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NCT ID: NCT04714320 Completed - Hypertension Clinical Trials

A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure

ASTRAAS
Start date: March 4, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of IONIS-AGT-LRx compared to placebo on seated automated office systolic blood pressure (SBP) from baseline to Study Day 85 in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications and to evaluate the effect of IONIS-AGT-LRx on ambulatory blood pressure, seated automated office SBP, seated automated office diastolic blood pressure (DBP), and plasma angiotensinogen (AGT) at each scheduled visit in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications.

NCT ID: NCT04713709 Completed - Opioid Overdose Clinical Trials

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

Start date: January 31, 2021
Phase: Phase 1
Study type: Interventional

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.

NCT ID: NCT04713592 Completed - Psoriasis Clinical Trials

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

IMMprint
Start date: February 26, 2021
Phase: Phase 3
Study type: Interventional

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04712669 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

Start date: March 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

NCT ID: NCT04712240 Completed - Clinical trials for Validation of Respiratory Rate Monitor Versus Capnography

Validating the Accuracy of a Continuous Respiratory Rate Measurement Device

Start date: November 17, 2021
Phase: N/A
Study type: Interventional

While respiratory rate is considered a critical vital sign, it often goes unmeasured or is ignored primarily due to shortcomings of the currently used measurement methods. Respiratory rate provides important information on a person's health condition and physiological stability, and an abnormal respiratory rate is a strong indicator that a health crisis is imminent. In fact, a sudden change in respiratory rate is one of the strongest predictors of mortality. Current techniques of monitoring respiratory rate have drawbacks that limit the frequency and convenience of the respiratory monitoring. Recognizing that closer respiration monitoring can save lives and improve quality of life, reduce hospital stays, and lower medical costs, the health care industry is seeking improved respiration monitoring products. The allocation of high-risk patients to intensive care for more careful monitoring or after surgery is often arbitrary, and such care might not be available routinely. For those patients who are cared for in 'general' wards where staffing levels are limited, a practical continuous monitor of respiratory rate would be of great value. This study will act as a pilot to determine the feasibility of using respiratory sensor device to monitor respiratory rate in hospitalized patients. Deriving a measurement of respiratory rate from a respiratory rate monitoring (RRM) device is a technological approach that may overcome these limitations. The device principle is based on a piezoelectric sensor where chest expansions and contractions generate very small amounts of current by the piezoelectric sensor. The expansion and contractions are measured very accurately by over-sampling, filtering and digital signal processing to remove noise and any bias generated by the piezoelectric sensor itself or the sampling circuitry. The study will be conducted from March 2021 to September 2021. During the first phase a convenience sample of 30 patients undergoing general anesthesia with muscle paralysis and mechanical ventilation will be recruited. This phase will help to validate the RRM against capnography in mechanically ventilated patients with a set respiratory rate. Following the first phase, 120 patients undergoing a procedure using sedation or spinal anesthesia will be recruited. Patients will be breathing spontaneously, and the respiratory rate will be monitored by capnography connected to the face mask or nasal prongs. Respiratory rate detected by capnography is recorded in the electronic medical records on a minute to minute interval.

NCT ID: NCT04711447 Completed - Scapular Dyskinesis Clinical Trials

Effect of Inhibitory Kinesio-tape of the Upper Trapezius on Lower Trapezius Muscle Excitation

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Shoulder pain increases excitation (or activity) of the upper trapezius (UT) and reduces excitation in lower trapezius (LT). Despite inconclusive evidence, kinesio-tape (KT) is often used to modify muscular excitation within the UT and/or LT to help correct alterations in scapular position and motion associated with shoulder pain/injury. The objectives of the current study were to determine if: 1) inhibitory KT to the UT acutely increases muscle excitation (whole-muscle and spatial distribution) within the LT in healthy individuals; and 2) if loading the limb alters the magnitude of change in muscle excitation of the LT. We hypothesize that: 1) inhibitory KT application to the UT will immediately increase whole-muscle LT excitation, and result in an inferior shift in the distribution of excitation within the LT compared to no tape and sham-KT tape conditions; and 2) the magnitude of immediate increase in LT excitation with KT would be greater in the loaded condition. A repeated-measures, crossover design was used to determine the impact of KT applied to UT and load on muscle excitation of the LT. Participants were asked to perform a repeated arm elevation task during three different taping conditions: no KT, experimental KT and sham KT. Each taping condition performed the repeated arm elevation task during two loading conditions: no load and loaded with 2.3 kilograms. All six conditions were tested during one visit with the no load condition preceding the loaded condition for each taping condition. A baseline trial (no KT; N-KT) was performed first, followed by both an experimental-KT (E-KT) and sham-KT (S-KT) condition. The order of the E-KT and S-KT conditions were randomized and the order was counterbalanced. Testing for each tape condition lasted approximately 10-minutes for a total of 45-minutes per participant including screening, EMG set-up and clean-up. KT was applied to the UT and muscle excitation (EMG amplitude) was measured in the LT using one single 32-grid high-density surface electromyography (HD-sEMG) electrode during a repeated arm elevation task.

NCT ID: NCT04711187 Completed - Clinical trials for Healthy Volunteer Study

Study of AT-527 in Healthy Subjects (R07496998)

Start date: November 2, 2020
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.

NCT ID: NCT04710134 Completed - Clinical trials for Asthma; Eosinophilic

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma

Start date: February 10, 2021
Phase: Phase 4
Study type: Interventional

Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

NCT ID: NCT04709835 Completed - COVID-19 Clinical Trials

Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

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

This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.

NCT ID: NCT04709575 Completed - Allergic Rhinitis Clinical Trials

Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

Start date: January 14, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.