Kornimate/medical-research-clean huggingface dataset:
use of letrozole for ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: a randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate

this is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. they occurred in about 8% of all pregnancies presenting to the emergency department. methotrexate (mtx), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy. letrozole is an aromatase inhibitor and can suppress estradiol levels. some recent studies have shown that its use can be applied in cases of ectopic pregnancy. the aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.

Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis of ectopic pregnancy * desire for reproduction * ease of return * undetermined pregnancy location with abnormal hcg growth * presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hcg level ≤ 3000 miu/ml * absence of fetal cardiac activity * average diameter of the adnexal mass ≤ 3.5 cm * hemodynamically stable * no significant abdominal pain (i.e, \< 6 on a visual analog scale) exclusion criteria: * presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician) * allergy to methotrexate or letrozole * a reduction in β-hcg ≥ 50% in 2 measurements with 48 hours between them or ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization * abnormal liver function test (alanine transaminase (alt) ≥ 2 times the upper limit of normal) * abnormal renal function test (glomerular filtration rate ≤ 45 ml/min) * hemoglobin \<10 g/dl * platelets \<120.000/ml * presence of heterotopic pregnancy * do not wish to participate in the study.

Keywords: ectopic pregnancy letrozole methotrexate
effect of oral oxytocin on women's response to emotional stimuli

Conditions: Healthy

Summary: the main aim of the study is to investigate whether orally administered oxytocin (24iu) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.

all subjects will complete a series of questionnaires firstly to control for possible pre-treatment confounders in terms of personality traits and mood: beck depression inventory-ii (bdi), autism spectrum quotient (asq), liebowitz social anxiety scale (lsas), state-trait anxiety inventory (stai), childhood trauma questionnaire (ctq), the second version of social responsiveness scale(srs-2), positive and negative affect schedule (panas). panas is administered before and after oral administration and after functional magnetic resonance imaging (fmri) scanning. in the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24iu) or placebo. blood samples are collected twice before and 30 minutes after oral administration to assess the plasma oxt concentrations change. 45 minutes after oral administration subjects will be required to finish fmri scanning including resting-state fmri task, emotional face task (happy, fear, angry and neutral faces), affective scene task (naps, nencki affective picture system, positive, neutral, and negative-valence scenes). after fmri scanning, subjects will be required to rate valence, intensity, and arousal responses (likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fmri scanning.

Eligibility criteria:
inclusion criteria: * healthy subjects without any past or present psychiatric or neurological disorders exclusion criteria: * history of brain injury * head trauma * substance abuse * medication * fmri contraindications (e.g. metal implants)

Keywords: oral oxytocin emotional processing anxiety reward
predictors of response to combined pegylated interferon and ribavirin in chronic hepatitis c infected egyptian patients

Conditions: Hepatitis C, Chronic

Summary: retrospective prospective cohort study aimed at assessing the predictors to the response to the antiviral combined therapy with pegylated interferon (both types: alfa 2 a and alfa 2 b) in hepatitis c virus infected egyptian patients.

retrospective prospective cohort study conducted on hcv infected patients treated with interferon alpha therapy, the retrospective part of the study includes the data of the patients retrieved from medical records from the period from september 2006 till january 2011. then from january 2011 the study became prospective national study. responders to therapy were defined by normalization of serum alanine aminotransferase (alt) and absence of detectable serum hcv rna at the end of treatment (48 weeks). relapsed responders to therapy were defined by normalization of serum alt and absence of detectable serum hcv rna at the end of treatment but with an increase of the serum alt and the presence of hcv rna at follow-up 72 weeks). non-responders were defined by elevated serum alt and the presence of hcv rna at the end of treatment. all patients will sign a written informed consent to share in this clinical registry by their data and biological samples. sub-studies will be conducted on subgroups of patients sharing in this main study after signing a written informed consent.

Eligibility criteria:
inclusion criteria: * age: above eighteen years and below 60 * detectable hcv rna in serum by pcr * alt level ranged from normal to three fold elevation. * minimum hematological values of hemoglobin of 10.5 g/dl for females, 12g/dl for males; white blood count 3×109/l; platelet counts not less than 100,000/mm3. * bilirubin, albumin, prothrombin time and creatinine within normal limits. * a suitable method for assessment of fibrosis lik liver biopsy or fibroscan will be done before the start of treatment to assess the degree of necroinflammatory response to hcv, which was further subgrouped by hai scoring system into mild, moderate \& severe. exclusion criteria: * decompensated cirrhosis * other causes of liver diseases * autoimmune disorders * uncontrolled diabetes * thyroid dysfunction * neurological or cardiovascular disease * malignancy

Keywords: peg interferon, ribavirin, hcv, genotype iv.
quality of life in patients who have undergone previous treatment for primitive neuroectodermal tumors

Conditions: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Long-term Effects Secondary to Cancer Therapy in Children; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: questionnaires that measure quality of life may improve the ability to plan treatment for patients with primitive neuroectodermal tumors. purpose: this phase iii trial is studying quality of life in patients who have undergone previous treatment for primitive neuroectodermal tumors.

objectives: primary * determine the quality of survival of patients in the uk and other european countries enrolled in previous international society of pediatric oncology (siop) 2 or 3 phase iii trials for treatment of pediatric primitive neuroectodermal tumors (pnet). * compare the quality of survival between children allocated to different treatments in these trials. secondary * determine the framework that will allow similar information to be collected across all participating countries in the pnet 4 trial that opened in autumn 2002. outline: this is a cross-sectional, multicenter study. pediatric oncologists, teachers, patients ≥ 12 years old, and parents of children age 3-11 years old complete six questionnaires to assess the patients' motor and sensory function, cognition, behavior, emotion, educational provision and achievement, social integration, and the subjective experience of the patients and their families. projected accrual: a total of 229 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * surviving primitive neuroectodermal tumor (pnet) patients previously enrolled in international pediatric oncology society (siop) 2 or 3 phase iii treatment trials * surviving pnet patients eligible for and treated according to pnet 3 protocol but not randomized * no metastatic disease at time of allocation to treatment * no current progressive disease patient characteristics: * no patient deemed unsuitable for this study by treating clinician prior concurrent therapy: * not specified

Keywords: long-term effects secondary to cancer therapy in children psychosocial effects of cancer and its treatment cognitive/functional effects childhood supratentorial primitive neuroectodermal tumor
a study of aripiprazole in the management of patients with schizophrenia in the general psychiatric practices

Conditions: Schizophrenia

Summary: the purpose of this clinical research study is to evaluate if aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.


Eligibility criteria:
inclusion criteria: * clinical dsm-iv diagnosis of schizophrenia * patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required exclusion criteria: * risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes * prisoners or subjects compulsory detained
effects of osteopathic treatment with cognitive training on low back pain

Conditions: Low Back Pain

Summary: the objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -omt- and cognitive training -ct) is more effective in the long term than the individual approaches (omt or ct) in patients with chronic lumbar pain, evaluating the numeric rating scale (nrs) and the rolland-morris disability questionnaire (rmdq) questionnaire


Eligibility criteria:
inclusion criteria: * aged between 30 and 65 y * diagnosis of aspecific chronic low back pain * minimum of 3 on the nrs score exclusion criteria: * neuropathic pain or chronic widespread pain * low back spinal surgery in the last three years * low back spinal surgery to osteoporosis and/or traumatic fractures * rheumatic disease * pregnancy or having a baby in the last 12 months * painful disease in evidence through rx, mri or ct in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.). * the subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months

Keywords: osteopathic manipulative treatment cognitive therapy chronic low back pain pain disability
register of patients with anti-phospholipids syndrome (aps) and/or systemic lupus erythematosus (sle)

Conditions: Anti-Phospholipids Syndrome (APS); Systemic Lupus Erythematosus (SLE)

Summary: the purpose of that register is to collect medical information about patients suffering of aps with or without associated sle.

recruitment of patients with aps and sle treated. retrospective and prospective register.

Eligibility criteria:
inclusion criteria: * patient with aps * patient with sle exclusion criteria: * dependent person * hospitalized without consent and not protected by law * detainee
interleukin-1β (rs 1143627 t/c) gene polymorphism may increase the risk of developing ldd in turkish population

Conditions: Lumbar Disc Degeneration; Low Back Pain; Inflammation

Summary: this study aims to show the association between the interleukin-1β (rs 1143627 t/c) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility.

background: lumbar disc degeneration (ldd), a complex process characterized by phenotypic and genotypic changes, causes low back pain. aims: this study aims to show the association between the interleukin-1β (rs 1143627 t/c) gene polymorphism and the patient's pain level, radiological features, functional disability, and spinal flexibility. method: a hospital-based case-control study included 50 ldd patients and 44 healthy controls. in this study, taqman allelic discrimination analysis was performed for the genotype of the interleukin-1β (rs 1143627 t/c) gene polymorphism. differences in interleukin-1β allele frequencies and genotypes were evaluated between patients and controls. relationships between allele presence/genotype and disease risk are reported as odds ratios (ors) with 95% confidence intervals (cis). the pfirrmann classification was used to grade the level of disc degeneration on mri scans, and the mcnab's classification was used to classify disc displacements. the pain levels of the patient group were evaluated with vas and their functional disability with odi. spinal flexibility was evaluated using the modified schober method and a digital inclinometer.

Eligibility criteria:
inclusion criteria: * patients with chronic low back pain (over 3 months * aged 18-60 years old * with magnetic resonance imaging (mri) evidencing ldd with pfirrmann classification exclusion criteria: * cauda equina syndrome * lumbar spinal stenosis * spinal deformities (scoliosis, kyphosis, spondylolisthesis) * vertebral fractures * inflammatory rheumatic diseases * diabetic neuropathy * pregnancy * drug and alcohol dependence * psychiatric illness * oncologic diseases * who refuse to sign the consent form and donate a blood sample for analysis of genomic dna.

Keywords: lumbar disc degeneration polymorphism interleukin 1 beta low back pain
predictors of proton pump inhibitor response in gastroesophageal reflux disease patients

Conditions: Erosive Reflux Disease; Non-erosive Reflux Disease; Functional Heartburn

Summary: proton pump inhibitor (ppi) is widely used in patients with gastroesophageal reflux disease (gerd), however, some patients fail to respond to ppi therapy. recent reporters suggest that depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses to a ppi treatments. nevertheless, the predictive factors of response to ppi treatment still remain controversial. therefore, the aims of this study were to investigate the efficacy of ppi therapy, and to evaluate the predictors of the ppi response in patients with symptomatic gerd by using the questionnaire which consisted of gerd symptoms, gerd impact scale (gis), epworth sleepiness scale (ess), pittsburgh sleep quality index (psqi), hospital anxiety and depression scale (hads), and who quality of life scale abbreviated version (whoqol-bref).


Eligibility criteria:
inclusion criteria: * adult subjects (from 16 to 85 years old) * the participants with gerd symptoms were treated a ppi therapy. * the participants completed a questionnaire. the questionnaire consisted of demographic data, gerd symptoms, gerd impact scale (gis), epworth sleepiness scale (ess), pittsburgh sleep quality index (psqi), hospital anxiety and depression scale (hads), and who quality of life scale abbreviated version (whoqol-bref). exclusion criteria: * patients with a history of gastrointestinal surgery, barrett's esophagus, esophageal motility disorder, peptic ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) were excluded. * patients who took the ppi therapy less than 4 weeks were excluded.

Keywords: erosive reflux disease (erd) non-erosive reflux disease (nerd) functional heartburn (fh)
visual outcome after vitrectomy with subretinal tpa injection

Conditions: Age-Related Macular Degeneration

Summary: evaluate the safety of eva surgical system

the purpose of this retrospective study is to evaluate the safety and clinical results using this surgical technique when performed using the eva surgical system and associated instrumentation and disposable surgical equipment

Eligibility criteria:
inclusion criteria: * patients with vtx subretinal tpa ( + phaco) * patients with submacular bleeding exclusion criteria: * none
the effects of restricted dietary of ages on the glycemic control, oxidative stress and inflammation

Conditions: Metabolic Syndrome

Summary: to evaluate the effects of dietary restriction of advanced glycated end products (ages) on glycemic control, oxidative stress and systemic inflammation, in a randomized, 44 subjects with metabolic syndrome for 8 weeks.both groups will be advised to follow same low energy diet and no changing in physical activity pattern.parameters related to metabolic syndrome, anthropocentric factors, oxidative stress(malondialdehyde), cml(ages factor in blood) and systemic inflammation factors (hs-crp وtnf-α ) will be measured at the baseline and at the end of the study.

metabolic syndrome (ms) is a cluster of cardiovascular risk factor abnormalities associated with increased risk of type 2 diabetes mellitus, cardiovascular disease, and all-cause mortality. non-enzymatic glycation plays an important role in the development of physiological and pathophysiological processes such as aging, diabetes, atherosclerosis, and chronic renal failure. preventing glycation can minimize diabetic complications. advanced glycation end products (ages) are formed endogenously when the carbonyl groups of reducing sugars nonenzymatically react with the free amino groups on proteins. ages are generated in vivo as a normal consequence of metabolism, but their formation is accelerated under conditions of hyperglycemia, hyperlipidemia and increased oxidative stress. it can also form in food processing and the variety and the amount of dietary ages (dage) depend on food nutrients, the heating used in food processing, ph conditions, presence of some metal ions (cu++, fe++) and water content. in this study 2 groups of metabolic syndrome patients(22 in each group) will receive same low calorie diet and one of the groups plus restricted dietary ages according to the international references.along 8 weeks the investigators will talk to each patient by phone and every months the participants will come and the investigators will take anthropocentric measurements and the recommendations for diets will review. the three-day 24-hour recall food questionnaire will take at first,middle and the end of program.

Eligibility criteria:
inclusion criteria: * 18-70 years of age * having three of the following five features: increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated tg (≥150 mg/dl), reduced hdl-c (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the national cholesterol education program adult treatment panel iii report exclusion criteria: * history of allergy * clinically diagnosed renal, pituitary, thyroid, infections and inflammations, cancer and using of insulin, using multivitamin mineral and vitamin b6 suplements. * using any * history of cancers. * pregnancy, lactation.

Keywords: ages( advanced glycation end products)
is bio-adrenomedullin (bio-adm) a prognostic factor in patients with covid-19 treated in the icu?

Conditions: Covid19

Summary: this is prospective, observational study using point of care test to determine bio-adm whole blood concentrations and its predictive value in patients with covid-19 treated in the icu.

about 5% of all patients infected with the sars-cov-2 virus require treatment in the icu. the main reason for admission to the icu is acute hypoxemic respiratory failure, which in most cases is associated with the need for mechanical ventilation. the progression of lung damage affects not only alveoli but also endothelium of the pulmonary vessels. occurring endotheliopathy is caused by direct infection with sars-cov-2 virus and activation of the immune system leading to an increased inflammatory reaction. damage to the endothelium barrier with concomitant cytokine storm lead to activation of the coagulation system and formation of microthrombotic events in the vascular bed, resulting in thromboembolic complications and development of multiorgan failure. the reflection of the above pathophysiological phenomena in laboratory tests is a significant increase in the concentration of d-dimers. at present, no specific markers of endotheliopathy in patients with sars-cov-2 are known. adrenomedullin (adm) is a peptide hormone that plays a key role in regulating the function of the endothelium, by modulating its integrity and permeability, it also has an effect on the vascular muscle, leading to vasodilation. recently, the role of adm has been intensively studied, including in sepsis. several studies have confirmed an association between elevated adm levels and poor prognosis in sepsis and septic shock. in these studies, measurements of various adrenomedullin precursors and free, biologically active adrenomedullin (bio-adrenomedullin, bio-adm) were performed. the role of bio-adm in the course of covid -19 remains unclear. the aim of the study is to determine the baseline concentration of bio-adm and to determine the dynamic of the concentration changes in three measurements in patients with covid-19 during icu treatment. additional measurement of bio-adm will be performed as standard monitoring in patients suspected of septic complications of the course of covid-19.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * polymerase chain reaction (pcr) confirmed covid-19 * severe stage of pneumonia caused by sars-cov-2 requiring oxygen therapy * informed consent to participate in the study exclusion criteria: * qualification to palliative care * life expectancy \< 48 h * mechanical ventilation at the beginning of the hospitalization * transfer from other icu * pregnancy

Keywords: bio-adrenomedullin point of care sepsis