Kornimate/medical-research-clean huggingface dataset:
flaxseed lignan (brevail)

Conditions: Polycystic Ovarian Syndrome

Summary: pcos is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). there is no universally accepted definition for pcos. the rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries. this study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (pcos) patients.


Eligibility criteria:
inclusion criteria: * must be 18 to 40 year old female with: * diagnosis of pcos by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), ferriman-galleway score \>8, and/or hyperandrogenemia defined as total testosterone \>80ng/dl or bioavailable testosterone \>8.4 ng/dl. * mentally competent. exclusion criteria: * use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months. * long-term or chronic use of oral antibiotics. * hysterectomy. * fsh \>15. * pregnancy/lactation. * consumption of flaxseed within the last month. * diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia. * use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.
effects of curcumin supplementation on lipid profile and inflammatory markers of patients with type 2 diabetes

Conditions: Non Insulin Dependent Diabetes

Summary: diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. various kinds of antidiabetic drugs have been developed, but most of them have side effects. recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. most of the studies conducted on animal model, and just a few of them are on human model. the present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: 1. tendency to participate 2. age range of 40-65 3. suffering from diabetes type 2 ( between 1 to 10 yeares) 4. bmi 18/5-30 5. patients with diabetes who administer oral hypoglycemic agents and do not use exclusion criteria: 1. patients with liver diseases 2. patients with kidney diseases 3. patients with inflammatory diseases 4. patients with liver diseases 5. administering herbal agents 6. administering multivitamins and minerals in past 3 months
a single-center, phase 2 study evaluating bilastine ophthalmic solution in the cac® model

Conditions: Allergic Conjunctivitis

Summary: to evaluate the efficacy of bilastine ophthalmic solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis


Eligibility criteria:
key inclusion criteria: * be at least 18 years old * be willing and able to avoid all disallowed medications and contact lenses * must have a pregnancy test if of childbearing potential * must be able to read an eye chart from 10 feet away key exclusion criteria: * must not have any allergies to the study medications * must not have any ocular or non ocular condition that investigator feels will interfere with study parameters * must not have used immunotherapy in the last 2 years * must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
kor pci - cad patients treated with pci: analysis of the korean nationwide health insurance database

Conditions: Coronary Artery Disease; Drug-eluting Stents; Drug-coated Balloon

Summary: current status and prognosis of coronary artery disease patients treated with coronary intervention - analysis of the korean nationwide health insurance database

this is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the national health insurance service. primary outcome is all cause of mortality. secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.

Eligibility criteria:
inclusion criteria: * all coronary artery disease patients wih korean nhis (national health insurance service)-listed pci exclusion criteria: * non-specified
innovative interventions for smoking cessation

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (vlnc) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. the study will determine if adding nicotine replacement medication to the very low content cigarettes (vlnc) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

the purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (vlnc) compared to the vlnc cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels. the following primary hypothesis will be tested: abstinence rates will be highest and the time to relapse will be the longest in the vlnc cigarettes plus nicotine patch condition compared to nicotine patch or vlnc cigarettes alone. other hypotheses include: 1. greater positive subjective responses to cigarettes will be observed with vlnc cigarettes plus patch vs. vlnc cigarette; 2. less drop-outs will be observed in the vlnc plus patch vs the other two conditions; and 3. less compensatory smoking will be observed in the vlnc plus patch condition compared to vlnc cigarette alone condition. cigarette smokers will be randomized to: 1. vlnc cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks; 2. nicotine patch for 6 weeks; or 3. vlnc cigarettes alone. outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Eligibility criteria:
inclusion criteria: * a) smoking at least 10 cigarettes daily for the past year; * b) in good physical health; * c) no contraindications for medicinal nicotine; and * d) stable, good mental health. exclusion criteria: * a) subjects must not be using other tobacco or nicotine products. * b) female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Keywords: smoking cessation nicotine free cigarettes
effect of daily intake of satiostat over 6 weeks on weight loss, glucose tolerance, gastrointestinal tolerance and gut microbiota.

Conditions: Obesity

Summary: satiostat is a composition comprising a specific dietary fibre component (a mixture of hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid component (long-chain fatty acids). the goal of this combination is to achieve long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release of satiety-signals from intestinal cells, and consequently reducing appetite and lowering food intake in humans. over a period of 6 weeks, volunteers will ingest satiostat as meal replacement at lunch and as first course at dinner. once before and after these 6 weeks the investigators will carry out an oral glucose challenge, measure satiation hormones and examine faeces (gut microbiota). volunteers will fill in a food diary and a questionnaire for gastrointestinal symptoms and quality of life. the whole study will take approximately 8-10 weeks.


Eligibility criteria:
inclusion criteria: * obese volunteers (bmi \> 30kg/m2) * otherwise healthy * informed consent as documented by signature (appendix informed consent form) exclusion criteria: * food allergies, food intolerance * evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening * chronic or clinically relevant acute infections * clinically relevant abnormalities in chemical, haematological or any other laboratory parameters * participation in drug trials within 2 months before start of the study * neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment * pregnancy: although no contraindication pregnancy might influence metabolic state. women who are pregnant or have the intention to become pregnant during the course of the study are excluded. in female participants of childbearing age not using safe contraception (oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) a urine pregnancy test is carried out upon screening. * antibiotic therapy within the last 3 months before inclusion * substance abuse, alcohol abuse * inability to follow procedures due to psychological disorders, dementia or insufficient * knowledge of project language (german). * participation in another study with investigational drug within the 30 days preceding and during the present study.
the effect of adding auditory information on head movements in people with non-traumatic neck pain

Conditions: Healthy; Neck Pain

Summary: this study sets out to investigate the potential effect of auditory disturbances on human movement

clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. this study sets out to investigate the impact of auditory disturbances on head movements.

Eligibility criteria:
control group: inclusion criteria (control): * able to speak, read and understand danish/english exclusion criteria (control): * pain from the neck or shoulder area during the past 6 months * experience of delayed onset muscle soreness (doms) during the week leading up to the test session * former surgery in neck or shoulder * current or previous chronic or recurrent pain condition that could affect the results * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses that could affect the results * regular use of analgesics * abnormally disrupted sleep in the last 24 hours preceding the experiment * lack of ability to cooperate neck pain group: inclusion criteria (neck pain): * idiopathic neck pain * able to speak, read and understand danish/english * reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion exclusion criteria (neck pain): * experience of doms during the week leading up to the test session * former surgery in neck or shoulder * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal (other than neck pain) or mental illnesses that could affect the results * abnormally disrupted sleep in the 24 hours preceding the experiment * lack of ability to cooperate

Keywords: neck pain kinematics
efficacy and safety of gemcabene in patients with low hdl-c and either normal or elevated triglycerides

Conditions: Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the effect of gemcabene on hdl-c, ldl-c, tg, and other lipid levels in patients with low hdl-c


Eligibility criteria:
inclusion criteria: * men or naturally postmenopausal or surgically menopausal women * 18 to 80 years of age * baseline hdl-c \<35 mg/dl (0.9 mmol/l) exclusion criteria: * creatine phosphokinase (cpk) \>3 × the upper limit of normal (uln) * body mass index (bmi) \>35 kg/m2 * uncontrolled hypertension \>95 mm hg * uncontrolled diabetes mellitus (hba1c \>10%) * renal dysfunction (blood urea nitrogen \[bun\] or creatinine \>2 × uln); * hepatic dysfunction (aspartate aminotransferase \[ast\] or alanine aminotransferase \[alt\] \>2 × uln) * uncontrolled hypothyroidism (tsh \>1.5 × uln) * myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months

Keywords: lipid regulator tg
clinical trial on pharmacokinetics and tolerability of ap707

Conditions: Pharmacokinetics; Tolerability; Safety

Summary: brief summary:this study aims to investigate the uptake of ap707, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

pharmacokinetic parameters and tolerability of ap707 is studied over 24 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form 2. male at the age of 30 - 60 years at study start 3. body mass index of 18 to 30 kg/m2 4. non-smoker, no use of any tobacco products, 5. good general health status (karnofsky score = 100; see annex 1, page 59) 6. current ecg without abnormal findings (no significant alterations from normal values, especially with regard to the qt interval (qtcf \< 450 ms) 7. physical examination, medical history without exclusionary findings 8. pulse rate between 50 and 90 bpm 9. blood pressure between systolic 90 - 140 mmhg, diastolic 50 - 90 mmhg 10. lab values for liver function (alt, ast, ap, bilirubin total) within normal ranges 11. lab value for renal function (s-creatinine, egfr according to ckd-epi) within normal range 12. negative test result on hiv i, hiv ii, hepatitis b cell surface antigen, hepatitis c antibody 13. negative test result of urine screening for cannabis and substance abuse exclusion criteria: 1. medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure 2. use of cannabis products within the last 8 weeks 3. use of opioids 4. former or present dependency (e.g. to alcohol, medicinal products, drugs) 5. participation in another clinical trial within the last four weeks prior to study inclusion 6. former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder 7. acute severe somatic disease (e.g. gastrointestinal diseases, influenza) 8. body temperature ≥ 38°c 9. present cardiovascular, respiratory, diabetic, or cancer disease 10. hepatitis a, b, c or other liver and renal disease 11. other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial 12. indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation) 13. taking any pharmaceutical products (including any medication interacting with metabolism of thc, e.g. st. john's wort)

Keywords: cannabis cannabis based medicine thc tetrahydrocannabinol
investigating prevalence of disordered eating in children with gi disorders

Conditions: Disordered Eating

Summary: gastroenterological disorders are disorders affecting the stomach, intestines and associated organs. symptoms of these types of disorders vary but often include vomiting, diarrhoea, weight loss and loss of appetite. due to the nature and symptomatology of these disorders research has suggested that sufferers may be vulnerable to developing disordered eating behaviours. treatment of such disorders often requires dietary restriction which has been found to lead to an obsessive preoccupation with food and in some cases to an increase in binge eating. further to this, symptoms of gastroenterological disorders such as vomiting have also been suggested to be linked with disordered eating. at the present there is limited research in this area and as such evidence is inconclusive. particularly little research has looked at this area in relation to adolescents, who have been recognised as being at increased risk for the development of disordered eating . gastroenterological disorders are likely to affect the typical development of eating habits and therefore it seems plausible they may also predispose adolescents to developing abnormal eating behaviours /weight concerns. the aim of this study is to further investigate the possibility that gastroenterological disorders may be a risk factor for disordered eating in children and adolescents. this study will recruit children/ adolescents aged 5-17 and their parents, who are attending great ormond street gastroenterology clinic and ask them to complete a screening questionnaire. the recruitment process will be on going for around 5 months until the study has around 300 participants. following this initial questionnaire, participants who are categorised as screening positively for disordered eating and a 10% sample of participants that screen negatively, will be contacted to complete a further questionnaire interview that will look more specifically into this area.


Eligibility criteria:
inclusion criteria: * children/adolescents between the age of 5-17 and their parents who are attending the gastroenterological clinic. we will recruit all patients that fall within the age range, including both new patients and existing patients. exclusion criteria: * parents/ adolescents unable to communicate english will be excluded from the current study. * children under the age of 5 and over the age of 17 will also be excluded.
using virtual reality (vr) models for robotic prostatectomy - unc

Conditions: Prostate Cancer

Summary: a prospective, randomized, controlled study designed to assess whether digital virtual reality (vr) models, created from existing ct scans and mris, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Eligibility criteria:
inclusion criteria: * patient is undergoing robotic prostatectomy being performed by participating surgeon * patient is willing to be randomized between intervention and control arms exclusion criteria: * patients with prior pelvic radiation * patients with prior androgen deprivation therapy * patients with prior localized ablative therapy * patients with prior turp or other surgical bph treatment
study of the influence of plasma exchange on the pharmacokinetics of rituximab

Conditions: Renal Transplant; Autoimmune Diseases

Summary: rituximab (a monoclonal antibody raised against cd20) is used to treat various immune disorders. in some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. the pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter. the aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab. the results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. the plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients. the enrollment in the study will not change the treatment of patients except for blood sampling. each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. for the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep. the plasma concentration of rituximab will be determined by elisa method (enzyme linked immunosorbent assay) the pharmacokinetic analyse will consist in the determination of the area under the concentration curve (auc) by a non compartmental approach. the auc levels will be compared (using the t student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) the efficacy of the treatment will be evaluated by the cd19+ b cell count.

Eligibility criteria:
inclusion criteria: * patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant * patient older than 18 years old * patient who have signed the written informed consent form exclusion criteria: * patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (nyha class iv)) * blood sampling impossibility * pregnant or breasting women

Keywords: rituximab plasma exchange autoimmune diseases
immunotherapy for elderly patients with chronic osteoporotic pain

Conditions: Osteoporotic Pain

Summary: osteoporotic pain is the most common clinical symptom in elderly patients. the course of pain is prolonged and the effect of clinical treatment is limited. this study will observe the therapeutic effect of thymosin alpha 1 on elderly patient with osteoporotic pain and explore its immunotherapy mechanism.

about 70% of the elderly patients suffered osteoporotic pain, mainly involving the limbs and low back. the pain prolonged and varies from mild to severe, and the effect of the clinical treatment is poor which has become a serious social problem. recent studies have put forward a new point of "bone immunology", which suggests that immune system, especially cd4+ t cell system, are involved in the regulation of bone formation, bone resorption and bone remodeling. so, in this study, the investigators will observe the therapeutic effect of thymosin alpha 1 on osteoporotic pain in elderly by observing the improvement of vas score before and after the treatment, as well as the changes of proportion of peripheral blood cd4+ t lymphocyte subsets, bone mineral density, serum bone biochemical index, neuropeptides, rankl and other cytokines levels will be evaluated. the clinical safety of thymosin alpha 1 in elderly patients with osteoporotic pain will also be observed.

Eligibility criteria:
inclusion criteria: * patients suffered osteoporotic pain diagnosed by specialists * vas scores greater than 5 * normal reading and understanding ability * communicate normally * volunteer to participate exclusion criteria: * mental illness * serious physical disease * unwilling to cooperate

Keywords: osteoporotic pain thymosin alpha 1