Kornimate/medical-research-clean huggingface dataset:
effects of antimuscarinics on cognition in spinal cord injury

Conditions: Mild Cognitive Impairment; Spinal Cord Injuries

Summary: prospective evaluation of the cognitive function of in-house patients suffering from an acute traumatic spinal cord injury before and three months after the initiation of antimuscarinic treatment. the following hypothesis will be tested: antimuscarinic treatment results in significantly worse cognitive test results three months after traumatic spinal cord injury compared to the pre-treatment results and the results of the control group.

there will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without antimuscarinic treatment (control). the control group will be investigated in order to determine the effects of traumatic spinal cord injury on cognition and the natural history of potential cognitive impairment within the first three months after spinal cord injury. six to eight weeks after traumatic spinal cord injury, patients are examined in order to determine the type of neurogenic bladder dysfunction they are suffering from. patients suffering from an overactive bladder will receive antimuscarinic treatment in order to prevent high urine storage and voiding pressures, that put the kidneys at risk. prior to the urologic examination, patients fulfilling inclusion criteria will be contacted. if informed consent is given, cognitive function will be evaluated in both patient groups using different standard neuropsychologic tests. the same neuropsychologic tests will be repeated three months later. evaluation will take place under standardized conditions (e.g. time of day). furthermore,different factors influencing cognition, e.g. depression, pain, medication, will be assessed at the beginning and end of the study.

Eligibility criteria:
inclusion criteria: * acute traumatic spinal cord injury * primary rehabilitation / in-house patient * 18-65 years of age * treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine * willingness and motivation to participate in study exclusion criteria: * lesion level above c4 * traumatic brain injury (initial glasgow coma score \< 13) * pre-existing dementia * pre-existing impaired cognitive function * previous antimuscarinic treatment * treatment group: antimuscarinic treatment other than oxybutynin, tolterodine * acute psychologic disorders, diseases, schizophrenia * alcohol abuse, consumption of illegal drugs (incl. marijuana) * moderate to severe depression (beck depression inventory score \> 18) * moderate to severe pain (international spinal cord injury pain basic data set) * progressive disease * tricyclic antidepressant * color blindness, impaired sight, blindness * insufficient german language skills * no informed consent

Keywords: mild cognitive impairment muscarinic antagonists spinal cord injuries urinary bladder, neurogenic urinary bladder, overactive overactive detrusor
a study to investigate an immunomodulatory therapy in adult patients with perennial allergic rhinoconjunctivitis

Conditions: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy

Summary: the purpose of the study is to test the efficacy of the combination treatment allqbg10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting


Eligibility criteria:
inclusion criteria: * mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens exclusion criteria: * clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments * use of any concomitant medication that could affect the patient's study treatment response or assessment results
evaluation of bioavailability of phenolic compounds from oxxynea®

Conditions: Dietary Modification

Summary: the aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. after a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of high-performance liquid chromatography coupled with a tandem mass spectrometry (hplc-ms) to identify and quantify phenolic metabolites. in parallel, post-prandial potential anti-oxidative and anti-glycemic properties of oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.


Eligibility criteria:
inclusion criteria: * in good general health * agreement to adhere to diet considerations exclusion criteria: * smoking * pregnancy / lactation * current use of any medication or food supplement * known allergic reaction to components of the supplement/placebo
cardiac arrhythmia pilot study (caps)

Conditions: Arrhythmia; Cardiovascular Diseases; Heart Diseases; Ventricular Arrhythmia

Summary: to compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias, and to evaluate their safety.

background: epidemiologic studies had indicated that complex ventricular premature beats made an independent contribution to risk of sudden death in survivors of a myocardial infarction (mi), and did not appear to be merely a reflection of their association with relatively severe myocardial damage. the potential for reduction in mortality by identification and administration of drugs capable of safely suppressing ventricular arrhythmias was tremendous. in 1982, there was incomplete knowledge regarding which types of ventricular arrhythmias responded to various kinds of drugs. a pilot study of antiarrhythmic agents helped clarify this issue. numerous antiarrhythmic agents with differing pharmacologic properties and side effects had been shown to suppress ventricular arrhythmias. it had also been postulated that antiarrhythmics might raise an individual's threshold for experiencing ventricular fibrillation. there had been several published reports of large (at least l00 patients), long-term clinical trials of antiarrhythmic agents in post-mi patients. none of these had yielded statistically significant results using mortality as the response variable. this might have been due to incorrect drug selection, inadequate sample size, inappropriate choice of patients, or the lack of impact of arrhythmia treatment on mortality. due to incomplete knowledge as to which drug(s) and combinations of drugs were most effective, it was considered to be premature to undertake a full scale trial in 1981-1982. however, the public health problem was of sufficient magnitude to warrant a pilot study to learn more about the efficacy and safety of various antiarrhythmic drugs singly or in combination. the protocol planning phase began in october l982. patient recruitment started in july l983 and ended in the summer of 1985. each patient was followed for one year. design narrative: randomized, double-blind, fixed sample. a total of 502 patients were randomly assigned to 5 treatment groups consisting of encainide, ethmozine, flecainide, imipramine, and placebo.

Eligibility criteria:
men and women. patients had acute myocardial infarction and ventricular arrhythmias.
the pathogenesis of osa in people living with hiv

Conditions: Obstructive Sleep Apnea; HIV/AIDS

Summary: the purpose of this study is to help us understand how hiv and/or anti-retroviral therapy (art) may predispose individuals to obstructive sleep apnea (osa). the traditional risk factors for osa are weight and age. however, people living with hiv on art seem to have osa even when they are thin and young. the study involves a detailed physiological sleep study and an mri of the head and neck to understand the underlying cause of osa in those with and without hiv.

participants who have sleep apnea and are using positive airway pressure (pap) with and without hiv will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria. subjects will undergo two overnight sleep studies (polysomnograms, psgs) and a mri scan of the upper airway. the first sleep study will evaluate the severity of sleep disordered breathing and will be identical to a clinical psg. the second sleep study will measure the physiological traits most important for osa, such as upper airway anatomy, control of breathing, sleep stability, and upper airway muscle activation. these measurements are performed while subjects sleep using pap, but the pap level is adjusted during the night, and the subject's response is measured. the mri scan will be of the head and neck and will occur during the evening time. subjects will be encouraged to sleep during this portion of the study, as well.

Eligibility criteria:
inclusion criteria: * men and women with physician-diagnosed osa who have been prescribed cpap ages \>= 40 years old * bmi 20 - 35 kg/m2 * for hiv group: physician diagnosis of hiv and viral suppression exclusion criteria: * not compliant with cpap (by medicare criteria, e.g. ≥4 hours per night on 70% of nights during a consecutive 30-day period via direct download or visual inspection of usage data). * use of medication that affects the traits, e.g. narcotics or sedative-hypnotics * any cardiovascular, pulmonary or renal disease other than well controlled hypertension or asthma. * pregnancy * currently smoking * any respiratory disorder other than osa or well controlled asthma * contraindication to mri
prostate cancer treatment and obesity in zoladex-astrazeneca treated patients

Conditions: Prostate Cancer; Obesity

Summary: the reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant zoladex therapy. secondary: to determine the quality of life differences among normal and overweight or obese prostate cancer patients by a quality of life questionnaire


Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer patients being on adjuvant zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy exclusion criteria: -prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment

Keywords: bmi prostate cancer recurrence
hip and knee scoring system to predict complication rate and candidacy for total hip and knee arthroplasty

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: this study is a prospective validation study of a new hip and knee replacement-specific questionnaire that can be used to predict postoperative complications. the purpose of this study is to confirm the validity of a new hip and knee scoring system to be used as a clinical tool to predict potential complication rates in patients undergoing total hip or knee replacement surgery. this scoring system aims to stratify patients into specific risk categories based a standardized calculated score. patients will be evaluated on health risk factors and severity of disease on radiographic imaging prior to surgery, associated to higher complication rates following surgery. the hopeful anticipated result of this study is a prospective validation of the scoring system with both statistical and clinical significance in predicting postoperative complication rates in patients with moderate to high health risk, this stratification system may prove meaningful by allowing these patients, especially those classified as high-risk, to be incorporated into more appropriate healthcare bundle payment systems that account for their higher financial demands. furthermore, the stratification may allow for preoperative counseling and a shift towards non-operative management, or surgeon-patient conversations regarding the need to modify a portion of their objective risks prior to surgical intervention. predictive risk models such as the one presented in the current study will be essential tools as the number of total hip arthroplasty procedures performed each year continue to increase and both the numbers of procedures and associated complications impose a significant cost on the u.s. healthcare system.


Eligibility criteria:
inclusion criteria: 1. patients must be male or female of any race. 2. patients much be age greater than 18 years old. 3. patients undergoing a primary total hip arthroplasty (tha) or total knee arthroplasty (tka) by participating surgeons at this institution. exclusion criteria: 1. patients with history of native joint infection or active periprosthetic infection according to musculoskeletal infection society (msis) criteria. 2. patients requiring removal of hardware during their primary total hip arthroplasty (tha) or total knee arthroplasty (tka). 3. patients requiring use of revision tha or tka components (stems, augments). 4. patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol
conjoint tendon resection during reverse total shoulder arthroplasty

Conditions: Shoulder Injuries; Patient Satisfaction; Internal Rotation Contracture-shoulder

Summary: reverse total shoulder arthroplasty (rtsa) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears. however, functional internal rotation (i.e., functional movements of the hand behind the body) is often unsatisfactorily restored and/or lost after rtsa. this study aims to compare the standard surgical approach for rtsa to rtsa with conjoint tendon resection with the targeted metric being postoperative functional internal rotation.

this study will be a prospective, randomized-controlled clinical trial comparing standard of care rtsa to rtsa with conjoint tendon resection in 64 patients undergoing rtsa by a single surgeon. participants and assessors will not be blinded to intervention. the primary outcome is postoperative functional internal rotation. secondary outcome measures include vas, ases, sane, promis, and vr-12 scores, as well as forward elevation and external rotation at the side, and complications at any time point. our null hypothesis is that patients who undergo conjoint tendon resection during rtsa will have significantly increased functional internal rotation and clinically significant improved above-mentioned scores compared to non-resected tendon patients.

Eligibility criteria:
inclusion criteria - all patients undergoing primary reverse total shoulder arthroplasty (rtsa) exclusion criteria * revision rtsa * rtsa for acute proximal humerus fracture or fracture sequela

Keywords: reverse total shoulder arthroplasty functional internal rotation conjoint tendon
a phase 2 study of panitumumab in patients with cetuximab-refractory metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

the study was amended with modification of inclusion criteria (from wild-type tumor kras gene to wild-type ras gene, including kras and nras exons 2, 3 and 4) ras mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. patients whose tumors will result ras mutated at the biomarkers central revision, will be replaced. therefore, the overall sample size at both the stages may be higher than the one initially planned.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of metastatic colorectal adenocarcinoma * a wild-type ras tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of kras exons 2, 3, and 4, and nras exons 2, 3, and 4 * failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. patients may or may not have been treated with bevacizumab. * documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment. * age at least 18 years * ecog performance status 0-2 * neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dl * bilirubin level less than 1.5 times uln * ast (sgot) and alt (sgpt) not greater than 2.5 times uln (or 5 times uln in presence of liver metastasis) * serum creatinine less than 1.5 times uln * effective contraception, if the risk of conception exists * life expectancy at least 3 months * written informed consent exclusion criteria: * symptomatic brain metastasis * interstitial pneumonitis or pulmonary fibrosis * any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer) * chemotherapy, radiotherapy or immunotherapy within the past 4 weeks * any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications * subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

Keywords: cetuximab-refractory
effect of iv lidocaine infusions on pain

Conditions: Pain

Summary: our goals for this study involve using intravenous lidocaine as it is normally used in the stanford pain management center to assess the effect of intravenous lidocaine on chronic pain. studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. our study will incorporate pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.

each patient will receive an intravenous infusion of lidocaine. drug will be infused using a computer-controlled paradigm. this paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. plasma concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of the medical team. this will be conducted according to standard medical practice for the infusion and the study procedures will not affect the infusion paradigm. total infusion time is approximately 1-2 hours. during the course of the study, the primary outcome measure was changed from blood oxygenation level dependent (bold) signal to pain intensity.

Eligibility criteria:
inclusion criteria:- subjects between the ages of 18 and 100 years for clinical component; subjects between the ages of 18 and 70 for the mri component * meets the study criteria of chronic pain of either peripheral or central origin * male or a non-pregnant, non-lactating female. if females are of reproductive potential (i.e., not surgically sterilized and/or not post menopausal), they must be practicing an accepted method of birth control, agree to a urine pregnancy test at the start of each study session (for patient scheduled through the clinic, this has already been addressed by the recommending physician) * is not currently on a sodium channel blocking agent, anticonvulsant, or tricyclic antidepressant, * must be able to comply with any other study requirements and complete experimental tasks * have no reported substance abuse within the past six months; exclusion criteria:- subject is lactating or pregnant; * subject suffers from clinically significant cardiac, pulmonary, renal or liver disease; * subject allergic to lidocaine. * mri component: any metal objects (especially surgical clips), devices, or implants or any other mri contraindication
immunotherapy with apc8015 (sipuleucel-t, provenge) for asymptomatic, metastatic, hormone-refractory prostate cancer

Conditions: Hormone-Refractory Prostate Cancer

Summary: this is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (provenge, apc8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma of the prostate * metastatic disease as evidenced by soft tissue and/or bony metastases * prostate-specific antigen value of at least 5 ng/ml * tumor progression while on hormonal therapy * castration levels of testosterone (defined as less than 50 ng/dl) * life expectancy of at least 16 weeks * adequate hematologic, renal, and liver function exclusion criteria: * visceral organ metastases * metastatic disease expected to be in need of radiation therapy within 4 months. * concurrent therapy with experimental agents

Keywords: asymptomatic metastatic hormone-refractory prostate cancer
post marketing surveillance to observe safety and efficacy of duavive

Conditions: Severe Vasomotor Symptom Associated With Menopause

Summary: to evaluate safety and efficacy of ce/bza in real practice in korea


Eligibility criteria:
inclusion criteria: 1. severe post menopausal vasomotor symptoms with uterus 2. postmenopausal osteopenia exclusion criteria: * women with undiagnosed abnormal uterine bleeding * women with known, suspected, or past history of breast cancer * women with known or suspected estrogen-dependent neoplasia * women with active deep venous thrombosis, pulmonary embolism, or history of these conditions * women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions * women who are receiving progestin, estrogen, or estrogen-agonists/antagonists * women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients * women with known hepatic impairment or disease * women with known protein c, protein s, or antithrombin deficiency or other known thrombophilic disorders * pregnant women, women who may become pregnant, and nursing mothers * women with hereditary problems of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.