914,565 results match your criteria controlled trial


Precription Digita Thraputic for atients with nsomnia ( a protocol for a pragmatic randomised controlled trial.

BMJ Open 2022 Aug 8;12(8):e062041. Epub 2022 Aug 8.

Center for Outcomes Research and Evaluation, Yale-New Haven Health, New Haven, Connecticut, USA.

Introduction: Cognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation. Read More

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PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores.

BMJ Open 2022 Aug 8;12(8):e064165. Epub 2022 Aug 8.

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Introduction: Frailty is a strong predictor of adverse postoperative outcomes. Prehabilitation may improve outcomes after surgery for older people with frailty by addressing physical and physiologic deficits. The objective of this trial is to evaluate the efficacy of home-based multimodal prehabilitation in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery. Read More

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Long-term outcomes following antenatal exposure to low-dose aspirin: study protocol for the 4-year follow-up of the APRIL randomised controlled trial.

BMJ Open 2022 Aug 8;12(8):e060632. Epub 2022 Aug 8.

Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Obstetrics and Gynaecology, De Boelelaan 1117, Amsterdam, The Netherlands.

Introduction: The use of low-dose aspirin by pregnant women to prevent preterm pre-eclampsia is gradually increasing. The administration of aspirin during pregnancy improves perinatal outcome, which could translate into improved child outcome in the long term. However, antenatal exposure to aspirin could have adverse effects on child development that may manifest later in life. Read More

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The relevance of urolithins-based metabotyping for assessing the effects of a polyphenol-rich dietary intervention on intestinal permeability: A post-hoc analysis of the MaPLE trial.

Food Res Int 2022 Sep 9;159:111632. Epub 2022 Jul 9.

Biomarkers and Nutrimetabolomics Laboratory, Department de Nutrició, Ciències de l'Alimentació i Gastronomia, Food Innovation Network (XIA), Institut de Recerca en Nutrició i Seguretat Alimentària (INSA), Facultat de Farmàcia i Ciències de l'Alimentació, Universitat de Barcelona (UB), 08028 Barcelona, Spain; Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Instituto de Salud Carlos III, Madrid 28029, Spain. Electronic address:

A polyphenol-rich diet reduced intestinal permeability (IP) in older adults. Our aim was to evaluate if participants categorized according to urolithin metabotypes (UMs) exhibited different responses in the MaPLE trial. Fifty-one older adults (mean age: 78 years) completed an 8-week randomized-controlled-crossover trial comparing the effects of a polyphenol-rich vs. Read More

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September 2022

The Effect of a Plastic Barrier Drape on Resuscitation Performance and Provider Contamination: A Randomized Controlled Simulation-Based Pilot Trial.

Simul Healthc 2022 Aug 5. Epub 2022 Aug 5.

From the CHLA Las Madrinas Simulation Center (L.C.Y., O.D., T.H., A.R., M.C., T.P.C.), Children's Hospital Los Angeles; Department of Anesthesiology & Critical Care Medicine (J.L., A.R., E.A.B., T.P.C.), Children's Hospital Los Angeles; Clinical Services, Respiratory Care (J.B., L.L., E.D.), Children's Hospital Los Angeles; Division of Emergency Medicine & Transport (C.L.), Children's Hospital Los Angeles; Clinical Services, Division of Nurse Professional Development (M.C.), Children's Hospital Los Angeles, Los Angeles; LC Young Nursing Consultants (L.C.Y.), Anaheim; Respiratory Care, Adventist Health Portland (L.L.), Colton; Keck School of Medicine (J.L., C.L., A.R., E.A.B., T.P.C.), University of Southern California, Los Angeles, CA; and Johns Hopkins Simulation Center (O.D.), Baltimore, MD.

Background: Patient barriers to protect health care workers from COVID-19 exposure have been studied for airway management. Few are tested for cardiopulmonary resuscitation (CPR). We sought to determine whether a plastic drape barrier affects resuscitation performance and contamination risks for a simulated cardiopulmonary arrest scenario. Read More

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Is Myofascial Decompression Effective at Increasing Hamstring Flexibility in the Athletic Population? A Critically Appraised Topic.

J Sport Rehabil 2022 Aug 8:1-5. Epub 2022 Aug 8.

Rehabilitation Sciences, Doctor of Athletic Training, Moravian College, Bethlehem, PA,USA.

Clinical Scenario: There are a variety of therapeutic modalities used to treat flexibility issues in athletes, which can be the main cause of hamstring injuries. Myofascial decompression is one modality used to treat these patients.

Focused Clinical Question: Is myofascial decompression effective at increasing hamstring flexibility in the athletic population? Summary of Search, "Best Evidence" Appraised, and Key Findings: The literature was searched for studies of level 2 evidence or higher that investigated the use of myofascial decompression to increase hamstring flexibility, that were published in the last 5 years. Read More

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Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo controlled randomized trial in healthcare workers.

Clin Microbiol Infect 2022 Aug 5. Epub 2022 Aug 5.

Ministry of Health, Madrid, Spain.

Objective: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk.

Methods: EPICOS is a double-blind, placebo-controlled randomized trial conducted in Spain, Bolivia, and Venezuela. Healthcare workers with negative SARS-CoV-2 IgM/IgG test were randomly assigned to: daily TDF/FTC plus HCQ for 12 weeks, TDF/FTC plus HCQ placebo, HCQ plus TDF/FTC placebo and TDF/FTC placebo plus HCQ placebo. Read More

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Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery.

Rev Esp Cir Ortop Traumatol 2022 Aug 5. Epub 2022 Aug 5.

Hospital Universitario Puerta del Mar, Avenida Ana de Viya, 21, 11009, Cádiz, España.

Objective: Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty.

Material And Method: A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. Read More

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N-acetylcysteine as prophylactic therapy for transplant-associated thrombotic microangiopathy: a randomized, placebo-controlled trial.

Transplant Cell Ther 2022 Aug 5. Epub 2022 Aug 5.

National clinical research center for hematologic diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China; Institute of Blood and Marrow Transplantation, Collaborative Innovation Center of Hematology, Soochow University, Suzhou, China; Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, Suzhou, China; State Key Laboratory of Radiation Medicine and Protection, Soochow University, Suzhou, China. Electronic address:

Background: Transplant-associated thrombotic microangiopathy (TA-TMA) is a life-threatening complication for patients undergoing hematopoietic stem cell transplantation (HSCT). N-acetylcysteine (NAC) has recently been considered as a potential treatment for patients with thrombotic thrombocytopenic purpura.

Objectives: To assess the value of NAC for the prevention of TA-TMA, we conducted a prospective study at the First Affiliated Hospital of Soochow University. Read More

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Focal vibration of the plantarflexor and dorsiflexor muscles improves poststroke spasticity: a randomized single-blind controlled trial.

Ann Phys Rehabil Med 2022 Aug 5:101670. Epub 2022 Aug 5.

Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, People's Republic of China.. Electronic address:

Background: Post-stroke spasticity is a cause of gait dysfunction and disability. Focal vibration (FV) of agonist-antagonist upper limb muscle pairs reduces flexor spasticity; however, its effects on ankle plantarflexor spasticity are uncertain.

Objective: To assess the effects of focal vibration administered by a trained operator to the ankle plantarflexor and dorsiflexor muscles on post-stroke lower limb spasticity. Read More

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Evaluation of the efficacy and safety of Unani Formulations in Pityriasis Versicolor: A randomized controlled trial.

J Ethnopharmacol 2022 Aug 5:115603. Epub 2022 Aug 5.

Drug Standardization Research Unit, National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, Eragadda, Hyderabad, 500032, India. Electronic address:

Ethnopharmacological Relevance: Pityriasis Versicolor (PV) is a commonly encountered infection of the skin caused by Malassezia species. Despite effective conventional antifungal drugs, the prevention and treatment of PV remain a challenge. The Unani pharmacopoeial preparations Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) have been used in the treatment of PV for a long time. Read More

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Efficacy of opioids in preemptive multimodal analgesia for total knee arthroplasty: a prospective, double-blind, placebo-controlled, randomized trial.

J Arthroplasty 2022 Aug 5. Epub 2022 Aug 5.

Department of Orthopaedics surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu 610041, China. Electronic address:

Background: Preemptive multimodal analgesia is a commonly used technique to control pain following total knee arthroplasty (TKA). This study aimed to evaluate the efficacy of preemptive opioids for pain management in patients who underwent TKA.

Methods: In this prospective, double-blind, placebo-controlled, randomized trial, 100 patients who underwent TKA at our hospital were randomized to the oxycodone or control group. Read More

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Flavonoid-containing supplements for preventing acute respiratory tract infections: A systematic review and meta-analysis of 20 randomized controlled trials.

Complement Ther Med 2022 Aug 5:102865. Epub 2022 Aug 5.

Department of Endocrinology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510000, China. Electronic address:

Background: This systematic review and meta-analysis was conducted to investigate the efficacy and safety of flavonoid-containing supplements in preventing acute respiratory tract infection (ARTI).

Methods: Randomized controlled trials (RCTs) investigating the effects of flavonoid-containing supplements on ARTI prevention in the aspects of ARTI incidence, mean ARTI sick days, symptoms, bio-immune markers, and adverse effects were searched in 5 databases. Data were searched from inception to November 26, 2021. Read More

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Training for occupational health physicians to involve significant others in the return-to-work process of workers with chronic diseases: a randomized controlled trial.

Disabil Rehabil 2022 Aug 8:1-11. Epub 2022 Aug 8.

Department of Health Sciences, Community and Occupational Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Purpose: To determine the efficacy of the "Training for Occupational health physicians To Involve Significant others" (TOTIS) e-learning module for improving occupational health physicians' (OHPs) knowledge, attitudes, and self-efficacy regarding involving significant others in the return-to-work process.

Materials And Methods: A randomized controlled trial with 87 OHPs, involving an intervention group and a wait-listed control group. Between-group differences in knowledge, attitude, and self-efficacy outcomes, and retention of effects were assessed using ANOVA and paired -tests. Read More

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Effect of 5-hydroxytryptophan on fatigue in quiescent inflammatory bowel disease: a randomized controlled trial.

Gastroenterology 2022 Aug 5. Epub 2022 Aug 5.

Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.

Background And Aims: Fatigue is highly prevalent among patients suffering from inflammatory bowel disease (IBD) and only limited treatment options are available. Based on the hypothetical link between low serum tryptophan concentrations and fatigue, we determined the effect of 5-hydroxytryptophan supplementation on fatigue in patients with inactive IBD.

Methods: A multicenter randomized controlled trial was performed at 13 Belgian hospitals, including 166 patients with IBD in remission but suffering from fatigue defined by a fatigue Visual Analog Scale (fVAS) ≥5. Read More

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Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

Am Heart J 2022 Aug 5. Epub 2022 Aug 5.

Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). Read More

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Is less more? Dismantling imaginal retraining and examining the effects of psychoeducation and embodied cognition on craving and alcohol consumption in problem drinkers: A randomized controlled trial.

Addict Behav 2022 Jul 16;135:107429. Epub 2022 Jul 16.

University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Neuroplasticity Working Group, Martinistr. 52, 20246 Hamburg, Germany; Max Planck Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, Lentzeallee 94, 14195 Berlin, Germany. Electronic address:

Background: Imaginal retraining, a type of approach-bias-modification performed in one's own imagination, is effective in reducing alcohol craving in problem drinkers. This study aims to segregate three main components of the original technique and compare their effectiveness in reducing craving and alcohol consumption.

Methods: The study was conducted online. Read More

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Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Authors:

Ann Intern Med 2022 Aug 9. Epub 2022 Aug 9.

Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

Design: Double-blind, randomized, placebo-controlled, clinical trial. Read More

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Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults.

N Engl J Med 2022 Jul;387(4):299-309

From the Division of Endocrinology, Diabetes, and Hypertension (M.S.L., S.H.C., K.A.R.), the Division of Preventive Medicine (N.R.C., E.K., I.-M.L., J.E.B., J.E.M.), and the Department of Radiology (B.K.), Brigham and Women's Hospital, Harvard Medical School (M.S.L., S.H.C., N.R.C., B.K., I.-M.L., J.E.B., J.E.M.), and the Department of Epidemiology, Harvard T.H. Chan School of Public Health (N.R.C., I.-M.L., J.E.B., J.E.M.) - all in Boston; California Pacific Medical Center Research Institute (P.M.C.), and the Departments of Epidemiology and Biostatistics (P.M.C., D.C.B., D.B.) and Medicine (D.C.B.), University of California, San Francisco - both in San Francisco; and the Department of Endocrinology, Creighton University School of Medicine, Omaha, NE (J.C.G.).

Background: Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.

Methods: In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D (2000 IU per day), n-3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Read More

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Optimized dual therapy for treatment-naive patients of Helicobacter pylori infection: A large-scale prospective, multicenter, open-label, randomized controlled study.

Helicobacter 2022 Aug 8. Epub 2022 Aug 8.

Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Background: The efficacy and safety of high-dose amoxicillin (AMX) and proton pump inhibitors (PPI) dual therapy raises much more attention in recent years. Comparative studies among the dual therapies are required to explore more suitable regimens. This study compared the efficacy, adverse events, and patient compliance of three different high-dose dual regimens in treatment-naive patients of Helicobacter pylori (H. Read More

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Evaluation of an on-site sanitation intervention against childhood diarrhea and acute respiratory infection 1 to 3.5 years after implementation: Extended follow-up of a cluster-randomized controlled trial in rural Bangladesh.

PLoS Med 2022 Aug 8;19(8):e1004041. Epub 2022 Aug 8.

Department of Forestry and Environmental Resources, North Carolina State University, Raleigh, North Carolina, United States of America.

Background: Diarrhea and acute respiratory infection (ARI) are leading causes of death in children. The WASH Benefits Bangladesh trial implemented a multicomponent sanitation intervention that led to a 39% reduction in the prevalence of diarrhea among children and a 25% reduction for ARI, measured 1 to 2 years after intervention implementation. We measured longer-term intervention effects on these outcomes between 1 to 3. Read More

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Spine Treatment Appraisal Report (STAR): Tranexamic Acid in Patients Undergoing Noncardiac Surgery: The POISE-3 Trial.

Authors:
Joseph R Dettori

Global Spine J 2022 Aug 8:21925682221117132. Epub 2022 Aug 8.

Spectrum Research, Inc, Steilacoom, WA, USA.

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Umbilical venous catheter- and peripherally inserted central catheter-associated complications in preterm infants with birth weight < 1250 g : Results from a survey in Austria and Germany.

Wien Med Wochenschr 2022 Aug 8. Epub 2022 Aug 8.

Department of General Pediatrics and Neonatology, Saarland University Medical Center, Kirrberger Str., Building 9, 66421, Homburg, Germany.

Background And Objective: Umbilical venous catheters (UVC) and peripherally inserted central catheters (PICC) are commonly used in preterm infants but have been associated with a number of serious complications. We performed a survey in Austria and Germany to assess the use of UVCs and PICCs in preterm infants with a birth weight < 1250 g and associated rates of catheter-related adverse events.

Methods: Electronic survey of participating centers of the NeoVitaA trial. Read More

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Emotional dysregulation and linguistic patterns as a defining feature of patients in the acute phase of anorexia nervosa.

Eat Weight Disord 2022 Aug 8. Epub 2022 Aug 8.

Department of Human Neurosciences, Sapienza University, Rome, Italy.

Purpose: This research aims to analyze the relationship between emotional regulation and the symbolic process in autobiographical narratives of a group of individuals diagnosed with restrictive anorexia nervosa (AN), compared to a non-clinical group. The study is framed within multiple code theory (MCT) (Bucci, 1997; 2021), which considers mind-body integration. The purposes of this study are to investigate whether participants of the AN group will show greater alexithymia and emotional dysregulation than the non-clinical group; and whether the specific linguistic and symbolic features, such as somato-sensory words, affect words, and difficulty in the symbolizing process will predict the AN group. Read More

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A systematic review and meta-analysis of randomised controlled trials in the management of neovascular glaucoma: absence of consensus and variability in practice.

Graefes Arch Clin Exp Ophthalmol 2022 Aug 8. Epub 2022 Aug 8.

The Medical School, Guy's King's & St Thomas' Medical School, King's College London, University of London, London, UK.

Purpose: Neovascular glaucoma (NVG) is characterised by neovascularisation of the angle and therefore elevated intraocular pressure (IOP). This results in progressive optic neuropathy and loss of visual acuity. Treatment aims to reduce IOP in order to prevent optic nerve damage. Read More

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Evaluation of post laparoscopic cholecystectomy pain after subcutaneous injection of lidocaine at port site versus lidocaine spray on gallbladder bed after cholecystectomy: a randomized controlled trial.

Langenbecks Arch Surg 2022 Aug 8. Epub 2022 Aug 8.

Department of Surgery, Arak University of Medical Sciences, Arak, Iran.

Purpose: The efficacy of intraperitoneal (IP) and incisional use of local anesthesia in laparoscopic cholecystectomy is a promising subject regarding post-operative pain control. In this study, we aim to compare these methods using lidocaine as the local anesthetic.

Methods: This study was a double-blinded randomized controlled trial. Read More

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The late onset of emotional distress in people with progressive multiple sclerosis during the Covid-19 pandemic: longitudinal findings from the CogEx study.

J Neurol 2022 Aug 8. Epub 2022 Aug 8.

Department of Neurology, Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX, USA.

Objective: An earlier follow-up study from the CogEx rehabilitation trial showed little change in symptoms of depression, anxiety and psychological distress during the first COVID-19 lockdown compared to pre-pandemic measurements. Here, we provide a second follow-up set of behavioral data on the CogEx sample.

Methods: This was an ancillary, longitudinal follow-up study in CogEx, a randomized controlled trial of exercise and cognitive rehabilitation in people with progressive MS involving 11 centres in North America and Europe. Read More

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The Watts Connectedness Scale: a new scale for measuring a sense of connectedness to self, others, and world.

Psychopharmacology (Berl) 2022 Aug 8. Epub 2022 Aug 8.

Centre for Psychedelic Research, Imperial College London, London, UK.

Rationale: A general feeling of disconnection has been associated with mental and emotional suffering. Improvements to a sense of connectedness to self, others and the wider world have been reported by participants in clinical trials of psychedelic therapy. Such accounts have led us to a definition of the psychological construct of 'connectedness' as 'a state of feeling connected to self, others and the wider world'. Read More

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