Kornimate/medical-research-clean huggingface dataset:
prevention of self-care deterioration in early adolescents with diabetes

Conditions: Type 1 Diabetes

Summary: establish the efficacy of a brief, clinic-based prevention program of teamwork coping skills for youth and their parents during in a high risk period of early adolescence (11-14 yrs) when parental involvement and self-care deterioration occurs.

promotion of optimal disease care and metabolic control in youth with type 1 diabetes is an important goal of disease management during early adolescence. typically youth assume increasing responsibility for these goals along with parental involvement and guidance. however, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results. the goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. to minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. meetings occur in-clinic in conjunction with four consecutive medical appointments. the educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. families discuss a variety of helpful educational diabetes topics and resources. the overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.

Eligibility criteria:
inclusion criteria: * seen for diabetes care at virginia commonwealth university or children's national medical center * child ages 11-14 * type 1 diabetes * fluent in english * ability to comprehend and complete questionnaires independently exclusion criteria: * the presence of any other major disease * the presence of any severe diabetic complications which could impair test performance * use of any medication that affects the cns other than insulin * inability to speak/comprehend and read english * placement in special classes for the mentally disabled
enalapril maleate on arterial stiffness in rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: this study evaluates the effect in artery stiffness of enalapril maleate in rheumatoid arthritis women patients. half of participants will receive 5 mg enalapril maleate every 12 hrs, while the other half will receive a placebo.

rheumatoid arthritis (ra) is a chronic inflammatory systemic disease considered as an independent cardiovascular risk factor that is associated with cumulative inflammatory load with an elevation of circulating levels of cytokines, which mediate the mechanism of endothelial cells activation by increasing the angiotensin converting enzyme (ace) function and generation of vasoconstriction. enalapril maleate is a prodrug that is hydrolyzed by hepatic esterases in enalaprilat, which is a potent inhibitor of ace. ace inhibition decreases vascular systemic resistance and mean, diastolic and systolic blood pressures in several hypertensive states, independently of the mechanism, ace inhibitors have a widespread clinic use for cardiovascular diseases. therefore, the researchers considered that there could be an association between the use of enalapril and the decrease in arterial stiffness.

Eligibility criteria:
inclusion criteria: * patients classified with ra according to the american college of rheumatology (acr) / european league against rheumatism (eular) 2010 * patients treated in the outpatient service of the rheumatology service of the hospital civil de guadalajara "dr. juan i menchaca". * sign an informed consent letter * under treatment with conventional disease-modifying antirheumatic drugs (dmards) exclusion criteria: * patients with a previous diagnosis of diabetes mellitus, systemic hypertension, thyroid, kidney or liver disease * history of acute myocardial infarction, cardiac arrhythmias, cerebral vascular event or heart failure * smoking active patients in the last 6 months * patients with a desire for close conception, pregnant or breastfeeding. * patients with blood pressure \<90/60 mmhg * patients who do not accept to participate in the study * patients with a bmi greater than ≥40 kg / m2 * non-palpable carotid and femoral pulses * unstable psychological state

Keywords: arterial stiffness enalapril maleate
vascular endothelial growth factor levels at hysteroscopic biopsies which taken from recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss Without Current Pregnancy

Summary: the aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has recurrent pregnancy loss.the endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.

this study is a prospective,observational,single-center study.ethical approval was obtained from the institutional review board.this study will be completed 30 patients with habitual abortus. endometrial vascular endothelial growth factor levels will be measured using flk-1 / kinase domain receptor / vascular endothelial growth factor receptor-2, ab-1 (rabbit pab), vascular endothelial growth factor (vegf) ab-7 (vg1), cluster of differentiation 34 (endothelial cell marker) ab-1 (qbend/10), vascular endothelial growth factor receptor-1 (n-term) (flt1) antibody kits. all assays will be performed according to the manufacturer's instructions.

Eligibility criteria:
inclusion criteria: * patients with recurrent pregnancy loss who accept to join the study. exclusion criteria: * patients whose age of \ 45 * patients with have any pregnancy.

Keywords: vascular endothelial growth factor, recurrent pregnancy loss
pirfenidone in treating patients with fibrosis caused by radiation therapy for cancer

Conditions: Radiation Fibrosis

Summary: rationale: pirfenidone may prevent or lessen fibrosis caused by radiation therapy. purpose: pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

objectives: * determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis. outline: patients receive oral pirfenidone 3 times daily. treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity. principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy. projected accrual: a total of 10-25 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities) * at least moderate impairment in at least 1 of the following principal functional abilities: * range of motion * strength * edema * swallowing * prior radiation for cancer received more than 6 months ago * no evidence of recurrent or metastatic cancer * no history of collagen vascular disease * no positive antinuclear antibody patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * hepatitis b and c negative renal: * not specified other: * hiv negative * no evidence of second primary cancer * no life-threatening situation requiring rehabilitation intervention * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no concurrent anticancer immunotherapy chemotherapy: * no concurrent anticancer chemotherapy endocrine therapy: * no concurrent anticancer hormonal therapy radiotherapy: * see disease characteristics * no concurrent anticancer radiotherapy surgery: * not specified other: * no other concurrent anticancer investigational agents * stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

Keywords: radiation fibrosis
pgl4001 versus gnrh-agonist in uterine myomas

Conditions: Uterine Myomas

Summary: this trial will assess the efficacy and safety of pgl4001 versus gnrh agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Eligibility criteria:
inclusion criteria: * be a pre-menopausal woman between 18 and 50 years inclusive. * have excessive uterine bleeding due to myoma * have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size * be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others. * if of childbearing potential the subject must be practicing a non-hormonal method of contraception. * have a body mass index (bmi) ≥ 18 and ≤ 40. exclusion criteria: * has a history of or current uterine, cervical, ovarian or breast cancer. * has a history of or current endometrium atypical hyperplasia or adenocarcinoma. * has a known severe coagulation disorder. * has a history of or current treatment for myoma with a selective progesterone receptor modulator (sprm) or a gnrh-agonist. * has a history of or known current osteoporosis. * has abnormal hepatic function at study entry. * has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study. * has a current (within twelve months) problem with alcohol or drug abuse. * is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.

Keywords: uterine myomas
belgian registry on coronary function testing

Conditions: Coronary Microvascular Dysfunction; Coronary Artery Vasospasm

Summary: the goal of this prospective, multicenter registy is to describe the 'real-world' use of coronary function tests, which may consist of bolus thermodilution measurements of coronary microvascular function and/or invasive vasoreactivity tests with acetylcholine, in the current belgian routine practice. the main questions it aims to answer are: * how frequent are coronary function tests performed * what is the indication for coronary function tests * what is the frequency of coronary microvascular dysfunction * what is the frequency of coronary artery vasospasm from each participant, data will be collected from their medical files concerning cardiovascular risk factors, relevant past medical history, non-invasive tests, procedural data, and follow-up data from routine in-patient visits. their are no specific study visits. optionally, patients will be asked to fill in questionnaires about anginal symptoms and quality of life.


Eligibility criteria:
inclusion criteria: * patient scheduled for coronary function test, comprising of intracoronary bolus thermodilution measurements of microvascular function, and/or intracoronary vasoreactivity tests with acetylcholine. * subject understands the study requirements and provides written informed consent. exclusion criteria: * subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. * subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. * documented or suspected pregnancy. * inability to provide written informed consent.
positive steps to enhance problem solving skills

Conditions: Adherence

Summary: this randomized control trial is to test the efficacy of a stepped-care "adaptive" antiretroviral therapy (art) adherence intervention ("positive steps") for hiv infected adolescents and young adults, ages 16 to 29. stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention.

hiv infected adolescents and young adults will be recruited from providence, rhode island, boston, massachusetts and chicago, illinois. participants will be equally randomized to: 1. "positive steps" - a stepped care, adherence intervention with integrated technology (2-way daily text messaging aimed at improving art adherence). if text messaging is not sufficient to overcome the barriers to art adherence;these individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy. 2. standard of care comparison group including a brief adherence educational session. this will consist of a review of medications and recommended dosing (i.e., to understand regimen), adherence expectations, toxicity expectations and medication misperceptions.the participant will then view a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication effectiveness.

Eligibility criteria:
inclusion criteria: * between 16 and 29 years of age * hiv-infected (perinatally, transfusion, or behaviorally-acquired) * currently taking or prescribed antiretroviral therapy and: 1) began taking art \ 3 and has missed one or more doses in the past week or more than 3 doses in the past month. * daily access to a cell phone * has lived in the greater providence, boston, or chicago area greater than three months * self-reports \< 90% art medication adherence in the past month (i.e., missed one or more doses in the past week or more than 3 doses in the past month) at screening * able to speak and understand english * not currently enrolled in another art-adherence intervention study * willing and able to complete all study visits in person or remotely via video conferencing platform exclusion criteria: * unable to give informed consent due to severe mental or physical illness, cognitive limitation, or substance intoxication at baseline visit * hiv-uninfected * not currently on antiretroviral therapy * does not own a cell phone * has lived in the greater providence, boston, or chicago area for less than three months or is planning to move outside the area within the next year * self-reports \> 90% art medication adherence in the past month and has been taking art for more than 3 months * unable to speak and understand english * currently enrolled in another art-adherence intervention study * not willing to and able to complete all study visits in person or remotely via video conferencing platform

Keywords: hiv art adherence adolescents
comparison of total, salivary and calculated free cortisol levels in patients with severe sepsis

Conditions: Severe Sepsis

Summary: background: the purpose of the present study was to compare serum total cortisol (stc), salivary cortisol (sac) and calculated free cortisol (cfc) levels at the baseline and after the acth stimulation test, in patients with severe sepsis (ss) and to determine the suitability of sac and cfc levels instead of stc for the diagnosis of adrenal insufficiency in patients with ss. methods: thirty patients with ss (15 men, and 15 women) were compared with 16 healthy controls. low dose acth stimulation test (1 µg) was performed on the first, 7th and 28th days of diagnosis of ss. stc and sac levels were measured during acth stimulation test.

more than 90% of circulating cortisol is predominantly bound to cortisol binding globulin (cbg), but also albumin. thus, in the presence of both hypoalbuminemia and decreased cbg levels, the ratio of bound to free cortisol levels can be altered. in this situation, measurement of fc becomes more important. direct fc measurement is time consuming and non-automated. thus, some indirect methods to determine fc levels had been introduced. the coolens' method may be practical to determine fc, it estimates fc levels from stc and cbg levels. in patients with ci, the synthesis of cbg and albumin is reduced leading to overestimation of adrenal insufficiency if we only use stc levels. since some studies demonstrated that salivary cortisol (sac) reflect free or unbound plasma cortisol levels, this method is used more often in clinical studies. stc and sac levels at baseline and after acth stimulation had been used in some studies in patients with critical illness. the aim of the present study was to compare stc, sac and calculated free cortisol (cfc) levels at baseline and after the acth stimulation test in patients with ss and determine the suitability of sac and cfc levels instead of stc for the diagnosis of adrenal insufficiency in patients with ss. and secondary aims of this study was to compare these parameters in patients with ss with healthy controls and check their effects on survival status of the patients.

Eligibility criteria:
inclusion criteria: * patients with severe sepsis. exclusion criteria: * diabetes mellitus, * pregnancy, and * use of glucocorticoids of any kind.

Keywords: hypothalamo pituitary adrenal axis
iota-carrageenan nasal spray in common cold

Conditions: Common Cold

Summary: the aim of this clinical trial is to investigate the effect of iota-carrageenan treatment on cold symptoms. the effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed.


Eligibility criteria:
inclusion criteria: * patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration * symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale * total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale * patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, echinacea); use of a daily multivitamin is allowed. exclusion criteria: * known hypersensitivity or are allergic to any component of the test device * clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease * severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps. * history of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores * taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics * common cold or flu like symptoms for more than 48 hours. * recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines) * current smoker (more than 10 cigarettes a day)
effect of intravenous lignocaine infusion on intraoperative end tidal desflurane concentration requirements

Conditions: Cholelithiases; Appendicitis; Ovarian Cysts

Summary: lignocaine is a local anaesthetic that is widely used in all medical and surgical fields. many clinical studies have shown that intravenous (iv) lignocaine given in the perioperative period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat, pain, opioid consumption, nausea, length of hospital stay. multiple animal studies have shown that iv lignocaine was able to lower anaesthetic gas requirements. desflurane is an anaesthetic gas that has a rapid onset and offset of action. this study aims to evaluate the effect of iv lignocaine infusion on desflurane requirements. hypothesis of the study is that iv lignocaine infusion reduces desflurane requirements.

all volunteers will be randomly assigned into two groups based on computer generated randomisation tables. group lignocaine will receive an iv bolus dose of 1.5 mg/kg of 2% lignocaine hcl diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. this is then followed by an iv infusion at the rate of 1 mg/kg/h of 2% lignocaine hcl in a 20 ml syringe which will be administered by another syringe pump. group placebo will receive an iv bolus of 10 ml of normal saline over a period of 3 min followed by an iv infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps. after induction of anaesthesia, all volunteers will be ventilated with aisys™ cs² anaesthesia machine. anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a total flow of 1.0 l/min. the end tidal desflurane (et-des) concentration will be adjusted to maintain a target bis of between 40-60. desflurane and study infusions will be discontinued and estimation of desflurane cost and volume used will be estimated at the end of surgery.

Eligibility criteria:
inclusion criteria: 1. american society of anaesthesiology (asa) i or ii patients. 2. patients aged between 18-75 years of age. 3. patients scheduled for elective laparoscopic cholecystectomy. 4. patients scheduled for laparoscopic hernioplasty. 5. patients scheduled for emergency laparoscopic appendicectomy. 6. patients scheduled for emergency laparoscopic cystectomy. 7. patient weight ranging from 50 - 100 kg. 8. surgery lasting at least one hour. exclusion criteria: 1. patients with a known allergy to study drug. 2. patients with body mass index (bmi) more than 35 kg m-2. 3. patients who are taking sedatives. 4. patients with chronic substance abuse.

Keywords: lignocaine desflurane
evaluating the effects of tradipitant vs. placebo in atopic dermatitis (epione)

Conditions: Atopic Dermatitis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the united states in subjects with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive); * diagnosed with atopic dermatitis; * suffering from chronic pruritus; * body mass index (bmi) of ≥18 and ≤40 kg/m2 exclusion criteria: * chronic pruritus due to condition other than atopic dermatitis (ad); * a positive test for drugs of abuse at the screening or evaluation visits; * exposure to any investigational medication in the past 8 weeks

Keywords: chronic pruritus eczema