Kornimate/medical-research-clean huggingface dataset:
a study of ritonavir (abt-538) when used with nelfinavir in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give ritonavir plus nelfinavir to hiv-infected patients. this study will also see how ritonavir and nelfinavir are absorbed by the body and how they affect the level of hiv in the blood.


Eligibility criteria:
inclusion criteria patients must have: * documentation of a positive elisa test for hiv confirmed by immunoblot, or a positive hiv rna test using the roche pcr assay, or the chiron bdna assay. * hiv rna measurement of \> 5,000 copies/ml within 3 weeks of baseline visit. * signed, informed consent from parent or legal guardian for patients less than 18 years of age. * access to a refrigerator for storing study drug. prior medication: allowed: anti-hiv therapy other than protease inhibitor therapy. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * evidence of acute infection, as measured by vital signs, physical examination, 12-lead electrocardiogram and laboratory assessments. * condition that may obscure the proper observation of the safety or activity of the treatment regimens. concurrent medication: excluded: * midazolam, alprazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, ergotamine, dihydroergotamine, and rifampin. * anti-retroviral therapy initiated prior to study entry. * any other medication, including over-the-counter medicine and alcohol, taken without the permission of the primary investigator. patients with the following prior conditions are excluded: * history of significant drug hypersensitivity. * history of psychiatric illness that would preclude compliance with the protocol. * prior enrollment in this study. prior medication: excluded: * investigational drugs within 30 days prior to drug administration. * prior treatment with licensed or investigational hiv protease inhibitor. 1. active substance abuse. * positive urine screen for recreational drugs. note: * the presence of cannabis is not exclusionary unless the investigator believes its use will interfere with patient compliance.

Keywords: drug therapy, combination hiv protease inhibitors ritonavir nelfinavir anti-hiv agents
a safety, tolerability, and efficacy study of vx-264 in participants with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of the study is to evaluate the safety, tolerability, and efficacy of vx-264 in participants with type 1 diabetes (t1d).


Eligibility criteria:
key inclusion criteria: clinical history of t1d with greater than or equal to (\>=) 5 years duration participant is on a stable diabetic treatment consistent use of continuous glucose monitoring (cgm) for at least 4 weeks before screening and willingness to use cgm for the duration of the study key exclusion criteria: prior islet cell transplant, organ transplant, or cell therapy
positive affect and mental imagery in the process of cognitive behavioural therapy

Conditions: Mental Disorders

Summary: background: research findings suggested that people with mental disorders show a dysfunctional upregulation of negative affect (na) but at the same time a dysfunctional downregulation of positive affect (pa) as distinct processes. nevertheless, established treatment approaches focus on the modification of problems and negative affect only. experimental paradigms with healthy and subclinical populations showed that pa inductions lead to higher flexibility in information processing, cognitive appraisal and action tendencies. higher amounts of pa were associated with more personal resources, higher psychological resilience and subjective well-being. preliminary evidence indicated that a focus on positive and functional aspects in the life of patients lead to better treatment sessions and outcome. however, the role of pa for the process in cognitive behavioral therapy remains unclear. method/design: in regard to this we developed the pacific-study, serving the following objectives: (1) to explore the trajectories of pa and na and their association with relevant process variables in an early phase of cbt treatment. (2) to develop and test the feasibility of a brief and easily implementable intervention to promote pa in psychotherapy sessions. (3) to analyze the impact of this intervention on the therapeutic process between and within cbt sessions and intermediate outcomes. the study includes a randomized contolled, longitudinal design in an outpatient research and treatment center. both a process and an intervention analysis will be conducted. in the process analysis, we will examine the course of pa and na in the first twelve sessions of cbt treatments. in the intervention analysis, we will examine the effects of a six-minute positive mental imagery intervention during an early phase of psychotherapy. the aim of this micro-intervention is to foster patients' in-session pa, which may lead to increased levels of subjective resources, resilience, and self-esteem (theory-driven outcome) as well as improvements in psychopathology and working alliance (secondary outcome). discussion: the study results may have important theoretical and practical implications on the use of pa in psychotherapeutic treatment. furthermore an economic implementation of strengths-oriented interventions in psychotherapy practice may be initiated.


Eligibility criteria:
inclusion criteria: * at least one mental disorder according to dsm-5 criteria * treatment at the center of mental health and psychotherapy, witten/herdecke university; outpatients clinic exclusion criteria: * current diagnosis of a severe episode of major depressive disorder * suffering from a psychotic disorder * suffering from substance use disorder * current episode of (hypo)mania * current suicidal risk * extensive experiences with guided mental imagery intervention * insufficient german language skills * currently receiving another psychological treatment

Keywords: positive affect mental imagery cognitive behavioral therapy psychotherapy process micro-intervention
sevoflurane protective effect on ischemia-reperfusion injury. multicenter, randomized controlled trial

Conditions: Microsurgical Free Flaps

Summary: this study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). the hypothesis is that the sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. the investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.


Eligibility criteria:
inclusion criteria: patient selected for plastic breast surgery with microsurgical free flap over 18 y asa i/ii exclusion criteria: unusual reaction to anesthetic drugs suspect for malignant hyperthermia vasculopathic disease coagulation disease

Keywords: balanced anesthesia inhalation anesthesia reperfusion injury microsurgical free flap
complications related to arthroscopic surgery of the hip - a prospective cohort study

Conditions: Hip Pathology; Femoracetabular Impingement

Summary: arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure. a retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1). moreover, it has been described that surgeons performing the procedure have a learning curve related to the number of complications described postoperatively. at the investigators' institution, hip arthroscopies have been performed since 2010 and the 3 surgeons have 4-12 years of experience. during the past years, changes have been made to secure the best possible comfort for the patient during the arthroscopic procedure. hence, there is a rationale for investigating complications after hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with the patient comfort in focus.


Eligibility criteria:
inclusion criteria: * all patients undergoing hip arthroscopic surgery at horsens hospital, denmark, during one year. exclusion criteria: * non
first evaluation of a craniofacial peripheral nerve stimulation system in chronic migraine

Conditions: Chronic Migraine

Summary: the purpose of this study is to demonstrate the safe use of the primus system in subjects with chronic migraine. this is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the primus system for the treatment of chronic migraine.


Eligibility criteria:
main inclusion criteria: * able and willing to provide informed consent * age ≥ 18 years and ≤ 84 years at time of consent * documented chronic migraine, defined as at least eight migraine days/month, for at least 1 year. * developed migraine before the age of 50 * documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: cgrp mabs or onabotulinumtoxin a * have at least 1 headache free day per month * stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment. * agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study. * mri available (not older than 4 years prior to study enrollment) or willing to undergo an mri to exclude structural lesions potentially causing headache * able and willing to complete a daily headache ediary main exclusion criteria: * any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms. * concomitant neuromodulation * previous failure to an implantable neuromodulation device for neurovascular headache * have an existing active implantable medical device nearby the implant location (e.g. dbs, cochlear implant, ...) * metal implants in the skull (e.g. skull plates, seeds) nearby the implant. * have a pacemaker of implantable cardioverter defibrillator (icd) * current opioid use, defined as one or more opioids on more than 4 days/month for 3 consecutive months. * use of botulinum toxin injections in the past 3 months. * women of childbearing age who are pregnant, nursing or not using contraception
metabolic equivalent of task (met) in the preoperative assessment in aortic surgery

Conditions: Aortic Diseases

Summary: reliable prediction of the preoperative risk is of crucial importance for patients undergoing vascular operations. the assessment of the metabolic equivalent of task (met) is an easy clinical evaluation of the functional capacity of an individual. a met is defined as the resting metabolic rate, that is the amount of the consumed oxygen at rest. according to the met concept a patient would be considered as "fit for surgery" when the stairs of two flights can be climbed and the housework can be fully managed by oneself. hypothesis: patients with a functional capacity over 4 met (fit for surgery) have less perioperative complications with the focus on cardiac pathology than patients with less than 4 met during aortic operations. patients and method: retrospective analysis of a single center unit of 296 patients undergoing open or endovascular aortic repair.


Eligibility criteria:
inclusion criteria: * data of all patients after open and endovascular aortic repair of the descending aorta from may 2009 till march 2016 exclusion criteria: * data of all patients with isolated operations on the ascending aorta or aortic arch
tailoring shared decision making for lung cancer screening in persons living with hiv

Conditions: Lung Carcinoma

Summary: this study tailors a shared decision making intervention for lung cancer screening in persons living with human immunodeficiency virus (hiv). information collected in this study may help doctors better understand how to perform lung cancer screening in persons living with hiv, so as to enhance shared decision making in persons living with hiv.

outline: aim i: participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of shared decision making (sdm). aim ii: participants receive the sdm intervention developed in aim i and provide feedback. participants may attend a telephone interview over 45 minutes 1 month later.

Eligibility criteria:
inclusion criteria: * aim i: patients with human immunodeficiency virus (pwh) enrolled in the local uw hiv cohort and primary providers at madison clinic and other seattle-based clinics serving pwh * aim i: using proposed united states preventive services task force (uspstf) guidelines, participants enrolled in the registry who are current or former smokers, report \>= 20 pack-years smoking history, and \>= 50 years old (n=165) will be eligible for recruitment * aim i: clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for pwh (n=48) will be eligible * aim ii: pwh who are eligible for lung cancer screening (lcs) based on proposed uspstf criteria exclusion criteria: * those found to be ineligible for lcs on coordinator review * are non-english speaking or have cognitive dysfunction that would prevent participation in sdm
descriptive study of variations in serum translocation markers of the intestinal microbiota in patients with gougerot-sjögren syndrome according to disease activity

Conditions: Sjogren's Syndrome

Summary: gougerot-sjögren syndrome or sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. the study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of gougerot-sjögren disease.


Eligibility criteria:
inclusion criteria: * the patient must be a member or beneficiary of a health insurance plan * patients with primary sjögren's syndrome according to the aecg criteria exclusion criteria: * the subject is participating in a category i interventional study, or is in a period of exclusion determined by a previous study * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * pregnant, parturient or breastfeeding patients * patients with secondary sjögren's syndrome
the effects of atorvastatin on the nitrogen oxide-system in patients with type 2 diabetes and nephropathy

Conditions: Nephropathy; Cardiovascular Diseases; Diabetes Mellitus

Summary: it has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. this effect can partly be related to a reduction in cholesterol levels in blood. nitric oxide (no) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. the purpose of this study is to investigate the effect of atorvastatin treatment on the no-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.

subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. during treatment periods subject are given a standardized diet. on the examination days subject are given l-nmma(l-ng-monomethyl arginine citrate), a no inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after l-nmma infusion. renal function is measured by renal clearance of 51cr-edta and urinary sodium, potassium and albumin concentration. urinary excretion of protein from sodium channels such as the nacl cotransporter (ncc), the na-k-cl cotransporter (nkcc) and the epithelial sodium channel (enac) will be measured to evaluate channel activity in the nephron. central blood pressure, pulse wave analysis, and augmentation index are measured using sphygmocor® from atcor.

Eligibility criteria:
inclusion criteria: * men and women * minimum 40 years * chronic kidney disease * estimated gfr (egfr) between 30 and 90 ml/min * diabetes mellitus type ii exclusion criteria: * nephrotic syndrome * anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease * neoplastic disease * alcohol abuse, * drug abuse * pregnancy or nursing * blood donation within a month before examination * hgb \< 6,0

Keywords: atorvastatin l-nmma no nephrology diabetes mellitus
comparative study between levobupivacaine and ropivacaine in the hip fractures of the elderly

Conditions: Hip Fractures

Summary: prospective, low-level, non-commercial intervention, comparative clinical trial (phase iv) of balanced, randomized groups, to compare the analgesic efficacy of the local anesthetics ropivacaine and levobupivacaine in peripheral nerve block in hip fracture surgery in the elderly .

there are several studies that try to identify the ideal anesthetic for the management and control of pain in hip fracture surgery in the elderly. the optimum would be to use an anesthetic with the lowest possible latency, since this will favor the start of surgery. and, at the same time, with a more lasting analgesia with the least motor impairment. therefore, it is essential to collect data on efficacy (effective block that allows us to mobilize the patient), latency, and analgesic scales appropriate to the cognitive state of the study sample.

Eligibility criteria:
inclusion criteria: * the patient will have to voluntarily sign and understand the informed consent that will be provided in writing. * patients over 65 years of age, with a hip fracture, who are going to be operated on at the salamanca university assistance complex (causa). exclusion criteria: * rejection of the technique. * allergy to any of the drugs. * coagulation disorders. * local infections instead of puncture. * vascular prostheses at the femoral level.
prebiotics and stress reduction in women

Conditions: Stress, Psychological

Summary: in modern life, many people state to experience stress. women compared to men report more and higher levels of stress. recent research found that supplementation of galactose-oligosaccharides (gos) resulted in reduced anxiety levels in british female students with higher anxiety scores at baseline in self-reported trait anxiety. moreover, supplementation of probiotics in germ-free rodents resulted in reduced levels of circulating corticosterone (cortisol in humans). these findings illustrate the potential of prebiotic supplementation, through the microbiota-gut-brain (mgb) axis, to improve mental health and wellbeing. the present study aims to study the effect of oligosaccharides on self-perceived stress.


Eligibility criteria:
inclusion criteria: * apparently healthy women * moderate or high stress level; dass42 stress sub-score ≥19 * age between 25 and 45 years * body mass index (bmi) between 18.5 and 30 kg/m2 * access to internet and a smart phone exclusion criteria: * any metabolic, gastrointestinal, inflammatory or chronic disease * history of gastro-intestinal surgery or having (serious) gastrointestinal discomfort * use of supplement to relief stress during or within 2 weeks prior to the start of the study * use of pre- and/or probiotics during the study (except for the study product) or within 4 weeks prior to the start of the study * use of medication that may influence the study results, such as laxatives * self-reported and/or clinical lactose intolerance * self-reported and/or active cow's milk protein allergy * pregnant or lactating (or having the wish to become pregnant during the study period, self-reported) * having used antibiotics in the 6 months prior to the start of the study
safety and efficacy of ectoin allergy nasal spray and ectoin allergy eye drops in the treatment of seasonal allergic rhinitis (sar) in children and adolescents

Conditions: Seasonal Allergic Rhinitis; Seasonal Allergic Conjunctivitis

Summary: ectoin acts on membranes by forming an ectoin-hydro-complex therewith providing a protection against external agents like aeroallergens. the effects of ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult seasonal allergic rhinitis (sar) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events. the aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of ectoin nasal spray and ectoin eye drops in pediatric and adolescent sar patients. it is assumed that ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of sar.


Eligibility criteria:
inclusion criteria: * children aged 5-17 years * diagnosed seasonal allergic rhinitis * general good health condition other than sar, and free of any concomitant conditions or treatment that could interfere with clinical investigation conduct, influence the interpretation of clinical investigation observations/results, or put the patient at increased risk during the clinical investigation * sum of total nasal score (tnss) ≥ 6 * sum of total ocular score (toss) ≥ 4 exclusion criteria: * - confirmed diagnosis of acute or chronic rhinosinusitis, as determined by the investigator * history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the screening visit) * chronic or intermittent use of intranasal, oral, intramuscular, intravenous or ophthalmic corticosteroids * ocular disorder other than allergic conjunctivitis, except hyperopia and myopia and strabismus * upper and lower airway respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (sars)\] within 4 weeks prior to clinical investigation start or development of a respiratory infection during the run-in period * start of specific immunotherapy within 1 month preceding enrolment in the clinical investigation or change in dose of immunotherapy throughout the trial * chronic moderate to severe asthma according to gina criteria which is treated with inhaled corticosteroids (ics) and additional anti-asthmatic treatment. patients with mild co-seasonal asthma must not change their dose regimen of ics within 4 weeks prior to the enrolment into the clinical investigation nor during the clinical investigation * other respiratory diseases (e.g. chronic obstructive pulmonary disease (copd), cystic fibrosis, alpha-1-antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, emphysema, etc.) * on investigators discretion