Kornimate/medical-research-clean huggingface dataset:
treatment outcomes in a non-study population of symptomatic mcrpc patients treated with radium-223

Conditions: Prostate Cancer Metastatic; Bone Metastases

Summary: this registry aims to evaluate the efficacy of rad-223 treatment in a non-study population of crpc patients treated earlier with docetaxel and patients not treated earlier with docetaxel and efficacy of the first subsequent therapy. the indication for treatment with radium-223 will be at the physician's decision. all patients treated with radium-223 can be included in this registry. the registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

serum and blood markers of bone metabolism will be evaluated at base line, 1st, 2nd, 3rd and 6th (or last) radium- 223 treatment. every blood draw prior to radium-223 treatment at baseline, tests include (but not restricted to): testosterone, vitamin d-25-oh (calciferol), c-reactive protein, rank ligand, il6, bsaf, p1np and ctx. patients need to be fasting when blood is collected. (2x8,5 ml gel tube; limited to 100 patients in selected centres). before 2nd, 3rd, 4th and 6th (or last) radium-223 treatment, tests include (but not restricted to): c-reactive protein, rank, ligand, il6, bsaf, p1np and ctx. patients need to be fasting when blood is collected. (2x8,5 ml gel tube; limited to 100 patients in selected centers). moreover, levels of osteoclast precursors (cd34+) will be evaluated (10 ml heparinized blood) prior to the first radium-223 treatment, 3rd and last treatment (limited to 100 patients in selected centres). all above-mentioned blood collections will be from the same venipuncture as standard clinical labs. experimental assessments will be evaluated for their value as biomarkers of treatment outcome.

Eligibility criteria:
inclusion criteria: * at the physicians discretion * age 18 year and older. * written informed consent exclusion criteria: * previous treatment with radium-223. * participation in another radium-223 study.

Keywords: radium-223
palliative 4pi radiotherapy in treating patients with recurrent glioblastoma multiforme

Conditions: Glioblastoma; Recurrent Brain Neoplasm

Summary: this pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. a new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.

primary objectives: i. to determine the accuracy of dose delivery and patient comfort with treatment time. ii. to evaluate normal tissue dose volume statistics and compare to standard planning. outline: patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. if an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation. after completion of study treatment, patients are followed up at 6 weeks.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary glioblastoma multiforme (gbm) * patient must have previously undergone standard chemoradiation- 59.4 gy (1.8 gy/fraction) or 60 gy (2.0 gy/fraction) with concurrent and adjuvant temodar (temozolomide) * patient must be diagnosed with recurrent gbm either with biopsy or radiographically * karnofsky performance status (kps) \>= 70 * ability to understand and willingness to sign a written informed consent * if a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment * for the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation) exclusion criteria: * patients with active infection * patients with kps \< 70 and/or unable to tolerate potentially longer treatment times * refusal to sign informed consent * pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment * note: concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
efficacy of tranexamic acid in brain tumor resections

Conditions: Brain Tumors; Neoplasms; Gliomas; Astrocytomas; Meningiomas

Summary: the purpose of this study is to determine whether tranexamic acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections.

brain tumor resection has been associated with increased blood loss and a significant increase in the incidence of intravascular disseminated coagulopathy. the development of coagulopathy in the context of tumor resection is associated with poor results. transfusion decision during the course of neurosurgical surgery offers benefits such as increased oxygen carrying capacity but may increase the risk associated with transfusions such as blood infections, hemolysis, lung injury and immunosuppression. the information available on tranexamic acid used in neurosurgery is little, therefore this opens up new alternatives in the techniques of reducing intraoperative bleeding. tranexamic acid is an antifibrinolytic agent that blocks the binding of plasminogen to the fibrin surface. it has been used to reduce blood loss during coronary revascularization, liver resection, obstetrics and orthopedic procedures. tranexamic acid intraoperatively has been shown to reduce blood loss up to 45%. the primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. there is no actual data on the utility of tranexamic acid to reduce blood loss in brain tumors resection surgery. we want to compare tranexamic acid to saline solution(placebo) to see whether tranexamic acid administration will reduce blood loss during brain tumor resection. reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion and perioperative incidents.

Eligibility criteria:
inclusion criteria: * patients who agree to participate by giving informed consent * eligible previously untreated patients with resectable brain tumor. exclusion criteria: * patients with previous thromboembolic events. * patients with coagulopathy or anticoagulation therapy. (abnormal pt, ptt) * patients with impaired renal function (creatinine \>1.1mg/dl) * patients with known contraindications to fibrinolytic treatment. * patients receiving rejection therapy. * patients with abnormal liver function. * known allergies to tranexamic acid.

Keywords: neoplasms tranexamic acid brain tumors
platelet-rich plasma (prp) treatment for medial retinaculum tear post medial patellar dislocation

Conditions: Patella-Dislocation

Summary: to check the influence of injected platelet-rich plasma (prp) on the healing of medial retinaculum and the redaction in recurrent dislocation of the patella.

autologous platelet-rich matrices may aid in the healing of ligaments \& tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (tgf)-beta1 and platelet-derived growth factor (pdgf) from platelet alpha-granules.

Eligibility criteria:
inclusion criteria: * age 18-40 years old * first time patella dislocation exclusion criteria: * pregnancy * mental or physical disabilities

Keywords: medial retinaculum tear s/p patella dislocation
acupuncture combined with nimodipine for prevention of post-stroke dementia

Conditions: Post-stroke Dementia

Summary: to observe the clinical efficacy of tcm acupuncture combined with western medicine nimodipine for prevention of post-stroke dementia by comparing with clinical conventional treatment methods.


Eligibility criteria:
inclusion criteria: 1. definite ischemic stroke or hemorrhagic stroke confirmed by head ct / mri examination 2. memory or cognitive and executive dysfunction. cognitive dysfunction will be determined after the mini mental state evaluation (mmse) score 3. age limited to 40-85 years, irrespective of gender 4. stable condition, clear consciousness, no aphasia, oral medication available 5. no major comorbidity, no major depression 6. consent and signed patient informed consent exclusion criteria: 1. had serious medical conditions, such as heart, liver, kidney, or endocrine disease 2. aphasia or hearing impairment 3. participants in other clinical trials 4. patients currently on medication to improve cognitive function

Keywords: randomized controlled trial post-stroke dementia acupuncture nimodipine
bedside genetic or pharmacodynamic testing to prevent periprocedural myonecrosis during pci (onside test)

Conditions: Stable Angina

Summary: patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. the strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.


Eligibility criteria:
inclusion criteria: * age 18-75 * elective pci exclusion criteria: * acute coronary syndrome (troponin \> 1 x uln), * administration of glycoprotein iib/iiia inhibitors, * chronic total occlusion, * lesions with extensive calcifications requiring rotational atherectomy, * platelet count \<70 000 /µl * high bleeding risk, * coronary bypass surgery in the previous 3 months, * severe chronic renal failure (egfr \< 30 ml/min) * requirement for warfarin, dabigatran, apixaban, rivaroxaban * history of stroke or tia, * weight \< 60 kg * known bleeding diathesis, * hematocrit of \ 52% * pregnancy

Keywords: clopidogrel prasugrel platelet function testing genotyping peri-procedural mi
ultrasound image quality of the brachial plexus at the interscalene space before and after shoulder arthroscopy

Conditions: Pain, Postoperative

Summary: ultrasound guided interscalene nerve blockade with local anesthesia is a standard regional anesthetic technique for providing postoperative analgesia during shoulder arthroscopy and wide variety of shoulder procedures. there is a paucity of data regarding the effects of shoulder arthroscopy on ultrasound image quality, including the effects of muscle mobilization and the use of large volume irrigation and subsequent tissue absorption, though increased neck circumference and airway edema are known complications of arthroscopic shoulder procedures. the objective of the study is to determine if there is a difference in ultrasound image quality of the interscalene block anatomy, by likert scale, pre- versus post-operatively in a cohort of patients undergoing shoulder arthroscopy who routinely receive blockade of the brachial plexus for postoperative analgesia. further, if there are differences in imaging quality, correlations with surgical and patient factors will be studied.


Eligibility criteria:
inclusion criteria: * subject is undergoing shoulder procedures involving arthroscopy * subject has consented to interscalene blockade for postoperative analgesia exclusion criteria: * patient refusal * contraindications to interscalene blockade, including significant pulmonary insufficiency, hemi-diaphragmatic paralysis, brachial plexus or degenerative neuropathy * allergy to proposed local anesthetic medication\\ * severe cervical spine disease. * bmi \>40 kg/m2 * neck circumference \> 50cm * failed preoperative interscalene blockade * patients known to be currently pregnant or actively breastfeeding * patients where english is a language barrier
efficacy and safety of alendronate in chinese children or adolescents with osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: alendronate should be considered as an alternative therapy of osteogenesis imperfecta (oi) because it significantly increased areal bone mineral density (bmd) and its z score, decreased fracture incidence, inhibited bone resorption biomarkers. alendronate exerted beneficial roles in different age brackets, especially in young patients with oi.


Eligibility criteria:
inclusion criteria: 1. children or adolescents aged 0-18 years, 2. had either a history of at least once minor-impact fracture or age and sex adjusted areal bmd z score of -1.0 or less at lumbar spine or total hip; 3. with or without blue sclera, impaired hearing, joint hypermobility or dentinogenesis imperfecta; 4. with or without slim long bone; with or without cranial epactal bones, signs of multiple fractures, bony deformity in skeletal x-ray films. exclusion criteria: 1. previous history of rickets, hyperparathyroidism, other metabolic or inherited bone diseases; malignant disease; coeliac disease; hyperthyroidism; 2. therapy history of bps within recent two years; severe renal failure (creatinine clearance \<40 ml/min), chronic liver disease; severe diseases of gastrointestinal tract; 3. unable to keep upright for at least 30 minutes daily .
study evaluating amg 706 in subjects with advanced solid tumors

Conditions: Tumors

Summary: this study will determine the safety and pharmacokinetics of amg 706 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: exclusion criteria:

Keywords: cancer antiangiogenesis solid tumors
diam™ spinal stabilization system long term follow up clinical plan

Conditions: Low Back Pain

Summary: a hybrid prospective/retrospective, multicenter, single-arm, data collection study.

collect long-term follow-up data with x-rays and ct on subjects who received the diam™ spinal stabilization system through the original ide protocol. data collected at one-time point from subjects with at least 5 years of follow-up data.

Eligibility criteria:
inclusion criteria: * subject randomized to the diam arm and treated with the diam™spinal stabilization system in the ide study or randomized to the control arm and crossed over to receive treatment with the diam™ spinal stabilization system in the ide study. * willing and able to consent to study procedures exclusion criteria: * na
efficacy and safety of vildagliptin in patients with type 2 diabetes with hba1c 9-11%

Conditions: Diabetes Mellitus, Type 2

Summary: this study was not conducted in the united states. the purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.


Eligibility criteria:
inclusion criteria: * blood glucose criteria must be met * not currently on drug therapy for type 2 diabetes * body mass index (bmi) in the range 22-45 exclusion criteria: * pregnancy or lactation * type 1 diabetes * evidence of serious diabetic complications * evidence of serious cardiovascular conditions * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
urinary disorders in subacute patients after stroke

Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Urinary Incontinence

Summary: this observational study will address urinary disorders in subacute stroke patients. patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.

this prospective observational study will include 100 patients after first ischaemic or hemorrhagic stroke directly transferred from an acute hospital to our institute for inpatient rehabilitation. within admission assessment, patients will be classified according to stroke type, stroke localisation and time since stroke. comorbidities will be recorded and associated neurological deficits will be assessed. post mictional residue will be determined in all patients one day after admission. the patients with urinary disorders will be treated according to the published official protocol, either using the immediate urination approach or the bladder diary approach. continence will be regularly assessed by the nursing staff. urination-disorder-related complications (pressure ulcers, falls and urinary infections), drug therapy and the use of continence aids will also be followed.

Eligibility criteria:
inclusion criteria: * subacute patients after ischaemic or hemorrhagic stroke; * direct transfer from acute hospital to complex inpatient rehabilitation at our institute. exclusion criteria: * incontinence before stroke; * previous brain injury or other brain disease; * previous bladder or prostate surgery; * inability to ambulate before stroke; * terminal disease with expected survival less than three months.

Keywords: stroke inpatient rehabilitation urinary disorders treatment
an international study to evaluate diagnostic efficacy of flurpiridaz (18f) injection pet mpi in the detection of coronary artery disease (cad)

Conditions: Coronary Artery Disease (CAD)

Summary: this is a phase 3, prospective, open-label, international, multicentre study of flurpiridaz (18f) injection for pet mpi in patients referred for ica because of suspected cad.


Eligibility criteria:
inclusion criteria: * the participant was a man or woman ≥18 years of age. * the participant had read, signed, and dated an informed consent form (icf) prior to any study procedures being performed. * at the time of enrolment, the participant had been scheduled via written documentation to undergo an ica for the assessment of cad. * the participant had undergone a clinically indicated spect or the participant was willing to undergo spect mpi for the purposes of the clinical study. * the participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal. * the participant was able and willing to comply with all study procedures as described in the protocol. exclusion criteria: * participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating. * participants who were unable to undergo all of the imaging procedures. * participants who had an established diagnosis of cad as confirmed by any of the following: 1. previous myocardial infarction (mi); 2. previous cardiac catheter angiography showing ≥50% stenosis; 3. previous coronary revascularisation, such as percutaneous coronary intervention (pci), thrombolysis or coronary artery bypass graft (cabg) placement. * participants incapable of undergoing either exercise or pharmacological cardiac stress testing. * participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing. * documented history of heart failure and/or cardiomyopathy and/or prior lv ejection fraction (lvef) \<50%). * participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ica. * participants undergoing evaluation for heart transplantation or with history of heart transplantation. * participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.

Keywords: positron emission tomography myocardial perfusion imaging (pet mpi) single photon emission computed tomography myocardial perfusion imaging (spect mpi) invasive coronary angiography (ica) coronary artery disease (cad)
characterization of hyperparathyroidism and vitamin d deficiency in obesity

Conditions: Vitamin D Deficiency; Secondary Hyperparathyroidism; Obesity

Summary: obese persons are known to have elevated levels of parathyroid hormone (pth) and low levels of vitamin d. these hormones are important in regulation of the body's calcium stores and bone health. we would like to investigate these abnormalities and the accuracy of our current diagnostic tests by comparing results of standard assays for vitamin d and pth to more specific tests, in obese subjects at baseline and as vitamin d is replaced. we will also compare two standard vitamin d replacement regimens to determine if one is more effective. this is a pilot study with two parts: part 1 will compare levels of pth and vitamin d using two different assays in obese subjects who have normal vitamin d and those who do not. we plan to enroll 20 subjects who have normal vitamin d levels and 40 subjects who have vitamin d insufficiency. all subjects will fill out questionnaires about the amount of calcium and vitamin d in their diet, and their recent sunlight exposure. we will ask for blood samples so that we can measure levels of calcium, vitamin d, albumin, creatinine, glucose, insulin and the different forms of pth. subjects who have vitamin d insufficiency will then be randomized to receive vitamin d2 or vitamin d3 in standard doses for eight weeks, in an open label trial. at four and eight weeks, these subjects will fill out the above questionnaires and have the blood tests repeated. for safety purposes, urine calcium will also be monitored.


Eligibility criteria:
inclusion criteria: * obese subjects with body mass indices greater than 40 kg/m2 or 35 kg/m2 with other medical conditions secondary to obesity * willingness to take vitamin d supplements * if baseline vitamin d level is \>25 ng/ml subjects will be eligible for the control group * if baseline vitamin d level is \<25 ng/ml subjects will be eligible for one of the two vitamin d replacement groups exclusion criteria: * hypercalcemia * kidney disease * liver disease * malabsorption * prior diagnosis of bone disease * medical conditions requiring daily use of calcium, antacids, or medications known to affect bone metabolism or interact with vitamin d * hypersensitivity to any formulation of vitamin d

Keywords: vitamin d deficiency secondary hyperparathyroidism obesity