Kornimate/medical-research-clean huggingface dataset:
intraoperative testing of colorectal anastomosis - air or water (methylene blue)?

Conditions: ColoRectal Cancer; Colonic Diverticulitis; Anastomotic Leak; Anastomotic Complication; Anastomosis

Summary: a leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis. two of the most common tests that are performed routinely are: 1. air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis. 2. injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis. the aim of the study is to compare the two methods, and to assess if there is a superior method. a secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis. in this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 undergoing elective colonic resection of their distal part of the colon/ rectum with colorectal anastomosis in a laparoscopic or open approach for a benign or malignant colonic disease. exclusion criteria: * emergent colonic resections, * colonic resections with no colorectal anastamosis

Keywords: anastomotic leak colorectal anastomosis testing intraoperative testing
high versus low dose of caffeine for apnea of prematurity

Conditions: Apnea; Preterm Infants

Summary: the optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants.

a randomized, double blind, clinical trial which will be conducted in neonatal intensive care unit, mansoura university children hospital, egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare high dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.

Eligibility criteria:
inclusion criteria: * newborn infant less than 32 weeks gestation with the diagnosis of apnea exclusion criteria: * newborn infants with gestational age more than 32 weeks. * newborn infant with congenital malformations or chromosomal anomalies.

Keywords: high dose of caffeine low dose of caffeine prevention
a drug interaction study between bosutinib and aprepitant in healthy volunteers

Conditions: Healthy

Summary: this is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. the primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (pk) profile of a single oral dose of bosutinib in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects with an informed consent document signed and dated by the subject. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol . * use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Keywords: bosutinib aprepitant drug interaction healthy volunteers pharmacokinetics chronic myelogenous leukemia
rc2s+: remediation of social cognitive impairments

Conditions: Schizophrenia

Summary: background: difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. according to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (tom); (3) attributional style; and (4 and 5) social perception and knowledge. the components of social cognition appear to be related to both symptomatology and functioning in everyday life. new strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes. the rc2s therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

methods: this is a randomized controlled trial to establish the validity of the rc2s+ program in schizophrenia. the project's main objective is to assess the impact of rc2s+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions. the study has four other objectives: 1. to assess the influence of the rc2s+ therapy versus control therapy on neurocognitive processes 2. to assess the impact of the rc2s+ therapy versus control therapy on social functioning 3. to assess the impact of the rc2s+ therapy versus control therapy on both positive and negative symptoms 4. to study the maintenance of benefits 3 months forward outcomes: to treat social cognitive impairments in people with schizophrenia.

Eligibility criteria:
inclusion criteria: * aged 18-45 years old * diagnosis of schizophrenia assessed with dsm5 criteria (apa, 2013) * no modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated * french native language or education in a french school since the first year of primary school * consent to participate to the study and agreement of the legal guardian * patients who have not benefited from cognitive remediation during the three months before inclusion exclusion criteria: * substance use disorder (criteria of dsm-5), except for caffeine and tobacco * neurologic disorders (vascular, infectious or neurodegenerative) * uncorrected visual deficit * medical drugs with cerebral or psychological effect (e.g, corticosteroids) * patients resistant to antipsychotic medication * pregnancy

Keywords: social cognition cognitive remediation emotions theory of mind attributions social perception
effect of age, weight and sex on levothyroxine pharmacokinetics

Conditions: Hypothyroidism Primary

Summary: this study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine

setting the study was conducted on the clinical research unit of an academic medical center. participants adults of any age being treated with levothyroxine for hypothyroidism were studied. interventions a single dose of 13c- lt4 was administered to hypothyroid subjects taking levothyroxine replacement. main outcomes and measures eighteen serial plasma samples were collected. one sample was obtained before the 13c- lt4 dose and the remainder over the 312-hour period post-dosing. 13c- lt4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using phoenix 6.4.

Eligibility criteria:
inclusion criteria: * age \>21 years at the time of consent * euthyroidism while undergoing treatment with lt4 * no other serious illness * ability to give written informed consent. exclusion criteria: * baseline hematocrit lower than 28.0% * tsh greater than 4.5 miu/l * kidney dysfunction * concomitant use of drugs that affect thyroidal axis interactions
registry experience at the washington hospital center, des - xience v

Conditions: Coronary Artery Disease

Summary: single center registry of patients who have received a xience v everolimus-eluting stent at the washington hospital center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (bms) and recently with the drug-eluting stents (des). the everolimus eluting, xience v stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to bms, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. while registry data is available from outside of the united states, it will be important to collect "real-world" data regarding the stent usage and outcomes in the united states. in this study we propose to follow patients who received at least one xience v® stent for at least 1 year post initial stent implantation.

Eligibility criteria:
inclusion criteria: * patients, male or female, \>18 years of age * patients who received at least one xience v drug-eluting stent at the washington hospital center exclusion criteria: * patients who received another type of des (other than xience v) or a bare metal stent at the time of initial xience v stent implantation
pregabalin in preventing acute pain syndrome in patients receiving paclitaxel

Conditions: Pain; Peripheral Neuropathy

Summary: this randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. pregabalin may control the pain caused by cancer treatment.

primary objectives: i. to obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (p-aps). secondary objectives: i. to obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. ii. to obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. tertiary objectives: i. to characterize neurological testing abnormalities that might occur with the p-aps, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (cipn). ii. to determine the pro incidence and characteristics of, and change in, p-aps and paclitaxel induced more chronic cipn over several cycles. these data will serve to confirm the results obtained in our previous natural history study n08c1. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive pregabalin orally (po) twice daily (bid), beginning on the first night of chemotherapy, for 12 weeks and then once daily (qd) for 1 week. arm ii: patients receive placebo po bid, beginning on the first night of chemotherapy, for 12 weeks and then qd for 1 week. after completion of study treatment, patients are followed up every 30 days for 6 months.

Eligibility criteria:
inclusion criteria: * age \> or equal to 18 years * ability to complete questionnaires by themselves or with assistance paclitaxel at a dose of 80 mg/m\^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy * paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for parp inhibitors). * life expectancy \> 6 months * eastern cooperative oncology group (ecog) performance status 0 or 1 * negative pregnancy test (serum or urine) done =\< 7 days prior to registration, for women of childbearing potential only (per clinician discretion) exclusion criteria: * pregnant women * nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects * previous diagnosis of diabetic or other peripheral neuropathy * current, planned or previous use, within last 6 months, of gabapentin or pregabalin * history of allergic or other adverse reactions to gabapentin or pregabalin * significant renal insufficiency with a history of a creatinine clearance (crcl) \< 30ml/min * prior exposure to neurotoxic chemotherapy * seizure history * diagnosis of fibromyalgia * previous exposure to paclitaxel
pediatric epilepsy study

Conditions: Epilepsy

Summary: this study will evaluate the safety and effectiveness of oxcarbazepine (trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


Eligibility criteria:
inclusion criteria: to enter this study, patients must: * have a diagnosis of partial seizures * have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication * be willing to be hospitalized for up to 5 days * weigh a minimum of 6.6 lbs * have had a previous cat scan/mri confirming the absence of space occupying lesions or progressive neurological disease * have normal laboratory results exclusion criteria: to enter this study, a patient must not have or be: * seizures caused by metabolic disturbance, toxic exposure, or active infection * a primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) * a history of status epilepticus within 30 days * seizures not related to epilepsy * this study has some aed restrictions * serum sodium levels \<135 meq/l * significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy * a history of chronic infection (e.g., hepatitis or hiv) * significant electrocardiogram (ecg) abnormalities * a nursing mother taking anti-convulsant drugs * a history of substance abuse (including alcohol) * previously demonstrated sensitivity/allergic reaction to trileptal or related compounds * used experimental medication within 30 days of entering this study

Keywords: partial seizures
primary immunodeficiency in kuwait

Conditions: Primary Immune Deficiency Disorder

Summary: * background/rationale: epidemiological data about primary immunodeficiency disorders (pidd) in kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity. * study hypothesis: pidd is relatively common in kuwait compared to populations from different geographic areas. the distribution of pidd in kuwait is different from other geographic areas with more severe forms being more frequent. * brief inclusion and exclusion criteria of study participants: pidd patients presented at different clinics/hospital in kuwait. patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded * estimated sample size of the study: all patients who were registered in knpidr since 2004 will be included in the study along with the new patients who will be recruited during the study period. * primary objectives: * determine the prevalence and frequency of different pidd in kuwait * identify clinical presentation patterns for pidd in kuwait * identify natural history of pidd in kuwait * help to asses epidemiology of pidd in kuwait * determine particularities about pidd affecting the population in kuwait * determine the health impact of pidd in kuwait * development of strategies to improve the care and the quality of life of patients with pidd


Eligibility criteria:
inclusion criteria: * pidd patients presented at different clinics/hospital in kuwait * exclusion criteria: patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect)
medium chain triglycerides as an adjunct to the modified atkins diet for women with catamenial epilepsy

Conditions: Epilepsy; Seizure; Catamenial Epilepsy; Medically Resistant Epilepsy; Medically Resistant Seizures

Summary: the modified atkins diet (mad) has been shown to be effective in treating intractable epilepsy. approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. the investigators have observed that despite an overall reduction in seizure frequency, some women on the mad continue to have breakthrough seizures in a catamenial pattern. the investigators hypothesize that women with a history of intractable epilepsy who have been on the modified atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.


Eligibility criteria:
inclusion criteria: * adult women ≥ 18 years * already on the modified atkins diet for at least 3 months and compliant with treatment * catamenial seizure pattern (by herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates) exclusion criteria (basic exclusion criteria for the modified atkins diet, so patients should have already been screened for these factors): * unwilling to restrict carbohydrates * significantly underweight (bmi \<18.5) * kidney disease * history of hypercholesterolemia (\>300 mg/dl) or hypertriglyceridemia (\>200 mg/dl) * metabolic or mitochondrial disorder * pregnancy * lactose intolerance or milk allergy * aversion to liquids or inability to eat solid food exclusion criteria (specific to this study): * men * women who are menopausal or peri-menopausal * prior use of betaquik® at any time for any duration * already using another ketogenic diet supplement on a sporadic basis (unless the patient is using one daily and is willing to continue doing so for the duration of this study) * already using coconut oil specifically for catamenial epilepsy within the month prior to enrollment (okay if patient only using for cooking throughout the month) * taking a hormonal contraceptive so that they do not menstruate (e.g. taking active instead of placebo oral contraceptive pills to avoid having a period) * anticipated need to adjust anti-epileptic medications within the next 6 months * anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months * pregnant or anticipated pregnancy within the next 6 months

Keywords: seizures epilepsy catamenial ketogenic diet modified atkins diet intractable epilepsy medically refractory epilepsy adult medium chain triglyceride
imaging with a new agent that finds a cancer protein called her2

Conditions: HER2-positive Carcinoma; HER2-positive Primary Malignancy

Summary: the purpose of this study is to test if an imaging agent called zr-dfo-pertuzumab that finds her2 proteins can be used to take pictures of her2-positive cancer.


Eligibility criteria:
inclusion criteria: * age 21 years or greater * any biopsy proven her2-positive malignancy. asco guidelines will be used to define her2-positivity for breast cancer. similar guidelines will be used for other cancer types as appropriate. * at least one malignant lesion on ct, mr, or fdg pet/ct within 60 days of protocol enrollment * ecog performance of 0-2 exclusion criteria: * life expectancy \< 3 months * pregnancy or lactation * patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds.

Keywords: 17-059 zr-dfo-pertuzumab
a dose evaluation study of the effect of plug placement on the efficacy and safety of the latanoprost punctal plug delivery system (l-ppds) in subjects with ocular hypertension or open-angle glaucoma

Conditions: Glaucoma; Ocular Hypertension (OH)

Summary: the purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the l-ppds (latanoprost punctal plug delivery system).


Eligibility criteria:
inclusion criteria: * male or female at least 18 years old * diagnosis of bilateral open angle glaucoma or ocular hypertension * unmedicated iop must be ≥22mm hg exclusion criteria: * any significant vision loss in the last year * no contact lens use for the length of the study * abnormal eye lids, eye infection or diseases to the eye * recent eye surgery * uncontrolled medical conditions