Kornimate/medical-research-clean huggingface dataset:
fat gain and cardiovascular disease mechanisms

Conditions: Hypertension; Sleep Apnea Syndromes; Obesity

Summary: understanding the mechanisms of obesity-induced hypertension is important both for prevention and therapy. studies of patients with established obesity have provided valuable information on pathophysiologic links between obesity and both blood pressure and cardiovascular risk. however, these studies are necessarily limited by the heterogeneity of obesity-associated disease so that the relative contribution of obesity or hypertension or other co-existing diseases to specific regulatory abnormalities is often not clear. clarification of whether any abnormalities associated with increased cardiovascular risk were present before or after the development of obesity has also been problematic. we therefore propose a series of novel studies directed at establishing the effects of increased body fat in otherwise healthy individuals. we will determine the distribution patterns of increased body fat and how both increased body fat and fat distribution relate to changes in blood pressure, and in neural, endothelial and inflammatory mechanisms which have been implicated in the development and progression of cardiac and vascular disease. we will study non-obese subjects with and without a family history of hypertension. these subjects will undergo an eight-week program of overfeeding with the objective of inducing a 4 kg fat gain. we will determine the nature of fat distribution in these individuals after the fat gain program and subsequently after an eight-week period of weight loss and restoration of normal body weight. measurements will be compared to those obtained in a matched control group with and without a family history of hypertension, who will continue their normal diets. we will test the following hypotheses: * individuals with a family history of hypertension will gain more visceral fat and upper body subcutaneous fat and will have greater blood pressure increases with overfeeding- compared with those without such a family history. * for all overfed subjects, increases in blood pressure and insulin resistance with fat gain will be most marked in those individuals with a predominantly upper body and visceral fat accumulation. * upper body and visceral fat gain will also be associated with greater impairment in cardiovascular function, higher nocturnal blood pressures and an increased likelihood of sleep disordered breathing.


Eligibility criteria:
inclusion criteria: * we will enroll up to 180 subject in order to fulfill screening requirements and have complete studies in 120 total (60 with and 60 without family history hypertension). * gender: male and female. * ages: 18 to 40 (inclusive). exclusion criteria: * body-mass index \> 33 kg/m2 * tobacco smoking or chewing * shift worker * any diseases * any prescription medications (except, oral contraceptives are permitted)
efficacy, safety and tolerability of denosumab in the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will determine the efficacy, safety, and tolerability of denosumab (amg 162) in the treatment of rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * diagnosis of ra. * all subjects will be required to have been taking a stable dose of methotrexate. * active ra at screening defined as greater than or equal to 6 swollen joints. * the presence of erosive disease exclusion criteria: * received any biologic agent (e.g., enbrel®, remicade®, humira®, kineret®) or arava® within 8 weeks before randomization; past use of these agents is allowed. * steroid use greater than 15 mg/day. * scheduled for surgery or joint replacement in the hands, wrists or feet.

Keywords: arthritis joint pain methotrexate
luna-emg to enhance motor functions in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the present study is to evaluate the effects of training performed with the luna-emg system to enhance motor functions of the lower limb in multiple sclerosis. this is a randomized open-label trial. patients will be randomized into the intervention group (luna-emg, 30-45 minutes once a week for 12 weeks) or in the control group (standard care). the effect of the training will be measured based on the muscular strength, walking tests, proprioception and a quality of life questionnaire.


Eligibility criteria:
inclusion criteria: * edss less or equal to 6.5 * between 18 and 70 years old * having signed the informed consent exclusion criteria: * acute pain syndrome * severe cognitive deficits * risk of fracture or unconsolidated fracture * rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints * severe ataxia and apraxia * epilepsy * pacemakers and similar implants * insufficient skin conditions
adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis

: knee osteoarthritis (koa) also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. the myofascial meridian is a new approach to the facial restriction .the knee capsules, the adductor muscles and the tipialis posterior are part of the deep front line which is a line of the myofascial meridian. exercise is the highest evidence in the treatment of knee osteoarthritis. the myofascial release is effective in the treatment of knee osteoarthritis so the study will investigate the effect of adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * mild to moderate unilateral or bilateral medial tibiofemoral oa grade ii-iii (k/l). * the age of the participants will range from 45 to 60 years old . * bmi ranged from 20-30 kg/m2 exclusion criteria: 1. severe knee oa (grade iv according to k/l classification). 2. congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee. 3. patients receiving oral or injected corticosteroids for the last 3 months . 4. history of knee surgery/fracture. 5. patients with acl and meniscus injury

Keywords: myofascial release knee osteoarthritis deep front line
patient perception and clinical efficacy of a collagen matrix for the treatment of peri-implantitis

Conditions: Peri-Implantitis

Summary: this is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (muco-graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.

nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa. therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis. the hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent kt mucosa. a sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed. peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.

Eligibility criteria:
inclusion criteria: * informed consent after the detailed information on the study. * adults aged at least 18 years old. * candidates for receiving augmentation of the peri-implant keratinized mucosa. * presence of the implant diagnosed with peri-implantitis (radiographic bone loss \> 2 mm, with a probing depth \> 5 mm, bleeding and/or suppuration (lang et al., 2011)). * absent or insufficient keratinized peri-implant mucosa (\<2 mm). exclusion criteria: * general contraindications for the dental/surgical treatment; * inflammatory or autoimmune disease of the oral cavity; * implant with radiographic intraosseous defects more than 3 mm; * smokers \> 10 cig/day; * allergy to collagen or analgesics/anti-inflammatory non-steroid drugs; * history of cancer in various parts of the body which required radiotherapy or chemotherapy during the last 5 years; * radiotherapy of the head or neck in the last 5 years; * actual medication with immunosuppressors, bisphosphonates or high doses of corticosteroids; * pregnant or lactating women; * women in fertile age, who do not use effective methods of contraception; * participants of other studies of biomedical investigation during the last 24 weeks before initiation of the study.
sertindole in asian patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in asia.

this study is the first randomised clinical trial performed in asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic. sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological profile. sertindole has shown significant improvements relative to placebo against both positive and negative symptoms of schizophrenia (measured by panss total, panss negative and positive subscale scores). it is well tolerated and shows placebo-level incidence of extrapyramidal symptoms (eps). sertindole is associated with a dose-dependent increase in the qt interval, but this does not translate into an excess mortality with sertindole relative to that of other recently developed antipsychotics in their respective clinical development programmes.

Eligibility criteria:
inclusion criteria: * male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia * positive and negative syndrome scales (panss) total score between 60 and 120 (extremes included) at screening and baseline * based on the patient's clinical status, an antipsychotic treatment is indicated * otherwise healthy * female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods exclusion criteria: * current axis i primary psychiatric diagnosis other than schizophrenia * has never before received antipsychotic drugs * has received a depot antipsychotic medication within less than one dose interval prior to screening * history of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (\<50 beats per minute) * congenital long qt syndrome or a family history of this disease, or in patients with known acquired qt interval prolongation (qtc above 450 msec in males and 470 msec in females at screening) * significant risk of suicide and/or violent behaviour * known history of narrow angle glaucoma * substance or alcohol abuse, current alcohol dependence * use of disallowed concomitant medication other protocol-defined inclusion and exclusion criteria may apply.
in vivo determination of cytochrome p450 activities in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: subjects will receive the "basel phenotyping cocktail" capsule orally with 120-200ml tap water in fasted state. after intake peripheral venous blood samples will be drawn. 12 patients (male and female) with liver cirrhosis for each child pugh category a, b, and c, and 12 age- and gender-matched healthy control subjects will be included (in total 48 participants).


Eligibility criteria:
inclusion criteria: * full mental and legal capacity. * signed informed consent prior to any study related procedure. * ability to communicate in german, sufficient to comprehend and adhere to study protocol. * normal physical examination, vital signs, laboratory workup, and combicaps lc study protocol version 1.2 09.08.2017 page 9 of 50 electrocardiogram (ecg) (in the opinion of investigator). * hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening (in the opinion of investigator). * no other conditions or circumstances that might interfere with compliance with study protocol (in the opinion of investigator). exclusion criteria: * known hypersensitivity to probe substances or any excipient of the drug formulation. * ongoing or past treatment with another investigational drug within 30 days prior to screening. * concomitant treatment with drugs that inhibit or induce cyp3a4, cyp2d6, cyp2c9, cyp2c19, cyp2b6 and cyp1a2 function (in the opinion of investigator). * actual infection * severe heart failure (nyha iv). * actual alcohol or drug abuse * positive results from urine drug screen at screening. * excessive caffeine consumption, defined as \>800 mg per day at screening\*. * subjects unwilling to stop consumption of alcoholic- and caffeine-containing beverages on study days until after the last sampling time-point of the study period. * intake of food products (immediately before or during study) known to be inducers or inhibitors of cyp450 (e.g. grapefruit juice) * loss of 250 ml or more of blood within 3 months prior to screening. * pregnant or lactating women * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * legal incapacity or limited legal capacity at screening. \*100 mg caffeine is approximately 1'000 ml coca cola®, 2½ espresso cups or 1 cup of strong coffee.

Keywords: cyp450 phenotyping in patients with liver cirrhosis
ketamine for low mood states in the er

Conditions: Depression; Suicide Ideation

Summary: the investigators hope to see if a commonly used drug such as ketamine could help depressed er patients feel better and improve their mood quickly.

rapid-onset antidepressants could have important clinical impact if their benefits extended to emergency department (ed) patients. we hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (iv) ketamine in depressed ed patients who presented with suicide ideation (si). the manuscript (article) for this study has been retracted because yale university conducted an investigation that determined that the description of the research was not accurate. the article misrepresents both the protocol-specified doses and the actual delivered doses of ketamine.

Eligibility criteria:
inclusion criteria: * adults (\>18yrs) presenting to the emergency department with symptoms of depression and/or suicide ideation (madrs\>30) with ability to give informed consent. * medically stable exclusion criteria: * psychosis, bipolar, or other significant physical or mental illness * pregnancy * non-voluntary status * urine drug screen positive for drugs of abuse

Keywords: depression suicide ideation emergency department ketamine
a phase ii, open-label study of clofarabine in paediatric patients with refractory/relapsed acute lymphoblastic leukaemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. it is a single arm study and has no comparator.

note: this clinical trial was conducted by bioenvision ltd. bioenvision ltd. was acquired by genzyme corporation oct 2007.

Eligibility criteria:
inclusion criteria: * have a diagnosis of all and confirmed by pathologic assessment. * be ≤ 21 years old at time of initial diagnosis. * eligible patients must have: primary refractory disease; or relapsed or refractory disease after a minimum of 2 prior blocks of treatment. * must not be eligible for therapy of higher curative potential. * have a karnofsky performance status of ≥ 50 or lansky performance scale of ≥ 30. * provide a signed, written informed consent from parent or guardian or young adult patients. * be able to comply with study procedures and follow-up examinations. * have adequate cardiac function without treatment. * have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, ast and alt, obtained within 7 days prior to registration. exclusion criteria: * received previous treatment with clofarabine. * patients with isolated extramedullary disease. * have received prior bmt or pbsct within the last 6 months. * have received prior bmt or pbsct more than 6 months ago, but now has compromised organ function. * have an active, uncontrolled systemic infection. * are pregnant or lactating. male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy. * have a psychiatric disorder that would interfere with consent, study participation, or follow-up. * have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment. * have any other severe concurrent disease. * have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function. * have cns disease.

Keywords: acute lymphoblastic leukemia clolar evoltra clofarabine refractory/relapsed acute leukemia pediatric acute leukemia
the influence of the volume of injuries and surgical operations on the results of pain treatment in patients with gunshot and mine-explosive wounds at the stages of treatment

Conditions: Chronic Pain

Summary: treatment of pain in patients with gunshot and mine-explosive injuries in the stages of treatment is important, because in 82.1% the pain becomes chronic. this indicates that treatment results need to be improved. one of the factors that can influence the outcome of pain treatment is the extent of damage and surgery.

the influence of the amount of damage and operative interventions on the results of pain treatment in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have its features. since in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria:
inclusion criteria: * the presence of gunshot wounds exclusion criteria: * no gunshot wounds

Keywords: pain treatment, wounds, damage, operative interventions
protein source, nutrition messaging, and food intake

Conditions: Obesity

Summary: the objective of this study is to determine how the protein source and the physical form of food consumed at breakfast impact food intake. research will be conducted by assessing feelings of hunger, food preference and blood glucose in healthy adults following the ingestion protein-based (animal versus plant) drinks similar calorie and protein content.


Eligibility criteria:
inclusion criteria: * healthy, no known health conditions exclusion criteria: * taking medication, excluding hormonal birth control * food allergies * food intolerances
a study of oral glp1ra rgt001-075 in adults with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 2 study designed to evaluate the efficacy of daily (qd) oral rgt001-075 glp1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in hba1c in adult patients with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control with diet and exercise and stable metformin treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of screening * screening hba1c 7.0-10.5% * male or female, age 18-75 years * screening bmi 24.5 - 40 kg/m2 * either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential exclusion criteria: * has received within the preceding 3 months prior to screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor \[dpp-4i\], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy * has active gi disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (nash), gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis b or c, or primary biliary cirrhosis, or elevated alanine aminotransferase (alt) levels at screening * has any history of myocardial infarction (mi), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to screening * has an estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 * has active proliferative diabetic retinopathy or macular edema * has a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2a or type 2b, thyroid c-cell hyperplasia, or medullary thyroid cancer * has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \<5 years prior to screening * has evidence of human immunodeficiency virus (hiv) and/or positive hiv antibodies historically or at screening * has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening * has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening