Kornimate/medical-research-clean huggingface dataset:
study of anxiety after a session of energy resonance by cutaneous stimulation

Conditions: Breast Neoplasm

Summary: performing a breast macrobiopsy can be extremely delicate and anxiety-provoking. it can have an impact on the course of future examinations. patients' emotional feelings also have a definite impact on the nursing staff. the purpose of the mbresc study is to evaluate energy resonance by cutaneous stimulation , a manual acupressure technique, in the management of anxiety prior to breast macrobiopsy.


Eligibility criteria:
inclusion criteria: * patient has received full information on the organization and purpose of the research, and has signed an informed consent form. * patient over 18 years of age * patient undergoing a diagnostic breast macrobiopsy for suspected breast cancer * patient undergoing a macro breast biopsy for the first time * patient affiliated to or benefiting from a social security schem exclusion criteria: * patient with a history of breast cancer or other pathologies requiring invasive procedures * patient with several lesions to be biopsied * patient with psychiatric pathology * patient under anxiolytic or psychotropic treatment initiated in the month before the breast macrobiopsy

Keywords: macrobiopsy anxiety energy resonance by cutaneous stimulation
"recovery 4 us" - a photovoice-based social media program

Conditions: Mental Illness; Social Isolation; Loneliness

Summary: this study is a randomized trial evaluating "recovery 4 us", a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.this innovative e-mental health program integrates internet and mobile technologies and is designed to be a self-sustaining recovery-oriented virtual community for individuals living with a disabling mental illness based on the principles of photovoice.

this study is a randomized trial evaluating "recovery 4 us", a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.this innovative e-mental health program integrates internet and mobile technologies and is designed to be a self-sustaining recovery-oriented virtual community for individuals living with a disabling mental illness based on the principles of photovoice. the "recovery 4 us" program which includes a mobile phone application and a password protected website, has three main components: 1) receipt of daily hope-inspiring message, paired with a corresponding visual image; 2) creation and viewing of recovery-oriented photovoice works; and 3) opportunity to attend community events initiated by members of the "recovery 4 us" community. the benefits of the "recovery 4 us" program will be evaluated through a randomized trial with n=60 participants. the study will take place at the boston university center for psychiatric rehabilitation. participants will be randomized to the experimental group (provided with a smartphone and access to "recovery 4 us" application and website) or the control group (provided with a smartphone but without access to the "recovery 4 us" app or website). we anticipate participation in the program will be associated with reduced loneliness, increased hopefulness, community participation, and overall recovery. the recruitment goal for this study was amended to n=70.

Eligibility criteria:
inclusion criteria: * are 18 or older * have been recipients of services at the bu cpr recovery center due to having a dsm-v diagnosis of mental illness, including dual diagnosis (dual diagnosis refers to co-occurring mental illness and alcohol/ substance use disorder) as indicated in their records * are interested in participating in a social media program * are fluent in english * have a basic ability to use a mobile phone exclusion criteria: * inability to give full and knowing consent

Keywords: mental illness loneliness hope community social media
study of pharmacodynamics, pharmacokinetics, safety and tolerability of vay736 in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study was to investigate the safety, tolerability and efficacy of vay736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (ipf).

this was an exploratory (non-confirmatory) randomized, patient-, investigator-, sponsor- blinded, placebo controlled study of vay736 in ipf patients. this study investigated the safety and efficacy of 300 mg vay736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. participants were randomized in a 1:1 ratio on top of local standard of care (soc), to receive vay736 or placebo. randomized subjects entered the treatment epoch (for up to 48 weeks), followed by two follow-up epochs: the pk/safety follow-up epoch and the pd/safety follow-up epoch. the pk/safety follow-up epoch lasted for 20 weeks. when the pk/safety follow-up epoch was completed, participants in the placebo arm were discharged from the study; but participants in the active arm (those who had received vay736) continued into the pd/safety follow-up epoch. participants in the pd/safety follow-up epoch were followed until b-cell recovery (in the peripheral blood), defined as: b cells \>=50/μl or b cells \>= 80% of baseline (whichever occurred first). if a participant had not recovered his/her b-cells after a period of 2 years from the last dose of vay736, then this participant was discharged from the study.

Eligibility criteria:
inclusion criteria: * a diagnosis of definite or probable ipf within 5 years of the screening visit * forced vital capacity (fvc) 40-90% predicted (inclusive) * diffusing capacity of the lungs (dlco), corrected for hemoglobin, 25-79% predicted (inclusive) * forced expiratory volume in first second (fev1)/fvc \>70% * unlikely to die from cause other than ipf within the next 3 years, in the opinion of the investigator * unlikely to undergo lung transplantation during this trial exclusion criteria: * emphysema \> fibrosis on screening high-resolution computed tomography (must be confirmed by central reader) * history of major organ, hematopoietic stem cell or bone marrow transplant * clinically diagnosed acute exacerbation of idiopathic pulmonary fibrosis (ae-ipf) or other significant clinical worsening within 3 months of randomization * new york heart association (nyha) class iii/iv congestive heart failure (chf), ejection fraction (ef) \<25% * current smoker * prior use of any b-cell depleting therapy (e.g., rituximab, ofatumumab, or other anti-cd20 mab, anti-cd40, anti-cd19,anti-cd22 mab, anti-cd52 mab, or anti-baff mab)

Keywords: idiopathic pulmonary fibrosis vay736
leflunomide in mild covid-19 patients

Conditions: COVID-19

Summary: this study aims to examine the tolerability of high dose of leflunomide in patients with covid-19 who are being managed in the outpatient setting.

this is a single are and single-center tolerability study of high dose leflunomide therapy in outpatient adult participants with mild covid-19. in vitro studies have shown antiviral effects of leflunomide against sars cov-2, but the clinical outcomes in the disease have been variable. our hypothesis is that targeting high risk patients earlier in the disease course and with a higher dose regimen are both required to see improvement in disease outcome measures in covid-19. this study aims to prove the tolerability of high dose leflunomide in this setting. patients are selected based on identification of mild covid-19 symptoms. investigators will enroll twenty patients and perform a detailed tele-helath interview to ensure they meet eligibility criteria and provide informed consent. 100 mg leflunomide daily for three days followed by 30 mg day will be prescribed. the subjects will be required to monitor their temperatures twice daily and a daily telephone call with an investigatory will review symptoms of disease and potential side effects of the drug. subjects can discontinue the drug after five days if they no longer have fever, or take the drug for up to ten days if required for fever resolution.

Eligibility criteria:
inclusion criteria: * being tested positive for sars-cov-2 in outpatient setting in drive-thru, ed, or ambulatory clinics at the university of chicago within 72 hours of enrollment. * age \>18 * mild covid-19, defined as the presence of any symptom consistent with an upper respiratory tract infection, including dry cough, sore throat, nasal congestion, fatigue, myalgia, headaches exclusion criteria: * participation in any other clinical trial of an experimental agent treatment for covid-19 * current hospitalization * known hypersensitivity to leflunomide * currently taking methotrexate * currently taking terliflunomide * known chronic kidney disease, stage 4-5, or receiving dialysis * history of liver disease * history of interstitial lung disease * pregnancy and lactation - pregnancy test required for females * inability to monitor body temperature (oral, axillary, tympanic or frontal) at least twice a day from study enrollment day (day 1) to the end of the study (day 14). * inability to provide informed consent to the study.

Keywords: leflunomide
hiv self-testing in implementation prep study

Conditions: HIV Prevention

Summary: this is a sub-study of an ongoing prep study ( hiv prep for men who have sex with men - msm - and transgender women - tgw: a demonstrative project in brazil, peru and mexico - imprep). msm/tgw enrolled to imprep study at the selected sites, who agree to participate in this hiv self test (hivst) sub-study, will be 1:1 randomized at the third study visit either to receive 5 hivst+voucher (intervention arm) or 5 vouchers alone (control arm) to secondarily distribute into their msm/tgw network. all vouchers are numbered invitations for priority access to individualized hiv risk assessment and combination prevention services, including prep, at the imprep sites. study population comprises imprep participants and their referred peers. sample size is going to be determined at an interim analysis performed when each city has enrolled 70 participants. trial participants will be at maximum 876 (438 intervention and 438 in the control arm) msm and tgw included in the imprep study who received prep for at least 6 months in the sites from rio de janeiro and lima. the study is designed as a multicenter, open, adaptative, randomized trial. the main study outcome is the voucher redemption proportion by arm.


Eligibility criteria:
inclusion criteria: * individuals who were included in the imprep study * performed at least 3 study visits, * accepted to participate in this sub study, * provide informed consent form exclusion criteria: * individuals included into imprep as a result of hivst secondary distribution

Keywords: pre exposure prophylaxis men who have sex with men
the acute effect of different kinesiological tape

Conditions: Chronic Back Pain

Summary: this study aims to compare the acute effects of different kinesiology tapes on pain, functional performance and trunk endurance in young adults with chronic low back pain. seventy young adults with chronic low back pain between the ages of 18-40 were included in our study. the individuals included in our study were divided into two groups by a simple randomization method. star-shaped kinesiology taping was applied to the 1st group, and i-shaped kinesiology taping was applied to the 2nd group. the demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. visual analogue scale (vas) to evaluate pain before taping, immediately after taping and 4 days after taping, oswestry low back pain disability scale (olbpds) to assess disability level, lumbar flexion repeat speed test, sit-and-stand test to evaluate functional performance in both groups. biering sorenson test was applied to evaluate the forward bending test with weight and trunk endurance.

star-shaped kinesiology taping was applied to the 1st group, and i-shaped kinesiology taping was applied to the 2nd group. the demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. visual analogue scale (vas) to evaluate pain before taping, immediately after taping and 4 days after taping, oswestry low back pain disability scale (olbpds) to assess disability level, lumbar flexion repeat speed test, sit-and-stand test to evaluate functional performance in both groups. biering sorenson test was applied to evaluate the forward bending test with weight and trunk endurance.

Eligibility criteria:
inclusion criteria: * between the ages of 18-40 who accept participating in the research, * low back pain for at least 3 months, * have no perception problems * can cope well, * individuals who regularly come to the controls and evaluations of the physical therapy program. exclusion criteria: * undergone spinal surgery, * have complain of low back pain due to inflammatory, tumoral, metabolic cause, orthopedic (pes planus, genu varum, genu valgum, scoliosis, etc.) or neurological (multiple sclerosis, stroke, etc.) problems that prevent treatment, spine or lower back pain. * have extremity surgery, * have another musculoskeletal disorder affecting the lower extremity, * pregnancy

Keywords: kinesiology taping visual pain scale oswestry chronic low back pain functional performance
internet-based intervention culturally adapted for treatment of depression in the ecuadorian population

Conditions: Depression

Summary: internet-based interventions are increasingly relevant as an alternative for reducing the gap in treatment of metal disorders such as depression, especially in resource-limited regions. in this study the investigators will try to evaluate the effectiveness of an internet-based intervention culturally adapted to the ecuadorian population for treatment of depression.

our participants will be randomized to one of the following three conditions: 1) internet-based intervention (ibi) with automated support (e.g. e-mails or text messages), 2) ibi plus human support by phone calls (automated + human support), 3) waiting list control group . the corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, three, six and twelve months. this study will use the smile is fun program for the treatment of depression previously adapted to the ecuadorian context.

Eligibility criteria:
inclusion criteria: * ability to understand and read spanish and access to internet and having an email address * access to a computer or smart phone with internet at home * criteria for diagnosis of depression disorder according to the mini interview and score between 5 to 9 (mild) 10 to 14 (moderate) and 15 to 19 (moderate/severe) on phq-9 exclusion criteria: * scores 20-27 (severe depression) on phq-9 * suicidal risk * severe psychiatric disorders (schizophrenia, substance dependence, bipolar disorder, psychotic illness) * receiving psychological treatment for depression at the time of recruitment

Keywords: cultural adaptation internet-based intervention depression
spectacle independence and overall satisfaction with acrysof® panoptix® toric intraocular lens

Conditions: Cataract

Summary: the study was designed to assess the spectacle independence and satisfaction of patients receiving the acrysof® panoptix® toric intraocular lens (iol) after uneventful cataract surgery.

this study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. clinical evaluations will include administration of a spectacle independence and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility criteria:
inclusion criteria subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal toric iol option * gender: males and females. * age: 40 or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * have regular corneal astigmatism with a magnitude that can be treated with a toric iol in the approved range (t3-t6) for the panoptix lens. * have 20/32 (0.2 logmar) or better potential acuity in both eyes exclusion criteria if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * irregular astigmatism (e.g. keratoconus) * corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye) * monocular status (e.g. amblyopia) * previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, dsaek, lamellar keratoplasty) * previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * diabetic retinopathy * macular pathology (e.g. armd, erm) * history of retinal detachment * subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating). the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: toric iol panoptix multifocal iol trifocal iol
feasibility of a brief trauma-informed yoga intervention for anxiety during the coronavirus disease (covid-19) pandemic

Conditions: Anxiety

Summary: this study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video. this study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness. the results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.

emerging data shows a high prevalence of anxiety during the first several months of the covid-19 pandemic in the united states. accordingly, there have been calls for supportive interventions for psychological health during the pandemic. due to physical distancing requirements, supportive interventions for psychological health will be most accessible if they can be administered remotely. trauma-informed yoga may support psychological health during the covid-19 pandemic, but research on remote delivery of trauma-informed yoga is needed. the present study will evaluate the feasibility and acceptability of trauma-informed yoga delivered remotely. in this study, the investigators will create an online delivery platform within redcap, a secure web application for research, that 1) hosts a 45-minute video of a trauma-informed yoga practice, and 2) collects data on participants' present moment experience of anxiety, mindfulness, and body awareness immediately before and after the yoga practice. feasibility and acceptability data will allow the investigators to evaluate recruitment methods and refine the delivery method of trauma-informed yoga in a way that aligns with participant preferences. the investigators will also evaluate the short-term effects of trauma-informed yoga on state anxiety, state mindfulness, and body awareness. this study will allow the investigators to pilot the remote delivery of trauma-informed yoga during the ongoing, highly stressful covid-19 pandemic and further develop trauma-informed yoga as a supportive intervention for psychological health.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * has an internet connection * willing to try a gentle yoga practice exclusion criteria: * cannot read or understand english

Keywords: yoga mind-body therapies complementary therapies online
comparative study of lokomat® exoskeleton vs c-mill® treadmill for gait recovery in rehabilitation.

Conditions: Stroke

Summary: the use of robotic technology for the treatment of gait in neurological pathologies has provided different results in scientific evidence. in patients with some types of acquired brain damage, such as stroke, the use of lokomat® therapy can bring improvements in aspects such as gait speed and balance, among other parameters and report greater functional recovery in subacute patients with greater deterioration. similarly, the use of another technological element such as the c-mill® reports improvements in various aspects of ambulation and balance in gait treatments for stroke patients. likewise, the impact on the person's recovery is not only beneficial for gait rehabilitation, but also improves the perception of well-being, which can be positive in the process of readaptation to daily life. the effect of both treatments for gait rehabilitation in adults with stroke and their impact on quality of life in the neurorehabilitation clinic will be studied. adults with stroke and their impact on quality of life at the lescer neurorehabilitation clinic lescer, madrid (spain).participants will be assessed at baseline, 4 weeks, 8 weeks and 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. specialist. * subjects who are cognitively capable and who sign the informed consent form. exclusion criteria: * severe cognitive impairment (mini-mental state examination \< 24.), or impairment that prevents correct understanding of the correct understanding of the messages and explanatory orders of the treatment and its conditions. conditions. * diagnosis of concomitant neurological diseases and craniocerebral trauma. cranioencephalic trauma. * other diseases that interfere with the gait process (e.g. disabling arthritis or arthrosis, other neurological diseases, other neurological diseases). disabling arthritis or osteoarthritis, other concomitant neurological diseases, etc.). - contraindications of the robotic tools themselves.

Keywords: stroke quality of life spasticity