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NCT ID: NCT04696055 Completed - Clinical trials for Hepatocellular Carcinoma

Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab. There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC. During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.

NCT ID: NCT04695860 Completed - Clinical trials for X-linked Hypophosphatemia

Anti-FGF23 (Burosumab) in Adult Patients With XLH

BurGER
Start date: January 7, 2021
Phase: Phase 3
Study type: Interventional

X-linked hypophosphatemia (XLH) rare genetic disorder due by inactivating mutations in the PHEX gene leading to increased levels in FGF-23. Elevated FGF-23 reduces renal phosphate reabsorbtion and and limits 1-alpha hydroxylase driven Vitamin D activation, eventually leading to phosphate wasting, defective bone mineralization and additional health issues. Burosumab is a recombinant fully human IgG1 monoclonal antibody developed to treat XLH by binding FGF23, thereby restoring normal phosphate homeostasis. BUR03 is a Phase 3b open-label, single-arm, single-center study to confirm the efficacy and safety of Burosumab treatment in adult (age ≥18 years) XLH patients without upper age limit and irrespective of baseline pain level and to further evaluate the efficacy in this cohort and the assocaited effect of treatment on physical functioning, mobility and activity. The study aims at enrolling and treating 34 subjects with a confirmed diagnosis of XLH with q4w s.c. injection of Burosumab 1mg/kg body weight over 48 weeks. Primary objective is to attiain normal serum phosphorus levels, secondary objectives include key parameters of physical function and activity, mobility and mineral homeostasis.

NCT ID: NCT04695678 Completed - COVID-19 Clinical Trials

Epidemiological Multicohort Study of Latent COVID-19 Infections

Start date: July 1, 2020
Phase:
Study type: Observational

Cross-sectional study to detect latent COVID-19 infections in residents and staff of old people's and nursing homes in the city of Solingen with a prospective follow-up of 6 months in a subgroup.

NCT ID: NCT04695431 Completed - Mast Cell Leukemia Clinical Trials

Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM

Start date: December 2, 2020
Phase:
Study type: Observational

BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.

NCT ID: NCT04691232 Completed - Ulcerative Colitis Clinical Trials

Autologous Ex Vivo Expanded Regulatory T Cells in Ulcerative Colitis

Start date: February 22, 2021
Phase: Phase 1
Study type: Interventional

Together with Crohn's disease (CD), ulcerative colitis (UC) is one of the major forms of inflammatory bowel diseases (IBD).Currently, no curative therapy is available, since the pathophysiology of this disease is incompletely understood (1-3) and clinical practice demonstrates that current therapies induce remission in subgroups of patients only. Scientific evidence suggests that colitogenic immune responses can be controlled by increasing the number of circulating regulatory T cells (Treg) (4). The production of large numbers of autologous Treg is possible by isolation of CD25+ cells from the whole blood of a patient and subsequent ex vivo expansion in the presence of the immunomodulatory drug rapamycin, Interleukin-2 (IL-2) and CD3/CD28 expander beads (5). ER-TREG 01 is a single-center, open-label, fast-track phase I dose-escalation study designed to assess the safety profile and maximal tolerated dose (MTD) of a single infusion of ex vivo expanded autologous Treg in patients with active ulcerative colitis.

NCT ID: NCT04690621 Completed - Periimplantitis Clinical Trials

Cross-sectional Examination of the Reliability of Oral Implants

PeriX2012
Start date: July 1, 2012
Phase:
Study type: Observational

Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.

NCT ID: NCT04690257 Completed - Pain Clinical Trials

Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture

Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Venipuncture is one of the most common stressful procedures in children. Managing pain and fear of venipuncture procedure recommended strongly because it may change children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. There was clear evidence that the distraction method is the most performed as a psychological technique performed to decrease venipuncture-related pain and distress and supporting its efficacy in children. The aim of this study to investigate the effectiveness of TICK-B on children's pain and anxiety during venipuncture procedure.

NCT ID: NCT04688775 Completed - Clinical trials for Cluster Headache, Episodic

Eptinezumab in Participants With Episodic Cluster Headache

ALLEVIATE
Start date: December 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

NCT ID: NCT04687839 Completed - Healthy Clinical Trials

Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.

NCT ID: NCT04687332 Completed - Clinical trials for Neurological Autoimmune Diseases

IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.