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NCT ID: NCT05155254 Active, not recruiting - Metastatic Melanoma Clinical Trials

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Start date: May 17, 2022
Phase: Phase 3
Study type: Interventional

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

NCT ID: NCT05147662 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood

Alfa-PROTECT
Start date: March 23, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat hemophilia A. Hemophilia A is a genetic disorder where the body does not create enough of a protein called clotting factor 8 (FVIII) present in the blood. People with hemophilia A may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding. In severe hemophilia A (clotting factor 8 levels less than 1%) bleedings are more likely to happen. In this study researchers want to learn more about the treatment called BAY94-9027. BAY94-9027 is an injectable medicine used to replace missing clotting factor 8. In BAY94-9027 the clotting factor 8 has been pegylated (combined with a substance called polyethylene glycol (PEG)). This is to make the treatment last longer in the body so that less injections are required. BAY94-9027 is already available for the prevention and treatment of bleeding in adults and children who are 12 years and older. BAY 94-9027 is also called Jivi. BAY94-9027 is not yet available for children aged 7 to less than 12 years. One potential specific risk of pegylated drugs is that proteins in the blood called antibodies are built. These may attach to the pegylation part of the drug and this in turn may lead to allergic reactions and the drug not working as well as it should during first 4 infusions. In studies that have been done so far, this has been seen in some children younger than six years, but not in 29 children aged 6 to less than 12 years treated with BAY94-9027. Further safety information related to how the body reacts to BAY94-9027 is however still needed for this age group. The main purpose of this study is to learn how safe BAY94-9027 is (safety) and how it affects the body (tolerability) in previously treated children with severe hemophilia A who are between 7 to less than 12 years. To answer this question, the researchers will study information about two medical problems of special interest, if allergic reactions occur (also called hypersensitivity) and if the drug is not working as well as it should (also called loss of efficacy) during the first 4 infusions. Allergic reactions may range from mild local reactions to widespread effects such as shortness of breath, skin rashes and low blood pressure. Only allergic reactions related to the study treatment will be considered. The assessment if loss of efficacy occurred will be based on the occurrence of bleeding, the clotting factor 8 level in blood after injection called recovery, clotting factor 8 inhibitor tests and measurement of antibodies against the PEG. The study has two parts, A and B. Part A takes 6 months and part B takes 18 months. In part A the participants will receive two injections of BAY94-9027 per week. In part B, the number of injections may be decreased, with up to five days between the injections. The participants in this study will visit the study site around 14 times and will have 15 phone visits. In part A, visit 1 is for screening. Visits 2 to 5 take place twice a week for two weeks. Visit 6 two weeks after visit 5, visits 7 to 10 take place monthly with visit 11 six weeks after visit 10. In part B, site visits will occur on month 9, 12, 18 and 24 and phone calls every month between the site visits. The participants' and their caregivers will record in an electronic patient diary information about when the study treatment was given and bleeding episodes that have happened. During the study, the study doctors and their team will - take blood samples, - do physical examinations, - review the participants' electronic diary - ask questions about the participants' quality of life, - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is a medical problem that happens during the study. Doctors keep track of all adverse events that happen in study, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05145231 Active, not recruiting - Cerebral Palsy Clinical Trials

valıdıty and relıabılıty of the turkısh versıon of the functıonal mobılıty Scale ın ındıvıduals wıth Cerebral Palsy

FMS
Start date: September 15, 2021
Phase:
Study type: Observational [Patient Registry]

Cerebral palsy (CP) describes a group of persistent disorders in movement and postural development that cause activity limitation, attributed to non-progressive disturbances occurring in the developing fetal or infant brain. Motor disorders of cerebral palsy are often accompanied by sensory, perception, cognition, communication and behavioral disorders due to epilepsy and secondary musculoskeletal problems.(Rosenbaum et al. 2007) Within the ICF, body functions are the physiological functions of body systems and anatomical parts of the body, such as body structures, organs, limbs, and components. Disorders are problems that appear as a significant deviation or loss in body functions or structure. The primary injury in CP is a brain lesion resulting from an upper motor neuron lesion that is thought to have a number of positive and negative features. Positive traits include spasticity, hyperreflexia, and co-contraction, while negative traits include weakness, loss of selective motor control, and balance and coordination deficits. The aim of the study is to examine the validity and reliability of the Turkish version of the Functional Mobility Scale (FMS) in individuals with cerebral palsy.

NCT ID: NCT05144841 Active, not recruiting - Clinical trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

Start date: January 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

NCT ID: NCT05144256 Active, not recruiting - Clinical trials for Pediatric Pyruvate Kinase Deficiency

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

ACTIVATE-KidsT
Start date: June 8, 2022
Phase: Phase 3
Study type: Interventional

ACTIVATE-KidsT (AG348-C-022) is a multicenter study designed to evaluate the efficacy and safety of treatment with mitapivat compared with placebo in pediatric participants with pyruvate kinase deficiency (PK deficiency) who are regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to < 6 years, 6 to < 12 years, 12 to < 18 years) and splenectomy status. Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 24-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

NCT ID: NCT05134324 Active, not recruiting - Chronic Stroke Clinical Trials

The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke

Start date: May 25, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

NCT ID: NCT05133336 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

EPICS-III
Start date: April 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT05132075 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

KontRASt-02
Start date: June 15, 2022
Phase: Phase 3
Study type: Interventional

This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

NCT ID: NCT05125809 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta

Orbit
Start date: February 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

NCT ID: NCT05124054 Active, not recruiting - Clinical trials for to Evaluate the Feasibility, Reliability, Validity, and Responsiveness of the QoR-15T

The Validity and Reliability of the Turkish Version of the Quality of Recovery-15 (QoR-15) Questionnaire

Start date: December 4, 2021
Phase:
Study type: Observational

Postoperative recovery is a complex process influenced by various factors such as patients, surgical methods and anesthetic properties. Such factors can be accompanied by many negative situations. Previous studies evaluating recovery following anesthesia primarily evaluated the incidence of morbidity, mortality, adverse anesthesia-related outcomes, and changes in vital signs (1-4). These parameters are important, but the quality of recovery of patients has been neglected in most studies. Therefore, various patient-reported outcome measurement scales and tools have been developed (1,3-8). One of these scales is Stark et al. It is the QoR-15 questionnaire developed by in 2013 (4). QoR-15 aims to assess the quality of early recovery and emotional health of patients after surgery (4,6). It is a 15-item questionnaire assessing the patient's emotional state, physical comfort, psychological support, physical independence and pain. This one-page QoR-15 questionnaire has been shown to be highly valid and reliable in patients who have undergone general surgery (4). QoR-15 has been verified and translated into many languages such as Japanese, French, Portuguese, Chinese, Swedish (13-17). It was reported in a systemic review that all translated versions of the QoR-15 had sufficient validity and reliability to assess the quality of postoperative recovery (19). However, an official Turkish version of the QoR-15 has not yet been developed or approved. The aim of this study was to develop the Turkish version of the QoR-15 (QoR-15T) and to evaluate its validity, reliability and responsiveness for Turkish-speaking patients receiving general and regional anaesthesia.