological outcomes up to 90 days. This thorough evaluation helps understand how the score may improve the timing and success of extubation in this vulnerable group.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
21 locations
A

Actively Recruiting

This research aims to observe the use of trastuzumab deruxtecan T-DXd in adults with HER2-low unresectable or metastatic breast cancer who have previously received chemotherapy in the metastatic setting or experienced disease recurrence within 6 months after adjuvant chemotherapy. The study will collect information on patient characteristics, how treatments are used, tolerability, management of side effects, and patient experiences with T-DXd, as well as data on conventional chemotherapy treatments in a registry. Participants will receive T-DXd or conventional chemotherapy as chosen by their doctors according to approved guidelines in routine clinical practice. No study drug is given by the research team since this is a non-interventional study. The conventional chemotherapy group will be analyzed separately to better understand treatment patterns and outcomes. During the study, researchers will gather data for up to 31 months, monitoring real-world time to next treatment, treatment patterns, safety events, use of treatments to manage side effects, and patient-reported outcomes including tolerability and quality of life. They will also track occurrences of nausea and vomiting through patient diaries. This information will help evaluate treatment use and patient experiences outside of clinical trial settings.

Age: 18Years +All Genders
211 locations
D

Actively Recruiting

Cervical pseudarthrosis is a challenging complication for spine surgeons, with rates ranging from 3 to 15 depending on patient factors and surgical approach. Diagnosing this condition is difficult due to non-specific symptoms and a lack of consensus on imaging methods. While CT scans are considered the gold standard for morphological assessment, they do not provide functional information about bone healing. Bone scintigraphy has historically been limited by resolution and anatomical detail, but new hybrid imaging technologies offer improved study of functional and anatomical correlations. This study is evaluating bone scintigraphy as a diagnostic tool for cervical pseudarthrosis, performed alongside the standard CT scan. The research aims to assess the sensitivity, specificity, and positive predictive value of bone scintigraphy compared to CT scans. Participants will undergo bone scintigraphy exams, and the ability of scintigraphy to predict bone healing at one year post-arthrodesis will also be evaluated. Participants will be adults over 21 years old who have undergone cervical arthrodesis and have a certain level of neck disability. Outcomes measured include diagnostic accuracy of bone scintigraphy and CT scans, as well as prediction of bone healing. The study involves clinical assessments and imaging over a 12-month period, with safety considerations including exclusion of pregnant or breastfeeding individuals and those needing urgent treatment. Total participation duration is about one year.

Age: 21Years - 99YearsAll GendersPhase Not Applicable
1 location
A

Actively Recruiting

Researchers are evaluating treatments for people newly diagnosed with multiple myeloma who are eligible for a stem cell transplant. This phase 3, open-label study compares the combination of elranatamab and lenalidomide to standard chemotherapy followed by autologous stem cell transplant ASCT during the consolidation phase. It also compares elranatamab to standard care during the maintenance phase to assess effects on disease progression and survival. Participants are randomly assigned to one of two groups during the induction and consolidation phase. One group receives standard induction therapy with 4 cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone, followed by high-dose chemotherapy with melphalan and ASCT, then D-VRd consolidation. The other group receives the same induction therapy followed by consolidation with elranatamab and lenalidomide. After consolidation, patients are re-randomized to maintenance therapy with either daratumumab plus lenalidomide for about two years or elranatamab monotherapy for about two years, with adjustments based on minimal residual disease MRD status. Participants will be closely monitored throughout the study, which may last several years. Researchers will assess MRD negativity rates after consolidation and progression-free survival during maintenance therapy. Safety and tolerability, overall survival, and quality of life will also be evaluated using questionnaires and medical assessments. The study involves regular visits for treatment, lab tests, imaging, and health evaluations to track disease status and treatment effects.

Age: 18Years - 69YearsAll GendersPhase 3
64 locations
E

Actively Recruiting

Researchers are studying the impact of a special training program for nurses and nursing assistants on elderly patients aged 75 and over who are hospitalized in specialized wards. The goal is to see if this training, adapted from a successful American nursing program called NICHE, can improve the care of elderly patients by reducing hospital-related complications and shortening the length of hospital stays. This training involves teaching healthcare staff about better geriatric care practices, especially to prevent confusion and other hospital-related issues common in older patients. The study compares two groups of patients one group admitted after the introduction of specially trained geriatric nurses and nursing assistants, and a control group admitted before this training was introduced. The training program is coordinated by Geriatric Mobile Teams GMT, who support and guide the nursing staff, helping to spread good geriatric care practices similar to hygiene correspondents in hospitals. The program is designed to improve overall hospital care for older patients by focusing on evidence-based practices. Participants length of hospital stay is measured as the number of days from admission to discharge, with data collected up to one month after admission. The study observes patients during their hospital stay to evaluate the effects of the training program on preventing complications related to hospitalization. The study spans from May 2023 to July 2027. Researchers assess patient outcomes based on medical records, including complications and duration of hospitalization, to determine if this nursing training improves care for elderly hospital patients.

Age: 75Years +All Genders
5 locations
I

Actively Recruiting

Healthy Volunteer

Death in emergency departments is a frequent and challenging event, with about 0.3 to 0.5 of emergency admissions resulting in death, often requiring decisions to withhold or withdraw life-sustaining treatments. This trial evaluates the impact of a new protocol involving human simulation and participation of partner families to improve how emergency staff announce these decisions, aiming to reduce stress and post-traumatic symptoms in families. The study also examines how such training affects caregivers communication skills and confidence during these difficult announcements. The study compares a model announcement protocol using human simulation and involvement of partner families in both a simulation center and real emergency settings against usual practices. Emergency services are grouped into clusters undergoing sequential training following a stepped wedge design. Professionals in the intervention group receive training in the DISCUSS announcement protocol, aiming to improve communication and reduce family distress when decisions about limiting or stopping treatments are made. Participants include relatives present at the emergency department when the treatment limitation decision is announced, as well as caregivers working in participating wards. Assessments include measuring post-traumatic stress symptoms in families at 7, 30, and 90 days after the announcement using validated scales. Caregivers communication assertiveness, self-confidence, stress levels, and satisfaction with the training are evaluated at several points up to 20 months. The study runs from January 2024 to January 2026 and includes a single-blind randomized design.

Age: 18Years +All GendersPhase Not Applicable
9 locations

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