Kornimate/medical-research-clean huggingface dataset:
transcranial direct current stimulation (tdcs) in the primary motor cortex in healthy individuals

Conditions: Basic Physiology; Brain Stimulation

Summary: the main aim of this study is to assess the short-term effects of active-tdcs (a-tdcs) on the m1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tdcs (s-tdcs) in healthy individuals. the main objective was to determine whether there were clinically relevant changes generated by tdcs and if they were superior to a sham intervention.


Eligibility criteria:
inclusion criteria: * asymptomatic participants * men and women aged 18 to 65 years exclusion criteria: * insomnia * nausea * headache * pregnancy * use of painkillers in the last 24 hours * presence of metal inside the head * pacemaker * wound on the area of electrodes' application * drug consumption; (j) recent application of tdcs * psychiatric disease impeding understanding of the study.

Keywords: transcranial direct current stimulation
safety and efficacy study of hgp1207 in patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; Systolic Dysfunction

Summary: the purpose of this study is to investigate the safety and clinical efficacy of hgp1207 (sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of chronic heart failure (nyha class ii and iii) * lvef ≤ 40% * elevated systolic pap: ≥ 40 mmhg * patients must be treated with an ace inhibitor, arb, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1 exclusion criteria: * patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms * patients who have received nitrates/no donor or cytochrome p450 3a4 inhibitors within 30 days prior to visit 1 * patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1 * history of hypersensitivity or allergy to sildenafil or any excipients of its formulation * patients with hypertension (sitsbp \>170 mmhg or sitdbp\>100 mmhg) or hypotension (sitsbp\<90 mmhg or sitdbp\<50 mmhg) * patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation * pregnant females or those of child bearing potential who have not had a negative pregnancy test
validation of retinal oximetry in glaucoma patients: a structural and functional correlation

Conditions: Open Angle Glaucoma; Low Tension Glaucoma

Summary: retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. up until today, very little is known about the metabolic alterations in the retina of glaucoma patients, since only techniques for surrogate measurements of metabolism (like blood flow velocities and vessel diameter) were available. oximetry has provided us with an important tool to study metabolism in glaucoma, and to correlate these findings with the available blood flow evaluation techniques. preliminary results by the group of prof stefánsson (2011) with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects are associated with decreased arteriovenous differences in retinal oxygen saturation. these data suggest that a change in oxygen metabolism occurs in glaucomatous retina. this reduced oxygen metabolism may be related to tissue atrophy. however, this explanation is still hypothetical, since the relation between these oximetry results and structural changes in the optic nerve have not been studied yet. 1. what are the oximetry values in a normal population of within the same age group as the glaucoma population? to answer this question, a normative database of the investigators retinal oximetry device needs to be constructed for healthy controls. 2. do glaucoma patients have different retinal oximetry values than these normal patients? are there any differences in retinal oxygenation between these glaucoma groups? to answer these questions, oximetry measurements will be performed in patients with normal tension glaucoma (ntg) and primary open angle glaucoma (poag). 3. is there an association between structural optic disc and retinal nerve fibre layer changes, using heidelberg retinal tomography (hrt), with alterations in retinal vascular oxygen saturation in ntg and poag patients? 4. are blood flow measurements, using colour doppler imaging (cdi), correlated with alteration in retinal vascular oxygen in ntg and poag patients?

1. oximetry pictures will be taken and analysed. 2. cdi exam will be performed. 3. visual field examen will be performed. 4. hrt will be performed.

Eligibility criteria:
inclusion criteria: * individuals over 18 years old * willing to sign an informed consent and able to comply with the requirements of the study * having no other ocular diseases besides glaucoma exclusion criteria: * history of ocular trauma * intraocular surgery (except for cataract surgery) * eye disease (except glaucoma) * systemic diseases with ocular involvement like diabetes

Keywords: open angle glaucoma low tension glaucoma oximetry
preoperative corticosteroids in autoimmune thyroid disease

Conditions: Graves Disease; Hashimoto Disease

Summary: this study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.


Eligibility criteria:
* inclusion criteria: ■ graves' disease or hashimoto's disease with positive thyroid autoantibodies (tgab, tpo, tsi, and/or trab) undergoing total thyroidectomy for their disease. * exclusion criteria: * pediatric patients \< 18 * prior treatment with rai * prior neck surgeries * known diagnosis of thyroid cancer * diabetic patients on medications * a history of adverse reactions to corticosteroids. * patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). this includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.
efficacy and safety of berberine ursodeoxycholate (htd1801) in patients with type 2 diabetes inadequately controlled with metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (htd1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin.

this phase 3, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of htd1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. to ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modifications, concomitant medications, and procedures for self-monitoring of blood glucose. following this period, patient eligibility will be reassessed. eligible patients will then be randomized 2:1 to receive htd1801 1000 mg twice daily (bid) or placebo for 24 weeks. patients who complete the double-blind treatment phase will enter an open-label extension period where all patients will receive htd1801 1000 mg bid for 28 weeks.

Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes * received a stable dose of metformin monotherapy for at least 8 weeks prior to screening * if used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening * have hba1c ≥7.5% to ≤11.0% (screening) and hba1c ≥7.0% to ≤10.5% (pre-randomization) * have fasting plasma glucose ≤13.9 mmol/l (screening and pre-randomization) * have a body mass index ≥19.0 kg/m\^2 to ≤35.0 kg/m\^2 exclusion criteria: * have type 1 diabetes * have had any acute diabetic complications within 12 months prior to screening * have had any grade 3 hypoglycemic event within 12 months prior to screening * have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot * have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening * have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization * have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
nephropathy in patients with sickle cell disease

Conditions: Sickle Cell Nephropathy

Summary: there are some diseases that give rise to diverse renal manifestations as does sickle cell disease

such involvement adversely affects virtually all major physiological processes in the kidney, and leads to complications that are common and chronic on the one hand (such as impaired urinary concentrating ability), and those that are rare and uniformly fatal on the other (such as renal medullary carcinoma) this steady adverse renal sequelae shortens the average lifespan of patients with scd. proteinuria and a reduced glomerular filtration rate are risk factors associated with increased mortality among those patients with approximately 16-18% of overall mortality in this patient group is due to kidney disease. once end stage renal disease is reached, the mortality of patients who are on haemodialysis and have scd is increased severalfold relative to the mortality of patients who are on haemodialysis but do not have scd. thus,although the average lifespan of patients with scd has increased during recent decades owing to improved management of complications outside the kidney,kidney disease contributes substantially to the still increased mortality in scd.

Eligibility criteria:
inclusion criteria: * all patients with sickle cell anemia attending the unit will be included in the study. exclusion criteria: * patient with any underlaying systemic diseases other than sickle cell anaemia
adding l-carnitine in clomiphene resistant polycystic ovary improves the quality of ovulation and the pregnancy outcome

Conditions: Treatment Resistant Disorders

Summary: adding l-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant pcos

patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with pco according to rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.

Eligibility criteria:
inclusion criteria: * patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with pco according to rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. the diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic. exclusion criteria: * age more than 40 years, * tubal,uterine or male factor infertility

Keywords: clomiphene resistant pcos induction of ovulation l-carnitine
clinical practice guideline for neonatal extravasation injury

Conditions: Extravasation Injury

Summary: this study is aimed to evaluate the effectiveness of an evidence-based clinical practice guideline in the prevention and management of neonatal extravasation injury, and to examine the change in nurses' knowledge of and adherence to the guideline.

a study with controlled before-and-after design was conducted. the clinical practice guideline was developed and a multifaceted educational program was delivered for nurses. neonatal outcomes were collected at baseline and after completion of the intervention. the changes in nurses' level of knowledge and adherence to the guideline were also measured.

Eligibility criteria:
inclusion criteria: * neonates who were admitted for intravenous medication or infusion therapy, and * neonates whose parents were equal to or over 18 years old and able to communicate in chinese or english. exclusion criteria: * neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.

Keywords: intravenous nursing newborn infant neonatal intensive care units evidence-based professional practice
a randomized clinical trial comparing open to mini-open rotator cuff repair for full-thickness rotator cuff tears.

Conditions: Rotator Cuff Tear

Summary: this study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rotator cuff tears. hypothesis: there is no difference in disease-specific quality of life outcome at two years between open versus arthroscopic mini-open repair for patients with full-thickness rotator cuff tears.

rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's quality of life. the standard treatment for full-thickness rotator cuff repair is with an open acromioplasty procedure. an alternative procedure for a full-thickness rotator cuff tear is with a combined procedure of arthroscopic acromioplasty and mini-open repair, which has the potential advantages of a preserved deltoid origin, lower perioperative morbidity, shorter hospital stays and less soft tissue dissection. the progression towards arthroscopic repair requires a comparison to the standard, open procedure for full-thickness rotator cuff tears, using validated outcomes in a randomized fashion. this study is designed as a multi-centre randomized controlled trial with a priori sample size calculation of 28 patients per group. patients presenting with unremitting pain, failed conservative treatment of at least 3 months, weakness of the rotator cuff and positive imaging indicating a full-thickness rotator cuff tear are eligible for the study. previous surgery on the affected shoulder and massive rotator cuff tears are excluded. patients are randomized using computer-generated block randomization, stratified by surgeon, to either open or mini-open rotator cuff repair. disease-specific quality of life is assessed using the validated rotator cuff quality of life questionnaire, a self-administered, 34-item questionnaire designed specifically to assess patients before and after surgery. it utilizes a visual analog scale scored out of 100, with a higher score reflecting a better quality of life.

Eligibility criteria:
inclusion criteria: * patients with unremitting pain in the affected shoulder who have failed conservative treatment for at least 3 months * weakness of rotator cuff (mrc grades 4-, 4 or 4+) * positive diagnostic imaging on the affected shoulder indicating a full-thickness rotator cuff tear which may include arthrogram, ultrasound or mri * age \> 18 years * english speaking exclusion criteria: * a massive rotator cuff tear as demonstrated by grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder * previous surgery to the affected shoulder

Keywords: rotator cuff open arthroscopic mini-open acromioplasty quality of life shoulder
computer aided detection of polyps in colonoscopy

Conditions: Colorectal Polyp

Summary: the aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. one of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. our hypothesis is that with the aid of skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.


Eligibility criteria:
inclusion criteria participants will be eligible for this study if they are: * undergoing colonoscopy with screening, surveillance, or diagnostic indications. * undergoing a procedure by a participating endoscopist. * have given informed consent. exclusion criteria participants will not be eligible for this study if they: * have a history of inflammatory bowel disease. * have a history of familial adenomatous polyposis. * are under the age of 40. * have had a colonoscopy within the previous three (3) years. * undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal ct imaging, unexplained weight loss, lynch syndrome, blood in stool or fit positive test. * entered with poor bowel preparation (inadequate for procedure as assessed by the investigator). * use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Keywords: screening colonoscopy artificial intelligence computer aided detection adenoma detection rate adenomas per colonoscopy surveillance colonoscopy colorectal cancer software as a medical device
role of pentoxifylline as an adjuvant therapy for adult patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study aimed to evaluate the therapeutic benefits of pentoxifylline (ptx) in treatment of adult patients with mdd as it has anti-inflammatory and phosphodiastrase inhibition activities.

in this study, the investigators evaluated the potential antidepressant effect of ptx in adult patients with mdd. the investigators hypothesized that mdd patients taking add-on ptx would present greater amelioration of their depressive symptoms than patients taking add-on placebo. furthermore, the investigators assessed the relationship between ham-d score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of mdd.

Eligibility criteria:
inclusion criteria: * eighty adult outpatients with the diagnostic and statistical manual of mental disorders-iv (dsm-iv) diagnosis of mdd based on a mini neuropsychiatric interview (mini) (american psychiatric association., 2000; sheehan et al., 1998), without psychotic features and a total 17 item ham-d score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (hamilton, 1960). * patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study. exclusion criteria: * patients with bipolar i or bipolar ii disorder * patients with personality disorders * patients with eating disorders * patients with substance dependence or abuse * patients with concurrent active medical condition * patients with history of seizures * patients with history of receiving electroconvulsive therapy (ect) * patients with inflammatory disorders * patients with allergy or contraindications to the used medications * patients with finally pregnant or lactating females

Keywords: pentoxifylline anti-inflammatory mdd phosphodiastrase inhibitors
gait evaluation in multiple sclerosis patients treated with glatiramer acetate

Conditions: Multiple Sclerosis

Summary: hypothesis: treatment with glatiramer acetate prevents deterioration of gait in multiple sclerosis (ms) patients. during the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

patients with a definite diagnosis of relapsing remitting multiple sclerosis (ms) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. the gait analysis will include kinematic evaluation using a charnwood dynamics coda cx-1 system, 4 amti force plates and a noraxon telemetric emg system. patients will be videotaped and will also undergo a detailed physical examination by a physical therapist. treatment with glatiramer acetate will be initiated after the gait analysis. therapy will be observed and controlled by a neurologist fromn the staff of the multiple sclerosis center. repeat gait analysis will be performed after one year of treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of multiple sclerosis * edss less than 5.5 * no cognitive disability exclusion criteria: * edss over 5.5 * inability to cooperate with gait analysis
peppermint oil pharmacokinetics/dynamics and novel biological signatures in children with functional abdominal pain

Conditions: Abdominal Pain

Summary: aim 1 - determine the pharmacokinetics of pmo (menthol) of three different doses in children with functional abdominal pain (fap) (n=30). aim 2 - determine pharmacodynamic effect of three different doses of pmo on gut microbiome composition and contractile activity/gut transit rate.

children with functional abdominal pain (fap) ages 7-12 years (n=30) will be recruited. the study participants will be admitted to the children's nutrition research center. a medical history and a general physical examination performed by the investigator or the research nurse. the height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. after application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples. at approximately 0900, subjects will receive one of three doses of pmo as a single oral dose. immediately prior to administration of the pmo, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of dna for cyp2a6 and ugt2b7 genotyping. after pmo administration, repeated blood samples will be obtained over 24 hours. at 2 hours after pmo administration, participants will be given a standardized meal and will eat ad libitum thereafter. after completion of the final (24 hours) blood samples, vital signs will be reassessed and the venous cannula removed. parents will receive a follow-up call from the research coordinator to access/evaluate if any adverse effects from dose or blood sampling received at the overnight study visit. prior to and after administration of peppermint oil (pmo) for 1 week at the dose defined above, children will undergo measurement of gut microbiome composition and gi motility and transit time. at the time of the stool collection, the child will also keep a 3 day diet history.

Eligibility criteria:
inclusion criteria: 1. children ages 7-12 years old 2. they will be able to complete the protocol 3. a child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain exclusion criteria: 1. children who have had past bowel surgery; 2. a child with documented gi disorders (e.g., crohn's disease); 3. a child with a serious chronic medical condition (e.g., diabetes); 4. a child with a weight and/or height \< 2 sd for age; 5. children with chronic conditions with gi symptoms (e.g., cystic fibrosis); 6. children with autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder; 7. children who have been treated with antibiotics/probiotics within 2 mo. (because of effects on microbiome analysis). 8. children who speak only spanish