Kornimate/medical-research-clean huggingface dataset:
epicardial adipose tissue thickness in polycystic ovary syndrome (pcos)

Conditions: Epicardial Adipose Tissue Pcos

Summary: the aim of the present study was to search whether epicardial adipose tissue thickness, a predictor of increased cardiovascular risk, increases in pcos patients or not and, if it does, to analyze the relationship of eatt with insulin resistance, adiponectin and biochemical and anthropometric parameters.

context: polycystic ovary syndrome (pcos) is characterized with chronic oligo/unovulations, hyperandrogenism and insulin resistance. insulin resistance is mostly attributed to visceral adipose tissue. epicardial adipose tissue thickness (eatt) is in close relation with atherosclerotic coronary heart disease and its importance in pcos is not determined yet. thus, we aimed to clarify eatt in patients with pcos and compare with healthy matched controls. in addition we searched plasma adiponectin levels to clarify its relationship with eatt in patients with pcos. settings: eatt was determined by echocardiography. insulin resistance is calculated as homa-ir and plasma adiponectin levels were determined with elisa radioimmunoassay at gülhane school of medicine, ankara, turkey. patients: patients with pcos and healthy controls who were similar in body mass index (bmi) and age (p=0.118, p=0.081, respectively) were enrolled in the study after having their written consents. results: mean eatt and homa-ir levels were significantly higher (p=0.001, p=0.001, respectively) while plasma adiponectin concentrations were significantly lower (p=0.0032) in patients with pcos than controls. there was no correlation between plasma adiponectin levels and eatt in subjects (p=0.824). eatt levels were in positive correlation with homa-ir, plasma triglyceride concentrations and body mass index (bmi) (p=0.022, p=0.027, p=0.022, respectively). homa-ir, triglyceride levels, hdl-cholesterol, lh/fsh ratio were most powerful determinants of eatt in logistic regression modeling (p=0.016, p=0.021, p=0.049, p=0.039, respectively). conclusion: eatt is increased in patients with pcos in concordance with homa-ir level and these findings may reflect the increased risk for atherosclerotic cardiovascular disease in this particular patient group.

Eligibility criteria:
inclusion criteria: * pcos patients, all of the women had normal thyroid-stimulating hormone and prolactin levels, and subjects without possible ovarian tumors, congenital adrenal hyperplasia exclusion criteria: * bmi greater than 35 kg/m2, any chronic renal or liver disease

Keywords: epicardial adipose pcos
comparison of csii and mdi in pediatric patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (csii, using dia:conn g8 insulin pump) in pediatric patients with type 1 diabetes using multiple daily insulin (mdi) injection

this trial consists of two crossover periods of 5 weeks each (mdi to csii or csii to mdi), followed by an extended period of 12 weeks (mdi or csii). each intervention period has wash-out period (5 days) excluded from the outcome measurements.

Eligibility criteria:
inclusion criteria: 1. the subject is aged 2-17 2. the subject with one or more of the below at diagnosis * serum c-peptide \< 0.6 ng/ml * positive glutamic acid decarboxylase (gad) antibody * positive islet cell antibody * positive anti-insulin antibody * positive anti-islet antigen-2 (ia-2) antibody 3. the subject was diagnosed with type 1 diabetes ≥ 1 year 4. the subject is treated with multiple daily insulin injection 5. the subject must have available continuous glucose monitoring (cgm) data with a percentage of active cgm time ≥ 70% in the past 4 weeks. exclusion criteria: 1. subjects who were treated with insulin pump therapy within 12 weeks prior to trial 2. any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial 3. subjects with underlying hematologic disorders that can affect the hba1c levels 4. subjects with underlying medical disorders that can affect glucose metabolism 5. subjects with a neuropsychiatric disorder such as depression or eating disorder 6. subjects with underlying thyroid disorders and abnormal thyroid function
influence of implants and locators for improved retention

Conditions: Mouth, Edentulous

Summary: the aim of this study is to assess the influence of this particular treatment method on the patients' quality of life and masticatory function.

for this prospective randomized controlled clinical trial patients with edentulous mandibles and tissue supported (full) dentures were treated with 2 dental implants and locators in order to improve prosthesis stability. the locator system is comprised of three parts: the locator implant attachment (locator abutment), the locator male and the locator denture cap. the abutment is inserted directly into the implant using a torque wrench, while the denture cap is placed into the base of the overdenture for polymerization using acrylic resin. custom retention is achieved via locator males - small color-coded (according to retention force) plastic inserts - which can be exchanged as needed.

Eligibility criteria:
inclusion criteria: * age 45-80 years (male or female) * sufficient full dentures in the mandible * must be able to clean their teeth on their own * edentulous mandible with interforaminal adequate bone for insertion of implants * implantation sites free of infections and root fragments * no need for treatment of the maxillary teeth * written informed consent exclusion criteria: * systemic diseases * mental disability that may affect the participant's ability to properly follow study instructions * oral mucosal diseases * long-term medication with steroids, bisphosphonates * known allergic reactions to dental materials * malignant tumor in the head and neck area * requirement of any concurrent radiotherapy or chemotherapy or any radiotherapy or chemotherapy within the last 10 years pregnancy or breastfeeding at study entry
observation of the gait cycle in patients with hemiplegia in order to improve the triggering of functional electrical stimulation

Conditions: Stroke

Summary: the main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a gaitrite system (beginning and end of the swing phase) in conditions without stimulation.


Eligibility criteria:
inclusion criteria: * patient has had a first ischemic or hemorragic stroke (supratentorial) within the last 6 months for the "recent stroke" group, or more than a year ago for the "old stroke" group * the patient can walk 10 m without human help, with or without a cane, and a deficit of the foot levator requiring the use of technical assistance to remedy this or involving walking problems * electrostimulated contraction of the anterior tibialis is possible * patient has been informed and has signed the consent form exclusion criteria: * cognitive disorder making participation in the study difficult * fixed plantar flexion, knee extended below 0° * patient refuses to sign consent * patient is not covered by a social security system * patient is under any kind of guardianship
botulinum toxin for treatment of seborrhic dermatitis in parkinsonian patients

Conditions: Parkinson Disease; Parkinsonism; Seborrheic Dermatitis

Summary: there's high incidence of seborrhic dermatitis among patients suffering from parkinson's disease. seborrhic dermatitis is caused by increased exertion of sebaceous glands. previous studies have shown an increase of sebum excretion rate in parkinsonian pateints. other studies demonstrated improvement in seborrhic dermatitis after anticholinergic treatment. from these studies we concluded that there might be hyperactivity of the parasympathetic system among pd patients, that cause increased exertion of sebum, therefore local injection of botulinium toxin, which inhibitis acetyl choline realese, might improve the rash of seborrhic dermatitis. 40 patients suffering from parkinson disease or other parkinsonian disorders will participate in this study. before treating the patients with botulinium toxin, we will measure the sebum exertion with the sebumeter device and make clinical evaluation of the rash. we will also take a picture of the rash. then botulinium toxin (60- 100 units) will be locally injected to the rash area. two weeks after the injection the patients will be called and evaluated clinicly and by the sebumeter. then they will be checked again after 3 weeks, after a month and after two, three and four month's.

exclusion criteria: * dementia * renal or liver failure * pregnancy or breast feeding * history of allergy to botolinium toxin * motor neuron disease or any other disease that insult the neuromuscular junction * treatment with amynoglycoside antibiotic. this study will include only patients that can give informed concent. sebumeter sm 810- this is the device we will use to measure sebum exertion before and after injecting botulinium toxin. the measurement is based on grease-spot photometry. a special tape becomes transparent in contact with the sebum on the skin surface. for the determination of the sebum, the measuring head of the cassette is inserted into the aperture of the device, where the transparency is measured by a light source sending light through the tape which is reflected by a little mirror behind the tape. a photocell measures the transparency. the light transmission represents the sebum content on the surface of the measuring area. a microprocessor calculates the result, which is shown on the display in µg sebum/cm² of the skin.

Eligibility criteria:
inclusion criteria: * parkinson disease patients that have seborrhic dermatits exclusion criteria: * dementia * renal or liver failure * pregnancy or breast feeding * history of allergy to botolinum toxin * motor neuron disease or any other disease that insult the neuromuscular junction * treatment with aminoglycoside antibiotic.

Keywords: seborrhic dermatitis parkinson's disease parkinson disease parkinsonism and seborrhic dermatitis
eating disorders in type 1 diabetes: mechanisms of comorbidity

Conditions: Type 1 Diabetes; Eating Disorder

Summary: the purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. summary of the study: if you choose to participate, you will complete a set of questionnaires and a structured interview. you will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. the questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. each call takes only a minute or two to complete. you will also be asked to call in and answer study questions at other times during the day, especially after eating. the study involves a minimum of 2 clinic visits to duke. participants who live greater than 1.5 hours from duke can be approved to take part in the study by phone/skype. participants will receive and return study materials through the mail.

eating disorders (ed) are far more prevalent among individuals with type 1 diabetes (t1d) than the general population. yet what accounts for the increased prevalence of ed in t1d, and how to effectively treat these patients is unknown. ed in t1d is dangerous. t1d patients with ed not only engage in behaviors common among non-diabetic ed patients (like binge eating), but also might omit insulin to prevent weight gain. the goal of this study is to understand the psychophysiological precipitants to ed behavior among t1d patients.

Eligibility criteria:
inclusion criteria: 1. adult (aged 18-65) 2. diagnosed with type 1 diabetes 3. clinically significant eating disorder symptoms 4. currently monitored by a physician exclusion: 1. severe hypoglycemic unawareness 2. pregnancy 3. current or history of psychosis or mania 4. current substance abuse 5. non-english speaking 6. significant deficits in intellectual functioning

Keywords: type 1 diabetes type 1 diabetes mellitus eating disorders insulin omission
one week versus four week heparin prophylaxis after laparoscopic surgery for colorectal cancer.

Conditions: The Primary Study Objective is to Assess the Efficacy and; Safety of Extended 4-week Heparin Prophylaxis Compared to; Prophylaxis Given for 8±2 Days After Planned Laparoscopic; Surgery for Colorectal Cancer.; The Clinical Benefit Will be Evaluated as the Difference in; the Incidence of VTE or VTE-related Death Occurring Within 30 Days; From Surgery in the Two Study Groups.

Summary: overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. four studies reported on the incidence of venous thromboembolism (vte) after laparoscopic surgery for cancer. these studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of vte. the aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.


Eligibility criteria:
inclusion criteria: * consecutive patients who had * planned laparoscopic surgery for * colorectal cancer will be included in the study provided no exclusion criteria will be found exclusion criteria: * age \< 18 years * surgery for non-cancer disease * duration of surgery \< 45 min * other indication for anticoagulant therapy * known cerebral metastases * kidney or liver failure * known hemorrhagic diathesis or high risk for bleeding * history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia * pregnancy or lactation * refusal of informed consent.

Keywords: colon-rectal cancer heparin prophylaxis laparoscopy
weight loss and abdominal fat responses to different diet compositions

Conditions: Obesity; Insulin Resistance; Metabolic Syndrome

Summary: the purpose of this study is to assess the effectiveness of two different reduced calorie diets that have different combinations of carbohydrate, fat, and protein content in 2 groups of study participants: insulin sensitive participants and insulin resistant participants. the hypothesis of the study is that people with high and low levels of insulin resistance may respond differently to different diet compositions in a real-world environment using meals that are commonly available.


Eligibility criteria:
inclusion criteria: * females between 18 and 65 years of age. * bmi 30-40 kg/m2 * stable weight within 10 lb (+/-) for last 2 months exclusion criteria: * pregnant or lactating. * must not currently be part of a structured weight loss program * taking a medication for diabetes (such as insulin, metformin, glyburide, glipizide, byetta, pioglitazone, or rosiglitazone) or a medication such as systemic glucocorticoids that are known to affect blood sugar or blood insulin. * beck depression inventory (bdi score \>19 and/or positively endorses the suicide question on the bdi-ii) * taking any chronic medication that has not had a stable dose for 1 month or longer. * diabetes mellitus defined as a fasting glucose ≥ 126 mg/dl on screening. * taking medications or dietary supplements that cause weight gain or weight loss (eg. antipsychotics (seroquel, zyprexa, and risperdal) and/or anorectics). * clinically significant laboratory abnormalities at the opinion of the investigators. * history of bariatric surgery * a history of: * type 2 diabetes, type 1 diabetes, or diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. cushing's syndrome and acromegaly. * liver disease, such as cirrhosis, or chronic active hepatitis b or c. * use of investigational drugs within 30 days of visit 1 * a pacemaker. * hospitalization for depression in the past 6 months, history of moderate to severe major depression. * any other condition that in the investigators' or sponsor's opinion could interfere with the results of the trial.

Keywords: obesity
a study to evaluate vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy

Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Summary: the purpose of this study is to obtain safety, efficacy, and pharmacodynamic data on the use of vutrisiran in patients with attr amyloidosis with cardiomyopathy who continued on extended use of vutrisiran, or switched from patisiran.


Eligibility criteria:
inclusion criteria: * patients who are participating in the patisiran parent studies aln-ttr02-011 or aln-ttr02-014 or who have completed the 24-month ole period in the vutrisiran parent study aln-ttrsc02-003 exclusion criteria: * has permanently discontinued study drug administration while participating in the parent studies, aln-ttr02-011, aln-ttr02-014, or aln-ttrsc02-003 * future or current participation in another investigational device or drug study, scheduled to occur during this study * has other medical conditions or comorbidities which, in the opinion of the investigator, would interfere with study compliance or data interpretation

Keywords: attr cardiomyopathy amylodosis ttr transthyretin ttr-mediated amyloidosis amyloidosis, hereditary, transthyretin-related rnai therapeutic transthyretin amyloid cardiomyopathy ttr cardiomyopathy attr-cm wild-type ttr v122i ttr amyloidosis amyloidosis, wild type hattr amyloidosis with cardiomyopathy attr amyloidosis with cardiomyopathy wtattr amyloidosis with cardiomyopathy
lev102 topical gel in acquired blepharoptosis

Conditions: Acquired Blepharoptosis

Summary: phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.

this is a phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, single-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. subjects will receive a one-time application of randomized, double-masked ip. approximately 30 subjects will be enrolled in this study. eligible subjects will be randomized to 1 of the following 3 treatment groups in a 1:1:1 ratio and will receive a single dose of double-masked ip externally on the upper eyelid of both eyes (ou):

Eligibility criteria:
inclusion criteria: subjects who meet all the following inclusion criteria will be eligible to participate in the study. subjects must: 1. be male or female subjects 25 years of age or older at the time of screening (visit 1) 2. have complaints of aesthetically unacceptable upper eyelid position for both eyes making them desirous for elevation, or have complaints of superior visual field defects in both eyes that impact activities of daily living 3. present with the following at screening (visit 1): a. at least one eye that meets both of the following criteria: i. margin reflex distance 1 mrd1 ≤2 mm (no visible central pupillary light reflex defaults to 0) ii. current corrected va, using subject's own prescription eyeglasses, if applicable, in the qualifying eye(s) of +0.3 logmar (logarithm of the minimum angle of resolution) or better as assessed by etdrs b. demonstrate upper eyelid elevation ≥0.5 mm change from baseline in mrd1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at screening 4. women of childbearing potential must agree to use an approved method of birth control from the date they sign the informed consent form (icf) until after the last study visit (follow-up visit) 5. be able to give informed consent and willing to comply with all study visits and examinations exclusion criteria: 1. have any other ocular pathology other than ptosis requiring treatment with topical prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye) 2. have narrow angles, glaucoma, intraocular pressure \>23 mmhg or diagnosis of ocular hypertension, cup-to-disc ratio of \>0.7, or history of any glaucoma eye surgery in either eye 3. have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye 4. have a history of allergic reaction to the investigational drug or any of its components 5. within 7 days of screening (visit 1), or anticipated use during the study, use of any systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oral decongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution, oxymetazoline topical dermatologic cream 6. subjects who are pregnant or breast-feeding

Keywords: blepharoptosis
analgesic effects of midazolam in human volunteers

Conditions: Analgesic Drugs; Antinociceptive Agents

Summary: this study evaluates analgesic properties of midazolam compared to placebo and fentanyl. each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.


Eligibility criteria:
inclusion criteria: * male and female volunteers * 18-40 years old * healthy * body mass index between 5th and 85th percentile * caucasian * non smoker or moderate smoker (\<10 cigarettes per day) * able to understand, write, and read german exclusion criteria: * acute or chronic pain condition (except for mild day-to-day pain on \<5 days/month) * previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics * symptoms of a clinically relevant illness in the 2 weeks before the first study day * hypertension * any known psychiatric condition * abuse of alcoholic beverages, drug abuse * known positive human immunodeficiency virus status * any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks * participation in a clinical trial in the 4 weeks preceding the study * known allergy against midazolam * known allergy against fentanyl * pregnancy or breast-feeding * unable or unwilling to give informed consent * unable or unwilling to follow investigator's instructions * unable or unwilling to comply with study protocol

Keywords: midazolam fentanyl
urinary leukotriene e4 levels in children with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: investigate urinary leukotriene e4 levels and determine if there is a correlation with severity of obstructive sleep apnea. the investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (osa).


Eligibility criteria:
inclusion criteria: * children 2-16 years of age * scheduled for polysomnogram exclusion criteria: * cardiovascular, neuromuscular, immunologic or craniofacial disorders * pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month * subjects who have already received treatment for osa with an oral appliance, continuous positive airway pressure (cpap) device * previously undergone tonsillectomy and/or adenoidectomy

Keywords: obstructive sleep apnea
safety, tolerability, pharmacokinetics and pharmacodynamics of iti-214 in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a phase i/ii randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic parkinson's disease (pd) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of iti-214.


Eligibility criteria:
major inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease (pd) * severity of pd assessed by hoehn and yahr staging score of 1 to 3 * maintenance on stable pd therapy major exclusion criteria: * clinical signs of dementia * suicidal ideation or behavior * considered medically inappropriate for study participation