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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effectiveness and safety of pirtobrutinib LOXO-305 compared to ibrutinib in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study includes participants who may or may not have received prior treatment for their cancer. Part 1 of the trial lasts up to six years, while Part 2 focuses on treatment-nafve participants with a specific genetic deletion 17p deletion and lasts up to two years. Participants will receive pirtobrutinib or ibrutinib orally, depending on their assigned study group. Part 1 compares pirtobrutinib to ibrutinib in a randomized, open-label design. Part 2 evaluates pirtobrutinib alone in participants with the 17p deletion who have not yet been treated. Treatment continues until disease progression, unacceptable side effects, or other study-defined reasons. During the study, participants undergo regular assessments including clinical evaluations and monitoring of their response to treatment using established criteria. Researchers measure overall response rates, progression-free survival, event-free survival, duration of response, overall survival, time to next treatment, symptom worsening, and treatment tolerability. Participation involves ongoing monitoring for up to six years in Part 1 and two years in Part 2 to evaluate long-term outcomes and safety.

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

Healthy Volunteer

Researchers are evaluating the effects of leg and heel massage on newborns pain during heel blood collection and on their physiological parameters like heart rate and oxygen saturation. The study compares babies receiving the massage to those receiving routine care, aiming to see if massage can reduce pain scores and improve vital signs during the procedure. This randomized controlled study involves newborns aged 2 to 28 days with stable vital signs and no contraindications for massage. The study divides participants into two groups one receives leg and heel massage immediately before the heel blood collection, with each leg and heel massaged for three minutes, while the other group receives routine care without massage. The heel blood collection is performed by the same pediatric nurse for all infants to ensure consistency. Random assignment to groups is done through a web-based system upon hospital arrival. Participants will have their pain assessed using the Newborn Infants Pain Scale, along with heart rate and oxygen saturation measurements taken five minutes before, during the first minute, and five minutes after the heel prick procedure. These measurements help researchers compare the effects of massage versus routine care. The study will last about nine months, with data collection focused on pain scores and physiological responses during the heel blood collection process.

Age: 1Day - 28DaysAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Hip and knee replacement surgeries are common among older adults, but many patients face pain, limited movement, and sleep difficulties during recovery. These problems can make daily tasks like walking or climbing stairs harder and reduce overall quality of life. Researchers are evaluating two different relaxation methods to see how they affect pain and sleep quality after such surgeries. The study compares relaxation exercises delivered through virtual reality technology with traditional relaxation exercises without virtual reality. Both approaches are provided alongside standard postoperative care. Patients are randomly assigned to one of these two groups, and the study is double-blinded to reduce bias. Participants will engage in the assigned relaxation exercises after surgery, and researchers will assess pain intensity and sleep quality over the first three days following the operation. The study will include evaluations of pain levels using standard scales and measures of sleep quality to understand how each relaxation method may support recovery. The total participation duration is centered around the postoperative period of three days.

Age: 18Years +All GendersPhase Not Applicable
1 location
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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.

Age: 18Years +All GendersPhase 2Phase 3
770 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating how a prenatal yoga program affects pregnant womens perception of traumatic childbirth, their self-view, and preferences for delivery methods. This study involves pregnant women aged 18 and older who are at or beyond the 16th week of pregnancy and do not have a high-risk pregnancy diagnosis. The research aims to compare outcomes between those who participate in prenatal yoga and those who receive routine prenatal care. Participants will be randomly assigned to one of two groups. The intervention group will attend eight prenatal yoga sessions, each about 45 minutes long, held twice weekly in groups of 8 to 12. The control group will continue with their usual prenatal care without additional interventions. The yoga program follows safe exercise guidelines for pregnancy and is conducted over approximately four weeks. Throughout the study, participants will complete questionnaires at three points before starting the yoga program, right after finishing the eight sessions, and one month later. These assessments measure traumatic childbirth perception, self-perception, and preferred delivery mode. This design allows researchers to monitor changes over time and evaluate the yoga programs potential impact compared to standard care.

Age: 18Years +FEMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are conducting a Phase III, multisite, randomized, double-blinded trial to compare pumitamig BNT327 combined with chemotherapy etoposide and carboplatin against atezolizumab combined with the same chemotherapy in participants with previously untreated extensive-stage small-cell lung cancer ES-SCLC. The study aims to evaluate treatment safety and effectiveness, including overall survival and progression-free survival. The study includes two stages Stage 1 has two treatment arms with different doses of pumitamig and one control arm receiving atezolizumab, while Stage 2 has one treatment arm with a different pumitamig dose and a control arm. Treatment involves intravenous infusions of the study drugs and chemotherapy. Participants may switch from carboplatin to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period, an induction and maintenance treatment period lasting up to 2 years or until disease progression or other endpoints, followed by a safety and survival follow-up phase. Participants undergo screening for eligibility before randomization. During the study, researchers monitor overall survival up to approximately 46 months, progression-free survival, response rates, adverse events, and quality of life through questionnaires. Safety follow-up visits occur after treatment ends. The total participation time may extend over several years, including treatment and follow-up assessments to evaluate long-term outcomes and safety.

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

This research aims to evaluate how dual-task training affects balance, exercise capacity, cognitive function, and quality of life in older adults with Type 2 Diabetes Mellitus DM. It focuses on whether combining cognitive tasks with physical exercise can better prevent falls and support active living compared to exercise alone or no intervention. The study addresses the high risk of cognitive decline and falls in this population due to diabetes-related impairments in brain and motor functions. Participants will be divided randomly into three groups a dual-task exercise group, a single-task exercise group, and a control group. Those in the dual-task group will attend 60-minute physiotherapy sessions three times a week for 8 weeks that include aerobic, strength, and balance exercises combined with cognitive tasks targeting memory, attention, and executive functions. The single-task group will receive the same physical training without cognitive tasks, while the control group will maintain their usual activities without exercise training during the study period. During the study, participants will be assessed using tests like the Time Up and Go Test and Berg Balance Scale to measure balance and mobility. Additional measures include cognitive assessments, exercise capacity tests, quality of life questionnaires, and muscle strength evaluations. These evaluations will take place at 2 weeks and after the 8-week training period. Researchers will monitor safety and functional improvements to understand the potential benefits of dual-task training in enhancing daily living and preventing falls among older adults with Type 2 DM.

Age: 65Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying how watching an educational video about ear tube surgery affects anxiety and fear in children aged 6 to 10 years undergoing this procedure. This randomized controlled trial compares children who view a specially designed video explaining the surgery, its steps, and what to expect, with children receiving the standard information currently given in the hospital. The goal is to see if the video can reduce preoperative anxiety and fear in these pediatric surgical patients. Children will be randomly assigned to one of two groups the educational animation group or the control group receiving standard care information. The educational video, lasting 3 to 4 minutes, is narrated by artificial intelligence and covers common fears, ear anatomy, details about the ear tube, and the surgical process. The control group will receive the usual information provided in the hospital ward. This study is conducted over a 12-month period starting from November 2024. Participants will be assessed using questionnaires before and after surgery to measure anxiety and fear levels, including the Child Anxiety Scale and Child Fear Scale. Data will be collected on childrens emotional responses and changes in anxiety and fear after the video intervention. The study also tracks sociodemographic information. Safety and adherence will be monitored throughout the trial, which ends in December 2025.

Age: 6Years - 10YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of using surgical masks compared to N95 masks on physical symptoms caused by surgical smoke in operating room nurses. The study focuses on understanding how different types of masks impact symptoms such as muscle weakness, respiratory issues, and eye irritation related to exposure to surgical smoke during surgeries. This interventional study involves nurses working in a hospital operating theatre setting. The study includes two groups where operating room nurses wear either a standard surgical mask or an N95 respirator during surgical procedures with exposure to surgical smoke. The nurses use each type of mask continuously for at least four hours per day over a four-week period. Physical symptoms are monitored and compared between the two mask types to assess their effect on symptom severity. Participants are asked to use the assigned mask type during surgeries and report their symptoms daily using rating scales and symptom tracking forms. Data collection occurs five days a week for four weeks both before and after surgery. Researchers measure physical symptoms such as muscle weakness, myalgia, muscle cramps, respiratory parameters, watery eyes, and redness. The study monitors symptom severity using a numerical rating scale and evaluates the differences between mask types to understand the impact on surgical smoke-related symptoms.

Age: 18Years +All GendersPhase Not Applicable
1 location