Kornimate/medical-research-clean huggingface dataset:
temozolomide in treating patients with recurrent oligodendroglial tumors

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.

objectives: i. determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (pcv) chemotherapy. ii. determine the feasibility and toxicity of temozolomide chemotherapy following pvc chemotherapy in these patients. outline: this is an open label, multicenter trial. temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. patients are followed every 2 months for the first 6 months and then every 3 months thereafter. projected accrual: a total of 16-29 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven oligodendroglioma or oligoastrocytoma (with at least 25% oligodendroglial elements) recurrent or progressive disease following both radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other nitrosoureas-based chemotherapy) contrast enhancing, measurable disease (at least one lesion measuring at least 1 cm) by ct or mri required within 2 weeks prior to study treatment within 3 days following concurrent surgery for the recurrence steroid doses stable or decreasing for at least 2 weeks prior to scan no extracranial disease patient characteristics: age: 18-69 performance status: who 0-2 life expectancy: at least 3 months hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.25 times upper limit of normal (uln) alkaline phosphatase no greater than 2 times uln ast/alt no greater than 2 times uln renal: creatinine no greater than 1.25 times uln creatinine clearance at least 60 ml/min other: not pregnant or lactating effective contraception required of fertile women no diseases interfering with follow-up prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics no more than one prior chemotherapy regimen at least 4 weeks since prior chemotherapy prior nitrosourea required at least 6 weeks since nitrosourea endocrine therapy: not specified radiotherapy: see disease characteristics more than 3 months since radiotherapy surgery: not specified other: no concurrent treatment with other investigational agents or other antitumor agents

Keywords: adult oligodendroglioma
723/726 proof of concept study in allergen challenge chamber in hannover

Conditions: Rhinitis, Allergic, Seasonal

Summary: this is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal gsk1004723 (1000µg), oral gsk835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. can have mild asthma. * males or female using contraceptives * aged 18 - 65 * weight 50kg+, bmi 19-32 kg/m2 * exhibit response to challenge chamber and skin prick test. * non-smoker * capable of giving informed consent * ast and alt\<2xuln; alkaline phosphatase and bilirubin \<or=1.5xuln exclusion criteria: * no nasal structural abnornmality/polyposis, surgery, infection. * any respiratory disease, other than mild asthma or seasonal allergic rhinitis * participated in another clinical study within 30 days. * subject has donated a unit of blood within 1 month * use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial. * history of sensitivty to drug * history of alcohol/drug abuse within 12 months. * positive hepatitis b antibody test * positive hiv antibody test * risk of non-compliance with study protocol * pregnant or llactating females * perenial allergic rhinitis * administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks. * past or present disease that may affect outcome, as judge by investigator * specific immunotherapy within 2 years

Keywords: proof of concept
insomnia in patients with metastatic lung cancer

Conditions: Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8

Summary: this study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

primary objective: i. evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer. outline: this is an observational study. patients undergo medical chart review and complete a questionnaire on study.

Eligibility criteria:
inclusion criteria: * have a diagnosis of metastatic non small cell lung cancer * undergoing 1st, 2nd or 3rd line of treatment or are in maintenance therapy * older than 18 years old at the time of diagnosis exclusion criteria: * subjects will be excluded if they are considered to have advanced terminal cancer, severe depression or other psychiatric disorder or a sleep disorder other than insomnia (sleep apnea, restless leg syndrome, sleep related disorder of breathing), regular use of psychotropic medication other than hypnotics (eg antidepressants) per chart review
a study of venetoclax in combination with bendamustine + rituximab or bendamustine + obinutuzumab in participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: this multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (gdc-0199, abt-199) administered in combination with bendamustine and rituximab (br) (mabthera/rituxan) or bendamustine and obinutuzumab (bg) to participants with first-line (1l)/previously untreated or relapsed/refractory (r/r) chronic lymphocytic leukemia (cll). the study will explore two venetoclax combination regimens in participants with 1l cll: br+venetolax (v) and bg+v. participants with r/r cll will be administered br+v.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing/refractory or previously untreated cll * eastern cooperative oncology group (ecog) performance score of less than equal to (\</=) 1 * adequate bone marrow function * adequate coagulation, renal and hepatic function * hematological values within the limits independent of growth factor support or transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow) exclusion criteria: * participants received an allogeneic stem cell transplant * known human immunodeficiency virus (hiv) positivity * uncontrolled autoimmune hemolytic anemia or thrombocytopenia * positive test results for chronic hepatitis b infection and hepatitis c virus (hcv) * received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy * significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
patient status engine (pse): early feasibility and usability study

Conditions: Cardiac Arrhythmia

Summary: this study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-icu hospitalized patients.

this study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-icu hospitalized patients on a selected nursing ward at the cleveland clinic heart and vascular institute. all patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. the patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Eligibility criteria:
inclusion criteria: * \>= 18 years old and able to provide informed consent * standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order exclusion criteria: * cardiac implantable device (pacemaker or icd) * contact precautions or isolation * telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)

Keywords: telemetry, patch monitor, alarm fatigue
ondansetron for the treatment of ibs with diarrhoea (ibs-d)

Conditions: Irritable Bowel Syndrome With Diarrhoea

Summary: irritable bowel syndrome is a common condition affecting 1 in 10 of the population. about a third of these suffer from diarrhoea, which severely impairs their quality of life. previous studies in nottingham have suggested that some patients with diarrhoea may have an excess of a chemical called serotonin in their gut. serotonin stimulates secretion and propulsion in the gut and contributes to diarrhoea. we are interested to see whether a drug, ondansetron, which blocks the effect of serotonin, would improve symptoms in patients with ibs and diarrhoea. we think the drug may work better in people with a specific gene type so your genetic makeup may be of influence and we would like to test this. because ibs symptoms fluctuate, one way to determine whether ondansetron is effective is to perform a randomised placebo controlled trial in which neither the patient nor the doctor knows which medication is being taken in each part of the study.


Eligibility criteria:
inclusion criteria: * ibs-d patients meeting the rome iii criteria. * male or female aged 18-75 years * women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study., (e.g. implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partners) * patients who are able to give informed consent. exclusion criteria: * women who are pregnant or breastfeeding * patients that, in the opinion of the investigator, are considered unsuitable. * patients who have had abdominal surgery which may cause bowel symptoms similar to ibs (please note, appendicectomy and cholecystectomy is not an exclusion) * patient unable to stop anti-diarrhoeal drugs * patients currently participating in another clinical trial or who have been in a trial in the previous three months since many patients will be on ssris or tricyclics antidepressants these will not be an exclusion criteria, provided they have been on medication at least 3 months and that the dose remains unaltered throughout the study.

Keywords: ibs d
safety and efficiency of photodynamic therapy for rectal cancer

Conditions: Advanced Rectal Cancer

Summary: this research is a prospective randomized controlled trial.it aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (pdt) through colonscopy compared with chemotherapy alone in patients presenting with advanced rectal cancer.


Eligibility criteria:
inclusion criteria: * 1.patients with advanced rectal cancer 2.patients are willing to join in this clinical trial. exclusion criteria: * 1.patients with advanced rectal cancer can not suffer pdt procedure. 2.allergy to photosensitizer

Keywords: rectal cancer rectal adenocarcinoma photodynamic therapy chemothrapy
treatment of intraosseous periodontal defects with amelogenins

Conditions: Periodontal Bone Loss; Periodontal Pocket

Summary: the aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following minimally invasive non surgical debridement (minsd) and application of amelogenins, compared to minsd alone. a total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (a) and no-amelogenin group (b).

the objective of the study will be compare the healing of periodontal intraosseous defects following treatment with minimally invasive non surgical debridement (minsd) and application of amelogenins compared to minsd alone. twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with minsd and application of amelogenins (a group) or minsd alone (b group). primary outcome will be "clinical attachment level" (cal) gain, while the secondary outcomes will be "probing depth" (pd), "gingival recession" (gr) and "radiographic defect angle" (rda). after local anesthesia, in a group minsd will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle. in the b group, only subgingival mechanical debridement (minsd) will be performed with an ultrasonic scaler with fine tips and micro-curette. finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.

Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis; * age ≥ 18 years old; * presence of at least 10 teeth per arch; * presence of at least two teeth with probing depth (pd) ≥ 5 mm per quadrant; * presence of at least one intraosseous pocket; * single-rooted and multi-rooted teeth. exclusion criteria: * patients with systemic diseases; * prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy; * pregnant or lactating; * tobacco smokers (≥ 10 cigarettes per day); * multi-rooted teeth with furcation involvement; * third molars.

Keywords: amelogenin periodontal therapy periodontal bone loss intraosseous bone defect
tap blocks with ropivacaine continuous infusion catheters vs single dose liposomal bupivicaine after kidney transplant

Conditions: Transplant;Failure,Kidney; Pain, Postoperative

Summary: this study is a comparison of the analgesic efficacy of transversus abdominis plane (tap) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot tap blocks with liposomal bupivacaine.

this study is a comparison of the analgesic efficacy of tap blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot tap blocks with liposomal bupivacaine. in the liposomal bupivacaine group, tap block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the tap. liposomal bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the tap. for those randomized to the tap catheter group, ultrasound guidance will be used for tap block and 5 mls 1% lidocaine will be used for skin infiltration. a peripheral nerve catheter will be placed approximately 3-5 cm into the tap space after injection of ropivacaine. a bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. an infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.

Eligibility criteria:
inclusion criteria: * patients ages 18 years or older * renal transplant recipients exclusion criteria: * patients less than 18 years of age * pregnant women * prisoners * opioid tolerant patients taking more than 30 mg/day of oral morphine equivalent analgesia * patients on systemic anti coagulation * patients unable to provide consent * hypersensitivity to amide-type local anesthetic or any component of the drug formula

Keywords: transversus abdominis plane block ropivacaine liposomal bupivacaine
tadalafil daily used post turp

Conditions: Erectile Dysfunction Following Urethral Surgery

Summary: to assess the effect of early tadalafil 5 mg once daily on persistent storage lower urinary tract symptoms (luts) and erectile function after transurethral resection of the prostate (turp).


Eligibility criteria:
inclusion criteria: * sexual active men exclusion criteria: * sexual inactive men * cardiac patients
efficacy of intraseptal anesthesia of 4% articaine with epinephrine achieved by computer-controlled delivery system

Conditions: Anesthesia, Local; Periodontitis

Summary: the aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (isa), achieved by computer-controlled local anesthetic delivery system cclads, for scaling and root planing, as a primary outcome of the study. in addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the isa achieved by 4% articaine with 1:100,000 epinephrine, using cclad system.

after including the patients into the study, patient needs to sign a written consent. after that, the next appointment will be scheduled. on the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. the next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. because it is painful treatment, anesthesia is needed to be administrated. patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine orabloc® (40 mg/ml articaine + 0.01 mg/ml epinephrine, pierrel s.p.a, capua, italy) in each group. doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. anesthesia will be obtained by cclads device anaject® (septodont, sallanches, franc). the intraseptal anesthesia (isa) will be the method of administrating the anesthesia. parameters of the device will be a mode with constant pressure, injection speed - mode low 0.005 ml/s. time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml. parameters of local anesthesia will be recorded by the pin-prick test. the pain will be rated by the visual-analogue scale (vas). the pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing. patients will be followed up the next day for local side effects and their need for analgesic medication.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * confirmed diagnosis of periodontitis * presence of minimum 20 teeth * absence of decay * preserved tooth vitality * good systematic health exclusion criteria: * allergy to articaine with 1: 100,000 epinephrine * pregnancy * lactation * medication uptake that affects the periodontal supporting tissues * acute pain, swelling, presence of gingival lesions

Keywords: intraseptal anesthesia isa cclads
pharmacodynamic analysis of the haemodynamic effects of a standard fluid bolus

Conditions: Shock

Summary: when the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. this treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 ml of fluid over approximately 10 to 30 minutes. the injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects. however, this treatment poses two problems. first, it is only inconsistently effective. it is possible that of the 250-500 ml of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly. however, the average part of the total volume that is ineffective on a large population of patients is not well known. second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. however, the average duration of effectiveness of a 250-500 ml fluid bolus, and the factors that influence this duration of effectiveness, are not well determined. the main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. the secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * hospitalisation in intensive care * haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated) * decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 ml/kg crystalloid bolus exclusion criteria: * pregnancy * refusal to participate by relatives of the patient or the patient himself * other therapeutic modification during volume expansion
probiotic beer to enhance gut health and immune system function

Conditions: Inflammation; Nutrition, Healthy

Summary: this study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption.

studies have shown that moderate alcohol consumption and probiotics have each shown immunomodulatory anti-inflammatory effects. however, to our knowledge, the effect of adding a probiotic strain to a beer drink, together with moderate alcohol consumption, on immunity and gut microbiome has yet to be studied. the probiotic beer used in this study taps on this unexplored research area and may potentially serve as a more healthful option to consumers than normal beer in the future, given the vast popularity of this beverage and probiotics.

Eligibility criteria:
inclusion criteria: * ability to give informed consent. * 21 - 60 years of age (inclusive) at screening. * healthy male, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. * race must be chinese. * willing to consume 1 beer can per day for 14 days. * not on any regular medications (western/ traditional). * no family history of alcoholism. exclusion criteria: * female. * a current smoker, have smoked, or is a user of tobacco products for the past 2 years. * history or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data. * history of alcoholism, alcohol dependence, alcohol abuse, alcohol allergy and/or any other alcohol use disorders. * history of type 1/ type 2 diabetes and use of anti-diabetic medications in the past. * regular use of medication that are known to have an effect on immune function. * regular use of aspirin. * a naïve alcohol drinker. * persons with known or ongoing psychiatric disorders or drug abuse within 3 years. * active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to first visit of the study. * treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study. * significant change in weight (+/- 5%) during the past month. * antibiotic use in the past 2 months.