Kornimate/medical-research-clean huggingface dataset:
dose determination safety and activity study of inhaled nx1011 to treat pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to determine the safety and maximum tolerated dose of inhaled nx1011 for the treatment of pulmonary arterial hypertension (pah).


Eligibility criteria:
inclusion criteria: * patient must either: * meet the pah diagnostic criteria at screening (based on a documented history of diagnosis as outlined in the american college of chest physicians \[accp\] 2004 evidence-based clinical practices guidelines)15; or * have elevated pulmonary pressure with a suspected pah diagnosis based on a clinical referral at screening for a rhc. * patient must have pah as defined by a mean pulmonary artery pressure (pap) \> 25 mmhg. * patient must have symptoms of pulmonary hypertension (ph) according to the world health organization (who) functional classification of pulmonary hypertension class ii through iv. * patient must consent to, be able to tolerate, and have adequate venous and arterial access for swan-ganz catheterization (sgc) and an arterial line. exclusion criteria: * clinically significant right-to-left intracardiac shunts based on doppler echocardiography with bubble study. * history of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis. * history of sustained ventricular tachycardia (vt-s) or ventricular fibrillation (vf) and cardiac arrest, or presence of atrial fibrillation. * active cardiac disease meeting the following criteria: * patient with elevated pulmonary capillary wedge pressures (pcwps) \> 25 mmhg. * patient with a history of myocardial infarction or coronary intervention within the last 60 days. * patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of baseline. * patient who cannot be withdrawn from nitrate therapy.

Keywords: pulmonary arterial hypertension pulmonary hypertension idiopathic pah ph associated with connective tissue disease (ctd) ph associated with interstitial lung disease (ild) ph associated with congestive heart failure (chf) ph associated with chronic obstructive pulmonary disease (copd)
pharmacokinetic properties of lorcaserin in the fed and fasted state

Conditions: Obesity

Summary: the purpose of this study is to evaluate the pk properties in fed and fasted men and women.


Eligibility criteria:
inclusion criteria: 1. males or females aged between 18 and 65 years (inclusive) 2. able to give signed informed consent 3. bmi 27-45 kg/m2, inclusive 4. eligible male and female subjects must agree not to participate in a conception process. 5. considered to be in stable health in the opinion of the investigator. exclusion criteria: 1. prior participation in any study of lorcaserin. 2. clinically significant new illness in the 1 month before screening 3. not suitable to participate in the study in the opinion of the investigator including an existing physical or mental condition that prevents compliance with the protocol 4. history of any of the following cardiovascular conditions: * myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ecg), cva, tia or rind within 6 months of screening; * cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening * unstable angina * history of pulmonary artery hypertension 5. positive result of hiv, hepatitis b or hepatitis c screens 6. malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins) 7. initiation of a new prescription medication within 1 month prior to screening. 8. recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening. 9. participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening 10. use of ssris,snris, and other medications must meet the washout period.
effects of aripiprazole in overweight patients treated with olanzapine for schizophrenia or schizoaffective disorder

Conditions: Body Weight Change; Schizophrenia; Schizoaffective Disorder; Psychotic Disorder

Summary: the primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

Keywords: patient weight change changes in metabolic status
deep brain stimulation (dbs) for the treatment of refractory alcohol use disorder (aud): pilot trial

Conditions: Alcohol Use Disorder

Summary: this is a phase i, non-blinded, non-randomized, pilot trial for safety and efficacy of dbs for aud. patients who meet inclusion and exclusion criteria will be identified and recruited from the practices of sunnybrook psychiatrists. five (5) to ten (10) subjects will be enrolled and study duration for each patient will be of one (1) year. our primary objective is to establish the safety of dbs in a patient population with treatment refractory aud. in addition to demonstrating safety, our second primary objective will be to evaluate if dbs-targeted nucleus accumbens in alcoholism is efficacious in the treatment-refractory patients with aud. this will be measured by various outcome measures that will include validated scales to assess addiction and craving behaviours.


Eligibility criteria:
inclusion criteria 1. female or male patients between age 18-70 2. diagnosis of alcohol use disorder (aud) as defined by the diagnostic and statistical manual fifth edition (dsm-5). 3. history of aud for at least 2 years, with evidence of repeated failure to respond to evidence-based aud treatments (psychosocial treatments plus pharmacotherapies such as disulfiram, naltrexone and acamprosate). 4. alcohol use disorders identification test (audit) scale score \>8 5. ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols exclusion criteria 1. any past or current evidence of psychosis or mania 2. current suicidal or homicidal ideation 3. active neurologic disease, such as epilepsy 4. visible brain damage or atrophy in ct or mri scan 5. any contraindication to mri or positron emission tomography (pet) scanning 6. likely to relocate or move during the study's one year duration 7. presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure. 8. patients with renal dysfunction (gfr\<60) 9. pregnant or lactating
drug exposure and depot medroxyprogesterone acetate (dmpa) in adolescent subjects

Conditions: Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding

Summary: the investigators are doing this study to look at how different doses of the depot medroxyprogesterone acetate (dmpa) shot effect weight gain and bone mineral density in teens. the investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving dmpa.

depot medroxyprogesterone acetate (dmpa) is a generic form of the depoprovera® shot. when receiving the birth control shot some girls gain a lot of weight while others do not. some girls also lose bone mineral density (bmd). bone mineral density is the amount of weight and thickness of the bones. in this study 1 of 3 doses of dmpa will be given as an injection into the muscle in the arm. the 150mg dose is approved for use in this age group by the food and drug administration (fda) when given into the muscle. the 104mg dose is approved for use in this age group by the fda only when given under the skin therefore it is considered experimental. the 75mg dose is also considered experimental as this dose is not fda approved regardless of how it is given.

Eligibility criteria:
inclusion criteria: 1. age 12-21 years 2. healthy, post-menarcheal female 3. self-selected to initiate depot medroxyprogesterone acetate (dmpa) 4. willingness to use a barrier method of contraception in addition to dmpa exclusion criteria: 1. chronic disease known to affect weight or bone mineral density (bmd) (e.g. diabetes, kidney) 2. use of medication known to affect weight or bmd (e.g. corticosteroids) 3. dmpa use within the past 12 months 4. pregnancy within the past 6 months 5. etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (oc, patch, vaginal ring) 6. weight exceeding 450 lbs 7. need for confidential contraceptive care for individuals \< 18 years of age.

Keywords: birth control contraceptive methods female contraception weight gain bone density
inguinal hernia operation and postoperative pain

Conditions: Pain, Postoperative; Inguinal Hernia; Quality of Life

Summary: inguinal hernia is a common disease, which is treated surgically when symptomatic. pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. the aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. our goal is also to find out how the pain affects the patients´ quality of life.


Eligibility criteria:
inclusion criteria: * 18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. primary and unilateral hernia. the operation performed at a day surgery unit. exclusion criteria: * female * bilateral hernia * incarcerated hernia * scrotal hernia * asa-classification \>3 * bmi \>35 or \<18 * no hernia found in clinical examination * liver cirrhosis * other contraindication for inguinal hernia operation * anticoagulant therapy, that needs bridge therapy when paused
comparison of the efficacy and safety of two insulin intensification strategies

Conditions: Diabetes Mellitus, Type 2

Summary: the study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * present with type 2 diabetes mellitus * have been taking metformin and/or pioglitazone * have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days * have glycosylated hemoglobin a1c (hba1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5 * have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/l, less than or equal to 121 milligrams per deciliter (mg/dl)\], or greater than 6.7 mmol/l (greater than 121 mg/dl) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons * not pregnant or breastfeeding exclusion criteria: * have type 1 diabetes * their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country * have a body mass index (bmi) greater than 45 kilograms per square meter (kg/m2). * have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks * have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study * have cardiac disease with a functional status that is class iii or iv * have a history of renal or liver disease * have had a blood transfusion or have a blood disorder

Keywords: metabolic diseases diabetes mellitus, type 2 glargine diabetes mellitus insulin lispro insulin
epidemiology of post-influenza bacterial pneumonia due to a panton-valentine leukocidin positive staphylococcus aureus

Conditions: Influenza; Staphylococcus Aureus Pneumonia; PV Leukocidin

Summary: secondary bacterial influenza pneumonia caused by panton-valentine leukocidin positive staphylococcus aureus is a rare complication but with poor prognosis. this pathology seems to affect young patients (20-40 years) without any medical history. since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. however, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies. the main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a panton-valentine leukocidin positive staphylococcus aureus


Eligibility criteria:
inclusion criteria: * patient treated for post-influenza bacterial pneumonia due to a panton-valentine leukocidin positive staphylococcus aureus in intensive care unit exclusion criteria: * minor patient * patient under protective measurement * absence of bacteriological and / or virological documentation

Keywords: influenza staphylococcus aureus pneumonia pv leukocidin icu
blood lipid-lowering effect of brown alga ecklonia cava

Conditions: Hypercholesterolemia

Summary: the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ecklonia cava extract on hyperlipidemia.

the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ecklonia cava extract on hyperlipidemia. the investigators measured improvement of lipid profile, including total cholesterol, triglyceride, hdl-cholesterol, and ldl-cholesterol.

Eligibility criteria:
inclusion criteria: * mild hypercholesterolemic subjects(≥200mg/dl of total cholesterol or ≥110mg/dl of ldl-cholesterol) exclusion criteria: * self-reported pregnancy, lactation * prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs
low-dose molecular breast imaging: comparison of breast cancer detection rate at initial screening and two-year follow-up

Conditions: Breast Cancer

Summary: the purpose of this research is to evaluate whether repeating a screening molecular breast imaging (mbi) study two years after an initial screening mbi study further improves breast cancer detection in women with dense breast tissue.


Eligibility criteria:
inclusion criteria: - past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign \[breast imaging reporting and data system (bi-rads) category 1 or 2\] exclusion criteria: subjects will be excluded if they: * are unable to understand and sign the consent form * are pregnant or lactating * are physically unable to sit upright and still for 40 minutes * have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.) * have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study * are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention * have undergone bilateral mastectomy * have had a prior mbi within 20 months of scheduled study mbi.

Keywords: dense breast tissue breast cancer screening molecular breast imaging breast cancer breast
tear lipid layer thickness with emollient eye drops

Conditions: Dry Eye Syndromes

Summary: crossover comparison of lipid layer thickness with two artificial tear formulations

this study will objectively evaluate two us monograph lubricant eyedrop formulations (allergan, plc). refresh optive advanced will be compared to an investigational formula with additional compendial ingredients (refresh optive mega 3) in subjects with dry eye symptoms and lipid layer thickness \< 75 nm at baseline in a randomized, cross-over (masked subject) design. we seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1 hour after each eye drop has been instilled. the stroboscopic video color microscope of king-smith is used for non-invasive lipid layer thickness measurement.

Eligibility criteria:
inclusion criteria: * age - at least 30 years * good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi) * ability to give informed consent * willing to spend time for the study; approximately one hour for a screening visit and additional 4 hours for the study assessments. study assessment will be conducted over 2 visit days, approximately 1 1/2 hours per day. * either gender * any racial or ethnic origin * stroboscopic video color microscope tear lipid thickness ≤ 75 nm exclusion criteria: * use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and restasis) used within 14 days of the screening visit or started prior to the measurement visit(s). * currently having punctal plugs inserted in lacrimal puncta * current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. clinically significant (active treatment) of blepharitis, sjogren's disease or other systemic disease that could influence meibomian gland dysfunction, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics or drugs that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested, * past eye surgery, such as, but not limited to, refractive surgery. subjects who have had cataract removal surgery more than one year ago, but less than 10 years ago may be considered as potential subjects. * female subjects may not be pregnant or lactating. (subject will be asked to self report these conditions.) * infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, hiv). (subjects will be asked to self-report these conditions.) * inability to complete the screening and examination * inability to provide analyzable data. for example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
use of the freestyle navigator continuous glucose monitoring system to enhance education and glycaemic control

Conditions: Diabetes Mellitus

Summary: to demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and hba1c.

study overview this is a multi-centre pilot study across 6 study sites, recruiting 50 subjects. each subject will use a freestyle navigator continuous glucose monitor for a period of 20 days at the start of the study, after which their healthcare professionals (hcps) may recommend changes to their glucose management based on the continuous glucose monitoring(cgm) data. subjects will then return to self-managing their diabetes with a blood glucose meter. after 2 months, subjects will use the freestyle navigator for a further 5 days and review their results and glucose management with their hcps. subjects will again return to self-managing their diabetes with a blood glucose meter until the end of the study, when the last freestyle navigator 5 day wear is completed and hba1c and measures of glycaemic variability are recorded.

Eligibility criteria:
inclusion criteria: * subject with type 1 or type 2 diabetes requiring multiple daily injections (mdi) (for \>1yr) * age 18-65 years * hba1c above 8.0% for previous 2 hba1c tests; the last hba1c result being obtained within 3 months prior to enrolment * completed a structured education programme meeting nice criteria between 6 to 24 months prior to enrolment. * testing blood glucose ≥ 4 times a day for previous 12 months exclusion criteria: * subject is currently on an insulin pump. * subject has known allergy to medical grade adhesives * subject has concomitant disease that influences metabolic control * subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management * subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring. * subject is receiving peritoneal dialysis solutions containing icodextrin * subject is pregnant / planning to become pregnant during study

Keywords: diabetes continuous glucose monitoring
an exploratory investigation of dietary supplementation and the effect on common pms and menstrual symptoms

Conditions: Menstrual Pain; Menstrual Discomfort

Summary: dietary supplementation is widely used to alleviate various symptoms of pms and menstruation such as bloating and cramping. providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported pms and menstrual discomfort when compared with a baseline without the intervention.

this is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort. it is hypothesized that the dietary supplement marketed as semaine pms \& period support will improve subjective wellbeing and biomarkers in trial participants. a total of 58 participants will be recruited for the trial following screening, with the expectation that at least 51 will complete the trial. the trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle. for both menstrual cycles the participants will complete a subjective wellbeing survey and provide a blood sample for biomarker analysis. the biomarker analysis will be performed through an at-home fingerprick blood test. to maximize consistency, the tests should be performed on the same days of each cycle - preferably on days 4 or 5. if absolutely necessary, however one day of buffer on either side will be allowed.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * female, aged 18-40 * willingness to refrain from ibuprofen or naproxen sodium (such as advil, aleve, motrin or midol) during each period (pill bleed) during the study * ability to take oral medication and be willing to adhere to the dietary supplement regimen * use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. hormonal contraception must allow for pill bleeds to occur. * moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. on a scale of 1-10, participants must report at least a 4 on two or more symptoms. * agreement to adhere to lifestyle considerations (see section 5.3) throughout study duration exclusion criteria: * current use of gnrh agonists and antagonists including lupron or orilissa * current use of an extended activity hormonal contraception (for example, depo-provera or nexplanon) * current use of hyperthyroid medication such as methimazole * current use of blood thinning medication * pregnancy, lactation, or attempting to become pregnant during study * known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, boswellia, milk thistle, quercetin or catechins)

Keywords: pms menstrual symptoms