Kornimate/medical-research-clean huggingface dataset:
temozolomide as maintenance therapy following induction chemotherapy in extensive stage small cell lung cancer

Conditions: Extensive-stage Small Cell Lung Cancer

Summary: temozolomide may delay progression in sequence with chemotherapy. this open-label, randomized,multicenter phase ii trial was designed to evaluate the role of temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage sclc.


Eligibility criteria:
inclusion criteria: * cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease * patients must have measurable disease, this can include brain metastases * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate bone marrow function, as defined by: absolute neutrophil count (anc) \>1,500/µl; platelets \>100,000/µl; hemoglobin \>=9.0 g/dl * normal organ function, defined as follows: aspartate aminotransferase (ast) and alanine aminotransferase (alt) \<=2.5 × the upper limit of normal (uln), or ast and alt \<=5 × the uln if liver function abnormalities are due to underlying malignancy; total serum bilirubin \<=1.5 × the uln; serum creatinine \<=1.5 × the uln * the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks * women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment * patients must be informed of the investigational nature of this study and sign an informed consent form exclusion criteria: * patients who are pregnant or breastfeeding * patients receiving other investigational agents * patients with leptomeningeal involvement * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * acquired immune deficiency syndrome (aids) based upon current cdc definition or hiv-positive patients on combination antiretroviral therapy. however, hiv testing is not required for entry into this protocol. the need to exclude patients with aids from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. excluding patients on haart is necessary due to the potential for pharmacokinetic interactions with temozolomide.

Keywords: small cell lung carcinoma
proteomic analysis of mononuclear cells after a high-fat, high-carbohydrate meal with or without orange juice

Conditions: Inflammation

Summary: a high-fat, high-carbohydrate meal (hfhc) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. a few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers. the present study will assess the effect of a single hfhc meal taken with water, orange juice or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals. twelve healthy, normal weight individuals consumed a hfhc meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. blood samples were collected before, 1, 3 and 5h after the meals.

background: a high-fat, high-carbohydrate meal (hfhc) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. a few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers. objectives: to study the effect of a single hfhc meal taken with water, orange juice (500ml) or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals. design and methodology: twelve healthy, normal weight individuals consumed a hfhc meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. blood samples were collected before, 1, 3 and 5h after the meals. blood glucose, insulin and lipid profile were measured. also, proteome analysis using tmt labeling was performed on peripheral-blood mononuclear cells collected before and at times 3 and 5h after the meal.

Eligibility criteria:
inclusion criteria: * healthy * normal weight * non-vegetarian exclusion criteria: * use of medication * alcohol consumption, * intense physical exercise * pregnant or lactating * overweight * obese * drug abuse * any disease such as diabetes, inflammatory conditions.
taperloc versus taplerloc microplasty

Conditions: Osteoarthritis

Summary: this evaluation is conducted to evaluate the safety and performance of two different stem lengths of the taperloc total hip system. per implant bone loss and migration of the stem are compared between the two groups with dual-energy x-ray absorptiometry (dexa) and radiostereomektric analysis

consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study. periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Eligibility criteria:
inclusion criteria: * patients with primary osteoarthritis of the hip scheduled for tha. * suitable anatomy for both stems * willingness and ability to follow study-protocol exclusion criteria * malignancy or metastatic bone disease. * any other disease severely affecting bone and mineral metabolism * ongoing or previous treatment (within 5 years prior to inclusion) with steroids * ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives. * ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs. * ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy. * ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.

Keywords: short femoral stem stress shielding stem migration implant survival dexa radiostereometric analysis
vojta therapy in multiple sclerosis.

Conditions: Multiple Sclerosis; Physical Therapy

Summary: this study evaluates the effectiveness of a vojta locomotion reflex program as short-term automatic postural control in patients with multiple sclerosis

in two consecutive weeks two interventions will be conducted: vojta group(a) and standard therapy group(b). the last one is based on balance exercises targeting core stability, bobath concept and sensory strategies. in the vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. in addition, during the study, a daily activity shall be prescribed in both groups: vojta exercise during 20 minutes for group a and walking for 20 minutes in group b.

Eligibility criteria:
inclusion criteria: * final diagnosis of ms according to mcdonald criteria. * walkability with or without assistance (4.0 to 6.5 in edss) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body. * older than 18 years-old. * escorted sessions, a family member or close person. exclusion criteria: * phase outbreak or outbreak in the 3 months before the study. * medication that prevents or limits the performance of the locomotion reflex. * participation in other studies during the conduct of this study. * score inferior to 6 in the abbreviated mental test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.

Keywords: vojta therapy core stability postural balance
a trial to investigate the effectiveness and safety of org 3236 (etonogestrel) tablets in men with urinary complaints suggestive of a benign enlargement of the prostate (304001)(p05806)

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: this trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on: * the prostate volume and the urinary complaints; * the urinary flow and the urinary volume in the bladder after voiding; * the progression of the disease; * the sexual function, well-being and urinary complaints-related quality of life. in addition the safety and the way the drug is absorbed and excreted by the body will be analyzed.


Eligibility criteria:
inclusion criteria: * signed written informed consent, obtained before screening evaluations; * men diagnosed with luts suggestive of bph: baseline ipss score of = 12 (moderate to severe); prostate volume of = 40 ml and \< 100 ml (based on trus); peak urinary flow rate = 15 ml/s with a voided volume of =125 ml * age at least 50 but not older than 80 years at screening * psa \< 10 ng/ml and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy) exclusion criteria: * a post void residual volume \>250 ml * use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug) * acute urinary retention within the past 12 months * history of surgery for bph, including other minimally invasive procedures * presence of urinary tract infection * presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation * cardiac or cerebrovascular event within the past six months * presence or history of any neurological disease associated with primary bladder dysfunction * presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal * clinically relevant abnormal laboratory result as judged by the (sub)investigator
airway management practice patterns in paediatric anaesthesia: a survey

Conditions: Paediatric Airway Management

Summary: respiratory adverse events continue to be the leading reason for perioperative critical events in children. it is crucial for the anaesthesiologist to anticipate, recognize and treat these respiratory adverse events. respiratory adverse events are one of the major causes of morbidity and mortality during paediatric anaesthesia. to avoid trouble, one must be prepared for trouble: if a difficult airway is very likely, anaesthesia should be administered by experienced anaesthesiologists and should only be performed in a protected well-equipped area where the personnel adequately trained. this survey focuses on assessment and management of paediatric airway and highlights the unique challenges encountered in children.

airway management is one of the key areas of paediatric anaesthesia practice. the paediatric patients have significant anatomical and physiological differences compared with adults, which impact on the techniques and tools that the anaesthesiologist might choose to provide safe and effective control of the airway. furthermore, there are a number of pathological processes, typically seen in the paediatric population, which present unique anatomical or functional difficulties in airway management. the presence of one of these syndromes or conditions can predict a "difficult airway". respiratory adverse events continue to be the leading reason for perioperative critical events in children. new developments in airway management in paediatric patients can only improve perioperative outcome if anaesthesiologists who are fully acquainted with these fundamental aspects of paediatric anaesthesia care for these children. this survey was taken out within members of the community of european anaesthesiologists, to describe and explore current patterns of their airway management in paediatric anaesthesia. the purpose of the study was to see whether there are more uniform practice patterns among anaesthesiologist with paediatric experience than those without paediatric experience. secondarily, the survey also explored anaesthetists'' knowledge about the risks of respiratory adverse events and, and about national organizations' recommendations. therefore, this survey highlighted some of the important anatomical and physiological differences and their implication in daily anaesthesiological practice.

Eligibility criteria:
inclusion criteria: * anaesthesiologists currently working in the operating rooms. exclusion criteria: * unwilling to join the study

Keywords: airway anatomy difficult intubation congenital syndromes
vienna near-infrared spectroscopy in cardiac arrest study (vinirsca)

Conditions: Cardiac Arrest

Summary: measurement of near-infrared spectroscopy (nirs) during and after out-of-hospital cardiac arrest (ohca) in the city of vienna and the tertiary university hospital of the medical university of vienna, austria. nirs will be evaluated as a tool for resuscitation quality assessment as well as a prognosticator for cardiac arrest outcomes. already-existing literature will be taken into account, and already-existing cutoffs and prognosticating values will be assessed and - if eligible - validated in a real-life setting.

patients suffering from out-of-hospital cardiac arrest (ohca) and receiving cardiopulmonary resuscitation (cpr) in terms of advanced life support (als) in the city of vienna, austria, will be included. a special study team will be dispatched to the event sites by the ambulance service. trained study fellows will include patients by placing nirs optodes on the patients' forehead as soon as possible during and/or after cpr. measurements will continue until 72h post return of spontaneous circulation (rosc) or the patient's death.

Eligibility criteria:
inclusion criteria: * \>18 years of age * out-of-hospital cardiac arrest exclusion criteria: * \<18 years of age

Keywords: nirs cardiac arrest
the safety of proctofoam-hc in the third trimester of pregnancy

Conditions: Hemorrhoids; Pregnancy

Summary: the purpose of this study is to evaluate the fetal safety of topical application of proctofoam-hc®, an antihemorrhoidal, in the third trimester of pregnancy.

hemorrhoids are a frequent condition in pregnancy. the rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. the safety of these antihemorrhoidal products has not yet been documented in pregnant women. proctofoam-hc® has been on the canadian market for 25 years. it combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine hcl. it is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain. we hypothesize that local application of proctofoam-hc® in the third trimester of pregnancy is safe for the mother and fetus.

Eligibility criteria:
inclusion criteria: * for intervention group, any pregnant woman with a primary anorectal condition during the third trimester of pregnancy * for control group, women in third trimester of pregnancy not treated with proctofoam, and matched on maternal age and smoking status * for either group,no other pregnancy complications exclusion criteria: * exposure to known teratogens during pregnancy as evident either during the prenatal or postnatal interview * insufficient english language skills to understand the questionnaires and assessment material * women who have received other corticosteroid medications (systemic or topical)during pregnancy * women with the following conditions: abscess, fistula, tuberculosis, varicella, acute herpes simplex or fungal infection * age less than 18 years * history of previous reaction to any of the product's components, such as: local irritation, hypertrichosis, hypopigmentation, etc. * known intrauterine growth restriction (iugr) or a chronic state that may cause iugr (sle, placental insufficiency). * multi fetal pregnancy * binge alcohol consumption (5 or more drinks on one occasion,in a row or within a short period of time)

Keywords: hemorrhoids pregnancy antihemorrhoidal proctofoam infants
trial of liposomal versus plain bupivacaine in minimally invasive general surgery procedures

Conditions: Pain, Postoperative

Summary: aim: to compare the postoperative outcomes after surgical infiltration with plain bupivacaine compared to liposomal bupivacaine in patients undergoing elective, minimally invasive, general surgery procedures. to the investigators knowledge, there are no head-to-head, prospective, randomized, controlled trials of plain bupivacaine versus liposomal bupivacaine to evaluate postoperative pain and return of function.

the investigators current standard has been to use liposomal bupivacaine routinely for surgical infiltration which was a change from the historical practice of infiltration with lidocaine/bupivacaine, plain bupivacaine or no local anesthetic at all. the change was made due to the perceived benefits in analgesia past the 12-24 hours that plain bupivacaine was effective. it is not clear, however, that there are statistically significant benefits in terms of reduced narcotic use and length of hospital stay and improved pain control and return of function post-operatively. primary outcomes: the investigators will then measure narcotic use post-operatively as calculated by combining measures of patient-controlled analgesia (pca) use for first 24 hours added to in-patient oral narcotic use (by referencing the electronic medical record (emr)) as well as out-patient oral narcotic use as reported by patients. subjective pain levels and pain interference scale and physical functioning scale will be evaluated pre-operatively and post-operatively with use of the pain assessment screening tool and outcomes registry (pastor) developed by the defense and veterans center for integrative pain management (dvcipm) as a measure of perioperative pain and function.

Eligibility criteria:
inclusion criteria: * age: 18 years or older * american society of anesthesiologists (asa) status 1, 2 or 3 * having an elective, minimally invasive, general surgery procedure at naval medical center san diego (nmcsd) exclusion criteria: * age: younger than 18 years old * pregnant women - safety of liposomal bupivacaine has not been studied in pregnant women * asa status greater than or equal to 4 * conversion to open procedure/laparotomy * history of reaction to local anesthetics * history of hepatic disease - local anesthetics are metabolized in the liver * history of pre-operative/concurrent condition requiring narcotic use * patient not able to adhere to post-operative pain control regimen outlined in methods section
52-week add-on to metformin comparison of saxagliptin and sulphonylurea, with a 52-week extension period

Conditions: Type 2 Diabetes

Summary: saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. this study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes, * treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to visit 1, * hba1c \>6.5% and ≤10.0% exclusion criteria: * type 1 diabetes, * history of diabetic ketoacidosis or hyperosmolar non-ketonic coma, * insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Keywords: dpp-4 inhibitors hba1c incretins
explorative study of degarelix for treatment of benign prostatic hyperplasia.

Conditions: BPH

Summary: this exploratory study will be conducted open label in a single investigational clinical unit. altogether 52 patients with benign prostate hyperplasia (bph) will be randomly assigned to receive 4 different treatments with degarelix.

the present study aims at exploring the potential of the currently available formulation of degarelix to treat bph with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/ml. two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.

Eligibility criteria:
inclusion criteria: each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study: 1. man, 55 to 75 years of age. 2. clinical diagnose of bph with a prostate volume more than 30 ml, a maximal uroflow of 12 ml/sec or less and an international prostate sympton score (ipss) of 13 or more at screening. 3. a prostate specific antigen (psa) value less than 10 ng/ml and no clinical evidence of adenocarcinoma of the prostate at screening. if a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study. 4. has a baseline testosterone level above 3 ng/ml at screening. exclusion criteria: any patient meeting one or more of the following exclusion criteria will not be included into the study: 1. previous surgery of the prostate. 2. previous treatment with gnrh agonists or gnrh antagonists. 3. treatment with 5-alpha reductase inhibitors, e.g., finasteride (prosca®)or dutasteride (avodart®) within the past 12 months before the study. 4. treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to screening part ii (or part i, if ipss is performed at screening part i). 5. treatment with any drug modifying the testosterone level or function within 12 weeks before screening visit part ii (or part i, if ipss is performed at screening part i).

Keywords: benign prostate hyperplasia bph pk/pd gnrh antagonist
therapeutic effects of berberine in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.

type 2 diabetes is health threats worldwide. however, treatment of this disease is limited by availability of effective medicines. all of the existing oral hypoglycemic agents have secondary failure after long term administration. thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. in diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. generally regarded as safe (gras) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. however, most of these botanical products are mixtures of multiple compounds. it is difficult to control their quality in the study or production. up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. berberine is the main active component of coptis chinensis french, which was used for thousands of years in china in the treatment of human diseases including diabetes. comparison(s): effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * hba1c \> 7.0% or fbg \> 7.0 mmol/l * stable or worsening glycemic control for at least 3 months exclusion criteria: * liver damage * kidney damage

Keywords: berberine type 2 diabetes treatment