Kornimate/medical-research-clean huggingface dataset:
study to assess fracture healing with sclerostin antibody - hip

Conditions: Fracture Healing

Summary: this is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (amg 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.


Eligibility criteria:
inclusion criteria: * males and females, age 55 to 95 years * fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by x-ray and in the opinion of the treating surgeon amenable to repair by internal fixation * internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures * intertrochanteric fracture: sliding hip screw or im nail * femoral neck fracture: sliding hip screw or at least 3 cancellous screws exclusion criteria: * severe symptomatic osteoarthritis of the lower extremity * inability to independently rise from armchair or walk 200 meters before hip fracture * presence of concomitant injuries such as rib fractures, wrist fractures, or acute symptomatic vertebral fractures which severely impair the ability to rise from a chair * associated extremity injuries including ipsilateral or contralateral fractures of the foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation, that may delay weight-bearing beyond one week after surgery * head-injury, as defined by glasgow coma scale \< 13 prior to randomization * use of bone grafts or bone substitutes at the time of fracture fixation * major polytrauma or significant axial trauma, with injury severity score \> 16 * pathological fracture or history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, cushing's disease, hyperprolactinemia * history of symptomatic spinal stenosis that has not been surgically corrected. if surgically corrected, the subject must be asymptomatic to be eligible for the study. * history of facial nerve paralysis * malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years * history of solid organ or bone marrow transplants * evidence of elevated transaminases (≥ 2.0 x upper limits of normal) or significantly impaired renal function (creatinine clearance of ≤ 30 ml/min) * evidence of current hypercalcemia or hypocalcemia (outside of 1.1 x the normal range) * bone morphogenic proteins (bmp)-2 or bmp-7 at the time of definitive fracture fixation

Keywords: amg 785 proximal femur fracture healing hip fracture
the effect of two different teaching approaches in nursing skills training

Conditions: Urinary Retention

Summary: the purpose of this study is effectiveness of peyton 4-step teaching method and halsted method on nursing students. the research was conducted as a randomized controlled experimental study with first-year nursing students on urinary catheter within the scope of the nursing fundamentals course of sakarya university health sciences institute. the result of personal information form, self-directed learning scale in clinical nursing practice, stress and satisfaction vas scale, urinary catheterization success pre and post-test and urinary catheter application skill checklist were comperisoned.

nursing is a discipline where teaching clinical skills is extremely important. in addition to the traditional methods used in laboratory practices in nursing, the use of innovative methods contributes to learning. this research was conducted experimentally to evaluate the effectiveness of the peyton and halsted teaching method in nursing student's urinary catheterization skill learning. the research was conducted as a randomized controlled experimental study with first-year nursing students within the scope of the nursing fundamentals course of sakarya university health sciences institute in the spring semester of the 2022-2023 academic year. the sample of the study consisted of 217 randomly selected students, 108 students in the experimental group and 109 students in the control group. in the research, peyton's 4-step teaching method was applied to the experimental group during urinary catheterization laboratory applications. for the control group, the traditional halsted method was used. data were collected with the personal information form, self-directed learning scale in clinical nursing practice, stress and satisfaction vas scale, urinary catheterization success pre- and post-test, and urinary catheter application skill checklist. the knowledge and skills learning levels of the experimental and control group students were compared. descriptive statistics, pearson chi-square, mann-whitney u and kruskal wallis tests were used to analyze the data.

Eligibility criteria:
inclusion criteria: * first year student at the faculty of nursing, * enrolling in the "fundamentals of nursing" course for the first time, * have watched the video recordings of the online application of sakarya university faculty of health sciences saüsem (sakarya university continuing education application and research center), * students who agreed to participate in the research exclusion criteria: * graduate of health vocational high school, * settled through the foreign student exam (yös), * after graduating from the fields that provide associate degree education related to health, they were placed in the nursing department with the vertical transfer exam (dgs), * students who take the "fundamentals of nursing" course as a repeat

Keywords: urinary catheterization peyton model halsted model laboratory applications
an oral gnrh antagonist to treat mild autonomous cortisol excess (mace) due to adrenal adenomas in postmenopausal women

Conditions: Mild Autonomous Cortisol Excess

Summary: the purpose of this research study is to determine if treatment with elagolix will improve body weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality as well as mood and quality of life in a female patient with mild hypercortisolism from adrenal overproduction of cortisol. many people with adrenal nodules, or non-cancerous growths in the adrenal glands, have mildly elevated cortisol levels. cortisol is a hormone normally made by the adrenal glands. it is increasingly being recognized that even mild elevations in cortisol levels can negatively impact blood glucose levels, serum cholesterol levels, weight and other metabolic parameters. this can lead to an increase in risk for cardiovascular disease. the study team is trying to determine if the medication elagolix might be an effective treatment for post-menopausal females with mild hypercortisolism. elagolix is a medication used to treat a medical condition called endometriosis by decreasing the body's production of sex hormones. growth of adrenal adenomas is thought to be driven by such sex hormones. therefore, by decreasing production of these hormones, the study team hopes to treat hypercortisolism caused by adrenal adenomas.


Eligibility criteria:
inclusion criteria: * post-menopausal women that have incidentally found adrenal adenomas with benign appearing characteristics on imaging (\<4 cm, non-contrast ct \<10 hu and/or lipid rich and benign appearing on mri) * absence of anti-anabolic clinical features of overt cushing's signs (proximal muscle weakness, \>three ecchymoses, hyperpigmented striae) and 2 of 3 of the following: * elevated 24 hr urine free cortisol (ufc) above the upper limit of normal (\>50 mcg/24 hours) in at least two complete 24-hour tests and/or * late night salivary cortisol more than upper limit of normal in at least two tests and/or * an abnormal dexamethasone suppression defined as post 1mg dexamethasone suppression test serum cortisol concentration of \>1.8 mcg/ml * clinic status of cessation of menses for 12 mo in a previously cycling woman and reflecting complete or nearly complete permanent cessation of ovarian function and fertility (26). * patients with osteoporosis that are not receiving treatment with either antiresorptive medications (bisphosphonates, denosumab) or anabolic agents (teriparitide, abaloparatide or romosozumab) exclusion criteria:

Keywords: mild autonomous cortisol excess (mace) adrenal adenomas postmenopausal women gnrh antagonist
creatine for depressed male and female methamphetamine users

Conditions: Depression; Anxiety; Methamphetamine Dependence

Summary: * assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users * assess creatine's effect on methamphetamine use * assess the safety of creatine in male methamphetamine users with depression


Eligibility criteria:
inclusion criteria: * current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse * current diagnosis of major depressive disorder (primary or substance-induced) * current diagnosis of an anxiety disorder (primary or substance-induced) * current hamilton depression rating scale score \> or = to 16 * current hamilton anxiety scale score \> = to 18 * if taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation exclusion criteria: * persons unable to provide adequate informed consent * persons who are at clinically significant suicidal or homicidal risk * primary substance-related diagnosis other than methamphetamine dependence or abuse * positive pregnancy test (females only) * history of renal disease * clinically significant medical or neurological illness identified by history, physical exam and laboratory testing * history of hypersensitivity reaction to creatine

Keywords: depression anxiety methamphetamine dependence
azathioprine versus placebo in pemphigus vulgaris treated with prednisolone

Conditions: Pemphigus Vulgaris

Summary: description: pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease with unknown etiology that affects mucosa and skin of patients with significant morbidity and mortality. the treatment back-bone is based on prednisolone administration. there are controversies on the opportunity of adding immunosuppressive drugs. for some, they are just corticosteroid sparing drugs. for others, they are disease modifying drugs. the purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone.

the purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in new cases of pemphigus vulgaris treated with prednisolone. official title: randomized, double-blind, placebo-controlled phase ii trial of azathioprine in new cases of pemphigus vulgaris receiving prednisolone randomized double blind controlled trial of azathioprine versus placebo in new cases of pemphigus vulgaris treated with prednisolone study type: interventional study design: treatment, randomized, double blind (subject, caregiver), placebo controlled, parallel assignment, safety/efficacy study condition intervention phase pemphigus vulgaris drug: azathioprine drug: prednisolone other: placebo phase ii

Eligibility criteria:
inclusion criteria: * lesions clinically consistent with pemphigus vulgaris * diagnosis confirmed by histology in terms of acantholysis within past month * positive dif exclusion criteria: * any nursing or pregnant woman * any history of chronic diseases including liver disease, chronic renal failure, chronic heart failure or ischemic heart disease * present diagnosis of hepatitis confirmed by serology or elevated hepatic enzymes; * clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following: * hepatobiliary ast or alt ≥ 1.5 × upper limit of normal (uln);alkaline phosphatase ≥ 1.5 × uln; or, total bilirubin \> 90% of the uln; * renal serum creatinine \> 1.5 mg/dl; or, significant proteinuria \> 2+ on urinary dip test; * hematologic hemoglobin \< 11 mg/dl; leukocytes \< 3.5 × 109/l; neutrophils \< 1.5 × 109/l; or, platelets \< 100 × 109/l; presence of anemia, leukopenia or thrombocytopenia * any sign of patient's non-compliance * known hypersensitivity to study drugs, prednisone or azathioprine * participating in another clinical trial at the time of screening and enrollment

Keywords: pemphigus vulgaris azathioprine prednisone
a study of ts-1 plus cisplatin in patients with advanced non-small-cell lung cancer

Conditions: Non-small-cell Lung Cancer (NSCLC)

Summary: objectives: 1. primary objective: to bridge the data of efficacy in term of overall response rate of ts-1 plus cisplatin in taiwanese advanced nsclc patients from that gained from japanese population 2. secondary objectives: a. to assess progression free survival b. to assess overall survival c. to bridge the safety profile by assessing the toxicities and tolerability


Eligibility criteria:
inclusion criteria: to be eligible for inclusion, each subject must fulfill all of the following criteria: 1. histologically or cytologically confirmed non-small cell bronchogenic carcinoma 2. stage iiib or iv disease 3. presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ≥20 mm with conventional ct/mri or ≥10 mm with spiral ct scan 4. performance status of ecog 0, 1 5. age between 20 and 74 years at registration 6. life expectancy of at least 12 weeks 7. ability to take the oral study medication (ts-1) 8. voluntarily signed the written informed consent form. exclusion criteria: * other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study * previously received chemotherapy or therapy with systemic anti-tumor effect * significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes * fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment * presence of mental disease or psychotic manifestation * participation in another clinical trial with any investigational drug within 30 days prior to entry * judged ineligible by physicians for participation in the study due to safety concern.
study for validation of immunological biomarkers in patients with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the investigators recently identified promiscuous hla-dr-derived epitopes from the human telomerase reverse transcriptase (tert) called universal cancer peptides (ucp), to study tumor-specific cd4+ t cell responses. the investigators found high frequency of naturally occuring ucp-specific th1 cells in long term survival of metastatic colorectal cancer (crc) previously treated by 5 fluoro-uracil -oxaliplatin (folfox) +/- bevacizumab regiment (godet et al. oncoimmunology 2012 and unpublished data). epitopes-crc02 is a french prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific cd4 th1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.


Eligibility criteria:
inclusion criteria: * performance status ecog-who 0, 1 or 2 * metastatic colorectal cancer histologically proved * signed written informed consent exclusion criteria: * previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease * history of autoimmune disease * patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study. * corticoids ≥ 1mg/kg * acute or chronic infectious disease during treatment or stopped for less than six months * other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. * patient under guardianship, curator or under the protection of justice.
post-marketing surveillance of prazaxa® on the long-term use in patients with nonvalvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to investigate the safety and efficacy of long-term use of prazaxa® capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (see).


Eligibility criteria:
inclusion criteria: - patients with nonvalvular atrial fibrillation who have never received prazaxa capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included. exclusion criteria: - none
a study of atr-101 for the treatment of congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia

Summary: this is a phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered atr-101 in subjects with classic congenital adrenal hyperplasia (cah). treatment duration will range from a minimum of approximately 2 months to 6 months per subject. a subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. each dose level will last 28 days.


Eligibility criteria:
inclusion criteria: * documented historical diagnosis of classic cah due to 21-hydroxylase deficiency based on: documented genetic mutation in the cyp21a2 enzyme consistent with a diagnosis of classic cah, or historical documentation of elevated 17-hydroxyprogesterone * biochemical marker of disease status of 17-hydroxyprogesterone ≥ 4 times the upper limit of normal * chronic glucocorticoid replacement therapy for at least 6 consecutive months * stable glucocorticoid and mineralocorticoid regimen for at least 1 month exclusion criteria: * non-classic cah * other causes of adrenal insufficiency * surgery within the previous 3 months prior to screening or planned surgery during study participation * history of active cancer requiring medical or surgical therapy within the past 6 months

Keywords: atr-101 classic congenital adrenal hyperplasia 21-hydroxylase deficiency cah
brain study of patients with frontal lobe dementia and parkinsonian disorders

Conditions: Alzheimer's Disease; Dementia; Down's Syndrome

Summary: the cognitive neuroscience section of the national institute of neurological disorders and stroke proposes to continue its cross-sectional and longitudinal studies of cerebral metabolism in frontal lobe dementias and atypical basal ganglia disorders. these studies include repeated assessments of neuropsychological and brain anatomical and metabolic function in subjects with these important and possibly related brain disorders.

objective to continue the cross-sectional and longitudinal studies performed by the cognitive neuroscience section of ninds on the neuroanatomy, cerebral metabolism, neuropsychology, and genetics of frontotemporal dementia, corticobasal syndrome, and related brain disorders. study population frontal lobe dementias and atypical basal ganglia disorders including frontotemporal dementia, corticobasal syndrome, and related brain disorders. design a cross-sectional assessment of neuropsychological, brain anatomical and metabolic function, and genetic measures in subjects with these disorders. outcome measures mri, fdg-pet, neuropsychological and clinical tests, genetics, and neuropathology.

Eligibility criteria:
* subjects will be recruited from the nih referral center, neurological and psychiatric clinics, from self or family referral in response to advertisements or from private physicians. healthy volunteers will include subjects who are considered at-risk for the development of ftd or cbs and subjects who serve as normal controls matched for key characteristics with the patients. inclusion criteria for patients: * diagnosis of possible / probable ftd or cbs * caregiver willing and able to accept the responsibilities involved in the study exclusion criteria: * pregnant women. women of childbearing potential will be screened by history for the possibility of pregnancy and undergo a urine pregnancy test. these women will be excluded from the imaging portions of the protocol. * behavioral symptoms that would preclude the gathering of data for the study * other medical or social condition that would preclude participation in the opinion of the investigators

Keywords: alzheimer's disease cerebral metabolism cerebrospinal fluid dementia of the alzheimer type 18-f-fluoro-2-deoxy-d-glucose (fdg) magnetic resonance imaging positron emission tomography x-ray computed tomography (ct) senile dementia down syndrome trisomy 21
pediatric epilepsy study in subjects 1-24 months

Conditions: Epilepsy

Summary: this study will evaluate the long-term safety of lamictal(lamotrigine)in subjects with partial seizures previously enrolled in protocol lam20006 and in subjects 1-24 months of age who have never received lamictal(lamictal-naive). for lamictal-naive subjects, lamictal will be added to the subject's current epilepsy medications.


Eligibility criteria:
inclusion criteria: * must have completed the open-label phase of protocol lam20006 or meet criteria for lamictal naive subjects as follows: * a confident diagnosis of epilepsy. * 4 or more partial seizures per month. * current treatment with 1 or 2 anti-epileptic drugs. exclusion criteria: * has seizures not related to epilepsy. * has a surgically implanted and functioning vagal nerve stimulator. * has previously been treated with lamotrigine. * is currently taking felbamate, acth (adrenocorticotrophic hormone) or is on the ketogenic diet. * use of experimental medication within 30 days of enrollment.

Keywords: epilepsy pediatric partial seizures
effects of insulin on hypotension and sarcopenia

Conditions: Diabetes; Sarcopenia; Hypotension, Orthostatic

Summary: in this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia

diabetes is common in the elderly. by the age of 70, approximately 25% of the population has diabetes and another 25% is at risk for diabetes. elderly patients with diabetes are at increased risk for disability and reduction in their instrumental and basic activities of daily living. the prevalence of frailty is higher in people with diabetes that with age matched controls without diabetes. one of the major contributing factors to frailty is sarcopenia. insulin is an important anabolic hormone that prevents protein breakdown and to a lesser extent stimulates protein synthesis. there is some evidence that the ability of insulin to stimulate anabolic processes may be reduced in diabetes. insulin has cardiovascular properties, resulting in simultaneous adrenergic and vasodilatory responses that have opposing influences on blood pressure. epidemiological studies have demonstrated that the use of insulin is a risk factor for syncope. the investigators will study 30 older adults age 65 and older with type 2 diabetes who have never taken insulin to manage their diabetes but now need insulin to manage their diabetes. data will be compared pre insulin start and 3 and 6 months after starting insulin.

Eligibility criteria:
inclusion criteria: * 65 years of age or older * type 2 diabetes for at least 5 years * insulin naive * now needs insulin to manage diabetes exclusion criteria: * anemia as defined by serum hematocrit * abnormal liver function tests * elevated serum creatinine * smoked within last 5 years * musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals * aortic stenosis

Keywords: diabetes sarcopenia hypotension tilt table test