Kornimate/medical-research-clean huggingface dataset:
a study to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of mk1006 (mk-1006-002)(completed)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of mk1006


Eligibility criteria:
inclusion criteria: * participant is between 18 and 55 years of age. participants up to 65 years of age may be enrolled in panels b and c * female participants must be postmenopausal or otherwise unable to have children * participant has a body mass index (bmi) less than or equal to 42 kg/m\^2 at the screening visit * participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. for panels b and c, participant may be treated with combination oral anti-hyperglycemic medications * participant is willing to follow the american heart association (aha) diet and exercise program throughout the study * participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start exclusion criteria: * participant has a history of stroke, seizures, or other neurological disorders * participant has a recent history of eye infection or other inflammatory eye conditions * participant has glaucoma or is blind * participant has had eye surgery within 6 months of study start (lasik is permitted) * participant has type 1 diabetes * participant cannot stop taking any of their current prescription or non-prescription medications during the study * participant consumes more than 3 alcoholic beverages per day * participant consumes more than 6 caffeinated beverages per day * participant has had major surgery or has donated blood within 4 weeks of study start * participant has multiple and/or severe allergies to drugs or food
nifurtimox versus benznidazole effectiveness and tolerance for chagas disease treatment

Conditions: Chagas Disease

Summary: chagas disease is caused by parasite trypanosoma cruzi. in argentina, there is an estimated of 1.600.000 infected people. due to migration phenomenon, most cases live in urban areas without vectorial transmission. pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. there are two available drugs for this disease; nifurtimox and benznidazole. they both has proven efficacy for acute face treatment, with different security profiles. there are not enough adequate studies comparing both drugs made in a large number of subjects. investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.


Eligibility criteria:
inclusion criteria: - patients between 0 and 18 years of age with confirmed chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with nifurtimox or benznidazole. exclusion criteria: - patients that abandoned follow-up
hypnopuncture for in vitro fertilization (ivf)

Conditions: Infertility

Summary: infertility is a common and distressful problem for many couples, with assisted reproductive techniques (art) such as ivf and icsi, with slightly more than 34% pregnancies per cycle. acupuncture is an ancient chinese treatment in which thin needles are inserted into various points along the skin, harmonizing" the body's "energy. acupuncture has been found to increase pregnancy rates following ivf/icsi treatments, and is believed to affect ovulation and fertility through elevation of beta-endorphin release and gnrh secretion, as well as reduced sympathetic response with increased blood flow to the uterus. the sympatho-inhibitory properties and impact on beta-endorphin levels of acupuncture, as well as its efficacy in treating depression, may be helpful in reducing stress among women undergoing fertility treatments as well. hypnosis is a mind-body technique which uses suggestions during a relaxed state to promote healing. hypnosis can also significantly reduce the sympathetic response, and is believed to produce uterine relaxation and quiescence during embryo transfer (et), which may lead to a reduction in embryo displacement from the uterine cavity. no research has been published on the use of hypnosis with acupuncture (hypnopuncture) in art. this is a pilot study to evaluate the effect of a combined regimen of hypnopuncture on clinical pregnancy rates in women undergoing ivf/icsi following two failed cycles. during the initial pre-treatment meeting, participants who fulfill all inclusion criteria and none of the exclusion criteria will undergo hypnotic induction, followed by suggestions for increased uterine blood flow. on the day of embryo transfer, participants will be randomly divided into either treatment or no-treatment groups. treatment will consist of the insertion of acupuncture needles into pre-determined points, to be followed by a hypnosis pre-recorded hypnosis session, as described above. patients in the control group will receive standard care without hypnopuncture and those participants in this group who do not conceive following the 3rd cycle will be treated with hypnopuncture during the 4th cycle, following et. a total of 100 women will be enrolled, 50 in each arm of the study.


Eligibility criteria:
inclusion criteria: * females patients age 18 years and older * primary infertility with negative endocrinology and us findings on evaluation * following two failed cycles of either ivf or icsi, defined as no clinical pregnancy (presence of fetal sac on ultrasound examination 6 weeks after embryo transfer). * no underlying axis 1 psychiatric disorder * ability to comply with study protocol exclusion criteria: * patients displaying symptoms of overt axis-1 psychopathology such as schizophrenia or severe depression. * current use of any cam therapy * current use of any fertility treatment other than those prescribed by the fertility clinic. * inability to comply with the study protocol

Keywords: infertility in vitro fertilization intracytoplasmic sperm implantation acupuncture hypnosis hypnopuncture
study to describe treatment patterns and outcomes in egfrm nsclc patients in belgium

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic egfrm nsclc in belgium


Eligibility criteria:
inclusion criteria: * male or female, aged at least 18 years * pathologically confirmed nsclc * tumour harbours a mutation of egfr * diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic nsclc, not amenable to curative surgery or chemoradiotherapy between 01 september 2015 and 31 december 2017 exclusion criteria: * no follow-up data available after diagnosis of locally advanced or metastatic egfrm nsclc * patients who objected to participation to the study

Keywords: egfrm nsclc locally advanced metastatic lung cancer
tobacco product susceptibility and substitutability by rurality and alcohol use

Conditions: Alcohol Use; E-cigarette Use; Cigarette Use

Summary: a high priority research area for the federal drug administration center for tobacco products (fda ctp) is determining who will start using tobacco products and who will stop using tobacco products. a population that has a disproportionately high amount of tobacco use are people living in rural areas. this indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. people in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. the purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. to accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. because rurality is a spectrum, the investigators will be using an index of relative rurality (irr) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.


Eligibility criteria:
cigarette/e-cigarette users inclusion criteria: * 21 years of age or older * smoke cigarettes or use e-cigarettes 25 or more days a month cigarette/e-cigarette non-users inclusion criteria: * 21 years of age or older * do not report using an e-cigarette or cigarette in the past month risky alcohol users inclusion criteria: * 21 years of age or older * a score of 8 or higher on the alcohol use disorder identification test non-risky alcohol users inclusion criteria: * 21 years of age or older * a score of 7 or lower on the alcohol use disorder identification test all groups inclusion criteria: * located in the usa * at least 100 complete studies on prolific exclusion critera: * failing attention checks during the screener
evaluation of colchicine and nonsteroidal anti-inflammatory drug combination therapy and renal function in gout patients

Conditions: Renal Impairment; Gout; Colchicine Adverse Reaction; Nonsteroidals (NSAIDs)Toxicity

Summary: our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and nsaids combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

background: gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. colchicine and nonsteroidal anti-inflammatory drug (nsaid) are the mainstay treatment of gout. concurrent use of colchicine and nsaids are more than half in all prescriptions of the gout patients. both colchicine and nsaids may cause renal impairment. however, the empirical evidence of renal impairment of colchicine and nsaids combination therapy is limited and even absent. objectives: this proposal will assess the association between colchicine and nsaids combination therapy and acute kidney injury. the investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a gout diagnosis * initially receiving at least one anti-gout drug exclusion criteria: * \<1 year of continuous health insurance enrollment * colchicine and nsaid use before the cohort entry date * patients with hemodialysis or peritoneal dialysis before the cohort entry date * patients with acute kidney injury before the cohort entry date

Keywords: acute kidney injury renal impairment nonsteroidal antiinflammatory drug drug-drug interaction
prospective study of comparison between the modified atkins diet and classic ketogenic diet for intractable childhood epilepsy

Conditions: Epilepsy

Summary: the ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (kd) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. fat is proven long-chain triglycerides. the efficacy of the kd has been proven by many multicenter trials. but, side effects of ketogenic diet therapy is severe. the modified atkins diet (mad) was designed and investigated at johns hopkins hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. the mad consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. some literature suggested that the mad is an effective treatment for refractory epilepsy. but, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of mad comparing to kd. the patients were recruited between age 3 to 18 years old with intractable epilepsy. enrolled patients were randomly assigned to either one of two groups; the kd group and mad group. the patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.


Eligibility criteria:
inclusion criteria: * age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment. exclusion criteria * patients heve been tried kd or mad before. * patients with renal stones, hyperlipidemia, cardiologic problems. * other conditions not adjust for dietary therapy.

Keywords: seizure control through dietary therapy in pediatric intractable epilepsy patients.
a study of efruxifermin in subjects with histologically confirmed nonalcoholic steatohepatitis (nash)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a multi-center evaluation of efruxifermin (efx) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven f1 - f4 nash.


Eligibility criteria:
key inclusion criteria: * males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit. * main study only: body mass index (bmi) \> 25 kg/m\^2 (unless the patient has biopsy-proven nash documented within the last 2 years). * main study only: must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (mri-pdff) at screening. * main study only: biopsy-proven nash. must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (nafld) activity score (nas) of ≥ 4 with at least a score of 1 in each of the following nas components: * steatosis (scored 0 to 3), * ballooning degeneration (scored 0 to 2), and * lobular inflammation (scored 0 to 3) * cohort c only: fibroscan® measurement \> 13.1 kpa. * cohort c only: cirrhosis due to nash. liver biopsy consistent with f4 fibrosis according to the nas system, confirmed by the central or local reader. exclusion criteria: * weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening. * type 1 and insulin-dependent type 2 diabetes. * poorly controlled hypertension (blood pressure \> 160/100).
imaging modalities for pancreatic collections

Conditions: Pancreas Necrosis

Summary: the purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes.

the aim of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies (including ct, mri, eus, and direct endoscopic visualization) to compare these techniques, develop standardized methods for analyzing these imaging studies, and use this information to enhance management of patients with pancreatic collections. there is very limited published literature on these peripancreatic lesions that compares all three of these modalities and thus we aim to study it in detail.

Eligibility criteria:
inclusion criteria: * patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis * age greater than 18 years exclusion criteria: * pregnant woman * age \<18 years * prisoners * other institutionalized individuals * patients who are decisionally impaired
a mindfulness-based intervention for older women with low sexual desire

Conditions: Hypoactive Sexual Desire Disorder; Sexual Dysfunction; Female Sexual Dysfunction

Summary: the overall aim of this research is to adapt and pilot test a multi-component, mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.

specifically, the investigators will conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of the intervention. fifty women will be randomized to the mindfulness intervention or an educational control group. both groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. feasibility, acceptability, facilitators, and barriers will be assessed by surveys after each session and after intervention completion. preliminary efficacy will be assessed by measures of sexual desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.

Eligibility criteria:
inclusion criteria: * meet criteria for a diagnosis of female sexual interest/arousal disorder * english-speaking * have a current sexual partner with whom they are or would like to be sexually active exclusion criteria: * active major depression * active substance abuse * current intimate partner violence * partner with active major depression * partner with active major substance abuse * significant relationship dissatisfaction * current use of antidepressants * untreated dyspareunia (sexual pain)

Keywords: hypoactive sexual desire disorder female sexual dysfunction low libido female sexual interest-arousal disorder low desire sexual dysfunction
long term functional outcomes of covid-19 patients treated by rehabilitation services viatelehealth

Conditions: SARS-CoV 2; SARS Pneumonia

Summary: this study seeks to assess the impact of physical and pulmonary rehabilitation on patients who have been diagnosed with covid-19 in the short and long term in hopes of establishing a best practices protocol for treatment of future patients with this disease.

the novel coronavirus that began in wuhan, china in late 2019 made an appearance in the united states in january 2020. it is a respiratory disease spreading rapidly from person to person. recent data shows that fibrosis is seen on the lungs, and possible myocardial damage. data shows that physical therapy was not highly utilized in recovery for these patients due to high ppe demands, and increased risk of exposure. this study will be using telehealth services to assess and treat these patients so physical therapy guidance is provided for movement and returning to prior level of function. currently there is no data showing the long term effects of the those who were able to utilize physical therapy in recovering from covid-19 this study will be looking at the differences in outcomes of covid-19 positive subjects who able to complete physical therapy telehealth visits versus those who did not. all groups will be tested at multiple data points for lung capacity, upper and lower extremity strength, and overall endurance to determine the long term functional effects. the control group were diagnosed with covid-19 and recovered before the physical and pulmonary protocol was implemented.

Eligibility criteria:
inclusion criteria: * \>age of 18 * positive covid-19 diagnosis in the last 6 months exclusion criteria: * age of \<18
efficacy and safety of lcz696 compared to placebo in patients with essential hypertension

Conditions: Hypertension

Summary: this study is a phase 2 study in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: 1. patients must give written informed consent before any assessment is performed. 2. patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmhg and \< 110 mmhg, and mean sitting systolic blood pressure ≥ 140 mmhg and \< 180 mmhg). 3. patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment. 4. patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance. exclusion criteria: 1. patients with severe hypertension. 2. patients with history of angioedema, drug-related or otherwise 3. pregnant or nursing women 4. women of child-bearing potential , who do not use adequate birth control methods 5. history or evidence of a secondary form of hypertension. 6. history of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, tia, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease. 7. diabetes mellitus. 8. previous or current diagnosis of heart failure (nyha class ii-iv). 9. clinically significant valvular heart disease at the time of screening. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension blood pressure lcz696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor arni essential hypertension
systemic hypothermia improves outcome of hypoxic-ischemic encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. however, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.

hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. moderate to severe hie of newborn infants is associated with a high rate of death or long-term disabilities. historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (hie). however, hypothermia was not effective beyond 6 hrs after brain injury. the aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe hie.

Eligibility criteria:
inclusion criteria: 1. gestation age ≥37 weeks and body weight \>2500g. 2. with one of the following factors: 1. apgar score\<5 at 5min; 2. assisted respiration \>3min due to respiratory distress; 3. ph≤7.1 of cord or arterial blood within 60min after birth; 4. clinical manifestation of encephalopathy during the first 10 hrs of life. exclusion criteria: 1. major congenital abnormalities; 2. head trauma or skull fracture causing major intracranial hemorrhage; 3. mild hie; 4. financial problems of the parents; 5. lack of permanent address; 6. postnatal age \> 10 hrs

Keywords: asphyxia hypothermia hypoxic-ischemic encephalopathy neonates