Kornimate/medical-research-clean huggingface dataset:
a degarelix trial in patients with prostate cancer

Conditions: Prostate Cancer

Summary: a phase iii extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy zoladex 3 month implant in patients with prostate cancer.

cs35a was an open-label, multicentre, comparative non-inferiority extension trial to the phase 3 cs35 trial (nct00946920). in the main cs35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. all participants who completed the main cs35 trial after initiation of the cs35a trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. patients entering the cs35a trial continued with the same 3-monthly treatment as they received in cs35 (i.e. degarelix 480 mg or goserelin 10.8 mg). it was intended that patients enrolled in the cs35a trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in cs35). it was, however, decided to prematurely terminate the cs35a trial due to an insufficient number of patients being enrolled. maximum exposure of treatment was 111 weeks (in both treatment arms). the baseline characteristics are based on the cs35a full analysis set (fas)defined as all participants who received at least one dose of degarelix or goserelin acetate during cs35a and had at least one efficacy assessment after dosing. all efficacy analyses were performed for the cs35/cs35a fas defined as all participants who received at least one dose of degarelix or goserelin acetate during cs35 and had at least one efficacy assessment after dosing. all safety analyses were performed for the cs35/cs35a safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during cs35.

Eligibility criteria:
inclusion criteria: * has given written consent prior to any trial-related activity is performed. (a trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient). * has completed the cs35 trial. exclusion criteria: * has been withdrawn from the cs35 trial. * has had end of trial visit in cs35 prior to approval of the cs35a protocol.
is self-transfusion safe after total knee arthroplasty in terms of nephrotoxicity of gentamicin from bone cement?

Conditions: Arthroplasty Complications; Total Knee Arthroplasty

Summary: considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. in addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed. therefore we performed a randomized study to assess: 1) the safety of self-transfusion in tka by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion. 2) the efficacy of self-transfusion in tka, with the concomitant administration of tranexamic acid. the serum concentration of aminoglycosides has been measured in two groups of 20 patients each, after tka, according to the use of self-transfusion. hemoglobin, renal function and calculated blood loss were compared at several time points between groups.


Eligibility criteria:
inclusion criteria: * end-stage of knee osteoarthritis, who scheduled for unilateral primary tka in our department exclusion criteria: * patients who had been treated with gentamicin within the past 10 days * known allergies against the bone cement * estimated glomerular filtration rate (egfr) \<30ml/minute * previous nephrectomy and history of renal transplant * contraindications against tranexamic acid

Keywords: gentamicin self-transfusion blood loss toxicity total knee arthoplasty
correlation of non-invasive assessment, using c.a 2.0 device, versus invasive assessment of lvedp

Conditions: Heart Failure

Summary: the purpose of the study is to determine the accuracy of non-invasive assessment of lvedp using the investigational device c.a 2.0.


Eligibility criteria:
inclusion criteria: 1. male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age 2. patient undergoing elective cardiac catheterization during which lved and aortic pressures are recorded 3. willing and able to sign informed consent prior to study initiation exclusion criteria: 1. subject has a baseline heart rate of \ 100 beats/min 2. subject has moderate to severe valvular disease 3. subject suffers from atrial fibrillation or other tachyarrhythmias 4. subject suffers from hemodynamic instability 5. subject is candidate for primary pci
comparison of posterior-anterior spinal mobilization and prone press up in patients with non specific low back pain

Conditions: Non-specific Low Back Pain

Summary: no previous literature found on the comparison of posterior-anterior spinal mobilization and prone press-up on pain, range of motion and disability in patients with non-specific low back pain. this study will approach the results of posterior- anterior spinal mobilization and prone press-up on pain, range of motion and disability in patients with non-specific low back pain. in previous researches the patients were not properly followed to see pre session, immediate after the session and after twenty- four hours effects of both interventions posterior- anterior mobilization and press-ups. secondly, they have not taken the control group in their studies. in current study two techniques along with conventional treatment will be compared in three different groups to see their individual effects and combine effect of maitland and mackenzie technique

non-specific low back pain refers to pain without any specific cause. the term "non- specific low back pain" refers to a condition where the cause of the symptoms cannot be identified with certainty, indicating that the underlying pathology is currently unknown and difficult to diagnose reliably. this pain is known for the main leading cause to effect activities of daily life, absenteeism and health care. non-specific low back pain is a widely known serious condition in the worldwide . this was a randomized control trial and patients were randomly selected according to inclusion criteria and divided into a and b and c groups. the base line demographic, clinical and disability data was collected through structured questionnaire. group a received both posterior-anterior mobilization on l4 and l5 level and prone press- ups technique along with a conventional therapy whether group b had received only posterior-anterior spinal mobilization along with the conventional therapy. while group c received prone press-ups technique along with conventional treatment. patient outcomes were measured at baseline, immediate after the session and 24 hours after the session outcomes measures (nprs, goniometer, odi).

Eligibility criteria:
inclusion criteria: * non-specific low back pain of duration \<3 months * both male and female age 22-40 * increased localized pain with lumber extension during standing * nprs \< 6 exclusion criteria: * spinal surgery * subject who administered epidural injections * psychological low back pain * history of injury from past 3 months * neurological deficit * hyper-mobility * subjects with mental disorder

Keywords: non specific low back pain range of motion disability
safety and effectiveness of tramadex-od after knee arthroscopy

Conditions: Postoperative Pain

Summary: extended-release tramadol is indicated for the management of moderate to severe pain in adults who require around-the-clock treatment. it provides an extended duration of action, more constant plasma concentrations, a reduced dosing frequency, and the potential for improved compliance and therapeutic outcomes. the present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.


Eligibility criteria:
inclusion criteria: * men and nonpregnant women * age: 18-65 years * asa classification i or ii * ambulatory knee arthroscopy under spinal anesthesia exclusion criteria: * pregnancy * intolerance to any opioid, tramadol or paracetamol * spine surgery in the past * renal or hepatic impairment * cardiac or respiratory conditions that put the patient at risk for respiratory depression * patients receiving: monoamine oxidase inhibitors, carbamazepine, quinidine, selective serotonin reuptake inhibitors or tricyclic antidepressants

Keywords: surgery, knee arthroscopy pain, postoperative tramadol, extended release
morning versus bedtime dosing of antihypertensive medication

Conditions: Hypertension; Blood Pressure; Drug Use

Summary: previous studies have shown that elevated nighttime blood pressure (bp) was more closely associated with cardiovascular mortality and morbidity than daytime and clinic bps. with increasingly advanced technology, not only 24-hour ambulatory but also home bp monitors can be used to evaluate nighttime bp. the validation study of the omron hem 9601t showed that the wrist-type home bp monitor could be a suitable and reliable tool for the diagnosis and management of nocturnal hypertension. however, up to now, there is no data on home nighttime bp in chinese patients and it is unclear if different dosing time would reduce ambulatory and home nighttime bps differently. the investigators therefore designed a multicenter randomized clinical trial to compare between morning dosing and bedtime dosing of antihypertensive medications in the difference in nighttime, daytime and the 24-h bp reductions evaluated by both ambulatory and home bp monitoring, and in target organ protections.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18-70 years old; 2. never treated for hypertension or stopped using antihypertensive drugs for at least 2 weeks; 3. in the two screenings,the clinical systolic bp should be in the range of 140-159 mmhg, the diastolic bp \< 100 mmhg; 4. the average 24-hour systolic bp ≥130mmhg, daytime systolic bp ≥ 135 mmhg, and nighttime systolic bp ≥ 120 mmhg; 5. the average of bilateral brachial-ankle pulse wave velocity ≥14m/s; 6. be willing to participate in the trial, sign the informed consent form, and be able to visit doctors by himself or herself. exclusion criteria: 1. secondary hypertension; 2. concomitant obstructive sleep apnea (stop-bang score ≥ 5), insomnia, parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime bp; 3. need to work at night; 4. ambulatory bp monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings); 5. concomitant diseases that need taking medications influencing bp; 6. coronary heart disease, myocardial infarction or stroke within recent 6 months; 7. atrial fibrillation or frequent arrhythmia; 8. abnormal liver function exemplified as an increased alanine transaminase (alt), aspartate transaminase (ast), total bilirubin (tbl) over the double of the upper limit of normal range; abnormal renal function exemplified as a serum creatinine ≥176 µmol/l; and plasma potassium ≥5.5 mmol/l or ≤3.5mmol/l; 9. pregnant or lactating women; 10. contraindications of angiotensin ii receptor blocker or calcium channel blocker; 11. other concomitant diseases which are considered not suitable to participate in the trial, such as thyroid diseases, acute infectious diseases, chronic mental diseases, tumor, etc.
impact of a popop on preoperative health, eligibility, and clinical & patient-reported outcomes in tja

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Avascular Necrosis; Rheumatoid Arthritis

Summary: in this pilot study, we will test the hypothesis that a popop for currently ineligible uams orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a bmi threshold \<40 kg/m2 required for surgical eligibility, and postoperative outcomes versus soc.

after being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. patients who meet eligibility criteria will be randomized into one of two groups: standard of care or the popop (20lighter).

Eligibility criteria:
inclusion criteria: * end-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at the university of arkansas for medical sciences (jeffrey stambough, dr. c. lowry barnes, dr. simon mears, and dr. benjamin stronach) * bmi between 41.00-48.00 kg/m2 at time of enrollment * over the age of 18 years * would consider undergoing a total joint arthroplasty if eligible * owns a smartphone or tablet with bluetooth capability, cell signal or wifi connection * willing to comply with the requirements of the study and provide informed consent prior to enrollment. exclusion criteria: * patients with a bmi less than 41.00 or greater than 48.00 * pregnancy * breastfeeding * history of a major organ transplant or other health issue requiring immunosuppressant drugs * strict vegetarian diet * diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression * patients scheduled for, or those who have previously undergone, bariatric surgery * patients unable to understand and speak english * patients requiring a revision or bilateral tja * patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access * incarceration

Keywords: total joint arthroplasty hip arthroplasty knee arthroplasty surgical ineligibility obesity patient reported outcome measures tja tha tka proms bmi hba1c
the comparative safety and effectiveness of warfarin and dabigatran prescribed in the non-valvular atrial fibrillation population with humana healthcare coverage

Conditions: Atrial Fibrillation

Summary: this study is an opportunity for boehringer ingelheim to collaborate with humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from humana's health plan operations.

study design: n/a

Eligibility criteria:
inclusion criteria: * patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of af on the index date or during the pre-index period. * patients must be continuously enrolled in a health plan during the pre-index period * patient must have a prescription for dabigatran or warfarin * patient must be treatment naive from all oral anticoagulant (oac) use prior to first oac prescription * aged 18-89 years on the index date. the index date is defined as the date of the first oac prescription exclusion criteria: * diagnosis of hyperthyroidism during the pre-index period, * having claims for any of the following within 3 months prior to the first diagnosis of af: cardiac surgery, pericarditis, myocarditis, pulmonary embolism. * any patients with at least one medical claim for valvular heart disease.
efficacy study testing herbal extract on metabolic parameters in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * between 18 and 75 years of age * male or non-pregnant, non-lactating female, at least 6 weeks postpartum * if of childbearing potential, is practicing birth control * bmi is more than or equal to 18kg/m2 and less than or equal to 35kg/m2 * if on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit exclusion criteria: * uses insulin for glucose control or has type 1 diabetes * history of diabetic ketoacidosis. * current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks. * active malignancy * significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure * end state organ failure or status post organ transplant * history of renal disease * current hepatic disease * history of severe gastroparesis * has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv * currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose * clotting or bleeding disorders * allergic or intolerant to any ingredient found in the study products
phase i study of lenalidomide, rituximab and ibrutinib in relapsed/refractory chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this study is for subjects diagnosed with recurrent or relapsed cll/sll. the purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. we want to find out what effects, good and/or bad, they have on patients with cll/sll. the hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.

treatment consists of dose escalations of lenalidomide and ibrutinib and fixed doses of rituximab. a small expansion cohort to include 10 patients will follow once the recommended phase ii dose is found.

Eligibility criteria:
inclusion criteria: * previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma that requires treatment * no prior systemic treatment within 4 weeks of enrollment * no corticosteroids within 2 weeks prior to study entry * measurable disease must be present * no concomitant anti-cancer therapies * ecog status \</= 2 * patients with hiv infection are eligible * patients with treated cll or sll in cns are eligible * non-pregnant and non-nursing * life expectancy greater than 60 days * adequate bone marrow, kidney and liver function * no major surgery within 28 days or minor surgery within 5 days of starting treatment exclusion criteria: * history od richter's transformation * history of prior allogeneic transplant * radioimmunotherapy within 1 year of enrollment * prior bruton's tyrosine kinase inhibitor or lenalidomide * history of allergic reactions to compounds similar to ibrutinib, lenalidomide or rituximab or hypersensitivity * active or uncontrolled autoimmune hemolytic anemia or itp * transfusion-dependent thrombocytopenia or bleeding disorders * active hepatitis b or c infections * history of known human anti-chimeric antibody positivity * history of erythema multiforme, toxic epidermal necrolysis, or stevens-johnson syndrome * history of uncontrolled seizures * autoimmune disorder that requires active immunosuppression * stroke or intracranial hemorrhage within last 6 months * history of congestive heart failure, myocardial infarction, unstable angina, uncontrolled arrhythmia or any class 3 or 4 heart disease in the last 6 months * no prior malignancy except if treated with curative intent with no active disease for more than 3 years; adequately treated non-melanoma skin cancer or cervical cancer in situ * using warfarin or similar vitamin k antagonists unable to swallow capsules or disease significantly affecting gastrointestinal function or inhibiting small intestine absorption

Keywords: lenalidomide ibrutinib rituximab cll sll
thriving, activity and social participation after stroke

Conditions: Stroke

Summary: the aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or tia.the intervention is inspired by a lifestyle redesign method developed in the usa. the study is conducted as a multi centre randomized controlled trial. participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres. the control group is offered physical activity at the senior centre once a week. the intervention group is offered the same with addition of the programme inspired by lifestyle redesign. the study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or tia.

stroke is a common disease among older people. in norway 60-70 000 people live with sequela after stroke. depressive symptoms, anxiety and social isolation are occurring among 20 to 60 percent. little is known about intervention for people with mild neurological symptoms who simultaneously perceive social isolation, depression and reduced satisfaction in their daily life after stroke. lifestyle redesign (lr) is developed in the usa and is a health promoting group intervention programme with focus on the participants' exchange of experiences and involvement. the aim of the study is to evaluate the effect on thriving, activity and social participation of a group intervention program inspired by lifestyle redesign for community dwelling persons with stroke. the study is conducted as a multicentre randomized controlled trial. participants are recruited from five hospitals and the intervention is carried through at six to seven senior centres. the control group is offered a physical activity programme at the senior centre once a week. the intervention group is offered the same with the additional intervention programme also once a week. the study will contribute to knowledge whether this group intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or tia.

Eligibility criteria:
inclusion criteria: * oral and written consent * age 65+ * clinical stroke ref who definition * home-dwelling previous to stroke * home-service less than twice a week previous to stroke * barthel adl-index \>14 of 20 * mms \>23 of 30 * be able to communicate evaluated by ulleval aphasia screening test exclusion criteria: * reduced consent * severe disease * clinical contradictions evaluated by the responsible physician

Keywords: group intervention stroke senior centres health promotion
virtual bladder training for overactive bladder syndrome in women. which symptom responds better?

Conditions: Overactive Bladder Syndrome

Summary: according to international urogynecological association and international continence society joint report on the terminology for female pelvic floor dysfunction, overactive bladder syndrome (oab) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. bladder training lasting for a minimum of 4 to 6 weeks is indicated as a first-line treatment. the investigators' goal is to compare changes in satisfaction, measured in terms of quality of life, in 2 groups of women with different main accompanying symptoms in oab (frequency vs. nocturia), before and after bladder training utilizing telemedicine (virtual bladder training), for 4 to 6 weeks.


Eligibility criteria:
inclusion criteria: * women over 18 years of age * live in buenos aires city * overactive bladder syndrome * access to virtual appointment exclusion criteria: * previous overactive bladder syndrome treatment. * prior stress urinary incontinence or pelvic organ prolapse surgery. * history of neurogenic bladder, pelvic organs prolapse or pelvic radiation. * pregnancy.

Keywords: overactive bladder syndrome bladder training