Kornimate/medical-research-clean huggingface dataset:
study of treatment with the combination of drospirenone plus ethinyl estradiol plus levomefolate calcium in mexican women seeking contraception

Conditions: Contraception

Summary: the objective of this study is to compare the red blood cell (rbc) and plasma concentrations of folate in subjects treated with drospirenone (drsp)/ethinyl estradiol (ee) plus levomefolate calcium (l-5-mthf) at 24 weeks with respect to basal determination. increased intake of folic acid (synthetic form of the naturally occurring b-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. this is important for women who may become pregnant following discontinuation of oral contraception. information about any side effects that may occur will also be collected.


Eligibility criteria:
inclusion criteria: * healthy, mexican female subjects requesting contraception * age \>/=18 to \</=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent * normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has to be taken at the screening visit, or a normal result has to be documented within the previous 6 months. human papilloma virus (hpv) testing in subjects with atypical squamous cells of undetermined significance (ascus) can be used as an adjunctive test. subjects with ascus can be included if they are negative for high-risk hpv strains. exclusion criteria: * pregnancy or lactation (less than 6 months since delivery, abortion, or lactation before start of treatment) * body mass index (bmi) \>30 kg/m2 * hypersensitivity to any ingredient in the study drug * any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. * undiagnosed abnormal genital bleeding * abuse of alcohol, drugs or medicine (eg, laxatives) * any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug

Keywords: levomefolate calcium contraceptives, oral, combined neural tube defects
effect of premodulated current versus diadynamic current on the management of tennis elbow.

Conditions: Tennis Elbow

Summary: 104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.

hey were recruited in the study from october 2020 to september 2021 and allocated randomly into two groups. group a received premodulated current in addition to exercises, and group b received diadynamic current with the same exercises. each patient signed the informed consent form approved by the faculty of physical therapy, october 6 university, egypt and prospectively registered (clinical trials.gov, identifier nct03338283). patients was selected according to the following criteria. inclusive criteria * patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension * lasting of the symptoms for 3 months * no previous physiotherapy interventions. exclusive criteria internal or external fixation * arthritis of elbow * contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.

Eligibility criteria:
inclusion criteria: * patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension * lasting of the symptoms for 3 months * previous physiotherapy interventions. exclusion criteria: * internal or external fixation * arthritis of elbow * contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
incidence, and survival medical expenditure of patients with multiple sclerosis

Conditions: Neurologic Signs and Symptoms

Summary: multiple sclerosis (ms) is a disease of autoimmune system which attacks the central nervous system and that is one of the most common inflammatory diseases and has caused a heavy disease burden on patients. in the world, the prevalence of ms is on the rise, and the annual growth rate of ms patients in taiwan is much higher than the whole world (3.78 times). however, it has no discussion or study in references at present, and it is worthwhile to research. ms is not a fatal disease, but its complications make the mortality of its patients three times higher than that of general population. this study will explore the survival and the causes of death for ms patients in taiwan by cohort study of fourteen years. in addition, in the recent years, the ms patients in taiwan and the medical resource consumption has increased largely, and it is necessary to conduct the research.

the study population is based on the 'national health insurance research database' (nhird) from 2001 to 2015 provided by taiwan ministry of health and welfare. the subjects are diagnosed as ms patients based on the 'registry for catastrophic illness'. first, the investigators will perform the statistical analysis of the incidence, the prevalence, the mortality and the trend analysis of the ms patients diagnosed each year. first, kaplan-meier method will be employed to examine the survival curves. next, cox proportional hazards model will be used to analyze the survival and related factors. last, multiple regression analysis will be then performed to analyze the influence of independent variables on patients' medical utilization in each year. in response to the lack of data on population-based epidemiological studies on ms diseases in asia, this research wishes to fill the gaps in the studies of global prevention and analyze the patient's survival, mortality risk factors and the medical utilization as a reference for national health policies.

Eligibility criteria:
inclusion criteria: * the subjects are diagnosed as ms patients exclusion criteria: * the subjects are not diagnosed as ms patients

Keywords: multiple sclerosis survival analysis cause of death medical resources
parametric cardiac 18f-flutemetamol pet imaging in attr cardiomyopathy

Conditions: Cardiomyopathies, Primary

Summary: 18f-flutemetamol (vizamyl) is a radioactive diagnostic agent indicated and fda-approved for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer's disease (ad) or other causes of cognitive decline. this study is designed to evaluate a novel use for 18f-flutemetamol in cardiac amyloidosis.

the goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18f-flutemetamol positron emission tomography (pet) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (attr-ca) at yale-new haven hospital. the primary outcome of the study will be comparisons in the magnitude of change in regional and global 18f-flutemetamol cardiac pet metrics between the baseline and six-month 18f-flutemetamol pet scans versus clinical stage and echocardiographic features (wall thickness, strain, lvef).

Eligibility criteria:
inclusion criteria: * 1. age \> 18 years * 2. diagnosis of attr cardiac amyloidosis (wild-type or v142i attr mutation) a. diagnosis of attr cardiac amyloidosis by established consensus diagnostic criteria of gillmore et al. (either invasive or non-invasive diagnostic pathways) * 3. plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study. * 4. stated willingness to comply with all study procedures and availability for the duration of the study * 5. able to understand and sign the informed consent document after the nature of the study has been fully explained. * 6. women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the flutemetamol. exclusion criteria: * 1. primary amyloidosis (al) or secondary amyloidosis (aa). * 2. prior liver or heart transplantation. * 3. active malignancy or non-amyloid disease with an expected survival of less than 1 year * 4. inability to lie flat for 60 minutes in the pet scanner * 5. history of prior treatment for attr cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment. * 6. pregnancy or lactation * 7. known allergic reactions to components of the 18f-flutemetamol and/or polysorbate 80 * 8. high risk for non-adherence as determined by screening evaluation.

Keywords: transthyretin amyloidosis
evaluation of xueshuantong in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the aim is to assess the effects and harms of xueshuantong lyophilized powder versus placebo in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.


Eligibility criteria:
inclusion criteria: 1. diagnosis of acute ischemic stroke. 2. patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle. 3. 4 ≤ nihss score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time. 4. female or male aged ≥ 18 years and ≤ 80 years. 5. provision of signed informed consent prior to any study-specific procedure. exclusion criteria: 1. patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization. 2. secondary stroke caused by tumor, traumatic brain injury, hematological disease or other diseases with the explicit diagnosis. 3. mrs grade ≥ 2 pre-morbid historical assessment. 4. other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases). 5. known severe impairment of liver function or renal function. 6. known hypersensitivity to study drugs. 7. known severe comorbidity with life expectancy \< 3 months. 8. known massive cerebral infarction combined with disturbance of consciousness (1a ≥ 2 in nihss), dementia, mental impairment, or unsuitable for participation, in the opinion of the investigator. 9. pregnancy or breastfeeding. 10. participation in another clinical study with an investigational product at any time during the 3 months prior to randomization (regardless of when treatment with the investigational product was discontinued).
social cognition in ageing and in frontotemporal lobar degeneration

Conditions: Frontotemporal Lobar Degeneration; Aging

Summary: the purpose of this study is to examine the age and the neurodegenerative disease effects on social cognition. secondary goals are to better understand the relationships between different component of social cognition, executive functioning, and behavior and describing the neuronal substrates associated to the alteration of the social cognition in ageing and dementia.


Eligibility criteria:
inclusion criteria: * all the participants * age between 40 and 80 years * minimum of 7 years of education * french native speaker * healthy subjects * non pathological dementia rating scale score * patients * clinical diagnosis of frontotemporal lobar degeneration exclusion criteria: * chronic neurological disease * encephalitis * endocrinal disease * hepatic disease * case history of head injury with loss of consciousness of more than one hour * case history of stroke * case history of cancer during the five last years except squamous cell carcinomas * alcoholism or drug addiction * major psychiatric disorders according the diagnostic and statistical manual of mental disorders
intraocular pressure, blood pressure, ocular perfusion and blood flow fluctuations in glaucoma patients

Conditions: Open Angle Glaucoma

Summary: to evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

hypotensive treatments for glaucomatous optic neuropathy (gon), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (iop) reduction. it is therefore important not only to identify ocular blood flow deficits in gon, but also document the influence of gon treatments on the ocular circulation

Eligibility criteria:
inclusion criteria: * open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes exclusion criteria: * younger than 18 years old * women of child bearing potential

Keywords: glaucoma, ocular, blood flow, fluctuations
rnf213 variants and collateral vessels in moyamoya disease

Conditions: Moyamoya Disease

Summary: the purpose of this study is to detect the association between rnf213 variants and collateral vessels in patients with moyamoya disease.

moyamoya disease (mmd) is a chronic cerebrovascular disorder characterized by the presence of occlusion which occurs at the internal carotid arteries and their main branches during the development of a basal collateral network. the ring finger 213 (rnf213) was identified as a strong susceptibility gene in patients with mmd in east asia. the role of rnf213 variants in pathogenesis of mmd is still unclear. specific "moyamoya vessels" correlate with the onset of stroke. the purpose of this study is to investigate the relationship between rnf213 variants and collateral vessels in patients with moyamoya disease, and provide potential pathogenesis of moyamoya disease.

Eligibility criteria:
inclusion criteria: * written informed consent is obtained * patients with age between 4-60 years * cerebral digital subtraction contrast angiography (dsa) reveal severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate 'moyamoya collaterals' exclusion criteria: * there are other vascular diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy * patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement * physical or subjective failure to cooperate with the examination or serious comorbid diseases

Keywords: moyamoya disease rnf213 variants collateral vessels
establishment of reproductive cohort and prediction model of genetic counseling for mitochondrial genetic diseases

Conditions: Mitochondrial Diseases

Summary: the goal of this observational study is to provide a reference for clinicians to conduct genetic counseling and carry out preimplantation genetic testing of mitochondrial patients. the main questions it aims to answer are: * the relationship between mitochondrial mutation load and clinical symptom * the symptomatic threshold of common mitochondrial dna mutations * the distribution of mitochondrial mutation load in offspring and genetic rule of mitochondrial dna mutation * the minimum number of eggs taken by preimplantation genetic testing in mitochondrial mutation carriers biological samples such as blood, urine, oral epithelial cells, nails, some granulosa cells, trophoderm cells, embryo culture fluid, embryo biopsy fluid, and embryo trophoblast cells of the participants will be collected and the mutation loads of them will be measured. the clinical symptoms and mutation load of the participants will be followed up once a year.

a total of 600 carriers of disease-causing mitochondrial dna mutations will be selected as the research objects. the basic information, reproductive history, clinical and genetic diagnosis, and clinical symptoms of the carriers will be investigated by questionnaire. biological samples such as blood, urine, oral epithelial cells, nails, some granulosa cells, trophoderm cells, embryo culture fluid, embryo biopsy fluid, and embryo trophoblast cells of the participants will be collected and the mutation loads of them will be measured. placenta and umbilical cord blood samples of some fetuses will be collected after delivery, and the mitochondrial dna mutation heterogeneity level will be determined. multiple logistic regression, sewell-wright equation, kimura equation, binomial distribution model, and machine learning model will be used to establish a prediction model of the incidence probability of mitochondrial diseases and predict the onset threshold of common mitochondrial dna mutations after standardizing. the distribution model of mitochondrial mutation load in offspring will be established to predict the maternal genetic risk of mitochondrial dna mutation. a prediction model for egg retrieval will be established to estimate the minimum number of eggs taken by preimplantation genetic testing in mitochondrial mutation carriers. finally, an online prediction platform for mitochondrial genetic disease genetic counseling will be established to provide standardized standards for mitochondrial disease genetic counseling and pgt.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mitochondrial dna diseases exclusion criteria: * none

Keywords: mitochondrial diseases mitochondrial dna mutation reproductive cohort genetic counseling
treatment of vitamin d deficiency with large bolus cholecalciferol

Conditions: Vitamin D Deficiency

Summary: comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin d deficiency.

study is looking at patients with diagnosed vitamin d deficiency (\<20ng/ml). participants are healthy adults between 18 and 75. no diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. participants are randomized into two treatment groups: (1) 5,000iu cholecalciferol daily or (2) one-time 300,000 international units (iu) cholecalciferol. vitamin d level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.

Eligibility criteria:
inclusion criteria: * age 18-75yrs old * serum 25(oh)-vitamin d level \<20ng/ml * patient of parkview adult medicine clinic * not currently on cholecalciferol \>2,000iu daily * no ergocalciferol administration within last week exclusion criteria: * history of hypercalcemia or hyperparathyroidism * history of chronic kidney disease with baseline creatinine \>1.1 * history of gastric absorption abnormalities * history of paget's disease or osteomalacia * history of thyrotoxicosis * known malignancy * currently pregnant * taking medications for osteoporosis or seizures * taking more than 1200mg/day of calcium * inpatient hospitalization at the initiation of study meds
a phase 1/2 study of vx-670 in adult participants with myotonic dystrophy 1 (dm1)

Conditions: Myotonic Dystrophy Type 1 (DM1)

Summary: the purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of vx-670 at different single and multiple doses in participants with dm1.


Eligibility criteria:
key inclusion criteria: - documented clinical diagnosis of dm1 with age of onset greater than (\>) 1 year of age and documented positive genetic test for dm1 in the subject with cytosine thymine guanine (ctg) repeat of at least 100 key exclusion criteria: - history of any illness or any clinical condition as pre-specified in the protocol other protocol defined inclusion/exclusion criteria may apply.

Keywords: dm1 dm2 myotonic dystrophy 1 myotonic dystrophy 2 myotonic dystrophy type 1 (dm1) myotonic dystrophy dm myotonia dystrophy myotonic myotonic disorders steinert disease vertex entrada vx-670 vx670 pmo aso myotonic muscular dystrophy muscular disorders, atrophic muscular diseases musculoskeletal diseases neuromuscular diseases nervous system diseases genetic diseases, inborn heredodegenerative disorders, nervous system neurodegenerative diseases muscular dystrophies
pre-hospital use of plasma for traumatic hemorrhage

Conditions: Shock, Hemorrhagic

Summary: type a thawed plasma (tp) will be compared in polytrauma patients who receive only normal saline (ns) (standard of care) before arrival at the hospital. the purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

investigational plan this will be an open-label, non-blinded, randomized clinical trial to investigate mortality (30 days) and morbidity of type a thawed plasma (tp) versus ns infusion at earliest contact, administered by emergency medical service (ems) supervisors to subjects who have sustained severe polytrauma / major hemorrhage (ptr / mh). the total study is expected to last 2 years with 210 patients enrolled. the two ems agencies involved in the study will each have one ems supervisor quick-response vehicle (qrv) equipped with an approved, validated refrigeration unit for tp transport. ems personnel trained in plasma administration and recognition of reactions may administer up to 2 units of tp to subjects approved for study enrollment. blood samples for coagulation and lipid testing will be drawn prior to tp administration by ems personnel,and repeated by hospital personnel at 30 minutes, 8 hours, and 24 hours post-injury. this study is approved for "exception from informed consent" (efic). once the patient has reached vcumc and has been entered into the vcumc health care system, the treating team will advise the study coordinator (sc) whether or not a subject is able to consent. as the plasma administration will occur in the field prior to arrival to vcumc, the sc will make every effort possible to obtain consent from the subject or legally authorized representative (lar) for continued study participation before the next intervention (8 hour blood specimen collection). the attempts to contact the lar will be documented in detail. if a subject lacks the ability to provide his/her own consent by the end of day 30, the consent signed by the lar will be the consent document in force at the subject's completion of the study and no further consent will be sought.

Eligibility criteria:
inclusion criteria: * blunt or penetrating trauma, * blood pressure (bp) systolic \ 108 beats per minute (bpm), * ongoing hemorrhage with unstable vital signs exclusion criteria: * wearing opt-out wrist band, * wearing medical alert jewelry / bracelet, etc. indicating jehovah witness or similar with objections to blood transfusions, * refusal to participate (by subject or lar), * communication barrier at the time of eliciting refusal (non-english speaking or non-spanish speaking), * not expected to survive transport to virginia commonwealth university medical center (vcumc), * documented do not resuscitate (dnr) order found, * cardiac arrest or cardio-pulmonary resuscitation (cpr) prior to randomization * penetrating head trauma, * known / obvious pregnancy, * prisoner, * burns \> 20% of body surface

Keywords: trauma hemorrhage plasma shock polytrauma