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NCT ID: NCT05147701 Recruiting - Glaucoma Clinical Trials

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Eye Diseases

Start date: February 1, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Eye diseases

NCT ID: NCT05145127 Recruiting - Hemophilia A Clinical Trials

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008. Study B7841005: approximately 145 adolescent and adult participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity <1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab). Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants <18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity <1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to <18 years and at least 80 participants will be aged ≥1 to <12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to <18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit/risk assessment in support of dosing participants aged ≥6 to <12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to <12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to <6 years. All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.

NCT ID: NCT05142085 Enrolling by invitation - Parkinson Disease Clinical Trials

Efficacy of Nano-PSO in Parkinson's Disease.

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The present research aims to carry out a double-blind, placebo-controlled clinical trial to study the efficacy of a new antioxidant. The primary outcome variables will be the changes observed in PD-motor and non-motor symptoms scales, as well as quality of life during a 6-months period. Global impression on the treatment will be rated after this period. Likewise, presynaptic changes will be studied in positron emission tomography studies, using 2 radiotracers and a dynamic image processing in patients with Parkinson's disease. 125 patients who have a definite diagnosis of PD will be included; 25 of them will be subjected to a triple-blind, clinical and molecular study. In addition, 25 other subjects from the same Institution and from 4 other collaborating centers will be part of the clinical arm of this study during the period September 2021- September 2022. During the first visit, various clinical data of the participants will be recorded such as: age, gender, family history, current medical conditions, and drugs dosage in addition to a comprehensive neurological examination. Subsequently, the signing of the informed consent will be obtained, and general laboratory tests and a brain RMI in 3dT1 and SWI sequences will be performed. A series of disease-specific scales will be applied in order to assess motor functional capacity, cognition, sleep, and other non-motor symptoms before drug delivery. Randomization will be made in blocks of 5 treatments: 3 nano-PSO and 2 placebos. Treatments will be delivered in form of bottles containing 100 capsules each after baseline and intermediate visit. 25 patients will also give their consent to perform 2 PET studies (positron emission tomography) to assess presynaptic dopaminergic function. This implies conducting these studies on 2 occasions (at the beginning and at the end of treatment), with emphasis on striatal activity to study the effect of treatment with Nano-PSO.

NCT ID: NCT05140590 Completed - Hypertension Clinical Trials

Interactions Between Antihypertensive Drugs and Drugs Prescribed in the Emergency Room

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Drug interactions (IFF) are events that occur when multiple drugs are administered at the same time to an individual. People with arterial hypertension generally require therapeutic regimens based on 2 or more drugs for their adequate control, which makes them patients with polypharmacy. When these patients require urgent medical attention, there is a risk that IFFs will occur between their base treatment and the drugs that are prescribed to solve the added condition. Objective. To determine the frequency of pharmacological interactions between antihypertensive regimens and drugs used in the emergency service of Hospital General de Zona No 51 (HGZ 51). Material and methods: Observational, descriptive, and prospective study. The participants will be eligible patients with systemic arterial hypertension treated in the emergency room of HGZ 51 in Gómez Palacio, Durango. Support systems will be used for clinical decision, to identify potential IFFs and to be able to classify them according to their mechanism (pharmacokinetics and pharmacodynamics) and severity. A descriptive statistical analysis will be carried out in the SPSS program using measures of frequency, dispersion and central tendency.

NCT ID: NCT05138133 Recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05137860 Recruiting - Clinical trials for Chemotherapeutic Toxicity

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

Start date: December 12, 2021
Phase: Phase 4
Study type: Interventional

Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.

NCT ID: NCT05134441 Recruiting - Multiple Sclerosis Clinical Trials

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

ENSURE-1
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)

NCT ID: NCT05133531 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

ACCESS-1
Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on patients with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for patients with PNH and how the combination compares with 2 existing treatments, one called ravulizumab and the other called eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: - How effective is the pozelimab + cemdisiran combination compared to ravulizumab? - How effective is pozelimab + cemdisiran combination compared to eculizumab? - What side effects may happen from taking the study drugs? - How much study drugs are in the blood at different times? - Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

NCT ID: NCT05133310 Recruiting - Sepsis Clinical Trials

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Start date: November 19, 2021
Phase: Phase 4
Study type: Interventional

In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.

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.