Kornimate/medical-research-clean huggingface dataset:
the liver health study for patients with nafld

Conditions: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis; Obesity

Summary: the study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.

the study has two phases. in phase i, liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will be tested for the ability to burn fatty acids. in phase ii, patients with nonalcoholic fatty liver disease will participate in either a nine-month lifestyle treatment program or undergo standard care. the goal is to determine how weight loss and exercise improve liver health. inpatient comprehensive metabolic tests are performed before and after the nine-months.

Eligibility criteria:
for phase i: any patient scheduled to undergo bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease. for phase ii: only subjects who have had a diagnosis of nonalcoholic fatty liver disease and completed phase i (and no subjects who have undergone bariatric surgery) inclusion criteria: 1. men and women (pre and post-menopausal) 2. overweight/obese with bmi ≥ 25.9 or \< 50.0 kg/m2 3. characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dl or 2h glucose 140-200 mg/dl) or diabetes type 2, or undergoing bariatric surgery 4. 22-65 years of age 5. sedentary, \< 60 minutes per week of structured physical activity 6. alcohol intake\< 20 g/d exclusion criteria: 1. having undergone bariatric surgery. 2. acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 years 3. other causes of hepatitis including hepatitis b \& c, autoimmune hepatitis, hemochromatosis, celiac disease, wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis, any clinical or biochemical evidence of decompensated liver disease 4. use of steroids or other drugs that cause nafld 5. pregnant or trying to become pregnant 6. inability to exercise on a bike or treadmill

Keywords: nonalcoholic fatty liver exercise weight loss diet
gutta-percha solvent on postoperative pain after root canal retreatment

Conditions: Postoperative Pain; Root Canal; Retreatment

Summary: the process of non-surgical retreatment includes removing the previous root canal filling materials, disinfecting and sealing the root canal system to prevent re-infection. gutta-percha is the most common root canal filling material used with various types of sealers. to remove gutta-percha, solvent has been suggested because of its ability to dissolve gutta-percha. the new formula, under the brand name, guttaclear, has been investigated for its comparable dissolving ability and lower cytotoxicity when compared with others that are currently used. however, no information is currently available of guttaclear solvent concerning postoperative pain. therefore, the present study will evaluate postoperative pain after non-surgical retreatment cases using guttaclear as a solvent compared with no solvent used. sixty participants are chosen and distributed into 2 groups, randomly. after the procedures, participants will receive the questionnaires about postoperative pain and the amount of medication intake. both will be recorded at six time periods: (1) immediately after procedure; (2) 6 hours after procedure; (3) 12 hours after procedure; (4) 24 hours after procedure; (5) 48 hours after procedure and (6) 72 hours after procedure.


Eligibility criteria:
inclusion criteria: * not be contra-indicated with medication used in this study (ibuprofen) * have a previously treated endodontic single-root tooth with the need of retreatment * all those teeth must be restorable * old root canal filling materials must be located at 1 to 3 mm from the radiographic apex in the periapical radiograph exclusion criteria: * open apex, root resorption or root perforation * participants presenting pre-operative pain and/or swelling at the appointment visit * taking analgesics or antibiotics less than one week before appointment visit * experiencing problems in completing the pain questionnaires * tooth which does not contain gutta-percha * cannot be patent through the apex at the appointment visit
effect of postoperative immobilization on healing after rotator cuff arthroscopic repair

Conditions: Rotator Cuff Tear

Summary: the study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.


Eligibility criteria:
inclusion criteria: * patients skeletally mature (older 18 years old) * small or medium rupture of rotator cuff * repaired with arthroscopic double row technique exclusion criteria: * impossibility to perform mri (claustrophobic, pacemaker, heart or brain metallic implants) * ac arthritis with mumford procedure * smokers * diabetes * postoperative complication (severe pain, thrombosis, infection) * psychiatric disorder
study of safety and efficacy of a rhpth[1-84] of fixed doses of 25 and 50 mcg in adults with hypoparathyroidism (relay)

Conditions: Hypoparathyroidism

Summary: use of pth (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. the use of pth (1-84) should result in a decrease of calcium and vitamin d supplements.

patients with a history of hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. during that time they will be monitored for safety (specifically calcium levels in blood or urine). in addition, the patients' intake of vitamin d and calcium will be measured.

Eligibility criteria:
main inclusion criteria: 1. previously completed 24 weeks of therapy and 4 weeks of follow-up in the replace study 2. with regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit 3. total serum calcium ≤ uln based on local laboratory results prior to randomization 4. serum 25(oh) vitamin d ≤ 1.5 times the uln within approximately 8 weeks prior to randomization main exclusion criteria: 1. any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements 2. use of raloxifene hydrochloride or intravenous (iv) bisphosphonates since the end of participation in the replace trial 3. chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride 4. pregnant or lactating women 5. any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of pth 6. use of any experimental drug other than npsp558 within 3 months of baseline.

Keywords: hypoparathyroidism, rhpth[1-84], npsp558
a study on the inter-hemispheric alpha ratio in kids with adhd (shark)

Conditions: ADHD

Summary: investigate the hypothesis that children with adhd have difficulty with the allocation of visio-spatial attention related to an inability to control posterior alpha brain oscillations. a paradigm will be used in which the aim is to address covert attention as similar recent studies did in adults with adhd.


Eligibility criteria:
inclusion criteria: for both groups * age between 7 and 10 years of age. * estimated iq above 80. * psychopharmaca- naïve or -free. for the adhd-group - a diagnosis of adhd, classified by the dsm-iv. exclusion criteria: * (co-morbid) psychiatric disorder (major depression, bipolar disorder, psychotic disorder, chronically motor tic disorder or gilles de la tourette, conduct disorder, autism spectrum disorder, eating disorder, anxiety disorder). * neurological disorders (e.g. epilepsy) currently or in the past. * cardiovascular disease currently or in the past. * serious motor or perceptual handicap. for the no adhd-group - no diagnosis of adhd, classified by the dsm-iv.

Keywords: alpha lateralization attention adhd oscillation
a safety study of arry-403 in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug arry-403 (as monotherapy or in addition to stable metformin therapy) in patients with type 2 diabetes. approximately 128 patients from the us will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * male or female (females must be of non-childbearing potential), between the ages of 18 and 70 years, inclusive. * diagnosis of type 2 diabetes. * fasted c-peptide value ≥ 0.8 ng/ml. * hba1c ≥ 6.5% and ≤ 10.0% for monotherapy cohorts (study drug only) or hba1c ≥ 7.5% and ≤ 10.0% for combination cohorts (study drug and on a stable regimen of metformin monotherapy that includes a morning dose for ≥ 8 weeks prior to first dose of study drug). * bmi ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 * additional criteria exist. key exclusion criteria: * recent history (i.e. less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), or other conditions at the discretion of the investigator. * significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia. * history of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, ph, or absorption. * a positive test for drugs or alcohol. * active infectious diseases including hepatitis b, hepatitis c, or human immunodeficiency virus (hiv). past history and inactive hepatitis b and c, as confirmed by serological testing, are allowed. * women who are pregnant or breastfeeding. * donation or loss of ≥ 550 ml of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug. * additional criteria exist.
mindfulness and mechanisms of pain processing in adults with migraines

Conditions: Migraine

Summary: although many adults with migraines use non-pharmacological treatment options, there is a lack of research on the use of many mind/body techniques specifically for headache. this research will further the understanding of the mechanisms, efficacy, and predictors of mind-body practices in adults with migraines.

migraine is a common and disabling pain condition. affective/cognitive processes, such as pain catastrophizing and emotional reactivity, often play a major role in migraine pain and disability. these processes may be just as important to target as the sensory aspect given their impact on outcomes and disability. because of this cognitive/affective load that builds over time in migraine, we hypothesize a) migraineurs perceive affective pain processing differently than non-migraineurs and b) mind/body therapies that target these factors may be especially beneficial and may differentially impact the affective component of migraine pain. evidence shows that meditation decreases affective (e.g., pain unpleasantness) over sensory (e.g., pain intensity) response to experimental pain and reduces pain by engaging brain regions important for cognitive and affective modulation of pain. by measuring both experimental and clinical pain, the study team will be able to test these hypotheses.

Eligibility criteria:
inclusion criteria: diagnosis of migraine; ≥18yo; ≥1 yr of migraines; 4-20 days/month with migraines; able and willing to participate in 8 weekly sessions and daily homework 30-45min exclusion criteria: current regular (weekly or more often) practice of meditation; any major unstable medical/psychiatric illness (e.g., hospitalization within 90 days, suicide risk, etc.); other non-migraine chronic pain condition (e.g., fibromyalgia, low back pain, etc.) or sensory abnormalities (e.g., neuropathy, raynaud's, etc.); diagnosis of medication overuse headache; volunteers with no pain ratings to frankly noxious stimuli (temperatures \> 49°c) or excessive responses to threshold temperatures (\~43°c); current or planned pregnancy or breastfeeding, any new medication started within 4 weeks of screening visit; unwilling to maintain stable current medication dosages for duration of trial; failure to complete baseline headache logs.

Keywords: migraine with aura migraine without aura pain controls mind-body
central nervous system stimulants and physical function in children with cerebral palsy

Conditions: Neurodevelopmental Disorders; Cerebral Palsy

Summary: the purpose of this study is to determine the effects of central nervous system stimulants, represented by methylphenidate and modafinil, compared to placebo control on motor performance in children with cerebral palsy. this study will be a triple-masked study per the american academy of neurology guidelines for clinical trials.

cerebral palsy (cp) is a neurological disorder that commonly cause disability and limit physical function in children, and this disability persists into adulthood. there are several treatment options for motor impairments associated with cp, including oral medications (diazepam or related benzodiazepines, baclofen, dantrolene, and tizanidine hydrochloride), intraspinal infusion (baclofen), paralyzing agents (botulinum toxin), and surgical interventions (dorsal rhizotomy). however, these interventions have drawbacks that could impact their benefits, such as drowsiness with oral medications and permanent change in muscle tone with the rhizotomy surgery. other rehabilitation interventions showed significant improvements in motor function such as constraint-induced movement therapy (cimt) and strength training. a few researchers attempted using central nervous system stimulants (i.e., modafinil \[provigil\]) off-label for improving motor control and reducing spasticity in children with cp. another medication that has been used for motor impairments is methylphenidate (mph), also a central nervous system stimulant. however, this medication was used for improving muscle tone and motor performance in children with attention-deficit/hyperactivity disorder (adhd), but not in children with cp. mph is useful for children with combined cp and adhd and showed beneficial results for adhd symptoms and behavioral outcomes with minimal side effects. therefore, the purpose of this pilot randomized controlled trial (rct) is to examine the effects of central nervous system (cns) stimulants (modafinil and mph) vs. placebo in addition to physical therapy intervention on gross motor function and spasticity in children with cp.

Eligibility criteria:
inclusion criteria: * children diagnosed with spastic diplegic or quadriplegic cp by a physician. * children aged between 7-12 years old. * children with cp classified as level i \& ii based on the gross motor function classification system (gmfcs). * children with cp that are receiving physical therapy for ≥ 3 months. exclusion criteria: * children that had a seizure attack in the past 6 months * children that have been diagnosed with attention deficit/ hyperactivity disorder (adhd) * children that had any surgery within the last 6 months * children that has lower-extremity contractures determined by the passive range of motion (hips, knees, and ankles) * children that use medications that interfere with spasticity (e.g., baclofen)

Keywords: methylphenidate modafinil physical therapy motor performance spasticity physical function
chronic heart failure with preserved ejection fraction - congestion evaluation

Conditions: Chronic Heart Failure; Preserved Ejection Fraction

Summary: heart failure (hf) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. congestion is the main source of symptoms and the leading cause of hospitalization for hf. furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic hf. the literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. the main objective of the chf-cov preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic hf with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute hf or iv diuretics injection in a day hospital.


Eligibility criteria:
inclusion criteria: * patients with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation * patient with preserved left ventricular ejection fraction (≥50%). * age ≥18 years * patients having received complete information regarding the study design and having signed their informed consent form. * patient affiliated to or beneficiary of a social security scheme exclusion criteria: * comorbidity for which the life expectancy is ≤ 3 months * dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion. * history of lobectomy or pneumonectomy lung surgery * severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * adult person who is unable to give consent * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
evaluation of non-inferiority of two fast follower nucleic acid amplification tests

Conditions: Tuberculosis

Summary: assess sensitivity and specificity of two nucleic acid amplification tests, namely epistem genedrive® and molbiotruenat™ in raw sputum compared to the who-endorsed genexpert® mtb/rif assay using a gold standard of four cultures

* estimate the accuracy of the epistem genedrive® and molbiotruenat™ in raw sputum and in sputum pellets. * assess the operational feasibility of epistem genedrive® and molbiotruenat™ * determine and compare costs between the epistem genedrive®, molbiotruenat™, and xpert mtb/rif tests

Eligibility criteria:
inclusion criteria: * • clinical suspicion of pulmonary tb (including cough ≥2 weeks and at least 1 other symptom typical of tb); * age 18 years or above; * willingness to have a study follow-up visit, if necessary, approximately two months after enrollment * willingness to provide 3 sputum specimens at enrollment * provision of informed consent. exclusion criteria: * • receipt of ≥48 cumulative hours or three or more doses of anti-tb treatment (defined as combination anti-tb therapy intended to treat active tb) within 60 days prior to completion of sputum collection; * inability to provide informed consent (e.g. mentally impaired) * enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a second and third sputum sample of ≥ 1ml each will be classified as early exclusions.
genetics and mechanisms of rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Leukocytes, Mononuclear; Genetic Association Studies

Summary: the study is aimed at revealing genetic background in rheumatoid arthritis (ra). for that purpose samples of dna will be collected from 500 ra patients and similar number of controls from whole slovakia. variations in several genes associated with ra will be evaluated. the second aim is to assess functional changes in immune cells from selected patients and their evaluation together with genetic background. the project has observational character without any intention to change the treatment of ra patients.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis or healthy exclusion criteria:
effectiveness and safety of frovatriptan for the management (acute treatment) of menstrual migraine

Conditions: Menstrual Migraine (MM) Headaches

Summary: females 18 years of age or older with at least one year history of menstrual migraine (mm) headaches participated in a phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (international headache society \[ihs\] grade 1) of mm compared with patients' current treatment.


Eligibility criteria:
inclusion criteria: 1. had mm headaches occurring between day -2 and day +3 of menses 2. had at least one year history of mm headaches 3. had at least 8 mm headaches in the previous 12 menstrual cycles (1 year) 4. had regular predictable menstrual periods (28 ± 4 days) exclusion criteria: 1. had a history of more than 15 headache days per month 2. as part of current mm treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of mm) 3. had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease 4. had significant cerebrovascular disease, including basilar or hemiplegic migraine 5. had uncontrolled hypertension: systolic blood pressure \>180mmhg and diastolic blood pressure \>95mmhg 6. had severe hepatic or renal insufficiency 7. used an analgesic medication (including both prescription and over-the-counter) for any reason \>50% of days per month

Keywords: migraine