Kornimate/medical-research-clean huggingface dataset:
the genetics of kidneys in diabetes (gokind) study

Conditions: Diabetic Nephropathy

Summary: kidney disease in diabetes (diabetic nephropathy) tends to run in families. it is likely, therefore, that there are genes that predict or are associated with either getting or not getting diabetic nephropathy. the gokind study will provide clinical information and dna for investigators to look for these genes. evaluation will be performed and dna obtained from approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without kidney disease. in some cases, samples for dna will also be obtained from the parents of these subjects. clinical information and dna will be coded so that individuals cannot be identified, but the dna can be linked to the clinical data from the individual. multiple investigators will be able to use this genetic material to test hypotheses about the genetics of kidney disease in diabetes.


Eligibility criteria:
inclusion criteria: type 1 diabetes mellitus with or without diabetic nephropathy; 19-54 years old; no other kidney disease
validation of a new generation of optimized orthoses for personalized treatment of adolescent idiopathic scoliosis

Conditions: Scoliosis; Adolescent Idiopathic Scoliosis (AIS)

Summary: adolescent idiopathic scoliosis affects 3-4% of the canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. the design is made relatively corsets empirically, hence the relative efficiency of this treatment. our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. in this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application


Eligibility criteria:
inclusion criteria: * 10 years or older * ais diagnosis * risser 0-2 * primary curve angles 20 degrees - 40 degrees * if female, either premenarchal or less than 18 months postmenarchal. exclusion criteria: * patients with a pre-existing cardiovascular condition * patients with symptom of a neurological disorder * patients with any other disorder of the musculoskeletal system affecting the lower limbs,

Keywords: scoliosis spine deformity brace 3d
colchicine has anti-diabetic effect

Conditions: Treatment Adherence

Summary: colchicine has antidiabetic effect and may be an option for type 2 diabetes management

observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. the ages of all patients were between 35 and 55 years. the aim of this study was to evaluate colchicine effect on a1c of newly diagnosed type2 diabetes compared to the metformin and control group on diet only. the first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. during the period of treatment, the investigators followed the patients if there were side effects of the drugs used. no side effects were monitored during the period of treatment except for gastric upset in some patients using metformin

Eligibility criteria:
inclusion criteria: * type 2 diabetes newly diagnosed age 35- 55 years exclusion criteria: * severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease

Keywords: type 2 diabetes colchicine inflammatory markers
dextenza therapy for treatment of allergic conjunctivitis

Conditions: Bilateral Conjunctivitis (Disorder)

Summary: this prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with dextenza versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * provide written informed consent and sign hipaa form * be willing and able to follow all instructions and attend all study visits * be able and willing to discontinue wearing contact lenses throughout the study period * have a bcva of ≥50 etdrs letters (20/100 snellen equivalent or better) in each eye as measured at screening visit * have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period * have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the screening visit exclusion criteria: * • known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders * have any ocular condition that in the opinion of the investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection) * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease * use of systemic, inhaled, or nasal steroids * use of new systemic antihistamine use within 30 days of screening visit * use of ocular or topical non-steroidal anti-inflammatory drugs (nsaids) * use of lid scrubs * use of decongestants * use of immunotherapeutic agents * use of monoamine oxidase inhibitors (maois) * have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of dextenza
post market surveillance of ozurdex® for branch retinal vein occlusion (brvo) and central retinal vein occlusion (crvo)

Conditions: Retinal Vein Occlusion; Macular Edema

Summary: this multicenter observational study will assess the efficacy and tolerability of ozurdex® in clinical practice, and will assess the time at which patients are considered for retreatment.


Eligibility criteria:
inclusion criteria: * macular edema * prescribed ozurdex® exclusion criteria: * none
virtual reality for generalized anxiety disorders

Conditions: Generalized Anxiety Disorder

Summary: the goal of this clinical trial is to apply virtual reality as an adjunct treatment for generalized anxiety disorder. the main question it aims to answer are: * determination of the efficacy of vr modules as an adjunct therapy in improving gad-7 scores * assessment of the acceptability of vr modules as an adjunct therapy to the standard of care participants will randomized into two arms: * control arm: standard of care only * intervention arm: standard of care + vr modules


Eligibility criteria:
inclusion criteria: 1. age between 18-59 2. the primary diagnosis is a generalized anxiety disorder 3. agree to participate and consented as per study protocol. 4. there is no change in the standard of care within the past two months prior to enrollment into the study. if a patient is on any psychotherapy, then there is no change in the type of current psychotherapy intervention. 5. gad- 7 more than or equal to 5. 6. able to come for the session as per scheduled. exclusion criteria: 1. documented or known case of permanent hearing/visual impairment e.g., vestibular abnormalities that represent significant contraindications for the use of vr or visual impairment e.g., cataract. 2. documented disorder as listed: * a. psychosis * b. psychosis disorder - previous case, known case of * c. claustrophobia * d. substance use * e. personality disorder * f. visual impairment that might hinder usage of virtual reality equipment * g. intellectual disabilities * h. all types of seizures including febrile seizure 3. the patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for gad).

Keywords: gad vr
bioequivalence of imp 08p1707f0 relative to pulmicort® (1.0 mg/2 ml suspension)

Conditions: Healthy

Summary: this study aims to demonstrate the bioequivalence between the formulation of budesonide 1mg/2ml nebuliser suspension (imp 08p1707f0) relaive to the reference product pulmicort(r) 1.0mg/2ml suspension.


Eligibility criteria:
inclusion criteria: * healthy, caucasian, male and female (16 male, 8 female) subjects 18 - 55 years of age * body mass index within the range of ≥ 18.5 and ≤ 30.0 kg/m2 * female subjects of childbearing potential1) agree to undergo pregnancy tests and to use at least an acceptable effective birth control method during the study and until 90 days after study end * negative covid-19 test result * findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * normal electrocardiograms (ecg) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study * normal vital signs (normal blood pressure and heart rate measured under stabilised conditions at screening visit after at least 5 minutes of rest in sitting position: systolic blood pressure 100 - 140 mmhg, diastolic blood pressure 60 - 90 mmhg and heart rate 50 - 100 beats per minute; normal body temperature (forehead, 35.5 °c - 37.0 °c)) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study (...) exclusion criteria: * history of hypersensitivity to the study drug or any related drugs or to any of the excipients * history or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma * clinically significant abnormal laboratory values * clinically significant ecg findings * clinically significant vital signs (...)
'improving urinary tract infection diagnosis in older patients: validation of a biomarker panel (uti-gold)'

Conditions: Urinary Tract Infection (Diagnosis)

Summary: the goal of this study is to improve the diagnosis of urinary tract infections (uti) in older people (≥65 years). the main research questions are: research questions * what is the optimal cut-off for each individual biomarker ngal,il-6,azu,timp2 and cxcl9 and associated, sensitivity, specificity, negative and positive predictive value. * sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microl (validation) * what is the optimal combination of biomarkers for uti diagnosis in older patients * as a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of uti within 2 months, and length of hospital stay. next to this, the performance of the astrego pa100 will be validated in diagnosing bacteriuria. participants will: * be asked to provide a urine sample once at the beginning of the study * be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks * have their vital parameters (temperature and blood pressure) measured once at the beginning of the study


Eligibility criteria:
inclusion criteria: * age 65 years or older * clinically suspected uti by treating physician * sufficient understanding of the dutch language exclusion criteria: * inability to obtain urine * inability to provide written consent * the presence of an indwelling catheter

Keywords: urinary tract infection biomarkers
emergent stenting in acute vertebrobasilar occlusions

Conditions: Acute Stroke; Ischemic Stroke, Acute; Vertebro Basilar Ischemia

Summary: in the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. however, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. the investigators investigated whether the improvement of clinical outcome was achieved in postprocedural 3-month.

acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (lvos) occur 0.8% - 5.7%. although mechanical thrombectomy (mt) has recently been the gold standard in lvos treatment, the futile recanalization (defined as unfavorable outcome despite early successful recanalization of target artery) rate was showed in posterior circulation higher than in anterior one. multiple randomized controlled trials (best, basics, baoche, attention) have recently reported the benefit of endovascular treatment better than of standard medical treatment for acute vertebrobasilar occlusions stroke. besides, up to 36% lvos with underlying intracranial stenosis and 64% with tandem lesions occured in the acute vertebrobasilar stroke. this was a reason why emergent stenting was considered to support the successful recanalization in the setting of failure of mechanical thrombectomy. moreover, the successful recanalization is one of the independent predictors of good outcomes. however, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. therefore, we aimed to investigate whether the impact of emergent stenting on the improved clinical outcome in vertebrobasilar occlusions.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * onset to treatment time \< 24 hours * nihss ≥ 10 * pc-aspects ≥ 5 on mri exclusion criteria: * premorbid mrs \> 2 * extensive, bilateral brain-stem infarction on neuroimaging * cerebellar mass effect on neuroimaging

Keywords: vertebrobasilar occlusions acute ischemic stroke emerging stenting
the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas

Conditions: Uterine Sarcoma

Summary: this is a phase iii study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.


Eligibility criteria:
inclusion criteria: * histologically confirmed uterine sarcoma (rereading in reference centers) * leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma * all stages \<= stage iii (figo modified for endometrial carcinoma) * full surgical exeresis * age \>= 18 years and physiological age \<= 65 years * negative extension check-up (thoracic and abdomino-pelvic tdm) * performance status (ps) \<= 2 (ecog) * normal haematologic functions (absolute neutrophil count \> 1,500/mm3, platelets \> 100,000/mm3) * serum creatinine \< 1.25 x uln * good hepatic check-up (total serum bilirubin \< 1.5 x uln; ast or alt \< 2.5 x uln) * absence of neuropathy \> grade 1 * left ventricular ejection fraction \> 50% (by isotopic or ultrasound scan determination) * written informed consent exclusion criteria: * low grade endometrial stromal sarcoma * time since surgery \> 8 weeks * specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones) * antecedents or evolutive psychiatric disorder * concurrent active infection or other serious uncontrolled systemic disease * antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix

Keywords: uterine sarcoma non metastatic
akkermansia muciniphilia and metabolic side effects of adt

Conditions: Prostate Cancer; Metabolic Syndrome; Obesity; Cardiovascular Morbidity; Bone Diseases; Hyperlipidemias; Diabetes

Summary: the overriding objectives of this study are: 1. primary outcomes: 1. to confirm that administration of oral acetate increases the proportion of a. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to placebo. 2. to confirm tolerability and assess for side effects of delayed oral acetate supplementation. 2. secondary outcomes: 1. to determine if increased counts of a. muciniphilia correlate with improved metabolic parameters and improved bone health.


Eligibility criteria:
for inclusion in this study, patients must fulfill all of the following criteria: 1. men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive adt (tnm stage tany, nany, m1) (see appendix i). 2. must have baseline conventional imaging with ct of the abdomen, and pelvis and bone scan. patients fulfilling any of the following criteria are not eligible for participation in this study: 1. age less than 18 2. primary neuroendocrine prostate cancer 3. treatment with adt within the year leading up to enrolment 4. planned or concurrent use of chromium supplementation for the study duration 5. planned or concurrent use of apple cider vinegar supplementation for the study duration 6. unable to provide informed consent or unable to understand or read the english language (unless accompanied by an interpreter) 7. inadequate liver function (\>2x upper limit of normal) 8. any other condition, chronic disease, or lifestyle factor, that, in the opinion of the qualified investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant 9. use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

Keywords: prostate cancer metabolic syndrome androgen deprivation therapy microbiome akkermansias muciniphilia cardiovascular disease
core training to improve abdominal strength strength and ankle proprioception in basketball players

Conditions: Proprioceptive Disorders

Summary: introduction. the prevalence of ankle injuries in basketball are high. the lack of balance in the ankle is one of the main causes that produces these injuries. the goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception in the ankle joint in basketball players. objective. to evaluate the effectiveness of core training to improve the strength of the abdomen and analyze if it produces improvement in proprioception in ankle of basketball players. study design. randomized, multicentric, single-blind clinical study with a follow-up period. methods. the 30 participants recruited will be randomly assigned to the two study groups: experimental (core training for strength in the abdomen) and control (without intervention). the treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. there will be three evaluations (pre-intervention, post-intervention and follow-up). on the dependent variables: strength core resistance (evaluated with trunk flexor test, trunk extender test, and side bridge test) and proprioception (measured with the star excursion balance tests and romberg test) with the kolmogorov smirnov statistical test we will calculate the normality and with the t-student test of paired data and an anova of repeated measures, we will obtain the difference between the three evaluations and the intra and intersubject effect, respectively. expected results. to observe improvement in strength in the abdomen and analyze if it produces improvement in proprioception in the ankle of basketball players.


Eligibility criteria:
inclusion criteria: * basketball players * federated in the community of madrid * male * with an age range of 18 to 40 years. exclusion criteria: * who have a musculoskeletal injury at the time of the study or who have suffered a lower limb injury in a period of three months before the study * that they are in an individualized personal training * not signed the informed consent document.

Keywords: core strength proprioception ankle basketball
efficacy confirmation trial of cdp870 without coadministration of methotrexate (mtx) in japanese rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the objectives of this study are to verify the superiority in efficacy (american college of rheumatology 20%: acr20) and investigate the pharmacokinetics and safety of cdp870 versus placebo without coadministration of mtx in active ra patients in whom mtx cannot be administrated.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria. * subjects must have active ra disease as defined by: * at least 6 tender joints and 6 swollen joints * esr of 28 mm/hour or crp of 2.0 mg/dl * subjects who have failed to respond or have been resistant to at least one dmard (including mtx) * subjects in whom mtx cannot be administered for any of the reasons(incomplete response/safety concerns) exclusion criteria: * patients who have a diagnosis of any other inflammatory arthritis * patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia) * patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy) * patients who have nyha (new york heart association) class iii or iv congestive heart failure * patients who currently have, or who have a history of, tuberculosis * patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease) * patients who currently have, or who have a history of, malignancy * female patients who are breastfeeding or pregnant, who are of childbearing potential * patients who previously received treatment with 2 or more anti-tnfα drugs or who previously failed to respond to treatment with 1 or more aint-tnfα drugs.

Keywords: rheumatoid arthritis certolizumab pegol cimzia
smoking cessation treatment for head and neck cancer patients

Conditions: Smoking Cessation

Summary: this is a pilot research study examining the use of varenicline (chantix) and the nicotine patch. the study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. the study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.


Eligibility criteria:
inclusion criteria: * age 18 or older * smoking 10 or more cigarettes per day * diagnosed with and completed an initial course of treatment for any type of head and neck cancer * life expectancy of 12 months or more exclusion criteria: * history of allergic reactions to adhesives * unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia * females of childbearing potential who are pregnant, nursing, or not practicing effective contraception