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NCT ID: NCT04622735 Completed - Acute Pain Clinical Trials

Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction

Start date: February 22, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

NCT ID: NCT04622020 Completed - Clinical trials for Whiplash Associated Disorder

Cervical Plexus Block (CPB) in Whiplash Associated Disorder (WAD)

Start date: June 26, 2020
Phase:
Study type: Observational

Whiplash is the most common injury associated with motor vehicle accidents and a major cause of disability and litigation. An acute whiplash injury follows sudden or excessive hyperextension, hyper flexion, or rotation of the neck affecting the soft tissues. It typically results from rear-end or side-impact motor vehicle collisions. Patients commonly present with pain and stiffness in the neck, headache, and upper backache. Chronic whiplash syndrome is characterized by symptoms of neck pain that persist for more than 3 months (1, 2). With over half a million people making whiplash injury claims per annum in the UK, it has a major impact on the healthcare and legal systems and also the economy. Over 40% of patients with whiplash injury report chronic neck pain and this is often refractory to conservative management (pain relief medications, physiotherapy). Current treatment involves burning the small nerves that supply the joints (facet joints) in the neck. Although they provide pain relief that can last 6-9 months, the nerves re-grow and the treatment has to be repeated. This treatment is a complex procedure that requires extensive training and has the potential to cause serious harm. There is new evidence to show that the pain in whiplash injury could be due to an impaired function of the neck muscles arising from whiplash trauma. Current treatment for this condition is injection of numbing medicine or steroids directly into the muscle. Although this treatment is safer than burning the facet nerves, it provides short-term relief. The investigators have shown that a novel treatment targeting the nerves that supply the muscles in the neck can provide durable relief in patients with chronic neck pain. The medication is injected into a specific area (plane) in the neck of the patient and is called cervical plexus block (CPB). The investigators currently offer CBP treatment as a standard treatment in the management of patients with chronic neck pain arising from whiplash injury. There are two types of CPB: CPB with numbing medicine (CPB-LA) and CPB with steroid. Aim of the study is to evaluate the effectiveness of two types of Cervical Plexus Block (CPB) treatment in reducing pain at three months in patients with refractory chronic neck pain from whiplash injury Methods: The proposed study is a prospective, observational pilot study that will be conducted at Leicester General Hospital over 36 months. Potential participants will be given an information sheet by the clinical team when they are seen in the outpatient clinic. The participants will have 24 hours to read the information sheet. Thereafter, the research team will approach the potential participant to obtain informed consent. After providing written consent, adult patients with chronic neck pain from whiplash injury will receive ultrasound guided CPB-LA in the theatre. If treatment provides >30% relief at 3 months, they will be re-assessed at six months and CPB-LAi will be repeated as per waiting list. If at 3 months, the pain returns to the baseline, CPB with steroid will be performed. If CPB with steroid does not provide any benefit, the participants will receive a rescue treatment (trigger point injection) within three months. Participants will be asked to complete questionnaires on pain scores and mood. Participation in the study will end at 9 months following the first CPB treatment on completion of relevant questionnaires.

NCT ID: NCT04621903 Completed - Covid19 Clinical Trials

A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

Start date: October 8, 2020
Phase: N/A
Study type: Interventional

The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

NCT ID: NCT04619628 Completed - COVID-19 Clinical Trials

Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19

Start date: December 11, 2020
Phase: Phase 1
Study type: Interventional

This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.

NCT ID: NCT04619550 Completed - Clinical trials for Osteoarthritis, Knee

Gait, Pain and Physical Activity After HTO

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

This study aims to investigate the relationship between pain, gait and activity intensity in HTO patients that are healed and have had their fixation plate removed. Inclusion criteria are: unilateral HTO with no concurrent procedure performed, fixation plate has since been removed, no subsequent operations performed on the lower limbs (hips to feet). Control participants will be recruited through local advertisements in and around the University of Winchester. Inclusion criteria for the control subjects are: no current pain in the lower limbs, no previous surgery on the lower limbs. Control subjects will also be age-matched to the HTO group. Knee function and pain scores will first be assessed through the implementation of a Knee Osteoarthritis Outcome Score, a Visual Analogue Scale, and a further pain intensity scale. Once this has been done, resting heart rate (HR) and body mass index (BMI) will also be measured as part of the completion of a Physical Activity Readiness Questionnaire (PAR-Q). A G-Walk gait analysis sensor, which has been validated for use in clinical settings, will then be attached to participants in order to measure spatiotemporal gait parameters during testing. Each participant will then conduct a series of four walking and four jogging test protocols, each lasting three minutes, on a flat treadmill. The intensity at which the participant must walk or jog during each test will be self-regulated and determined by a rating of perceived exertion (RPE) of 9, 11, 13 or 15 on a 6-20 Borg scale. All participants will be verbally anchored to the Borg scale before conducting the first walk/jog test. The order in which the tests are performed will be randomised in advance of each test session. Half way through each test (90 seconds), participants will be presented with a VAS and pain intensity scale to indicate the current level of pain they are experiencing in their knee. At this stage, they will also be asked to confirm that they are still maintaining the target RPE of that particular test. Once a test is finished, participants will complete another VAS and pain intensity scale and rest in a seated position until their heart rate returns to their pre-determined resting level before the next test commences. The leg for which healthy controls report pain levels will be chosen randomly prior to the test session.

NCT ID: NCT04618341 Completed - Depression Clinical Trials

A Clinical Study of Online Active Play Program With Adolescents

Start date: March 30, 2020
Phase:
Study type: Observational

To assess the efficacy of an online, active play program (Revival Active Program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old. Program was conducted during Covid-19 lockdown from March 2020 to June 2020 to support children and families in isolation.

NCT ID: NCT04618211 Completed - Clinical trials for Hereditary Angioedema

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

RAPIDe-1
Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

NCT ID: NCT04618185 Completed - Cystic Fibrosis Clinical Trials

Gut Imaging for Function & Transit in CF - GIFT-CF 3

GIFT-CF3
Start date: October 21, 2020
Phase:
Study type: Observational

An observational study of patients with cystic fibrosis (CF) starting treatment with Kaftrio (Elexacaftor / Tezacaftor / Ivacaftor) as part of routine clinical care, following EMA licensing (approved end of Aug 2020). - Patients with CF who are p.Phe508del homozygotes will already be receiving the less effective CFTR modulator drug Symkevi (Tezacaftor / Ivacaftor) and will switch to KaftrioTM. - Patients who are who are compound heterozygotes with at least 1 copy of p.Phe508del currently have access to no effective CFTR modulator and will be starting a CFTR modulator (Kaftrio) for the first time. Participants attend a study visit before Kaftrio treatment commences, followed by visits at 12 and 24 weeks after starting treatment. At each visit they will be scanned before and after standardised meals in the morning and mid-day (11 scans in total over 6 hours). No intravenous contrast or bowel preparation will be used. Participants will complete questionnaires on gastrointestinal symptoms as well as providing stool and sputum samples for assessment of microbiome and stool for inflammatory mediators and pancreatic function (elastase). **Following an extension, participants had a further visit at 76 weeks post starting Kaftrio, updated in detailed description**

NCT ID: NCT04616937 Completed - Anxiety Clinical Trials

Prebiotics and Mental Health: Behavioural

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

A behavioural study of the microbiota-gut-brain axis in brain development and mental health