Kornimate/medical-research-clean huggingface dataset:
red yeast rice in subjects with clinically localized prostate cancer undergoing active surveillance

Conditions: Prostate Cancer

Summary: agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. red yeast rice (ryr), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. laboratory studies have also shown that ryr has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. it is thought that ryr may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.

red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. there is a strong rationale for the use of ryr in patients being managed with active surveillance for localized, low risk, prostate cancer. to date, no human studies utilizing ryr in this setting have been reported.

Eligibility criteria:
inclusion criteria: * histologically diagnosis of prostate adenocarcinoma * being monitored by active surveillance for favourable risk prostate cancer * tumour material from most recent prostate biopsy available with sample * scheduled to have an active surveillance mandated transrectal ultrasound (trus) guided biopsy within 6 - 12 months of day 1 of the study exclusion criteria: * previous malignancy in the past 5 years * no previous or concurrent treatment for prostate cancer * inability to undergo trus biopsy * ecog \> 2 * known or previous history of liver disease

Keywords: nonmetastatic localized prostate active surveillance
effect of omalizumab in patients with severe persistent non-atopic uncontrolled asthma

Conditions: Asthma

Summary: this study will assess the change in the expression of fcεri receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


Eligibility criteria:
inclusion criteria: severe persistent asthma with the following characteristics: * uncontrolled according to global initiative for asthma (gina) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year. * treated with high-dose inhaled corticosteroid (i.e. \> 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid). * non-atopic, i.e. negative blood multiallergic testing and negative aspergillus-specific ige-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens exclusion criteria: * current smokers or smoking history stopped for less than 3 years or \> 10 pack years. * asthma exacerbation during the 4 weeks prior to randomization. * active lung disease other than non-atopic asthma. * patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years. * pregnant or nursing (lactating) women. * treatment with omalizumab. other protocol-defined inclusion/exclusion criteria may apply

Keywords: severe asthma, non-atopic, omalizumab
prospective clinical investigation comparing standard wound closure technique with drains (control) to standard wound closure techniques with tissuglu® and no drains (test) in mastectomy

Conditions: Cancer, Breast

Summary: comparing standard wound closure technique with drains (control) to standard wound closure techniques with tissuglu® and no drains (test) in mastectomy

a prospective, randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques with tissuglu® and no drains (test) in mastectomy. patients will be enrolled for 90 days from day of surgery. it is expected that it will take 6-9 months for the full duration of the study including the 90 day follow up period.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age; 2. provide signed and dated informed consent form; 3. willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study; 4. willing to follow instructions for incision care and follow guidelines related to resumption of daily activities; 5. agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete; 6. in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications; 7. requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy; 8. ≤ asa 3 - american society of anesthesiologists physical classification system exclusion criteria: 1. pregnancy or lactation; 2. known medical condition that results in compromised blood supply to tissues; 3. known or suspected allergy or sensitivity to any test materials or reagents; 4. any condition known to affect wound healing, such as collagen vascular disease; 5. receiving antibiotic therapy for pre-existing condition or infection; 6. planned immediate breast reconstruction; 7. concurrent use of fibrin sealants or other internal wound care devices; 8. unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study; 9. requiring a mastectomy with alnd (as determined at time of surgery); 10. be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.
ibrutinib and lenalidomide with dose adjusted epoch-r in subjects with relapsed/refractory diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma Relapsed; Diffuse Large B Cell Lymphoma Refractory

Summary: this is a phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with da-epoch-r in subjects with relapsed/refractory diffuse large b-cell lymphoma (dlbcl).

this is a phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. part 1, will determine the mtd of the combination of ibrutinib, lenalidomide and da-epoch-r in subjects with dlbcl. ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. da-epoch-r will be given at standard doses. for part 2, the mtd determined in part 1 will be the dose used for all subjects. if no mtd is identified, then subjects in part 2 will be treated with the maximum administered doses (mad, treatment doses from dose level 4). the primary objective for part 2 is to determine the orr of ibrutinib and lenalidomide in combination with da-epoch-r in subjects with abc dlbcl as analyzed by gene expression profiling when treated at recommended phase 2 dose (rp2d).

Eligibility criteria:
major inclusion criteria: * eastern cooperative oncology group (ecog) performance status of ≤2 * pathologically confirmed relapsed/refractory dlbcl * subjects must have ≥1 measurable disease site on ct scan (≥ 1.5 cm in longest dimension). * adequate hepatic and renal function: * ast or alt ≤2.5 x uln * serum creatinine ≤ 2.0 mg/dl and creatinine clearance ≥60 ml/min/1.73 * bilirubin ≤1.5 x uln * adequate hematologic function: * anc \>1,000 cells/mm3 * platelets ≥75,000 cells/mm3 * hemoglobin ≥8.0 g/dl * prothrombin time (pt) and activated partial thromboplastin time (aptt) must be ≤1.5 x the upper limit of the normal range (uln) * must be registered into the revlimid rems™program and be willing to comply with the requirements of revlimid rems™. major exclusion criteria: * known central nervous system lymphoma * any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks * radio- or toxin-immunoconjugates within 10 weeks * prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug

Keywords: dlbcl abc gcb primary mediastinal b-cell lymphoma pharmacyclics lenalidomide lymphoma rituximab epoch recommended phase 2 dose(rp2d)
neuropathic pain in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: pathogenesis of inflammatory diseases is suitable for eliciting neuropathic pain. the aim of this study is to evaluate the frequency of np among psa patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

neuropathic pain (np) is the pain arising from a primary lesion or a dysfunction of nervous system. np can affect central or peripheral nervous system and can be caused by numerous factors such as inflammation or neuroplastic changes. inflammation can sensitize nociceptors in sensory nerves by promoting prostaglandin e2 and i2 secretion thus, cause neuropathic pain. besides, a mixed pain pattern with neuropathic components is thought to be developed in chronic pain conditions. in this point of view, pathogenesis of inflammatory diseases is suitable for eliciting np. in arthritic joints, even non-arthritic tissues are affected by the disease and a condition called peripheral sensitization develops. previous studies about np and inflammatory diseases link have focused on rheumatoid arthritis and number of studies about np and psoriatic arthritis (psa) is limited. in this manner the aim of this study is to evaluate the frequency of np among psa patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

Eligibility criteria:
inclusion criteria: * being aged≥18 * being diagnosed psa according to caspar criteria exclusion criteria: * additional conditions that could cause neuropathic pain (e.g. radiculopathy, polyneuropathy, depression, fibromyalgia) * history of fracture or surgery * endocrinopathies that could cause neuropathic pain (e.g. dm) * malignancy

Keywords: neuropathic pain psoriatic arthritis
the effect of scapular dyskinesia on the scapular balance angle & upper extremity sensorimotor function in spastic stroke patient. the patients were diagnosed with the lateral scapular slide test, fugl-meyer upper extremity (fmue) scale scores & scapular balance angle test (sba).

Conditions: Post Stroke Scapular Dyskinesia

Summary: to investigate the effect of scapular dyskinesia on the scapular balance angle \& upper extremity sensorimotor function in spastic stroke patient.

background: post stroke scapular dyskinesia leads to scapulohumeral pain \& dysfunction were associated with decreased motor function, somatosensory function, limited range of motion, and spasticity. objective: to investigate the effect of scapular dyskinesia on the scapular balance angle \& upper extremity sensorimotor function in spastic stroke patient. methods: sixty patients from both sexes were participated in this study. all the patients were diagnosed as spastic stroke patients. the patients were divided into two equal groups; group a (30 patients): with high scapular dyskinesia scores, group b (30 patients): with low or no scapular dyskinesia scores. the patients were diagnosed with the lateral scapular slide test using palpation meter (palm) device, fugl-meyer upper extremity (fmue) scale scores \& scapular balance angle test (sba).

Eligibility criteria:
inclusion criteria: * patient diagnosed as stroke patient * stroke onset at least 5 months prior to study enrollment and * decreased sensorimotor function in the affected arm, but ability to use the arm to some extent in daily activities with functional to subfunctional manual muscle test * age ranged from 35:50 * both sexes exclusion criteria: * difficulty to communicate or to understand test instructions * other conditions that caused pain (for example fibromyalgia and arthritis) * severe depression or other psychiatric symptoms * patient with other upper limb musculoskeletal problems
observational real-life study of cabozantinib in monotherapy or in combination with nivolumab in advanced renal cell carcinoma (rcc)

Conditions: Advanced or Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to describe the real-life use of cabometyx® in monotherapy or in combination with nivolumab in belgium in patients with advanced or metastatic renal cell carcinoma (1st, 2nd and later lines of treatment)


Eligibility criteria:
inclusion criteria: * males or females aged 18 years and older * patients scheduled to receive cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma * decision to treat patients with cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study * provision of written informed consent exclusion criteria: * participation in another interventional clinical study at the same time * previous participation in this clinical study
efficacy and safety of ciclesonide in preschool children with asthma (2 to 6 years) (by9010/m1-207)

Conditions: Asthma

Summary: the aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. the study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * written informed consent by the parents or legal guardians of the patient * outpatients * good health with the exception of asthma * documented diagnosis of asthma for more than 6 months * use of rescue medication only or pretreatment with a controller drug main exclusion criteria: * concomitant severe diseases * diseases contraindicated for the use of inhaled steroids * other relevant lung diseases causing impairment in pulmonary function * recurrent, episodic wheezing only * history of life-threatening asthma * history of any mechanical ventilation * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation * premature birth (\< 32 weeks gestation)

Keywords: asthma ciclesonide child pediatric
a study evaluating the efficacy and the benefit of integrated personalized diabetes management (pdm) for diabetic patients.

Conditions: Type II Diabetes Mellitus

Summary: this study is a german, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated pdm care by measuring hba1c levels in patients with type 2 diabetes. patients will be randomized into two groups to use accu-chek smartpix software and accu-chek smartpix device.

outcome of both studies (rd001732 and rd001231) will be integrated and additionally reported as pdm-provalue study program (integrated personalized diabetes management) due to the high similarity in study characteristics, design and study results.

Eligibility criteria:
inclusion criteria: * existence of a signed informed consent form (before any study procedure) * diagnosed type 2 diabetes mellitus * age ≥18 years * insulin therapy for ≥6 months: bot, sit, ct or ict * hba1c ≥7.5% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days before study visit 1 (patient's inclusion) * longer-term care (at least for the duration of the 12-month study participation) by the trial site * insured by the statutory health insurance (gkv) as a compulsory member or voluntarily insured member or as a family co-insured member * willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the german language, spoken and written exclusion criteria: * treatment of diabetes with insulin pump (csii) * methodic and continuous with the use of particular software for processing of smbg data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (egfr \< 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye) * existing tumor illness (primary tumor/local recurrence/ metastases except basal cell carcinoma) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). within a tumor free time of \< 5 years medical affairs will decide about individual cases * permanent use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy * known alcohol and drug abuse and medication abuse * known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement) * existing pregnancy, breast-feeding or plan to become pregnant during study participation * physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently * dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member

Keywords: diabetes
efficacy of physical therapy intervention in cervical angina patients at jerash university office employees, "randomized clinical trail".

Conditions: Cervical Radiculopathy

Summary: cervicogenic angina (ca) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. because ca mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed nakajima h, 2006. patients with ca may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. clinicians and patients are unaware that ca symptoms are stemming from cervical spine disorders. however, the mechanism of pain occurrence in patients with ca remains unclear.

randomized control trail (rct) will be used in the study. participants will be divided into two groups (experimental and control groups). each group will include 30 participants. the study population will be employees working in ju from different departments. a total of 60 participants will be included in the study. their weight ranged from (50 kilograms) to (100 kilograms). and their height ranged from (150 centimeters) to (190 centimeters). and their body mass index ranged from (22.2) to (27.7). this will be divided into 2 groups with 30 participants in each group. the data collected will focus on measuring the range of motion (rom) of the cervical spine using an electro-goniometer, the pain using visual analogue scale (vas), and the hart rate (hr) using an electro cardio graphic (ecg). the study setting will be ju, located in jerash city, jordan.

Eligibility criteria:
inclusion criteria: * cervical spondylosis, cervical disc, cervical instability exclusion criteria: * cardiovascular diseases ( ischemic heart disease, heart failure, valvular disease)
cognitive exercise therapy approach (bety) in childhood rheumatic diseases

Conditions: Childhood Rheumatic Diseases; Juvenile Idiopathic Arthritis (JIA)

Summary: cognitive exercise therapy approach (bilişsel egzersiz terapi yaklaşımı-bety), an innovative method developed for adults with rheumatism, aims to develop behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains in pediatric rheumatology. bety also recognizes the importance of family education in achieving these goals. however, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as bety in childhood rheumatic diseases. bety is an innovative exercise approach based on the biopsychosocial model that aims to change the patient\&#39;s cognitions through exercise developed on patients with rheumatism. this approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. it is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually. interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with bety, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.


Eligibility criteria:
jia, jspa, jpsa according to ilar 2017 classification criteria; fmf according to özen-yalçınkaya classification criteria; jsle according to slicc 2012 classification criteria; jssc according to acr-eular 2013 criteria; jdm according to acr-eular 2017 classification; and individuals followed by a pediatric rheumatologist with a diagnosis of cno and crmo will be included. inclusion criteria: * patients who were followed up with a diagnosis of childhood rheumatic disease in the division of pediatric rheumatology, department of pediatrics, hacettepe university faculty of medicine * 7-18 years old * individuals who volunteered to participate in the study will be included. exclusion criteria: * advanced heart/lung/liver/kidney disease, neurological disease and malignancies * having undergone major orthopedic surgery * not volunteering to participate in the study

Keywords: childhood rheumatic diseases biopsychosocial model bety cognitive exercise therapy approach
is the sudden onset of dizziness a symptom of acute liver dysfunction?

Conditions: Dizziness

Summary: dizziness is one of the most common complaints among patients admitted to the emergency department (ed). in most cases, the etiology remains unclear. dizziness has a broad differential diagnosis. the initial symptoms of ald can include many general complaints. aim of this study is to investigate whether sod is a symptom of ald, the necessity of liver function tests for patients with sod in the ed, and a cost analysis of liver function tests.

dizziness is one of the most common complaints among patients admitted to the emergency department (ed). in most cases, the etiology remains unclear. dizziness has a broad differential diagnosis. the initial symptoms of ald can include many general complaints. the diagnosis of acute liver dysfunction (ald) can usually be made by initial symptoms, physical examination, and biochemical tests, including liver function tests (lfts) with high sensitivity and specificity. lfts include albumin, bilirubin, coagulation factors (activated partial thromboplastin time (aptt) and international normalized ratio (inr)), and liver enzymes, such as alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphates (alp), and y-glutamyl transpeptidase (ggt), which are marker of hepatic damage. aim of this study is to investigate whether sod is a symptom of ald, the necessity of lfts for patients with sod in the ed, and a cost analysis of lfts.

Eligibility criteria:
inclusion criteria: 1. adult patients who were experiencing sudden onset dizziness of unknown etiology for the first time were included in the study exclusion criteria: 1. patients with a history of chronic diseases such as any liver disease,diabetes mellitus, hypertension,congestive heart failure, hepatitis b or c infection 2. patients with any central dizziness attacks 3. patients with hemodynamically unstable and emesis; 4. patients receiving drugs that could affect liver function tests, such as, acetaminophen, antibiotics, oral contraceptives, antihypertensive drugs (e.g., angiotensinconverting enzyme inhibitors), or hormones (e.g.,estrogen) 5. patients who was experienced dizziness with systemic diseases 6. patients with any neurological disorders 7. patient who do not want to participate in the study