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NCT03781791
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo. \- Study Update- Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.
NCT04849988
This Phase 2 trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 30 sites in the United States. Study subjects will be divided evenly across a low dose group, a medium dose group, a high dose group, and a placebo group for one treatment cycle.
NCT05065411
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor \[Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)\]. STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treatment Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria.
NCT05780541
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6.
NCT04195906
The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).
NCT03682770
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16. Secondary objectives are: * To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16 * To assess whether dupilumab as (indefinite \[continuously\]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 * To assess whether dupilumab as (limited \[previously\]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22 * To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo * To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio * To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary \[e-diary\]) during the up-dosing phase
NCT04119557
The main purpose of this study is to learn more about the safety of LY3471851 when given by injection just under the skin to participants with psoriasis. The study will last up to 48 weeks and may include up to 23 visits to the study center.
NCT03429543
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c \< 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c \>= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c \>= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
NCT03734588
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with severe hemophilia A and no measurable inhibitor against FVIII.
NCT05049330
Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.
NCT02115503
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic rejection episodes in renal transplant subjects. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be followed for 3 years.
NCT03709706
This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.
NCT02841540
A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
NCT01474811
The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.
NCT04461600
The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.
NCT04276415
This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).
NCT04581785
The SUNRISE trial is a first-in-human (FIH), open-label, Phase 1/2 clinical trial designed to assess the safety, tolerability and preliminary efficacy of a single intravenous infusion of hLB-001 in pediatric patients with MMA characterized by methylmalonyl-CoA mutase gene (MMUT) mutations. hLB-001 is a liver-targeted, recombinant engineered adeno-associated viral (rAAV) vector utilizing the LK03 capsid (rAAV-LK03), designed to non-disruptively integrate the human methylmalonyl-CoA mutase gene at the albumin locus. The trial is expected to enroll pediatric patients with ages ranging from 6 months to 12 years, initially starting with 3 to 12 year-old patients and then adding patients aged 6 months to 2 years.
NCT03651830
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the high or low mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.
NCT05796440
This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.
NCT00319579
Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand. Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.
