Kornimate/medical-research-clean huggingface dataset:
the long term outcome of varus derotational osteotomy for legg-calvé-perthes' disease

Conditions: Legg-Calvé-Perthes Disease

Summary: background: varus derotation osteotomy (vdro) is one of the most popular surgical treatments for legg-calvé-perthes disease yet its long term results have not been assessed. our purpose was to determine the long term clinical and radiographic outcomes of these patients. methods: forty patients (43 hips) who had undergone vdro for lcpd who participated in a long term follow-up study a decade ago were approached for the present study. all patients were treated in our institution during 1959 to 1983 with proximal vdro. the patients were invited to for a medical interview and a physical examination. they were also asked to fill out questionnaires and to provide or undergo a standing anteroposterior (ap) pelvic and a lateral hip radiographs during the visit. patients were asked to self-grade their hip pain as none, mild, moderate or severe and to grade their back pain using the visual analogue scale (vas) between 0-10. details regarding daily function, physical activity, work status and family history were obtained. all participants completed the harris hip score (hhs) with a maximum score of 100 and the short form-36 which is composed of 8 sections and has a maximum score of 100. the physical examination included an assessment of the hip range of motion, leg length discrepancy and the presence of a trendelenburg sign. radiographic parameters evaluated were the tonnis grade (with a score between 0-3), head size ratio, and the center-edge (ce) angle.


Eligibility criteria:
inclusion criteria: * all patients were treated in our institution during 1959 to 1983 with proximal vdro and were examined a decade ago exclusion criteria: -
study of multistep pharmacological and invasive management for cardiogenic shock

Conditions: Cardiogenic Shock

Summary: the purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support.

cardiogenic shock is characterized by a decrease in cardiac output and increased ventricular pressures, with subsequent symptoms and signs of systemic hypoperfusion. in spite of the multiple pharmacological chances the in-hospital mortality rate is still very high (around 60% of patients) and nowadays there is not a therapeutic "reference standard" associated with an improved survival at short and midterm. adrenaline is a mainstay of resuscitation therapy during cardiopulmonary arrest, however, it is not clear whether this inotrope actually facilitates an improvement in patients affected by cardiogenic shock. in a small local evidence-based experience, contrary to current opinion, it has been shown that adrenaline may still have a role in the treatment of patients with low output state. this phase ii study tests the hypothesis that adrenaline infusion, integrated in a multistep approach at increasing intensity, can be a valid support with limited side effects.

Eligibility criteria:
inclusion criteria * age ≥ 18 and \< 75, men and women; * 1) sbp \ 90 mmhg or map \> 60 mmhg. * pre-existing diagnosis of heart failure with reduced ejection fraction (left ventricle systolic function ≤35%). * moreover, eligible patients have to fit at least one of the following criteria/items of overt hypoperfusion: mixed venous oxygen saturation \ 2 mmol/l; oliguria \< 0.5 ml/kg/h for at least 6 hours. * eligible patients shouldn't have contraindications to hrt. exclusion criteria * cardiogenic shock symptoms beyond 6 hours. * septic shock with evident septic focus. * cardiogenic shock due to acute myocardial infarction. * cardiogenic shock due to acute myocarditis. * cardiogenic shock due to pulmonary thromboembolism. * reiterating major arrhythmias: vt or vf or af, with ventricular rate \> 160 bpm. * severe aortic valve disease. * obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease * severe peripheral vascular disease that contraindicates mechanical support insertion. * cardiogenic shock secondary to either cardiac or non-cardiac surgery. * post-cardiac arrest syndrome following out of hospital cardiac arrest * comorbidities with ominous prognosis (life expectancy \< 1 year). * end-stage organ failure. * pregnant, lactating or subjects planning pregnancy during the course of the trial. * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Keywords: adrenaline extra corporeal life support inotropes
clinical study evaluating safety and efficacy of fluticasone furoate in people with asthma

Conditions: Asthma

Summary: a randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids

this will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. subjects meeting all the inclusion criteria and none of the exclusion criteria during visit 1 (screening visit) will enter a two week run-in period. subjects failing screening will not be eligible for re-screening. during the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (pef), asthma symptom score and rescue albuterol/salbutamol use. at visit 2 (end of run-in/randomisation visit), subjects meeting the eligibility criteria will be randomised to either inhaled fluticasone furoate 50 mcg or inhaled placebo. in addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. subjects will attend 4 on-treatment visits at visits 3, 4, 5, and 6 (weeks 2, 4, 8 and 12 respectively). subjects will receive treatment for 84 days (12 weeks). a follow-up contact will be performed 1-week after completing study medication (visit 7). subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).

Eligibility criteria:
inclusion criteria: * signed informed consent * outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit * both genders; females of child bearing potential must be willing to use appropriate contraception during the study * pre-bronchodilator fev1 of at least 60% predicted * fev1 reversibility of at least 12% and 200mls * current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist exclusion criteria: * history of life-threatening asthma exacerbation within the past 10 years * asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months * current or recent respiratory infection or current oral candida infection * presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome * known or suspected allergy to study drug or materials * taking another investigational medication or prohibited medication during the study * previous treatment with inhaled fluticasone furoate in a phase ii or iii study * current smokers or former smokers with significant tobacco exposure * children in care
treatment of complex regional pain syndrome with once daily gastric-retentive gabapentin (gralise)

Conditions: Complex Regional Pain Syndrome I (CRPS I)

Summary: the purpose of this study is to see if an fda-approved drug (gralise) can help people with certain types of neuropathic pain without causing too many side effects.

this research is being conducted to see if the drug gralise can help people with complex regional pain syndrom type i (crps i) without causing too many side effects. crps i is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). gralise is approved by the u.s. food and drug administration (fda) to treat postherpetic neuralgia (a complication of the disease shingles, which is caused by the chickenpox virus), but is not approved to treat crps i.

Eligibility criteria:
inclusion criteria: 1. subject will be between 18 to 80 years of age. 2. subject has not been on gralise. 3. subject has not been on gabapentin for at least one month. 4. subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the gralise treatment. 5. subject has a vas pain score of 5 or above at the beginning of the study. 6. subject has had crps i for at least three months to avoid clinical uncertainty and minimize the study variation. 7. female subjects of childbearing age must have a negative urine pregnancy test at the initial visit. exclusion criteria: 1. subject has severe liver or renal disease that will affect the elimination of gralise. (renal dysfunction is defined as egfr \< 60. hepatic dysfunction is defined as lfts ≥ 3x uln.) 2. subject has pending litigation related to his/her crps i condition. 3. subject is pregnant or lactating. 4. subject is allergic to gabapentin or gralise. 5. subject has a positive urine (illicit) drug test. 6. subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history. 7. subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.

Keywords: crps i
absorbable versus permanent mesh fixation trial in laparoscopic midline ventral hernia repair

Conditions: Ventral Hernia

Summary: to compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (belgian) prospective randomized single-blinded trial. all patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.


Eligibility criteria:
inclusion criteria: * written informed consent from the adult patient (18 years and older, no maximum age) * primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair exclusion criteria: * no written informed consent * hernia defects larger than 10cm diameter in width * 'hostile' abdomen; open abdomen treatment * contraindication to pneumoperitoneum * emergency surgery (incarcerated hernia) * lateral or parastomal hernia sites

Keywords: ventral hernia
early stepping verticalization in icu for abi patients

Conditions: Brain Injury; Consciousness Disorders

Summary: verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (abi) and to be safe in icu. the investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to abi. consecutive patients with vegetative state or minimally conscious state were enrolled in icu on the third day after an abi. they were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. once stabilized, patients were transferred to a neurorehabilitation unit for an individualized treatment. outcome measures were assessed on the third day from the injury (t0), at icu discharge (t1) and at rehab discharge (t2).


Eligibility criteria:
inclusion criteria: * glasgow coma scale (gcs) ≤8 for ≥24h from the event; * diagnosis of vegetative state or minimally conscious state on the third day after the injury; * adequate pulmonary gas exchanging function; * stable hemodynamics exclusion criteria: * sedation; * unstable intracranial pressure (icp); * cerebral perfusion pressure (cpp) \<60 mmhg; * fractures or skin lesions in thorax, abdomen or lower limbs; * deep vein thrombosis; * body weight \>130 kg; height \>210 cm.
tigulixostat, phase 3 study, allopurinol controlled in gout patients

Conditions: Gout; Hyperuricemia; Gout Flare; Tophi

Summary: the aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of tigulixostat in gout patients with hyperuricemia.


Eligibility criteria:
inclusion criteria: * male or female subjects between the ages of 18 85 years, inclusive. * subjects with hyperuricemia and a history or presence of gout per american college of rheumatology/european league against rheumatism (acr/eular) 2015 criteria. * subjects who are currently on urate-lowering therapies (ult) with an sua level ≥6.0 mg/dl at screening (visit 1); or subjects who are currently not on ult with an sua level ≥7.0 mg/dl at screening (visit 1). subjects currently on ult will undergo washout and must have an sua level ≥7.0 mg/dl at visit 3 to be randomized and participate in the study. * subjects with a body mass index ≤50 kg/m2 and estimated glomerular filtration rate (egfr) ≥30 ml/min/1.73 m2 at screening (visit 1). exclusion criteria: * subjects with secondary hyperuricemia and enzymatic defects. * subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (visit 1). * subjects who have received pegloticase to treat gout which has not responded to the usual treatments. * subjects who have not been receiving stable doses of drugs known to affect sua levels for the last 3 weeks prior to screening (visit 1). * subjects with a history of xanthinuria (elevated levels of xanthine in the urine).

Keywords: gout hyperuricemia xanthine oxidase inhibitor
is the ebjis definition of prosthetic joint infection meaningful in our clinical practice?

Conditions: Periprosthetic Joint Infection (PJI)

Summary: this retrospective multi-center, multi-national cohort study is to validate the european bone and joint infection society (ebjis) definition of prosthetic joint infection. specifically, it is to analyze the outcome of the infection likely group and compare it to the infection unlikely group as well as other subgroups within previous validated definitions (musculoskeletal infection society (msis)/international consensus on musculoskeletal infection (icm) 2013 and icm 2018).

periprosthetic joint infection (pji) is a major burden for healthcare systems. the european bone and joint infection society (ebjis) proposed a new set of criteria introducing a three level 'traffic light' distinction: infection unlikely, infection confirmed but also an intermediate group called infection likely (but nor confirmed). this retrospective multi-center, multi-national cohort study is to validate the ebjis definition of prosthetic joint infection. specifically, it is to analyze the outcome of the infection likely group and compare it to the infection unlikely group as well as other subgroups within previous validated definitions (musculoskeletal infection society (msis)/international consensus on musculoskeletal infection (icm) 2013 and icm 2018).

Eligibility criteria:
inclusion criteria: * tha/tka patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018 exclusion criteria: * less than two years follow up * less than four intraoperative microbiology samples (synovial fluid, tissue samples, implant sonication) * no preoperative/intraoperative synovial fluid differential leukocyte count

Keywords: infection likely group infection unlikely group european bone and joint infection society (ebjis) revision total hip arthroplasty (tha) revision total knee arthroplasty (tka)
clinical evaluation of fractional bi-polar rf for symptoms of sui and vulvovaginal atrophy

Conditions: Stress Urinary Incontinence; Vulvovaginal Signs and Symptoms

Summary: clinical evaluation of fractional bi-polar radio-frequency for symptoms of stress urinary incontinence and vulvovaginal atrophy

the objective of this trial is to evaluate the safety and efficacy of the morpheusv applicator for symptoms of stress urinary incontinence and vulvovaginal atrophy

Eligibility criteria:
inclusion criteria: * signed informed consent to participate in the study. * female subjects, 35 and 75 years of age at the time of enrolment with primary and moderate to severe symptoms of sui, who had scored at least 6 out of 12 according to severity index developed by sandvik * she has produced a leak during the bladder "cough" stress test. * 18 out of 27 for the stress incontinence questions and were confirmed as having predominant sui on the medical, epidemiologic, and social aspects of aging urinary incontinence (mesa) questionnaire completed at the screening assessment. * general good health confirmed by medical history and skin examination of the treated area. * the patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period. exclusion criteria: * - pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. * permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane. * current or history of cancer, or premalignant condition in the treatment area. * severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases. * pregnancy and nursing. * impaired immune system due to immunosuppressive diseases such as aids and hiv, or use of immunosuppressive medications. * patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, may be treated only following a prophylactic regimen. * poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction. * any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. * history of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * history of bleeding coagulopathies or use of anticoagulants in the last 10 days. * any surgery in treated area within 3 months prior to treatment. * simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study. * six months delay is required if other recent treatments like light, co2 laser or rf were performed on the same area. * use of isotretinoin (accutane®) within 6 months prior to treatment. * as per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
study of the efficacy and safety of ublituximab in patients with relapsed or refractory b-cell non-hodgkin lymphoma

Conditions: Non-Hodgkins Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia; Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); Primary Central Nervous System Lymphoma

Summary: the purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory b-cell lymphoma who were previously treated with rituximab.


Eligibility criteria:
inclusion criteria: * relapsed or refractory b-cell lymphoma * measurable or evaluable disease * previously treated with at least one line of rituximab or a rituximab based therapy * patients ineligible for high dose or combination chemotherapy + stem cell transplant * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * no active or chronic infection of hepatitis b or c and no history of hiv based on negative serology exclusion criteria: * prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry * prior autologous or allogeneic stem cell transplantation within 3 months of study entry * history of severe hypersensitivity or anaphylaxis to prior rituximab * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements * pregnant women

Keywords: lymphoma rituxan relapsed refractory
a study of viracept in hiv-positive women

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give viracept plus stavudine (d4t) plus lamivudine (3tc) to hiv-positive women with a cd4 count \<= 400 cells/mm3. this study also examines how the body handles viracept when given with d4t and 3tc.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 t cell count \<= 400 cells/mm3. exclusion criteria prior medication: excluded: * prior therapy or less than 1 month of therapy with d4t and/or 3tc. * prior protease inhibitor therapy.

Keywords: placebos drug therapy, combination stavudine hiv protease inhibitors lamivudine nelfinavir anti-hiv agents
patient preference for biopsy notification

Conditions: Elevated Risk for Melanoma

Summary: effective communication between physician and patient is fundamental to effective care. the recent introduction of electronic patient on-line portals has the potential to change the communication landscape. the investigators surveyed patients to assess their preferred modality for biopsy notification at 3 institutions with differing patient access to on-line portals, to ascertain what patient preferences are currently and if it has changed from historical preferences. our hypothesis is that as patients become more familiar with ln-line portals, their preferences will likely reflect familiarity with this modality.


Eligibility criteria:
inclusion criteria: * patients who were 18 years of age or older and english speaking were eligible to participate exclusion criteria: * younger than 18, non-english speaking.
effect of alirocumab on lipid metabolism in adults with elevated ldl-cholesterol

Conditions: Hypercholesterolemia

Summary: primary objective: to assess the effects of subcutaneous (sc) doses of alirocumab on the elimination (measured by fractional clearance rate (fcr)) of apolipoprotein b (apob) in low density lipoprotein (ldl) in adults with mildly elevated ldl-cholesterol (ldl-c). secondary objectives: to assess the effects of sc doses of alirocumab on: * various parameters of the metabolism and turnover in plasma of different lipoproteins * plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (hdl-c), triglycerides, low density lipoprotein cholesterol (ldl-c), apob, lipoprotein(a) (lp(a)) * lipoprotein particle size profile * pcsk9 (free and total) concentrations in serum to assess safety and tolerability of alirocumab. to assess emergence of anti-alirocumab antibodies. to document serum alirocumab concentrations.

total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.

Eligibility criteria:
inclusion criteria: generally healthy; ldl-c level in serum or plasma ≥ 100 mg/dl and \< 190 mg/dl at screening. exclusion criteria: * ldl-c ≥ 160 mg/dl at screening if more than 2 major coronary heart disease risk factors, as defined in national cholesterol education program guidelines. * receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.