Kornimate/medical-research-clean huggingface dataset:
clinical protocol for the treatment of patients with previously untreated chronic lymphocytic leukemia with a combination of bendamustine and ofatumumab

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: investigational drug: ofatumumab (azerra) route of administration: intravenous (iv) hypothesis: this study is designed to assess the toxicity and overall response rate. ofatumumab is a fully human monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of cll as a single agent. it is thought that by combining it with bendamustine, an fda approved treatment for cll, the effect on cll will be greater than if ofatumumab is given alone. participation: approximately 38 previously untreated cll subjects will participate in this study over two years. treatment plan: a maximum of 6 cycles of treatment will be allowed. during day 1 of cycle 1 ofatumumab iv 300mg will be administered. on day 1 of all cycles ofatumumab treatment will be followed by bendamustine iv 90mg/m2. on day 2 of all cycles, bendamustine iv 90mg/m2 will be administered. on day 3 of all cycles, neulasta sq 6mg will be given. on day 8 of cycle 1 only patients will receive ofatumumab iv 1000mg. during cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only. follow-up: patients will be followed monthly for six months, then every three months for five years then annually thereafter.


Eligibility criteria:
inclusion criteria: * must be \>/= 18 years old and able to provide consent * must have diagnosis of cll as defined by nci criteria * must be previously untreated for cll * must require chemotherapy * serum creatinine \<1.8 mg/dl * bilirubin must be \</= 2 mg/d, unless secondary to tumor * must have adequate liver function (as defined as \<2x uln, unless related to cll) * performance status 0-2 * women of child bearing age must be willing to use accepted/effective method of birth control. exclusion criteria: * not have received prior treatment with cytotoxic chemotherapy or immunotherapy. * not have autoimmune hemolytic anemia or autoimmune thrombocytopenia * not have history of corticosteroid treatment for cll * not have cns disease * not have clinically significant infections * patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible. * not have positive serology for hepatitis b or hepatitis c * not have be known to be hiv positive * not have new york classification iii or iv hear disease

Keywords: cll bendamustine ofatumumab blood cancer leukemia lymphocyte hematology non-hodgkin lymphoma small lymphocytic lymphoma nevada cancer institute cephalon glaxosmithkline
studying the preference of tadalafil to sildenafil in men with problems getting an erection across nations

Conditions: Impotence

Summary: study to determine if men from around the world prefer sildenafil to tadalafil.


Eligibility criteria:
inclusion criteria: * must be of legal age according to your country. * must have had a history of erectile dysfunction for at least 3 months. * must currently and have been using sildenafil for the last six weeks. * agree to not use any other ed treatment during the study. * anticipate the same female sexual partner for the study. exclusion criteria: * history of other primary sexual disorder * treatment with nitrates * have a penile implant or clinically significant penile deformity * history of certain heart problems * do not meet certain lab value reference ranges
vacuum vs manual drainage during unilateral thoracentesis

Conditions: Pleural Effusion; Pleural Diseases; Thoracic Diseases

Summary: the purpose of this study is to determine if there are any differences in terms of safety, pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.

patients with pleural effusions routinely undergo thoracentesis in which a catheter is placed into the pleural space to remove the fluid both for diagnostic and therapeutic reasons. in this setting, large amounts (often liters) of fluid are removed to palliate the patient's symptoms of breathlessness. thoracentesis is the most commonly performed and least invasive method to remove pleural fluid. these frequently performed using a catheter drainage system where a small, flexible temporary catheter is inserted over a needle into the pleural cavity. after insertion of catheter into the pleural space, the operator has two drainage system options: 1. manual drainage via syringe-pump that connects to drainage bag or 2. drainage into a vacuum bottle. both are routinely performed in almost every hospital in the united states. pleural pressure (ppl) is determined by the elastic recoil properties of the lung and chest wall. normal pleural pressure is estimated to be -3 to -5 cm h20 at functional residual capacity. during drainage of pleural fluid, negative pressure is applied either via syringe during manual drainage or via vacuum using vacuum drainage bottle. hypothetically more negative pressure can translate to increased perception of pain or visceral pleural injury. two techniques (manual vs vacuum drainage) are used based on the operator preference and both are standard of care. to our knowledge there is no head to head comparison of these two available systems of drainages during thoracentesis of pleural effusions. knowing if one is superior to the other will aid future clinicians.

Eligibility criteria:
inclusion criteria: * patients undergoing unilateral therapeutic thoracentesis exclusion criteria: * patients with a history of prior significant pleural or lung based procedures/surgeries (not a simple thoracentesis) * prior enrollment in this study * patients ability to comprehend and consent to this procedure and clearly communicate any pain or other symptoms that arise from this procedure

Keywords: pleural effusion pleural drainage thoracentesis
afatinib monotherapy in patients with erbb-deregulated metastatic urothelial tract carcinoma after failure of platinum based chemotherapy

Conditions: Urologic Neoplasms

Summary: the purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying erbb2 or erbb3 (erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or erbb2 amplifications (cohort a), and egfr (epidermal growth factor receptor) amplification positive tumours (cohort b), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis. the antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (pfs6). this will be the primary endpoint of the trial. a key secondary endpoint will also be defined, the objective response rate (orr).


Eligibility criteria:
inclusion criteria: * recurrent or metastatic urothelial cancer * patients must have failed prior platinum based treatment (adjuvant or 1st line) * archival tissue sample available for biomarker testing at pre-screening and tissue banking. * patients should complete a pre-screening biomarker analysis and should fulfill the following: for cohort a tumour should show a erbb2 (epidermal growth factor family receptor 2) or erbb3 mutation, or erbb2 gene amplification; for cohort b tumour should show egfr (epidermal growth factor receptor) amplification. * further inclusion criteria apply exclusion criteria: * prior use of egfr, erbb2 or erbb3 targeted treatment * chemotherapy within 4 weeks prior to the start of study treatment. biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first * known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis * further exclusion criteria apply
prenatal corticosteroids and antioxidants in preterm infants

Conditions: Oxidative Stress

Summary: premature infants are highly susceptible to oxidative stress because of the immaturity of their antioxidant defense system. the use of prenatal glucocorticosteroids administered to the mother improves respiratory function and overall outcome. the investigators hypothesize that prenatal glucocorticosteroids favor the expression and competence of the antioxidant defense system.

this is an observational study recruiting extremely low gestational age neonates (\<28 weeks gestation) whose mothers received or not full scheduled prenatal glucocorticosteroids. healthy term newly born infants acted as controls. at birth cord blood were drawn for the following analytical determinations: reduced and oxidized glutathione; malondialdehyde; superoxide dismutase; catalase; glutathione peroxidase; glutathione reductase; glutathione s-transferase. in addition, first urine voided was collected for ortho-tyrosine/phenylalanine and 8-hydroxy-2-oxo-deoxyguanosine/2-deoxyguanosine determination. analytical data and clinical outcomes are compared.

Eligibility criteria:
inclusion criteria: * gestational age \<28 weeks * registered used or not of prenatal glucocorticosteroids by the mother exclusion criteria: * use of pro-or-antioxidant drugs by the mother during gestation * major congenital malformations * prenatal inflammation (e.g.:chorioamnionitis) * chromosomopathies * uncertainty about gestational age

Keywords: antioxidant enzymes glutathione oxidative stress prematurity respiratory distress non enzymatic antioxidant defense system enzymatic antioxidant defense system
ketogenic diet with radiation and chemotherapy for newly diagnosed glioblastoma

Conditions: Glioblastoma (GBM)

Summary: this study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (gbm). these changes occur from use of a ketogenic diet. this research has 2 goals: 1. show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels. 2. show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a gbm.

the investigators propose to offer this study to patients with newly diagnosed glioblastoma multiforme (gbm) that undergo gross total resection (gtr) or subtotal resection (str) of their tumor. post-operatively, these patients and their families will be instructed in the implementation of the ketogenic diet (kd) and it will be started as soon as possible following surgery to achieve ketosis and reduction of blood sugar. patients will receive standard chemoradiotherapy with fractionated external beam radiation (60gy) and concurrent oral temozolomide chemotherapy followed by 12 adjuvant cycles of temozolomide chemotherapy on a standard dose schedule. outcome measures of the study group will be compared to historic controls in the treatment arm from the european organization for research and treatment of cancer (eortc) temozolomide study published by roger stupp et al, new england journal of medicine, march 10, 2005. note: gross total resection (gtr), subtotal resection (str), temozolomide (temodar), and radiation therapy are routine care for gbm and are not an investigational component of this study. study end-points: primary: ketogenic diet (kd) tolerance and compliance in brain tumor patients. the diet will be considered tolerable if the patient chooses to remain compliant. compliance is monitored by the dietician using self reporting of diet, blood glucose and blood ketone levels. secondary: overall survival, time to recurrence, health and therapy-related quality of life. overall survival and progression free survival will be measured and compared to the historic controls who received chemoradiotherapy in standard dose scheduling. laboratory correlate: molecular/immunohistochemical analysis of tumors that do and do not respond to a kd.

Eligibility criteria:
inclusion criteria: * adult patients, 18 - 80 years of age, * a single enhancing lesion of the brain with mri appearance consistent with gbm * pathologic confirmation of gbm * zubrod performance scale (zps) \< 2 * must be able to undergo mri imaging with gadolinium * must have access to a computer and the internet (to use ketocalculator© on-line database) exclusion criteria: * unable to undergo mri with gadolinium * genetic disorders of fat metabolism * patients receiving sodium valproate (may cause false ketone reading in urine) * diabetes * enrolled in another treatment trial for gbm

Keywords: ketogenic diet brain tumor glioma glioblastoma radiation chemotherapy temozolomide
appropriate duration of anti-platelet strategy in patients with advance chronic kidney disease after new generation drug eluting stents (adapt-ckd)

Conditions: Chronic Kidney Diseases

Summary: the purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.

prospective, open label, multicenter randomized clinical trial

Eligibility criteria:
inclusion criteria: 1. over 19 years old 2. chronic renal failure stage iiib, iv, v (ckd-epi egfr \<45 / \<30 / \<15 or dialysis) 3. patients treated with a new generation drug eluting stent. 4. patients who signed consent form exclusion criteria: 1. over 85 years old 2. patients with high risk of bleeding 1) history of hemorrhagic stroke 2) stroke, dementia or central nervous system damage within 1 year 3) head trauma or brain surgery within 6 months 4) tumor in the skull 5) if aortic dissection is suspected 6) internal bleeding within 6 weeks 7) in case of active bleeding or bleeding disorder 8) in case of major surgery, trauma or bleeding within 3 weeks 3. patients who need oral anticoagulant 4. pregnant women or women of childbearing age 5. life expectancy is less than 1 year 6. patients with a history of intracranial bleeding 7. moderate to severe hepatic impairment (child-pugh class b or c)

Keywords: anti-platlet therapy chronic kidney disease new generation drug eluting stents
non-inflatable supraglottic airway (ni-sga) vs. face mask (fm) as a primary interface device for neonatal resuscitation

Conditions: Neonatal Resuscitation

Summary: prospective, randomized controlled trial to be performed at one center, of term and late preterm infants requiring resuscitation. prenatal consent will be obtained. at randomization, babies will be resuscitated following neonatal resuscitation program (nrp) guidelines and ventilated using the t-piece resuscitator with either a face mask (fm) or non-inflating supraglottic airway. video will be collected during resuscitation as well as written documentation. primary outcome will be time to spontaneous breathing, length of resuscitation, and need for endotracheal intubation.

mothers who are close to delivery of a term or near term infant with estimated fetal weight of 2500gms will be approached for consent to randomize their infant to resuscitation with mask or non-inflatable supraglottic airway (nisga) if resuscitation is required. study personnel in delivery will open sequential envelopes with randomized code to indicate which device is to be used if necessary. the resuscitator will be blinded until determination of need of respiratory support. at that time, the appropriate randomized device (face mask or nisga) will be handed to the resuscitator for use along with t-piece resuscitator. video data capture will be used to record type, length and response to resuscitation. this information will be translated to a database prior to destruction of video.

Eligibility criteria:
inclusion criteria: * newborns \> or = 2000gms requiring positive pressure ventilation within the first 2 minutes of life exclusion criteria: * newborns with expected fetal weight \<2000 grams * known congenital malformations * multiple gestation (twins and above) * history of meconium stained fluid

Keywords: supraglottic airway neonatal resuscitation ventilation term infant
self-management for anxiety, depression and somatoform disorders

Conditions: Anxiety Depression (Mild or Not Persistent); Major Depressive Disorder, Single Episode, Unspecified; Neurotic, Stress-related and Somatoform Disorders

Summary: anxiety, depression and somatoform disorders are highly prevalent in primary care. very often these conditions remain undiscovered and/or untreated. in order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (counseling assistant - ca) and a general practitioner (gp) on-site its own practise. the ca's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

anxiety, depression and somatoform disorders are highly prevalent in primary care. very often these conditions remain undiscovered and/or untreated. managing it is time-consuming and communication-intensive. furthermore, the management is restraint by the high contact-frequencies in primary care practices in germany. in order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (counseling assistant - ca) and a general practitioner (gp) on-site its own practise. the ca's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

Eligibility criteria:
inclusion criteria: * patients scoring \>= 5 on the patient health questionnaire (german version), corresponding to a probable or established diagnosis of anxiety, depression or somatoform disorder exclusion criteria: * negation of inclusion criteria
flavored intravenous ondansetron administered orally for the treatment of persistent vomiting

Conditions: Gastroenteritis

Summary: the purpose of this study is to give children with gastroenteritis with persistent vomiting flavored intravenous ondansetron orally. the investigators test the palatability of the drug and check the serum level of ondansetron at 4 hours .

this is a prospective pilot study for children,3-8 years of age presented to the pediatric emergency department in the state of qatar between september 2014 and january 2015, with acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in the last 24 hours, and who had failed oral rehydration trial in the department as per the department oral hydration protocol. acute gastroenteritis was defined as diarrhea and vomiting for less than a week period. hydration level was assessed for all patients on arrival, and eligible patients were enrolled after obtaining an informed written consent.enrolled patients received intravenous ondansetron form orally after being flavored 1:1 with ora-sweet, the dose of ondansetron was determined based on the patient presenting weight. palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. all patients were kept nil per oral for 30 minutes and then oral rehydration trial was started as per the department rehydration protocol. if the drug was vomited within 30 min of administration, a similar second dose was given. blood level for ondansetron was collected 4 hours after the successful drug administration and was sent to the department laboratory within 5 min. patients were sent home when they were ready for discharge as per the treating physician discretion. all patients were followed by a telephone call after 24 hours to assess the safety and efficacy of the orally taken ondansetron.

Eligibility criteria:
inclusion criteria: * children 3-8 years of age. * acute simple gastroenteritis with mild to moderate dehydration. * more than 2 episodes of vomiting in 24 hours period. exclusion criteria: * known hypersensitivity to ondansetron. * seizure disorder. * chronic liver or kidney diseases. * on any chronic medication.

Keywords: ondansetron palatability vomiting
speakfree heat and moisture exchanger (hme)

Conditions: Laryngeal Cancer; Laryngectomy

Summary: the purpose of the study is to evaluate the new blom-singer speakfree disposable hands free valve heat and moisture exchanger (hme). the investigators will compare the speakfree to other modalities of stomal occlusion (digital occlusion and digital depression of an hme) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. in addition, the investigators will compare the speakfree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).


Eligibility criteria:
inclusion criteria: * participants who have undergone a total laryngectomy who have and use a voice prosthesis as their primary form of communication for at least 3 months prior to study enrollment. * participants must have had at least 2 voice prosthesis management visits from a speech pathologist at the university of miami prior to study enrollment. * participants must have fully healed suture lines. * participants must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials) * current hme use for a minimum of 1 month * participants willing to complete the survey and provide a signed informed consent form * males and non-pregnant females over the age of 18 exclusion criteria: * participants who do not have a voice prosthesis. * participants who have dysarthria. * participants who are currently receiving treatment for head and neck cancer. * participants who have an underlying neurologic condition potentially impacting speech.

Keywords: stoma voice prosthesis total laryngectomy heat and moisture exchanger (hme)
the use of thrombin generation assay in detection of central line related thrombosis (crt) in critically ill patients

Conditions: Central Line Complication; Thrombosis, Venous

Summary: to study thrombin generation parameters in critically ill patients with and without central line related thrombosis (crt).


Eligibility criteria:
inclusion criteria: * age ≧ 18; and * admitted to the mixed medical-surgical intensive care units of queen mary hospital in hong kong; and * clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; and * expected to have the central catheter in place for at least 5 days in their icu stay. exclusion criteria: * patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism; * patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; or * patients with active solid organ or hematological malignancies; or * patients already receiving therapeutic anticoagulation prior to study recruitment; or * patients with thrombosis detected in the insertion site before central catheter insertion; or * patients with a central venous catheter already in place prior to icu admission; or * patients admitted to the icu for post-operative care; or * patients admitted to the icu for trauma care; or * patients requiring extra-corporeal life support (ecls); or * patients with poor window or inaccessible for ultrasonographic examination; or * pregnancy/post-partum within 6 weeks

Keywords: thrombin generation central line related thrombosis