Kornimate/medical-research-clean huggingface dataset:
long-term study of cs-3150 as monotherapy or in combination with other antihypertensive drug in japanese patients with essential hypertension

Conditions: Essential Hypertension

Summary: to examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of cs-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 years or older at informed consent * subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ace inhibitor, or angiotensin-ii receptor blockade arb during run-in period (sitting systolic blood pressure sbp ≥ 140 mmhg and \< 180 mmhg, sitting diastolic blood pressure dbp ≥ 90 mmhg and \< 110 mmhg, and mean 24hr sbp ≥ 130 and dbp ≥ 80 mmhg) exclusion criteria: * secondary hypertension or malignant hypertension * diabetes mellitus with albuminuria * serum potassium level \< 3.5 or ≥ 5.1 meq/l (≥ 4.8 meq/l if receive ace inhibitor, or arb) * reversed day-night life cycle including overnight workers * estimated glomerular filtration rate egfr \< 60 ml/min/1.73 m\^2.

Keywords: essential hypertension long-term treatment mineralocorticoid receptor antagonist
anti-interleukin-5 (il-5) study for hypereosinophilic syndrome

Conditions: Hypereosinophilic Syndromes; Eosinophilic Gastroenteritis; Churg-Strauss Syndrome; Eosinophilic Esophagitis

Summary: toxicity of anti-il-5

the purpose of the study is to assess the toxicity of anti-il-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.

Eligibility criteria:
inclusion criteria: * adequate renal, cardiac, and hepatic function * not pregnant or breastfeeding * a diagnosis of hypereosinophilic syndrome such as: * idiopathic hypereosinophilic syndrome; * eosinophilia myalgia syndrome; * eosinophilic gastroenteritis; * churg-strauss syndrome; * eosinophilic cellulitis; * benign hypereosinophilia; or * eosinophilic esophagitis. * maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine * blood eosinophil counts greater than 750 cells/mcl exclusion criteria: * creatinine \> 3 x upper limit for age * ast \> 5 x upper limit for age * platelet count \< 50,000/mm3 * cardiac function: 1. nyha class iiib or iv (patients with shortness of breath or fatigue with mild exertion or at rest); 2. patients with symptomatic supraventricular or ventricular arrythmias requiring treatment; 3. patients requiring iv heart failure medications; 4. angina or acute myocardial infarction * history of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the patient or impact on the validity of the study results * history of allergic or adverse response to previous antibody type therapy * history of allergic or adverse response to anti-il-5 therapy * evidence of, or history of, a parasitic infection (within past 1 year) * participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation * receipt of anti-il-5 therapy in the past * blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation * abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study. * patients who do not have eosinophil levels \> 750 cells/mcl after the run-in period. patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level \> 750 cells/mcl, assuming that they meet all other eligibility requirements. * positive serum pregnancy test * breastfeeding * unable to use effective birth control methods for duration of study * unable or unwilling to give voluntary informed consent/assent
exercise and transcranial magnetic stimulation: increasing brain plasticity in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing bdnf-trkb (brain-derived neurotrophic factor (bdnf) and its receptor, trkb,) signaling and cortical plasticity in patients diagnosed with parkinson's disease (pd) vs. healthy controls matched by age. second, a prospective, randomized, double blind trial of transcranial magnetic stimulation (tms) magstim rapid2 therapy system (tms) (real or sham) and aerobic exercise. this exploratory feasibility study will look at bdnf-trkb signaling and cortical plasticity.

twenty-four pd patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. in group 1, subjects will participate in daily sessions of sham-rtms followed by supervised aerobic exercise (sham rtms+aerobic); in group 2, subjects will participate in a combination of rtms and supervised aerobic exercise (real rtms+aerobic). serum bdnf-trkb signaling in lymphocytes and tms-based electrophysiological measures of ltp-like plasticity will be measured. a comparison of such measures in a group of patients with pd and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.

Eligibility criteria:
inclusion criteria: * diagnosis of pd according to the uk brain bank criteria, confirmed by a neurologist with expertise in movement disorders; * hoehn and yahr stage ii to iii; * on a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months. inclusion criteria (healthy controls) * male or female; aged 35-85 exclusion criteria (healthy controls) * history of seizure disorder, including febrile seizures; * neurological disorder including pd, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s); * major or unstable medical illness; * pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed); * untreated depression, or score of \>20 on beck depression inventory ii; * taking any of the following medications within the six weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, calcium channel blockers, beta blockers, tadalafil, vardenafil, avanafil, and sildenafil; * diagnosis of dementia, or montreal cognitive assessment (moca) \<20; * any clinically significant abnormality on vital signs * cardiopulmonary limitations: untreated high blood pressure, history of heart insufficiency (class ii-iii), coronary vascular disease, angina, arrhythmia, dyspnea on exertion and asthma

Keywords: transcranial magnetic stimulation exercise brain plasticity
prom by amnioquick duo+ in egyptian women

Conditions: PROM (Pregnancy)

Summary: preterm premature rupture of the membranes (pprom) is responsible for one-third of all preterm births. optimum treatment relies on accurate diagnosis and gestational age. the diagnosis of pprom is made by a combination of examination, patient history and some simple tests.

premature rupture of the fetal membranes (prom) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. prom may be subdivided into term -prom (tprom, i.e. prom after 37 weeks of gestation) and preterm prom (pprom, i.e. prom prior to 37 weeks of gestation). pprom occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.the diagnosis of pprom is made by examination , patient history and simple testing. patient history has an accuracy of 90% for the diagnosis of pprom

Eligibility criteria:
inclusion criteria: * pregnant ladies with prom from 20- 37 weeks exclusion criteria: * gestational age \>37 wks non reassuring ctg signs of chorioamnonitis ( fever , maternal or fetal tachycardia , foul cervical discharge , uterine tenderness or high tlc ) antepartum hemorrhage
singapore neurologic infections program

Conditions: Central Nervous System Infections

Summary: worldwide, central nervous system infections such as inflammation of brain (encephalitis), inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe infectious in origin result in significant illness and death and healthcare costs. vast majority of central nervous system infections remain without an identifiable cause. there is also concern about new and emerging infections. this study thus intends to fill in the gaps in knowledge with regards to central nervous system infections in singapore to give a thorough description of burden of causes of central nervous system infections and detection of outbreaks of new pathogens. patients suspected of central nervous system infection will be recruited from 5 restructured singapore hospitals and their blood and other clinical specimens will be sent for testing. patients will also be followed up to assess long term outcomes and socio-economic costs of these infections. this will help clinicians, policymakers and public health officials in estimating financial and societal costs of cns infections in singapore.

the study aims to: 1. to describe the epidemiology of cns infections in singapore. 2. to improve the diagnosis of aetiologies of cns infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing. 3. to evaluate the prognosis, long-term outcomes and socio-economic costs of cns infections. 4. to establish an archive of biological tissues from patients with encephalitis and cns infections that can be utilized for future testing for emerging novel pathogens or non-infectious aetiologies. the study will recruit 400 patients over 2 years from 5 restructured hospitals in singapore. as this is not a comparative study, sample size was not determined. the study involves clinical and laboratory data collection. data will also be collected on quality of life and for health economic analysis. the quality of data and its integrity will be periodically reviewed by the principal investigator and members of the study team. all samples stored will be de-identified and all data will be de-identified during analysis.

Eligibility criteria:
inclusion criteria: 1. clinical suspicion for central nervous system (cns) infections, or 2. any two of the following, 1. fever or history of fever (≥ 38 °c) during the presenting illness 2. seizures of new onset 3. focal neurological deficits 4. cerebrospinal fluid white cell count pleocytosis (\> 4 white blood cells (wbc)/ul) 5. abnormal neuroimaging suggestive of cns infection. 6. abnormal electroencephalogram (eeg) suggestive of cns infection 7. depressed or altered level of consciousness, or 3. no alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc) exclusion criteria: 1. patient or next of kin unwilling to give consent 2. patients with indwelling ventricular devices such as evd (external ventricular drain), vp (ventriculo-peritoneal) shunts

Keywords: encephalitis viral infections central nervous system
measurement of natural killer cell activity in whole blood in men being screened for prostate cancer with biopsy

Conditions: Immunity, Innate; Prostatic Neoplasm

Summary: this study will look at measuring the activity of natural killer (nk) cells using the in vitro diagnostic device nk vue in subjects being screened for prostate cancer using prostate biopsy.

the nk vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon-gamma using an immunoassay. nk vue is intended to be used for the monitoring of the immune status of individuals. measurement of nk cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where nk cell activity has been shown to be affected.

Eligibility criteria:
inclusion criteria: 1. male aged ≥ 18 years old 2. able to read and sign an approved informed consent form 3. soon to be undergoing a needle prostate biopsy for suspected prostate cancer; patients with a history of prior biopsy are not excluded provided the biopsy was negative 4. all prior and current recorded psa levels are \< 11 ng/ml (minimum of 2 values must be available) 5. digital rectal exam performed or scheduled to be performed prior to biopsy exclusion criteria: 1. any other established malignancy with the exception of basal cell carcinoma 2. at time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient 3. chronic inflammatory condition requiring anti-inflammatory treatment such as rheumatoid arthritis, crohn's or ulcerative colitis, lupus or any connective tissue condition which, in the opinion of the investigator, might affect the immune response 4. presently taking any of the following classes of medications on a regular basis: * 5-alpha reductase inhibitors * anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid * anti-androgens * testosterone replacement therapy
effect of propofol and sevoflurane on lactate during anesthesia for pediatric heart catheterisation

Conditions: Metabolic Acidosis

Summary: propofol is routinely used for general anesthesia during pediatric heart catheterisation. propofol infusion syndrome (pris) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. metabolic acidosis is regarded as an early warning sign of pris. in this study the effect of propofol and sevoflurane on serum base excess, ph and lactate are examined during pediatric heart catheterisation.

in this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (n = 22) or sevoflurane (n = 18) with ethic committee approval. base excess, ph and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. changes relative to baseline were analysed by paired t-test with correction for multiple testing. the study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.

Eligibility criteria:
inclusion criteria: * indication for heart catheterization under general anesthesia exclusion criteria: * participation in another study * preexisting metabolic acidosis * contraindication against propofol

Keywords: propofol metabolic acidosis pediatric cardiology anesthesia
botanical oil supplementation in diabetic and metabolic syndrome subjects

Conditions: Diabetes; Metabolic Syndrome x

Summary: this study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.


Eligibility criteria:
inclusion criteria: * adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by ncep/atpiii criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood tg greater than or equal to 150mg/dl or be taking tg lowering medications; 3. blood hdl cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on htn medication 5. fasting glucose greater than or equal to 100 mg/dl. * participants on statins or glucose lowering drugs if dosages are stable for 3 months exclusion criteria * children/young adults less than 21 years of age * currently using anti-inflammatory drugs including nsaids, oral/iv steroids or injection antiinflammatory drugs(for ra), aspirin greater than 100mg/day * taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids ok. * currently using niacin, fibrates or fish oil * blood pressure greater than 170/100 * hb1ac greater than 10% * tg greater than 500 mg/dl * myocardial infarction/vascular surgery/stroke within the past year * any stage ii,iii,iv heart failure * prior cholecystectomy * end stage renal disease * bmi less than 23 or greater than 45 * pregnancy * alcohol use greater than 14 drinks per week * current self reported tobacco or illicit drug use * intolerance or allergy to fish oil * participants taking insulin on qd or bid doses, stable for 3 months

Keywords: diabetes metabolic syndrome inflammation botanical oils
constraint-induced movement therapy and hand arm bimanual training in children with hemiplegic cerebral palsy (cp)

Conditions: Cerebral Palsy; Hand Function

Summary: the combination of the constraint-induced movement therapy (cimt) method as a complement to hand arm bimanual training (habit) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic cp.


Eligibility criteria:
inclusion criteria: * active wrist extension/dorsiflexion of at least 20; * macs 1-3; * gmfcs 1-2; * enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence. exclusion criteria: * seizures; * severely increased muscle tone; or hemi arm to good; * orthopedic surgery on the upper extremity; * botulin toxin injections within the past half year to the upper extremity; * inability to understand instructions or cognitive/behavior/concentration.

Keywords: cerebral palsy
effect of manipulation on coccydynia

Conditions: Coccyx Disorder; Pelvic Floor; Weak; Stretch

Summary: the aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.

subject: coccydynia is a painful condition characterized by inflammation and discomfort in the coccyx region, commonly known as the tailbone. it can significantly affect an individual's quality of life by impairing their ability to sit, stand, or engage in daily activities. various treatment approaches have been explored to alleviate the symptoms of coccydynia, including manipulation techniques and exercise interventions. however, to date, there is a scarcity of research investigating the combined effects of manipulation and exercise for patients with coccydynia. purpose: the purpose of this study is to evaluate the efficacy of combining manipulation techniques with exercise interventions for patients diagnosed with coccydynia, a painful condition affecting the coccyx region. despite the debilitating impact of coccydynia on daily activities and quality of life, there is a limited understanding of the optimal treatment approach for this condition. this study aims to address this knowledge gap by investigating the potential benefits of combining manipulation and exercise in managing coccydynia.

Eligibility criteria:
inclusion criteria: * chronic (3 months) coccydynia * age over 25 and under 60 years * no ongoing antidepressant treatment * no medicolegal litigation or occupational-accident etiology exclusion criteria: * undergoing an operation aimed at the anal area * those with additional diseases such as radiculopathy etc.
safety and efficacy of vildagliptin versus nph insulin add-on to glimepiride in type 2 diabetes mellitus patients.

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to evaluate safety and efficacy of vildagliptin versus nph insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type 2 diabetes mellitus. * contraindicated or intolerant to take metformin. * hba1c of ≥ 7.0% and ≤ 8.5% * current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled * other protocol-defined inclusion/exclusion criteria may apply exclusion criteria: * patients who are taking any other anti-diabetes drug (oral or injection) other than an su component in the preceding 12 weeks. * acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month * patients taking sulfonylurea for longer than 5 years * history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures * pregnancy * other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes mellitus, diabetes
mepolizumab as a steroid-sparing treatment option in the churg strauss syndrome

Conditions: Churg Strauss Syndrome

Summary: the purpose of this study is to determine whether mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent churg-strauss syndrome (css).

specific aims: 1. document the safety of mepolizumab therapy in patients with css. 2. demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-il5 therapy. 3. demonstrate the efficacy of anti-il5 therapy in improving the signs and symptoms of css by: 1. measuring serum markers of css disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, c-reactive protein and ige levels. 2. assessing the activity level of vasculitis via the birmingham vasculitis activity score 3. evaluating asthmatic response via serial peak flow and fev1 measurements as well as asthma symptom scores using the juniper scale. 4. assessing changes in novel parameters such as fractional excretion of nitric oxide and il-5 levels.

Eligibility criteria:
inclusion criteria: * age \>18 years old * diagnosis of churg strauss syndrome * maintained on stable corticosteroid dose of at least prednisone 10mg daily (or equivalent) prior to enrollment in study * if on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be able to maintain that dose for the duration of the study exclusion criteria: * hypereosinophilic syndrome * wegener's granulomatosis * malignancy * parasitic disease * pregnant or nursing * if female and of child-bearing potential, must have negative pregnancy test prior to each infusion of study medication and must adhere to acceptable method of contraception (with \<1% failure rate) * any other medical illness that precludes study involvement

Keywords: churg strauss syndrome