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NCT ID: NCT04974333 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes

SANENT
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

The SANENT trial is a primary care-based, prospective, two-arm, randomized controlled, open-label, blinded-endpoint study with the aim to compare a diabetes management strategy using an information board and a mobile application versus standard care in patients with uncontrolled type 2 diabetes. This trial aims to recruit 1440 type 2 diabetes patients during a period of six months until the requested number of participants have been achieved. The total length of the intervention will be one year. The SANENT trial protocol is presented according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) recommendations

NCT ID: NCT04965675 Recruiting - Clinical trials for Chronic Migraine in Children

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

PROSPECT-2
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

NCT ID: NCT04965636 Recruiting - Clinical trials for Hypereosinophilic Syndrome

Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)

SPHERE
Start date: August 24, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.

NCT ID: NCT04964583 Recruiting - Covid19 Clinical Trials

Hidroxicloroquina With Azitromicina Versus Hidroxicloroquina and Placebo Int Patients With Mild COVID-19

Omehecatl
Start date: January 20, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Chloroquine and hydroxychloroquine are two antimalarial drugs that are also used in autoimmune diseases. Chloroquine analogs have been shown to inhibit endosome acidification and exhibit nonspecific antiviral activity at high micromolar concentration in vitro against a wide range of emerging viruses (HIV, dengue, hepatitis C, chikungunya, influenza, Ebola, SARS, and MERS ). virus) and more recently COVID-19. On the other hand, azithromycin is a macrolide antibiotic indicated for infections caused by sensitive pathogens, but which in combination with Hydroxychloroquine has shown a synergistic effect against the SARS-CoV-2 virus. International studies show the lack of beneficial effect in hospitalized or mechanically ventilated patients. Referring that because these medications reduce the in case of having a beneficial effect it would be in the early onset, to avoid inflammation (cytokine storm), and thus prevent hospitalizations. The present study focuses on characterizing the possible synergy of the fixed combination of hydroxychloroquine associated with azithromycin in the treatment of Covid-19 from mild to moderate manifestations. Three treatment schemes are proposed with a 10-day follow-up, a) the fixed combination of Hydroxychloroquine / Azithromycin (combination of interest), b) Hydroxychloroquine (active comparison group) and c) non-active control group, using placebo. A group of patients between 18 and 75 years old is considered, who may or may not present other comorbidities. Follow-up will be carried out through quantification of viral load, evaluation of the systemic inflammatory state, changes in clinical manifestations and possible effect on the reduction of hospitalizations. Therefore, it is proposed to carry out the following project. objective To determine the efficacy and safety of Hydroxychloroquine / Azithromycin fixed combination compared to Hydroxychloroquine or placebo in outpatients with Research design: Phase II, multicenter, prospective, randomized, parallel, longitudinal, double-blind study. Medications to use Group 1. Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days. Group 2. Hydroxychloroquine 200 mg, one tablet every 12 hours for ten days. Group 3. Placebo one tablet every 12 hours for ten days.

NCT ID: NCT04963296 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

ALLEGORY
Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

NCT ID: NCT04961996 Recruiting - Early Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

NCT ID: NCT04960709 Recruiting - Clinical trials for Muscle Invasive Bladder Cancer

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin

VOLGA
Start date: August 5, 2021
Phase: Phase 3
Study type: Interventional

A global phase 3, multicenter, randomized, trial, to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in combination with Enfortumab vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer. The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC). Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

NCT ID: NCT04958265 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

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

This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.

NCT ID: NCT04951622 Recruiting - Myasthenia Gravis Clinical Trials

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

NCT ID: NCT04942002 Recruiting - Treatment Clinical Trials

Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

Start date: June 15, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.