Kornimate/medical-research-clean huggingface dataset:
prospective rct comparing perioperative pain

Conditions: Arthroplasty Shoulder

Summary: this study is a non-blinded randomized controlled trial comparing the use of a preoperative "mini" block plus postoperative local infiltration of exparel (liposomal form of bupivacaine) versus a partial single shot nerve block in subjects undergoing primary reverse or total shoulder arthroplasty to see which is more effective in controlling surgery related pain. to do so, we will utilize the visual analog scale (vas) to measure pain intensity. opioid consumption will be recorded on a pain monitoring sheet.


Eligibility criteria:
inclusion criteria: * all individuals undergoing primary reverse and total shoulder arthroplasty by the shoulder service at thomas jefferson university hospital, methodist hospital or rothman specialty hospital. exclusion criteria: * psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or schizophrenia * revision arthroplasty or arthroplasty for fracture * unable/unwilling to consent for enrollment * unable to complete postoperative pain survey * known adverse drug reaction or allergy to the medications used * chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic diffuse musculoskeletal pain) * patients taking long acting opioid pain medications (including extended release opioid pain medications and methadone) * patients under the age of 18 years * patients with history of hepatic disease * pregnant or breastfeeding women.
structural and microbiological characterization of arterial catheter biofilm in icu's patients using optical coherence tomography

Conditions: Biofilms; Arterial Catheterization, Peripheral; Bacteremia; Tomography, Optical Coherence

Summary: 29.3% of bacteremias in intensive care units (icu) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality. it is now accepted that biofilm as a role on bacterial development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias. the investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in icu patients could help preventing bacteremias or have a more specific treatment when it appears.


Eligibility criteria:
inclusion criteria: * patient or relative informed of the study and having declared their non-objection * patient over 18 years old * patient hospitalized in icu with an arterial catheter exclusion criteria: * patient unable to express consent * patient whose collection of the arterial catheter is impossible or for whom storage at 4°c is impossible * patient with arterial catheter removed outside the usual procedure of the icu * patient admitted in icu with an arterial catheter already in place
vagal nerve stimulation in mtbi

Conditions: PTSD; mTBI

Summary: mild traumatic brain injury (mtbi) and posttraumatic stress disorder (ptsd) are important conditions for the veterans administration (va) that frequently occur together in combat veterans from the conflicts in afghanistan and iraq. in many veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. this study will examine a new intervention called non-invasive vagal nerve stimulation (nvns) and its effects on memory and symptoms of ptsd and mtbi as well as brain and physiology in veterans with mtbi and ptsd.

this projects will assess the effects of non-invasive vagal nerve stimulation (nvns) on neurobiology and cognition in combat veterans with mild traumatic brain injury (mtbi) and co-morbid posttraumatic stress disorder (ptsd) during the performance of stressful tasks (traumatic scripts, mental arithmetic) and verbal declarative memory tasks using measurement of memory performance, peripheral inflammatory markers in blood (il6) and cardiovascular responses using wearable gated sensing devices and electro- and seismocardiography, as well as brain response (anterior cingulate, hippocampus) measured with high resolution positron emission tomography (hr-pet) and radiolabelled water (15o\[h2o\]). the investigators hypothesize that nvns but not sham control will result in enhanced memory, and hippocampal activation with memory encoding, and reduced cardiovascular, sympathetic, and inflammatory responses to stress. the investigators will also assess the effects of nvns and sham on memory retention when applied to the encoding phase of a declarative memory learning task repeated daily over a four day period and on ratings of ptsd and pain in veterans with mtbi and co-morbid ptsd and repeat assessments after three months of twice daily treatments.

Eligibility criteria:
inclusion criteria: * veterans with mtbi and ptsd exclusion criteria: * amnesia for the inciting event lasted longer than 24 hours * glasgow coma scale score after 30 minutes was less than 13 * loss of consciousness more than 30 minutes * positive pregnancy test * meningitis or other neurological disorder other than mtbi * alcohol or substance abuse use disorder based on the scid within the past 12 months * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the scid * active suicidal ideation based on criteria outlined below * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness * active neuroleptic, opiate, or benzodiazepine treatment * structural abnormality on brain mri or ct

Keywords: vagus nerve stress disorders, posttraumatic traumatic brain injury memory hippocampus emission tomography
effect of sildenafil citrate compared to estrogen as adjuvant therapy for unexplained infertility

Conditions: Subfertility, Female

Summary: . this study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

the study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. patients were divided into 3 groups. group 1 included 48 patients who received oral estradiol valerate (cyclo-progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral sildenafil (respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with cc 50mg/12hr from 2nd to 7th day of cycle. every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Eligibility criteria:
inclusion criteria: * aged between 18 to 40 years * unexplained infertility (primary or secondary) * had a regular menstrual cycle; * patent tubes; * husbands with normal semen parameters. exclusion criteria: * hypotension; * cardiovascular, hepatic, and renal diseases; * uncontrolled diabetes mellitus; * anovulatory infertility; * ovarian cysts; * pelvic adhesions; * hyperprolactinemia; * abnormal thyroid functions; * multiple uterine fibroids; * patients on nitrates; * suspicion of endometriosis and adenomyosis, * subjects have known to receive any treatment for fertility in the last six months
out-of-hospital non-invasive ventilation for patients with acute respiratory failure

Conditions: Respiratory Insufficiency; Respiratory Failure

Summary: in the past, patients suffering from acute respiratory failure had to be treated with oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.

single center, prospective, randomized, intention-to-treat clinical trial. the study has been performed within a two tier ems system of a major city. prehospital emergency physicians are on scene in every patient enrolled to the study. patients with acute respiratory failure (sao2 \ 20/min) were enrolled to the study using envelopes for randomisation for either "conventional" (o2 + medication) or "niv." vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started. primary endpoints are 28-day mortality, hospital-, icu- and respirator-days, saps, sofa ii and complications. secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on spo2, co2, respiratory rate, heart rate and blood pressure.

Eligibility criteria:
inclusion criteria: * acute respiratory failure * at least 18 years old * cooperative exclusion criteria: * cardiac arrest * respiratory arrest * unconscious * uncontrollable agitation * less than 18 years old

Keywords: respiratory insufficiency respiratory failure
testing the efficacy of different dosages of lercanidipine to reduce hypertensive blood pressure in normal weight and obese patients

Conditions: Hypertension

Summary: a double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension


Eligibility criteria:
inclusion criteria: * body mass index (bmi): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included); * essential hypertension i or ii who: * 140 mmhg ≤ bps ≤ 179 mmhg and bpd ≤ 109 mmhg at the end of the placebo run-in phase; exclusion criteria: * secondary hypertension; * diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl; * subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight; * history or presence of angioneurotic oedema; * subjects developing a hypertensive crisis during wash-out or placebo run-in period;

Keywords: lercanidipine, calcium antagonist, hypertension, obesity
pilot study for testing safety of repetitive magnetic stimulation for treatment of dry eye

Conditions: Dry Eye; Sjogren's Syndrome; Aqueous Tear Deficiency; Meibomian Gland Dysfunction; Dry Eye Syndromes

Summary: the study aims to test the safety of repetitive magnetic stimulation (rms) treatment for dry eye disease. patients are asked to undergo a one-time treatment with epitech ocular magnetic stimulation device on one eye in the first stage and both eyes sequentially in the second stage of the study. changes are monitored for over a study period of 3 months.


Eligibility criteria:
inclusion criteria: 1. males and females, 18-80 years old 2. subjects with moderate to severe dry eye syndrome 3. subjects able to understand the requirements of the protocol and provide informed consent. exclusion criteria: 1. eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene 2. a concurrent ocular disease including ocular infection or pterygium. 3. ocular surgery within the previous 6 months and lasik within the previous 1 year. 4. any ocular injury or ocular herpes infection within past 3 months 5. anticipated necessity to wear contact lens in the duration of the study. 6. unstable thyroid disorders (drugs tx not stable in the last 3 months). 7. alcoholism 8. pregnant or nursing women 9. documented hiv positive 10. cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes) 11. any conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck 12. significant heart disease or cerebrovascular disease 13. history of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (cns) tumors. 14. participation in another ophthalmic clinical trial within past 30 day 15. any other specified reason as determined by the clinical investigator.
an adaptive intervention for adolescents at risk for suicide: a pilot smart

Conditions: Suicide; Self Harm

Summary: to inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a sequential, multiple assignment, randomized trial (smart) pilot of a motivational interview (mi)-enhanced safety planning intervention (mi-safecope). findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.


Eligibility criteria:
inclusion criteria: * suicide attempt (previous month), and/or * suicidal ideation (previous week) exclusion criteria: * severe cognitive impairment or altered mental status (psychosis, manic state) * transfer to medical unit or residential placement * no availability of a legal guardian * no cell phone with text messaging capability

Keywords: adaptive intervention sequential, multiple assignment, randomized trial (smart) adolescent motivational interviewing suicide attempt safety planning mobile technology
a clinical research of car t cells targeting cd19 positive malignant b-cell derived leukemia and lymphoma

Conditions: Leukemia; Lymphoma

Summary: the main purpose of this research is to verify the safety of cd19 targeted chimeric antigen receptor t cells and to determine the proper dosage of car t cells infused.

nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. innovative therapy is urgently required. chimeric antigen receptor (car)-modified t cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (cd19) positive b cell malignancies. to design better car t cells, we have developed new cd19 cars. preclinical studies have demonstrated effective killing of cd19 target cells. in this study, the cd19 cars, will be evaluated in cd19 positive leukemia/lymphoma patients. the primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. in addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell derived acute lymphoblastic leukemia(all), chronic lymphocytic leukemia(cll) and non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 4 years to 75 years. 5. disease progresses but reserves reaction to recent treatments. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. exclusion criteria: 1. hiv affected. 2. patients are allergic to cytokines. 3. central nervous system leukemia within 28 days. 4. uncontrolled active infection. 5. acute or chronic gvhd. 6. treated with t cell inhibitor. 7. pregnancy and nursing females. 8. other situations we think improper for the research.

Keywords: car t leukemia lymphoma
isometric resistance exercise for hypertension

Conditions: Hypertension

Summary: background: isometric resistance exercises (ires) have great potential to improve blood pressure (bp) control. however, the effectiveness of ires in reducing ht is still unknown because their hypotensive effects have not been detected using ambulatory bp measurements (abpm), which are the current standard for bp measurement. methods: this first adequately-powered rct will involve 390 patients with ht who do not meet the current physical activity guidelines defined by the world health organization. participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the ire (wall squat) group or stretching exercise (active control) group. a well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. adherence to the program will be monitored using smartwatches, and regular contact with patients through social media will help ensure adherence. all patients will be followed up for 1 year to investigate the long-term effects of ires on bp. control group will receive exact same treatment except that ire is replaced by frequency-matched and time-matched stretching exercise. the primary outcome measure will be systolic daytime abpm bp at 24 weeks. secondary outcome measures will include other bp and abpm parameters at 12 weeks, 24weeks and 1year, cfpwv at baseline, 24 weeks and 1year, and fmd at baseline and 24weeks. safety data will be collected and reported.


Eligibility criteria:
inclusion criteria: * a suboptimal daytime sbp of \>135-160 mmhg on a 24-h abpm * reported no regular physical activity or less than that recommended for adults by the world health organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week) * on stable doses of anti-ht medication(s) for ≥4 weeks if the patient is receiving drug treatments; * agree for no drug changes during the intervention period (24 weeks); exclusion criteria: * cannot provide informed consent * unwillingness to repeat abpm * relative contraindications to abpm (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies) * severe osteoarthritis pending knee replacement surgery * known secondary ht * use of ≥3 anti-ht medications at maximum doses or ≥4 anti-ht medications * sbp or dbp are \>160 mmhg or \>100 mmhg, respectively, on abpm at baseline or at 12 weeks follow-up to ensure safety * pregnancy/breastfeeding * active malignancy
safety and efficacy of 12 weeks of varenicline for smoking cessation in smokers with depression

Conditions: Smoking Cessation; Depression

Summary: patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. phase 2 and phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. this smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Eligibility criteria:
inclusion criteria: * male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt * smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (co) \> 10 ppm at screening * current or past diagnosis of mdd without psychotic features, either single or recurrent, using dsm iv tr based on clinical assessment and confirmed by scid and at least one of the following: * on stable antidepressant treatment for mdd (stable dose for at least 2 months) * major depressive episode, using dsm iv tr, in the past 2 years successfully treated exclusion criteria: * current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar i disorder, bipolar ii disorder. * subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements.. * current use of either bupropion or nortryptiline.

Keywords: smoking smoking cessation smoking cessation in depressed subjects
cranial-nerve non-invasive neuromodulation (cn-ninm) for balance deficits after mild traumatic brain injury (pilot trial)

Conditions: Mild Traumatic Brain Injury

Summary: the purpose of this study is to determine the feasibility of combining pons therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. this study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility. * goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase. * completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed. * useability: all therapists and subjects must rate useability as good or better. * success of blind: subject accuracy at guessing group membership must be at or near 50%.


Eligibility criteria:
inclusion criteria: 1. veteran or servicemember 2. 18 to 50 years old 3. sustained one or more mild traumatic brain injury (mtbi)s 4. demonstration of balance deficits on the sensory organization test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample)) 5. available for the duration of the study exclusion criteria: 1. history of traumatic brain injury (tbi) of any severity other than mild tbi 2. presence of active substance abuse condition 3. any condition for which posturography is contraindicated (e.g. leg amputation or fracture) 4. diagnosed neurological disorder with balance sequelae, other than tbi (e.g. parkinson's disease, incomplete spinal cord injury, or multiple sclerosis) 5. orthostatic hypotension as defined by: 1. a systolic blood pressure decrease (from supine to sitting) of at least 20 mmhg 2. a diastolic blood pressure decrease of at least 10 mmhg, or 3. a pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion 6. an implanted medical device 7. pregnancy 8. oral infection 9. known transmissible disease (hiv, hepatitis, influenza, tb) 10. exam signs of serious disorder other than mtbi as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).

Keywords: mild traumatic brain injury
targeting the neurobiology of rrb in autism using n-acetylcysteine: open label

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using n-acetylcysteine (nac), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. the findings from this research will shed light on the mechanisms of action underlying the clinical benefits of nac and the effects of nac on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder.


Eligibility criteria:
inclusion criteria: * participation in an associated single-dose (irb-54931, nct04278898) or randomized, controlled trial of nac (irb-63262, nct05664789). * stable medication regimens (≥ 30 days) with no anticipated changes during the trial. exclusion criteria: • the presence of significant medical problems that reduce medical stability.

Keywords: magnetic resonance imaging n-acetylcysteine restricted and repetitive behaviors electroencephalography