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NCT ID: NCT03912636 Completed - Rumination Clinical Trials

Role of Vagal Tone in Rumination Syndrome

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Rumination syndrome is a condition in which people repeatedly and unintentionally regurgitate undigested or partially digested food from the stomach, rechew it, and then either re-swallow it or spit it out. The mechanism of the disease is not well understood. The investigators believe that discomfort in the stomach during and immediately after meals may be an important factor for this disease. The reason for such discomfort can be due to an alteration of nervous regulation of the stomach. The investigators can study the nervous regulation that affects the stomach and other parts of the body by analysing in detail an electrocardiogram that is performed continuously for several hours. From this analysis, The investigators can study a parameter called cardiac vagal tone (CVT). Diaphragmatic breathing (DiaB) is a respiratory exercise, in which people mainly move their abdomen to breath. DiaB is a common treatment for rumination syndrome. Patients doing DiaB can reduce the number of rumination episodes. The mechanism by which DiaB improves rumination is unknown. There is another type of breathing called slow deep breathing (SlowDB), in which people mainly breathe with their chest. SlowDB is used as a therapy for increased pain in the food pipe (oesophagus) and it might also be effective on rumination syndrome. The investigators believe that both DiaB and SlowDB can improve rumination, by modifying the nervous control of the stomach (that the investigators can monitor by measuring continuously cardiac vagal tone (CVT)). The aims of the study are to investigate the association between gastric discomfort during a meal, CVT variations (measured with the electrocardiogram during the meal) and the severity of rumination episodes. The investigators will also study how DiaB and SlowDB can modify this variable during the test. In a second step, The investigators will assess the clinical effect of respiratory exercises (DiaB and SlowDB) on the severity and frequency of regurgitations in patients diagnosed with rumination syndrome. Method This research consists of two separate studies. 1. Study1 (to investigate the mechanism of rumination syndrome) 10 healthy volunteers and 10 rumination patients will join Study1 on 3 separate days. On each visit, the investigators will place electrocardiogram sensors and a belt that can measure the thorax or abdominal movement. All subjects will get instructions to perform SlowDB or DiaB, answer some questionnaires, eat the test meal, perform normal breathing/DiaB/SlowDB for 15 minutes, and stay quietly on the chair for 3 hours. 2. Study 2 (to assess the effect of DiaB and SlowDB on rumination syndrome) 10 patients with rumination syndrome will join Study 2. On the first visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform either DiaB or SlowDB. After the first visit, subjects perform DiaB or SlowDB during 15 minutes after every meal for 4 weeks. On the second visit, subjects will have the test meal, answer the symptom questionnaire 1 hour after the meal, and learn how to perform the other respiratory exercise. After a 2-week break, subjects will perform the other respiratory exercise for the next 4 weeks. On the last visit, subjects will have the test meal and answer the symptom questionnaire 1 hour after the meal.

NCT ID: NCT03912233 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).

NCT ID: NCT03912142 Completed - Clinical trials for Obstetric Anal Sphincter Injury

Diagnosis of Obstetric Anal Sphincter Injuries (OASIs) Using Transperineal Ultrasound Scan (TPUS)

Start date: February 27, 2017
Phase:
Study type: Observational

It is common for women to sustain perineal trauma following their first vaginal delivery. Sometimes these can extend to the anal sphincter, and these are referred to as Obstetric Anal Sphincter Injuries (OASIs). Occasionally OASIs may not be detected at delivery. If these tears are missed they would not be repaired and this may lead to incontinence of wind (flatus) or of faeces, both of which can have a significant impact on quality of life. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the anal sphincter defects and to investigate whether the use of TPUS immediately after primary repair of OASIs is an useful tool to minimise an inadequate repair. The investigators would also like to look at changes that occur to the pelvic floor muscles during labour and to identify injuries to the pelvic floor muscle (levator ani) by ultrasound. Such injury to pelvic floor muscle is associated with vaginal prolapse.

NCT ID: NCT03911713 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Start date: April 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

NCT ID: NCT03909906 Completed - Mood Clinical Trials

Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress

Start date: April 3, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to assess the chronic effects (14 days) of Euphytose® on psychological state, physiological stress responses and any resulting changes in gut microflora communities as compared to placebo.

NCT ID: NCT03909425 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography

DANA
Start date: September 2, 2019
Phase:
Study type: Observational

The purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. The target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition. This is a single-site study and does not involve any masking or treatment allocation.

NCT ID: NCT03909100 Completed - Clinical trials for Non-invasive Fat Reduction

International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

Start date: July 29, 2019
Phase: N/A
Study type: Interventional

This study aims to generate data that conveys participant's experiences such as their overall satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes.

NCT ID: NCT03907982 Completed - Clinical trials for Persistent Atrial Fibrillation

Investigation of Therapeutic Ablation Versus Cardioversion for AF

ORBITA-AF
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.

NCT ID: NCT03907969 Completed - Clinical trials for Advanced Malignancies

A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.

Start date: October 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a modular Phase I/IIa, open-label, multi-centre, study of AZD7648 administered orally, either as a monotherapy, or in combination with either cytotoxic chemotherapies or novel anti-cancer agents in participants with advanced malignancies.

NCT ID: NCT03907748 Completed - Depression Clinical Trials

Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia

HOMESIDE
Start date: November 20, 2019
Phase: N/A
Study type: Interventional

This international study evaluates the impact of home-based caregiver-delivered music and reading interventions for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music or reading intervention with the person they are caring for. The interventions aim to decrease behavioural and psychological symptoms of dementia as well as improve quality of life and well being of both people living with dementia and their caregivers. Participants will be allocated into a music intervention group, a reading intervention group or standard care group. In addition, the researchers will seek to determine the cost-effectiveness of using the music intervention.