Kornimate/medical-research-clean huggingface dataset:
trans-spinal magnetic stimulation (tsms) in parkinson's disease- related musculoskeletal pain

Conditions: Musculoskeletal Pain; Parkinson Disease

Summary: parkinson disease is the second most common neurodegenerative disease. pain is the frequent non-motor symptom that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. there is currently no evidence-based treatment for pd-related pain in general. nociceptive pain is the most frequent pain in pd an is frequently musculoskeletal in nature. epidural spinal cord stimulation is known to provide analgesic effects in several types of pain syndromes. here we test analgesic effects of a non-invasive trans-spinal magnetic stimulation as an add-on treatment for nociceptive (musculoskeletal) pain directly related to parkinson disease.

background: pain is frequent non-motor symptom in parkinson's disease (pd) that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. nociceptive pain is the most frequent subtype, mainly musculoskeletal in nature. there is currently no evidence-based treatment for pd-related pain in general. the present study tests the effectiveness and safety of non-invasive trans-spinal magnetic stimulation (tsms) to treat musculoskeletal pain directly related to pd in a sham-controlled randomized approach. patients and methods: this is a randomized, sham-controlled trial including 40 subjects, aged between 18 and 85 years, with musculoskeletal pain directly related to pd, that will be randomized to receive tsms active or tsms sham in a 1:1 ratio. enrollment will take place at the pain center of the university of são paulo and movement disorders center of the university of são paulo. we have decided to perform an interim analysis when 24 patients will be included in the trial in order to assess safety and calculate effect size of the active intervention, after meeting with the research and statistical board. a decision will thereafter be made to, either: 1: halt the study due to futility, 2: continue the study with a new target sample size based on the calculations made with the effect from the n= 24 sample. expected results: the study hypothesis is that non-invasive trans-spinal magnetic stimulation is superior to sham and it is safe to use that device in patients with nociceptive (musculoskeletal) pain in pd.

Eligibility criteria:
inclusion criteria: * parkinson disease * parkinsson disease related musculoskeletal pain * signed term of informed consent exclusion criteria: * pregnant or lacting women * predominant neuropathic pain * the presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation; * who wishes at any time to abandon the study;

Keywords: non-motor symptom musculoskeletal pain parkinson disease treatment trans-spinal magnetic stimulation
postoperative new-onset proteinuria and adverse outcomes.

Conditions: Surgery; Proteinuria; Mortality

Summary: we aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in chinese people who underwent surgery. the exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. the primary outcome was 30-day mortality. the secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate.


Eligibility criteria:
inclusion criteria: * surgery patients exclusion criteria: * kidney or urinary surgery * missing urinalysis results * dipstick proteinuria indicated a value of "≥ trace" at least once preoperatively * with dialysis, end-stage renal disease, or with urinary tract infection at baseline * missing follow-up information
n-acetylcysteine in the treatment of ptsd and addiction

Conditions: PTSD; Addiction

Summary: examine the effects of n-acetylcysteine on ptsd symptoms, craving and substance use in veterans with ptsd and comorbid substance use disorders.

with the increased number of military veterans returning from conflicts in afghanistan and iraq diagnosed with posttraumatic stress disorder (ptsd), there is a high vulnerability of these individuals to develop a substance use disorder (sud). while there have been a host of studies focused largely on dopaminergic mechanisms of drug reward, they have not led to the development of adequate treatments for either preventing people diagnosed with ptsd from developing sud or for treating comorbid ptsd/sud. based on extensive work with addictive drugs and preliminary data from our group, the investigators propose that stress impairs prefrontal cortex regulation of the basal ganglia habit circuitry and this pathology renders ptsd patients susceptible to developing sud. moreover, the known effects of addictive drugs to further impair prefrontal regulation are synergistic with this pathology, thereby making treatment of comorbid ptsd/sud particularly difficult. preclinical studies have revealed that glutamate levels within the nucleus accumbens have been implicated in drug seeking behavior in the animal model of relapse. the amino acid precursor n-acetylcysteine (nac) appears to restore glutamate to normal levels and may also prevent glutamate levels from spiking following subsequent stimulant use. the primary goal of the proposed study is to evaluate the efficacy and safety of n-acetylcysteine in preventing relapse in drug dependent individuals with ptsd or subthreshold ptsd. veterans with substance use disorders who have achieved at lease one week of abstinence will be randomized to either placebo or nac (2400-3600mg/day) for 8 weeks.

Eligibility criteria:
inclusion criteria: * 18-65 year old * u.s. military veteran, reservist, or national guard member * dsm-iv diagnostic criteria for current (past 6 months) sud and ptsd or subthreshold ptsd (i.e., met criteria for cluster b (re-experiencing) and either cluster c (avoidance) or d (hyperarousal), as well as duration of one month and clinically significant impairment) * score of \> 21 on the mini-mental state exam (mmse). exclusion criteria: * unstable medical conditions * bipolar or psychotic disorders * seizures or asthma * prior treatment with nac * suicidality * enrolled in ongoing ptsd treatment (pharmacotherapy or psychosocial) * females: could not be pregnant or lactating
safety and efficacy study of suvorexant in participants with primary insomnia - study b (mk-4305-029)

Conditions: Primary Insomnia

Summary: this is a multicenter study to test the hypothesis that suvorexant (mk-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep.


Eligibility criteria:
inclusion criteria: * must be ≥18 yrs old on the day of signing informed consent * diagnosed with primary insomnia * good physical and mental health * participant ≥65 yrs old score at least 25 on the mini mental state examination * a female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception * reports difficulty with initiating and maintaining sleep during the 4 weeks prior to visit 1 (accordingly to specific protocol criteria) * reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to visit 1 * regular bedtime is between 9 pm-1 am * willing to refrain from napping while in study * able to read, understand and complete questionnaires and all diaries * willing to limit alcohol, caffeine, and nicotine consumption while in the study * for a portion of participants: must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory exclusion criteria: * female participant is pregnant and/or breastfeeding at prestudy visit, or expecting to conceive while in study * history or diagnosis of another sleep disorder * difficulty sleeping due to a medical condition * history of a neurological disorder * history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication * ongoing depression * history of substance abuse or dependence * history or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ecg) at prestudy visit * taking certain prohibited medications * consumption of the equivalent of \>15 cigarettes a day * history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * participant is considered morbidly obese * previously randomized in another investigational study of suvorexant
effect of problematic smartphone use

Conditions: Smartphone Addiction

Summary: there is no study that examines the effect of problematic use of smartphones, which has become a global problem today, on reaction time and cognitive functions together. this study was planned to examine the effect of problematic smartphone use on upper extremity functions and cognitive functions. participants' problematic smartphone use will be evaluated with the smartphone addiction scale short form. within the scope of upper extremity functions, quick disabilities of arm, shoulder \& hand questionnaire, reaction time and grip strength will be evaluated. reaction time will be measured with blazepod trainer (blazepod trainer device, play coyotta ltd, tel aviv, israel). jamar dynamometer (performance health, warrenville, il) will be used to evaluate grip strength. cognitive functions will be assessed using the stroop test çapa form, trail making test and cognitive failures questionnaire.


Eligibility criteria:
inclusion criteria: * to be between 18-25 years old * using a smartphone for at least 1 hour a day * volunteering to participate in the study exclusion criteria: * having undergone a surgical operation involving the upper extremity within the last 6 months * history of trauma to the shoulder, elbow, hand and wrist in the last 6 months * presence of a diagnosed neurological, rheumatic or psychiatric disease

Keywords: problematic smartphone use smartphone addiction cognitive function reaction time upper extremity problem
the effect of anti-calcitonin gene-related peptide (cgrp) receptor antibodies on the headache inducing properties of cgrp and cilostazol in migraine patients

Conditions: Migraine; Migraine Without Aura; Migraine With Aura

Summary: a randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. followed by a 6-month open-label extension.


Eligibility criteria:
inclusion criteria: * patients with migraine with or without aura according to the international classification of headache disorders with a frequency of ≥4 migraine days per month * 50-100 kg weight * participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent exclusion criteria: * any other primary headache disorder according to the international classification of headache disorders except for tension-type headache * any secondary headache disorder according to the international classification of headache disorders * migraine attack during the preceding 48 hours on provocation day * headache during the preceding 24 hours on provocation day * treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year * daily consumption of any other drug/medication than oral contraception (birth control) * consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception * pregnant or active breastfeeding participants * any cardiovascular diseases including cerebrovascular disorders * information in patient history or during physical examination indicating psychiatric disorders or substance abuse * information in patient history or during physical examination that the screening physician deems relevant for participation in the study
molecular epidemiology of myocardial infarction and stroke in older adults - ancillary to chs

Conditions: Coronary Disease; Cardiovascular Diseases; Heart Diseases; Cerebrovascular Accident; Myocardial Infarction

Summary: to investigation the association of thrombosis and inflammation genes with sub-clinical cardiovascular disease and with incident myocardial infarction and stroke in older adults.

design narrative: the study represents a collaborative effort among investigators of the cardiovascular health research unit, department of genome sciences at the university of washington (uw), and the multi-center cardiovascular health study (chs), including the chs blood laboratory at the university of vermont. the study links advances in thrombosis and inflammation biology, large-scale human genomics, and population and statistical genetics, with the unique resources of chs, a large, bi-racial cohort of older adults. in older men and women without clinically apparent vascular disease, carotid intimal-medial thickness or imt (a measure of subclinical atherosclerosis), c-reactive protein (a sensitive marker of inflammation), and d-dimer (a global marker of activation of the hemostatic system) predict subsequent clinical events such as myocardial infarction (mi) and stroke. while the therapeutic benefits of thrombolytic therapy and aspirin suggest a major role for clotting and inflammation in the etiology of coronary disease and stroke, the genetic determinants of these risk factors, which are also influenced by traditional lifestyle risk factors such as smoking and obesity, remain largely unexplored in older adults. the setting for this study is the cardiovascular health study, a cohort study of 5888 older adults designed to assess risk factors for stroke and coronary disease. data on traditional risk factors, on measures of subclinical disease, and cardiovascular events are available to the ancillary study. by integrating recent clinical and experimental data on age-related and vascular bed-specific regulation of blood coagulation, and incorporating complete human genomic dna sequence variation data from the nhlbi-funded uw program for genomic applications, the investigators will evaluate thoroughly the association of thrombosis and inflammation genes with (1) carotid imt, crp, and d-dimer levels measured at baseline and (2) incident mi and stroke in adults \>65 years old followed for up to 12 years.

Eligibility criteria:
no eligibility criteria
pharmacodynamic/pharmacokinetic interactions between oral roflumilast and inhaled formoterol

Conditions: Healthy

Summary: this phase i, open, randomized controlled, multiple-dose, parallel-group study investigated the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral roflumilast and inhaled formoterol. healthy male subjects were assigned to treatment a or treatment b. subjects in treatment a received 500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18. subjects in treatment b received 48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. impedance cardiography, ecg, serum potassium and glucose concentrations and effects on blood eosinophils assessed potential pharmacodynamic interactions. in addition, the safety and tolerability were evaluated. pharmacokinetic parameters were assessed for roflumilast, roflumilast n-oxide, and formoterol.


Eligibility criteria:
inclusion criteria: * age between 18 and 45 years * normal body weight as indicated by a body mass index (bmi) between 18 and 30 kg/m2 and a body weight \> 50 kg * assessed as healthy, based on a screening examination including medical history, physical examination, bp, pur, ecg, and clinical laboratory results * caucasian exclusion criteria: * suspected lack of compliance * participant in any other study or donation of blood during the last 30 d before start of this study (last day of intake of medication - first day of medication in the following study) * any active disease, acute or chronic (also psychiatric diseases) * any signs or present history of cardiac diseases (e.g. qtc interval acc. to bazett ≥ 430 ms, pq ≥ 220 ms), in particular tachycardiac arrhythmia, third-degree av-block, idiopathic-subvalvular aortic stenosis or hypertrophic-obstructive cardiomyopathia * proneness to symptomatic orthostatic dysregulation, fainting or "blackouts" (medical history), or to orthostatic hypotension defined by sbp \< 90 mm hg (standing blood pressure, 30 s after raising up from a supine position) * gastrointestinal surgery except from appendectomy and herniotomy * hiv or hepatitis screening positive or not performed (in case of a positive hiv test, the subject had to be informed by a physician in personal communication * drug screening positive or not performed * excessive xanthine consumption (more than 5 cups of coffee or equivalent per day) * non-compliance for measurements of impedance cardiography (feasibility was proven and documented at the screening visit by one test procedure)

Keywords: drug interactions pharmacodynamic interactions pharmacokinetic interactions formoterol healthy subjects phase i study roflumilast
hbsag seroclearance in adults with hbv related liver fibrosis after receiving combined therapy of peg-ifn and tenofovir.

Conditions: Liver Fibrosis

Summary: liver fibrosis caused by hepatitis b virus (hbv) infection is easy to progress to liver cirrhosis and liver cancer, with great harm and poor therapeutic effect. nucleos(t)ide analogues (nas) are the most commonly anti-hbv drugs currently . long-term use of nas can inhibit hbv dna and achieve the purpose of reducing poor prognosis. however, adverse prognosis, such as liver cirrhosis and liver cancer, cannot be completely eliminated even under the status of virologic inhibition under the action of nas. current studies have shown that the lower the hbv surface antigen (hbsag) is, the better the long-term prognosis is. as another anti-hbv drug, pegylated-interferon-α (peg-ifn-α) has the immune regulation effect that nas do not have, which can bring irreplaceable effects in hbsag reduction and liver fibrosis reversal. therefore, the combined therapy of nas and peg-ifn-α is a hot issue in the field of liver diseases over the world, but the research and application of the combined therapy in patients with liver fibrosis are very few. the preliminary results of our previous research showed that the combined therapy of peg-ifn-α and nas in patients with hbv related fibrosis were safe, and had a significant effect on hbsag decline. on this basis, this study intends to carry out a multicentre, non-randomized concurrent controlled trial, comparing the safety and efficacy between combined therapy (peg-ifn-α plus tenofovir) and tenofovir monotherapy in patients with liver fibrosis, especially focusing on hbsag's decline and clearance, and the improvement of liver fibrosis degree, in order to find a better therapy, and to guide the clinical decision making.


Eligibility criteria:
inclusion criteria: * 1.positive hepatitis b surface antigen; 2.infection of hepatitis b virus dna \> 0.5 year before anti-hbv treatment; 3.receiving treatment of nucleoside/nucleotide analogues at least one year before recruited; 4.age from 18 to 55 years old; 5.normal liver function(alt\<uln,ast\<uln and tbil\<uln); 6.undetectable hepatitis b virus dna or less than 100iu/ml; 7.liver biopsy suggested fibrosis of liver into f1\~f3(metavir score system) or lsm between 6 and 12 kpa measured by fibroscan; 8.liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm. exclusion criteria: * 1.decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2.pregnancy, lactation or female has plan of pregnancy within 18 months; 3.accompanied with other active liver diseases(hav, hcv, hdv, hev, autoimmune liver disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver disease, etc.)； 4.accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases; 5.accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions; 6.patients who fail to comply with this research arrangement and sign an informed consent form; 7.patients can not follow-up; 8.investigator considering inappropriate.
effect of manual therapy on jaw movement and function in patients with bruxism

Conditions: Bruxism; TMJ Pain

Summary: hypothesis 1. there will be no significant statistical effect of trigger point pressure release and deep striking massage on pain level in patients with bruxism. 2. there will be no significant statistical effect of trigger point pressure release and deep striking massage on range of motion in patients with bruxism. 3. there will be no significant statistical effect of trigger point pressure release and deep striking massage on sleep quality index in patients with bruxism. 4. there will be no significant statistical effect of trigger point pressure release and deep striking massage on proprioception awareness in patients with bruxism. 5. there will be no significant statistical effect of trigger point pressure release and deep striking massage on stress in patients with bruxism. 6. there will be no significant statistical effect of trigger point pressure release and deep striking massage on anxiety in patients with bruxism. 7. there will be no significant statistical effect of trigger point pressure release and deep striking massage on temporomandibular (tmj) function in patients with bruxism. 8. there will be no significant statistical effect of trigger point pressure release and deep striking massage on oral health impact profile in patients with bruxism.


Eligibility criteria:
inclusion criteria: 1. the volunteers diagnosed with bruxism based on the criteria of the american academy of sleep medicine 2. positive self-report of awake bruxism. 3. self-report of muscle fatigue or tenderness on awakening. 4. sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching. exclusion criteria: 1. severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression). 2. using medications that influence sleep or motor behavior. 3. direct trauma or past surgery in the orofacial region. 4. on physical, speech, dental, or psychological therapy at the time of study entry. 5. currently undergoing physical therapy for tmd. 6. neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease. 7. the presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion. 8. more than two missing teeth, except third molars; 9. systemic and/or degenerative diseases.