Kornimate/medical-research-clean huggingface dataset:
calcium and lipid metabolism

Conditions: Obesity

Summary: we hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. we will also measure concentrations of lipids, glucose, hormones and enzymes associated with fat and carbohydrate metabolism to determine alterations and mechanism of the metabolic changes.

the incidence of obesity has rapidly increased in recent years and reached epidemic proportions in the united states. recent epidemiological data has shown an inverse relationship between calcium intake and body fat and emerging research suggests that inadequate dietary calcium consumption may increase obesity. studies in mice have shown that an increase in dietary calcium consumption creates a shift in the utilization of energy stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as fat) to expenditure (as heat). we will give 1500 mg of calcium a day for three months to women who habitually consume low levels of dietary calcium. the following measurements will be made before and after calcium supplementation: body fat by dexa, lipolysis by infusion of stable isotopes of 1,1,2,3,3-\[2h5\] glycerol , hepatic glucose production by infusion of stable isotopes of 6,6-\[2h2\] glucose, lipogenesis by measurement of fatty acid synthase activity (14c radiochemical assay) , mrna expression ( real time polymerase chain reaction) and protein content (elisa), indirect calorimetry measurement of non-protein respiratory quotient (nprq), energy expenditure, fat and carbohydrate oxidation. serum calcium, glucose, cholesterol, triglycerides, ldl, hdl, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(oh)2d, 25(oh)d and urinary calcium excretion will also be measured.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 30 kg/m2 * taking oral contraceptives * having regular menses exclusion criteria: * pregnant * history of metabolic bone, renal or thyroid disease, * history of diabetes mellitus, or gestational diabetes mellitus * cigarette smoking * self-administration of calcium supplements * regular aerobic activity, i.e. jogging \> 1 mile/day

Keywords: obesity calcium carbonate dietary supplements lipolysis
misoprostol+oxytocin vs. carbetocin in cs

Conditions: Cesarean Section

Summary: this prospective randomized double-blind clinical trial will be conducted at ain-shams university maternity hospital, cairo, egypt. patients eligible for elective lower segment cesarean section will be randomized to 2 groups. group 1: will receive 400 ug misoprostol following + 10 iu oxytocin intravenous slowly after cord clamping. group 2: will receive 100 ug carbetocin intravenous after cord clamping.


Eligibility criteria:
inclusion criteria: * women with singleton pregnancy women scheduled for elective cs full term (gestational age ≥37 weeks). exclusion criteria: * hypersensitivity to oxytocin, carbetocin or prostaglandins * contraindication to prostaglandins (e.g. glaucoma) * history of significant heart disease * severe asthma * epilepsy * history or evidence of liver * renal or vascular disease * history of coagulopathy * thrombocytopenia or anticoagulant therapy * women with hellp syndrome * eclampsia * women presenting by placental abruption * contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Keywords: misoprostol oxytocin carbetocin prevention post-partum hemorrhage
safety and efficacy study of botulinum toxin type a for the treatment of neurogenic overactive bladder

Conditions: Overactive Bladder

Summary: the purpose of this study is to assess the safety and effectiveness of botulinum toxin type a in treating overactive bladder in spinal cord injury or multiple sclerosis patients


Eligibility criteria:
inclusion criteria: * urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * inadequate response to anticholinergic medication used to treat overactive bladder exclusion criteria: * history or evidence of pelvic or urologic abnormality * previous or current diagnosis of bladder or prostate cancer * urinary tract infection at time of enrollment
a clinical study of tqb3616 capsules combined with anlotinib hydrochloride capsules or standard chemotherapy second-line and above in the treatment of advanced lung cancer

Conditions: Advanced Lung Carcinoma

Summary: this is an open, multi-cohort, exploratory phase ii study on the safety and efficacy of tqb3616 combined with anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.


Eligibility criteria:
inclusion criteria: 1. subjects with pathologically proven small cell lung cancer(sclc) or/and locally advanced ( stage ⅲb/ ⅲc), metastatic or recurrent (stage iv) non small cell lung cancer(nsclc). 2. cohort 1: subjects with sclc who had previously received at least one chemotherapy containing platinum or got disease progression during chemoradiotherapy or after the last treatment. 3. cohort 2: subjects with locally advanced, metastatic/relapsed nsclc who had previously received only one pd (l) 1 inhibitor alone or in combination with platinum-based chemotherapy. 4. subjects with measurable lesions as defined by recist 1.1. 5. aged ≥ 18 years ; eastern cooperative oncology group (ecog) score: 0 \~ 1; expected survival ≥ 3 months. 6. laboratory indicators meet the requirements. 7. non-pregnant or non-breastfeeding women; negative pregnancy subjects. 8. subjects voluntarily joined the study and signed the informed consent form. exclusion criteria: 1. subjects who received prior therapy with anlotinib hydrochloride capsules. 2. cohort 2: subjects with epidermal growth factor receptor(egfr) mutation and anaplastic lymphoma kinase(alk) translocation. 3. subjects with central squamous cell carcinoma with a risk of hemoptysis. 4. subjects who have developed or is currently suffering from other malignancies within 5 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ. 5. subjects who have brain metastases with symptoms or control of symptoms for less than 2 months. 6. subjects with difficulty taking oral medication. 7. subjects with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. 8. subjects with spinal cord compression who have failed to be cured or relieved by surgery and or radiotherapy. 9. subjects who have received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks prior to the first dose of the drug. 10. subjects who have not recovered to ≤ ctcae grade 1 (excluding alopecia) due to the adverse event of prior therapy. 11. subjects with significant surgery or significant traumatic injury within 28 days before randomization. 12. subjects with arterial/venous thrombosis within 6 months. 13. subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders. 14. subjects with any severe and/or uncontrolled disease. 15. subjects whose large vessels are involved by tumor from imaging (ct or mri). 16. subjects who have hemoptysis and maximum daily hemoptysis ≥ 2.5ml within 1 month before the first dose. 17. subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator. -
analyzing gene regions that may interact with the effectiveness of high blood pressure drugs

Conditions: Myocardial Infarction; Cerebrovascular Accident; Death, Sudden, Cardiac

Summary: high blood pressure is one of the most common health problems in the united states. there are many drug treatment options for high blood pressure, but these medications are not always effective. people with treated high blood pressure can still suffer from other serious cardiovascular health problems, including heart attack, sudden death, or stroke. genetic variations may cause some people to be more susceptible to these cardiovascular outcomes despite treatment. this study will identify new gene regions that may influence the effectiveness of high blood pressure drugs in preventing the above mentioned cardiovascular conditions.

high blood pressure affects nearly one in three individuals in the united states. there are many factors that can cause high blood pressure, including family history and genetic traits, kidney disease, stress, diabetes, and diet. if left untreated, high blood pressure can increase one's risk for stroke, heart attack, and heart failure. there are four major classes of drugs used to treat high blood pressure, which include diuretics, beta blockers, angiotensin converting enzyme (ace) inhibitors, and calcium antagonists. each class works differently in treating high blood pressure, and certain gene regions may affect the effectiveness of the various high blood pressure drugs. the purpose of this study is to identify new gene regions that may influence the effectiveness of the four major high blood pressure drug types in preventing a heart attack, sudden death, or stroke. this study will draw upon specimens and data from three large population-based studies: the group health population, the cardiovascular heart study, and the jackson heart study. new samples of dna and laboratory data will only be collected from participants in the group health population. the remaining samples will be pre-existing samples from the other two studies. through a whole-genome study of the dna samples, researchers will distinguish genomic regions of interest for the four major drug classes to identify associations between the drugs and genes in the population. researchers will further genotype the "interesting" genomic regions discovered in the whole-genome study. ethnic-specific genetic variations will also be identified to fully characterize the genetic variations. the study will be replicated to assess the validity of the findings.

Eligibility criteria:
inclusion criteria: * experience of a first heart attack, stroke, or sudden death * member of the group health center (ghc) treated for high blood pressure * enrolled at least 1 year in one of the three study populations * treated for high blood pressure with one of the four major classes of high blood pressure drugs (diuretics, beta-blockers, ace inhibitors, or calcium antagonists)

Keywords: cardiovascular epidemiology genomics genome-wide association study
the effects on cognitive function of levetiracetam (keppra®) compared to carbamazepine (tegretol®, carmazepine®) as monotherapy for children with partial seizure; a multicentric randomized controlled study

Conditions: Focal Epilepsy

Summary: unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. this study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects. this multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period.


Eligibility criteria:
inclusion criteria: 1. patients from age 4 to 16, who have been diagnosed with focal epilepsy 2. patients who have experienced minimal two unprovoked seizures, or patients who have had one unprovoked seizure and have shown focal abnormality in the eeg 3. patients who have not received any antiepileptic medications prior to the study (those who have been treated with rescue medication are eligible) 4. patients with eligible consent or with legal guardians have given official consent exclusion criteria: 1. patients with progressive cns disease, or systemic illness 2. patients with level of sgot/spgt above the doubled normal level or bun/creatinine above the 3 times of the normal range 3. patients who had used other anti-epileptic medication during any period of the trial, including baseline period. (benzodiazepine used as rescue therapy is acceptable) 4. patients who show hypersensitive reaction to the study medication. 5. patients with any psychological problems. 6. patients deemed inappropriate for the study by the investigators

Keywords: levetiracetam, carabamazepine
extension study of two dosing schedules of adalimumab in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: extension study of two dosing schedules of adalimumab in subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * subject participated and relapsed in prior ps study exclusion criteria: * subject has other active skin diseases * multiple concomitant therapy restrictions and/or washouts (topicals, uv, other systemic ps therapies) * poorly controlled medical conditions * history of neurologic symptoms suggestive of central nervous system (cns) demyelinating disease. * history of cancer or lymphoproliferative disease * history of active tb or listeriosis, or persistent chronic or active infections * known to have immune deficiency or is immunocompromised * clinically significant abnormal laboratory test results * erythrodermic psoriasis or generalized pustular psoriasis
biomarkers in the diagnosis of acute compartment syndrome

Conditions: Acute Compartment Syndrome; Tibia Fracture

Summary: this prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.

patients with a tibial fracture are included. p-myoglobin and p-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. an expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome. blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.

Eligibility criteria:
tibial fracture group inclusion criteria: - traumatic tibial fracture exclusion criteria: * malignancy * acute myocardial infarction * kidney failure (gfr ≤35 ml/min) * muscle disease * paraplegia/tetraplegia non-fracture group inclusion criteria: - suspected acute compartment syndrome exclusion criteria: * malignancy * acute myocardial infarction * kidney failure (gfr ≤35 ml/min) * muscle disease * paraplegia/tetraplegia * associated fracture * acute vascular event
impact of vasculitis on employment and income

Conditions: Vasculitis; Systemic Vasculitis; Behcet's Disease; CNS Vasculitis; Cryoglobulinemic Vasculitis; Eosinophilic Granulomatosis; Temporal Arteritis; Wegener Granulomatosis; Henoch-Schoenlein Purpura; Microscopic Polyangiitis; Polyarteritis Nodosa (PAN); Takayasu's Arteritis; Urticarial Vasculitis

Summary: the purpose of this study is to learn about the impact of vasculitis on employment and income in patients with different systemic vasculitides. all patients enrolled in the vasculitis clinical research consortium (vcrc) patient contact registry, living in usa or canada, and followed for more than 1 year since the vasculitis diagnosis will be invited via email to participate in this study, based on an online survey.

all individuals with vasculitis participating in the vcrc contact patient registry, living in the usa or canada, and with a follow-up period of ≥1 year since the diagnosis of vasculitis will be invited by email to complete an online questionnaire. they will be asked several questions about their disease, their employment and work status before diagnosis and over the course of their disease, their work capacity and the financial impact on their lives. the survey data will be stored by the rare diseases clinical research network's data management and coordinating center (dmcc) at the university of south florida. the data will be de-identified. names or other personal health information will not be collected. if a participant is enrolled in the vasculitis patient-powered research network (v-pprn) university of south florida (usf) institutional review board pro00018514, the participant can choose to provide their email address. upon conclusion of the study period, the data will be sent to the vcrc principal investigator and the protocol 5536 co-principal investigators. all data collected will be sent to the database of genotypes and phenotypes (dbgap) to be stored indefinitely per the rare disease clinical research network (rdcrn) data sharing policy.

Eligibility criteria:
inclusion criteria: * diagnosis of a systemic vasculitis: vcrc patient contact registry includes patients with behcet's disease, cns vasculitis, cryoglobulinemic vasculitis (cryoglobulinemia), eosinophilic granulomatosis with polyangiitis (churg-strauss) (css), giant cell (temporal) arteritis (gca), granulomatosis with polyangiitis (wegener's) (gpa), henoch-schönlein purpura (iga vasculitis), microscopic polyangiitis (mpa), polyarteritis nodosa (pan), takayasu arteritis (tak), and urticarial vasculitis. * age ≥18 years old * living in usa or canada * vasculitis diagnosis made ≥1 year ago * language requirements: questionnaire will be in english only exclusion criteria: * inability to provide informed consent and complete survey
impact of speac® system data on therapeutic decisions related to convulsive seizure patient's refractory to aeds

Conditions: Epilepsy Intractable

Summary: this is an open label, randomized, prospective study of the impact on healthcare utilization of a surface electromyography (semg) based seizure monitoring and alerting system for veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.


Eligibility criteria:
inclusion criteria: 1. subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization. 2. subjects suspected of experiencing one or more spells per month. 3. subjects has failed at least 3 anti-epileptic drugs (single or combination). 4. male or female between the ages 22 to 99. 5. if female and of childbearing potential, subject must agree to not become pregnant during the trial. 6. can understand and sign written informed consent or will have a legally authorized representative (lar) who can do so, prior to the performance of any study assessments. 7. subject or primary caregiver must be competent to follow all study procedures. 8. subject must be willing to use the seizure monitoring and alerting system for a prolonged period (up to five months), for a minimum of 30 hours/ week. exclusion criteria: 1. the subject cannot be pregnant, or nursing. 2. the subject cannot be sensitive or allergic to adhesives or tapes. 3. the subject may not be enrolled in another clinical trial. 4. the subject is homeless or in a home without a power supply.
comparison of mechanism of early and late vascular responses following treatment of st-elevation acute myocardial infarction with two different everolimus-eluting stents: randomized controlled trial between biodegradable polymer and durable polymer stent (mechanism-ami-rct)

Conditions: Coronary Artery Disease

Summary: to place two different everolimus-eluting stents (ees), a bioabsorbable polymer ees (synergy®) and a permanent-type polymer ees (xience®), randomly to the st-elevation acute myocardial infarction (ami) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (fd-oct). the primary endpoint is the 2-week strut coverage rate by fd-oct.


Eligibility criteria:
inclusion criteria: 1. patients with new coronary lesion indicated for pci using des 2. patients whose age at acquisition of consent is 20 to less than 85 years 3. patients who themselves or whose representatives showed the written consent 4. patients who will undergo cardiac catheterization 2 weeks later (staged pci on the other vessel or confirmatory angiography at the treated site) exclusion criteria: if the following exclusion criteria are satisfied, the patient should not be enrolled in this study even after acquisition of patient's consent: 1. when the follow-up after 12 months is considered difficult (the patient's residence should also be considered) 2. when there is no obvious acs finding in angiography (decisions should be left to operator) 3. patients with shock 4. patients whose culprit lesion is the left main coronary trunk 5. lesion with the reference vascular diameter of \<2.0 mm or ≥4.5 mm visually 6. ami that occurred newly at the site where a stent has already been placed 7. chronic renal failure in which the serum creatinine concentration at visit is ≥2.0 mg/dl 8. patients undergoing hemodialysis 9. tumor-bearing patients whose life prognosis is expected to be within 2 years 10. patients for whom the surgical operation requiring withdrawal of antiplatelet drug is scheduled within 3 months 11. female patients during pregnancy or scheduled to be pregnant 12. patients with a past history of the side effect of aspirin, clopidogrel or prasugrel (when the patient is confirmed for the safety of ticlopidine, this does not apply even if there is the side effect of clopidogrel or prasugrel)