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NCT ID: NCT06072157 Recruiting - Clinical trials for Healthy Participants

Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria

Start date: August 28, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. The study will be conducted in 4 parts: a single-ascending dose part (Part A) in healthy participants, a multiple-ascending dose part (Part B) in healthy participants with an expanded cohort (Part C) in participants with chronic spontaneous urticaria (CSU), and a single ascending dose SC injection cohort (Part D) in healthy participants.

NCT ID: NCT06071793 Recruiting - Critical Illness Clinical Trials

Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

FIT-ICU
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay. The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.

NCT ID: NCT06069700 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Protocol Summary The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ. Sample Size: N= 50 Study Population Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; have a chronic infectious disease; uncontrolled hypertension; other neurological disorders (not attributed to their primary diagnosis); cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities; those with pacemakers or elevated cardiovascular risk; ongoing litigation surrounding their injury; have been diagnosed with a moderate or severe brain injury prior to enrolment; post-concussive symptoms persisting beyond 12-months. Study Design The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations. Start Date: May 2023 End Date: September 2025 Primary Objective: The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.

NCT ID: NCT06068842 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer

METRIX
Start date: November 3, 2023
Phase:
Study type: Observational

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial.

NCT ID: NCT06067828 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

ATHLOS
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

NCT ID: NCT06067789 Recruiting - Surgery Clinical Trials

The ALOFT Pilot Trial

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

The ALOFT Pilot Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) of neuraxial versus general anesthesia for lower limb revascularization surgery that are necessary to support a successful, large-scale evaluation. We will concurrently use implementation science methodology to further refine processes for the larger trial. The future full ALOFT trial will be designed to evaluate the comparative effectiveness of two different anesthesia types for improving outcomes.

NCT ID: NCT06067230 Recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults

Start date: October 6, 2023
Phase: Phase 3
Study type: Interventional

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

NCT ID: NCT06066684 Recruiting - Clinical trials for Osteo Arthritis Knee

Pain Phenotyping in Knee OA: a Pilot Trial

Start date: September 18, 2023
Phase:
Study type: Observational

Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Despite TKA resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'TKA non-responders'. Two pain conditions - myofascial pain syndrome (MPS) and central sensitization - frequently coexist with signs of OA and may contribute to a TKA non-responder profile. MPS, caused by knots within skeletal muscle, can contribute to an OA patient's pain and dysfunction. In central sensitization, faulty pain sensing leads to increased pain sensitivity. However, there is currently no established process to identify these sources of pain and potential associated TKA non-responder risk. Our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential TKA nonresponders. This new approach may increase healthcare efficiency (reduce TKA waitlist and length of hospital stay), and help patients receive the right care at the right time.

NCT ID: NCT06066528 Recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

SYNCHRONIZE™-2
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06066307 Recruiting - Olfactory Disorder Clinical Trials

Olfactory Performance in Culinary Arts Students

Start date: September 25, 2023
Phase: Phase 4
Study type: Interventional

The COVID-19 pandemic brought impaired smell and taste to the forefront of international public awareness and clinical importance. Loss of smell can impair awareness of environmental hazards, alter appetite, and have negative effects on social behavior and well-being. Despite the significant functional impact associated with impaired olfaction, few effective treatments are available. Olfactory training (OT), the mainstay of treatment, is a self-administered therapy which involves a routine of repetitive brief odor exposures over several weeks. The process has been shown to improve odor discrimination, identification and detection threshold. However, the structured design and daily time commitment may be difficult to adopt for some patients, leading to poor compliance. Moreover, OT only exposes patients to a limited number of odours, failing to replicate the complexity of odor mixtures experienced daily in our chemosensory environment. OT has mainly been studied with four conventional odours encompassing the major odor categories; phenyl ethyl alcohol/rose (flowery odor), eucalyptol (aromatic), citronellal/lemon (fruity), and eugenol (clove) (resinous); however, this neglects the importance of emphasizing odors that culturally specific or personally relevant to the patient. For some patients, these factors could hinder their ability to adopt and comply with therapy. In contrast, cooking is a culturally ubiquitous activity that is already performed daily by most people, and naturally exposes us to personally meaningful and culturally relevant odors. However, there have been no published studies investigating the impact that odors encountered during meal preparation have on olfactory performance and development. The present study aims to compare the olfactory effects of culinary skills training to those of a conventionally designed OT program. To achieve this, olfactory testing will be conducted on students enrolled in a professional culinary skills training program at Fanshawe College, and a control group consisting of students in non-olfactory dependent programs at the same institution. To compare the effect of cooking to conventional OT, the study will be repeated for a second semester and students will be asked to perform concurrent OT.