Kornimate/medical-research-clean huggingface dataset:
n-acetyl cysteine effect on liver function after mitral valve replacement

Conditions: Oxidative Stress; Liver Dysfunction

Summary: this study aimed at the impact of the n-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. following a clinical trial design, 34 candidates of on-pump mvr, aged 30 to 70 years, with normal liver and renal function were selected. the candidates were randomly divided into intervention: iv150 mg/ kg n-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 17 in each group).

in a randomized controlled prospective study in a teaching hospital after approval of the ethical committee and informed consent 34 candidates of on-pump mvr, aged 30 to 70 years, with normal liver and renal function were selected. the candidates were randomly divided into intervention: iv150 mg/ kg n-acetyl cysteine over 15 min then 50 mg/kg over 4 hrs, and control groups (normal saline as placebo) (n = 17 in each group).and we will assess the effect of nac on intra-operative hemodynamics and post-operative its protective rule against oxidative stress and liver dysfunction.

Eligibility criteria:
inclusion criteria: * age from30 to 65 years * both sexes * patients undergoing on-pump elective mvr with cold cardioplegia. exclusion criteria: * • patient refusal. * allergy to any of the study medications. * emergency procedures. * systolic dysfunction left ventricular ejection fraction \<40%. * pre-existing hepatic dysfunction, as evident by elevated liver enzymes and bilirubin which is defined as an increase in liver enzymes ast and alt \>10 times of baseline. * patients on chronic use of drugs that might affect liver functions, e.g. nsaid, steroids, and anticonvulsants.

Keywords: mda liver function n-acetylcystien
normaderm phytosolution global observational study

Conditions: Acne, Adult

Summary: the objective of this 3-month observational study was to assess, in 2827 adults, the benefit of np alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

acne is a chronic inflammatory condition, impacted by exposome factors. a dermocosmetic, normaderm phytosolution (np), was developed to target hyperkeratosis, inflammation, and sebum, while protecting the skin barrier, and to be used either alone or in addition to acne medications. np is a dermocosmetic specifically developed for acne-prone skin. the lightweight cream is easily absorbed and targets acne pathogenesis thanks to salicylic acid 2% for skin exfoliation, phyco-saccharide 2% for sebum reduction, and vitamin cg as anti-inflammatory ingredient, as well as ingredients that enable regeneration of the disrupted skin barrier, such as vichy mineralizing water 60%, bifida ferment lysate 1%, and hyaluronic acid 0.2%. the study was conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the french health authorities and the favorable opinion of the ethics committee). qualitative variables were described as numbers and percentages. 95% confidence intervals (ci) were calculated, where required. quantitative variables were described as number, mean, standard deviation, median, minimum, maximum and number of missing data. all statistical analyses were performed at a 5% significance using 2-sided tests, except normality, tested at the threshold of 1% (shapiro-wilk test).

Eligibility criteria:
inclusion criteria: adult men or women (age \>18 years old) with mild to moderate acne (gea scale 1-3). exclusion criteria: patients taking isotretinoin. patients presenting with highly inflammatory acne, grade 4 or 5 on the gea scale. patients presenting with nodules.

Keywords: acne observational study dermocosmetic
treatment of atrial fibrillation in finland

Conditions: Atrial Fibrillation

Summary: finfib 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in finland. the investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants.

finfib 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation (af) in finland. it will produce important information such as whether the introduction of the new agents has taken place in accordance with the treatment guidelines in different parts of finland. working hypothesis is that the treatment of af has improved since the introduction of new antiarrhythmic drugs and anticoagulants. however, the investigators also expect to find out that there are geographical differences in the use of these agents. the expect outcome is that the investigators will identify these differences and be able to better homogenize the treatment of af in different parts of the country and different levels of the health care system. the study data will be obtained in the form of a cross-section sampling over two weeks. all patients with ecg-diagnosed af who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. the investigators estimate the number of patients will be about 1000. aside from background information, risk data (e.g. cha2ds2vasc), symptoms (ehra classification), medication, examinations and the choice of treatment, the only data recorded about each patient with af will be date of birth and gender. the patients will be divided into four groups according to type of af: 1. new onset af, 2. paroxysmal af, 3. persistent af, 4. permanent af. the data will be obtained by the local study doctor using online, protected data collection program. the data will be stored on a secured server, which can be accessed for data entry by the investigators at the study centers. the database is not a personal data register, as identity codes will not be stored at any point and individual patients cannot be identified later through the database. only the investigator group will have the rights to use the database.

Eligibility criteria:
inclusion criteria: all adult patients with ecg-diagnosed af who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. exclusion criteria: none

Keywords: atrial fibrillation anticoagulation antiarrhythmic medication cha2ds2vasc score has-bled score chads2 score
dexmedetomidine on optic nerve sheath diameter

Conditions: Intracranial Hypertension

Summary: dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. the investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

laparoscopic lower abdominal surgery requires the trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. dexmedetomidine, a selective alpha2 receptor agonist might attenuate the sympathetic activation and contribute to stable hemodynamics. the investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of colorectal cancer * planed for laparoscopic low anterior resection exclusion criteria: * morbid obesity (body mass index \> 30 kg.m-2) * history of cerebrovascular disease * history of respiratory disease * uncontrolled cardiovascular disease
intramedullary nailing versus plate fixation of ankle fractures. a prospective, randomized controlled trial.

Conditions: Ankle Fractures

Summary: the purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (imn) and plate fixation of weber b ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.

open reduction and internal fixation (orif) is the gold standard treatment for unstable weber b fractures, using compression screws and a neutralization plate. in the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. due to concerns with complications related to orif, the technique with intramedullary fixation has been introduced. this method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.

Eligibility criteria:
inclusion criteria: * acute unstable weber b fracture (unimalleolar, bimalleolar or trimalleolar fractures). * operable with both methods of surgery within 3 weeks after injury. * men and women ≥ 60 yoa. exclusion criteria: * prior injury or pathology with reduced ankle function. * other acute foot/ankle/leg injury that will affect ankle function. * fracture of the posterior malleolus that need fixation. * injury / pathology that may affect rehabilitation. * open fracture. * inoperable patient. * dementia (mmse score ≤ 24 points), reduced competent to consent, not able to express himself/herself in norwegian or english.
trinova-3: a study of amg 386 or amg 386 placebo in combination with paclitaxel and carboplatin to treat ovarian cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer

Summary: the purpose of this study is to determine whether amg 386 or amg 386 placebo in combination with paclitaxel and carboplatin are effective in the treatment of ovarian cancer.


Eligibility criteria:
inclusion criteria: * female subjects 18 years of age or older with figo stages iii-iv epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded * subjects with figo stage iiia or iiib disease must have undergone pds for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization * subjects with figo stage iiic or iv disease must either: * undergo pds for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or * plan to have ids following 3 cycles of paclitaxel and carboplatin plus amg 386 or amg 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer * ecog performance status of 0 or 1 * adequate bone marrow, renal and hepatic function exclusion criteria: * prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer * previous abdominal and/or pelvic external beam radiotherapy * history of central nervous metastasis * history of arterial or venous thromboembolism within 12 months prior to randomization * clinically significant cardiovascular disease within 12 months prior to randomization

Keywords: primary peritoneal cancer
dosage-dependence of graded exercise therapy in patients with patellofemoral pain syndrome.

Conditions: Patellofemoral Pain Syndrome

Summary: with this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, pfps).

exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (pfps), but there is still no consensus on recommending any specific rehabilitation program. this study evaluates two different therapeutic exercise regimens in patients with pfps and their effect on pain at rest and function. supervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.

Eligibility criteria:
inclusion criteria: presence of at least 3 symptoms of the following: pain when * walking stairs * squatting * running * cycling * sitting with knees flexed for a prolonged period of time * grinding of the patella * other positive physical tests (clarke's test, patellar crepitus, tenderness upon palpation of the posterior surface of the patella, patellar facets or surrounding structures) exclusion criteria: * knee osteoarthrosis/ arthritis * previous knee injury or knee operations * patellar tendinopathy * osgood- schlatter's disease * other defined pathological conditions of the knee

Keywords: knee anterior cruciate ligament pain patella exercise therapy
a comparison of primary tka rehabilitation using a smart orthotic versus outpatient physical therapy

Conditions: Arthropathy of Knee

Summary: this will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (tka). population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. all tka patients are prescribed physical therapy (pt) for rehabilitation post-operatively. the investigators will compare this current treatment with a new, validated, wearable smart knee brace (fm2 knee brace) that can be used for rehabilitation post-tka. following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient pt versus fm2 knee brace). outpatient pt group will be prescribed routine six-week course of outpatient pt (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. the fm2 knee brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. the investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. the investigators will also plan to record additional pros, therapy compliance, and complication rates. the investigators will compare the two groups to test whether the new fm2 knee brace is noninferior to regular pt when recovering from tka, and if the new technology could be an alternative to outpatient pt.


Eligibility criteria:
inclusion criteria: * ages 18-100 * indicated for primary total knee arthroplasty * possess a smartphone with capabilities to use the focusmotion app and fm2 knee brace * home discharge post-operatively exclusion criteria: * prior ipsilateral knee surgery * prior manipulation under anesthesia of either knee * bmi \> 40
a pediatric longitudinal evaluation to assess the long-term safety of protopic for the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is an observational study to assess the long-term safety of protopic® ointment for the treatment of atopic dermatitis. patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. no drug is distributed during this observational trial.

data will be collected at enrollment and every 6 months thereafter either by interview, internet, or physician office visit. each subject will be followed for 10 years in this study.

Eligibility criteria:
inclusion criteria: * subjects who first used protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of atopic dermatitis may enroll into the study.

Keywords: atopic dermatitis child tacrolimus ointment protopic ointment
inflammatory aspects of glucose in hyperlipidemia and diabetes

Conditions: Atherosclerosis; Leukocyte Activation Disorder; Type 2 Diabetes Mellitus; Familial Combined Hyperlipidemia

Summary: in this study, we will investigate both inflammatory systems in healthy volunteers and patients with t2dm on insulin therapy and hyperlipidemia (both familial hyperlipidemia (fh) and familial combined hyperlipidemia (fch)) during an ogtt.

cardiovascular disease (cvd) is number one killer in the netherlands. insulin resistance and dyslipideima are the main causes of cvd. recently, we have shown that there is an acute leukocyte activation after an oral glucose tolerance test (ogtt) in patients with newly-diagnosed diabets mellitus type 2 (t2dm). leukocyte activation is an important and obligatory aspect in the process of atherosclerosis. complement system is another important inflammatory component in atherosclerosis, which becomes activated in the postprandial phase. in this study, we will investigate both inflammatory systems in healthy volunteers and patients with t2dm on insulin therapy and hyperlipidemia (both familial hyperlipidemia (fh) and familial combined hyperlipidemia (fch)) during an ogtt.

Eligibility criteria:
inclusion criteria: * provide written informed consent * aged 45-65 years * bmi \< 35 kg/m2 exclusion criteria: * emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. subjects who are not able to understand the patient information * diabetes mellitus treated with oral antidiabetic medicine * type 1 diabetes mellitus * peripheral artery and/or coronary disease * untreated hypertension * alcohol use \> 2 units/day * aberrations in kidney, liver and thyroid function * use of any experimental medication within 6 months of the study * the use of immunosuppressive drugs
clinical study to evaluate the efficacy and the safety of eradication therapy for helicobacter pylori in functional dyspepsia

Conditions: Functional Dyspepsia; Helicobacter Pylori Infection

Summary: the role of helicobacter pylori infection in functional dyspepsia remains controversial. several randomized controlled trials in western countries have shown no significant advantage over placebo. but some recent studies in asian population were different compared to the result of studies in the western population. at the present time, it seems to be difficult to conclude the efficacy of the h.pylori eradication therapy in patients with h. pylori-infected functional dyspepsia. the investigators hypothesize that eradication of helicobacter pylori has a sustained global symptom improvement in patients with h. pylori infected functional dyspepsia.

functional dyspepsia: diagnosed by rome iii criteria of functional gastrointestinal disorder treatment regimen: combination of proton pump inhibitor, amoxicillin, clarithromycin for 7 days placebo: same shaped placebo drugs

Eligibility criteria:
inclusion criteria: * functional dyspepsia by rome iii criteria * normal endoscopic findings * h. pylori positive by urea breath test exclusion criteria: * patients with severe concomitant systemic disease * patients with gi surgery * females with pregnancy or breast-feeding * irritable bowel syndrome, inflammatory bowel disease * duodenal ulcer, gastric ulcer, gi bleeding * history of eradication therapy of helicobacter pylori * malignancy * psychosomatic disease

Keywords: rome iii criteria
mesalazine oral suspension in active eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

this is an open-label, monocentric exploratory phase iia pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (eoe).

Eligibility criteria:
inclusion criteria: * signed informed consent * male or female patients, 18 to 75 years of age * confirmed clinico-pathological diagnosis of eosinophilic esophagitis (eoe) according to established diagnostic criteria * negative pregnancy test in females of childbearing potential exclusion criteria: * other causes for esophageal eosinophilia * clinical and endoscopic signs of gastroesophageal reflux disease (gerd) * any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]) * any known or suspicion for relevant infectious diseases associated with clinical signs, * known intolerance/hypersensitivity/resistance to the imp or excipients or drugs of similar chemical structure or pharmacological profile * existing or intended pregnancy or breast-feeding

Keywords: esophageal dysfunction, esophageal inflammation
assessment of macrophage activation syndrome in still's disease in italy

Conditions: Macrophage Activation Syndrome (MAS); Still Disease, Juvenile Onset; Still's Disease, Adult-Onset

Summary: assessment of macrophage activation syndrome in still's disease: retrospective chart analysis of patient history, symptom resolution and treatment characteristics in italy

this is an observational, retrospective cohort study on the treatment utilization and outcomes of macrophage activation syndrome (mas) refractory to glucocorticoids (gc) in patients with still's disease. the study will be conducted entirely through medical chart abstraction; all data will be taken from the patient's medical record, with no additional assessments. the study will be conducted in italy.

Eligibility criteria:
inclusion criteria: * age \>6 months and ≤80 years at the beginning of the index mas episode. * diagnosis of still's disease (sjia or aosd diagnosis). * diagnosis of mas according to treating physician in the medical record. * patients who have received at least 3 consecutive days of gc after diagnosis of mas and/or are judged by the investigator to be refractory to gc due to clinical worsening of patient's condition. * the onset of the index mas episode occurred between 01 january 2012 and 30 september 2022. * according to local regulations, waivers of consent will be sought for study participants from the appropriate regulatory authorities and/or the independent ethics committee (iec)/institutional review board (irb). o for patients not covered by waivers of consent, signed, and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age (with patient assent, as applicable) or who have died, should be obtained before any study-related activities are undertaken. exclusion criteria: * a diagnosis of primary hlh prior to the beginning of the index mas episode. * confirmed malignancy prior to the beginning of the index mas episode. * patient treated with any investigational product as a part of clinical trial during the index mas episode.