Kornimate/medical-research-clean huggingface dataset:
the effect of ethanol extract physalis angulata linn. in scleroderma patients with standard therapy

Conditions: Scleroderma

Summary: study about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified rodnan skin score, reduce inflammation, immunological response and fibrosis: a randomized clinical placebo controlledtrial with a prospective cohort study on scleroderma outpatient clinic in cipto mangunkusumo hospital in jakarta and hasan sadikin hospital in bandung, from january 2016 to july 2017

background. scleroderma is a systemic autoimmune disease that can not be cured, the progression of the disease still difficult to prevent and lead to increased morbidity and mortality. disease-modifying anti-rheumatic drugs (dmards) as standard immunosuppressant drugs to reduce, eliminate, inhibit inflammation and fibrosis in scleroderma patient is still less effective. objectives. to evaluate the effect of ethanol extract of physalis angulate linn to reduce skin fibrosis based on mrss, esr, baff, scd40l, and p1np in scleroderma patients with standard therapy methods. a randomized, double-blind, placebo-controlled clinical trial on scleroderma patients with standard therapy, who admitted to cipto mangunkusumo hospital jakarta and hasan sadikin hospital bandung, from january 2016 to july 2017. patients must be controlled every month until three months for follow up. subjects were divided into two parallel group, one of intervention group, and one of placebo group

Eligibility criteria:
inclusion criteria: 1. patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type. 2. patients who routine control in rheumatology outpatient clinics in ciptomangunkusumo hospital jakarta and hasan sadikin hospital bandung rshs who received standard therapy for scleroderma with a stable dose over the past 3 months. 3. the research subjects aged 15 to 60 years. 4. subjects with modified rodnan skin score ≥ 5. 5. disease duration ≥ 1 year exclusion criteria: 1. impaired liver function with cirrhosis 2. chronic renal dysfunction (chronic kidney disease stages 4-5). or creatinine levels\> 2 mg / dl in the last 1 month prior to randomization. 3. other autoimmune disease/overlap syndrome. 4. received a steroid/prednisone \>10 mg/day in the last 1 month. 5. patients who are pregnant or breastfeeding. 6. patients with active tuberculosis and or are being treated with anti-tuberculosis medicines. 7. severe heart disease. (heart disease with impaired function according to the new york heart association class iii or iv) 8. history of allergies to herbal ciplukan / physalis angulate linn. or a history of hypersensitivity to certain drugs. 9. hypotension (bp \<90/60 mmhg) 10. hypoglycemia (glucose level \<70 mg / dl) 11. do not want to participate in the study

Keywords: erythrocyte sedimentation rate modified rodnan skin score b-cell activating factor soluble-cd40ligand procollagen type-1 n-terminal propeptide scleroderma
the sinonasal microbiome

Conditions: Sinonasal Disorder; Chronic Rhinosinusitis (Diagnosis)

Summary: chronic rhinosinusitis is an inflammatory disease of the sinonasal mucosa with significant impact and limited treatment options. chronic rhinosinusitis (crs) poses an important public health problem and causes a large impact on individual quality of life. studies of crs have been limited by access to tissue, the complexity of the sinonasal physiology, a lack of available biomarkers, the absence of useful animal models, a paucity of cohorts with biological samples for analysis, and limited well-designed clinical trials or investigations of immune function. therefore, novel strategies for identifying biological mechanisms underlying this disease are in great need. using prospective samples from well characterized subjects, the investigators intend to profile the mucosa associated-bacteria in the nose and sinuses. in parallel, using sinus tissue from patients undergoing surgery, the site will interrogate the epithelium for mucosal immune function to understand host-microbe interaction. this study hypothesizes that the microbial profile of the sinuses initiates an immune responses which leads to chronic inflammation in susceptible people. this study would provide the first comprehensive data on what bacteria are present in the nose and sinus and could lead to important knowledge useful in sinonasal disease.


Eligibility criteria:
inclusion criteria: * age\>18 years * diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy exclusion criteria: * use of immunosuppressants * immunodeficiency * inability to stop sinusitis related medications for 10 days
analysis of therapeutic management strategies for anal suppurations of crohn's disease

Conditions: Crohn Disease; Anal Suppurations; Drainage Procedure

Summary: determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of crohn's disease at 12 months.

the management of anoperineal suppurations of crohn's disease is most often based on clinical practice recommendations, the results of randomized controlled trials and also the analysis of monocentric cohort studies from expert centres. in these latter studies, there is an overall improvement in patients during follow-up with a high level of satisfaction (two thirds of cases), often assessed by the operator himself or the clinician who provides therapeutic management. the most striking finding is the one that highlights the use of combined therapeutic strategies combining immunosuppressants, biotherapies, antibiotics, surgical drainage and surgical reconstruction procedures to varying degrees. thus, the absence of fistula pathway flow in the long term is the consequence of both maintenance treatment with biotherapies and several surgical procedures. when the characteristics of fistula pathways considered healed on clinical examination are analysed by mri exploration, an active unhealed pathway persists in two thirds of cases, again emphasizing the inadequacy of clinical examination as a means of assessing recovery. for this reason, fistula pathway closure strategies do not provide much greater benefit than simple removal of the drainage loop. conversely, medical treatment optimization strategies based on mri evaluation of the therapeutic response have demonstrated high efficacy. it is necessary to (re)define the therapeutic management of patients with anoperineal lesions. this strategy must be based on a better initial stratification of patients based on prognostic factors derived from available scientific data. a second step consists in setting therapeutic efficacy objectives that take into account the control of the inflammatory component of anal crohn's disease and the preservation of the anatomical and functional capital of the anus. only a large prospective cohort at the national level provides the opportunity to study these prognostic factors and to specify the level of optimal therapeutic responses

Eligibility criteria:
inclusion criteria: * persons over 18 years of age * people suffering from anal suppuration of crohn's disease for whom a drainage procedure is planned. * person who has received written and oral information about the protocol and has not expressed opposition to participate in the study. exclusion criteria: * no one who is unable to have an anesthetic, structural or psychological examination by mri and/or surgery. * person planning a planned absence that could hinder participation in the research (travel abroad, relocation, impending transfer); * person with an associated pathology that is a priority for care; * vulnerable person (minors, persons under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision
continuous quality improvement for diabetes

Conditions: Diabetes

Summary: the purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. the investigators will compare health outcomes for groups of adult patents with diabetes. one group will be managed by our traditional approach to diabetes care. the second group's care delivery is structured according to a design consistent with the chronic care model (ccm).

the study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. the effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.

Eligibility criteria:
inclusion criteria: * primary care physicians practicing in a designated site with \> 200 patients assigned to their panel who have been diagnosed with diabetes exclusion criteria: * refusal to give informed consent

Keywords: diabetes chronic care management resource utilization outcome glycohemoglobin hospitalization
electrical stimulation to improve recovery after peripheral nerve injury

Conditions: Hemifacial Paralysis; Bell Palsy

Summary: after nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. electrical stimulation (es) of injured nerves may speed up axon growth and improve recovery. this study will assess if es accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy. this study of es in these patients will investigate: i) nerve regeneration over long distances; ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and iii) changes in functional outcomes in a patient population with much less variability. our study will provide evidence about the effect of es in improving outcomes in patients with nerve injuries.


Eligibility criteria:
inclusion criteria: patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have; * i) isolated unilateral facial nerve palsy and * ii) a functioning contralateral facial nerve. exclusion criteria: * any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy. * patients with severe cognitive impairment, which would limit their participation

Keywords: unilateral facial nerve palsy facial nerve palsy facial palsy facial paralysis cross facial nerve graft cfng peripheral nerve stimulation electrical stimulation e-stim free muscle transfer fmt
electrical stimulation in individuals with chronic neck pain

Conditions: Pain; Neck Pain; Neck Pain Chronic; Pain Intensity Assessment; Functional Status

Summary: the primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. the secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.

chronic neck pain is a common problem in individuals of all ages. approximately two-thirds of individuals experience neck pain at least once in their lifetime. the methods used to treat non-specific neck pain are conservative-oriented, with medical treatment and physiotherapy being the first-line modalities. electrotherapy tools like transcutaneous electrical stimulation (tens), interferential current, diadynamic current, laser, and ultrasound are used to treat chronic neck pain. so are thermal modalities like hot packs, cold packs, hydrotherapy, and infrared; exercise therapies like neuromuscular control, diversified therapeutic exercises, range of motion (rom) exercises, and strengthening exercises; and interventions like massage, mobilization-manipulation, and traction. methods that reduce pain and improve function are essential in treatment. electrotherapy is a commonly used treatment among physical therapy modalities. while the results of the use of tens, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. the primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. the secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own. the study's hypotheses are as follows: hypothesis 1: there is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain in participants with chronic neck pain. hypothesis 2: there is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on functionality in participants with chronic neck pain.

Eligibility criteria:
inclusion criteria: participants must be aged 18 to 60. participants must report chronic neck pain for a minimum duration of three months. participants experiencing pain must have a visual analog scale (vas) score of at least 3. exclusion criteria: participants with a history of neck or shoulder surgery participants diagnosed with a rheumatic or neurological disorder

Keywords: transcutaneous electric nerve stimulation diadynamic current neck pain chronic
the role of umbilical cord thickness in prediction of fetal macrosomia in patients with gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: the aim of this work is the prediction of fetal macrosomia by measuring: 1. hba1c. 2. umbilical cord thickness. 3. interventricular septum thickness.

this prospective case control study will be carried out at ain shams university maternity hospital between april 2015 and october 2015 on 80 patients. the patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. a verbal consent will be taken from each patient. the following investigation will be performed: 1. calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester. the ultrasound examination will be with voluson e6 equipped with a 3.5 hz trans-abdominal probe at fetal medicine unit of maternity hospital ain shams university. 2. ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively. during ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device. the cross sectional area of wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured. 3. hba1c levels will be measured for diabetes patients. all the patients will be subjected to : 1. full history taking including last menstrual period, medical history and past obstetric history. 2. detailed general physical history examination and obstetrics examination. 3. ultrasound examination in fetal medicine unit maternity hospital ain shams university. 4. venous blood samples will be taken from patients with gestational diabetes mellitus in clinical pathology department ain shams university, to measure the level of hba1c using immunoassay technique. the patients will be followed up till delivery. the neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.

Eligibility criteria:
inclusion criteria: 1. singleton gestation. 2. gestational age over 27 weeks. 3. intact membranes. 4. normal umbilical morphology (two arteries and one vein). 5. diagnosis of gestational diabetes. exclusion criteria: 1. the presence of fetal congenital anomalies. 2. multifetal pregnancy. 3. maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.). 4. patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation. 5. patients who used cigarettes or alcohol during pregnancy.
food effect study of d-0502 tablet in healthy volunteers

Conditions: Breast Cancer

Summary: this is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.


Eligibility criteria:
inclusion criteria: 1. subjects must be medically documented as healthy and acceptable at physical examination. 2. subjects must have a bmi between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher. 3. subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator. 4. subjects must have a normal urinalysis, egfr, ecg or results considered not clinically significant by the principal investigator. 5. subjects must be female with postmenopausal status defined as meeting at least one of the following criteria: 1. have undergone a bilateral oophorectomy any time in life; 2. age ≥60 years, or 3. age \ 40 milli-international units per milliliter (miu/ml) and an estradiol value \<40 picograms per milliliter (pg/ml) (140 picomoles per liter \[pmol/l\]). 6. subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study. exclusion criteria: 1. subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator. 2. subjects who have any history or suspicion of kidney stones. 3. subjects who are positive for human immunodeficiency virus (hiv), hepatitis b, and/or hepatitis c. 4. subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before day 1 of study medication dosing. 5. subjects had undergone major surgery within 3 months prior to day 1. 6. subjects who is participating in a clinical research study involving the administration of an investigational or marketed drug or device, or who received any investigational test article within 5 half-lives or 30 days prior to day 1 study medication dosing. 7. subjects with positive urine drug screen test at screening. 8. subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
short term study of recombinant human insulin-like growth factor i in children with hyperinsulinism

Conditions: Hyperinsulinism

Summary: objectives: i. confirm the inhibitory effect of recombinant human insulin-like growth factor i (igf-i) on insulin secretion in children with hyperinsulinism. ii. define the effects of short term igf-i therapy on postprandial blood sugar levels in this patient population. iii. characterize the effects of short term igf-i therapy on fasting behavior, and other insulin dependent parameters, in this patient population.

protocol outline: octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. patients receive test meals of sustacal on days 3 and 4 and are assessed for insulin response. beginning on day 5, patients are given recombinant human insulin-like growth factor i subcutaneously every 12 hours for a total of 3 doses. the first dose (on day 5) is given 30 minutes before a sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of hyperinsulinism (i.e. evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) suboptimal control of blood sugar (i.e. inability to fast at least 10 hours with a blood sugar of 60 mg/dl or greater) no suspected insulinoma must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia --prior/concurrent therapy-- see disease characteristics --patient characteristics-- hematopoietic: no anemia or other concerns of blood volume depletion renal: no renal dysfunction other: * no known malignancy * no other major medical conditions

Keywords: endocrine disorders hyperinsulinism rare disease
laparoscopic internal gastric banding, new simple and costless weight loss procedure

Conditions: Morbid Obesity

Summary: the purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

in this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

Eligibility criteria:
inclusion criteria: * bmi more than 40 with or without co-morbidity or more than 35 with co-morbidity * approval to share in the study * patients fit for laparoscopic surgery exclusion criteria: * patient age less than 18 or more than 50 years old * refusal to share in the study * unfit for surgery * patients with gastroesophageal reflux disease clinically or by investigation
sodium hyaluronate ophthalmic solution, 0.18% for treatment of dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study was to determine if sodium hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * documented history of dry eyes for at least 3 months. * ocular discomfort due to dry eyes. * presence of corneal and conjunctival staining. * other protocol-defined inclusion criteria may apply. exclusion criteria: * women who are pregnant or lactating. * contact lens wear within 1 week before screening and during the study. * ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to screening. * punctal plugs or punctal occlusion initiated within 3 months of screening * other protocol-defined exclusion criteria may apply.

Keywords: dry eyes ocular discomfort