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NCT ID: NCT05006287 Active, not recruiting - Atrial Fibrillation Clinical Trials

The Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery

Start date: October 12, 2022
Phase: Phase 2
Study type: Interventional

A small pilot study comparing different blood thinners (non-vitamin K oral anticoagulants [NOACs] and warfarin) will be conducted in people at risk for blood clots after open-heart surgery. This study will help us design a much bigger study to test the effectiveness and safety of different blood thinners in people after open-heart surgery. The study will test the following hypotheses: (1) Our standardized use of different blood thinners is feasible in patients early after cardiac surgery. (2) NOACs are safe to use early after cardiac surgery.

NCT ID: NCT05006066 Recruiting - Healthy Clinical Trials

The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain

Start date: July 12, 2021
Phase:
Study type: Observational

Temporal summation is a mechanism that enhances pain perception. It is a natural mechanism present in most individuals. Generally, temporal summation is measured by the application of a moderately painful stimulation for several seconds.However, there is still no official recommendation in the literature. There is therefore a great disparity in the protocols. Some studies apply thermal stimulation (heating the skin) while others apply mechanical stimulation (applying pressure). Another point of contention is that some studies apply continuous stimulation for 2 minutes while others apply a series of several small stimulation of 1 second). Between these studies, the amplitude of temporal summation varies according to the stimulation performed. Note also that the study population is also very different between studies. In these conditions, it remains difficult to know the impact of the nature of the stimulation on the measured amplitude of the temporal summation.

NCT ID: NCT05005975 Active, not recruiting - XLP Clinical Trials

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Start date: August 10, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of oral dersimelagon.

NCT ID: NCT05005507 Terminated - Clinical trials for Hepatitis B, Chronic

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection

PENGUIN-2
Start date: November 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).

NCT ID: NCT05005442 Active, not recruiting - Clinical trials for Hematological Malignancies

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)

Start date: September 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

NCT ID: NCT05004896 Recruiting - Bipolar Disorder Clinical Trials

Ketamine for Treatment-Resistant Bipolar Disorder

KET-BD
Start date: July 4, 2022
Phase: Phase 2
Study type: Interventional

Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD). However, no completed or ongoing randomized control trials (RCTs) have evaluated the effects of repeated doses of IV ketamine for a homogenous sample of patients with treatment-resistant bipolar disorder (TRBD). The primary research goal is to determine the acute antidepressant efficacy, safety and tolerability of four repeated sub-anesthetic doses of IV ketamine in moderate to severe TRBD. Secondary aims include evaluating effects of IV ketamine on suicidal ideations, quality of life, function and duration of effects. Herein, a two-site (University Health Network and Ontario Shores Centre for Mental Health Sciences), phase II, double-blinded, midazolam-controlled, two-week RCT evaluating the efficacy, safety and tolerability of four flexibly-dosed adjunctive ketamine infusions (0.5-0.75mg/kg infused over 40 minutes) for acute treatment of moderate to severe TRBD (type I & II) is proposed. The primary outcome will be Montgomery-Åsberg Depression Rating Scale (MADRS) scores, determining the between group difference in change from baseline to day 14, using analysis of covariance (ANCOVA), with 14-day MADRS as the outcome and baseline MADRS and stratification variables (sex, bipolar type) as covariates. Secondary outcomes include evaluating response and remission rates, safety, tolerability (including treatment-emergent mania), and effects on suicidality, anxiety, quality of life, function and the duration of effects (to day 28).

NCT ID: NCT05004740 Active, not recruiting - COVID-19 Vaccine Clinical Trials

Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

Start date: January 17, 2021
Phase:
Study type: Observational

This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.

NCT ID: NCT05004727 Recruiting - Psoriasis Clinical Trials

Multi-Center PAMPA Study

PAMPA
Start date: February 16, 2022
Phase: Phase 4
Study type: Interventional

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of our proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

NCT ID: NCT05004428 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Learn More About Chronic Kidney Disease (CKD) in Patients With Type 2 Diabetes Mellitus (T2DM)

CKD-T2DM
Start date: August 14, 2021
Phase:
Study type: Observational

In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied. Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time. In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients. The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments. This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.

NCT ID: NCT05004129 Recruiting - Clinical trials for Congenital Myotonic Dystrophy

Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy

REACH CDM X
Start date: August 23, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label phase 2/3 study for individuals with Congenital Myotonic Dystrophy (Congenital DM1) who participated in the preceding AMO-02-MD-2-003 study or individuals with either Congenital or Childhood Onset DM1 who are treatment naïve.