Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lcz696 in comparison to olmesartan in elderly patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to access the efficacy and safety of lcz696 compared to olmesartan in elderly asian patients for the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * patients must give written informed consent before any assessment is performed * patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmhg and \< 180 mmhg * patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance exclusion criteria: * patients with severe hypertension (msdbp ≥ 110 mmhg and/or mssbp ≥180 mmhg). patients with history of angioedema, drug-related or otherwise * patients with history or evidence of a secondary form of hypertension * transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke * history of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (pci) during the 12 months prior to visit 1. * current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates). * patients with type 1 or type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication * patients with previous or current diagnosis of heart failure (nyha class ii-iv). * patients with a clinically significant valvular heart disease at the time of screening * women of child-bearing potential, who do not use adequate birth control methods other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, blood pressure, lcz696, dual inhibitor, neprilysin, nep inhibition, vasopeptidase, arni, angiotensin receptor
risperidone treatment in schizophrenia patients who are currently taking clozapine

Conditions: Schizophrenia

Summary: this study will determine whether adding the drug risperidone (risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. however, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. an emerging trend in treatment is the addition of a second antipsychotic drug. this study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy. participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. neurological tests, self administered questionnaires, and interviews are used to assess patients.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for schizophrenia or schizoaffective disorder * current clozapine treatment * moderate illness severity and inadequate positive symptom response to clozapine treatment * 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml exclusion criteria: * organic brain disorder * mental retardation * medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol * pregnancy * dsm-iv criteria for current alcohol or substance dependence within the last 6 months or dsm-iv criteria for alcohol or substance abuse within the last month * previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks
effect of a pomegranate extract on cardiovascular risk markers in overweight healthy subjects

Conditions: Overweight

Summary: the investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract. the investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-ldl as well as other inflammatory markers. the correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.


Eligibility criteria:
inclusion criteria: * aged 40-65 years * body mass index (bmi) \>27 kg/m2 * healthy status (no illness in the previous 3-months). exclusion criteria: * smoking. * pregnancy/lactation. * severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, crohn disease etc.). * previous gastrointestinal surgery * recent use of antibiotics (within 1-month prior to the study) * suspected hypersensitivity to pomegranate or any of its components * consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication. * regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire). * intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.

Keywords: pomegranate cardiovascular urolithins microbiota polyphenols nutraceutical dietary supplement
a trial to evaluate the loading dose required to achieve therapeutic serum teicoplanin concentration timely

Conditions: Staphylococcal Infections

Summary: the purpose of this study is to determine whether the standard dosage of teicoplanin is adequate to produce timely the trough level \> 10 mg/l, which is considered to be effective in the treatment of methicillin-resistant staphyllococcus aureus (mrsa) bacteremia.

in our hospital, the minimum inhibitory concentration of 100 mrsa isolates in 2003 for teicoplanin is 2 mg/l. due to its time-dependant bacteriocidal effect, the trough level should exceed 10 mg/l, particularly in the elderly, for mrsa bacteremia. however, it is known that standard dosage of teicoplanin often produces inadequate serum trough levels, and mrsa infections may recurred. therefore, to evaluate the loading dose required to achieve therapeutic concentration timely, we compare the trough levels between those given standard dose (6 mg/kg) and those given increasing loading dose (12 mg/kg). we also monitor the occurrence of adverse drug effects and clinical response.

Eligibility criteria:
inclusion criteria: * patients over 16 years of age who have blood culture-proven mrsa bacteremia and did not receive teicoplanin or vancomycin in the previous one month are enrolled. exclusion criteria: * those who are allergic to teicoplanin or who have the need to use higher doses, 12 mg/kg/dose, such as endocarditis, osteomyelitis, septic arthritis and burn patients, are excluded.

Keywords: teicoplanin
exoskeletal support in stroke

Conditions: Stroke

Summary: this interventional study will measure motor performance, including 3d movement analysis and muscle activity, in response to exoskeleton assistance. the cohort design will compare stroke patients to healthy controls. data collection will be conducted in a single, 2-hour session. investigators will also access stroke patients' brain mris that were obtained as standard of care during acute admission for stroke.


Eligibility criteria:
inclusion criteria: healthy controls: * having obtained the age of 18 years * neurologically healthy (i.e., no history of: traumatic brain injury, peripheral neuropathy, seizures, etc.) * strongly right-handed according to at least 80% score on the edinburgh handedness inventory (oldfield, 1971; veale, 2013). the use of right-handed participants is a common feature in this field of study. this is due to the slight differences in arm control between left- and right-handed individuals (sainburg \& kalakanis, 2000). * ability to give informed consent survivors of stroke: * having obtained the age of 18 years * have a diagnosis of stroke more than six months prior to entry into the study; * have the ability to reach, unsupported, to approximately 70% of arm length * ability to give informed consent exclusion criteria: all participants * have any conditions that limit their capability of using a head mounted display (hmd) for a vr environment or cooperate with the protocol. * have any orthopedic injuries to the upper extremities. * have neurological injuries other than stroke. * have excessive pain in any joint of either arm that could limit the ability to cooperate with the protocols. * visuospatial neglect * apraxia * global inattention * legal blindness
a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer

Conditions: Rectal Cancer; Neoadjuvant Therapy

Summary: this is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.


Eligibility criteria:
inclusion criteria: * age ≥18 years, male or infertile female * patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy * neoadjuvant therapy according to guideline recommendations * endoscopic biopsy with access to biopsy tissue for subsequent rna-seq testing * patients who do not have a combination of primary malignant tumors elsewhere. * patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form. exclusion criteria: * samples are not collected, stored, or processed in accordance with specified requirements * sample does not meet the requirements for subsequent rna-seq testing * cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma. * the patient refuses or is unable to complete the entire neoadjuvant treatment * lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results. * other patients who, in the judgment of the investigator, do not meet the enrollment requirements
clinical investigation of the next generation intraocular lens

Conditions: Cataract

Summary: an investigational iol designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

the next generation tecnis iol designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal iol. assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logmar and spectacle wear frequency.

Eligibility criteria:
inclusion criteria: * minimum 22 years of age * bilateral cataracts for which posterior chamber iol implantation has been planned * corneal astigmatism: * normal corneal topography * availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits * signed informed consent and hipaa authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries * ability to understand and respond to a questionnaire in english exclusion criteria: * irregular corneal astigmatism * inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * prior corneal refractive (lasik, lasek, rk, prk, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs * poorly-controlled diabetes * patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes * concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial * desire for monovision correction
evaluation of the gametocytocidal efficacy and safety of primaquine in uncomplicated falciparum malaria in uganda

Conditions: Falciparum Malaria

Summary: the purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the who for reducing p. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.

a single dose of 0.75mg/kg primaquine base is recommended by the who to block transmission of falciparum malaria from infected humans to mosquitoes by clearing gametocytes. however, the optimal dose for safety and efficacy has not been evaluated. dose-finding data is important because primaquine has a dose-dependent risk of causing haemolysis (destruction of blood cells) in pre-disposed individuals, such as those with g6pd deficiency. g6pd deficiency is most prevalent in malaria-endemic areas. therefore, it is essential that data on primaquine's safety is available in such areas. the investigators hypothesise that lower doses of primaquine have a lower risk of adverse effects compared to the who-recommended dose, but retain the transmission-blocking efficacy. the investigators propose to test this hypothesis in a four-arm clinical trial with a non-inferiority design to evaluate the efficacy and a superiority design to evaluate the safety of the who dose (0.75mg/kg) and lower doses of primaquine for clearance of p. falciparum gametocytes in children in uganda. the study will include a pharmacokinetic analysis.

Eligibility criteria:
inclusion criteria: * age \>/= 1 year and \</= 10 years * weight over 10kg * fever \>38 degrees c (tympanic) or history of fever in the last 24 hours * p. falciparum parasitaemia \<500 000/µl * normal g6pd enzyme function exclusion criteria: * enrolled in another study * evidence of severe illness/ danger signs * known allergy to study medications * haemoglobin \< 8g/dl) * started menstruation * pregnancy or breastfeeding * primaquine taken within the last 4 weeks * blood transfusion within the last 90 days * non-falciparum malaria co-infection

Keywords: malaria uncomplicated malaria gametocytocidal drug gametocytocidal gametocyte primaquine transmission blocking malaria transmission sexual parasite sexual stage uganda africa
the efficacy of laser assisted hair removal in the treatment of acne keloidalis nuchae; a pilot study

Conditions: Acne Keloidalis Nuchae

Summary: laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in acne keloidalis nuchae (akn).


Eligibility criteria:
inclusion criteria: * patients suffering from akn
exercise in severe mental illness. the psychiactive project 2.0

Conditions: Exercise Therapy; Severe Mental Illness

Summary: the purpose of this randomized controlled trial is to study the feasibility, adherence and effects of two exercise interventions on body weight, body composition, anthropometric and fasting blood measures, physical fitness, quality of life, and lifestyle habits in patients with severe mental illness.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of psychiatric disorder (icd-10). * stabilized antipsychotic medication during the last month. exclusion criteria: * clinical instability. * substance abuse. * comorbidities contraindicating.

Keywords: exercise severe mental illness adherence wearables activity trackers exergames
dynamic variation of impedance cardiography(dyvic) as a diagnostic tool of acute heart failure (ahf)

Conditions: Heart Failure

Summary: the study aimed to evaluate the diagnostic performance of cardiac output (co) change after the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.

acute heart failure (ahf) is a frequent condition in emergency department and is responsible of high number of admissions, complications, and deaths. despite advances in diagnostic techniques, ahf diagnosis still be challenging . measurement of cardiac output (co) is used to evaluate global cardiac function and changes in co may be used to identify a change in the hemodynamic status of patient. the gold standard of measuring co is thermodilution catheterization, however it is an invasive technique with high risks. impedance cardiography (icg) is a noninvasive method for measuring co. it is performed by applying small electrical current to the chest through electrodes placed on the neck and sides. the pulsatile flow of blood causes fluctuations in the current, and the device calculates co from the impedance waveform. in practice, the investigators connect the device "biopac" by using four electrodes which the investigators place on the base of the neck (posterior face) and on the base of the thorax (posterior face). the ecg recording is taken simultaneously with two other electrodes placed at the right upper limb and left lower limb. in addition to detecting the electric current and the ecg, heart sounds are recorded using a sensor that is placed at the mitral site. each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then co is measured (baseline co). ntg (0.6 mg) is then given to the patient sublingually and co measurement was repeated. co is calculated by averaging three measurements at one minute intervals at baseline and after ntg administration. deltaco was defined as the percent of change of baseline co after ntg test.

Eligibility criteria:
inclusion criteria: * 18 year old or above non traumatic acute dyspnea exclusion criteria: * ecg diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours, * pericardial effusion , * chest wall deformity suspected of causing dyspnea, * coma, * need for mechanical ventilation or vasopressor drugs, * serious and sustained arrhythmia, * pace maker, * severe mitral valve disease, severe pulmonary arterial hypertension, * renal failure (creatinine \>350µmol/l.

Keywords: dyspnea acute heart failure bio-impedance biopac system
scalp blocks for pediatric external ventricular drainage placement

Conditions: Hydrocephalus in Children; Regional Block; Pediatric Anesthesia

Summary: external ventricular drainage (evd) provides cerebrospinal fluid drainage in hydrocephalus. in adults, the neurosurgeon can place evd at the bedside. in children, it is mainly preferred to be placed in the operating room under general anesthesia. however, general anesthesia may negatively affect oxygenation (during the intubation period) or cerebral blood flow (due to hypotension). this study investigates the use of regional block methods (without general anesthesia) in children for evd placement.

external ventricular drainage (evd) provides cerebrospinal fluid drainage in hydrocephalus. in adults, evd can be placed by the neurosurgeon at the bedside. in children, it is mainly preferred to be placed in the operating room under general anesthesia. however, general anesthesia may negatively affect oxygenation during a prolonged intubation period, leading to hypoxemia. furthermore, hypotensive effects of general anesthesia may cause ischemia due to decreased cerebral blood flow. additionally, on the other hand, painful stimuli caused by surgical incisions or pins may cause hemorrhagic events due to a hypertensive period. therefore, scalp blocks and local anesthetic infiltrations are recommended to prevent such adverse events. although general anesthesia has been a routine for many anesthesiologists for evd placement in children, this research hypothesizes that scalp blocks (along with sedatives) can be used as an anesthesia method for evd placement. this study investigates the use of regional block methods (to avoid general anesthesia) in children for evd placement.

Eligibility criteria:
inclusion criteria: * children undergoing external ventricular drainage exclusion criteria: * children who were intubated preoperatively.
prospective study of motion preservation evaluation below fusions of the spine in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this study is to evaluate the relationship of a) the distal fusion level b) the total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with adolescent idiopathic scoliosis.

the motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. the purpose of this study is to evaluate the relationship of a) the distal fusion level b) the total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with adolescent idiopathic scoliosis to answer the following specific clinical questions: 1. further elucidate the motion behavior of the distal unfused spinal segments, specifically: 1. does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)? 2. can predictive factors be identified with post-operative altered motion? 2. further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae. 3. determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in lenke 5/6 patients fused selectively (thl/l only) versus nonselectively (th and thl/l)). 4. determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (health related quality of life outcome tools) to motion in the distal unfused segments.

Eligibility criteria:
inclusion criteria: * patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria: * patient age \< 21 years * male or female * diagnosis of adolescent idiopathic scoliosis * any lenke classification type * underwent surgical correction of the spinal deformity with a fusion * are due for their 10 year post-operative visit exclusion criteria: * patients will be excluded from study inclusion if they meet the following exclusion criteria: * neuromuscular co-morbidity

Keywords: adolescent idiopathic scoliosis spinal deformity treatment outcomes