Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of oral vt-1161 in patients with onychomycosis of the toenail

Conditions: Onychomycosis

Summary: several properties of vt-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines. this study will evaluate the effectiveness and safety of vt-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months. the additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.


Eligibility criteria:
key inclusion criteria: distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail. positive culture for dermatophytes and positive koh. nail ≤ 3 mm thick at the distal end. at least ≥ 2 mm of the proximal end of the great toenail must be free of infection. subjects must be able to swallow tablets. women of childbearing potential and males must use acceptable birth control methods throughout the study. key exclusion criteria: presence of subungual hematoma or melanonychia. presence of dermatophytoma/nail streaks and severe onychorrhexis. significant dystrophy or anatomic abnormalities of the great toenail. presence of any other infections of the foot. evidence of clinically significant major organ disease. poorly controlled diabetes mellitus. onychomycosis involving more than 8 toe nails. recent use of systemic antifungal therapy. recent of any topical antifungal nail therapy. recent use of systemic corticosteroid therapy. recent use of immunosuppressive medication. history of prolonged qt intervals. known human immunodeficiency virus (hiv) infection. known significant renal or hepatic impairment. known history of intolerance or hypersensitivity to azole antifungal drugs.
absolute bioavailability of bms-626529 after oral and intravenous dosing

Conditions: Infection, Human Immunodeficiency Virus

Summary: a phase i absolute bioavailability study of bms-626529 following oral and intravenous dosing


Eligibility criteria:
inclusion criteria: * generally healthy * bmi 18.0-32.0 kg/m2 * men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days * men must refrain from sperm donation for the length of the study and for 90 days * sign informed consent exclusion criteria: * significant medical illness * tobacco use in the last 12 months * major surgery within 4 weeks of study administration * donation of blood within 4 weeks of study administration * current or recent (within 3 months of study administration) of gastrointestinal disease
comparison between two ss-oct biometry

Conditions: Cataract Senile

Summary: since recently a second swept-source optical coherence tomography (ss-oct) optical biometry device was launched (anterion, heidelberg engineering). aim of this study is a retrospective data collection of patients who were measured with both ss-oct optical biometry devices and to assess the limits of agreement of the two devices. retrospective comparison of two ss-oct biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.

this a retrospective study including data acquired from patients that attended pre-surgical examination as it is the standard in the investigator's hospital. the iol master 700 (carl zeiss meditec ag, jena) and the heidelberg anterion (heidelberg engineering, germany) are biometry devices that use swept-source optical coherence tomography technology in combination with a multidot-keratometer, that obtain two-dimensional images of ocular structures. the difference between the two devices resides in the wavelength of the infrared laser: 1200-1400nm for the anterion and 1050nm for the iol master 700. the ss-oct devices provide a scan depth of 44mm and a resolution in tissue of 22 μm for the iol master 700 and of 14x16.5 mm and 30 μm for the heidelberg anterion.

Eligibility criteria:
inclusion criteria: * age-related cataract exclusion criteria: * nystagmus * physical inabilities that could interfere with fixation * dens cataract * macular or corneal pathologies that could compromise fixation during the measurements.

Keywords: biometry ss-oct cataract
lups-lipids and glucose under prospective surveillance

Conditions: Metabolic Syndrome; Type 2 Diabetes

Summary: prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes

the lups-study is a collaboration between asklepios clinics hamburg gmbh and university clinic hamburg eppendorf, germany. this study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from "healthy workers" (25-60years) to better understand phenotype-genotype associations leading to mets and type 2 diabetes.

Eligibility criteria:
inclusion criteria: * 25-60 years men and women willing to give consent exclusion criteria: * diabetes (type 1 or 2)

Keywords: metabolic syndrome, syndrome x, mets, type 2 diabetes
evaluation of pancreatic pseudocyst drainage with a metal stent

Conditions: Pancreatic Pseudocysts

Summary: the purpose of this study is to study the evaluation of the effectiveness of endoscopic pancreatic pseudocyst drainage using a metal stent.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years or older 2. subject has pancreatic pseudocyst 3. subject has medical indication for drainage of the pancreatic pseudocyst 4. subject must be able to give informed consent exclusion criteria: 1. any contraindication to endoscopic pseudocyst drainage 2. subject is unable to give informed consent
assessment of the internal urethral sphincter and the vagina by three dimensional ultrasound

Conditions: Urinary Incontinence Due to Urethral Sphincter Incompetence

Summary: continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane. the internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium. on ultrasound scanning tissue echo will be detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure. three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and specific for the diagnosis of stress urinary incontinence.

the internal urethral sphincter used to be said it's a muscular ring but the investigators will visualize by three dimensional ultrasound it's a cylinder in shape and it's the cause of stress urinary incontinence by being torn by stretching the vagina during normal delivery.

Eligibility criteria:
inclusion criteria: * signed an informed consent * patient with stress urinary incontinence * patient have done a vaginal delivery * patient with genital prolapse exclusion criteria: * refusal to sign an informed consent * patient have urinary tract infection * patient with pregnancy * patient have vaginal infection * patient who has undiagnosed vaginal bleeding
a first in patient, study of investigational drug pf-03446962 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to test the safety and effectiveness of pf-03446962 when given as a single agent. tumors require new blood vessels to support their ability to grow and to spread (metastasize). new treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.


Eligibility criteria:
inclusion criteria: * advanced measurable or non-measurable solid tumors * adequate bone marrow function * adequate liver function * adequate renal function * be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures exclusion criteria: * chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication * active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months * any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event * qtc prolongation defined as qtc \>450 msec * patients with known brain metastasis * patients with peritoneal carcinosis at risk of bleeding * major surgical procedure within 4 weeks of treatment * pregnancy or breastfeeding

Keywords: solid tumors transforming growth factor beta activin receptor-like kinase 1
exploring the effect of the transcendental meditation® technique on migraine frequency and functionality: a single arm study

Conditions: Migraine; Migraine with or Without Aura

Summary: this research will explore the effect of the transcendental meditation® technique on migraine intensity and frequency. it will be a single-arm pilot study involving 30 participants recruited from migraine treatment facilities and support groups in the us.

the objective of this study is to assess the safety, feasibility, and effects of the practice of the transcendental meditation technique in adults with migraines. this study will involve 30 participants recruited from migraine treatment facilities and migraine support groups in the us. the study will span three months, with all participants practicing transcendental meditation (tm) while continuing their usual lifestyle and medication regimen. pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. all potential subjects will keep a daily migraine diary for 30 days before inclusion in the study, both to assess migraine status and to adhere to study protocols during the study. all the subjects will receive tm instruction, followed by bi-weekly group meetings and one-on-one sessions for 3 months to monitor progress and ensure correct practice.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine with or without aura, based on ichd3 criteria * 6-14 migraine days/month. * ≥ one-year history of migraines starting before the age of 50. * ≥ 18 years old or ≤ 60 years old * willing to attend follow-up sessions. * willing to practice tm twice a day for 20 minutes. * fluent in english. willing to continue the same medication without any additional medicine in good general health, with no other diseases expected to interfere with the study. exclusion criteria: * \> 60 years old or \< 18 years old * already practicing transcendental meditation. * pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence * medication overuse headache (moh) * current/planned pregnancy or breastfeeding * new prophylactic migraine medicine started within 4 weeks of the screening visit * unwilling to maintain stable migraine medication dosages * failure to complete baseline headache logs.

Keywords: migraine meditation transcendental meditation
safety & efficacy of peg-asp-based ccrt in early stage enktl

Conditions: Extranodal NK/T-cell Lymphoma

Summary: the purpose of this multi-center, single arm, phase ⅱ clinical trail is to evaluate the efficacy and toxicity of concurrent chemoradiotherapy by using single-drug pegaspargase for patients with enktl in stage ie to iie.

the treatment regimen included ccrt ( involved field radiotherapy 50gy, concurrent 2 cycles of pegaspargase treatment ) followed by 4 cycles of pegaspargase. chemotherapy and rt were performed simultaneously within one week after enrollment. the administration regimen was as follows : day1, deep intramuscular injection of 2500 unit/m2 pegaspargase at three different sites, and repeated once every 3 weeks. 3d conformal radiotherapy was performed using 4 or 6 mv photons generated by a linear accelerator. the radiation dose was 50 gy, 2.0 gy / time, 1 time / d, for 5 weeks. the clinical target volume ( ctv ) of limited stage ie patients was defined as bilateral nasal cavity, bilateral ethmoid sinus and ipsilateral maxillary sinus. the ctv of extensive stage ie patients was extended to the affected tissues. the ctv of stage iie lesions also included the involved cervical lymph node area.

Eligibility criteria:
inclusion criteria: 1.the patient was pathologically diagnosed as enktl and had not received any previous treatment for enktl;2.the estimated survival time ≥ 3 months. 3.18-75 years old ; 4. ann-arbor stage was ie-iie ; 5. ecog performance status 0-2 ; 6.clinicians judged that patients were suitable for concurrent chemoradiotherapy ; 7.no radiotherapy or hormone drugs were received within 4 weeks before treatment;8.after the patients were enrolled in the trial, they could not accept other drugs that may have therapeutic effects on enktl ; 9.wbc≥ 3 × 109 / l, ne ≥ 1.5 × 109 / l, plt ≥ 100 × 109 / l ; 10.serum creatinine ≤ 1.5mg / dl, creatinine clearance rate ≥ 50ml / min ; 11.alt, ast ≤ 3 × uln ( normal upper limit ) ; total bilirubin ≤ 2 × uln ; 12.serum fibrinogen level ≥ 1.0g / l ; 13.signed informed consent form. exclusion criteria:1.symptomatic cns involvement, previous or current accompanied by other malignant tumors ; 2.the primary lesion is enktl from non-upper respiratory gastrointestinal tract ; 3.patients with poor general condition, ecog performance status \>2 ; 4.women in pregnancy or lactation; 5.the patient ( male or female ) has the possibility of fertility but is unwilling or does not take effective contraceptive measures; 6. known allergies to test drugs or any excipient component of these products ;7.doctors believe that patients are not suitable for concurrent chemoradiotherapy; 8.active infection ( determined by the researcher ) ; 9.according to the researchers ' judgment, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;10. have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.

Keywords: extranodal nk/t-cell lymphoma concurrent chemoradiotherapy pegaspargase
safety and efficacy of freezing and thawing of human eggs in assisted reproductive technology

Conditions: Infertility

Summary: the purpose of this study is to determine the effectiveness of the viacell's product media for freezing and thawing human eggs for future use in assisted reproductive technology.

viacell's product is an investigational product intended to broaden reproductive options for women through freezing and thawing of human eggs. the egg is a large cell with a high water content, historically making it difficult to freeze. it uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw eggs for future use. following informed consent, female subjects will be screened according to the inclusion/exclusion criteria of the protocol and eligible subjects will undergo hormonal stimulation using standard ivf drugs.

Eligibility criteria:
inclusion criteria: * women 21-35 years of age * women with male factor infertility seeking ivf treatment * negative history of female infertility * non-smoking for at least 1 year exclusion criteria: * greater than one miscarriage * more than one previous failed ivf attempt

Keywords: ivf male factor infertility cryopreservation cryoprotective agents egg freezing
virtual reality intervention for speech anxiety

Conditions: Public Speaking; Speech Anxiety

Summary: exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (vr) environment. the present study is designed to evaluate whether mood state moderates outcome to a brief vr exposure intervention.

the goal of this clinical trial is to compare outcomes of vr exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. the overarching aim of the present study is to determine whether mood state prior to engaging in a brief vr exposure therapy session for public speaking anxiety impacts treatment outcomes. the study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing vr based exposure therapy. public speaking and social anxiety outcomes are measured immediately post-intervention and one week later. researchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.

Eligibility criteria:
inclusion criteria: * self-report of 18 years of age or older * current student at boston university * ability to read english to provide informed consent * familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet). * for phase 2: speech anxiety scale score of ≥ 14 on the personal report of communication apprehension, public speaking subscale (prca-ps) exclusion criteria: * previous participation (i.e., no participant may take the survey more than once).
effects of metformin on hepatic ffa metabolism

Conditions: Type 2 Diabetes; Dyslipidemia

Summary: background: metformin treatment has beneficial effects on both glucose and lipid metabolism. whereas there is general agreement that the blood glucose lowering effect of metformin results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug lowers blood triglyceride concentration. there are indications that it enhances hepatic free fatty acid (ffa) oxidation thus diminishing substrate for reesterification and resecretion as very-low-density-lipoprotein (vldl) triglycerides (tg). however, the liver is not easily accessible for sampling in humans and data on the clinical effects of metformin in the liver are therefore lacking. this may change due to the increasing use of the positron emission tomography (pet) technique. using pet isotopes (11c or 18f) coupled to either palmitate or a fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling. aim: to determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes. design: randomized, placebo controlled, double-blind parallel study with patients receiving either metformin or placebo. a control group of bmi and age-matched non-diabetic individuals will receive metformin for 3 months. hypothesis: metformin lowers vldl-tg secretion and circulating triglycerides by increasing hepatic fatty acid oxidation


Eligibility criteria:
inclusion criteria: * recently diagnosed type 2 diabetes * age 50-70 years * bmi\<40 exclusion criteria: * insulin treatment * nash (non alcoholic steatohepatitis) * cancer * anemia * hba1c\>8.5 % * chronic or acute pancreatitis * alcohol or medicine abuse * allergy towards metformin * claustrophobia * severe obesity (weight \>130 kilogram)

Keywords: type 2 diabetes hepatic fatty acid oxidation dyslipidemia metformin
efficacy and feasibility of an intermittent weight loss program.

Conditions: Obesity

Summary: the goal of the study is to measure the effect of an approach including phases of active weight loss broken by weight stabilisation periods (named intermittent weight loss) on the metabolic profile. first, the intermittent weight loss approach will contribute to create an artificial transitory steady state during the weight loss treatment that will help to minimize the adverse effects of the standard approach on muscle mass and resting metabolic rate. second, despite a comparable fat mass loss, the intermittent weight loss approach will improve the metabolic profile to a greater degree compared to the standard approach. finally, the intermittent weight loss approach will be associated with less weight regain after the treatment since the beneficial effect on muscle mass and metabolic rate.

excessive levels of body fat are associated with metabolic disturbances predictive of an increased risk of coronary heart disease (cad). it is presently unclear as to the magnitude of weight loss needed to accrue metabolic benefits. despite the effectiveness of weight loss to reduce obesity levels, studies have shown that only minor decreases in body weight (5-10%) are needed to clinically improve cad risk factors. our data suggested that a 10% reduction in body weight is as effective in improving the metabolic profile as a 20% decrease in body weight. thus, the question are : " is it possible to further improve the metabolic profile over that 5-10% weight loss threshold?" and "could several 5-10% body weight loss (intermittent weight loss approach) have additive effects on the metabolic profile?". we would like to follow-up on these observation to better understand 1) the association between weight loss and improvements in the metabolic profile and 2) why minor decreases in body composition and body fat distribution are as effective as more important reduction.

Eligibility criteria:
inclusion criteria: * women who had stopped menstruating for more than 1 year * waist circumference \> 90 cm * sedentary (\< 2 times a week of structured exercise) * non-smokers * low to moderate alcohol consumers (\< 2 drinks per day). exclusion criteria: * we excluded subjects with the following conditions based on medical history and physical examination and on laboratory testing of kidney and liver functions, serum tsh, fasting glucose and lipid profile, and 75g-ogtt * cardiovascular disease, peripheral vascular disease or stroke * diabetes * moderate to severe hypertension (resting blood pressure \> 170/100 mm hg); * body weight fluctuation \> 5 kg in the previous 6 months * thyroid or pituitary disease * hormonal replacement therapy at any time during the previous 6 months * medication that could affect the metabolic profile

Keywords: diet caloric restriction intermittent diet obesity postmenopausal women