Kornimate/medical-research-clean huggingface dataset:
a randomised, single centre, double-blind, two-period, cross-over trial in healthy subjects investigating the bioequivalence between subcutaneous injections of semaglutide produced by two manufacturing processes

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.


Eligibility criteria:
inclusion criteria: * healthy subjects * body mass index (bmi) of 18.5-30 kg/m\^2 (both incl.) exclusion criteria: * history of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders * use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide * smoking, drug or alcohol abuse * female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide

Keywords: mm
nocebo effect in osa patients with cpap treatment

Conditions: Obstructive Sleep Apnea

Summary: this study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with cpap treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (osa) in treatment with cpap.

background: the presence of side effects in the first few weeks of treatment with cpap is common. however, it has never been evaluated whether side effects could be related to the presence of the nocebo effect in this population. main objective: to assess whether the information provided by health care professionals may influence the number of reported adverse events and compliance in patients with obstructive sleep apnea (osa) in treatment with cpap. methodology: unicentric randomized clinical trial that will include 80 patients over 18 years of age with a recent diagnosis of osa and indication for treatment with cpap. participants will be recruited consecutively and will be randomly assigned in a 1: 1 ratio to receive usual information or more detailed information in possible adverse effects of treatment during the cpap adaptation visit. follow-up will be performed at 1 month and 3 months after starting cpap treatment. side effects and treatment compliance in each of the groups will be blindly assessed. descriptive statistics and differences in the number of side effects and hours of compliance between the two groups will be performed.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with osa with indication for cpap treatment 2. to be over 18 years old 3. sign informed consent for study participation. exclusion criteria: 1. patients previously treated with cpap. 2. patients with other previous treatments for osa (surgery, mandibular advancement device, etc.) 3. presence of any other previously diagnosed sleep disorder 4. patients with\> 50% central sleep apnea or cheyne-stokes respiration 5. diagnosis of a mental or physical condition that makes difficult to complete questionnaires
exercise as an modulator of immunological risk factors for osteoporosis

Conditions: Osteoporosis

Summary: this is the second phase of a study designed to determine the immunological effects of long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis (phase 2). the results indicate that six months of moderate intensity exercise reduces bone resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood mononuclear cells.

in a before and after trial involving 43 healthy adults the investigators measured the effect of six months of supervised exercise on the spontaneous and phytohemagglutinin-induced production of osteoclastogenic cytokines (interleukin-1α, tumor necrosis factor-α), anti-osteoclastogenic cytokines (transforming growth factor-β, interleukins 4 and10), pleiotropic cytokines with variable effects on osteoclastogenesis (interferon-γ, interleukin-6), and t cell growth and differentiation factors (interleukins 2 and 12) by peripheral blood mononuclear cells. the investigators also measured lymphocyte phenotypes, and serum markers of bone formation (osteocalcin), bone resorption (c-terminal telopeptides of type i collagen), and bone homeostasis (estradiol, vitamin d2, testosterone, parathyroid hormone, insulin-like growth factor).

Eligibility criteria:
inclusion criteria: * normal exercise treadmill test exclusion criteria: * any medical condition that would prevent participation in a six month exercise program

Keywords: exercise osteoporosis cytokines
percutaneous bilateral versus unilateral metal stent for hilar cholangiocarcinoma

Conditions: Hilar Cholangiocarcinoma

Summary: cholangiocarcinoma (cca) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (hcc). a majority of the cca (50-70%) was presented in the area of the biliary duct bifurcation. recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival. however, in recent european society of gastrointestinal endoscopy (esge) biliary stenting clinical guideline and asia-pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (hcca), whether we should deployment bilateral or unilateral metal stent for patients with hcca was not clearly recommended due to the absence of randomized controlled trials.

patients with advanced hilar obstruction (bismuth iii and iv), ptbs had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ercp). the advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis. guideline recommendation european society of gastrointestinal endoscopy (esge) biliary stenting clinical guideline and asia-pacific consensus recommendations the goal of palliative stenting of hcca is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ercp in retrospective study.there are no randomized clinical trials compared with these two internal biliary drainage methods in hcca using metal stent. the aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with hcca.

Eligibility criteria:
inclusion criteria: written informed consent; jaundice duo to biliary obstruction; the diagnosis is based on typical features on mri and magnetic resonance cholangiopancreatography or histologic and cytologic confirmation is established by percutaneous biopsy (x ray-guided) or exploratory laparotomy; bismuth type ⅱ、ⅲ、ⅳobstruction; performance status (eastern cooperative oncology group, ecog) 0-2; all patients were considered unsuitable or refuse for resection on the basis of general medical condition and/or tumor extent. exclusion criteria: refuse to participate and provide informed consent; bismuth ⅰtype obstruction; performance status (eastern cooperative oncology group, ecog) 3-4. portal vein involvement; prior history of stent; concomitant renal insufficiency; severe cardiopulmonary diseases; uncontrolled systemic infection or sepsis; accompany other malignancy or serious medical illness which may reduce the life expectancy. contraindications for ptbs.

Keywords: cholangiocarcinoma jaundice metal stent ptbs
ready to act - health education in people with hyperglycaemia

Conditions: Type 2 Diabetes Mellitus; Behavior

Summary: a pre-randomized study in primary health care was designed to investigate health education in a subpopulation extracted from general practitioners (gps) in one danish county in the treatment arm of the addition (anglo-danish-dutch study of intensive treatment in people with screen-detected diabetes in primary care) study, dk. the overall objective of the 'ready to act' health education programme was to support the participants' competences in daily life and act appropriately with respect to their dysglycaemic condition. the achievement of action competence involved four learning objectives: intrinsic motivation, informed decision-making, action experience and social involvement. the programme was delivered in primary care settings (health centre or gp surgeries) by nurses, dieticians, physiotherapists and gps.


Eligibility criteria:
inclusion criteria: * age 40-69 years at the time of screening and diagnosed with screen-detected t2d, igt or ifg (according to who criteria). exclusion criteria: * women who were pregnant or lactating, those with a psychotic illness or an illness with a prognosis of less than one year.

Keywords: prevention screening type 2 diabetes action competence family practice health services research
yoga and aerobic exercise effects on cognition

Conditions: Stress, Psychological

Summary: the purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.

eligible participants will be randomized to one of three groups: 1. sun salutations (yoga), 2. aerobic exercise (walking on a treadmill), 3. seated rest (watching educational videos). each activity will be 30 minutes in duration. immediately before and after the 30 minute intervention, participants will undergo psychosocial and cognitive assessments. prior to the intervention, participant's physical activity will be tracked for one week, via a consumer grade accelerometer. baseline and post-intervention testing will include a cognitive battery, psychosocial questionnaires, flexibility testing and physiological measures.

Eligibility criteria:
inclusion criteria: * anyone between the ages of 18-45 years * anyone with a score of 3 or higher on the generalized anxiety disorder symptom checklist of the diagnostic and statistical manual 5. that is, anyone meeting 3 or more symptoms, on more days of the week than not, for the past 6 months: 1. restlessness, feeling keyed up or on edge. 2. being easily fatigued. 3. difficulty concentrating or mind going blank. 4. irritability. 5. muscle tension. 6. sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep). * ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate) * access to a smartphone and willingness to allow research staff to install a mobile activity tracker application (and space to allow for installation) * willingness to be randomized into one of three groups exclusion criteria: * anyone who is physically active (≥30 minutes, 2 or more times/week, for the last 3 months) and/or a regular practitioner of yoga or mind-body activities (≥30 minutes, 2 or more times/week, for the last 3 months). * anyone with serious chronic medical conditions that would preclude them from participating without a physician present, or anyone with a risk of seizure, or anyone having psychiatric and/or neurological disorders. * anyone who does not consent to wearing the fitbit, or does not have a smartphone that allows us to download an app on their phone. * pregnant women. * anyone incapable of performing the following movements at a moderate intensity- sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up. * anyone with blood pressure of 200/105 or more, and anyone who scores 1 or more on the physical activity readiness questionnaire * anyone refusing or unwilling to be randomized into either of the conditions.

Keywords: physical activity walking moderate intensity acute intervention
markers of executive attention development in preschoolers

Conditions: Attention Deficit Disorder

Summary: this project aims to identify precursors of executive attention that can serve as early markers of add.


Eligibility criteria:
inclusion criteria: * normal schooling * parental consent exclusion criteria: - psychotropic drug
tapirs technique plus adjustable compression system in treatment of venous leg ulcers

Conditions: Venous Ulcer

Summary: the aim of this study is to determine the percentage of healing of active venous ulcers following terminal axial perforator interruption reflux source (tapirs technique) and adjustable compression system versus a control group using the traditional multilayer bandages.

venous ulcer due to venous insufficiency causes an important morbidity to those people suffering from this condition. most of therapies available under the obligatory health plan (pos, acronym in spanish) to date cover the cleaning of the ulcerous lesion and its medical handling using saline solutions, topical antibiotics and elastic dressings, implying an important intake from health resources due to its chronicity and the delay in ulcers healing, which usually takes periods ranging from 12 months to several years. therapeutic alternatives, which can guarantee optimal, fast and persistent in time healing, should be identified. the aim of this study is to determine the percentage of healing of active venous ulcers (using a clinical, etiological, anatomic and physiopathologic classification (ceap), c6) following endovascular laser treatment (evlt) of axial vein hypertension plus ultrasound-guided foam sclerotherapy of superficial venous reflux under knee, closing perforator veins and terminal reflux under de ulcer in patients with chronic venous ulceration (tapirs technique) plus compression with an adjustable compression system (juxta cures) versus a control group using the traditional multilayer bandages. the investigators expect that the minimal surgical invasive approach closing all the superficial venous reflux plus adjustable compression system will diminish the time of ulcer healing compared with standard treatment of multilayer bandage care.

Eligibility criteria:
inclusion criteria: venous ulcer ulcer present for at least 4 weeks ankle-arm index greater or equal to 0.8 mmhg exclusion criteria: severe hepatic disease severe cardiac disease severe pulmonary disease deep venous thrombosis active participation in other clinical trials limitation in the ankle movements others limitations to move their self

Keywords: venous ulcer vein juxta cures foam laser
portal venous hemodynamic changes after hepatectomy

Conditions: Ascites; Hepatectomy

Summary: the aim of this study is to investigate the pathophysiological mechanisms underlying the formation of posthepatectomy ascites with a focus on the significance of changes in portal venous hemodynamics after hepatic resection. by evaluation of other factors that may be involved in the formation of ascites this study may help to show to what extent the increase of portal venous pressure contributes to ascites formation. detailed knowledge about pathogenetic factors concerning the formation of postoperative ascites might help preventing protracted hospital stay and further inconveniences to the patient.

the mechanisms underlying the development of large-volume ascites after hepatectomy remain poorly understood. while studies on animal models suggest an increase of portal venous pressure after hepatectomy that may in turn favor the transudation of fluid into the peritoneal cavity further factors may be critically involved in the postoperative formation of ascites. these factors may include a drop in serum protein levels (and colloid osmotic pressure), a transient impairment in renal function and a surgery-induced capillary leakage. however, a better knowledge of the pathophysiology represents the prerequisite for efficient treatment. in the present study the impact of changes in hepatic hemodynamics after hepatectomy on development of ascites will be investigated. enrolled patients will receive measurement of portal venous flow and pressure as well as hepatic artery flow before and after hepatic resection. associations of changes in these parameters with development of postoperative ascites and further postoperative complications will be evaluated.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective hepatic resection * age equal or greater than 18 years * informed consent exclusion criteria: * evidence of ascites or hypalbuminemia preoperatively * renal insufficiency * expected lack of compliance * impaired mental state or language problems

Keywords: patients undergoing elective hepatic resection
a study to evaluate the efficacy, safety, and pharmacokinetics of lacosamide in neonates with repeated electroencephalographic neonatal seizures

Conditions: Electroencephalographic Neonatal Seizures; Epilepsy

Summary: the purpose of the study is to evaluate the efficacy of lacosamide (lcm) versus an active comparator chosen based on standard of care (stoc) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ens) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (aed) treatment.


Eligibility criteria:
inclusion criteria: * participant must be ≥34 weeks of corrected gestational age (cga), \<46 weeks of cga, and \<28 days of postnatal age (pna) * participants who have confirmation on video-electroencephalogram (eeg) of ≥2 minutes of cumulative electroencephalographic neonatal seizures (ens) or ≥3 identifiable ens prior to entering the treatment period * participants must have received either phenobarbital (pb), levetiracetam (lev), or midazolam (mdz) (in any combination) before entering the study * participant weighs at least 2.3 kg at the time of enrollment informed consent * an independent ethics committee (iec)-approved written informed consent form (icf) is signed and dated by the participant's parent(s) or legal representative(s) exclusion criteria: * participant with seizures responding to correction of metabolic disturbances (hypoglycemia, hypomagnesemia, or hypocalcemia) or with seizures for which a targeted, known treatment is available * participant has seizures related to prenatal maternal drug use or drug withdrawal * participant has a clinically relevant electrocardiogram (ecg) abnormality, in the opinion of the investigator * participant receiving treatment with phenytoin (pht), lidocaine (ldc), or other sodium channel blockers at any time

Keywords: electroencephalographic neonatal seizures epilepsy neonatal study participants vimpat lacosamide lcm pediatric video-eeg
genotyping 2 snps in chinese breast cancers

Conditions: rs185670819 and rs183489969

Summary: the purpose of this study is to determine the frequency of two single nucleotide polymorphisms (snps) by sanger-sequencing in breast cancers and healthy controls .

since the 1990s breast cancers incidence of china has increased more than twice as fast as global rates. chinese patients are responsible for 12.2% of all newly diagnosed breast cancers and 9.6% of all deaths to world breast cancers. breast cancer is now the second frequently diagnosed cancer and is the leading cause of cancer-related death in chinese women. two of the most prevalent breast cancer susceptibility genes are brca1and brca2. however，because of population based genetic heterogeneity, the frequency of brca1/brca2 mutation is not as high in caucasian population as in china. anyway, the mean age at diagnosis of breast cancer in china is almost 10 years younger and more cases are diagnosed before 40 than those in caucasians. therefore, it is believed that there are certain specific susceptibility loci in chinese breast cancers. in preliminary experiments, investigators found two germline mutations may associate with chinese breast cancers. the purpose of the study is to determine the frequency of two germline mutations by sanger-sequencing in a larger sample of chinese breast cancers

Eligibility criteria:
inclusion criteria: * woman aged superior to 18 years old inform consent signed woman without breast cancer and family history of cancer exclusion criteria: * no inform consent signed patient under guardianship, curatorship psychosocial disorder

Keywords: snp,breast neoplasms
a randomized trial of iud versus hormonal contraception in hiv-infected women in zambia

Conditions: Pregnancy; HIV Infection

Summary: a randomized trial of the intrauterine contraceptive device (iud) versus user's choice hormonal contraception (injectable progestins or oral contraceptive pills) among hiv-infected, recently post-partum women in lusaka, zambia.

in the year 2000, there were over 37, 000 new acceptors of family planning in the lusaka district clinics. a variety of methods were prescribed, including combined oral contraceptive pills, injectable progestins, the intrauterine copper device, condoms, and others. the most recent sentinel survey of reproductive age women estimated that approximately 30% of reproductive age women in lusaka are hiv-infected. since voluntary hiv counseling and testing is not yet universally available in many of the district clinics, women receive all different types of contraception regardless of their hiv status. there is some observational data published recently that suggests hormonal contraception may increase hiv viral load in the female genital tract and potentially increase hiv transmission to the male partner. by contrast, barrier methods have historically been very unpopular in stable couples and are not used consistently in many cases despite intensive counseling. the iucd represents one of the most inexpensive and effective methods of birth control available in lusaka. however, it has not been studied adequately to make policy recommendations regarding its use in hiv infected women. the purpose of this study will be to evaluate safety and acceptability of the iucd versus hormonal methods of contraception in hiv-infected and uninfected women in lusaka. specifically, we will 1) compare the contraceptive effectiveness of the iucd to the standard practices of user-chosen hormonal contraception, 2) compare the rates of pelvic infection between iud and hormonal contraceptive users, and 3) compare rates of method discontinuation. patients who have a continuing second trimester pregnancy, serologically confirmed hiv infection, a desire for 24 months of contraception, and a willingness to be randomly assigned either an iucd or hormonal contraception postpartum will be screened at 32 weeks in their pregnancies to receive either an iucd or user chosen hormonal contraception postpartum. women will then be seen at postpartum weeks 4-6 for method randomization and then at months 6, 12, 18 and 24 to monitor pregnancy, continuation of method, side effects and any other problems. women will be encouraged to return for problems at any time. at least once yearly, women will have a complete physical exam. cd4 and hiv clinical status will be monitored regularly.

Eligibility criteria:
inclusion criteria: * desire for at least 2 years of continuous contraception * two or fewer sexual partners in the prior year exclusion criteria: * advanced hiv disease (who stage iii or iv) * history of a bleeding disorder * history of pid within the prior five years * less than 16 years of age (the "age of majority" in zambia).

Keywords: contraception women hiv/aids iud iucd