Kornimate/medical-research-clean huggingface dataset:
jejunal ketogenesis and type 2 diabetes

Conditions: Obesity, Morbid; Diabetes Mellitus, Type 2; Intestines; Incretins

Summary: the goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. the type of study is an exploratory trial with the participants as own controls. the main questions it aims to answer are: 1. does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. are insulin resistance, the incretin glp-1 release and the glucose transporter sglt1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?

the investigators have recently shown that the mucosa in the middle small intestine, the jejunum, in human volunteers produce ketones bodies.this situation is thus contrary to the common view that ketone bodies are formed by the liver during fasting/starvation. obesity is commonly associated with hyperglycaemic conditions and diabetes mellitus type 2.this has given rise to the question of whether obesity results in disturbances in the intestinal food-induced ketogenesis and whether this influence contributes to the development of type 2 diabetes mellitus? the project's questions are therefore: 1. does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. are insulin resistance, the incretin glp-1 release and the glucose transporter sglt1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes? 3. if no to 2: what is the difference?

Eligibility criteria:
inclusion criteria: * bmi 35 to 45 kg/m2 exclusion criteria: * insulin-treated diabetes * sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.) * diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment * continuous nsaid use * preferably otherwise medication-free (exceptions can be made) * not operated on in the abdomen (appendectomy excluded) * previously known organic gastrointestinal disease, except for gastroesophageal reflux disease (gerd) * smokers * pregnancy and breastfeeding * history of drug abuse or other circumstances deemed to jeopardize the patient's ability to participate in the research project
the dynamic fluctuation of donor microbiota affects the prognosis of fecal microbiota transplantation for c. difficile infection

Conditions: Clostridium Difficile Infection; Fecal Microbiota Transplantation

Summary: fecal microbiota transplantation (fmt) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. recently, fmt has been widely used in the treatment of various gastrointestinal diseases, including but not limit in cdi. in this study, we focused on the demonstration of fmt action mechanism in cdi treatment.


Eligibility criteria:
inclusion criteria: 1. aged over 18 years old; 2. positive stool test for clostridium difficile 16s rdna and/or glutamate dehydrogenase; 3. can tolerate nasojejunal tube and complete full course of fmt treatment; 4. the clinical data are relatively complete and there is follow-up available for evaluation exclusion criteria: 1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism; 2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) intervention with antibiotics during treatment
a pilot open label trial of hiv therapy with d4t (stavudine), ddi (didanosine), nelfinavir and hydroxyurea in subjects with recent hiv infection

Conditions: HIV Infections

Summary: to assess the magnitude and duration of the antiviral activity in plasma and the incidence and time to total suppression of detectable hiv rna in plasma. to assess the long-term safety and tolerability of this combination therapy and the magnitude and duration of the effect of these drugs over cd4 cell counts.


Eligibility criteria:
inclusion criteria patients must have the following symptoms and conditions: * treatment naive. * recent hiv infection. * baseline laboratory values within acceptable ranges. * written, informed consent from parent or legal guardian for patients \< 18 years old. * available for follow-up for at least 96 weeks. exclusion criteria co-existing condition: patients with the following conditions and symptoms are excluded: * documentation of other cause for previously mentioned clinical conditions. * intractable diarrhea. * signs and symptoms of bilateral peripheral neuropathy \>= grade 2. * inability to tolerate oral medication. * hemophilia, other bleeding disorder, or no accessible tonsillar or lymph node tissue. patients with the following prior conditions are excluded: history of acute or chronic pancreatitis. 1. use of potent neurotoxic drugs is not permitted. * no other anti-hiv therapy allowed. * nelfinavir should not be administered concurrently with rifampin or rifabutin, terfenadine (seldane), astemizole (hismanal), cisapride (propulsid), triazolam (halcion), and midazolam (versed). 1. any prior antiretroviral therapy. * prior vaccination with a candidate hiv therapeutic vaccine. * previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment. * previous therapy with rifampin or rifabutin, terfenadine (seldane), astemizole (hismanal), cisapride (propulsid), triazolam (halcion), and midazolam (versed) within 14 days prior to study entry or at any time while on study. active alcohol or substance abuse.

Keywords: pilot projects hiv-1 didanosine drug therapy, combination stavudine hydroxyurea rna, viral nelfinavir anti-hiv agents viral load
durapore vs. hy-tape to secure the endotracheal tube

Conditions: Erythema

Summary: while adhesive tape is commonly used to secure endotracheal tubes (ett) during general anesthesia, its use is also associated with facial skin injuries. although a variety of adhesive tapes are used in clinical practice, few studies have investigated the likelihood of adhesives in producing injury. the purpose of this randomized, controlled, non-inferiority study was to compare the proportion of facial skin injury with durapore™ vs. hy-tape®.

adhesive tapes are often used on the patient's face during general anesthesia. they are used to fix the tracheal tube, nasopharyngeal temperature probe, nasogastric tube, and nerve stimulator electrodes. an adhesive tape used in anesthesia needs to provide fast, secure adhesion to prevent dislodgement of critical devices. the tape should be secure over time, with changes over temperature, humidity, or exposure to fluids as occurring in the operating room. however, the tape should be gentle enough that removal should not cause skin trauma to the face. while the skin irritation is generally limited to mild erythema that resolves on its own within a day or two of receiving anesthesia, the irritation may affect patient satisfaction. furthermore, serious injury, including full-thickness epidermal loss with purpura has occurred at tufts medical center with the use of 3mtm durapore tape, requiring several doctor visits in follow up. medical adhesive related skin injuries are estimated to impact at least 1.5 million patients annually in the us with significant costs per incident. (1) at tufts medical center, a variety of adhesive tapes are used to secure the endotracheal tube during anesthesia, including 3mtm durapore (acrylate- based tape) and the hy-tape® pink tape (zink-based tape) with no preference for one or the other. hy-tape's zinc oxide-based adhesive is claimed to be soothing to delicate skin, and removes with minimum trauma, thereby reducing the chance of skin tears and tape burns. it also has the unique quality of providing maximum adhesion when it reaches body temperature, without getting more aggressive or breaking down over time as acrylic-based adhesive tapes do. however, there is no scientific evidence to support this claim. the purpose of this study is to compare the proportion of skin erythema after general anesthesia with the use of duraporetm vs. hy-tape®.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. surgeries scheduled for anesthesia of duration more than 30 minutes after induction. exclusion criteria: 1. any patient that does not consent 2. patients \< 18 years old 3. surgery in the prone position 4. surgery on the head, brain, neck, teeth, mouth, eyes, or face any patient who has: 5. pre-existing skin erythema or other skin trauma 6. lips piercings
single center food allergy oral immunotherapy study

Conditions: Immune System Diseases

Summary: the primary objective of the study is to develop a customized regimen for oral immunotherapy that reflects what the subject is allergic in a clinically significant way (i.e., the offending food allergen is defined as a food allergen with a positive skin test or positive specific ige and a positive dbpcfc). therefore, the investigators prefer that both single and multiple food allergy subjects are included in the study.


Eligibility criteria:
inclusion criteria: * moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old. * sensitivity to food allergen will be documented by a positive skin prick test result (see appendix for details) or allergen specific immunocap ige level with 7 ku/l as a lower limit of eligibility. exclusion criteria: * no absolute contraindications are known. however, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). * subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an icu, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Keywords: multiple food allergies
comprehensive medication monitoring on heart failure patient outcomes

Conditions: Heart Failure，Congestive

Summary: the purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the patient medication profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.

congestive heart failure has an exceptionally high rate of hospital admission and is responsible for more re-admissions (23.5% at 30 days) in the united states than the 2nd and 3rd leading causes combined. inadequate medication reconciliation both on admission and discharge from the hospital is a significant cause of medical error. in one study of cardiovascular patients, 44% believed they were taking a medication they were not, and 96% were unable to recall at least one medication they were taking. in the same study patients omitted on average 6.8 medications from their medication list. medication optimization through improved adherence and reconciled medical records has been postulated to significantly improve admission and 30-day hospital readmission rates. sano has developed a blood-based comprehensive medication monitoring tool that identifies and quantitates 235 prescription drugs and drug metabolites. it does not detect illicit drugs. this tool, which produces an output report designated the 'patient medication profile', is designed to be used with clinical decision support to improve medication adherence, reduce medication errors, and optimize medication therapy. for heart failure patients, the investigators hypothesize that deploying the patient medication profile with clinical decision support at key points of treatment intervention will a) improve medication adherence, b) identify and reconcile significant discrepancies in the medication list, c) result in reduced hospital admissions, and d) result in better overall patient outcomes. these outcome expectations are relative to usual care for heart failure patients.

Eligibility criteria:
inclusion criteria: * patients must have a regularly scheduled visit to a university of pittsburgh medical center (upmc) cardiology clinic in oakland * patients must have heart failure with reduced ejection fraction (≤40%) * patients have admitted to upmc hospital facility between one and five times in past 12 months * patients must be able to provide informed consent for present study * patient age \> 18 years exclusion criteria: * enrolled in hospice * patient on home inotrope (dobutamine or milrinone) * world health organization (who) group 1 or group 5 pulmonary hypertension * patient with current ventricular assist device (vad) * not able to communicate in english

Keywords: clinical decision support drug levels in blood therapeutic drug monitoring medication adherence medication therapy management
improving time-based prospective memory in tbi

Conditions: Traumatic Brain Injury

Summary: this research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (tbi).

this research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (tbi), particularly improving the ability to remember to do things in the future.

Eligibility criteria:
inclusion criteria: * sustained a moderate-to-severe tbi at least one year prior to assessment * fluent in english * demonstrate impairment in strategic cognitive abilities exclusion criteria: * significant neurological history other than tbi * significant psychiatric history (e.g., bipolar disorder, schizophrenia) * significant substance abuse history * steroid and/or benzodiazepine use

Keywords: traumatic brain injury tbi brain injury
non-invasive measurement of pulmonary dysfunction in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. the two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

this project proposes the utilization of a novel non-invasive real-time breathing sensor - pneurip- to measure pulmonary function (pf) in children with high-level cerebral palsy. currently the standard measures of pf such as spirometry and peak flow meters are too strenuous for children and those with severe cp, as a result they have low compliance rates. the pneurip does not require active user participation and can passively measure pf. it consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through respiratory inductance plethysmography (rip). readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an ipad. the pneurip yields indices of work of breathing (wob) which includes the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. this sensor takes little time to set up and readings are provided instantaneously. the wob indices provide a screening tool for pulmonary diagnosis and treatment, decrease the risk for pneumonia and respiratory illness, and has the potential to act as a marker for scoliosis in children with high-level cp. the impact on the field will be to have a simple and fast way to measure pulmonary function in children and adults with severe cp and correlate this to measures of function and scoliosis severity as the effects of scoliosis, which is common in cp, on pulmonary function is unclear. measures of motor function are classified by the gross motor functional classification system (gmfcs), ranking from i to v, with worsening disability from near normal gait in type i to complete wheelchair use in type v. this project will address gmfcs levels iv and v which includes people using wheelchairs. the two specific aims are a) measure wob indices non-invasively using the pneurip sensor in children with cp who use a wheelchair (gmfcs level iv, v) and validate the use of wob indices as a screening test for pulmonary dysfunction., 2) determine the correlation between wob indices and the degree of scoliosis using the pneurip sensor in 250 children with cp who use a wheelchair (gmfcs level iv, v).

Eligibility criteria:
inclusion criteria: * subjects should have cerebral palsy a gmfcs levels iv, v exclusion criteria: -
stress analysis of hip dysplasia

Conditions: Hip Dysplasia

Summary: the main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (pao).

pao was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. it is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.

Eligibility criteria:
inclusion criteria: * patients aged 18-40 years * patients who have undergone periacetabular osteotomy by dr. peters for treatment of hip dysplasia. * patients who have previously participated in irb #10983 "comparative stress analysis of hip dysplasia". exclusion criteria: * persons with a history of allergies to lidocaine or seafood. * children under the age of 18. * persons incarcerated, on trial, or parole. * women who are pregnant. * subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.
transcutaneous carbon dioxide pressure (tcpco2) monitoring for the prediction of extubation failure in the icu

Conditions: Ventilator Weaning

Summary: difficult weaning from ventilation and extubation failure are major issues in intensive care, concerning 30% and 12% of patients respectively. these can be partly explained by the lack of accuracy of spontaneous breathing trial (sbt) failure criteria to predict extubation failure. the investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure (tcpco2) monitoring during sbts. the results showed that the difference between maximum and initial tcpco2 (or δtcpco2) was significantly higher in the group of patients who failed sbts according to the usual criteria. moreover, the results suggested that δtcpco2 could be an accurate and early criterion for sbt failure. the size of the study could not examine δtcpco2 regarding extubation failure. therefore, the main objective of this study is to determine if δ tcpco2 during sbts is associated with extubation failure.


Eligibility criteria:
inclusion criteria: * \> 18 years old, * icu indicated * invasive mechanical ventilation via orotracheal or nasotracheal intubation * presence of criteria for initiation of the weaning process as stated on our icu's protocol * resolution of the disease leading to mechanical ventilation exclusion criteria: * mechanical ventilation during less than 24 hours * tracheotomy and tracheostomy at icu admission * pregnancy * patient under legal protection * patient enrolled in another study regarding weaning or co2 metabolism

Keywords: e02.880.820.950
the role of post-traumatic inhibition of the innate and adaptive immune system in the development of infectious complications in severely injured patients

Conditions: Multiple Trauma; Sepsis; Innate Immune Response; Disorder of Neutrophils; Multiple Organ Dysfunction Syndrome

Summary: patients admitted to the intensive care unit after severe injury are prone to suffer from infectious complications and even sepsis. despite tremendous efforts the etiology of this increased susceptibility to infectious pathogens is incompletely understood. clinical signs and symptoms as well as current diagnostic clinical tests (wbc, crp, cytokines, interleukines) lack sensitivity or specificity for adequate prediction of the development of infectious complications or sepsis. neutrophil granulocytes, cells of the innate immune system, play an important role in the defence against invading bacterial pathogens and are crucial in preventing fulminant infections. for successful eradication of a bacterium neutrophils need to exert specific functions: chemotaxis, migration, phagocytosis, degranulation and production of radical oxygen species. much research has focused on the effect of trauma on neutrophil's individual capacities to kill bacteria with conflicting interpretations as a result. for adequate determination of the neutrophil's capacity to eradicate bacteria from tissue of trauma patients we developed novel in-vitro assays in which neutrophils are tested for all of these functions combined. this assay allows us to identify dysfunctional neutrophils adequately. the main focus of this study is the determination of the functionality of aberrant neutrophils circulating in the peripheral blood of severly injured following trauma.


Eligibility criteria:
inclusion criteria: * admitted to the icu * expected stay of at least 2 days * age: 18 - 80 years * informed consent (when proxy consent is obtained and the patient leaves the icu in good mental health, personal informed consent is additionally necessary) exclusion criteria: * immunosuppressive medication * hiv and related diseases

Keywords: inflammation multiple organ failure sepsis wounds and injuries pathologic processes shock infection systemic inflammatory response syndrome neutrophils pmn granulocytes innate immunity icu intensive care polytrauma host-pathogen
nesiritide for ventilated congestive heart failure

Conditions: Congestive Heart Failure; Mechanical Ventilation; Using Nesiritide; Venous Return; Cardiac Function

Summary: the congestive heart failure is a common disease among patients who receive cardiac surgery and may lead to prolonged ventilation support. nesiritide was a potential therapy for congestive heart failure. this study aimed to compare the nesiritide induced hemodynamical status changes among congestive heart failure patients with invasive ventilation support.


Eligibility criteria:
inclusion criteria: * age≥18 years； * congestive heart failure; * with mechanical ventilation； * with hemodynamic monitoring devices; * the physicians made the decision of using nesiritide. exclusion criteria: * unstable hemodynamic status； * severe renal dysfunction.

Keywords: congestive heart failure nesiritide
a study of tocilizumab in patients with rheumatoid arthritis who have an inadequate response to current non-biologic dmards

Conditions: Rheumatoid Arthritis

Summary: this single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic dmards. patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic dmards.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * moderate to severe rheumatoid arthritis; * inadequate response to current non-biologic dmards exclusion criteria: * rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis; * previous treatment with other biologics.