Kornimate/medical-research-clean huggingface dataset:
effects of virtual reality (vr) based distraction and relaxation therapy on moderate and severe pain

Conditions: Pain

Summary: this is a prospective, single-arm, open, single-center clinical study. this study is a pilot study to explore the use of vr based distraction and relaxation therapy as an adjunctive analgesic method for chinese patients with moderate to severe pain. after screening, patients with moderate to severe pain who meet the study inclusion criteria receive vr therapy for 15 minutes to evaluate the effectiveness and safety of vr therapy.


Eligibility criteria:
inclusion criteria: * males and females ≥18 years old. * average pain intensity≥4 on a 0-10 numerical rating scale (nrs) in the past 24 hours. * be able to communicate in chinese. * be able to read and write chinese. * willing to comply with study procedures and restrictions. * willing and able to sign informed consent. exclusion criteria: * shingles on the eyes, ears, head, face, or hands. * trigeminal neuralgia. * severe vision impairment. (patients with clear vision wearing glasses or contact lenses are allowed) * severe hearing impairment. * disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction, cholecystitis, etc. * history of severe motion sickness. * injury to eyes, ears, face, or neck that impedes comfortable use of virtual reality. * injury or dysfunction of hands or upper limbs that impedes comfortable use of virtual reality. * diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of virtual reality. * history of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc. * females currently pregnant. * current or completion of participation within 4 weeks before screening in any interventional clinical study * patients whom the investigator considers not suitable to participate in this study.

Keywords: pain virtual reality distraction therapy relaxation therapy
comparison of static and dynamic opening with neural sliding in cervical radiculopathy

Conditions: Cervical; Cervical Radiculopathy

Summary: the aim of this randomized controlled trial is to determine the effects of static and dynamic opening with neural sliding in patients with cervical radiculopathy for reducing pain, enhancing cervical range of motion and improve functional status.

static opener is a neurodynamic technique for cervical radiculopathy for reducing pressure on the nervous system that causes intervertebral foramina to remain in the open position for a certain period. this enables blood flow to return to neural tissue so that oxygenation is improved, along with slider mobilization will reduce symptoms and give better healing to the inflamed nerve. when the intervertebral foramina remain open for a considerable amount of time axoplasmic flow is reestablished, oxygenation is improved, increases blood flow along with venous return and nerve gets more nutrients and all the inflammatory exudate is taken off resulting for early improvement. dynamic opener is a neurodynamic technique in opening direction to repetitively open and close the intervertebral foramina and produces oscillatory movements that cause pumping effect on the nerve and help to drain edema due to inflammation and help reduce pain and increase the range also.

Eligibility criteria:
inclusion criteria: * : • spurling +ive * distraction test +ive (alleviate symptoms) * pain, paresthesia and numbness in rt/lt ul in dermatomal pattern of median nerve * mri confirmed spondylosis or disc herniation * age 35-60 exclusion criteria: * • cervical spine fracture * ra * cervical myelopathy * systemic neurological conditions * osteoporosis

Keywords: cervical radiculopathy static opener dynamic opener slider neurodynamic
cbt vs. abm vs. for social anxiety

Conditions: Social Phobia

Summary: adults with social anxiety disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1). outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on diagnostic and statistical manual (dsm) iv criteria. the investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

120 adults with social anxiety disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy (cbt), attention bias modification treatment (abm)). outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on dsm-iv criteria. the investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

Eligibility criteria:
inclusion criteria: * diagnosis of generalized social anxiety disorder, lsas\>50 * if on medication, patients must be on a stable dose * hebrew language fluency exclusion criteria: * primary axis i or axis ii disorder other than sad * suicidal ideation * substance dependence within the past three months or current substance abuse * mental retardation or another pervasive developmental disability * current or past schizophrenia or psychosis, current bipolar disorder, or organic brain syndrome
a clinical trial follow-up study of the genesis ii posterior stabilized total knee replacement

Conditions: Osteoarthritis

Summary: the purpose of this study is to look at the outcomes of the genesis ii posterior stabilized total knee replacement.


Eligibility criteria:
inclusion criteria: * a combined deformity of \<30 degrees = group 1 * a combined deformity of \>30 degrees = group 2 * patient is willing to consent to participate in the study * patient is available for follow-up through at least 2 years but preferably 5 years * patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk * patients who are fluent in english and are able to understand their role in a clinical trial exclusion criteria: * active, local infection or systemic infection * fibromyalgia patients * patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule
vaser treatment of axillary hyperhidrosis/bromidrosis

Conditions: Axillary Hyperhidrosis

Summary: patients with excessive underarm odor and sweating and/or odor are treated with the vaser system to determine the vaser's effectiveness in reducing underarm sweat and odor

patients with excessive underarm sweat and/or odor are recruited. the effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. they are surgically treated with the vaser system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. additional lifestyle evaluations are completed for comparison to pre-surgery answers.

Eligibility criteria:
inclusion criteria: * 18 years or older * willing and able to appear for all scheduled, post-operative visits * have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment exclusion criteria: * under the age of 18 * have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) skoog procedure, ets) * have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days * are deemed inappropriate candidates for surgery due to medical or mental health reasons * are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery * elect not to participate in the study

Keywords: hyperhidrosis bromidrosis bromhidrosis osmidrosis hircismus excessive underarm sweat perspiration body odor
v-flex plus ptx drug eluting coronary stent

Conditions: Coronary Artery Disease

Summary: the study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.


Eligibility criteria:
inclusion criteria: * patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. * patient must be an acceptable candidate for coronary artery bypass surgery * patient or legal guardian must have given informed consent * patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an ivus examination and a diagnostic angiogram. exclusion criteria: * patient must be less than 18 years old * patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. * patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye. * women of child bearing potential. * patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Keywords: coronary artery restenosis patency drug eluting stent
imcy-t1d-002: long-term follow-up study of t1d patients previously treated with imcy-0098 or placebo

Conditions: Type 1 Diabetes Mellitus

Summary: this study is the follow-up of study imcy-t1d 001 (eudract: 2016-003514-27, nct03272269) in which patients with recent onset t1d have been treated with imcy-0098 or placebo. at the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (v3 - week 48) the safety, the immune responses and the clinical parameters. the study involves a follow-up of 6 months after the end of the initial participation to the imcy-t1d-001 study. subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study imcy-t1d-001. for each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). the patients will undergo planned assessments and procedures as outlined in the table of study procedures.

in this long-term follow-up (ltfu) study, the below objectives will be assessed 36 and 48 weeks after the first injection of imcy-0098 in the study imcy-t1d-001, in patients treated with imcy-0098 at three doses or placebo: primary objective the primary objective of this study is to assess the long-term safety. secondary objective the secondary objective of this study is to evaluate the clinical response to imcy-0098 by assessing disease activity. exploratory objectives * to evaluate the proinsulin-specific cytolytic cd4+ t cells induced by imcy-0098 * to evaluate the impact of imcy-0098 on autoreactive t-cell responses specific for autoantigens expressed by islet β-cells (proinsulin, gad65, igrp) on the longer-term. * to evaluate the impact of imcy-0098 on autoantibodies against gad65, ia 2, znt8 and insulin * transcriptomic analysis on mrna extracted from samples collected for immunogenicity

Eligibility criteria:
inclusion criteria: * all patients who were treated with imcy-0098 or placebo in the imcy-t1d-001 clinical trial who are willing to participate to this long-term follow-up study. exclusion criteria: * ongoing pregnancy or lactation * history of or current malignancy (except excised basal cell skin cancer) * primary or secondary immune deficiency disorders * human immunodeficiency virus (hiv) infection. * ongoing treatment with immunosuppressive agents with the exception of topical or intra nasal corticosteroids. * treatment with an investigational drug within the past 3 months
evaluating the efficacy of pecs ii block versus axillary ring block in rotator cuff repair patients

Conditions: Shoulder Pain

Summary: our current standard of care is to perform an interscalene peripheral nerve block for patients receiving rotator cuff repair surgery as it is an effective opioid-free alternative for post-operative pain control. however, many of these repairs require a supplemental incision for an open biceps tenodesis, which is not covered by the interscalene block. the intercostobrachial nerve covers this incision and is targeted by an axillary ring block or a single shot nerve block in the fascial plane between the pectoralis minor and serratus anterior muscles (otherwise termed as a pecs ii block). this study will attempt to delineate if one is superior in postoperative analgesia and mitigating intraoperative stimulation by comparing an axillary ring block to a pecs ii block. patients receiving a rotator cuff repair with biceps tenodesis without histories of chronic opioid use and respiratory compromise will be eligible to be enrolled in the study. all patients will receive an interscalene block and group 1 will receive a supplemental axillary ring block and group 2 will instead receive a pecs ii block. after surgery, the patients' pain score will be assessed upon pacu arrival, at 6 hours after block, and 2 weeks postoperatively. their opioid requirements will also be assessed. our primary outcome is pain score at 6 hours following the block.


Eligibility criteria:
inclusion criteria: * medically optimized patients who will undergo an elective surgery for an arthroscopic rotator cuff repair with open biceps tenodesis exclusion criteria: * women who are pregnant or breastfeeding, history of chronic opioid use, respiratory compromise, smokers, or allergy to local anesthetics or opioids.
stms for substance use-disordered veterans

Conditions: Cocaine Addiction; Opioid Addiction; Alcohol Addiction

Summary: the purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.

all non-life-saving human research studies suspended by sponsor in response to covid19 social distancing policies the goal of this proposal is to evaluate preliminary participant response to a pilot, controlled, feasibility study to evaluate changes in craving, substance use, and quality of life after 6 weeks of a low-risk non-invasive brain stimulation technique, called synchronized transcranial magnetic stimulation (stms), compared to sham, in veterans with a substance use disorder (sud). an important focus of this application will be evaluating the acceptability, tolerability, and safety of stms in this population. to the investigators knowledge, stms has never been used for suds, and holds considerable promise as a future treatment option for these prevalent disorders. however initial work in the acceptability, tolerability, and safety of this approach must be conducted first. this project is the first step towards the investigators long-term goal, which is to combine non-invasive brain stimulation with individualized psychotherapy or pharmacotherapy to reduce sud problems and improve quality of life for veterans.

Eligibility criteria:
inclusion criteria: * eligible male and female veterans * between ages 18-70, * veterans who currently meet criteria for sud, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures * ongoing medications and psychotherapy will be allowed to continue unchanged during the study * for safety, participants must also meet established criteria for mri exposure, which is implemented as a conservative measure given the novel application of stms in this population exclusion criteria: * pregnancy/lactation, * history of moderate or severe traumatic brain injury, * current or prior neurologic disorder or lifetime history of * seizure disorder * cns tumors * stroke * cerebral aneurysm, * unstable medical condition, * active suicidality as assessed with the columbia-suicide severity rating scale * primary psychotic disorder.

Keywords: transcranial magnetic stimulation
study of difluprednate in the treatment of inflammation following ocular surgery (st-601-004)

Conditions: Inflammation

Summary: the purpose of this phase iii study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility criteria:
inclusion criteria: * scheduled for unilateral ocular surgery. exclusion criteria: * systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
women first: preconception maternal nutrition

Conditions: Maternal Malnutrition; Growth Failure; Mortality; Morbidity; Stunting

Summary: multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

the objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.

Eligibility criteria:
inclusion criteria: * 16-35 years of age; * expectation to have first or further pregnancy without intent to utilize contraception * hb \>8 g/dl exclusion criteria: * nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.

Keywords: preconception maternal nutrition lbw length-for-age maternal nutrition supplement multi-micronutrient fortified lipid-based supplement infant growth low-resource settings
home-based exercise for smi

Conditions: Serious Mental Illness

Summary: older veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have reduced physical function (endurance, strength, mobility) that leads to lower quality of life. exercise interventions are effective at improving physical function and could have a tremendous impact on this population. despite the established benefits of exercise, there has been little work focused on improving multiple aspects of physical function in older veterans with serious mental illness. the purpose of this study is to examine the feasibility and acceptability of a home-based exercise program for older veterans with serious mental illness.

older veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have significantly compromised physical function that leads to heightened rates of falls, hospitalizations, nursing home admissions, as well as early mortality. in fact, this population's physical function is compromised across multiple domains including mobility, endurance, and strength. exercise is effective for increasing all domains of physical function (i.e., mobility, endurance, strength) in older veterans. but, environmental difficulties (e.g., lack of transportation), low motivation, and medical issues affecting older veterans with serious mental illness contribute to low engagement rates and high dropout rates in facility-based exercise programs. individualized home-based exercise programs, which are safe and effective for older veterans with health challenges, could address the main barriers to exercise in older veterans with serious mental illness by promoting greater accessibility and individual tailoring. the purpose of this study is to evaluate the feasibility and acceptability of a 12-week home-based exercise program for older veterans with serious mental illness.

Eligibility criteria:
inclusion criteria: * veteran enrolled at providence vahcs * age 50 or older * chart diagnosis of smi (i.e., schizophrenia, schizoaffective disorder, or bipolar disorder) * clinically stable defined as no inpatient psychiatric admission in the prior three months and no changes in psychiatric treatment in prior month * medically safe to participate in exercise defined by no inpatient medical admission in prior three months and sign-off by veteran's medical provider exclusion criteria: * diagnosis of alzheimer's or related dementia * presence of any medical contraindication for exercise including unstable angina, active proliferative diabetic retinopathy, oxygen dependence, or frank incontinence * already participating in regular exercise defined as at least 60 minutes/week every week for prior six months or currently enrolled in a va exercise or health promotion program

Keywords: schizophrenia schizoaffective disorder bipolar disorder exercise physical function home-based
long-term outcomes of tunnel technique

Conditions: Recession, Gingival

Summary: few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. the aim of this randomized controlled trial (rct) was to compare the 4-year outcomes of the caf versus the pouch/tunnel (tun) technique both associated with ctg.


Eligibility criteria:
inclusion criteria: * miller's class i recessions; * recession of 2 mm to 5 mm; * maxillary incisors, canines or premolars; * identifiable cementoenamel junction (cej); * patients minimum 18 years old; * no/controlled periodontal disease; * asa1 or asa2 (american society of anesthesiologists) general health status; * providing a signed informed consent form. exclusion criteria were: * smokers; * presence of cervical carious lesion; * pocket depth greater than 4 mm; * sites where previous muco-gingival therapy was performed; * pregnancy. * in presence of non-carious cervical lesions, the anatomical cej was reconstructed by the use of a composite before the procedure.
study to evaluate and compare safety and pharmacokinetics of the hcp1004 and vimovo 500/20mg in healthy korean male

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate and compare safety and pharmacokinetics of the hcp1004 and vimovo 500/20mg in healthy korean male


Eligibility criteria:
inclusion criteria: * bmi: 18.0 - 27.0 kg/m2 * willingness to sign the written informed consent form exclusion criteria: * evidence of clinically relevant pathology * history of relevant drug and food allergies * positive screen on drugs of abuse * participation in a drug study within 60 days prior to drug administration.