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NCT ID: NCT05882058 Recruiting - Clinical trials for Small Cell Lung Carcinoma

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

Start date: September 25, 2023
Phase: Phase 2
Study type: Interventional

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. Participants are put into 2 groups randomly, which means by chance. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include an over-night stay to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.

NCT ID: NCT05880823 Recruiting - Clinical trials for Cervical Degenerative Disc Disease

Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc

Start date: January 1, 2024
Phase:
Study type: Observational

This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.

NCT ID: NCT05879978 Recruiting - Clinical trials for Neuroendocrine Neoplasms

A Study to Test How Well Different Doses of BI 764532 in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

Start date: May 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is open to adults with small cell lung cancer and other neuroendocrine tumours that are positive for the tumour marker Delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of BI 764532 that people can tolerate when taken together with another medicine called ezabenlimab. BI 764532 and ezabenlimab are antibodies that may help the immune system fight cancer. Participants get BI 764532 and ezabenlimab as infusions into a vein. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

NCT ID: NCT05879757 Recruiting - Multiple Myeloma Clinical Trials

Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

Start date: October 17, 2023
Phase:
Study type: Observational

In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.

NCT ID: NCT05878769 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 28, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

NCT ID: NCT05878717 Recruiting - Clinical trials for Scleroderma, Systemic

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

BLISSc-ILD
Start date: September 13, 2023
Phase: Phase 3
Study type: Interventional

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

NCT ID: NCT05878314 Recruiting - Clinical trials for Hormone Receptor Positive HER-2 Negative Breast Cancer

Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer

Start date: April 25, 2023
Phase:
Study type: Observational

PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.

NCT ID: NCT05876754 Recruiting - Cholangiocarcinoma Clinical Trials

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

ProvIDHe
Start date: May 3, 2023
Phase: Phase 3
Study type: Interventional

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

NCT ID: NCT05876221 Recruiting - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura

Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura

PREDICT2020
Start date: October 30, 2023
Phase:
Study type: Observational

The interpretation of platelet counts has to be revaluated in the light of caplacizumab. By effectively blocking platelet binding sites on VWF-multimers, the nanobody leads to a rapid normalization of the platelet count within 3 to 4 days. Most importantly, caplacizumab uncouples platelet counts from ADAMTS13 activity and thereby launches unprecedented thrombocyte dynamics, with potential pitfalls for over- and undertreatment. A relevant number of patients responds to caplacizumab with a brisk increase in platelet count, followed by a marked dip of platelets (patient on the left). This may mislead treating physicians into re-intensifying therapy, with a respective risk for adverse side-effects and complications. Taken together, these observations call for reliable descriptions and the identification of predictive parameters to predict the platelet response upon administration of caplacizumab in a large patient cohort. Here, PREDICT-2020 is designed as a retrospective study to specifically address the following aspects: - Identifying and describing clusters of platelet responses to caplacizumab - Identifying potential pitfalls for treating physicians - Predicting the individual thrombocyte response - Correlating platelet responses with individual patient outcome

NCT ID: NCT05875194 Recruiting - Clinical trials for Tobacco Use Disorder

Influence of tDCS on the Brain Activation Measured During the Decision Not to Smoke in High-risk Situations

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Substance use disorders (SUD) are characterized by increased automatized responses to drug-related cues (cue-reactivity) and deficient cognitive control. Cue-reactivity (CR) can be elicited by internal (e.g. mood) or external (e.g. situations) cues closely related to consumption. Therefore, one aim for relapse prevention is to control CR by the enhancement of cognitive control, e.g., via noninvasive brain stimulation (NIBS) of cortical areas involved in inhibitory control. However, thus far, treatment effects of NIBS for relapse prevention in SUD are only moderate, despite clear neurophysiological targets. Critically, NIBS is commonly applied in highly standardized laboratory situation, not related to CR, neglecting the current individual (brain-) state. In the current study, relapse-relevant (brain-) states will be evoked in individual, naturalistic settings outside the laboratory and monitored by functional near-infrared spectroscopy (fNIRS; assessing cortical activation patterns) and heartrate variability (HRV; as a periphery physiological measure) to capture the optimal (cortical) state for subsequent NIBS by means of transcranial direct current stimulation (tDCS). The aim of this highly innovative approach is increasing the efficiency of relapse prevention in SUD. At its heart, multimodal measurements during real-world (substance-related) choices with high ecological validity will be used to identify markers for individual optimal target states for tDCS. In contrast to current approaches, the target brain state of the individual adaptively controls the tDCS to maximize therapeutic outcome. One obstacle is to clear the data from artefacts to interpret data at a single-trial level, which requires this proof-of-concept study. This data is prerequisite for further clinical randomized-controlled studies in patients with SUD.