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NCT ID: NCT04507321 Completed - HIV Infections Clinical Trials

Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254

Start date: September 24, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants. This study will assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using [14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism and excretion following administration of a [14C]-radiolabeled oral suspension. Each participant will be involved in the study for up to 10 weeks which will include a screening period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least 13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in treatment Period 2.

NCT ID: NCT04507256 Completed - COVID-19 Clinical Trials

AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.

NCT ID: NCT04505189 Completed - Anorexia Nervosa Clinical Trials

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Start date: May 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group.

NCT ID: NCT04504838 Completed - Asthma Clinical Trials

The Asthma Breathing Record Study

ABRS
Start date: February 11, 2020
Phase:
Study type: Observational

The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.

NCT ID: NCT04504435 Completed - Leishmaniasis Clinical Trials

Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants

Start date: September 29, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH) study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of a single ascending dose (SAD), crossover design where each participant will receive a maximum of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period, according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a 2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1 regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate the effect of safety, tolerability and PK of a single dose of GSK3494245 following food administration.

NCT ID: NCT04503811 Completed - Frailty Clinical Trials

Sense of Control in Frail Older Persons

CONtrol
Start date: September 15, 2021
Phase:
Study type: Observational

The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England. In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. The researcher is interested in understanding participants' experiences of a sense of control and how health and social care services affect this experience. Although research has shown that rehabilitation can be effective in maintaining physical activity often frail older people do not wish to take up the rehabilitation services provided. Research in this area has been dominated by health care professionals' views about frailty and how services should be provided. Services could be improved by learning from the first-hand experiences of older people living with frailty and what they feel increases their level of control and wellbeing within their service use. The factors which increase their sense of control and wellbeing can then be built into future service development, inform care policies, and provide new understanding for future research to develop services which are more attractive and relevant for older frail people. All persons aged 65 years and over, with a diagnosis of frailty will be eligible to take part in one to one interviews with the researcher. From the interviews principles underpinning good practice which enhances the sense of control and wellbeing in older people's lives and within the services received will be identified. These will be shared with professional care providers including nurses, doctors, and physiotherapists who routinely work with frail older people to gain insights into how these principles can be integrated into practice and developed in policy and future service development. The findings will, therefore, help to develop services which ensure that they are supportive and increase a sense of control in life rather than getting in the way of this. The study is expected to last 12 months and up to 30 participants (20 older people and 10 Hospital staff) will be recruited to take part in the study.

NCT ID: NCT04503512 Completed - Clinical trials for Osteo Arthritis Knee

Surgical Excision of the Fat Pad

Start date: October 23, 2012
Phase: N/A
Study type: Interventional

Introduction: The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located intra-articularly. Its function is not well known. During knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. Other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. This surgical step fat pad resection is a very small part of the whole total knee replacement procedure. A previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (P = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening. A randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. However this study did not evaluate the functional outcome in both groups. To our knowledge, there are no RCT looking at the effect of the excision or preservation of the fat pad in TKR and the functional outcomes post operatively. Study Hypothesis: Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

NCT ID: NCT04502862 Completed - Asthma Clinical Trials

A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

MORPHEO
Start date: August 10, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: - To evaluate the effect of dupilumab on additional patient reported sleep outcomes - To evaluate the effect of dupilumab on objective sleep assessment - To evaluate the effect of dupilumab on asthma symptoms - To evaluate the effect of dupilumab on lung function - To evaluate the safety of dupilumab

NCT ID: NCT04502615 Completed - Clinical trials for Single Leg Hop Grass Surface

Effect of Sand on Knee Load and Muscle Activity During a Single Leg Landing Task

Start date: March 3, 2020
Phase: N/A
Study type: Interventional

This study evaluates the effect of different surfaces on the load experienced by the knee when landing from a single leg hop. A sand, pliable grass and firm (hard floor) surface will be compared when hopping from a 30 cm height. Each subject will complete 5 hops on each surface in a random order. The muscle activity in selected muscles of the lower limb will also be investigated to see how this differs in the landing leg, when landing on the different surfaces.

NCT ID: NCT04501978 Completed - Covid19 Clinical Trials

ACTIV-3: Therapeutics for Inpatients With COVID-19

TICO
Start date: August 4, 2020
Phase: Phase 3
Study type: Interventional

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.