Kornimate/medical-research-clean huggingface dataset:
a phase 2b, study of linsitinib in subjects with active, moderate to severe thyroid eye disease (ted)

Conditions: Thyroid Eye Disease; Graves Orbitopathy; Endocrine System Diseases; Eye Diseases; Thyroid Associated Ophthalmopathy; Graves Ophthalmopathy; Thyroid Diseases; Orbital Diseases; Proptosis; IGF1R; Exophthalmos; Hashimoto

Summary: the overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule igf-1r inhibitor) administered orally twice daily (bid) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (ted).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of graves' disease and/or autoimmune hashimoto's thyroiditis associated with active moderate to severe ted with a cas ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at screening and baseline * confirmed active ted (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia. * subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[ft4\] and free triiodothyronine levels \[ft3\] \< 50% above or below the normal limits) at screening. * does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of screening and is not planning for any such treatment during the course of the study. exclusion criteria: * decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months. * corneal decompensation unresponsive to medical management. * previous orbital irradiation or orbital surgery. * any glucocorticoid use (intravenous \[iv\] or oral) with a cumulative dose equivalent to \>= 1g of methylprednisolone or equivalent for the treatment of ted within 3 months of screening. * prior igf-1r inhibitor therapy for any condition.

Keywords: thyroid associated ophthalmopathies
bumetanide in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: this study aims to investigate bumetanide in patients with biologically confirmed alzheimer's disease (ad). bumetanide is a potent diuretic administered orally and is fda approved for the treatment of edema and hypertension. repurposing bumetanide as a medication for ad has been proposed based on data that demonstrated its ability to "flip" the apoe genotype-dependent transcriptomic signatures in ad mouse and cell culture models. critically, this discovery was subsequently explored in electronic health record cohorts, which revealed that among individuals over the age of 65, bumetanide exposure was significantly associated with a lower prevalence of ad in three independent datasets. primary objective: to evaluate the safety and tolerability of bumetanide when administered to participants with biomarker-confirmed alzheimer's disease. secondary objective: to evaluate the clinical and biomarker effects of bumetanide in participants with mild cognitive impairment or mild dementia due to alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mild cognitive impairment or mild dementia due to alzheimer's disease. * alzheimer's disease medications are planned to remain stable throughout. * willingness and ability to complete all aspects of the study including assessments, neuropsychological testing, and mri. exclusion criteria: * clinically significant abnormalities in screening laboratory tests * chronic liver disease * renal insufficiency * poorly managed hypertension * participants taking the following concomitant medications, based on the current prescribing information for bumetanide: lithium, drugs with ototoxic potential, drugs with nephrotoxic potential, probenecid, and indomethacin.
a study on predictive model for new-onset diabetic foot in type 2 diabetes patients.

Conditions: Diabetic Foot

Summary: a retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by cox proportional hazards model.

diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality. most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. this study aims to conduct a retrospective cohort based on shandong provincial qianfoshan hospital healthcare big data platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 2 diabetes 2. hospitalized patients 3. the interval between two records is more than one year exclusion criteria: 1. any history of ulcer or amputation previously 2. the patients with type 1 diabetes 3. pregnant during the study 4. patients with malignant tumors 5. complicated with serious organ dysfunction, such as heart, liver and kidney

Keywords: diabetes mellitus, type 2 diabetic foot predictive model cohort study
endometrial receptivity after gnrh agonist triggering

Conditions: Ovarian Hyperstimulation Syndrome

Summary: conventional luteal phase support after human chorionic gonadotrophin (hcg) triggering in women undergoing in vitro fertilization/intracytoplasmic sperm injection (ivf/icsi) provides adequate pregnancy rates and live birth rates, but ovarian hyperstimulation syndrome (ohss) still occurs in 1-3% of the patients. if gonadotropin-releasing hormone agonist (gnrha) are used instead of hcg, ohss does not occur, but clinical results are somehow diminished. by testing different luteal support protocols on women undergoing gnrha triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hcg triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (ohss incidence).


Eligibility criteria:
inclusion criteria : * healthy oocyte donor women * aged 18-35 years * with a menstrual cycle length of 26-35 days * normal ultrasound scan of uterus and ovaries * normal basal hormones * no contraindication for controlled ovarian stimulation (cos) * willing to participate in the study and providing written informed consent. exclusion criteria: * subjects with current or previous history of an endocrine abnormality * subjects with an abnormal outcome of blood biochemistry or hematology * subjects with an abnormal cervical smear * subjects with a chronic disease * subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the cos treatment * pregnancy * subjects who had a previous history of ovarian hyperresponse or ovarian hyperstimulation syndrome (ohss), polycystic ovary syndrome (pcos) or a basal antral follicle count (afc) of more than 20 on ultrasound (11 mm, both ovaries combined) . * previous low ovarian response to fsh or hmg treatment (i.e. cycle cancelled due to insufficient ovarian response or less than 6 oocytes obtained). * a history of recurrent miscarriage, * smoking more than 10 cigarettes per day. * not willing to comply with study procedures

Keywords: endometrial receptivity gene arrays agonist triggering endometrial gene expression ohss
physiotherapy following disc surgery: long term follow-up of a rct

Conditions: Intervertebral Disc Displacement

Summary: hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained from survivors of disc surgery that would have considered the type of postoperative care. objectives: 1) to evaluate the long-term effects of postoperative comprehensive physiotherapy starting 1 week after lumbar disc surgery. 2) to assess the relative risk of segmental instability in the operated segment 12 years following lumbar disc surgery.

design: twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. setting: outpatient department of physical medicine \& rehabilitation. participants: of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. interventions: in the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. measurements: low back pain rating score (lbprs; manniche 1993), functional x-rays of the lumbar spine. all data are collected by blinded students and physicians at the department of pm\&r, vienna medical university.

Eligibility criteria:
inclusion criteria: * all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original rct and had completed the treatment originally allocated * all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original rct and had not completed the treatment originally allocated exclusion criteria: * n.a.

Keywords: disc herniation surgery physiotherapy, exercise therapy randomized long term follow up
evaluate the maintenance of efficacy of spd489 in adults aged 18-55 years with moderate to severe binge eating disorder

Conditions: Binge Eating Disorder

Summary: to evaluate maintenance of efficacy based on time to relapse between spd489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and clinical global impression - severity (cgi-s) scores for patients who responded to spd489 by the end of the open-label treatment phase.


Eligibility criteria:
inclusion criteria: 1. subject is between 18-55 years of age, inclusive. 2. subject meets the following criteria for a diagnosis of bed: * recurrent episodes of binge eating. an episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a 2-hour period) an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions, and a sense of lack of control over the eating (eg, a feeling that one cannot stop eating or control what or how much one is eating). * the binge eating episodes are associated with at least 3 of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating. * marked distress regarding binge eating. * the binge eating occurs, on average, at least 2 days a week for 6 months. * the episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa. 3. subject is consistently able to swallow a capsule. exclusion criteria: 1. subject has current diagnosis of bulimia nervosa or anorexia nervosa. 2. subject is receiving psychotherapy or weight loss support within the past 3 months. 3. subject has used psychostimulants to facilitate fasting or dieting within the past 6 months. 4. subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease. 5. subject has abnormal thyroid function. 6. subject initiated treatment with a lipid lowering medication within the past 3 months. 7. subject has a history of moderate or severe hypertension. 8. subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder. 9. subject has glaucoma. 10. subject is female and pregnant or nursing. 11. subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
a naturalistic study of ketamine for treatment resistant mood disorders

Conditions: Treatment Resistant Depression; Bipolar Depression; Ketamine; Major Depressive Disorder

Summary: this study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of iv, nasal spray and oral ketamine for treatment-resistant mood disorders.

current pharmacological treatments for depression prove unsatisfactory efficacy with a proportion of subjects demonstrating treatment-resistant depression (trd). the observation applies both to major depressive disorder (mdd) as well as bipolar i depression. there is growing evidence that the glutamatergic system plays a role in the pathophysiology and treatment of depression. discovery of rapid, although transient antidepressant effect of ketamine, an n-methyl-d-aspartate (nmda) receptor antagonist used in a single sub-anaesthetic intravenous dose in unipolar, bipolar and treatment-resistant patients provides evidence for a glutamatergic antidepressant. subsequent studies confirmed this effect in repeated doses. further research demonstrated that repeated ketamine infusions result in sustainable antidepressant effect with both, twice-weekly and thrice-weekly administration schedules. however, the worsening of depression may occur after infusions are completed. given the risk of relapses, there is a definite need for the development of new strategies to maintain the beneficial effects of ketamine treatment. in the present study, the investigators aim to openly assess the safety, tolerability, and effectiveness of repeated, individually tailored iv, nasal spray and oral ketamine for treatment-resistant mood disorders. the investigators intend to explore questions regarding optimal dose, treatment frequency and duration.

Eligibility criteria:
inclusion criteria: 1. major depressive disorder (mdd) or bipolar disorder (bd) diagnosis as provided by dsm-5 criteria 2. trd defined as the patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose of at least two trials of first-line evidence-based treatments and/or electroconvulsive therapy (ect) exclusion criteria: 1. pregnancy and lactation 2. hypersensitivity to ketamine 3. uncontrolled hypertension 4. other uncontrolled somatic diseases that may impact safety per investigators judgement

Keywords: treatment resistant depression bipolar depression ketamine multiple series major depressive disorder
application of proteome profiler antibody arrays to find angiogenetic predictors in glioma paitents.

Conditions: Glioblastoma Multiforme; Angiogenesis

Summary: bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. in our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.

pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.

Eligibility criteria:
inclusion criteria: * age older than 20 year old. * glioblastoma patients who will receive chemoradiation treatment. exclusion criteria: * none

Keywords: glioblastoma bevacizumab
the effect of vitamin d on the serum thioredoxin, tbp-2, thioredoxin reductase, gene expression of tbp-2 in patients with type ii diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this study is the comparision between the effects of vitamin d or placebo supplementation for 2 months in serum level of thioredoxin, tbp-2 and thioredoxin reductase activity in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention - exclusion criteria: people who have used vitamin d supplements in last 3 months, having chronic renal disease , gi disease, hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or thiazolidinediones, smokers -

Keywords: thioredoxin tbp-2 thioredoxin reductase vitamin d diabetes
bioequivalency study of meloxicam tablets under fasting conditions

Conditions: Inflammation

Summary: the objective of this study was the bioequivalence of a roxane laboratories' meloxicam tablets, 15 mg, to mobic® tablets, 15 mg (boehringer ingelheim) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to meloxicam or any comparable or similar product.

Keywords: anti-inflammatory
evaluating a novel mobile app for social cognition in psychosis

Conditions: Schizophrenia; Psychosis

Summary: to develop, and then evaluate a mobile phone app to deliver therapy homework activities between group sessions (social cognition intervention) in individuals with psychosis. the investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable. the investigators will also assess whether there is an initial indication that offering homework via the app improves outcomes following the group therapy.

this study is a pilot, feasibility trial of a clinical intervention. the investigators will initially pilot the app with three clinical participants, who will be asked to use the app for a period of three days and provide feedback as to whether there are any difficulties with usability, glitches, display, etc. two therapy groups will then be run consecutively. the therapy delivered will be a modified version of group training for social cognition in psychosis (grasp). both groups will receive their homework tasks delivered via an app. participants will undergo an assessment before and after the therapy, and a follow up interview as detailed in the measures section below. primary objective: to evaluate a mobile app to deliver therapy homework between sessions of a social cognition therapy group for individuals with psychosis. the investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable. secondary objective: to assess whether there is an initial indication that our intervention improves social cognition skills.

Eligibility criteria:
inclusion criteria: * a diagnosis on the psychosis spectrum (using either dsm 5, dsm-iv, or icd-10 \[f20-f29\]) * age 18-65 years * good command of the english language * premorbid iq of over 70 * owns a smartphone or willing to use a study smartphone for the required period * likely to benefit from social cognition intervention as assessed by clinical team \[for intervention part\]. exclusion criteria: lacks capacity to give informed consent to participate in research * poses significant risk to self or others * inability to understand verbal or written english (i.e. inability to understand information sheet or requires an interpreter). * high levels of psychotic symptoms which precludes meaningful participation * unsuitable to attend groups (group-therapy part only)
improving the selection of patients with glioblastoma multiforme for treatment with epidermal growth factor receptor inhibitor therapies

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

objectives: primary * identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial ncctg-n0177. secondary * identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial ncctg-n0074. outline: this is a multicenter study. tissue samples from patients enrolled on clinical trials ncctg-n0177 or ncctg-n0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. biological markers include epidermal growth factor expression, viii mutant p53 gene, p-akt, p7056k, s6, 4ebp1, stat-3, plc-g, erk, erbb2, erbb3, erbb4, platelet-derived growth factor receptor, igf1r, interleukin-6, fadd, and mgmt. projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
all patients entered onto n0177 and n0074 who have appropriate archived clinical specimens.

Keywords: adult giant cell glioblastoma adult gliosarcoma adult glioblastoma
long-term pulmonary outcomes after infection with sars-cov-2

Conditions: Sars-CoV2; Covid19

Summary: the objective of this study is to assess the long-term outcomes after hospital admission with covid-19 with respect to pulmonary function, physical capacity, imaging, quality of life and socioeconomic outcomes.

patients will be invited to follow-up visits 3 and 12 months after hospitalization with covid19. inclusion will take place during 2020. we expect to enroll 180 non-icu patients and 36 icu patients.

Eligibility criteria:
inclusion criteria: * infection with sars-cov-2 exclusion criteria: * unable to attend hospital visits due to frailty or severe disease * unable to understand and complete questionnaires due to intellectual or language limitations / deficits