Kornimate/medical-research-clean huggingface dataset:
helicobacter pylori eradication in non-diabetic non-alcoholic steatohepatitis

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-ir (homa-ir) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.

helicobacter pylori (hp) antigens have been found in the liver of individuals with benign and malignant liver diseases. the role of hp in the pathogenesis of non-alcoholic fatty liver disease (nafld) is controversial. this randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to hp and the evidence of fatty liver in ultrasonography. after excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have nafld. those with nafld liver fat score greater than (-0.64) and positive urea breath test (ubt) were enrolled. they were randomly assigned to lifestyle modification alone or lifestyle modification plus hp eradication groups. quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for hp eradication was performed in two weeks. hp eradication was documented by ubt. liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, homa-ir, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

Eligibility criteria:
inclusion criteria: * dyspeptic patients with positive antibody to h.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic. exclusion criteria: * alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any medication during the past 3 months, previous history of peptic ulcer, previous history of h.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating women.

Keywords: steatohepatitis, helicobacter pylori, insulin resistance, alanine aminotransferase, aspartate aminotransferase,
a study into pain relief given by asp8477 for peripheral neuropathic pain (either post-herpetic neuralgia or painful diabetic peripheral neuropathy) and its safety

Conditions: Post-Herpetic Neuralgia (PHN); Neuropathic Pain; Painful Diabetic Peripheral Neuropathy (PDPN)

Summary: the purpose of this study is to assess the painkilling efficacy of asp8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with asp8477.

the study will consist of a screening period, single-blind treatment period, double-blind randomized withdrawal period and follow-up period.

Eligibility criteria:
inclusion criteria: * pdpn subject must have: * established diagnosis of diabetes (type i or ii) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (hba1c) ≤ 11% at screening. * stable glycemic control (hba1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to screening. * at least a 1-year history of dpn pain. * diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to screening based on pi judgment and subject-reported medical history. * phn subject must have pain present ≥ 6 months after healing of the herpes zoster rash. exclusion criteria: * subject has significant pain of an etiology other than pdpn or phn, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ecg, clinical intolerance to non-steroidal anti-inflammatory drugs (nsaids) or asp8477, depression, psychosis or psychiatric or neurological illness, bmi of over 35, renal impairment or failure, alcohol (etoh) or drug abuse, gi complaints. * previous investigational therapy within 28 days or 5 half lives

Keywords: peripheral neuropathy phn pain pdpn
comparative safety and bioequivalence of two treatments in the treatment of acne vulgaris

Conditions: Acne

Summary: the purpose of this study is to compare the safety and bioequivalence of perrigo's product to an fda approved product for the treatment acne vulgaris.


Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects, 12 to 40 years of age (inclusive), with a clinical diagnosis of at least moderate facial acne vulgaris * inflammatory lesion (papules and pustules) count of 20 to 50 (inclusive) * non-inflammatory (open and closed comedones) lesion count of 25 to 100 (inclusive) * no more than two nodulocystic lesions (i.e., nodules and cysts) on the face including those present on the nose, were enrolled. * subjects must also have had a baseline iga score of 3 or 4 on a severity scale of 0 to 4 to be enrolled. exclusion criteria: * subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. * presence of more than 2 facial nodulocystic lesions (i.e. nodules and cysts) * subjects with active cystic acne or polycystic ovarian syndrome * presence of any other facial skin condition that, in the investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations (e .g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculiti s). * excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. * acne conglobata, acne fulminan s, or secondary acne (chloracne, drug-induced acne, etc.) * use of antipruritics including antihistamine, within 24 hours prior to all study visits (visit l/baseline through visit 4). * use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days of study entry and throughout the study (other than study supplied cleanser and lotion). * use within 6 months prior to baseline or during the study of oral retinoids (e.g. accutane"') or therapeutic vitamin a supplements of greater than 10,000 units/day (multivitamins are allowed). * use within 1 month prior to baseline or during the study of therapeutic vitamin d supplement (multivitamins are allowed). * use within 1 month prior to baseline or during the study of 1) systemic steroids', 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout), or 4) systemic anti-inflammatory agents". (' intranasal and inhaled corticosteroids do not require a washout and may be used throughout the study if at a stable and standard dose. "subjects may use acetaminophen for pain relief, as needed, throughout the study) * use within 14 days prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparation (e.g. azelaic acid,etc.) 4)a-hydroxy/glycolic acid, 5) benzoyl peroxide, 6) topical anti-inflammatory agents, or 7) topical antibiotics.
a multicenter, randomized, double-blind, double-dummy trial of azithromycin sr compared with levofloxacin for the treatment of acute symptoms of chronic bronchitis

Conditions: Bronchitis, Chronic

Summary: this study was performed to confirm that a single 2.0-g dose of azithromycin sr is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis secondary objectives: to assess safety and the bacteriologic efficacy of both treatment regimens


Eligibility criteria:
inclusion criteria: adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence. exclusion criteria: key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active tb, pulmonary malignancy, cystic fibrosis).
cd71 in dried blood spots in healthy males

Conditions: Healthy Athletes

Summary: understand the effect of recombinant epo (repo) boosting and microdosing on the hematological module of the athlete biological passport (abp) * measure the change in cd71 longitudinally in subjects from both cohorts * assess whether repo administration can be detected in a dried blood spot (dbs) using recent advances in analytical methodologies * compare windows of repo detection using both athlete biological passport models and direct detection using analytical methods in urine, blood, and dbs

despite being banned by the world anti-doping agency, blood doping is a common method of performance enhancement used by athletes wishing to gain an unfair advantage over their competition. a common way to achieve this increase is by using erythropoiesis stimulating agents (esa's), namely recombinant erythropoietin (repo). though laboratory tests have been developed for the direct detection of all known isoforms of exogenously administered esas in both urine and blood, athletes have found ways to circumvent these testing measures using techniques such as microdosing.

Eligibility criteria:
inclusion criteria: active individuals, preferably those that participate regularly in endurance athletics either for sport or for leisure, between the ages of 18 and 45 - participants should have ferritin \> 35 ng/ml and transferrin saturation \> 20% at the time of enrollment exclusion criteria: individuals currently enrolled in a registered testing pool for anti-doping purposes * individuals with the intent to compete in sanctioned athletic events during the study period * unwillingness to provide urine samples or blood samples * not actively exercising * individuals who show a high risk for mi/cad, stroke, chf, and venous thromboembolism (vte)., as defined by the principal investigator * individuals with known drug allergies * individuals with ekg abnormalities, as determined by the principal investigator * individuals who have chronic kidney disease, hiv, cancer, hepatitis b, hepatitis c, or are planning surgery during the study * individuals with history of acute or chronic medical or psychiatric condition * gfr (creatinine clearance) \<60 ml/min * ferritin \>270 ng/ml * individuals who have a baseline hemoglobin concentration greater than 15.5 g/dl or a baseline hematocrit above 47% * individuals with blood or iron disorders, including polycythemia, hemochromatosis, anemia, or iron-deficiency anemia * individuals with a history of bleeding or bone marrow aplasia * individuals who are diabetic or with a history of cardiac or hepatic disease or history of drug abuse
homeopathic treatment of premenstrual syndrome

Conditions: Premenstrual Syndrome-PMS

Summary: the proposed study will focus on premenstrual syndrome (pms) symptom alleviation for women diagnosed as suffering from the syndrome with the drsp questionnaire. the women will be treated with homeopatic remedies. the improvement of pms symptoms will be evaluated using the daily record of severity of problems questionnaire (drsp). the questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

premenstrual syndrome (pms) is a set of physical, emotional and behavioral symptoms that occur during the week preceding menstruation and which alleviate when the menstrual flow begins. pms affects millions of women during their reproductive years. mild symptoms, which usually do not interfere with daily activities, are experienced occasionally by almost all ovulatory women. between 8-30% of ovulatory women suffer from moderate to severe pms symptoms, which may even require treatment. the more severe form of pms, premenstrual dysphoric disorder is considered to affect up to 8% of ovulatory women. this severe form is associated with severe disruptions in work function, family, or social relationships. to date, therapeutic interventions are insufficient and ranges from stress reduction and lifestyle changing to hormonal therapies and the use of psychotropic medications. while traditional medications do not necessarily offer satisfactory alleviation of pms symptoms homeopathy can offer a significant alleviation of pms symptoms for an extended period of time. the proposed study will focus on pms symptom alleviation for women diagnosed as suffering from the syndrome with the drsp questionnaire. five homeopathic remedies (natrum muriaticum, lachesis, sepia, nux vomica and pulsatilla ) will be used, in five different therapy groups. the women will be allocated to the groups according to their matching to the remedy according to homeopathic principles. in each group the women will either be treated with the appropriate remedy or with a placebo remedy. women who do not match any of these five groups will be allocated to a sixth group receiving either folliculinum that is given as general indication for pms in homeopathy or placebo. the improvement of pms symptoms will be evaluated using the daily record of severity of problems questionnaire at (drsp). the questionnaire will be completed daily by women for 2 months prior to receiving the treatment and for 3 months following treatment with a single dose of the homeopathy treatment.

Eligibility criteria:
inclusion criteria: * age between 18 and 50 years. * suffers from the pms, confirmed by the drsp questionnaire, for at least one year * read and write in * signing the informed consent form exclusion criteria: * comorbidity. * use of medications. * menstruation complains which do not correlate to the menstruation cycle. * inability to be in a daily contact with the experiment center (e.g., by phone, electronically). * participating in another clinical trial in the last 30 days.
multiple-dose pharmacokinetics (pk), and pharmacodynamic (pd) effect of nsi-189 phosphate in depression patient subjects

Conditions: Depression

Summary: this is a randomized, double-blind, placebo-controlled, multiple-dose escalation in depressed human subjects study.


Eligibility criteria:
inclusion criteria: 1. patient has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent, authorizing to use of protected health information in accordance with national and local patient privacy regulations. 2. males and females 18 to 60 years of age, inclusive, at the time of informed consent. 3. diagnosis of major depressive disorder, recurrent, as per dsm-iv-tr criteria and confirmed by scid-ct. their major depressive episode must be confirmed via scid mood module interview administered by remote, independent raters. note: both patients who are being treated with antidepressants and patients who are not on antidepressants but had a history of taking antidepressants are permitted in the study. 4. montgomery-asberg depression scale (madrs) score of 15 to 30, inclusive, at screening and baseline. 5. the following applies to female patients:non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from screening until the end-of-study. 6. the following applies to male subjects:

Keywords: neurogenesis hippocampal stem cells depression stroke
effects of sustained natural apophyseal glides in combination with mckenzie extension protocol in the management of discogenic low back pain

Conditions: Low Back Pain; Disk Prolapse; Disk Herniated Lumbar; Sciatic Radiculopathy

Summary: lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. mckenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. thus, the current study will not only look into the positive effects of mckenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with mckenzie's extension protocol in the management of discogenic low back pain.


Eligibility criteria:
inclusion criteria: * both male and female participants * aged 18-50 years old * low back pain intensity less than 80/100mm on visual analogue scale * positive centralization phenomenon * low signal intensity of iv disc on t2 - weighted mri * high intensity zone towards the posterior aspect of the disc on mri exclusion criteria: individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study. -
clinical performance of withings move ecg software for atrial fibrillation detection

Conditions: Atrial Fibrillation

Summary: withings move ecg watch is designed to record ecg and detect automatically atrial fibrillation. the aim of this study is to validate the performance of move ecg watch to detect atrial fibrillation compared to a reference 12-lead ecg.

patients with atrial fibrillation are included in hospitals. on each patient, ecg with move ecg and the reference 12-lead ecg are recorded simultaneously. both records are then reviewed by independent cardiologists to assess 1. the presence or absence of atrial fibrillation 2. if waveforms of ecg recorded with move ecg compared with the reference.

Eligibility criteria:
inclusion criteria: * male or female who are 18 years or older * subject who signed the written informed consent form exclusion criteria: * vulnerable subject with regard to regulations * pregnant, parturient or breastfeeding woman, * subject who is deprived of liberty by judicial, medical or administrative decision, * underage subject, * legally protected subject, or subject who is unable to sign the written informed consent form, * subject who is not beneficiary or not affiliated to a social security scheme, * subject within several of the above categories, * subject who refused to participate in the study, * subject in physical incapacity to wear a wrist-worn watch * subject with electrical stimulation by pacemaker
ultrasound biofeedback for speech sound disorders

Conditions: Speech Sound Disorders

Summary: children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. these images will be used to cue the child to change the tongue position when producing speech sounds.


Eligibility criteria:
inclusion criteria: * participants must be native english-speaking children with no known hearing or vision deficits. participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist. exclusion criteria: * participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as down syndrome or autism, or intellectual disability. during initial testing, participants must score below a standard score of 75 on the goldman-fristoe test of articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound
azd8683 single ascending dose study

Conditions: Healthy Volunteers

Summary: the aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of azd8683 following single ascending dose administrations in healthy male subjects.


Eligibility criteria:
inclusion criteria: * provision of signed, written and dated informed consent prior to any study specific procedures * have a body mass index (bmi) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start exclusion criteria: * any clinically significant disease or disorder * any clinically significant abnormalities at screening examinations * use any prescribed or non-prescribed medication

Keywords: safety tolerability healthy inhalation
spyral pivotal - spyral htn-off med study

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: the purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.


Eligibility criteria:
inclusion criteria: * individual has office systolic blood pressure (sbp) ≥ 150 mmhg and \<180 mmhg and a diastolic blood pressure (dbp) ≥ 90 mmhg after being off medications. * individual has 24-hour ambulatory blood pressure monitoring (abpm) average sbp ≥ 140 mmhg and \< 170 mmhg. * individual is willing to discontinue current antihypertensive medications. exclusion criteria: * individual lacks appropriate renal artery anatomy. * individual has estimated glomerular filtration rate (egfr) of \<45. * individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus. * individual has one or more episodes of orthostatic hypotension. * individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. * individual has primary pulmonary hypertension. * individual is pregnant, nursing or planning to become pregnant. * individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (nsaids) for two or more days per week over the month prior to enrollment. * individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. * individual works night shifts.

Keywords: uncontrolled hypertension renal denervation