Kornimate/medical-research-clean huggingface dataset:
a study of sativex® for pain relief in patients with advanced malignancy.

Conditions: Palliative Care; Pain; Cancer

Summary: the purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.


Eligibility criteria:
inclusion criteria: * the patient has advanced active cancer for which there is no known curative therapy. * the patient is able (in the investigators opinion) and willing to comply with all study requirements. * the patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. * the patient is receiving a sustained release (sr) fixed dose of opioid therapy (excluding methadone). n.b. the opiate therapy must be step iii according to the world health organization (who) analgesic ladder. * the patient is willing to continue to take their regular daily baseline opioid regimen (sr) at the same dose, throughout the duration of study. exclusion criteria: * the patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. * any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. * any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. * the patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). * the patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.

Keywords: pain cancer palliative
cognitive behavioral therapy group for older adults delivered by telethealth

Conditions: Major Depressive Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder

Summary: the present aim of the study is to to adapt an established, manualized enhanced group cbt (cbt-e) for seniors to a telehealth format, which will allow us to offer the group virtually during the covid-19 pandemic.

the goal of this project is to adapt an established, manualized enhanced group cbt (cbt-e) for seniors to a telemedicine format. currently the geriatric psychiatry service associated with the nova scotia health authority offer two cbt-e groups every year. they are usually facilitated by psychiatry residents, under the supervision of a staff psychiatrist. due to the risk of covid-19, we will not be holding in-person groups this year. instead we will offer the group in a smaller, telemedicine format. for this project, we will change the group structure and activities to allow it's delivery in a virtual format. this study will assess feasibility, tolerability of the telehealth format by using the system usability scale and group satisfaction survey. it will also assess response to online therapy buy using pre- and post-group questionnaires including the beck depression inventory, beck anxiety inventory and perceived quality of life questionnaire. paired t-tests will be used to analyse the data and determine whether there has been an improvement in participant's symptoms and quality of life.

Eligibility criteria:
inclusion criteria: * people over the age of 65 * diagnosis of either or both major depressive disorder (mdd) of mild or moderate severity and an anxiety disorder, including generalized anxiety disorder, social anxiety disorder or panic disorder. exclusion criteria: * patients with psychosis * patients with dementia * patient with severe major depressive disorder or anxiety disorder * patients with antisocial or borderline personality disorder * patients with acute suicidal ideation. * older adults who do not have access to the technology required for group; computer, phone or tablet with a webcam and access to internet these are also exclusion criteria for the cbt group outside of the study. people younger than 65 are also excluded from the group because it is offered to older adults only.
multimodal prehabilitation for colorectal surgery

Conditions: Colorectal Cancer; Colorectal Cancer Stage III

Summary: despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. the pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. the process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. however, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. these results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. in the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.


Eligibility criteria:
inclusion criteria: * referred for scheduled surgery for nonmetastasized colorectal cancer * age \> 18 years old exclusion criteria: * asa 4-5 * poor english or french comprehension * severe co-morbid disease interfering with ability to perform exercise at home or complete testing

Keywords: colorectal cancer colorectal surgery prehabilitation surgical recovery exercise referred for scheduled resection
a group therapy based on the bio-psycho-social treatment approach for women with chronic pelvic and chronic belly pain

Conditions: Pain, Chronic; Pain, Pelvic; Pain, Abdominal; Depression; Sex Disorder; Endometriosis

Summary: the project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

to treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. the therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy. all patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.

Eligibility criteria:
inclusion criteria: women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study exclusion criteria: * no participation in the group therapy * finishing the group therapy prematurely (\>3 missed sessions)

Keywords: coping multidisciplinary group therapy psychotherapy physiotherapy
the effect of aromatherapy on anxiety in patients

Conditions: Anxiety; Pain

Summary: preoperative anxiety is considered a potential and preventable risk factor for postoperative complications.

alot of patients face fear from intervention such as radiofrequency. the group of patients with chronic knee osteoarthritis already and mostly have some sore of psychological upset, radiofrequency itself , even in the presence of good periinterventional local anesthetic infiltration, the patients suffer pain and stress. it is well evidenced that aromatherapy specially with lavender oil offers some sort of anxiety alleviation, pain alleviation and protection against postoperative nausea and vomiting

Eligibility criteria:
inclusion criteria: * adult patients with knee osteoarthritis * scheduled for genicular nerve radiofrequency exclusion criteria: * allergy to lavender * psychological disorders * upper respiratory tract illness
treatment of lower respiratory tract infection in selected hospitals in southern sri lanka (treat-sl)

Conditions: Lower Resp Tract Infection

Summary: this is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (ecdst) for the diagnosis and treatment of lower respiratory tract infection (lrti) among patients at three sites in southern province, sri lanka. the primary objective of this trial is to determine the impact of an electronic clinical decision support tool (ecdst) on clinical outcomes and antibacterial prescription in subjects with lrti in the intervention group compared to the control group. the study will enroll 765 patients ≥ 14 years of age. medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed (a maximum of 14 days).


Eligibility criteria:
inclusion criteria: 1. admitted within prior 48 hours 2. have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following: 1. new cough or sputum production 2. chest pain 3. dyspnea or tachypnea (respiratory rate \>20 breaths/minute) 4. abnormal lung examination 3. have evidence of acute infection, as indicated by at least one of the following: 1. self-reported fever or chills 2. documented fever ≥38 ̊ c (100.4 ̊ f) 3. documented hypothermia \<35.5 ̊ c (95.9 ̊ f) 4. leukocytosis (white blood cell count \>10,000/mm3) 5. leukopenia (white blood cell count \<3000/mm3) 6. new altered mental status 4. ability and willingness of patient, parent or legally authorized representative (lar) to give informed consent 5. ability of children 14-17 years of age to provide assent 6. ability to complete follow-up encounter at 30 days in person or by telephone exclusion criteria: 1. hospitalized recently (within last 28 days) 2. if they have been enrolled into this clinical trial previously 3. surgery in the past 7 days 4. if they are unable or unwilling to complete the follow-up encounter 5. if they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital) 6. if they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials: 1. vasopressor therapy 2. cystic fibrosis 3. known severe immunosuppression (i. cancer or another condition with neutropenia (absolute neutrophil count \<1000/ microl; ii. solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. active graft-versus-host disease or bronchiolitis obliterans; iv. on chronic steroids equivalent to prednisone 20mg daily for ≥ 2 weeks or other targeted cytotoxic or biologic immunosuppressants within the prior 4 weeks; v. human immunodeficiency virus infection with a cd4 cell count \<200/mm3) 4. have an accompanying non-respiratory infection 5. have evidence of a lung abscess or empyema 6. have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation

Keywords: ecdst
open-label safety extension study of gevokizumab in erosive osteoarthritis of the hand

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.


Eligibility criteria:
inclusion criteria: * diagnosis of hand osteoarthritis * joint tenderness and/or redness * at least one erosion by x-ray (as determined by the central reader) * contraceptive measures adequate to prevent pregnancy during the study exclusion criteria: * history of inflammatory disease other than hand erosive osteoarthritis (eoa) including: secondary post-traumatic osteoarthritis (oa); rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia * history of gout, pseudogout, or hemochromatosis * history of allergic or anaphylactic reactions to monoclonal antibodies * history of recurrent or chronic systemic infections * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: erosive osteoarthritis osteoarthritis osteoarthritis of the hand
fumaric acid versus fumaric acid plus narrow band type b ultraviolet (uvb) for psoriasis

Conditions: Plaque Psoriasis

Summary: the main objective of the study is to evaluate the additional effect of a narrow band type b ultraviolet (uvb) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (fae) in comparison to fae monotherapy. the secondary objectives are to evaluate the effect of an additional narrow band uvb therapy on the cumulative fae dose required to reach psoriasis area and severity index (pasi) 75 in comparison to fae monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the fae treatment is a positive predictive factor for the treatment response.


Eligibility criteria:
inclusion criteria: * patient with moderately severe to severe psoriasis (bsa ≥ 10 and pasi ≥ 10) * age between 18 and 80 years old exclusion criteria: * pregnant woman and satisfying women * cancer, chronic infections, autoimmune diseases * gastrointestinal illnesses * liver diseases * renal malfunctions
a study to evaluate the efficacy and safety of ast-001 in asd children

Conditions: Autism Spectrum Disorder

Summary: 1. study purpose: to demonstrate the superiority of ast-001 compared to placebo in improving core symptoms of autism spectrum disorder (asd) in children with asd. 2. background: asd is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. there are no approved medicines to treat the core symptom of asd. although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. ast-001 is developed to treat the core symptom of asd. 3. design: multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial followed by an open-label extension treatment period


Eligibility criteria:
inclusion criteria: * those who meet the criteria of diagnostic and statistical manual of mental disorder (dsm)-5 during screening * during screening period, individuals who are diagnosed with asd through adi-r assessment * subject with a cgi-s score of 4 or higher as a result of clinical global impression(cgi) evaluation during baseline visit(visit 2) * subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form * in case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial * subject whose legally authorized representative is able to participate in the provision of reliable information about the subject's condition, execute all scheduled site visits, oversee ip administration, fully understand and speak korean, and conduct survey evaluation regarding the subject exclusion criteria: * at the time of screening, subject has the medical history, concomitant condition, or surgical history * during the screening period, uncontrolled medical conditions, * during the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator * at the time of screening, weight over 60kg * inappropriate to participate in the trial determined by investigator
testing an evidence-based supported employment model in autistic young adults

Conditions: Autism Spectrum Disorder; Intellectual Disability

Summary: this study aims to enhance employment outcomes for young adults with autism and intellectual and developmental disabilities (idd) through the implementation of an evidence-based supported employment model known as individual placement and support for autism (ips-aut). the study will evaluate the feasibility, acceptability, and effectiveness of ips-aut in promoting competitive integrated employment (cie). the trial will involve partnerships with supported employment agencies, training providers in ips-aut, and assessing employment outcomes and implementation factors. the ultimate goal is to create a scalable, evidence-based employment support model for individuals with autism.

this study builds on prior research and pilot testing of ips in the autism and idd community by implementing a 12-month hybrid type 1 trial to evaluate the effectiveness and implementation of ips-aut. the current study will include three primary aims: consumer support toolbox development: using data from previous focus groups, researchers will develop and test a consumer support toolbox (cst) to align ips services with autistic consumer needs. ips-aut implementation and outcomes evaluation: a 12-month hybrid type 1 trial will assess feasibility, acceptability, fidelity to ips standards, and employment outcomes. the study aims for a minimum 50% success rate in competitive integrated employment and at least 75% feasibility and acceptability. mediators of employment outcomes: researchers will explore the role of parent/carer engagement and work-related social cognition in improving employment success. this trial is designed to prepare for a larger r01-funded study by refining implementation strategies and addressing key barriers. participants will include young adults with autism, their employment providers, and caregivers, with data collected through surveys, focus groups, interviews, and standardized assessments. the study is funded by the national institute of mental health and conducted in collaboration with supported employment agencies in california.

Eligibility criteria:
inclusion criteria: california supported employment agency clients meeting the following criteria: * community diagnosis of autism spectrum disorder, demonstrated by a letter from a healthcare provider, psychologist, other mental health professional, regional center representative, or school psychologist. * aged 21-40 years. * minimum 4th-grade reading level (approximately mild id). * not currently employed but seeking employment. exclusion criteria: - not interested in employment.
immunity to infection in healthy participants and participants with cancer

Conditions: Influenza; SARS-CoV-2; Hematologic Malignancy; Solid Tumor

Summary: many cancer patients are highly susceptible to infection and respond poorly to vaccination. this observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. the aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. in this context, the investigators will also evaluate immunity to medically indicated severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and seasonal influenza vaccine received by study participants during standard care (vaccines are not part of the study).

cancer and its treatments are associated with dysregulated immune systems, and cancer patients are highly susceptible to infections (e.g., influenza, sars-cov-2). importantly, cancer patients often respond poorly to vaccination. the molecular and cellular mechanisms underlying immune dysregulation and poor immunity in cancer patients are manifold, variable among individual patients/conditions, and poorly understood. an in-depth understanding of these mechanisms is essential to identifying novel strategies to prevent infectious diseases and developing individualized therapies. in this observational study, the investigators will collect blood samples from 200 participants with hematological and oncological malignancies and healthy participants and analyze the cellular and humoral immune status in the context of sars-cov-2 and influenza infection and vaccination within these samples using systems biological tools. medically indicated vaccination against sars-cov-2 and influenza during study participation is allowed. this study aims to (1) examine the fundamental innate, cellular, and humoral immune responses to pathogens that form the basis of immunological memory and (2) identify molecular and cellular mechanisms responsible for the reduced immune immunity to viral pathogens in participants with cancer.

Eligibility criteria:
inclusion criteria: * you are aged 18 years or older. * you are able to understand and give informed consent. * participants with cancer: you are suffering from cancer * healthy participants: you are a healthy individual. exclusion criteria: * you are unable to give informed consent. * you have been suffering from an acute infection with fever during the last three days. * you have a hb level of less than 9 g/dl. * you have a human immunodeficiency virus (hiv) or hepatitis c virus (hcv) infection.
virtual reality and cervical mobilization

Conditions: Neck Pain; Virtual Reality

Summary: the aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. in addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.


Eligibility criteria:
inclusion criteria: * neck pain persisting for at least 3 months * being between the ages of 18-65, * being sedentary (not included in any physical therapy program in the last 6 months), -\>10 points from the neck disability index exclusion criteria: * history of previous spinal surgery * neurological, cardiopulmonary, musculoskeletal disease affecting physical performance * any pathology in the shoulder joint * spinal trauma history * pregnancy