Kornimate/medical-research-clean huggingface dataset:
health outcomes in rheumatoid arthritis in greece

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a chronic debilitating disease, causing severe pain and progressive joint destruction and leading to partial loss of mobility. the disease has a severe impact on patients' quality of life, due to the pain and physical impairment it causes, which can also result in psychological and social difficulties. moreover, the chronic nature of the disease deems necessary the long-term use of medication, causing significant costs to the patient and the healthcare system. the decline in functional ability can cause problems at work, with reduced productivity or even unemployment. in addition, ra can limit the patients' ability for self-care, hence imposing a further burden on the patients' families and the society. many international studies have confirmed the reduced quality of life for people suffering from ra \[1-3\], as well as the large economic impact of the disease on the patients, the health system and society \[4-6\]. however, no assessment of the above impact of ra on the greek population has been published so far. a wide research of the literature confirms the relationship between costs and quality of life on the one hand and functional ability (as measured by the health assessment questionnaire) on the other hand. \[7-8\] the impact of functional ability on quality of life is straightforward, however studies also demonstrate that as disease symptoms progress, without proper treatment, the overall costs undertaken by the patient or the healthcare system can rise significantly. on the other hand, if effective treatment can lessen or postpone the most serious consequences of the disease (such as extensive joint damage that could lead to surgical replacement), the savings on healthcare can offset some of the costs of the more effective drug therapies. in the light of the above findings, it seems important that in order to properly assess therapeutic strategies for ra patients it is necessary to have an accurate view of the total burden of ra on the population. it is also important to be able to establish a robust relationship between functional ability and impact of ra on costs and quality of life.

the study will use a prevalence-based approach, recruiting patients at various stages of disease. subjects will be enrolled sequentially as per their order of appearance at the site, until the maximum allowed number of subjects is reached at each site.

Eligibility criteria:
inclusion criteria: * subjects aged 18 years or older * confirmed diagnosis of theumatoid arthritis by investigating physician. * evidence of a personally signed and dated informed consent document (or legally acceptable representative). exclusion criteria: * simultaneous participation in an interventional clinical trial.

Keywords: observational non-interventional prospective
superseton pilot studie

Conditions: Perianal Fistula; Perianal Crohn Disease

Summary: rationale: perianal fistulas are a common incapacitating problem. many patients are treated by seton drainage to prevent recurrent abscess formation. nowadays, vessel loops or sutures are used for drainage. the knot of these seton drains can cause complaints of pain or tenderness if it presses against the external opening of the fistula or even slides in to the fistula tract. medishield b.v. designed a knotless seton drain, the superseton. this could decrease the pain complaints caused by the knot. objective: the aim of this study is to determine the feasibility of superseton placement in patients with perianal fistulas. study design: the design of the study is a feasibility study. study population: patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are eligible. intervention: the superseton will be placed at the outpatient clinic in patients that already have a seton in situ. this seton will then be exchanged by the superseton. in case patients do not have a seton in situ, the superseton can be placed at the operating theatre in day care setting instead of a regular seton. main study parameters/endpoints: the primary outcome is seton failure (loosening of the seton). secondary outcomes are time of procedure, complications and quality of life measured by the pdai ('perianal disease activity index'). nature and extent of the burden and risks associated with participation: the superseton will be placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. there are no additional risks involved. the seton will be placed at the outpatient clinic in patients with a seton in situ, or at the operating theatre in day care setting in patients with a perianal abscess without a seton. the material that is used for the setons is of medical grade polyurethane, this is the same material of catheters that are already used in clinical practice (instech btpu 027). the setons including the insert (btpu) are supplied sterile (synergy health). sample size calculation: a group of 60 patients will be included to determine feasibility of the superseton. the proposed treatment protocol is considered feasible if at least 70% of the supersetons stay in place.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * written informed consent * perianal fistula with a seton in situ or a recurrent perianal fistula for which a new seton will be placed exclusion criteria: * patients with a pacemaker or an icd in situ * rectovaginal fistula * patients with a stoma * life expectancy \< 2 years * the inability of reading/understanding and filling in the questionnaires * dementia or altered mental status that would prohibit the understanding and giving of informed consent * participation in another trial

Keywords: knotless seton quality of life perianal disease activity index
a feasibility study of an emotion-focused mindfulness group

Conditions: Depression; Anxiety

Summary: living with symptoms of mental illness is associated with psychosocial impairment as it can affect someone's ability to work, their relationships and level of functioning. this also has high economic costs on a societal level. it has been shown that an increase in self-compassion may result in a secondary benefit of reducing psychological distress, which could offer substantial benefits. there is little empirical data on emotion focused mindfulness (efm) interventions for the population we are studying. this study aims to address this gap in the literature and practice, thus advancing the field.

study design the proposed study is a non-controlled, open-label, repeated measures intervention study. it is a two year feasibility study. procedure: recruitment participants will be recruited through the mount sinai academic family health team. patients who experience symptoms of depression and/or anxiety, may be referred by any member of the family health team, self-referrals through the family health team will also be accepted. patients will be screened for eligibility for the efm group by the group facilitators. patients may participate in the efm group and refuse to participate in the research study. when patients agree to participate in the group intervention, patients will then be asked about interest in participating in this research. group facilitators will provide details about the study. interested patients are given the consent form to review. the group facilitator leaves the room and the research associate will then come into the room to obtain written consent. intervention the group will run for 8-weeks. each group session is 2 and a half hours. half way through the intervention there will be a 5 hour retreat on the weekend. a typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. then group members will have time to report on recollections from meditation and facilitators will provide feedback. there is a break and the second part of the group focuses on a didactic teaching topic. topics change each week. efm groups will run between september 2016 and june 2018.

Eligibility criteria:
inclusion criteria: must be patient of mount sinai academic family health team * adults over the age of 18 years * symptoms of depression and anxiety as identified by the patient and/or family physician * sufficient english language skills to participate in the group (based on assessment of group facilitators) * committed and willing to engage in the group work, such as listening to others, speaking in front of others (based on assessment of group facilitators) exclusion criteria: (each based on assessment by group facilitators) * active suicidality * severe depression * possible alcohol abuse * high tendency to dissociate * personality style that may disrupt group formation processes, participation in interpersonal group processes, and/or developing a meditation practice

Keywords: mental health mindfulness shame
hydroxychloroquine vs. azithromycin for outpatients in utah with covid-19

Conditions: COVID-19

Summary: this study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed covid-19.


Eligibility criteria:
inclusion criteria: * adult, age\>44 years, competent to provide consent * confirmed covid-19, via a positive nucleic acid assay for covid-19 within the last 7 days exclusion criteria: * participants already prescribed chloroquine, hydroxychloroquine, or azithromycin * allergy to hydroxychloroquine or azithromycin * history of bone marrow transplant * known g6pd (glucose-6-phosphate dehydrogenase deficiency) deficiency * chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or glomerular filtration rate \< 20ml/min/1.73m2 * liver disease (e.g. child pugh score ≥ b or ast (aspartate transaminase)\>2 times upper limit) * psoriasis * porphyria * known cardiac conduction delay (qtc \> 500msec) or taking any prescription medications known to prolong qt interval * concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone * prisoner * weight \< 35kg * inability to follow-up - no cell phone or no address or not spanish or english speaking * receipt of any experimental treatment for sars-cov-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation * no symptoms attributable to covid-19 * pregnant or nursing

Keywords: sars-co-v-2 hydroxychloroquine azithromycin
testing a new self-help intervention for infertility related distress: a pilot study

Conditions: Infertility, Female

Summary: this pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

twenty women with infertility living in saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. outcomes will also be measured weekly for three weeks post-intervention. feedback about how to improve the program will also be collected.

Eligibility criteria:
inclusion criteria: * has been trying to get pregnant for 12+ months and has failed or is currently undergoing fertility treatments due to a diagnosis of infertility * lives in saskatchewan, canada * reports a high level of distress related to infertility, as indicated by a fertiqol score below 52 or at least mild anxious or depressive symptoms (gad-7 score of 5 or above or phq-9 score of 5 or above) exclusion criteria: * has a history of suicide attempts * is currently experiencing suicidal ideation * reports severe depressive symptoms, as indicated by a phq-9 score above 19 * reports severe anxious symptoms, as indicated by a gad-7 score above 14

Keywords: infertility-related distress depression anxiety
insole-based visual biofeedback for weight-bearing in total hip replacement

Conditions: Total Hip Replacement; Visual Biofeedback; Weight Bearing

Summary: the study investigates the effects of visual biofeedback, based on a sensorized system for the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal instructions of the physiotherapist, on weight bearing distribution in patients who underwent first total hip replacement. the study is a randomized controlled trial, with parallel groups, without blinding.

forty patients, who underwent first total hip replacement surgery were enrolled and divided into two groups on second postoperative day. experimental group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images on three monitors. control group followed verbal instructions of physiotherapist during training. from 4th to 10th postoperative day both groups followed the same rehabilitation program including exercises to restore correct weight bearing.

Eligibility criteria:
inclusion criteria: * 75 ≤ years of age, * absence of conditions that could alter the gait cycle, * absence of conditions that could reduce or alter visual ability, * etherometry ≤ 0.5 mm * mini-mental state examination (mmse) score ≥ 24. exclusion criteria: -
efficacy, safety, and pharmacokinetics (pk) of triptorelin 6-month formulation in patients with central precocious puberty

Conditions: Central Precocious Puberty

Summary: the study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. the total study duration per patient will be 12 months (48 weeks).


Eligibility criteria:
inclusion criteria: 1. onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the tanner method), and candidate to receive at least 12 months of gnrh agonist therapy after study entry. 2. aged 2-8 years inclusive (i.e. \< 9 years) for girls and 2-9 years inclusive (i.e. \< 10 years) for boys at initiation of triptorelin treatment. 3. initiation of triptorelin treatment at the latest 18 months after onset of the first signs of precocious puberty. 4. difference (δ) bone age (greulich and pyle method) - chronological age ≥ 1 year. 5. pubertal-type lh response 30 minutes following a gnrh agonist stimulation test before treatment initiation (leuprolide acetate 20 μg/kg sc) ≥ 6 iu/l. 6. clinical evidence of puberty, defined as tanner staging ≥ 2 for breast development for girls and testicular volume ≥ 4 ml (cc) for boys. 7. informed consent signed by one parent or both parents (as per local requirements), by the liable parent or by the legal guardian (when applicable); assent signed by the child if ≥ 7 years. non-inclusion criteria: 1. gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. 2. non-progressing isolated premature thelarche. 3. presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. patients with hamartomas not requiring surgery are eligible. 4. evidence of renal (creatinine \> 2 x uln) or hepatic impairment (bilirubin or asat \> 3 x uln). 5. any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use \[except mild topical steroids\], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumour). 6. prior or current therapy with a gnrh agonist, medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (igf 1). 7. major medical or psychiatric illness that could interfere with study visits. 8. diagnosis of short stature, i.e. \> 2.25 sd below the mean height for age. 9. positive pregnancy test. 10. known hypersensibility to any of the test materials or related compounds. 11. use of anticoagulants (heparin and coumarin derivatives).
progressive muscle relaxation exercises on sleep, fatigue and pain in pancreatic and colon cancer patients

Conditions: Pancreatic Cancer; Colon Cancer

Summary: with regular practice, relaxation has been found to have many benefits such as reducing sensitivity to pain and fatigue, facilitating the transition to sleep, and improving quality of life. therefore, this study was planned to examine the effects of progressive muscle relaxation exercises applied to pancreatic and colon cancer patients receiving chemotherapy on sleep, fatigue, and pain.

a total of 18 sessions of progressive relaxation were performed, 3 days a week for 6 weeks.

Eligibility criteria:
inclusion criteria: * being over 18 years of age * being able to communicate adequately * not having a psychiatric problem * those who are determined by a physician to have no physical obstacle to exercise * individuals who can use technological devices * patients who have had at least 3 cycles exclusion criteria: * those with communication problems * those with psychiatric problems * patients doing any exercise * individuals with phones that do not have a voice recording feature * individuals with phones that do not have a whatsapp feature
a scalable, community-based program for war and refugee trauma

Conditions: PTSD

Summary: in low and middle-income countries, access to state-of-the-art mental health care is often limited. islamic trauma healing (ith) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. the investigators will execute a hybrid effectiveness-implementation randomized controlled trial (rct) of ith versus delayed ith to evaluate mental health effectiveness and ease of implementation.

background: somalia has long been in a state of humanitarian crisis; trauma-related mental health needs are extremely high. access to state-of-the-art mental health care is limited. islamic trauma healing (ith) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. the 6-session intervention combines islamic principles with empirically-supported exposure and cognitive restructuring principles for posttraumatic stress disorder (ptsd). ith reduces training time, uses a train the trainers (ttt) model, and relies on local partnerships embedded within the strong communal mosque infrastructure. methods: the investigators will conduct a hybrid effectiveness-implementation randomized control trial (rct) in the somaliland, with implementation in the cities of hargeisa, borama, and burao. in this study, a lay-led, mosque-based intervention, islamic trauma healing (ith), to promote mental health and reconciliation will be examined in 200 participants, randomizing mosques to either immediate ith or a delayed (waitlist; wl) ith conditions. participants will be assessed by assessors masked to condition at pre, 3 weeks, 6 weeks, and 3 month follow-up. primary outcome will be assessor-rated posttraumatic stress symptoms (ptsd), with secondary outcomes of depression, somatic symptoms, and well-being. a ttt model will be tested, examining the implementation outcomes. additional measures include potential mechanisms of change and economic evaluation. conclusion: this trial has the potential to provide effectiveness and implementation data for an empirically-based principle trauma healing program for the larger islamic community that may not seek mental health care or does not have access to such care.

Eligibility criteria:
inclusion criteria: * experienced a dsm-5 criterion a trauma at least 12 weeks ago * report current re-experiencing or avoidance ptsd symptoms * islamic faith * 18-70 years of age exclusion criteria: * immediate suicide risk, with intent or plan * cannot understand consent/visible cognitive impairment
motivation of patients diagnosed with multiple sclerosis to become citizen researchers

Conditions: Multiple Sclerosis

Summary: the study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (nespa). the aim is to gain knowledge on motivational factors for using a digital tool for collecting data on nespa and incorporate this knowledge into a form which can be used in requirement specifications for such a digital tool.


Eligibility criteria:
inclusion criteria: * age 18 or above * read, write and understand danish exclusion criteria: * aphasia * severe cognitive impairment

Keywords: multiple sclerosis qualitative study motivation
septic management and outcome of open fracture

Conditions: Open Fracture; Pseudarthrosis; Bone and Joint Infection

Summary: the aim is the study of the management and outcome of the open fractures. some open fractures will become pseudarthrosis. thoses pseudarthrosis may be septic or not. the management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).


Eligibility criteria:
inclusion criteria: * all patients with open fractures exclusion criteria: -

Keywords: bone and joint infection pseudarthrosis open fracture