Clinical Trials Logo

Filter by:
NCT ID: NCT05605678 Recruiting - Hemophilia A Clinical Trials

Hemophilia Non-Interventional Study Prior to SerpinPC Intervention (PRESent-5)

Start date: December 9, 2022
Phase:
Study type: Observational

The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B. Participants in the study may be eligible to enroll in future planned interventional studies to be conducted by Sponsor.

NCT ID: NCT05605210 Active, not recruiting - Fatigue Clinical Trials

Stimulation Sites and Fatigue Induced by Neuromuscular Electrical Stimulation in Healthy Individuals

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Neuromuscular electrical stimulation (NMES) is a tool used in training protocols and in clinical practice to prevent or attenuate atrophy and improve the ability to produce muscle strength in different populations. Although widely used, the effects of NMES can be limited by discomfort and early fatigue induced by electrical current. Previous studies have investigated alternatives to minimize muscle fatigue, reduce muscle discomfort and increase muscle performance. A measure adopted to reduce the NMES's deleterious effects is the choice of stimulation site. More specifically, muscle contractions can be evoked by applying electrical pulses to the trunk of peripheral nerves (nNMES) or terminal branches of the nerve at the muscle belly level (mNMES). There is evidence that the mNMES stimulates the more superficial motor units (MUs), while the deeper MUs of the muscle remain inactivated, or, to recruit them, an additional increase in current intensity and stimulation frequency may be required. On the other hand, in direct nerve stimulation (nNMES) both superficial and deep MUs are recruited regardless of NMES intensity. Based on these observations, a new application modality of NMES emerged, the intercalated nerve and muscle stimulation (iNMES). In this strategy, electrical pulses are intercalated or alternated between the mNMES and nNMES sites, intending to reduce the high frequencies at which the MUs are activated during NMES, recruiting both superficial and deep MUs, and reducing muscle fatigue during evoked contractions. Although iEENM is a promising strategy to potentiate the NMES effects, few studies have investigated the iNMES effects on neuromuscular fatigue, and the existing literature is solely focused on the analysis of the tibialis anterior muscle, limiting the findings' inferences for other muscles important for lower limb functionality (e.g., quadriceps femoris). Therefore, the objective of this study is to compare the effects of nNMES applied to the femoral nerve (FN-NMES), of mNMES applied to the rectus femoris' motor point (MP-NMES), and iNMES applied simultaneously to both sites (FNMP-NMES) on knee extensors' functional (muscle fatigue) and clinical (discomfort) parameters in healthy individuals, through a randomized clinical trial. Our study has three hypotheses. In our first hypothesis, muscle fatigue during an electrical stimulation protocol will be lower with the FNMP-NMES modality, followed by FN-NMES, and will be higher with MP-NMES. Thus, FNMP-NMES will present a smaller reduction in maximal voluntary isometric contractions (MVICs) immediately after the fatigue protocol, a smaller relative reduction between the final compared to the initial evoked torque, a greater number of contractions for the evoked torque to reduce 50% with respect to the initial torque during the NMES fatigue protocol, and a greater total work compared the FN-NMES and MP-NMES modalities. In our second hypothesis, low frequency (20 Hz) NMES will produce greater total work and less fatigability of the knee extensors (smaller reduction from pre to post MVIC, smaller percentage reduction at the final compared to the initial evoked torque, a greater number of contractions for the evoked torque to reduce 50% compared to the initial evoked torque, and greater total work) compared to a high stimulation frequency (100 Hz). Furthermore, the total work will be higher and the fatigability lower with FNMP-NMES, followed by FN-NMES, and finally MP-NMES, regardless of stimulation frequency. Finally, the third hypothesis is that discomfort will be less with FNMP-NMES, followed by FN-NMES, and finally MP-NMES, regardless of stimulation frequency.

NCT ID: NCT05605093 Recruiting - COVID-19 Clinical Trials

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)

Start date: December 23, 2022
Phase: Phase 3
Study type: Interventional

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

NCT ID: NCT05603845 Active, not recruiting - Severe Asthma Clinical Trials

Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

iOUTRUN
Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

NCT ID: NCT05603403 Completed - Clinical trials for Signs and Symptoms, Digestive

Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

Probiatop
Start date: October 20, 2022
Phase: Phase 4
Study type: Interventional

A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiatop in the Treatment of Digestive Symptoms. Phase IV. The casuistic presented in this protocol is 150 participants randomized at a 1:1 ratio (75 receiving Probiatop and 75 receiving placebo), balanced by age, sex, prebiotic intake* and summation of the Gastrointestinal Symptom Rating Scale (GSRS) questions related to the domains of diarrhea (questions 11, 12, and 14), indigestion (questions 6, 7, 8, and 9), and constipation (questions 10, 13, and 15) separated by intensity and frequency. Participants with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of questions 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo.

NCT ID: NCT05603143 Terminated - COVID-19 Clinical Trials

Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

BIRCH
Start date: November 5, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to test how well the study drug, obeldesivir (formerly GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

NCT ID: NCT05601271 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Effect of Allopurinol on Markers of Mineral and Bone Metabolism

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Hyperuricemia is a common condition in patients with chronic kidney disease (CKD) in the glomerular filtration rate. Recently, it has been suggested that uric acid is related to a mineral and bone disease of CKD (CKD-MBD) since the high concentration of uric acid is associated with the harmful effect of vitamin D. The proof of concept of the association between acid uric acid and CKD-MBD is based on a prospective study (sample size 6) that observed, after 1 week of use of allopurinol, an increase in the concentration of 1,25(2D, a result independent of the concentration of calcium, phosphorus, 25(OH)D and PTH. An experimental study found that hyperuricemia could modify the expression of the 1α-hydroxylase enzyme, consequently reducing 1,25(OH). The current study aims to evaluate the action of allopurinol on CKD-MBD biomarkers (25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus). We hypothesize that allopurinol can improve serum levels of 1,25(OH) 2D and PTH. This is a controlled, randomized, double-blind study, defined as a filtration rate < 60ml/1.73 m², according to the CKD-EPI equation. Inclusion criteria: patients with stages III, IV and V CKD who are not on dialysis with a serum level of 25(OH)-vitamin D >20 ng/ml. Exclusion criteria: Patients diagnosed with gout, undergoing treatment with allopurinol, patients already in use and drugs with sensitivity to the drug. Based on a previous study, we calculated a sample for 2 groups (placebo and drug) with pre and post-measurements (a total of 4). Considering a standard deviation of 4 and a difference of 7 in the treated group, 3 in the placebo group, and an alpha error of 5%, we calculated a sample of 25 patients in each arm.

NCT ID: NCT05598203 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

Every year there is an increase in people with diabetes all over the world. Because it is a disease associated with several comorbidities and is increasing, there is a need for more effective treatments. Lifestyle changes combined with medication are the best strategies for the treatment and reduction of comorbidities. Therefore, the present study posits the hypothesis that the integration of nutritional education groups into standard treatment, within a nutrition-specialized outpatient clinic, may yield additional enhancements in health parameters among patients diagnosed with type 2 diabetes. The driving force behind this research lies in the pursuit of more effective strategies to enhance glycemic control, diminish the risk of complications, and elevate the overall quality of life for these patients. Our motivation stems from a commitment to base our interventions on scientific evidence and strive towards meaningful improvements in diabetes management outcomes. A randomized clinical trial will be conducted with adult patients with a previous diagnosis of type 2 diabetes. Patients will be divided into two groups (intervention: nutritional education added the usual care; and control: usual care). The outcomes analyzed will be: glycemic control, lipid profile, body mass and dynapenia obesity, blood pressure values, eating behavior, diabetes complications and adherence to recommendations.

NCT ID: NCT05597735 Recruiting - Monkeypox Clinical Trials

Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

UNITY
Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older). The primary objective is to evaluate the clinical efficacy, as assessed by time to all visible lesion(s) resolution, of tecovirimat treatment + Standard of Care (SOC) compared to placebo + SOC for patients with monkeypox. The secondary objective is to evaluate the clinical efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms and virological shedding, and the safety of tecovirimat treatment + SOC compared to placebo + SOC in patients with monkeypox.

NCT ID: NCT05597423 Completed - Resistance Training Clinical Trials

Massage as Recovery Strategy After Resistance Training

Start date: November 7, 2022
Phase: N/A
Study type: Interventional

Within the routine of resistance training, stimulus are implemented to meet predetermined goals for its practitioners. In order for there to be a balance in the imposed loads, a recovery period is necessary for supercompensation to occur. Recovery is a multifactorial process and to consider an individual recovered it is necessary to respect the integration of physiological, biomechanical and psychological factors, in addition, perceptual markers, which are not widely investigated in the literature, seem to be effective recovery markers. Massage is a technique that stands out for its wide use after physical exercise in order to help accelerate the recovery process. In the literature, studies that investigated the influence of massage on performance did not find positive results and some authors question the real need to apply the technique to aid recovery. However, in the perceptual parameters, massage seems to have a good influence, such as pain reduction, perception of fatigue and improvement in the perception of recovery. Thus, understanding the experience that massage can provide during a training period can be an important outcome along with variables already used. The hypothesis of this study is that massage will improve perceptual parameters over a training period and, consequently, will improve the experience between training sessions without positively or negatively interfering in performance.