Kornimate/medical-research-clean huggingface dataset:
primary prevention of major depression in later life

Conditions: Depression

Summary: the institute of medicine has called for studies of "indicated" preventive interventions to reduce the incidence of mental illness in persons already symptomatic but not yet presenting with fully developed clinical syndromes. the investigators' advanced center for interventions and services research in late life mood disorders has embraced the development and testing of preventive interventions as one of its key objectives. the investigators propose to test the following hypotheses related to primary prevention of major depressive episodes in old age, focusing on elderly patients who have symptoms of emotional distress but who are not yet presenting with the full syndrome of a major depressive episode. hypothesis 1: problem solving therapy (pst) will be superior to an attention-only control (dietary education) in lowering the two-year incidence of episodes of syndromal major depression in already symptomatic elderly primary care patients. hypothesis 2: pst will also prevent higher levels of depressive symptoms and associated disabilities, over a two-year period of follow-up.

306 participants will be randomly assigned to either problem solving therapy or to a dietary education control. pst will consist of 6 to 8 sessions, distributed over 6 to 16 weeks, teaching participants a structured process of problem definition, generation of potential solutions, evaluation and choice of solution, and its implementation. the dietary education control will consist of 6 to 8 sessions also, distributed over 6 to 16 weeks. subjects assigned to the diet condition will receive education in healthy eating practices (e.g., food pyramid, types of food and calories recommended for people age 60 and above, tips on shopping for healthy food, food preparation, and healthy eating behavior). subjects will be followed up to 2 years. length of study is 24 months.

Eligibility criteria:
inclusion criteria: * age 50 or greater * center for epidemiological studies of depression scale (ces-d) score of 11 or higher * folstein mini-mental state score of 24 or higher * not currently receiving antidepressant medication or participating in other mental health treatment exclusion criteria: * episode of major depression within the past 12 months * episode of alcohol or other substance abuse within the past 12 months * life time history of bipolar disorder or other psychotic disorder * diagnosis of any neurodegenerative disorder or of dementia (alzheimer's, vascular, or frontotemporal dementia, etc.)

Keywords: depression prevention prevention of depression depression in the elderly late life depression depression in old age treatment of depression in primary care patients sub syndromal depression minor depression
smoking study with behavioral therapy for hypertensive patients

Conditions: Cigarette Smoking; Hypertension

Summary: in total, 260 patients with pre- and stage i hypertension, who are regular smokers, will be randomized to: varenicline alone or varenicline plus behavioral therapy. patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (co) and cotinine monitoring. a significantly higher proportion of behavioral therapy patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. clinic and 24-hour blood pressure (bp) and heart rate (hr) will be primary clinical outcomes. the investigators expect that bp and hr will decrease more among behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate decreases in these indices.


Eligibility criteria:
inclusion criteria: * regular smokers, with no period of abstinence exceeding 3 months in past year * expired co of at least 8 ppm * self-reported desire to stop smoking * at least 18 years of age * resting systolic bp of 120-160 mmhg and/or diastolic bp of 80-100 mmhg but otherwise in good health (see exclusion criteria) * if on antihypertensive medication, have not changed medications during the previous month and do not intend to change in the next 3 months * english speaking exclusion criteria: * receipt of smoking cessation treatment (behavioral or pharmacological) in the past month * serious or unstable medical disease within the past 6 months, including myocardial infarction, cancer, congestive heart failure, kidney failure, stroke, or seizures * evidence or history of allergic reactions contraindicating varenicline use or clinically significant laboratory or electrocardiographic (ecg) abnormalities * breastfeeding, pregnant or not using effective contraception if a woman of childbearing potential * arm circumference of \>42 cm, which precludes accurate bp monitoring * serious psychiatric illness in past 6 months (e.g., schizophrenia, psychosis, suicide risk, drug or alcohol dependence other than nicotine) * use of tobacco containing products other than cigarettes in past month and do not agree to abstain from use of these products during study participation * ongoing use of any of the following medications: nicotine replacement therapies, monoamine oxidase inhibitors, antipsychotics, mood stabilizers, or naltrexone * in recovery for pathological gambling

Keywords: smoking varenicline behavioral therapy abpm hypertension
postprandial glucodynamic response to insulin glargine/lixisenatide fixed ratio combination in japanese patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in japanese patients with type 2 diabetes mellitus (t2dm). secondary objectives: * to assess the pharmacokinetics (pk) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in japanese patients with t2dm. * to assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in japanese patients with t2dm. * to assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in japanese patients with t2dm.

the total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.

Eligibility criteria:
inclusion criteria : * japanese male or female patients with t2dm diagnosed for at least 1 year prior to the time of screening as established in the medical history. * patients aged 20 to 75 years at screening. * body mass index ≤35 kg/m\^2 at screening. * glycohemoglobin ≥7.0% and ≤10.0% at screening. * fasting c-peptide ≥0.6 ng/ml at screening. exclusion criteria: * diabetes other than t2dm. * history of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening. * history of hypoglycemia unawareness. * hemoglobinopathy or hemolytic anemia. * history of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period. * history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. * clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment. * personal or family history of medullary thyroid cancer (mtc) or genetic conditions that predispose to mtc (e.g., multiple endocrine neoplasia syndromes). * if female, pregnancy or breast-feeding. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study of lc23-1306 in healthy male subjects

Conditions: Acute Coronary Syndrome

Summary: this will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. adverse events, physical examinations, vital signs, ecg and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects between the ages of 20 and 50 years at screening 2. subjects with body mass index (bmi) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). bmi (kg/m2) = body weight (kg)/ {height (m)}2. 3. subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an institutional review board (irb) - approved informed consent prior to performing any of the screening procedures. 4. findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests

Keywords: phase1 healthy subjects antiplatelet agent
penile implant intraoperative measurements planning chart

Conditions: Erectile Dysfunction; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction With Diabetes Mellitus; Erectile Dysfunction Due to Arterial Disease; Erectile Dysfunction Due to Injury; Erectile Dysfunction Due to Neuropathy; Erectile Dysfunction Following Simple Prostatectomy; Erectile Dysfunction Due to Venous Disorder; Erectile Dysfunction With Type 1 Diabetes Mellitus; Erection; Incomplete; Erectile Dysfunction Due to Endocrine Disease

Summary: this is a chart of penile size measurements where penile length and width are recorded intra-operatively prior to penile prosthesis implantation to guide the surgeon to the correct and adequate post-operative penile size

the chart records preoperative penile dimensions as penile length and circumference both relaxed and stretched, both in a de-tumescent and erect state, before after intra-operative injection of 1cc prostaglandin e1 respectively, to enhance pharmacological tumescence. the implantation of the penile implant will resume with the cavernosal sparing technique. after the penile prosthesis has been implanted, penile length and girth will be measured and the penile implant dimensions will be recorded in the chart. the pimp chart will assist the surgeon in assuring he sized the penis most adequately with the implant by taking the penile dimensions ( length and circumference). to assure that the penis was not oversized with the implant, the post-operative penile length should not exceed the pre-operative penile tumescent stretched length. to assure that the penis was not undersized, the postoperative penile length should not be less than the pre-operative tumescent non-stretched penile length.. the chart will also document the patients' penile dimensions pre and post operatively and could be used as an objective tool for post-operative patient counseling and reassurance about the results of the penile implant surgery.

Eligibility criteria:
inclusion criteria: * erectile dysfunction not responding to medical treatment exclusion criteria: * patients refusing penile prosthesis implantation as a treatment modality for their erectile dysfunction

Keywords: erectile dysfunction penile implant penile prosthesis
tissue flossing in tennis elbow patients

Conditions: Tennis Elbow

Summary: the aim of the present intervention is to determine the effectiveness of the application of tissue flossing in patients with tennis elbow

the application of tissue flossing has been deemed to provide beneficial results in patients with ankle range of motion limitation. although, tissue flossing is widely extended among athletes due to its effectiveness in pain, function and range of motion, the evidence is limited. the aim of the present protocol is to determine the effectiveness of tissue flossing in patients with tennis elbow.

Eligibility criteria:
inclusion criteria: * elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia. * diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities. * reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle. * pain with stretching or contraction of the wrist extensor muscles. exclusion criteria: * upper limb fractures, surgery or concomitant disease. * red flags presence. * mental disorders.

Keywords: physiotherapy
clinical study to determine the optimal operation parameters during co2 removal with the abylcap® system

Conditions: ARDS (Acute Respiratory Distress Syndrome); Respiratory Acidosis

Summary: this prospective study includes 5 patients with ards (acute respiratory distress syndrome) treated by mechanical ventilation. in case of respiratory acidosis, extracorporeal co2 (carbon dioxide)removal might be necessary. we hereby work with the abylcap system with the oxygenator lilliput2 as co2 remover (bellco, italy). the patients (m/v) are older than 18, not pregnant, have a bmi\<30, and no contraindication for anticoagulation therapy. under standard conditions patients are treated with a blood flow of qb=300ml/min and a gas flow (100% 02) of qg=7l/min. blood sampling is performed from the arterial bloodline in the patients at 0, 1h, 3h, 24h, 48h, 72h, 96h, and 120h. a parameter study is also performed to optimise co2 removal. herewith, blood samples (1ml) are taken from the inlet and outlet line of the lilliput2 at the previously mentioned time points and for different flow setting: blood flow (qb) 200-300-400ml/min and gas flow (qg) 1.5, 3, 6, 7, 8l/min blood samples are analysed for the different blood gases from which the extraction in the co2 remover can be calculated for each setting of qb (blood flow) and qg (gas flow).


Eligibility criteria:
inclusion criteria: * patients with ards and respiratory acidosis on the intensive care unit * treated with the abylcap system (bellco, italy) * not pregnant
cmr rate of newly diagnosed cml-cp patients treated with nilotinib

Conditions: Chronic Myelogenous Leukemia in Chronic Phase

Summary: "this is a single-arm, open-label, multi-center study of complete molecular response (cmr) in adult patients with newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukemia in chronic phase (cml-cp). the study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. the primary end point is rate of confirmed cmr in newly diagnosed philadelphia chromosome positive cml-cp patients."


Eligibility criteria:
inclusion criteria: patients with ph+ cml-cp within 3 months of diagnosis. male or female patients' ≥ 18 years of age. patients must have adequate end organ function. exclusion criteria: previously documented t315i mutation. other cml treatment is an exclusion criteria with the following exception: while awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (tki) approved by the fda for frontline treatment. patients taking a tki prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy. impaired cardiac function as defined by the protocol. patients with contraindications to receiving nilotinib, including concomitant medications.

Keywords: cml chronic myelogenous leukemia leukemia cml-cp nilotinib
the sahlgrenska anti-vegf study

Conditions: Neovascular Age-related Macular Degeneration

Summary: the study investigates whether patients treated for neovascular (wet) age-related macular degeneration (amd), with intravitreal injection with bevacizumab (avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (eylea). the study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.


Eligibility criteria:
inclusion criteria: signed informed consent. ≥50 years, regardless of gender. diagnosed with the neovascular (wet) form of age-related macular degeneration through diagnosed neovascular vascular membranes with oct-a and, if necessary, also fa / icg, according to clinical routine. distance visual acuity ≥34 (etdrs) on the current study eye. exclusion criteria: other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment. previously received treatment for the neovascular (wet) form of age-related macular degeneration. diagnosed with diabetes (all types). degenerative state of the macula that prevents vision improvement such as central areolar atrophy or other pronounced dry amd or fibrosis, in the current study eye. other choroidal neovascularization (cnv) of the type pcv or due to grave myopia i.e. ≥ 6.0 diopters (d) or secondary to other retinal disease, in the current study eye. unregulated intraocular pressure (iop) \> 30 mmhg despite pharmacological treatment in the current study eye. have had a stroke or heart attack ≤6 months ago. inability to access information (e.g. due to dementia) or inability to conduct examinations (e.g. etdrs examination), according to the investigator's assessment. inability to receive oral and written information in swedish (in need of an interpreter). included in another intervention study. fertile woman i.e. a woman who has had menstruation for the past 12 months or has not undergone permanent sterilization (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
differences between the bayley-ii and the bayley-iii in very preterm infants at 2 years

Conditions: Infant Development

Summary: the objective of this randomized study is to test the hypothesis that scores on the bayley scales of infant development-iii (bayley-iii) are higher than scores on the bayley scales of infant development-ii (bsid-ii) in the same group of infants who were born very preterm.

the objective of this randomized crossover study is to test the hypothesis that scores on the bayley scales of infant development-iii are higher than scores on the bayley scales of infant development-ii in the same group of infants who were born very preterm. first, however, the investigators must demonstrate that significant "learning" does not occur when the tests are administered 4-8 weeks apart. the investigators hypothesize that scores on the bayley-iii will be higher than scores on the bsid-ii, irrespective of the order in which the tests are administered.

Eligibility criteria:
inclusion criteria: * birth weight \<2000 grams and \<32 weeks * corrected age of 18-22 months. exclusion criteria: * english is not the primary language in the child's home. * parent is unable to give informed consent for research participation. * parent is unable to commit to returning for follow-up testing in 4-8 weeks. * infant has severe medical illness or disability expected to impact his/her ability to participate in testing (ex: blindness, deafness, severe cerebral palsy, autism, tracheostomy). * no exclusion for economic status, gender, race or ethnicity. * participation in a rct that restricts timing and administration of developmental testing.
the effect of nutrition and fluid intake in the first stage of labor

Conditions: Labor Pain; Nutrient Intake; Fluid Therapy

Summary: birth is a process that requires large amounts of energy. as a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. information regarding the safety and effectiveness of increased hydration during labor is still controversial. there is no consensus on whether this hydration should be given with intravenous solutions or orally. the study aims to determine the effect of fluid intake in labor on the delivery process, maternal-fetal outcomes, and postpartum satisfaction of the mother.

method of study: the study was planned as a randomized controlled experimental study to evaluate the effect of fluid intake during labor on mothers and babies. location and characteristics of the research: the research will be conducted in the delivery room of sakarya training and research hospital. population and sample of the study: the research will consist of pregnant women who apply to sakarya training and research hospital with signs of the onset of labor and will have an expected vaginal delivery in the delivery room. annually, 7000-8000 women give birth in the hospital, and approximately 50% have an expected vaginal delivery. all pregnant women who met the sampling criteria and volunteered to participate in the study during the study's implementation will be included. the research will be carried out in 3 groups experimental and control groups. the study will be conducted with a total of 90 pregnant women, 30 of whom are in each group.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the research * agreeing to abide by the protocol * being able to read and write, * ages 18-35 years * 37-40 pregnancy weeks * first pregnancy, * single fetus * bmi ≤ 28, * head presentation * cervical dilatation of \<6 cm or less (latent phase) * height ≥ 1.50 cm exclusion criteria: * communication barriers (speech, hearing, mental), * disability (physical or mental problem, drug use), * chronic diseases (hypertension, diabetes, etc), * gastrointestinal problems before and during pregnancy * comply with the fluid intake protocol during labor, * pregnant women who are scheduled for elective cesarean section * pregnant women considered to be at immediate cesarean risks, such as diabetic pregnant women with cephalopelvic incompatibility, multiple pregnancies, preeclampsia, and macrosomic fetus

Keywords: labor nutrition fluid labor pain maternal outcome fetal outcome
the epidemiology of acute respiratory distress among children, a retrospective cross-sectional study

Conditions: Acute Respiratory Distress

Summary: l respiratory distress is still a major concern in pediatric medicine. l in this study we evaluated the symptoms and causes of respiratory distress among children in a tertiary hospital. l we found that tachypnea is the most common symptom and asthma is the most common cause of respiratory distress in children.


Eligibility criteria:
inclusion criteria: * patients older than one month * signs or symptoms of respiratory distress, including tachypnea, bradypnea, cyanosis, respiratory muscle retraction, nasal flaring, tachycardia, and bradycardia exclusion criteria: * patients older than 18 years old * apnea * known cardiac diseases