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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying patients with splenomegaly or those who have had a splenectomy without a known cause, focusing on the possible presence of Gaucher disease GD and Acid Sphingomyelinase Deficiency ASMD. These conditions may be linked to monoclonal gammopathy of undetermined significance MGUS and multiple myeloma MM, which have been found more frequently among Gaucher and ASMD patients. The study aims to improve diagnosis of unknown causes of splenomegaly and undiagnosed cases of MGUS or MM in these patients. The study involves using standard diagnostic procedures for unknown splenomegaly and splenectomy patients, including collecting blood samples for a dry drop test DBS. This test measures enzymatic and genetic activity related to Gaucher disease and ASMD, alongside analysis of LisoGl1 and LisoSM biomarkers. No specific treatment or intervention is applied since this is an observational study. Participants will undergo clinical evaluations and blood sampling to help identify the prevalence of Gaucher disease and ASMD over a 36-month period. Researchers will track how many patients with unknown splenomegaly or MGUSMM have these enzyme deficiencies. The study is observational, with no treatment assigned, and participants will be monitored during their routine medical consultations throughout the study duration.

Age: 18Years - 99YearsAll Genders
23 locations
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Actively Recruiting

This research aims to evaluate a motivational training program designed for pre-service Physical Education teachers. The study focuses on fostering motivating teaching styles and reducing demotivating ones, based on Self-Determination Theory and the circumplex model. It addresses the need for effective initial teacher education programs to better prepare future Physical Education teachers in motivating and engaging their students. The study involves at least 38 pre-service teachers divided into two groups. The experimental group will complete a 14-hour training program with both theoretical and practical components focusing on motivation and teaching styles. The control group will follow the usual Masters in Physical Education Teacher Education curriculum without this specific training. Participants will complete questionnaires measuring teaching styles, teaching competence, and motivation at baseline, 4 weeks, and 8 months after starting. Additionally, focus groups will gather in-depth feedback on the training programs quality, applicability, and strengths or weaknesses. Independent researchers will conduct assessments, and external experts will moderate focus groups to ensure objective data collection throughout the study period.

All GendersPhase Not Applicable
1 location
N

Actively Recruiting

Inflammatory bowel disease IBD, including ulcerative colitis UC and Crohns disease CD, involves chronic inflammation affecting the digestive tract with periods of flare-ups. This study evaluates the real-world effectiveness and safety of granulocytapheresis GMA using the Adacolumn device in adult patients with UC or CD. GMA selectively removes inflammatory cells from the blood to reduce inflammation and is considered as an alternative or complementary treatment to corticosteroids and biological therapies in IBD management. Participants will receive GMA treatment with Adacolumn, typically following the standard regimen of one session per week for five weeks. In some cases, induction regimens with two sessions per week or maintenance regimens with one to two sessions per month may be used. The study is noninterventional and conducted across about 30 sites, aiming to enroll approximately 350 patients. Treatment use and regimens will be observed according to routine clinical practice without interfering with patient care. Patients will be followed through up to four visits baseline, and follow-ups at about 1 month, 6 months, and 12 months after the last induction session. Data collection includes clinical remission rates, steroid use, adverse events, quality of life assessments, and biomarker changes. All assessments coincide with routine care visits. The primary outcome is the proportion of patients achieving steroid-free remission at six months, with additional secondary outcomes evaluating remission rates, treatment regimens, safety, and quality of life over 12 months.

Age: 18Years +All Genders
30 locations
O

Actively Recruiting

Researchers are conducting a national, multicenter observational study called SOGUG-PRINCIS to collect and analyze data on patients with genitourinary cancers treated with recently approved drugs under routine clinical practice in Spain. This study is both retrospective and prospective, aiming to validate real-world effectiveness of these drugs and support future funding decisions. It will serve as a registry where new subprojects will open whenever new drugs receive authorization. The study follows patients who have started treatment with specific drugs funded by the Spanish National Health System, including darolutamide combined with androgen deprivation therapy and docetaxel for hormone-sensitive prostate cancer, adjuvant nivolumab after surgery for urothelial carcinoma, and enfortumab vedotin for urothelial carcinoma. All treatments follow their approved dosing and administration guidelines and standard clinical practice. Participants progress will be monitored through routine data collection to evaluate outcomes such as progression-free survival at 18 months, relapse-free survival at 24 months, and overall survival at 12 months after starting treatment. Data will be gathered from patients treated at participating centers, with follow-up continuing as per routine care. The study does not intervene in treatment decisions, which are made independently before enrollment.

Age: 18Years +All Genders
84 locations
O

Actively Recruiting

This research aims to understand the safety of drugs used to treat inflammatory bowel diseases IBD during pregnancy and breastfeeding, focusing on outcomes for both mothers and their children. The study is observational and will follow pregnant women diagnosed with IBD Crohns disease, ulcerative colitis, or unclassified IBD over five years in Spain. It will also track the health and development of their children for up to four years, particularly looking at serious infections and other serious adverse events. Participants are grouped based on their exposure to IBD medications during pregnancy or shortly before conception those treated with biologic drugs, those treated with immunomodulators, and those not exposed to these drugs. Data will be collected at multiple points during pregnancy and after birth, including disease activity and serious adverse events for the mother, and development, infections, and other health events for the children. The study uses questionnaires and regular follow-ups every three months for children until age four. During the study, mothers will provide information through in-person visits and remote contacts, including completing developmental questionnaires for their children yearly. Researchers will gather detailed clinical data at baseline and during each trimester, delivery, and postpartum. The main outcomes measured include rates of serious infections and adverse events during pregnancy and in children up to four years old. The study also assesses developmental status and the risk of malformations or neoplasms in children related to exposure to IBD drugs.

Age: 18Years +FEMALE
73 locations