Kornimate/medical-research-clean huggingface dataset:
post-marketing safety surveillance of xueshuantong-injection : a registry study

Conditions: Adverse Drug Event; Adverse Drug Reactions; Anaphylactic Reaction; Severe Adverse Reactions

Summary: this registry aims to monitor the safety of xueshuantong injection and to identify the potential risk factors for the adverse drug reactions.

xueshuantong-injection is a kind of natural compound injection with panax notoginseng saponins(pns). it's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. however, more and more case reports about the adverse drug events of panax notoginseng saponins have been reported in recent years. therefore, this registry of xueshuantong-injection aims to monitor the safety and find the incidence of adverse drug reactions to xueshuantong-injection. moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.

Eligibility criteria:
inclusion criteria: * patients who use xueshuantong-injection in the monitoring departments of certain hospitals exclusion criteria: * none
development and validation of a nirs-based sinusitis screening

Conditions: Sinusitis

Summary: the research at university of california irvine, beckman laser institute and praxis biosciences incorporation, develope near-infrared trans-illumination methods. the optical imaging tool that can determine acute sinusitis and the response to treatment therapy.

in the united states, approximately one in seven people develop sinusitis each year, and 20 million cases of acute bacterial sinusitis become chronic to require medical treatment. the optic light from the illumination wand travelled through the pallet into the sinuses and exited the face. the optic device can determine air-filled and fluid/tissue-filled spaces in the sinus cavity during clinical exam.

Eligibility criteria:
inclusion criteria: * male or female 18 years of age and older * subject with normal sinus * subject who has been diagnosed and confirm by their physician exclusion criteria: * younger than 18 years old * pregnant women
the use of music for neonates post-cardiac surgery

Conditions: Heart Defects, Congenital

Summary: the purpose of this study is to explore the feasibility of implementing nurse-led music therapy in a cohort of neonates admitted to the cardiac intensive care unit (cicu) post congenital heart surgery. in the proposed setting, the use of a standardized nurse-led music therapy protocol for post-operative neonates would build upon current successful nurse-led efforts to wean sedatives and opioid use for patients admitted to the cicu. the investigators believe data generated from this exploratory feasibility study may serve to further inform a larger study involving the use of music therapy in the cardiac intensive care.

a predetermined recording of a music playlist meeting the properties of sedative music is being developed in consultation with a boston children's hospital (bch) music therapist. properties of sedative music include soothing, stable, constant, and relatively unchanging, slow tempo and light rhythmic emphasis, constant volume and rhythm, lullaby style, repetitious and no separate melody for chorus/bridge. the music recorded for the neonates has been produced specifically for this study. in accordance with the recommendations for soothing music, bch music therapists have recorded english nursery rhymes (figure 1) in the key of c major at 60bpm with acoustic guitar and voice. the playlist will be stored on an apple ipod touch and will be delivered through a bluetooth speaker that is positioned centrally (so that the sound input is received binaurally) at the subjects head or feet for a period of 20 minutes once during a 12-hour shift for 14 days or until mechanical ventilation has been discontinued, whichever is first. the literature supports a duration of up to 30 minutes of music therapy followed by at least 30 minutes of silence, with a maximum of four hours per day. music played for longer than 30 minutes has the potential to be a source of over-stimulation/agitation. there is some evidence to suggest that playing music for long periods of time (two four-hour segments) has a negative effect. in addition, it seems reasonable and likely to assume that the neonate could have a period of 30 minutes when they will not require an intervention associated with post-operative care. the protocol will target a 20 minute playlist. this will allow for variation in the length of songs while ensuring that music will not be played for longer than 30 minutes. there will be at least 30 minutes of quiet between music therapy session.

Eligibility criteria:
inclusion criteria: * greater than 37 weeks gestation, * between 0 to 30 days of age * 24 hours post congenital heart surgery * receiving mechanical ventilation * background noise level (at bedside) at the time of music therapy must be 55db or less. exclusion criteria: * hemodynamically unstable or end of life * if patient is in a closed giraffe bed * evidence of hearing impairment * patient has known or suspected active seizure disorder
computerized personal interventions for alzheimer's patients

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate alzheimer's disease (ad), or at least delay its deterioration. in addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.

reminiscence therapy and cognitive training are two of the most common non-pharmacological therapies used to treat ad. to date, there is no clear evidence regarding the impact of these treatments on the cognitive function of people with ad. the inconclusive evidence may be due to methodological limitations, the availability of a limited number of controlled studies, the lack of standardized interventions and the need for sensitive assessment tools. increasingly, computerized systems are being designed to support both the cognitive assessment of patients with alzheimer's disease and the administration of novel non-pharmacological interventions. studies suggest that such systems may be of clear benefit. for example, in an initial study involving patients with ad, computerized cognitive training systems have been shown to be of value in providing a more standardized approach to cognitive training. also, another study found that the use of a computerized system for reminiscence therapy was successful in facilitating patient-caregiver interaction. our research is a collaborative effort designed to test the effects of two such computer-supported interventions in patients with mild ad. the purpose of the research is to compare the efficacy of personalized computerized reminiscence therapy and that of computerized cognitive training to a control group. the reminiscence therapy program is based on developing an internet-based personalized reminiscence system, which will facilitate flexible interactive use by patients and caregivers. the importance of a personalized system is especially salient in immigrant, or in highly mobile, societies due to the heterogeneous background of the patients. separate preliminary studies have found positive effects of each system. the research will use various measures to evaluate the efficacy of both treatments, including the mindstreams (neurotrax corp., nj) computerized neuropsychological assessment instrument, which will serve as the cognitive outcome measure.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of alzheimer's disease * mmse score of 14-26 exclusion criteria: * visual impairment * auditory impairment * psychiatric disorders

Keywords: alzheimer dementia computer cognitive training reminiscence therapy
shift: studying hiv immunology after fecal transplant

Conditions: HIV/AIDS; Dysbiosis; Inflammation

Summary: shift is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of fecal microbiota transplant (fmt) in hiv-infected participants on stable antiretroviral therapy (art).

this study is designed to test the safety and tolerability of fecal microbiota transplant (fmt) in hiv infected individuals on stable antiretroviral therapy (art). additionally, the study will examine potential effects of fmt on hiv immune activation, which has been linked to hiv disease progression.

Eligibility criteria:
inclusion criteria: 1. men and women ages 18 - 75 years. 2. hiv-1 positive: 3. ability and willingness of participant or legal guardian/representative to provide informed consent. exclusion criteria: 1. patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules) 2. use of investigational therapies or investigational vaccines within 90 days prior to study entry 3. serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry 4. history of positive hcv antibody with detectable hcv rna in plasma within 48 weeks prior to study entry. 5. history of positive hbsag within 48 weeks prior to study entry 6. liver cirrhosis, history of c. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy. 7. current diagnosis of diabetes 8. bmi \>35 9. either breastfeeding or pregnant within 24 weeks prior to study entry 10. tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment) 11. use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry. 12. use of probiotics and prebiotics (supplements and products) within 30 days of the study. yogurt with live cultures is allowed. 13. diagnosed bacterial enteric infection within 30 days prior to study entry. 14. acute diarrhea within 30 days of study entry. 15. weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
does vaginal washing affect the success rate of the labour induction?

Conditions: Labor Induction; Dinoprostone Vaginal Insert; Vaginal Infection; Effect Increased

Summary: investigators will use dinoprostone(propess tm) for cervix ripening and labor induction in term pregnant women.vaginal ph base is achieved with the effect of hormones in pregnancy and associated with this, vaginal infections rates increase. with the vaginal application of propess, the preparate remains in the vagina for a long time, with controlled release,creating a film layer against bacteria and especially fungal infections and it was thought that this could be a reason for unsuccessful birth induction by preventing release of this ovule. the aim of this study is to observe whether or not the rate of caesareans with the indication of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing the rate of unsuccessful inductions.

the study will include patients meeting the study criteria monitored in the delivery . verbal and written informed consent will be obtained from all patients before starting the study. the patients will be randomised to 2 groups. in one group, vaginal lavage (the vagina will first be washed with saline in a 20cc injector) will be applied then propess will be used and in the other group propess will be used without any lavage. it is planned to include 70 patients in each group.

Eligibility criteria:
inclusion criteria: * patients with singleton pregnancies * term gestational week (defined as\>37 weeks), * fetal cephalic presentation * participiants with with intact amniotic membrane * reactive fetal heart rate * cervical modified bishop's score \<5 exclusion criteria: * patients with with multipl pregnancies * participiants with malpresentation anomalies * participiants with nonreassurring fetal heart rate * participiants with more than three contractions in 10 minutes * participiants with contrandications for using prostaglandins * participiants with fetal anomaly * participiants with fetal demise * participiants with emercency delivery indications, * participiants with previous cesarean delivery or have other uterine surgery * participiants with cephalopelvic disproportion
evaluation of the effect of corticotomy and low level laser therapy on orthodontic tooth movement

Conditions: Dental Malocclusion

Summary: the aim of the present study was to compare, a standard efficient technique in accelerating otm as surgical corticotomy as a gold standard versus surgical corticotomy combined with lllt in an attempt for further acceleration of otm.

the study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (corticotomy and laser versus corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. in addition, the impact of both interventions on root resorption was assessed. the present study was carried on 16 female patients. all patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.

Eligibility criteria:
inclusion criteria: 1. post pubertal patients with age more than 17 years. 2. class i or class ii (angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage. exclusion criteria: 1. patients having missing permanent canine teeth in maxillary arch. 2. history of trauma or root canal treatment in maxillary canines. 3. history of previous orthodontic treatment. 4. history of hormonal disorder or syndrome.
a multicenter, double-blind, parallel phase iii study

Conditions: Influenza

Summary: a multicenter, randomized, double-blind, active-controlled, parallel phase iii

a multicenter, randomized, double-blind, active-controlled, parallel phase iii study to investigate the efficacy(immunogenicity) and safety of gc3110a(quadrivalent influenza vaccine) after intramuscular administration in healthy subjects

Eligibility criteria:
criteria: inclusion criteria: * given written informed consent * healthy korean adults (age: over 19 ) * korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures * those who are able to comply with the requirements for the study exclusion criteria: * inability in written/verbal communication * subjects who have participated in other interventional study within 30 days * alcohol or drug abuse within 6 months * who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment * disorders in immune function * history of guillain-barré syndrome * disease/medications which are likely to cause any severe bleeding * active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination * oral temperature \>38.0 ℃ at the vaccination day * erythema, tattoo, injury at shoulder (vaccination site) * hypersensitivity with egg, chicken, or any of the vaccine components, or neomycin, gentamicin * influenza vaccination within 6months * any vaccination within 30 days * concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months * pregnant or breast-feeding women * clinically significant underlying diseases or medical history at investigator's discretion

Keywords: qiv quadrivalent influenza vaccine influenza vaccine vaccination
ultrasound-guided bilateral rectus sheath block for robotic single-port gynecologic surgery

Conditions: Gynecologic Disease

Summary: rectus sheath block (rsb) is a kind of anterior abdominal wall block. it has postoperative analgesic effect for abdominal surgery with midline incision. robotic gynecologic surgery is accompanied by significant postoperative pain and usually iv-pca is used to manage the pain.the purpose of this study is to investigate the analgesic effect of ultrasound-guided rsb to single-port robotic gynecologic surgery which has incision site at umbilical area. patients will randomly assigned to two groups, rsb group and control group. each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by iv-pca by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

patients of rsb group will be performed ultrasound-guided bilateral rsb after induction of general anesthesia. the procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. after the procedure, a surgery scheduled will be proceeded. patient of control group will be proceeded the surgery after induction of anesthesia. all patients will use total 100 ml of iv-pca containing 800 µg of fentanyl for 48 hours postoperatively. if a patient complains pain more intense than vnrs 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Eligibility criteria:
inclusion criteria: * robotic single-port gynecologic surgery * american society of anesthesiologists (asa) physical status classification i-ii * age: 21-60 exclusion criteria: * gynecologic cancer operation * history of previous abdominal surgery * allergy to local anesthetics(ropivacaine) * opioid tolerance * coagulopathy * infection at the needle insertion site * difficulty to cooperating
safety and efficacy trial of hp802-247 in the treatment of chronic venous leg ulcers

Conditions: Venous Ulcer; Venous Stasis Ulcer; Ulcer

Summary: this study is being done to find out if an investigational product called hp802-247 can help people with venous leg ulcers. investigational means that hp802-247 has not been approved by the u.s. food and drug administration (fda). this research is being done to compare the efficacy of hp802-247 plus compression therapy against vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. vehicle looks the same as hp802-247 but contains no cells. at least 440 subjects will participate. the study is going to be conducted in approximately 5 countries at approximately 50 sites across the european union.

see brief summary

Eligibility criteria:
inclusion criteria: * provide informed consent. * age ≥ 18 years and of either sex. * willing to comply with protocol instructions, including allowing all study assessments. * have a venous leg ulcer (vlu) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2 * venous insufficiency confirmed by duplex doppler ultrasound examination for valvular or venous incompetence. * arterial supply adequacy confirmed * target ulcer involves a full thickness skin loss, but without exposure of tendon, muscle, or bone. * target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months). * acceptable state of health and nutrition exclusion criteria: * history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin b. * prior diagnosis of systemic lupus erythematosus with elevated anti-dna antibody titers, buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication. * therapy with another investigational agent within thirty (30) days of screening, or during the study. * a target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). * documented history of osteomyelitis at the target wound location within 6 months preceding the screening visit. * refusal of or inability to tolerate compression therapy. * therapy of the target ulcer with autologous skin graft, apligraf™, or dermagraft™ within 30 days preceding the screening visit. * history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). * any prior exposure to hp802-247 or its vehicle.

Keywords: venous leg ulcer ulcer venous stasis compression venous venous stasis ulcer vlu wound varicose veins venous insufficiency dvt deep vein thrombosis
study investigating a delayed-release pancrelipase in patients with exocrine pancreatic insufficiency due to cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with pei due to cystic fibrosis.


Eligibility criteria:
inclusion criteria: * confirmed cf diagnosis by two positive chloride sweat tests or gene analysis * confirmed pei by historical cfa \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months) * subjects of 12 years or older * currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months * clinically stable condition without evidence of acute respiratory disease or any other acute condition * females of child-bearing potential must agree to continue using a medically acceptable method of birth control exclusion criteria: * ileus or acute abdomen * history of fibrosing colonopathy * history of distal ileal obstruction syndrome within 6 months of enrollment * use of an immunosuppressive drug * any type of malignancy involving the digestive tract in the last 5 years * known infection with hiv

Keywords: pancreatic exocrine insufficiency cystic fibrosis
investigation of effects of delayed feedback on non-motor symptoms in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: learning deficits are frequent in individuals with parkinson's disease. clear feedback is integral because through feedback individuals know whether they should stick with an action that they have been doing (if the feedback is positive), or change their course of action (if the feedback is negative). learning though immediate feedback has been shown to be depended on the brain chemical dopamine that is disrupted in individuals with parkinson's disease. during learning, feedback can also be presented after a delay. the investigators propose that learning through delayed feedback will lead to greater learning in individuals with parkinson's disease, since learning through delayed feedback does not rely on dopamine. during the proposed paradigm, participants with parkinson's disease complete a multiple-choice test. after making their selection on the multiple-choice test, they either see feedback immediately or are given feedback 25 minute later after reviewing their selection on the multiple-choice test. the investigators hypothesize that participants will learn better when they are provided with delayed feedback.


Eligibility criteria:
inclusion criteria: * only participants with scores above 24/30 on the montreal cognitive assessment will be recruited for participation to exclude dementia. exclusion criteria: * individuals with neurological conditions other than pd such as epilepsy, multiple sclerosis, brain tumors, etc. will be excluded to control for the effects these conditions have on the brain and behavior.

Keywords: parkinson disease learning feedback