Kornimate/medical-research-clean huggingface dataset:
a prospective study on incidence and prevention of contrast-induced nephropathy in croatia

Conditions: Kidney Diseases; Contrast Media Reaction

Summary: the study is analysis of the incidence of contrast-induced nephropathy (cin) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. patients are randomly assigned to the three groups: 1) peroral hydration, 2) na bicarbonate (nahco3), and 3) nahco3 plus n-acetylcysteine (nac) infusion. serum creatinine (scr), blood urea nitrogen (bun), and neutrophil gelatinase-associated lipocalin (ngal) are measured before and 48 hours after the angiography. cin was defined as an absolute increase of 0.5 mg/dl or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure

patients are randomly assigned to the three groups: 1) peroral hydration, 2) na bicarbonate (nahco3), and 3) nahco3 plus n-acetylcysteine (nac) infusion the first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure. the second group receives 3 ml/kg/hour of na bicarbonate, an hour prior to angiography and 1 ml/kg/hour, within six hours after angiography. the third group receives parenteral nac (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to na bicarbonate solution on the day of the angiography. the low-osmolar iodinated contrast agent was used.

Eligibility criteria:
inclusion criteria: * angina (stable, unstable) * coronary artery disease * cardiomyopathy * valvular disease * vasculitis * peripheral arterial disease exclusion criteria: * kidney dysfunction * uncontrolled hypertension (systolic blood pressure \>160 mm hg and/or diastolic blood pressure \>100 mm hg) * pregnancy * lactation * history of allergic reaction to contrast agents * cardiogenic shock * pulmonary edema * multiple myeloma * urgent coronary angiography * receiving contrast agents two days prior to the study and 48 hours within the study

Keywords: acetylcysteine sodium bicarbonate lipocalins creatinine blood urea nitrogen
laryngeal adaptation for speech and swallowing

Conditions: Stroke; Spinocerebellar Ataxia; Cerebral Stroke; Dysphagia; Dysarthria

Summary: this study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. the findings from this proposal will be the first step toward implementing rehabilitation techniques that help patients to prevent speech and swallowing errors before they occur.


Eligibility criteria:
patient inclusion criteria: all stroke and ataxia ataxia * dna diagnosis of sca6 and phenotype consistent with the dna diagnosis * no recessive, x-linked or mitochondrial stroke * bilateral or unilateral middle cerebral artery (mca) stroke * no structural abnormalities (i.e. nodules) * dysphagia involving laryngeal dysfunction stroke and ataxia with speech and swallowing disorders * no structural abnormalities * dysphagia involving laryngeal dysfunction patient exclusion criteria: * montreal cognitive assess. \<24 * moderate to severe hearing loss * barium allergy * other confounding speech disorder (i.e. stuttering) * chemo-radiation, surgical head and neck treatment * smoking hx in the past 5 yrs or \>5 years at any one time * twenty one years of age or older * breathing disorders or diseases

Keywords: speech swallowing rehabilitation stroke deglutition dysphagia dysarthria laryngeal ataxia
optimizing influenza vaccination in surgical oncology patients

Conditions: Influenza

Summary: seasonal influenza (flu) is a significant and sometimes serious health issue in the u.s. the centers for disease control (cdc) estimates that over 200,000 people are hospitalized in the u.s each year related to the flu. public health campaigns advocate widespread vaccination for the flu, and especially for high risk people. people with cancer are high risk, with an increased risk of developing complications from the flu, such as pneumonia, bronchitis, or worsening of other medical conditions. as part of their vaccination campaign, the cdc strongly encourages inpatients to be vaccinated prior to hospital discharge. accordingly, stony brook hospital has enacted a policy that mandates screening all hospital inpatients for vaccination prior to discharge. while physicians or patients can opt not to vaccinate, the default is to proceed. surgical oncologists have several concerns about vaccinating their patients after major surgical procedures. patients with cancer have impaired immunity, and the ability of our patients to mount an effective immune response to the vaccine is unclear. conversely, due to their immunocompromised state, our patients may be more susceptible to complications from the vaccine, such as influenza-like-illness (ili), or have higher rates of postoperative complications due to the additional immune challenge of the vaccine. previous studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ transplantation, but the combination of cancer and major surgery remains unstudied. this is a collaborative study with infectious diseases and microbiology to evaluate the response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon cancers). patients will be randomly selected to receive the vaccine either 2 weeks preoperatively or postoperatively at the time of discharge. serum antibody response, rates of ili and post-op complications will be analyzed. the long term goal of this study is two-fold: to determine the optimal time to vaccinate this group of patients in relation to their surgery, and to improve compliance with vaccination.


Eligibility criteria:
inclusion criteria:patients with gastric or pancreatic cancer, soft tissue sarcoma or peritoneal surface malignancy who will undergo surgery with curative intent are eligible. - exclusion criteria:those with a contraindication to vaccination, patients who have a splenectomy (whether planned or not) and those who have had the flu for the year are not eligible. -

Keywords: influenza cancer vaccination immune response to influenza vaccination
treatment satisfaction of insulin glargine plus insulin apidra compared with nph insulin plus insulin apidra in recently diagnosed type 1 diabetes children and adolescents

Conditions: Diabetes Type 1

Summary: a randomized, crossover, open study in order to compare treatment satisfaction with insulin glargine plus insulin apidra vs nph insulin plus insulin apidra in newly diagnosed children and adolescents with type 1 diabetes. the study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. according to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin glargine and than 12 weeks with nph insulin or 12 weeks with insulin nph ad than 12 weeks with insulin glargine. patients will complete dtsq (diabetes treatment satisfaction questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

a randomized, crossover, open study in order to compare treatment satisfaction with insulin glargine plus insulin apidra vs nph insulin plus insulin apidra in newly diagnosed children and adolescents with type 1 diabetes. 134 patients with new onset diabetes type 1, diagnosed 12 months previously at maximum will be enrolled. the study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. according to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin glargine and than 12 weeks with nph insulin or 12 weeks with nph insulin and than 12 weeks with insulin glargine. the study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks. height,weight,vital signs, hba1c and insulin doses will be determined during the clinical visits. patients will complete dtsq (diabetes treatment satisfaction questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm. the dtsq questionnaires consists of dtsq parents- for patients below the age of 13, and dtsq teen for those above age 13.

Eligibility criteria:
inclusion criteria: 1. type 1 diabetes diagnosed less than 12 months prior to study entry 2. age: 7-20 years old. 3. hba1c\>/=8.0 4. signing inform consent form exclusion criteria: 1. any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study. 2. patients participating in other device or drug studies. 3. any contraindication to insulin glargine and or insulin apidra and or insulin nph according to smpc. 4. inability, of adolescent or parent, to understand/complete the treatment satisfaction questionnaire.

Keywords: treatment satisfaction insulin glargine insulin apidra nph insulin
a trial of a walter reed army institute of research (wrair) live attenuated virus tetravalent dengue vaccine in healthy us adults

Conditions: Dengue

Summary: this descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the wrair dengue vaccine compared to a placebo.

subjects will be randomized into one of 6 groups. one group will receive a placebo vaccine and the others will receive one of 5 different dengue vaccine formations. each subject will receive two doses six months apart. study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. all subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

Eligibility criteria:
inclusion: * healthy male or female adult 18-45 years at the time of vaccination * free of obvious health problems as established by medical history and physical examination before entering into the study * written informed consent obtained from the subject * able to read the subject information sheet and consent form * subjects who the investigator believes can and will comply with the requirements of the protocol * females must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions as defined in the protocol for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series exclusion: history of: * recurrent migraine headache * any neurological or behavioral disorder or seizures * drug abuse or alcohol consumption (more than 2 drinks per day) * allergic disease/reaction likely to be exacerbated by vaccine * urticaria related to mosquito bites requiring medical attention * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect * any confirmed or suspected immunosuppressive or immunodeficient condition; * seropositive for hbsag, anti-hcv or anti-hiv * acute disease at the time of enrollment * chronic hepatomegaly or splenomegaly * use of any investigational or non-registered drug or vaccine within 30 days preceding study or planned use * planned administration of a vaccine not foreseen by the study protocol 30 days ±each vaccine dose * planned move during study * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or administration of immunoglobulins and/or blood products, within 90 days preceding the first dose or planned administration during the study period * any chronic systemic drug therapy to be continued during the study period

Keywords: dengue infection
romanian entropy clinical study network

Conditions: General Anesthetic Drug Adverse Reaction

Summary: the critically ill patient is one of the most complex cases with regard to the optimization of the anesthesia, as well as postoperative management. one of the most important steps in the complex management of such patients is the modulation of anesthesia for every patient needs. we start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. we also believe that by individualizing the anesthesia by monitoring the entropy it is possible to obtain an appropriate management regarding hemodynamic complications during anesthesia including tachycardia, bradycardia, hypotension and hypertension.


Eligibility criteria:
inclusion criteria: * asa physical status i, ii, iii; * written consent accepted to be enrolled in the study; in polytrauma patients in the operation theatre who are brought directly through the emergency department, written consent is obtained from the relatives, in accordance to the national law number 206, of 2004, for a good and correct scientific research, in the situation where the patient is no capable to sign or give the written consent; exclusion criteria: * cardiac pacemaker; * atrial fibrillation at the time of presentation in the operation theatre; * any subject with epidural catheter, placed pre-operatively; * allergy to propofol or another anesthetic drugs; * pregnancy; * presence of neuromuscular disease; * presence of neurologic disease;

Keywords: general anesthesia entropy hypnosis
study of recombinant factor viii fc fusion protein (rfviiifc) in subjects with severe hemophilia a

Conditions: Severe Hemophilia A

Summary: the study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant factor viii fc fusion protein (rfviiifc) in previously-treated subjects with severe hemophilia a.


Eligibility criteria:
inclusion criteria: 1. male and 12 years of age and older and weigh at least 40 kg 2. diagnosed with severe hemophilia a (baseline factor viii level less than 1%) 3. history of at least 100 exposure days to any factor viii product exclusion criteria: 1. history of factor viii inhibitors 2. kidney or liver dysfunction 3. diagnosed with another coagulation defect other than hemophilia a
analgesic efficacy of dexmedetomidine as adjuvant to levobupivacaine in ultrasound-guided erector spinae plan block for modified radical mastectomy

Conditions: Acute Pain

Summary: to evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.

premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ecg, temperature and capnography), an intravenous cannula will be placed and secured. ultrasound guided erector spinae plane (esp) block will be given with patient in sitting position depending on surgical site (left or right) esp block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then trapezius muscle, rhomboidus major muscle, and erector spinae muscle, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle. general anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) no other narcotic, analgesic or sedative will be administrated during operative period. standard monitor (mean arterial blood pressure, heart rate , oxygen saturation \& end-tidal co2) will observed and recorded every 30 min till end of surgery post-operative: the patient will be transferred to the post anesthesia care unit (pacu) and will be monitored for: 1. vital signs (heart rate, noninvasive blood pressure, and oxygen saturation). 2. rass score (richmond agitation \& sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1) 3. numerical rating score (nrs) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1). (4)time and amount to request analgesia (pca patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at nrs≥3. (5) side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.

Eligibility criteria:
inclusion criteria: * female patient * american society of anesthesiologists (asa) i and ii physical status * age from 25 to 70 years old * scheduled for either left or right modified radical mastectomy (mrm). exclusion criteria: * infection of the skin at or near site of needle puncture, * coagulopathy, * drug hypersensitivity or allergy to the studied drugs, * central or peripheral neuropathy, * significant organ dysfunction cardiac dysrrhythmias, * obesity (bmi\>35kg/m2) * recently use analgesic drugs.
5x-multiplier vs 3-tier model for discharge opioid prescriptions after intra-abdominal cancer surgery: a randomized clinical trial

Conditions: Intra-abdominal Cancer

Summary: to compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.

primary objectives: the co-primary objectives of this study are as follows: 1. to determine differences in the initial ome prescribed upon discharge between each algorithm/model. 1. to determine ome usage by day 14 after hospital discharge. secondary objectives: secondary objectives are as follows: 1. to determine rates of patients with zero ome upon discharge. 2. to determine rates of ome refill requests and completions at 15- and 30-days post-operation. 3. to determine number of unused or leftover pills at 15- and 30-days post- operation 4. to determine persistent opioid use at 30-days, 3-months, and 6-months post-operation 5. to elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use 6. to assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation. 7. to determine patient satisfaction with either prescribing model.

Eligibility criteria:
inclusion criteria: * participants ≥18 years of age * participants undergoing any of the following abdominal surgeries on an elective basis at md anderson cancer center: * open pancreatectomy * open hepatectomy * open resection of retroperitoneal sarcoma * open nephrectomy * open cytoreductive surgery (in ovarian cancer) * participants with a planned inpatient admission of at least 48 hours after surgery * opioid-naive patients who use less than or equal to 7.5 mg ome per day (on average) during the 30 days prior to consent * participants able to understand and willing to sign an informed consent document * english and non-english-speaking participants exclusion criteria: * participants requiring non-elective (emergent or urgent) surgery will be excluded * participants with a current or previous history of substance abuse disorder, including alcohol or drugs * participants prescribed long-acting chronic pain medications * participants using hydromorphone or fentanyl or under the care of a chronic pain specialist * participants unable or unwilling to participate in follow-up study requirements (e.g., qol surveys, opioid log) * participants discharged on palliative or hospice care * participants with a history of allergic reactions to opioids * participants enrolled in any other opioid discharge protocol * participants who are pregnant * participants who are cognitively impaired
safety and efficacy of oral miltefosine in patients with post kala azar dermal leishmaniasis (pkdl)

Conditions: PKDL

Summary: miltefosine efficacy will be \>85%


Eligibility criteria:
inclusion criteria: * 12 years or older * nodules and papules consistent with post kala-azar dermal leishmaniasis * parasitological confirmation of leishmania infection exclusion criteria: * platelet count \<100x 109/l, * leukocyte count \<2.5 x 109/l , * hemoglobin \< 8.0 g/100 ml , * liver function tests \>3 times upper limit of normal range, * bilirubin \>2 times upper limit of normal range, * serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range); * any non-compensated or uncontrolled condition, * lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter; * treatment with any anti-leishmanial drug within the previous 12 weeks.

Keywords: pkdl miltefosine
new biomarkers for invasive fungal infections in paediatric haemato-oncology

Conditions: Haemato-oncological Paediatric Patients Under Intensive Chemotherapy

Summary: the availability of sensitive and specific fungal biomarkers could be a precious help to improve the management of patients suffering from fungal diseases, not only by allowing preemptive treatment, but also by offering objective elements to assess patient therapeutic response and prognosis. the use of such biomarkers could also contribute to accurately evaluate novel antifungal drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective treatments and dose selection in product development. using two or three tests may increase the sensitivity to detect ifi. the results of the serum assays will be correlated to the definition of 'proven' fungal infection as defined by the eortc/msg criteria published in 2008. based upon results from adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-d glucan could reasonably have a 90% sensitivity (with a 95% ci between 73% and 98%) under the current design. as concern the aspergillus fumigatus pcr, sensitivity and specificity could be estimated between 63% to 100% and 87% to 96.7%, respectively.


Eligibility criteria:
inclusion criteria: 1. any febrile episode in : * either a neutropenic child suffering from acute lymphoblastic leukemia under induction chemotherapy or relapse, acute myeloblastic leukemia under chemotherapy (all cycles of chemotherapy included) or myelodysplasic syndrome * an allogenetic hematopoietic stem cell transplantation recipient child, from conditioning till 3 months or receiving aggressive immunosuppressive therapy for at least 1 months 2. age of children will be from 3 months till 18 years 3. informed consent from the parents and from children older than 12 years obtained exclusion criteria: 1. any previous history of fungal infection (proven, probable or possible) with prescription of secondary oral prophylaxis (voriconazole or posaconazole) under current use at the time of the study. 2. any previous episode already enrolled (only one episode/patient).
to assess the efficacy and safety of otx-ded for the short-term treatment of signs and symptoms of dry eye disease

Conditions: Dry Eye

Summary: to assess the efficacy and safety of otx-ded for the short-term treatment of signs and symptoms of dry eye disease.

randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of otx-ded (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of dry eye disease (ded). the subjects will be followed for approximately 2-3 months from screening to the last visit.

Eligibility criteria:
inclusion criteria: * dry eye disease diagnosis * vas eye dryness severity score ≥ 40. exclusion criteria: * are unwilling to discontinue use of contact lenses * are unwilling to withhold use of artificial tears.

Keywords: dexamethasone ophthalmic insert