Kornimate/medical-research-clean huggingface dataset:
function evaluation of older patients with vertigo and intervention study of new rehabilitation methods

Conditions: Vertigo

Summary: by evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention.


Eligibility criteria:
inclusion criteria: older than 60 years old it meets the diagnostic criteria of vertigo disease agree to participate in the experiment exclusion criteria: complete paralysis caused by severe cerebrovascular diseases patients with disability and dementia and long-term bedridden unwilling to cooperate with the visitors patients who did not meet the inclusion criteria
evaluation of daclatasvir (dcv) in combination with sofosbuvir (sof) in children with chronic hepatitis c (chc) infection

Conditions: Hepatitis C; Chronic Hepatitis

Summary: the purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis c infection


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants monoinfected with hcv genotype -1 to -6 * hcv rna ≥1,000 iu/ml at screening * participants who are hcv-treatment naïve or treatment experienced * participants in cohort 1 must have a body weight ≥ 45kg at day 1 exclusion criteria: * mixed genotype hcv infections * evidence of an ongoing medical condition contributing to chronic liver disease other than hcv * evidence of cirrhosis, either compensated or decompensated * prior exposure to sofosbuvir and/or ns5a inhibitor other protocol defined inclusion/exclusion criteria could apply
a study comparing cancer imaging approaches in people with lobular breast cancer

Conditions: Breast Cancer; Lobular Breast Carcinoma; Breast Carcinoma; Metastatic Breast Cancer; Metastatic Lobular Breast Carcinoma; Metastatic Breast Carcinoma

Summary: the purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ilc. this study will compare pet/ct (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18f)-fluoroestradiol (fes) with a standard imaging approach for detecting and monitoring ilc, pet/ct scans using the radiotracer 18f-fluorodeoxyglucose (fdg). these scans will be referred to as fes pet/ct scans and fdg pet/ct scans.


Eligibility criteria:
inclusion criteria: * adult patient \> 18 years old * biopsy-proven metastatic ilc * confirmed er+ breast cancer from either primary tumor or metastatic biopsy (er receptor percent staining ≥ 10% of tumor cells by ihc) * her2-negative per asco/cap * ecog performance status score of 0, 1 or 2. * patient can have received up to 2 lines of therapy in the metastatic setting * life expectancy of at least 12 months exclusion criteria: * low er expression defined as er \<10% of tumor cells by ihc * patients who have been on adjuvant er-blocking endocrine therapy with serm or serd without an 8- and 24-weeks washout, respectively. (the use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors). * pregnancy or lactation or parturient or nursing mother * patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of \<12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason.

Keywords: breast cancer lobular breast cancer lobular breast carcinoma breast carcinoma metastatic breast cancer metastatic lobular breast cancer metastatic lobular breast carcinoma metastatic breast carcinoma 24-134 memorial sloan kettering cancer center
efficacy of ykp3089 in patients with photosensitive epilepsy

Conditions: Epilepsy

Summary: the aim of this study is to evaluate the ability of a single oral dose of ykp3089 to abolish or clearly reduce the ips-induced photo-paroxysmal eeg response in photosensitive epilepsy patients, and to measure the onset and duration of the effect. several cohorts will be used, to sequentially investigate different doses.


Eligibility criteria:
inclusion criteria: * male or female age 18-60 years. * a diagnosis and history of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs. * if the patient is taking two concomitant medications, the second drug must be levetiracetam, gabapentin or pregabalin. * a reproducible ips-induced photo-paroxysmal response (ppr) on eeg of at least 3 points on a frequency assessment scale (see section 6.16) in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded over the 2 months prior to study entry in at least one eye condition. * patients in otherwise good health (with the exception of epilepsy), as determined by the pi via the medical history, a physical examination and screening laboratory investigations. * a body mass index (bmi) between 18 and 35. * able and willing to provide written informed consent to participate in the study in accordance with the ich, gcp guidelines. exclusion criteria: * a history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures). * women who are pregnant or lactating. * women of reproductive potential who do not agree to use effective birth-control methods. * patients taking medications that are known substrates of cyp2b6 and cyp2c19 including but not limited to phenytoin, phenobarbital, omeprazole, fluvoxamine and efavirenz. * any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study. * an active cns infection, demyelinating disease, degenerative neurological disease or any cns disease deemed to be progressive during the course of the study that may confound the interpretation of the study results. * any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study. * patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (ast and alt). * a history of alcoholism, drug abuse, or drug addiction (within the past 12 months). * patients who would normally be contraindicated for ykp3089 administration. * patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.

Keywords: epilepsy seizures
study of alxn1850 in participants with hypophosphatasia (hpp)

Conditions: Hypophosphatasia

Summary: this is an open-label, dose-escalating study to assess safety, tolerability, pharmacokinetic (pk), pharmacodynamic (pd), and immunogenicity of alxn1850 when given intravenous (iv) and subcutaneous (sc) to adults with hpp.


Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of hpp * not anticipated to require further treatment with enzyme replacement therapy to treat participant's hpp after study completion * willing and able to follow protocol-specified contraception requirements * willing and able to give informed consent exclusion criteria: * primary or secondary hyperparathyroidism or hypoparathyroidism * fracture within 12 weeks of screening * current or relevant history of unstable physical or psychiatric illness * significant allergies * asfotase alfa use within 6 months and/or positive for asfotase alfa antidrug antibody/neutralizing antibodies

Keywords: hpp enzyme replacement therapy low alkaline phosphatase tissue-nonspecific alkaline phosphatase tnsalp
first-in-man study of single and multiple ascending doses of a new drug for neurological disorders

Conditions: Healthy Subjects

Summary: the primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults


Eligibility criteria:
key inclusion criteria: * signed informed consent * healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests * males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive) * women must have a negative serum pregnancy test at screening and a negative urine pregnancy test predose on day -1 * body mass index (bmi) between 18.0 and 29.9 kg/m2 (inclusive) * systolic blood pressure (sbp), diastolic blood pressure (dbp) and pulse rate (pr) between 90-140 mmhg, 50-90 mmhg and 50-90 bpm (all inclusive), respectively key exclusion criteria: * history or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment * previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Keywords: healthy subjects first-in-man safety
the effects of pythagorean self-awareness intervention on young adolescents in primary school-α one arm clinical trial

Conditions: Stress; Health Promotion; Adolescence

Summary: in this one arm clinical trial, students of the 6th grade in a primary school participated in the psai for 8 weeks. self-report questionnaires and hair cortisol concentrations were used for the evaluation of the aforementioned variables at baseline and at the end of the intervention.


Eligibility criteria:
inclusion criteria: * attended the 6th grade of primary education. exclusion criteria: * . absence of parental informed written consent * diagnosis of mental health problemc. * presence of any disease that could influence glucocorticoid levels * pharmacological treatment that could influence cortisol levels * practice of other stress management techniques

Keywords: holistic program self-awareness pythagorean self-awareness intervention psai stress adolescence school bullying healthy lifestyle cognitive intervention
the impact of magnesium on exercise tolerance, quality of life and clinical outcomes in chronic heart failure patients

Conditions: Magnesium Deficiency; Heart Failure

Summary: magnesium supplementation could improve cardiac performance. patients with chronic heart failure (chf) are magnesium deficient and we hypothesized that 1 year supplementation of oral magnesium comparted to placebo will improve exercise duration time and quality of life.

magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function. patients with chronic heart failure (chf) are magnesium deficient. the activation of the renin-angiotensin-aldosterone system and the use of diuretics are associated with depletion of potassium and magnesium in chf. magnesium deficiency stimulates aldosterone production and secretion, while magnesium infusion decreases aldosterone production production by inhibiting cellular calcium influx. adamopoulos et al recently found that chf in patients \[mainly new york heart association (nyha) ii-ii\] with low serum magnesium ≤ 2 meq/l was associated with increased cardiovascular mortality (but had no association with cardiovascular hospitalization) compared to those with serum magnesium \> 2 meq/l in a long-term follow-up of 36 months, suggesting that most of these deaths were likely sudden (arrhythmic) in nature. furthermore, stepura and martynow demonstrated that oral magnesium orotate used as adjuvant therapy in severe nyha iv chf patients increased 1-year survival rate and improved clinical symptoms and patient's quality of life compared to placebo. the investigators hypothesized that 1-year supplementation of oral magnesium compared to placebo to chf patients will improve exercise duration time and quality of life.

Eligibility criteria:
inclusion criteria: * chf patients nyha ii-iv \> 3 months * diuretic therapy \> 3 months * signed informed consent exclusion criteria: * chronic renal failure (serum creatinine \> 3 mg/dl) * ami/acs\< 3 months from randomization * cardiac or other organ transplantation * uncontrolled hypo/hyperthyroidism * chronic diarrhea * life expectancy \< 1 year * known psychiatric disease which inhibits patient's enrollment to the study * inability to come for follow-up visits * any planned operation/invasive procedures in the near 6 months * uncontrolled cardiac arrhythmias * inability to perform 6 minute walk testing * any participation in another interventional clinical trial \< 1 month from randomization * any malignancy with life expectancy \ 2 degree without a pacemaker

Keywords: magnesium heart failure
the effects of vilazodone on glutamate in the anterior cingulate cortex in anxious unipolar depressives

Conditions: Major Depressive Disorder; Anxiety; Comorbidity

Summary: the purpose of this study is to determine whether vilazodone is more effective than citalopram for the treatment of anxious depression. we will use neuroimaging to see whether there are changes in the brains of patients receiving the drug vilazodone that are different from those of citalopram. these changes may show that vilazodone affects the brain differently than most other kinds of standard antidepressant medications.

this study proposes to utilize recent advances in magnetic resonance spectroscopy (mrs) techniques that permit reliable measurement of glu in humans (9) to examine whether vilazodone and citalopram exert differential effects on glutamatergic neurotransmission in the acc of anxious unipolar depressed patients. functional connectivity as measured by blood oxygen level dependent (bold) mri will be assessed to determine the relationship between the change in connectivity and the change in glu levels with treatment. we also propose to examine, in an exploratory fashion, the relative effect of the two drugs on bold activation in the insula cortex.

Eligibility criteria:
inclusion criteria: * female, aged 18-50 years. * meets dsm-iv criteria for unipolar major depression. * madrs score \> 20. * subject exhibits clinically significant anxiety and ham-a score \> 15. * capable of providing informed consent. * has an established residence and phone. exclusion criteria: * a clinically significant medical condition which could impact the response of the individual to antidepressant treatment (e.g. diabetes, cancer, lupus or other autoimmune illness). stably treated hypothyroidism (tsh \< 2) will be permitted. * beta blockers, antidepressants, antipsychotics, lithium, antiepileptic medications, steroids (oral and inhaled), chronic use of nonsteroidal antinflamatory medications (infrequent sporadic use permitted), or other medications with the potential to interfere with the antidepressant effects of vilazodone. * pregnancy. * in women of childbearing potential an unwillingness to use reliable methods to prevent pregnancy. * history of manic or psychotic symptoms. * history of seizure or epilepsy. * history of alcohol or drug dependence and active use of substances in the past month. * active alcohol or drug abuse. * ingestion of 4 or more caffeinated beverages a day, on average.

Keywords: depressive disorder anxiety comorbidity magnetic resonance imaging magnetic resonance spectroscopy citalopram vilazodone serotonin uptake inhibitors receptor, serotonin, 5-ht1a
evaluation of the levels of pain and discomfort between two methods of leveling and alignment

Conditions: Crowding

Summary: the duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods. researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. this study consists of two groups, patients will be randomly assigned to one of these two groups.

pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. it was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain. corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. it was used to accelerate tooth movement in animals and case report studies. its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique. no study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.

Eligibility criteria:
inclusion criteria: 1. age range between 18 and 24 years 2. completion permanent dentition (except third molars) 3. mild to moderate crowding (2-6 mm according to little's index) 4. absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment exclusion criteria: 1. systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery 2. medical conditions that affect tooth movement (corticosteroid, nsaids) 3. patients had previous orthodontic treatments 4. poor oral hygiene or concurrent periodontal disease
brain natriuretic peptide (bnp) levels in patients in non invasive mechanical ventilation

Conditions: Respiratory Insufficiency

Summary: the purpose of the study is to evaluate variation of bnp in non invasive mechanical ventilated patients with severe acute respiratory failure.

the aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation bnp levels at admission and during the following 24 hours during non invasive mechanical ventilation (non invasive positive pressure ventilation or continuous positive airway pressure). because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that bnp could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.

Eligibility criteria:
inclusion criteria: * severe respiratory distress (use of respiratory accessory muscles); * respiratory rate \> 25 per minute; * respiratory acidosis (ph \ 45 mmhg); * pao2/fio2 \< 250 exclusion criteria: * age \< 18 years; * facial deformities; * pneumothorax; * shock or systolic arterial pressure below 90 mmhg with amine infusion; * life-threatening arrhythmias; * need for immediate endotracheal intubation (pao2/fio2 \< 100 with fio2 100%, respiratory rate \< 10, gcs \< 8); * lack of co-operation from the patient; * recent esophageal-gastric surgery; * inability to clear secretions; * drugs that may interfere with bnp secretion; * severe obesity; * hepatic cirrhosis with ascitis; * endocrine disease.

Keywords: natriuretic peptide brain continuous positive airway pressure intermittent positive pressure breathing respiratory insufficiency
study evaluating safety and immunogenicity of 13-valent pneumococcal conjugate vaccine with influenza vaccine in adults

Conditions: Pneumococcal Infections

Summary: the 13-valent pneumococcal conjugate vaccine (13vpnc) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). as trivalent influenza vaccine (tiv) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).


Eligibility criteria:
inclusion criteria: * generally healthy male or female adults 65 years of age or older. * available for the duration of the trial - approximately 2 months. * no previous vaccination with any pneumococcal vaccine. * no history of severe adverse reaction associated with a vaccine. * no allergy to egg proteins (eggs or egg products) and chicken proteins.

Keywords: pneumococcal disease pneumococcal conjugate vaccine
enhancing recovery in coronary heart disease (enrichd) patients

Conditions: Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Infarction; Myocardial Ischemia

Summary: to evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

background: as medical treatments for coronary heart disease have become more sophisticated, they have also become more costly. evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients' quality of life, including return to work and to normal levels of functioning, has been mixed. at the same time. recent data suggest that psychosocial factors, such as social isolation and depression, are important predictors of morbidity and mortality in coronary heart disease patients. these studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients. to the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients, the human and financial costs associated with coronary heart disease can be reduced. the initiative originated in the working group on psychosocial interventions which met in june 1992. the initiative was given concept clearance by the october 1993 national heart, lung, and blood advisory council. the request for proposals was released in september 1994. design narrative: the study design compared a psychosocial intervention group, in which patients were provided with social and psychological treatment designed to decrease social isolation and depression, with a standard medical care group. the combined endpoint was death and reinfarction, measured for up to 4.5 years following hospital discharge. secondary endpoints included assessment of health quality of life (hql). the protocol was approved in may 1996. recruitment began in october 1996 and ended on october 31, 1999 with 2,481 patients enrolled.

Eligibility criteria:
men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented mi and who are depressed and/or have low social support. patients must be enrolled with 28 days of the index mi.