Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of combination treatment of fimasartan/atorvastatin in patients with essential hypertension and dyslipidemia

Conditions: Essential Hypertension, Dyslipidemia

Summary: the objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at week 8 in patients with essential hypertension and dyslipidemia.


Eligibility criteria:
inclusion criteria: 1. voluntarily provided a written consent to participate in this clinical study 2. male or female adults aged 19-70 years 3. patients must have been confirmed essential hypertension and dyslipidemia at screening visit (v1) 4. uncontrolled blood pressure (140 mmhg ≤ mean sisbp \< 180 mmhg) at the pre- baseline visit (v2) after wash-out period 5. able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion exclusion criteria: 1. severe hypertension with mean sitting systolic blood pressure(sisbp)≥180 mmhg or sitting diastolic blood pressure(sidbp) ≥110 mmhg at the screening visit (v1) and the pre-baseline visit (v2), or orthostatic hypotension accompanied by symptoms 2. difference of sitting systolic blood pressure(sisbp) ≥ 20 mmhg and sitting diastolic blood pressure(sidbp) ≥ 10 mmhg between lt and rt arms for 3 consecutive times at the screening visit (v1) 3. secondary hypertension patients: secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's syndrome, pheochromocytoma, and polycystic kidney disease) 4. uncontrolled diabetes mellitus (currently on insulin, or hba1c \>9% at the pre-baseline visit (v2)), or uncontrolled hypothyroidism (tsh ≥1.5 times the upper limit at the pre-baseline visit (v2)) 5. heart disease (heart failure of new york heart association (nyha) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (v1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. 6. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis 8. cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (v1) 9. pregnant or lactating women
modulation of anaerobic gut bacteria of arsenicosis patients by probiotics

Conditions: Chronic Arsenic Poisoning

Summary: the role of anaerobic bacteria in the pathogenesis of palmer arsenical keratosis is not known. this can be evaluated by administering probiotics. thirty patients from an arsenic affected area will be provided two probiotics capsules per day orally for 12 weeks and stool samples will be collected for qualitative and quantitative analysis of anaerobic bacteria. similar number of arsenic exposed controls and healthy volunteers from the same area will be included with similar protocol for comparison. like aerobic bacteria, anaerobic bacteria may be modulated by probiotics in arsenicosis patients.

recent study done by our laboratory shows that there are reduction in the number of e. coli in the gut of patients with arsenical keratosis which is increase by the administration of probiotics (manuscript is preparing). however, e.coli contribute only about 0.1% of the total gut bacteria. it is not known whether anaerobic bacteria play an important role in the pathogenesis of arsenical keratosis. this can be evaluated by administering probiotics. thirty patients of moderate arsenical palmer keratosis from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria. they will be provided two probiotics capsules per day orally for 12 weeks. water sample will be collected before starting the study for confirming the diagnosis. stool samples will be collected twice (before and after completion of the study) for qualitative and quantitative analysis of anaerobic bacteria. similar number of arsenic exposed controls (30) and healthy volunteers (30) from the same area will be included in this study and they will be provided probiotics capsules with similar dosage and duration. like aerobic bacteria, anaerobic bacteria may be modulated by probiotics in arsenicosis patients.

Eligibility criteria:
inclusion criteria (patients): * history of taking arsenic contaminated water (\>50 ppb) for more than 6 months * patients having moderate arsenical keratosis present on palm of the hand * patients those voluntarily agree to participate inclusion criteria (arsenic exposed controls): * family member of the patient * drinking arsenic contaminated water from the same source as patient * those voluntarily agreed to participate * no sign/symptoms of palmer keratosis inclusion criteria (healthy volunteers): * drinking arsenic safe water \<50 ppb) * those voluntarily agreed to participate exclusion criteria: * pregnancy * lactating mother * patient receiving treatment of arsenicosis * any other chronic disease like tuberculosis, diabetes, asthma

Keywords: chronic arsenic poisoning palmer arsenical keratosis
follow-up of breast cancer and multiple myeloma patients previously enrolled in nih gene therapy studies

Conditions: Gene Transfer

Summary: this study will provide follow-up evaluations of breast cancer or multiple myeloma patients who received gene therapy (gene transfer) as part of their participation in an nih protocol. gene therapy is a new technology, which may involve a permanent change in the patient s genetic code. therefore, although the risk of long-term harmful effects of this therapy is very small, the food and drug administration requires prolonged monitoring of patients health status. patients previously enrolled in nih protocols 96-c-0007, 93-c-0208, 92-c-0161, or 92-h-0057 will be followed under the current protocol. no further gene therapy will be provided in this study. patients health status will be evaluated for an indefinite period of time, or as long as they are willing to be monitored. they will provide a blood sample once a year and will be interviewed about their health status twice a year for the first 5 years after gene therapy and once a year thereafter. these procedures are done to look for the development of any diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be related to side effects of the gene transfer.

this protocol aims to provide long-term follow-up of breast cancer and multiple myeloma subjects previously receiving autologous primitive marrow and blood hematopoietic cells exposed to gene transfer retroviral vectors on the following protocols: mb 294 (92-c-0161; t-92-0018), mb 310 (93-c-0208; t-92-0192), mb 361 (96-c-0007; t-95-0096) or (92-h-0057; t-92-0139) at the national cancer institute and the national heart, lung, and blood institute. subjects will undergo an annual health history and annual complete blood counts will be performed. blood samples will also be collected annually (either locally or off-site by the subjects' personal physicians) for testing for presence of the gene transfer vector and vector integration sites.

Eligibility criteria:
* inclusion criteria: subjects who received gene transfer products on the following protocols: mb 361, 96-c-0007, t-95-0096; mb 294, 92-c-0161, t-92-0018; mb 310, 93-c 0208, t-92-0192; or 92-h-0057, t-92-0139. exclusion criteria: patients unwilling to participate.

Keywords: gene transfer hematopoietic stem cells follow-up
a clinical comparison of two soft multifocal contact lenses

Conditions: Presbyopia

Summary: the study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

the aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: 1. they were at least 42 years of age and had capacity to volunteer. 2. they understood their rights as a research subject and were willing and able to sign a statement of informed consent. 3. they had had a full eye examination within the past two years (by self-report). 4. they were willing and able to follow the protocol. 5. they habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months. 6. they had refractive astigmatism of no greater than -0.75dc. 7. they could be fitted with the study lenses within the power range available, and achieved binocular distance hcva of +0.20 or better in the study lenses. exclusion criteria: subjects were not eligible to take part in the study if: 1. they had an ocular disorder which would normally contra-indicate contact lens wear. 2. they had a systemic disorder which would normally contra-indicate contact lens wear. 3. they were using any topical medication such as eye drops or ointment. 4. they were aphakic. 5. they had had corneal refractive surgery. 6. they had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus. 7. they were pregnant or lactating. 8. they had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
gleevec trial in patients with newly diagnosed chronic phase chronic myelogenous leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: this study will evaluate the molecular response to high dose gleevec in newly diagnosed patients with chronic myelogenous leukemia (cml) in chronic phase. this study will evaluate the ability of gleevec to reduce the amount of abnormal protein that occurs in patients with cml. patients who are eligible to participate will be treated for 18 months. this trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with cml.


Eligibility criteria:
inclusion criteria: participants must meet all of the following criteria: * male or female patients 18 years and older. * patient with a diagnosis of chronic myelogenous leukemia in chronic phase * within 6 months of initial diagnosis. * received any treatment for cml for less than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. exclusion criteria: * late chronic phase, accelerated phase or blastic phase * taking any other investigational agents within 28 days of starting the study * if sibling donors have been identified and where allogeneic bone marrow transplantation will be the first line treatment. * another primary malignancy /cancer unless it is not considered clinically significant or does not require active intervention. * if patients have heart problems or complications * pregnant or breast-feeding females * severe and/or uncontrolled disease such as diabetes, chronic renal disease, etc. * chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). * diagnosis of human immunodeficiency virus (hiv) infection. * received any treatment for cml for longer than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide. * patient previously received radiotherapy to greater than 25% of the bone marrow. * patient had a major surgery within 4 weeks prior to study entry

Keywords: cml chronic myelogenous leukemia right trial us177 csti571
does having a spouse present during epidural analgesia affect stress levels in the parturient and her spouse?

Conditions: Labor Pain

Summary: it is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor. couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is not present. before and after epidural anlgesia, both the spouse and parturient will be have their blood pressure and pulse checked. in addition, both will have their salivary amylase measured. salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. to check this enzyme, a sample of saliva is given.


Eligibility criteria:
inclusion criteria: * healthy term parturients exclusion criteria: * diabetes * preterm labor * mouth pathologies

Keywords: parturient epidural analgesia labor spouse stress levels salivary amylase
evaluation of the analgesic efficiency of the transcutaneous neurostimulation in the charcot syndrome marie tooth on the pains of lower limbs

Conditions: CHARCOT MARIE TOOTH DISEASE

Summary: the charcot syndrome marie tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). in the literature and in our recent study (evaluation of the pain in the disease of cmt - reference center of the neuromuscular diseases - chu bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. the care of the pain in the charcot syndrome marie tooth is not codified. the transcutaneous neurostimulation(tens) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. no study was realized this day on the use of the tens with analgesic aim in the cmt. we suggest studying the analgesic efficiency of the tens in the charcot syndrome marie tooth on the pains of lower limbs, the most frequent painful location in our recent works. the main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (eva), at least 30 %. the secondary objectives will be to estimate repercussions on the functional capacities ( onls), the quality of life (sf(sci-fi) 12), the satisfaction (eva), the global impression(printing) of change ( pgic), the consumption of analgesic, dn4, npsi (neuropathic pain symptom inventory), concise questionnaire of the pains ( qcd), had (hospital anxiety and depression scale).


Eligibility criteria:
inclusion criteria: * age included between 18 and 75 years * affected by cmt confirmed on clinical, family criteria, electrophysiological and / or genetics * pain ≥ 3 months * eva pain ≥ 4/10 * patient having given his written consent and lit(enlightened) * patient susceptible to be followed regularly during at least 3 months * patient member to the social security exclusion criteria: * expanding patients of associated neurological pathology * patients having resorted to the tens in the last 3 months * medical history of cancers, collagen and quite other pathology which can interfere with the experimental procedure * patient carrier of a pacemaker or an active implantable medical device * cutaneous hurt on the territory to be stimulated * venous or arterial thrombosis or thrombophlebitis in the territory to be stimulated * patient participant in another biomedical research on the pain or the period of exclusion of which in a study is not ended * patient under guardianship or deprived of all his liberties
long-term behavioral and cognitive outcomes of deep brain stimulation in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this observational study is to evaluate the long-term effect of dbs-stn on cognitive and behavioral outcomes in parkinson's disease (pd) patients. pd patients will be assessed over time using tests, questionnaires and standardized clinical scales. an initial assessment (t0) and annual follow-up assessments will be carried out for 5 years. researchers will compare data collected from patients with dbs versus patients with best medical therapy.


Eligibility criteria:
inclusion criteria: * parkinson's disease patients candidates for dbs of the subthalamic nucleus * parkinson's disease patients with best medical treatment exclusion criteria: * patients unable to complete study assessments

Keywords: parkinson disease deep brain stimulation cognitive dysfunction mood anxiety quality of life
non-penetrating deep sclerectomy versus trabeculotomy- trabeculectomy operation in treatment of primary congenital glaucoma

Conditions: Congenital Glaucoma

Summary: the high success rate of the non-penetrating deep sclerectomy (npds) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood pcg. in deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. this membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure. the aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma


Eligibility criteria:
inclusion criteria: * patients with pcg younger than 6 years old with a hcd between 12-14 mm ware exclusion criteria: * patients with anterior segment anomalies, * secondary glaucoma * previous anterior segment surgeries * patients more than 6 years old
hydrogen-rich water and appetite in obesity

Conditions: Obesity

Summary: the main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone glp-1 in men and women with obesity. this randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.

the primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating glp-1 levels in obese men and women

Eligibility criteria:
inclusion criteria: * age 18-65 years * body fat \> 30% in women and \> 25% in men * not physically active * informed consent signed exclusion criteria: * major chronic disease and acute injuries * history of dietary supplement use during the past 4 weeks * history of obesity pharmaceuticals use during the past 8 weeks * no consent to randomization * participation in other studies

Keywords: dihydrogen appetite ldl cholesterol supplementation
the benefits of nature for mood and cognition in persons with and without parkinson's disease

Conditions: Parkinson Disease; Mood; Cognition

Summary: this online study aims to explore the benefits of nature for mood and cognition in persons with and without parkinson's disease. for the purpose of this survey, "natural environment" refers to places that primarily consist of natural elements, such as vegetation, water bodies, and landscapes. this includes greenspaces (such as parks, gardens, neighborhood streets lined with trees, forests, or nature reserves) bluespaces (such as next to beaches, lakes, rivers, ponds, or waterfronts), and desert regions, among others.

to participate in this online study, you will need an email address, and a smartphone or laptop/desktop with internet access. if you are eligible to participate, you will be sent a link to an online survey (qualtrics). we will ask questions about demographic and health information, followed by questions about exercise habits, exposure to natural environments (including greenspaces and bluespaces, among others), and questionnaires assessing mood, motivation, cognition, sleep, stress, quality of life, and related functions. the survey should take roughly 20-25 minutes to complete. this is an observational study only, and not an interventional study. compensation: a $15 amazon gift card will be offered to those who complete the survey all the way through with good effort.

Eligibility criteria:
inclusion criteria: for persons with parkinson's disease: * participants must be at least 40 years old * have a diagnosis of idiopathic pd * be proficient english speakers * have functional vision * have internet access, and access to a smartphone/laptop/desktop for persons without parkinson's disease: * participants must be healthy middle-aged and older adults, with no diagnosis of neurological/neurodegenerative conditions * participants must be at least 40 years old * be proficient english speakers * have functional vision * have internet access, and access to a smartphone/laptop/desktop exclusion criteria (both groups): * diagnosis of dementia * poor vision (non-functional range) * lack of access to internet or to a smartphone/ laptop/desktop computer.

Keywords: nature natural environments
evaluation of endoscopic treatment of zenker's diverticulum using ligasure

Conditions: Zenker Diverticulum

Summary: the primary objective of this study is to evaluation the success of endoscopic treatment of zenker's diverticulum using a ligasure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.

our secondary objectives are: a. to evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters. b. to evaluate the prevalence of post-operative complications.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 12 months of follow-up * the patient has a zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van overbeek classification exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient (or his/her person-of-trust) refuses to sign the consent * it is impossible to correctly inform the patient * the patient does not read french * the patient is pregnant * the patient is breastfeeding * the patients has a contraindication for a treatment necessary for this study, or for general anesthesia * the patent has a history of complications related to hemostasis * the preoperative checkup indicates potential for hemostasis related problems

Keywords: ligasure v (tm)