Kornimate/medical-research-clean huggingface dataset:
offloading interventions for diabetic foot problems in upper egypt

Conditions: Diabetic Foot Ulcer

Summary: offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. many forms of offloading are available, with many limitations to apply in clinical practice. in this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.

abnormal glucose metabolism gradually impairs sensation in both feet. impaired sensation leads to recurrent attacks of inflammation "acute charcot arthritis". eventually, the foot becomes deformed with abnormal shape of the plantar surface. during walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. this high pressure leads to skin ulceration "pressure ulcer". these pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved. offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers. the diabetic foot clinic at assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. this clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient. the investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, oidfua. this study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.

Eligibility criteria:
inclusion criteria: * diabetes, loss of protective sensation, forefoot pressure ulcer exclusion criteria: * ankle/brachial index less than 0.7, severe infection

Keywords: offloading plantar pressure diabetic foot ulcer removable offloading device adherence
the genetics of dilated cardiomyopathy: a quebec-based study

Conditions: Dilated Cardiomyopathy (DCM)

Summary: dilated cardiomyopathy (dcm) affects about 200,000 canadians. eighty percent of these cases are of unclear cause, often occuring in families. we believe that mutations in specific already-identified genes contribute to dcm in quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". two hundred patients with dcm followed in our heart function clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. the samples will be tested in the laboratory of cardiovascular genetics at the royal victoria hospital.


Eligibility criteria:
inclusion criteria: * followed at muhc heart function centre * documented ef of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm. * patient's written consent exclusion criteria: * patients with a known underlying condition that results in a weakened and enlarged heart * patients unable to read and understand the consent form * patients who do not wish to participate
evaluating the safety and efficacy of proellex® (cdb-4124) in premenopausal women with symptomatic uterine fibroids

Conditions: Uterine Fibroids

Summary: premenopausal women with symptomatic uterine fibroids will be randomized to either proellex 25mg or 50mg or placebo for one treatment cycle (four months). safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

subjects with documented uterine fibroids, screening ufs-qol severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. the study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (pk) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Eligibility criteria:
inclusion criteria: * speak, read and understand english or spanish; * not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study; * one uterine fibroid must be identifiable and measurable by transvaginal ultrasound; * menstrual cycle lasting from 24 to 36 days; * history of excessive menstrual bleeding; * negative urine pregnancy test at screening. exclusion criteria: * six months or more (immediately prior to screening visit) without a menstrual period; * prior hysterectomy; * prior bilateral oophorectomy; * pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study; * documented endometriosis, active pelvic inflammatory disease (pid), platelet dysfunction, or von willebrand's disease; * any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ascus) associated with human papilloma virus (hpv); * subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system; * subject with known active infection with hiv, hepatitis a, b or c, gonorrhea, or chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Keywords: uterine fibroids
a team model of hypertension care in african americans

Conditions: Hypertension

Summary: this team education and adherence monitoring (team) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive african american patients in five wisconsin cities. the study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (bp) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.

researchers screened and enrolled 20-25 subjects in each study pharmacy. intervention pharmacists and technicians attended a 7-hour team training program on bp monitoring, jnc 7 guidelines, and specially designed tools for assessing and improving medication adherence, lifestyle, patient scheduling and retention, and collaboration with physicians. intervention teams received specially designed tools, automatic bp monitors, and furniture for setting up and implementing a blood pressure clinic at their pharmacy. staff from control pharmacies received printed information only and provided "usual care". outcomes will be determined by blinded data collectors who will re-check patients' bps and administer follow-up surveys after 6 and 12 months. researchers also will survey pharmacy staff and review pharmacy records to determine changes in refill adherence and prescribing.

Eligibility criteria:
inclusion criteria:is african american and 18 years old or older; has active prescription for bp drug; obtains all bp drugs at the study pharmacy; is able to read and fill out short questionnaires; is able to come to pharmacy for 6 monthly pharmacy visits if needed; has screening bp between 140/90 mm hg and 210/115 mm hg. exclusion criteria: history of organ transplant or kidney dialysis, symptoms of advanced congestive heart failure, memory impairment that interferes with daily functioning,terminal illness,pregnancy, alcohol or substance abuse problem,physician recommendation of exclusion for other condition that may require special care or limit participation in the study.

Keywords: hypertension in african americans
gsk1550188 a 52 week study of belimumab versus placebo in the treatment of subjects with systemic lupus erythematosus (sle) located in northeast asia

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in northeast asia with systemic lupus erythematosus (sle) over a 52 week period.

the purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (iv) every 4 weeks compared to placebo, in patients with sle when added to standard of care therapy, as measured by the sle responder index (sri) at 52 weeks, defined by a composite endpoint using selena sledai score, physician's global assessment (pga) and bilag a and b organ domain scores.

Eligibility criteria:
inclusion criteria: * age 18 years and older. * have a clinical diagnosis of sle according to the american college of rheumatology (acr) classification criteria. * have active sle disease. * have positive anti-nuclear antibody (ana) test results. * are on a stable sle treatment regimen. * females of childbearing age are willing to use appropriate contraception exclusion criteria: * have received treatment with any b cell targeted therapy at any time. * have received a biologic investigational agent in the past year. * have received 3 or more courses of systemic corticosteroids in the past year. * have received intravenous (iv) cyclophosphamide within 180 days prior to day 0. * have severe lupus kidney disease. * have active central nervous system (cns) lupus. * have had a major organ transplant. * have significant unstable or uncontrolled acute or chronic diseases or conditions not due to sle. * have a planned surgical procedure. * cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix. * have required management of acute or chronic infections in the past 60 days. * have current drug or alcohol abuse or dependence. * have a historically positive test, or test positive at screening for hiv, hepatitis b, or hepatitis c. * have an iga deficiency. * have severe laboratory abnormalities. * have had anaphylactic reaction to x-ray contrast agents or biologic agents. * suicidal behavior or ideation.

Keywords: sledai asia placebo blys pga bilag systemic lupus erythematosus selena lupus sri efficacy b cell sle flare index belimumab safety phase iii b lymphocyte
study of gemcitabine + pegph20 vs gemcitabine alone in stage iv previously untreated pancreatic cancer

Conditions: Stage IV Pancreatic Cancer

Summary: phase 1b: open label (all patients receive pegph20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of pegph20 to use in combination with gemcitabine in stage iv previously untreated pancreatic cancer patients. phase 2: randomized, double blind study to compare the effect of overall survival of gemcitabine plus pegph20 vs gemcitabine plus placebo in stage iv previously untreated pancreatic cancer patients.

pegph20 is a pegylated version of human recombinant ph20 hyaluronidase that, in preclinical studies, has been shown to remove ha from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (pda) overexpress ha. pda tumor tissue may be especially sensitive to the ha-degradation properties of pegph20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with stage iv previously untreated pancreatic cancer. this phase 1b/2 study will assess safety, tolerability, treatment effect, and various pk/pd endpoints.

Eligibility criteria:
key inclusion criteria: * patients with histologically confirmed stage iv adenocarcinoma of the pancrease previously untreated for metastatic disease * one or more metastatic tumors measurable on ct scan per recist 1.1 criteria * life expectancy of at least 3 months * signed, written irb/ec-approved informed consent * a negative serum pregnancy test, if female key exclusion criteria: * known brain metastasis * new york heart association class iii or iv cardiac disease, myocardial infarction within the past 12 months * active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * known allergy to hyaluronidase * women currently pregnant or breast feeding

Keywords: pancreatic cancer stage iv untreated
systematic ecg screening for atrial fibrillation among 75 year old subjects in the region of stockholm and halland, sweden

Conditions: Atrial Fibrillation; Stroke

Summary: the purpose of this study is to determine whether screening for atrial fibrillation by intermittent ecg recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.


Eligibility criteria:
inclusion criteria: * men and women 75-76 years of age living in the region of stockholm or halland exclusion criteria: * not fulfilling the inclusion criteria

Keywords: screening stroke prevention cost effectiveness
elevated stearoyl-coa desaturase-1 expression predicts the disease severity of severe acute pancreatitis

Conditions: Acute Pancreatitis; Organ Failure, Multiple

Summary: in this study, the investgatiors aimed to investigate the associations between serum levels of stearoyl-coa desaturase-1（scd-1） and the disease severity as well as the presence of adverse clinical events, such as local complications, organ failure, mortality and so on.in this prospective study, participants were divided into two groups based on serum scd-1 concentration on admission and prospectively observe the disease severity and clinical outcomes of them.


Eligibility criteria:
inclusion criteria: 1. diagnosis of acute pancreatitis (atlanta standard), abdominal pain occurred within one week of admission; 2. apacheii score is more than 8 and ranson score is greater than 3; 3. age 18-75; 4. obtaining informed consent. exclusion criteria: 1. pregnancy pancreatitis; 2. patients with the following disease history: severe cardiac, pulmonary, renal, liver function insufficiency or immunodeficiency disease.
t3 versus t4 sympathicotomy for treatment of primary palmar hyperhidrosis

Conditions: Compensatory Hyperhidrosis; Recurrence

Summary: t3 versus t4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis

palmar hyperhidrosis (ph) is a benign sympathetic disorder that does not threaten health but affects daily activities, and may causes social withdrawal and even depression.1 an incidence of up to 1% has been reported by various series in the literature. the incidence in men and women is the same; however women are more likely to seek medical attention, which may explain the higher incidence of female patients in most surgical series \[2,3\]. although various treatment options are available, including topical and systemic therapies, iontophoresis, regional nerve block, and botulinum toxin injection, each has its limitations 4. video-assisted thoracoscopic sympathetic surgery is currently a worldwide accepted treatment of primary palmar hyperhidrosis (ph) 5. however, compensatory hyperhidrosis (ch) is the most common and serious side effect that occurs in 30-70% of patients after t2 or t2-3 sympathectomy 6. for that now t2 sympathetic surgeries are seldom used in ph. procedures that involve t3 or/and t4 sympathetic ganglions are widely accepted in many centers with favourable results.5 but some patients still present with certain degrees of ch or over dry hands after operation 7, 8. the aim of this study is to compare the two methods for the treatment of ph, in which the sympathetic chain was transected in merely one segment, on the level of either the third or the fourth ribbed, defined as t3 sympathicotomy or t4 sympathicotomy, respectively. emphasis was placed on the evaluation of the efficacy, side effects, and patients' satisfaction rate to these two types of surgical therapy.

Eligibility criteria:
inclusion criteria: * patients with primary palmar hyperhidrosis exclusion criteria: * patients with pleural adhesion * bleeding diathesis * local infection * patients with certain anatomic anomalies
effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants

Conditions: Development of Control of Breathing

Summary: to determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.

to measure the effects of baseline oxygenation in extremely low birth weight preterm infants on: i) the early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to co2 ii) the immediate (\< 1 minute) ventilatory response to hyperoxia iii) the pco2 apneic threshold iv) the breathing pattern during quiet and rem sleep v) the morphology of periodic breathing cycles vi) the incidence and morphology of sighs

Eligibility criteria:
inclusion criteria: * gestational age 23 0/7 - 27 6/7 weeks * enrolled in the cot trial at the health sciences centre and the st. boniface general hospital in winnipeg * postnatal age between 21 days and 70 days * informed written consent obtained from at least one of the parents. exclusion criteria: * need for mechanical ventilation, ncpap or o2 * sepsis or other known causes of apnea.

Keywords: hypercapneic response hyperoxic response breathing pattern periodic breathing sighs
the antimicrobial potential of diclofenac sodium as an intracanal medicament

Conditions: Endodontic Disease; Pulp Disease, Dental; Intracanal Medication

Summary: the goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. the main question\[s\] it aims to answer are: • will the diclofenac sodium (nsaids) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.

the aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. the evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having pai score ≥ 2.

Eligibility criteria:
inclusion criteria: * patients with teeth diagnosed with apical periodontitis * periapical index (pai) ≥ 2 * the teeth are restorable exclusion criteria: * teeth with immature roots * non restorable teeth * medically compromised patients with systemic complication that would alter the treatment. * teeth with internal/external root resorption * patient with an allergy to diclofenac sodium

Keywords: sodium diclofenac intracanal medication calcium hydroxide apical periodontitis
transcutaneous electrical acupoint stimulation for the treatment of adhd

Conditions: ADHD

Summary: rationale: transcutaneous electrical acupoint stimulation may improve attention deficit hyperactivity disorder (adhd). purpose: this randomized-controlled trial study of treating attention deficit hyperactivity disorder of school-aged children with transcutaneous electrical acupoint stimulation to see how well it works compared to sham transcutaneous electrical acupoint stimulation.

objectives: primary to determine whether true transcutaneous electrical acupoint stimulation(teas) administered twice weekly for 4 weeks (8 sessions) compared to sham teas causes a significant improvement in symptoms of adhd according to the investigator-rated clinical global impression-improvement (cgi-i) scores at week 4. secondary to evaluate the changes from baseline to week 4 of clinical global impressions scale-severity of illness (cgi-s)，conners'parent rating scales-revised: short form (cprs-r: s) score, conners'teacher rating scales-revised: short form (ctrs-r: s) score, go/no-go task performances, and the concentration of oxygenated hemoglobin within the prefrontal cortex. outline: this is a single-center study. patients are randomized to two treatment arms. arm i: patients receive teas twice weekly for 4 weeks . arm ii: patients receive sham teas twice weekly for 4 weeks .

Eligibility criteria:
inclusion criteria: * patients must be conform to adhd clinical diagnostic criteria (dsm-v). * patients' ages are between 6\~12 years old. * an informed written consent from parents and participants exclusion criteria: * patients have a history of illness that concomitant with other mental and neurological disorders. * patients's iq score are lower than 75. * patients have had prior teas or other acupoints-associated treatment experiences. * left handedness.