Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of human neural stem cells for parkinson's disease patient

Conditions: Parkinson Disease

Summary: this pilot study will evaluate the safety and efficacy of an investigational cell transplantation therapy, h-nsc, in patients with parkinson's disease, through nasal drug delivery, a new delivery way. all patients will receive the therapy, which consists of human neural stem cells,

h-nsc is a cellular therapeutic consisting of human fetal neural stem cells (h-nsc). h-nsc injection will be delivered through nasal way for patients with parkinson's disease (pd). the study will enroll 12 moderate to severe pd patients to be treated with the cell injection therapy at the same dose. the total therapy course will be four weeks，one dose for one week. the follow up will be two times within 24 weeks after finishing the treatment. the main objective of the study is to evaluate the efficacy and safety of the cell transplantation by this new delivery way.

Eligibility criteria:
inclusion criteria: * patient diagnosed with idiopathic pd, at least with two key symptoms (static tremor, bradykinesia, rigidity ) , without any other evidence of secondary parkinson's syndrome. * disease course ≥7 years，modified hoehn-yahr is 3-5 stage * patient age ≥35 years * patients receiving a stable dose of levodopa for at least 1 months with the expectation that the treatment will remain unchanged throughout the course of the study * the doses of levodopa ≥300mg •signed informed consent form (icf) by patient self or his law-in relationship before enrollment. exclusion criteria: * hepatic dysfunction(transaminase ≥1.5 normal range), renal dysfunction(cr\>2.0mg/dl or 177μmol/l)，cardiac dysfunction or other severe systematic diseases etc. * suffering malignancy or during anti-cancer treatment period. * pregancy, lactation or possible pregancy and plan to pregancy patient * attended other intervention clinical trial within 3 months aftre getting icf, or during other ongoing intervention clinical trial * investigator think inappropriate patient for this protocol

Keywords: parkinson disease neural stem cell nasal delivery
oral polypodium leucotomos for melasma

Conditions: Melasma

Summary: primary objective: to determine whether there is improvement in the melasma of participants taking oral polypodium leucotomos secondary objective: to determine whether oral polypodium leucotomos is well tolerated in study subjects with melasma. to determine whether treatment with polypodium leucotomos improves the health-related quality of life.

polypodium leucotomos is a fern, also known as calaguala used by the natives of northern honduras as a treatment against malignant tumors used in spain and central america for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo. oral polypodium leucotomos is safe and effective in patients with melasma.

Eligibility criteria:
inclusion criteria: * healthy female subjects 18-50 years of age. * female subjects with epidermal melasma. * female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study. * subjects with fitzpatrick skin types ii, iii, \& iv * subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma. exclusion criteria: * pregnant or lactating * dermal melasma * hormonal therapies less than or equal too 4 weeks prior to study * use of photosensitizing medications * simultaneous use of any form of treatment for melasma * subjects who were concurrently receiving light therapies * subjects who were unwilling to limit the amount of sun exposure * simultaneous ( or past 30 day) participation in a clinical research study.

Keywords: melasma
"loss of resistance" versus compuflo® for epidural placement

Conditions: Pain; Epidural Analgesia

Summary: the purpose of this study is to compare how well the compuflo® computerized syringe pump works as compared to the traditional method of inserting an epidural (a needle placed in one's back to give pain medicine).

it is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic, abdominal, and lower extremity surgeries, as a method of postoperative pain management after surgery, and for pain relief during labor and delivery. however, despite the various benefits of epidural anesthesia, this procedure is not utilized to its maximum potential in the operating room. one reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space. current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space. compuflo®'s pressure-sensing technology provides an objective measurement for proper placement of the epidural. very little advancement has been made in improving training to identify the correct location of the epidural space. epidural anesthesia has a relatively higher failure rate when performed by residents in training. the skills of trainees differ greatly, and there are no standard teaching methods to teach epidural anesthesia. statistical analysis conducted by naik et al. concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency. the compuflo® is a computerized syringe pump capable of volume and pressure-controlled infusion. it has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip. pressures are continuously monitored and displayed, which are reflected by acoustic changes in tone. a dramatic pressure decrease and a high tissue compliance (pressure does not increase despite continuous infusion) signifies entrance into the epidural space. combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents (constant pressure on the plunger). it combines the "feel" of inserting an epidural needle with the visualization of the pressure level, as well as a sound indicator to indicate proper placement.

Eligibility criteria:
inclusion criteria: * any obstetric patient presenting for vaginal delivery desiring epidural anesthesia * american society of anesthesiologists (asa) physical classification i-iii * aged 18-65 years exclusion criteria: * obstetric patients presenting for cesarean section * american society of anesthesiologists physical classification ≥ iv * contraindications for epidural anesthesia * allergy to local anesthetics

Keywords: epidural placement compuflo®
xylitol for caries prevention in inner-city children

Conditions: Dental Caries

Summary: the purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.

this is a two group, 30 month randomized controlled clinical trial to assess, in conjunction with other primary preventive modalities, the use of xylitol gummy bears as snack food during school hours to reduce dental caries among children attending kindergarten at the time of recruitment. classrooms in five elementary schools were randomized to receive xylitol gummy bears or the control sugar-free (fiber) gummy bears. all gummy bears were formulated to be similar in size, consistency, color, and sweetness. they were in six bright colors attractive to children, and in strawberry and cherry flavors which are popular among children. children were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the mouth. the children received xylitol or placebo gummy bears throughout the 9 month kindergarten year, 3 times/day within the supervised school environment. in addition to gummy bears, all participating children received oral health education, tooth brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants when the first permanent molars have completely erupted. this design allows for the comparison between the current best recommended public heath practices and the addition of the new strategy, xylitol gummy bear snacks. children were enrolled in kindergarten and followed until the middle of 2nd grade.

Eligibility criteria:
inclusion criteria: * attending kindergarten in one of the participating schools * must have parental permission exclusion criteria: * children with severe stomach illness (ex. crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, etc.) * children with strict dietary restriction (ex. diabetes)

Keywords: dental caries xylitol prevention
psychobiology of stress and alcohol craving

Conditions: Alcohol Use Disorder; Stress Reaction; Social Stress; Craving; Behavior

Summary: in this feasibility study the investigators are using a setup of stress-related body sensors including established as well as innovative sensor-based measures to identify predictor profiles for alcohol-related behavioral and neural measures in alcohol use disorder (aud). long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.

the long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting. in patients with alcohol use disorder (aud) stress exposure is known to affect craving, cue-reactivity and relapse risk. here, the investigators aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity). in addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the investigators will integrate innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance.

Eligibility criteria:
inclusion criteria: * heavy drinking, defined by alcohol consumption of at least 20g alcohol per day (at 5 days per week) * sufficient ability to communicate with the investigators, to answer questions in oral and written form * fully informed consent * written informed consent exclusion criteria: * withdrawal of the declaration of consent * positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine) * lifetime history of dsm-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence. * current threshold dsm-5 diagnosis of major depressive disorder, or presence of suicidal intention * history of severe head trauma or other severe central nervous system disorder (e.g., dementia, parkinson's disease, multiple sclerosis) * current use of medications or drugs known to interact with the cns within at least four half-lives post last intake
clinical outcomes of the alps proximal humerus plating system

Conditions: Proximal Humeral Fracture

Summary: the purpose of this study is to document the performance and clinical outcomes of the a.l.p.s® proximal humerus plating system. specific aims: * conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs * obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions * document revisions, complications, and adverse events

the purpose of this study is to document the performance and clinical outcomes of the a.l.p.s® proximal humerus plating system. specific aims: * conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs * obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions * document revisions, complications, and adverse events

Eligibility criteria:
inclusion criteria: * patients who present with a proximal humerus fracture requiring primary or revision orif using a.l.p.s proximal humerus plating system * patients who present with a proximal humerus fracture that involves the metaphysis * 18 years or older exclusion criteria: * patients under the age of 18 * patients who have an infection, sepsis, or osteomyelitis * patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support) * patients who do not speak english (do to unavailability of non-english surveys) * patients who have known risk factors of pathologic fractures (e.g. bone metastasis) * patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years * patients who have type 1 diabetes * patients who have other bone disease (e.g. osteogenesis imperfecta, paget's disease, thyroid disease, vitamin d deficiency, hyperparathyroidism) * patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
the safety and effectiveness of urolift: lift pivotal study

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of the study is to evaluate the safety and effectiveness of the urolift(r) system when used in subjects with symptomatic benign hyperplasia (bph). primary effectiveness will be achieved by looking at the improvement of international prostate symptom score (ipss) and safety will be reviewed based on pertinent adverse events.

the randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the ipss of the treatment group to the ipss of the control group at the 3 month follow-up. subjects in the active treatment group undergo urolift system treatment. subjects in the control group undergo a cystoscopy procedure. all subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.

Eligibility criteria:
inclusion criteria: * males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (bph) exclusion criteria: * size, volume,length of prostate
role of dynamic movement intervention in children with spastic diplegia

Conditions: Spastic Diplegia

Summary: the study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy.


Eligibility criteria:
inclusion criteria: * age ranged from 4-7 years. * they can walk alone short distance and climb stairs holding on rail (grade i \& ii according to gmfcs). * they can understand and execute instructions. * they will be medically stable. * degree of spasticity will be ranged from 1 to 1+ degree according to the modified ashworth scale. exclusion criteria: * visual impairment (visual loss- cataract- myopia- hyperopia). * hearing impairment (deafness) * cognitive problem. * uncontrolled convulsions. * orthopedic surgery for the affected lower limbs within one year. * botulinum toxin injection within the last 6 months or within the study period.

Keywords: dynamic movement intervention
clinical study of da-001 as a treatment for telogen effluvium

Conditions: Telogen Effluvium

Summary: the primary objective of the study is to assess the safety and efficacy of da-001 as a treatment for telogen effluvium

da-001 is a topical alpha 1 agonist combined with a taar receptor agonist. da-001 was studied in a population of women that suffer from excessive hair shedding. da-001 demonstrated significant reduction in hair shedding. this study aims to assess the safety and efficacy of da-001 as a treatment for telogen effluvium.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosed with telogen effluvium * willing and able to apply the treatment as directed, comply with study * otherwise healthy * able to give informed consent exclusion criteria: * a medical history that may interfere with study objectives * women who are pregnant, lactating, or planning to become pregnant during the study period * subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc) * subjects who have known allergies to any excipient in da-001 * subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation * subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation * subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation * subject is unable to provide consent or make the allotted clinical visits

Keywords: hair shedding
sleep disturbance and bipolar disorder

Conditions: Bipolar Disorder; Dyssomnias

Summary: the study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. we are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.


Eligibility criteria:
inclusion criteria: bipolar disorder patients with sleep disturbance 1. meeting diagnostic and statistical manual of mental disorders, 4th text revision (dsm-iv-tr; apa, 2000) diagnostic criteria for bipolar disorder type 1 (established with the scid: structured clinical interview for dsm-iv). 2. being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. on the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. however, it is necessary to assess comorbidity for reporting purposes. 3. participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist. 4. experience distress related to significant sleep disturbance. exclusion criteria: 1. presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, copd) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia; 2. alcohol or drug abuse (except nicotine) within the past year 3. active posttraumatic stress disorder 4. evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome) 5. patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months. 6. pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the gaba a receptor complex and are fda approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as st. johns wort. 7. use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).

Keywords: bipolar disorder insomnia sleep disturbance cognitive behavioral therapy
effect of dexmedetomidine on stress study of pituitrin in laparoscopic hysteromyoma surgery

Conditions: Hysteromyoma

Summary: this study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. it is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. pituitrin includes oxytocin and vasopressin. vasopressin increase body stress reaction through hypothalamic pituitary adrenal(hpa) axis. the hpa axis has has main role to the body stress reaction. dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.


Eligibility criteria:
inclusion criteria: surgery will be scheduled as first case in the morning at 9 am. on arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index. exclusion criteria: diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.

Keywords: stress dexmedetomidine
effectiveness registry to study therapies for arthritis and inflammatory conditions: the corrona certain sub-study

Conditions: Rheumatoid Arthritis

Summary: the corrona certain sub-study of the consortium of rheumatology researchers of north america, inc. is a sub-study of the corrona data collection program. the certain sub-study is designed to systematically collect and document use patterns, effectiveness, comparative effectiveness and safety of biologic agents used in the management of rheumatoid arthritis (ra).

biologic therapies (including biologic medications like enbrel, humira, remicade, cimzia, simponi, actemra, rituxan and orencia) have changed the treatment of ra, but the differences in safety and/or effectiveness of each biologic therapy are not all known. we are doing this study in order to try to see if one or more of these treatments are better than the others. the use of databases like the corrona organization database gives us information that helps us to understand why such drugs are used, reasons for starting or stopping drugs, for whom they are prescribed, and to monitor changes in patients' abilities to perform daily activities and gather information on family or social history.

Eligibility criteria:
inclusion criteria: * the corrona certain sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. male and female patients, who 1. are at least 18 years of age; 2. have a documented diagnosis of ra by their treating rheumatologist; 3. have at least moderate disease activity; and 4. are initiating a biologic agent that has not be used for their treatment in the past are eligible to participate. moderate disease activity is defined by a cdai score greater than 10. exclusion criteria: disease other than ra that do not meet the inclusion criteria

Keywords: rheumatoid arthritis registry ra biologic medications rheumatology