Kornimate/medical-research-clean huggingface dataset:
ckd-11101 phase 3 sc study

Conditions: Anemia of Chronic Kidney Disease

Summary: the aim of this study was to compare and evaluate efficacy and safety of subcutaneous ckd-11101 versus darbepoetin alfa in patients who have renal anemia not on dialysis.

this was designed as randomized, double-blind, multi-center, phase 3 clinical study to evaluate the efficacy and safety of subcutaneous ckd-11101 versus darbepoetin alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis. the selection criteria will be evaluated in patients who are receiving anemia correction among patients with 19 years of age or older and who had anemia in chronic renal failure of stage 3 or above. subjects who are identified to meet all inclusion criteria will be randomized to test group and control group at 1:1 ratio and go through 24-week correction period and efficacy evaluation period. during correction period and efficacy evaluation period, subjects will visit the clinical study center every 2 weeks to receive processes designated for each visit and be administered investigational product from the investigator in charge of drug administration. in the safety evaluation period, all subjects will be administered test drug for 28weeks.

Eligibility criteria:
* inclusion criteria 1. patients with 19 years of age or older 2. patients with chronic renal failure of stage 3 or above who are not on dialysis 3. patients with the hb levels of 8 to 10g/dl measured at screening 4. patients with enough body iron stores who meet the following item: -serum ferritin ≥ 100ng/ml or transferrin saturation ≥ 20% 5. patients who have provided written consent to participate in the clinical trial voluntarily * exclusion criteria 1. patients who are expected to need dialysis within a year or patients with rapidly progressive chronic renal failure 2. patients who have received drug treatment such as erythropoiesis stimulating agent for the purpose of correcting anemia within 12 weeks prior to screening 3. patients who have received red blood cell transfusion within 12 weeks prior to screening 4. patients with uncontrolled hypertension 5. patients who had hypersensitivity to erythropoietin agents 6. patients who had known hypersensitivity to mammalian cell-derived products or additives 7. patients with history of severe cardiovascular diseases 8. patients whose anemia is not caused by chronic renal failure or may affect anemia correction including the following conditions: 9. patients whose ast/alt test results performed at screening exceeds twice of normal upper limit 10. patients who have experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
study of intramuscular ropivacaine injections for treatment of pediatric headache

Conditions: Headache; Migraine

Summary: objective: to determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

methods: the study will be a double-blind randomized control trial. patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 ml of 0.5% ropivacaine on each side, placebo injections with 1 ml normal saline on each side, or no intervention at all. if randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection. the location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. if after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. pain will be reassessed at the time of ultimate disposition. the scale used to assess severity will vary based on the child's age.

Eligibility criteria:
inclusion criteria: * chief complaint of headache * age 7-17 years exclusion criteria: * presence of fever * meningismus * headache that wakes the child at night * known organic brain disease, mass, or tumor * history of stroke * history of allergy to ropivacaine or other aminoacyl local anesthetics * history of liver disease * history of impaired cardiac function * abnormal neurologic signs * a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome * cognitive inability to communicate the intensity of pain. * history of shunt or other intracranial hardware

Keywords: headache migraine ropivacaine
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of dnl593 in healthy participants and participants with frontotemporal dementia (ftd-grn)

Conditions: Frontotemporal Dementia

Summary: this is a phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of single and multiple doses of dnl593 in two parts followed by an optional open-label extension (ole) period. part a will evaluate the safety, tolerability, pk, and pd of single doses of dnl593 in healthy male and healthy female participants of nonchildbearing potential. part b will evaluate the safety, tolerability, pk, and pd of multiple doses of dnl593 in participants with frontotemporal dementia (ftd) over 25 weeks. part b will be followed by part c, an optional 18-month ole period available for all participants who complete part b.


Eligibility criteria:
key inclusion criteria: part a: * women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 55 years * bmi of ≥ 18 to ≤ 32 kg/m² * when engaging in sex with a woman of child bearing potential, two forms of birth control are required part b: * women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 80 years. women who are of childbearing potential but on highly effective, low user dependent contraceptive methods will be allowed. * bmi of ≥ 18 to ≤ 32 kg/m² * have a clinical dementia rating® plus national alzheimer's coordinating center frontotemporal lobar degeneration global score ≥ 0.5 * have confirmed granulin (grn) mutation via genetic testing or historical records available for review by investigator * when engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception part c: * all participants who completed part b of this trial are eligible for an 18-month ole if the participant has no unresolved clinically significant teaes, where continued dosing may represent a risk to participant safety. key exclusion criteria: * have any history of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders * have a history of malignancy, except fully resected basal cell carcinoma or other malignancies at low risk of recurrence * have a clinically significant history of stroke, cognitive impairment due to causes other than ftd, seizure within 5 years of screening, or head trauma with loss of consciousness within 2 years of screening * have a positive serum pregnancy test or are currently lactating or breastfeeding

Keywords: ftd ftd-grn granulin
impaired wound healing in diabetic foot ulceration

Conditions: Diabetes Mellitus; Healthy Volunteers

Summary: an observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. the study also examines the association of a specific type of cell with the rate of wound healing.

an observational study which entails: medical history; physical examination; blood tests; mri; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). this study also involves 2 visits to the beth israel deaconess medical center in boston, ma. (joslin-beth israel deaconess foot center, lowry outpatient laboratory, mri suite).

Eligibility criteria:
inclusion criteria: * current diagnosis of type i or type ii diabetes mellitus. * ulcer present for minimum 4 weeks * have adequate circulation to the foot * can return for follow-up visits * be able to read and sign the informed consent form before enrollment exclusion criteria: * active charcot's foot ulcer on the foot to be studied * presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease * alcohol or drug abuse problems * treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents * presence of infectious disease that can preclude epc measurements (including hiv, hepatitis b and c) * pregnancy
effect of functional lumbar stabilization exercises in women with menstrual low back pain

Conditions: Low Back Pain

Summary: menstrual low back pain (lbp) is one of the common complaints among women. menstrual lbp may be attributed to the spinal instability resulting from ligament laxity due to hormonal change. the purpose of this study was to investigate the effect of functional lumbar stabilization exercises on pain, disability and kinesiophobia in women with menstrual lbp.

pain intensity using numeric pain scale (nps), oswestry disability index (odi), roland-morris questionnaire (rmq) and tampa scale of kinesiophobia (tsk) were collected at base line and at the end of treatment (after three months) in both groups.

Eligibility criteria:
inclusion criteria: * having low back pain lbp during menstrual phase (days 1-6) of the menstrual cycle. * suffering from low back pain during all menstrual cycles in the year before the study. * no back pain or low back paiun at times other than the menstrual phase. * pain intensity during menstrual lbp greater than 5 in numeric pain scale exclusion criteria: * history of spinal surgery, spinal or pelvic fracture and hospitalization for severe trauma or car accident, urinary tract infection, vaginal infection and known neurological disorders. * pain intensity lesser than 5 in numeric pain scale

Keywords: stabilization exercises, pain, disability, menstruation
the use of ultrasound for botulinum toxin subscapularis muscle injection guidance in spastic hemiplegic shoulder pain

Conditions: Hemiplegia, Spastic

Summary: the aim of the study is to describe the efficacy of a new approach to the subscapularis muscle under us guidance for the injection of botulinum toxin in patients that underwent a stroke suffering from hemiplegic shoulder pain. pain and spastic shoulder are common findings in hemiplegic patients following a stroke. the pain interferes with rehabilitation prolonging hospitalization and is related with decreased quality of life. there is a close relationship between spasticity of the subscapularis muscle and pain the patients show a clinical picture of adduction and internal rotation of the shoulder, elbow and wrist and fingers flexion with a limited external rotation of the shoulder. the investigators suggest that paralyzing the subscapularis muscle with botulinum toxin may alleviate pain in the hemiplegic shoulder. best produced when injected in a specific area of the muscle where a higher concentration of motor points exists.

treatment using injection of botulinum toxin to the subscapularis spastic muscle has been described in the literature and is a common practice in hemiplegic shoulder. the injection technic in this pathology is described by using anatomical landmarks of the shoulder region without using medical imaging. on the other hand, injections to the subscapularis muscle has also been described using ultrasound guidance but not for this specific pathology. there are no evidence-based guidelines describing us guided spastic subscapularis muscle injection. injecting this muscle while in its spastic state requires a modulated approach harrison et.al described cadaveric dissections of the subscapularis muscle and proposed a technique to reach the motor point zone of this muscle in our study the investigators follow the injection description published by dong wook rha on cadavers based on harrison's lateral approach description. the ultrasound enables a correct identification of the target muscle avoiding possible complication of vessel or pulmonary puncture in our study the investigators will try to prove the efficacy of the lateral approach to the subscapularis muscle using ultrasound and nerve stimulator

Eligibility criteria:
inclusion criteria: post stroke patients * complaints of pain in hemiplegic shoulder * spasticity of subscapularis muscle * coherent * hebrew speakers exclusion criteria: * aphasia * allergy to botulinum toxin * pregnant women
the effectiveness of electronic reminders in improving elastic compliance in orthodontic patients

Conditions: Malocclusion; Compliance, Patient

Summary: fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. however, their success is largely dependent on the patient's compliance. failure to wear the elastics as instructed will reduce efficacy of treatment, ultimately increasing treatment time and potentially producing imperfect alignment of teeth. the hypothesis tested is that daily electronic reminders via a mobile application can significantly increase patient compliance, thus effectively improving treatment outcomes.

despite advancements in various aspects of orthodontic treatment, patient compliance remains a critical factor in attaining a successful treatment outcome. more specifically, patient compliance in the use of intraoral elastics is an important component of the treatment plan of certain patients. failure to wear elastics as directed will ultimately result in increased treatment time, and imperfect alignment of the teeth. persuading adolescent orthodontic patients to wear intraoral elastics consistently is difficult in the short appointment times of a typical practice. studies have shown that adolescents respond at a higher level to a more constant form of communication, as well as a method more closely associated with their generation. as smartphones have become an everyday appliance for most of the general public, mobile applications (apps) have the capability to serve as an effective avenue for communication between doctor and patient. recent studies in both dentistry and medicine have reported that active reminders via mobile phone improve appointment attendance, adherence to medication schedules, and positive behaviour changes. the investigators will utilise the "calendar" app to communicate via daily reminders with patients undergoing orthodontic treatment with fixed appliances and class ii intraoral elastics, and they will measure the improvement in the malocclusion. this will allow study of whether or not electronic reminders can significantly increase compliance. as more apps are developed, this communication method may have the potential to greatly impact the way orthodontists and patients interact outside of the office. if effective, these apps could become a cornerstone of the compliance efforts of many orthodontic practices. this would benefit both the orthodontist and the patient, as it would decrease time and money spent for both parties as well as reduce the overall sense of frustration felt during extended orthodontic treatment.

Eligibility criteria:
inclusion criteria: * full fixed appliances with intraoral class ii elastics full-time * wearing class ii elastics for between 6 weeks \& 3 months * have smartphone with calendar-type app exclusion criteria: * orthognathic surgery planned * craniofacial disorders

Keywords: intraoral elastics
comparison study of insulin glargine and nph insulin

Conditions: Diabetes

Summary: this study will compare the safety, effectiveness, and cost of two different types of long-acting insulin.

in this study the investigators will be comparing two long-acting insulins, insulin glargine and nph insulin. the trial will be evaluating differences in effectiveness, safety and cost between the two agents when used in patients on more than 80 units or 1unit/kg long-acting insulin. the investigators hypothesis is that patients switched from lantus to nph will have improved blood glucose control.

Eligibility criteria:
inclusion criteria: * adult patients at 22 providence medical group primary care clinics * diagnosis of type 2 diabetes mellitus * currently using greater than 80 units/day of insulin glargine or greater than 1 unit/kg/day of insulin glargine * current a1c \> 8.5% (within 3 months of randomization) exclusion criteria: * diagnosis of type 1 diabetes mellitus * age \> 85 years * self-reported history of severe hypoglycemia or hypoglycemia unawareness * hospice/limited life expectancy * current enrollment in providence medical group medication assistance program * current use of a glp1 agonist (i.e., liraglutide, exenatide, exenatide extended-release) * end stage renal disease (i.e., dialysis or estimated glomerular filtration rate \<15 ml/min/1.73m2) * cirrhosis * unstable coronary artery disease or chronic heart failure (i.e. an exacerbation or hospitalization within 6 months pre-randomization) * psychiatric condition that prevents adequate follow-up (i.e., \> 3 missed follow-up visits within a 3 month period or persistent non-adherence to dosing or monitoring recommendations) * active alcohol or drug abuse * inability to provide informed consent

Keywords: diabetes insulin glargine nph insulin
validation of a novel device for screening patients with symptoms of obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to evaluate the sensitivity and specificity of the belun ring pulse oximetry system for screening of obstructive sleep apnea (osa) in adults during standard polysomnography sleep study conditions. the primary outcome metric is the apnea-hypopnea index (ahi). the goal, in its entirety, is to evaluate the performance of the belun ring pulse oximeter during a standard polysomnography sleep study and its ability to compare to the determined apnea-hypopnea index (ahi) of the subjects. it is expected that the belun ring pulse oximeter will adequately record spo2, pulse rate, body position and heart rate variability throughout the duration of the study.


Eligibility criteria:
inclusion criteria: * subject must have the ability to understand and provide written informed consent. * subject is 18 to 90 years of age. * subject must be willing and able to comply with study procedures and duration. * male or female of any race. exclusion criteria: * subject requires oxygen therapy or noninvasive ventilation. * subject has a current diagnosis of chronic obstructive pulmonary disorder (copd), neuromuscular disease, periodic limb movement, or narcolepsy. * compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) * subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists. * subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ecg electrodes, respiration monitor electrodes or other medical sensors (self-reported). * unwillingness or inability to remove colored nail polish from test digits. * other known health condition, which should be considered.
radial nerve block for treatment of tennis elbow

Conditions: Pain, Elbow

Summary: background: lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis. objectives: the primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. the primary outcome measure is pain measured through the visual analogue scale (vas) at 1 and 2 weeks. methods: this is a prospective randomized, double blind clinical trial. patients will be randomly allocated into two groups. group i will receive radial nerve block guided by a nerve stimulator. group ii patients will receive placebo through radial nerve block. patients will be followed up for 2 weeks.

lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. it is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. it is common in workers whose job requires manual and repetitive work . although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis. to our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.

Eligibility criteria:
inclusion criteria: * 18 years and above * presenting with refractory elbow pain exclusion criteria: patients with: * osteoarthritis, * rheumatoid arthritis, * olecranon bursitis, * radial nerve entrapment
programmed intermittent bolus versus continuous infusion for epidural analgesia in abdominal surgery

Conditions: Analgesia, Epidural; Pain, Postoperative

Summary: epidural analgesia is an efficient way to relieve pain after major abdominal surgery. two different protocols are used to provide analgesia: continuous epidural infusion (cei) and programmed intermittent boluses (pieb). cei consists in the delivery of a continuous administration of the intended hourly dose. pieb consists in the administration of sequential high pressure boluses of the intended dose. although some studies in the postoperative setting have observed that pieb reduces the total dose needed to ensure adequate pain control, the clinical value of this finding is still uncertain. moreover, nursing and medical interventions to the epidural infusion rates are frequently needed in the first 48 postoperative hours to optimize the provision of analgesia. these interventions add to the already important nursing workload associated with major abdominal surgery, and are correlated with suboptimal analgesia for the patient. this randomized controlled trial aims to compare the effect of epidural pieb on the workload as a reflection of adequate analgesia compared to the standard cei protocol in use. the investigators hypothesize that the use of pieb decreases the number of interventions needed to obtain adequate analgesia.


Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) * major abdominal surgery in an elective setting * thoracic epidural (between t7 and t12) exclusion criteria: * contraindication to bupivacaine * contraindication to morphine * decision to keep the patient intubated and sedated at the end of the surgery * chronic opioid use (\> 3 months) * pregnancy

Keywords: anesthesia, epidural postoperative period analgesia, patient-controlled