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NCT ID: NCT05082168 Recruiting - Sepsis Clinical Trials

Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients

PROFICIENT
Start date: February 1, 2021
Phase:
Study type: Observational

Capnodynamic monitoring has the potential to offer continuous and non-invasive measurements of heart and lung function in patients requiring ventilation in an intensive care setting. Since mechanical ventilation with full patient synchronization is commonly used in ICU, capnodynamic monitoring can be immediately embedded in clinical care and compared to current methods of monitoring cardiac output, lung volumes and oxygen delivery. This observational study will explore capnodynamic monitoring in mechanically ventilated patients with a range of cardiorespiratory compromise.

NCT ID: NCT05082051 Completed - Clinical trials for Exocrine Pancreatic Insufficiency

Oral CDX-7108 in Healthy Adults and EPI Subjects

Start date: October 11, 2021
Phase: Phase 1
Study type: Interventional

Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency. No clinical studies have yet been performed with CDX-7108 and its effects in humans are unknown. This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety, tolerability, pharmacokinetics (PK) of escalating single and multiple oral doses of CDX-7108 in healthy adult subjects and to evaluate the pharmacodynamics of a single dose of oral CDX-7108 in a proof-of-concept (POC) study in subjects with exocrine pancreatic insufficiency (EPI).

NCT ID: NCT05081609 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

IL Believe
Start date: January 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

NCT ID: NCT05081557 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

AD-VISE
Start date: November 17, 2021
Phase:
Study type: Observational

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants >=12 years old in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

NCT ID: NCT05081245 Recruiting - Clinical trials for Autism Spectrum Disorder

ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

Start date: September 13, 2022
Phase: Phase 2
Study type: Interventional

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.

NCT ID: NCT05080283 Completed - Clinical trials for Adult Cochlear Implant Recipients

Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.

PINNA
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN'.

NCT ID: NCT05079919 Active, not recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT05079230 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

ENHANCE-3
Start date: July 7, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

NCT ID: NCT05077904 Recruiting - Clinical trials for Stereotypical Prolonged Seizures

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Start date: December 7, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

NCT ID: NCT05076617 Enrolling by invitation - Clinical trials for Stereotypical Prolonged Seizures

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

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

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.