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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
P

Actively Recruiting

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Age: 18Years - 130YearsAll GendersPhase 3
709 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
T

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
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Actively Recruiting

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Age: 18Years +All Genders
211 locations
E

Actively Recruiting

Researchers are investigating the use of bone tomoscintigraphy to diagnose cervical pseudarthrosis, a complication that can occur after cervical spine surgery. This condition can cause pain and instability, and its diagnosis is challenging due to nonspecific symptoms and limitations of current imaging methods. The study aims to evaluate the diagnostic value of bone scintigraphy compared to CT scans, which are currently considered the standard but lack functional information about bone healing. Participants will undergo a bone scintigraphy exam in addition to the usual CT scans performed in current practice. This imaging technique combines functional and anatomical data to potentially improve the accuracy of diagnosing cervical pseudarthrosis. The study will compare the sensitivity, specificity, and predictive value of bone scintigraphy and CT scans over a 12-month period. During the study, participants will have clinical scores assessed and imaging tests including bone scintigraphy and CT scans. Researchers will monitor how well bone scintigraphy detects pseudarthrosis and predicts bone consolidation at one year after surgery. The study will last up to 12 months, with assessments focusing on imaging and clinical evaluation to understand the effectiveness of bone scintigraphy in this diagnostic role.

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

Actively Recruiting

Researchers are conducting a phase 3, open-label, randomized study in adults aged 18 to 69 with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation ASCT and high-dose chemotherapy. The trial aims to evaluate the effectiveness and safety of using elranatamab and lenalidomide as alternatives to standard chemotherapy in the consolidation phase, and to compare elranatamab alone with standard maintenance therapies. This study involves about 824 patients across approximately 70 sites and addresses important outcomes like minimal residual disease MRD negativity, progression-free survival, and overall survival. Participants receive standard induction therapy with four cycles of D-VRd daratumumab, bortezomib, lenalidomide, dexamethasone followed by either ASCT and D-VRd consolidation standard arm or elranatamab with lenalidomide consolidation experimental arm. After consolidation, patients enter a maintenance phase where they are re-randomized to receive either daratumumab plus lenalidomide or elranatamab monotherapy for about two years. Treatment adjustments depend on MRD status and disease progression during maintenance. Throughout the study, participants undergo regular assessments including disease evaluations and safety monitoring. Researchers measure MRD negativity rates, progression-free survival, overall survival, adverse events, and quality of life using validated questionnaires. The trial offers long-term follow-up, lasting up to around 10 years, to capture comprehensive data on treatment effects and patient well-being.

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

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
E

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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