Kornimate/medical-research-clean huggingface dataset:
comparisons of two types of rehabilitation robot for upper extremities

Conditions: Stroke

Summary: comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)


Eligibility criteria:
inclusion criteria: * hemiplegic patients secondary to first cerebrovascular accidents * onset ≥ 3 months * 8 ≤ fugl-meyer assessment score ≤ 30 * shoulder or elbow flexor spasticity modified ashworth scale ≤ 3 * cognitively intact enough to understand and follow the instructions from the investigator exclusion criteria: * history of surgery of affected upper limb * fracture of affected upper limb

Keywords: stroke
a protocol for the use of chlorhexidine gluconate saturation for the reduction of dental biofilm formation on polymethylmethacrylate restoration

Conditions: Dental Plaque

Summary: chlorhexidine gluconate (chx), as an anti plaque agent, is commonly used with a variety of products. in this study we, the investigators at hadassah medical organization, intend to examine the efficacy of a single dip in chx of provisional restoration prior to oral cementation. if the protocol is effective, we intend to calibrate it and recommend clinical use of the protocol. the examination of biofilm formation will be both with electron microscope and confocal scanning laser microscope.


Eligibility criteria:
inclusion criteria: * any volunteer without systemic condition exclusion criteria: * intake of antibiotic drug three months prior to experiment

Keywords: chlorhexidine gluconate polymethylmethacrylate anti-bacterial agents
bioequivalence study for lamotrigine tablets 200 mg under fed condition

Conditions: Healthy

Summary: this is an single dose,two-way, crossover, oral bioequivalence study.

the study was an single dose, two-way, crossover, oral bioequivalence study of lamotrigine tablets 200 mg of dr. reddy's laboratories limited, india comparing with that of lamictal® tablets 200 mg of glaxosmithkline inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. the washout period is 14 days between the two periods of the study.

Eligibility criteria:
inclusion criteria: 1. healthy males and females at least 18 years of age inclusive 2. informed of the nature of the study and given written informed consent 3. have a body weight within 15% of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 100 lbs. exclusion criteria: 1. hypersensitivity to lamotrigine (lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions. 2. any history of a clinical condition which might affect drug absorption, metabolism or excretion 3. recent history of mental illness, drug addition,drug abuse or alcoholism 4. donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood. 5. received an investigational drug within the 4 weeks prior to study dosing. 6. currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. this prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician. 7. tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing. 8. if female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Keywords: bioequivalence lamotrigine crossover
long-term success rate of transvaginal mesh for the treatment of pelvic organ prolapse: the extended rct study

Conditions: Pelvic Organ Prolapse

Summary: the original rct trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of pop stage iii-iv in terms of efficacy, safety and cost-effective at 1-year follow-up. this study will follow women in the original rct study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. recruitment into this study is open only to women that already participated in previous rct, no new treatment interventions will be given. recruitment into the previous rct is closed. women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

the previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. the original rct study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. the goal of this long-term follow-up study is to extend the follow-up of women in the previous rct study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. the primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. a supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.

Eligibility criteria:
inclusion criteria: * women enrolled in previous rct study exclusion criteria: * inability to provide informed consent. informed consent will be obtained prior to each telephone interview and each in-person visit. * subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.

Keywords: pelvic organ prolapse surgery plastic pelvic floor polypropylenes
micra transcatheter pacing system continued access study protocol

Conditions: Bradycardia

Summary: medtronic is sponsoring the micra continued access (ca) study to provide continued access to the micra system while the marketing application is under review by the food and drug administration (fda).

the micra ca study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the micra system when used as intended. all subjects enrolled in the micra ca study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. fda approval). patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.

Eligibility criteria:
inclusion criteria: * subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * subject meets class i or ll indication for implantation of single chamber ventricular pacemaker and is intended to be implanted with a micra system * subject able and accessible for follow-up per study requirements * subject is at least 18 years of age * patient is not enrolled in a concurrent drug and/or device study that may confound registry result. exclusion criteria: * subject has had an acute myocardial infraction (ami) within 30 days of implant * subject has implantation of neurostimulator or any other chronically implanted device which uses current in the body * subject with mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (lvad) * subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head. * subject who femoral venous anatomy is unable to accommodate a 23 french introducer sheath or implant on the right side of the heart (for example due to obstructions or sever tortuosity) in the opinion of the implanter * subjects with known intolerance to nickel-titanium (nitinol) alloy * subject for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated * subjects with life expectancy less than 12-months * subject is enrolled in a concurrent drug and/or device study that may confound ca study results
the registry study of genetic alterations of oropharyngeal cancer in taiwan

Conditions: Oropharyngeal Squamous Cell Carcinoma

Summary: we will use the next-generation sequencing (ngs) technology to identify genomic alterations of taiwanese hpv positive and negative oropharyngeal squamous cell carcinoma (opscc) for novel biomarker development and the study design of potential clinical trials or translational research.

in the past decade, next-generation sequencing (ngs) technology has enabled cancer genome sequencing in screening and searching for new cancer genes in an efficient manner. this massive sequencing technique not only help to identify new altered genes for novel biomarker development, but also reveal gene alterations sensitive or resistant to specific therapies. because the difference of genomic profiling between taiwanese hpv positive and negative opscc is not clear yet, we propose this multi-center research project to address this issue. in this study, we will collect tumor tissues and clinical information from patients with opscc and create a platform for data storage and sharing.

Eligibility criteria:
inclusion criteria: 1. ages 20 and above 2. pathological reported as squamous cell carcinoma of head and neck 3. available p16 immunohistochemical staining status (restricted to the opscc subgroup) 4. participants have both archival tumor tissues from the primary head and neck scc and from the first recurrent tumor (for the recurrence subgroup) 5. recurrence status is defined as the reappearance of the disease occurring more than 6 months following curative surgery and/or chemoradiotherapy in the recurrence subgroup 6. willingness to provide archival or newly obtained tumor tissues for current study proposal 7. life expectancy more than 3 months 8. patients fully understand the protocol with the willingness to have regular follow-up exclusion criteria 1. inability to cooperate by providing a complete medical history 2. no available tumor tissues for genetic testing 3. undesirable compliance 4. having a known additional malignancy that is progressing or has required active treatment within the past 3 years. participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded

Keywords: human papillomavirus oropharyngeal squamous cell carcinoma next-generation sequencing precision medicine
a trial for evaluation of clinical efficacy and safety of healing stone navel belt in patients with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the purpose of this study is to determine whether healing stone navel belt is safe and effective in the treatment of primary dysmenorrhea.


Eligibility criteria:
inclusion criteria: * age : female adults aged 15\~45 years * subjects should diagnosed as primary dysmenorrhea, should have a primary dysmenorrhea at least a 1-day during menstrual. * subjects should have 21\~42 days menstrual cycle. * menstrual pain : primary dysmenorrhea at least a 1-day during menstruation is over 5 vas(visual analogue scale) without drug. * subjects must have no serious internal medicine. * subjects must provide signed informed consent prior to participation in any study-related procedures exclusion criteria: * subject that oral contraceptive taken within 3 months * pregnancy or lactation. * subject have contraceptive that secrete hormone. * secondary dysmenorrhea * pelvis inflammatory disease patient * other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study.

Keywords: healingstone
a drug-drug interaction study between bms-663068 and oral contraceptives in healthy female volunteers (ddi)

Conditions: Infection, Human Immunodeficiency Virus

Summary: this is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (ddi) study in healthy female subjects on oral contraceptives (oc). there is no formal research hypothesis to be statistically tested. it is expected that coadministration of bms-663068 with oc will not affect the pharmacokinetics (pk) of either ethinyl estradiol (ee) or norethindrone (ne).


Eligibility criteria:
inclusion criteria: * healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive * women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing ee and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to day -1 exclusion criteria: * any significant acute or chronic medical illness other protocol defined exclusion criteria could apply.
the treatment of glabellar frown lines

Conditions: Glabellar Frown Lines

Summary: the purpose of this study is to show that two fda-approved botulinum toxin drugs called xeomin® and botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).

this is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxina (xeomin®) to onabotulinumtoxina (botox®) in the treatment of glabellar frown lines.

Eligibility criteria:
inclusion criteria: * outpatient females 18 to 50 years of age * moderate to severe glabellar frown lines exclusion criteria: * glabellar frown lines at rest rating 3 on the 4-point facial wrinkle scale * previous treatment with botulinum toxin * previous treatment with biodegradable fillers in glabellar area within last 12 months * any severe or uncontrolled systemic disease, malignant tumor, or medical history of hiv infection * known hypersensitivity to incobotulinumtoxina or onabotulinumtoxina or to any of their excipients * intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection

Keywords: glabellar frown lines frown lines facial wrinkles
the need of revisiting to an outpatient clinic after the prescription of vonoprazan or esomeprazole

Conditions: Gastroesophageal Reflux

Summary: after vonoprazan (20mg/day) or esomeprazole (20mg/day) for 4weeks is prescribed for patients with erosive esophagitis diagnosed by esophagogastroduodenoscopy, the number of patients who will visit our outpatient clinic again due to some reasons without any appointments is compared with vonoprazan group and esomeprazole.

1. patients who have erosive esophagitis diagnosed by esophagogastroduodenoscopy is enrolled. 2. vonoprazan (20mg/day) or esomeprazole (20mg/day) is prescribed for 4weeks the patients randomly without next appointments. 3. some patients may visit our outpatient clinic again due to some reasons without any appointments. 4. the number of the patients who revisit our outpatient clinic again is compared with vonoprazan group and esomeprazole.

Eligibility criteria:
inclusion criteria: * outpatients belonging to american society of anesthesiologists class i or ii * patients have erosive esophagitis diagnosed by esophagogastroduodenoscopy shortly before the prescription exclusion criteria: * other acid blockers are taken
app-based education and goal-setting in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid arthritis (ra), aiming to improve self-efficacy for the management of ra-related symptoms. the intervention consists of education, lifestyle advice and remote monitoring elements and is based on principles of goal setting, self-efficacy theory and behavioural economics, embedded within a platform supported by motivational features and gamification. the primary endpoint is defined as achieving at least a minimal clinically important difference in arthritis-related self-efficacy (the ases-score) at the follow-up visit in favour of the intervention group when compared to the control group. moreover, although qualitative studies have highlighted concerns among both patients and healthcare professionals that mobile apps might induce illness behaviour by increasing patients' awareness of their symptoms, this has rarely been studied in detail. consequently, data regarding the effects of remote monitoring on symptom hypervigilance remain limited and conflicting. therefore, this trial additionally aims to assess (as a key secondary objective) if a mobile app-based intervention is associated with changes in pain catastrophising, as a conceptualisation of hypervigilance to symptoms.


Eligibility criteria:
patients will be considered eligible for participation in the study if they: * are able and willing to provide written informed consent for participation. * are 18 years of age or older. * have a diagnosis of ra made by a rheumatologist, with a minimal time since diagnosis of 16 weeks. this time frame was chosen based on conceptual reasons and previous work of our research group, suggesting that the dynamic and impactful first weeks after diagnosis are not the ideal time window to assess psychosocial outcomes. * are able to understand and read dutch. * have access to a smartphone that meets the technical requirements to run the study application, including an android (8.0 or more recent) or apple ios (14.0 or more recent) operating system, and feel comfortable using it. in order to include an optimally representative patient population, no additional exclusion criteria will be applied for this study.

Keywords: self-management mobile health smartphone applications education patient-reported outcomes lifestyle goal-setting remote monitoring
prevalence of presenting diseases for elderly patients admitted to emergency department

Conditions: Geriatric Disorder

Summary: the number of elderly patients admitted to the emergency department (ed) is dramatically increasing.

the number of elderly patients admitted to the emergency department (ed) is dramatically increasing. most emergency physicians have not been trained in specific geriatric approaches, and many report being less comfortable when dealing with older patients. aim of this study is the investigation the most common conditions affecting older patients in the ed.

Eligibility criteria:
inclusion criteria: * elderly patients who visited the emergency department exclusion criteria: * patients below 65 years of age * patients with missing data in medical records

Keywords: elderly patients prevalence emergency department use main presenting disease
the safety and efficacy of the enhanced recovery after surgery(eras)applied on cardiac surgery with cardiopulmonary bypass

Conditions: Valvular Heart Disease

Summary: this study evaluates the enhanced recovery after surgery (eras) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. half of participants will adherence to the eras, while the other half will under the conventional postoperative care.

enhanced recovery after surgery (eras) or fast-track surgery is a perioperative and postoperative care concept initiated in the early 1990s aiming to reduce the length of hospital stays following elective abdominal surgery. the success of eras depends highly on multidisciplinary teamwork and patient compliance. this study intends to compare the enhanced recovery after surgery (eras) concept applied to patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass under traditional perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an effective perioperative management during cardiopulmonary bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.

Eligibility criteria:
inclusion criteria: * heart function grade ii - iii (using the cardiac function classification method formulated by american heart disease institute) * the in - hospital was treated with extracorporeal circulation operation and general anesthesia. * had a good cognition, and signed the informed consent. * aged between 18 and 70. * the age, clinical examination and other generally situation of the two groups of patients had no statistical significance. exclusion criteria: * combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease. * patients with severe mental disorders cannot cooperate with the treatment. * emergency operation * have taboo of echocardiography and pulmonary catheterization by echocardiography. * patients have been fitted with a pacemaker. * allergic to erythropoietin. * suspected or had alcohol, drug abuse history. * spinal deformity or paravertebral lesions.

Keywords: enhanced recovery after surgery