Kornimate/medical-research-clean huggingface dataset:
hepa wash treatment of patients with acute-on-chronic liver failure in intensive care units

Conditions: Acute on Chronic Hepatic Failure

Summary: patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. hepa wash(r) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. the new system has shown a high detoxification capacity in in-vitro and preclinical studies. the aim of the study is to evaluate the safety and efficacy of the hepa wash system in patients with acute-on-chronic liver failure in the intensive care unit.


Eligibility criteria:
inclusion criteria: 1. patients with documented clinical or histological evidence of cirrhosis and 2. acute decompensation in previously stable cirrhotic liver disease and 3. bilirubin ≥ 2 mg/dl and 4. sofa ≥ 9 calculated after 12 hours of optimal medical therapy and 5. patient is in the intensive care unit and 6. informed consent of the patient or the legal representative and 7. patients are 18y or older and 8. enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5) exclusion criteria: 1. untreatable extrahepatic cholestasis 2. patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the icu admission. 3. pao2/fio2 ≤ 100 mmhg (respiratory sofa-score of 4) 4. patients who receive a vasopressor support of dopamine \>15 µg/kg/min or epinephrine \>0.1 µg/kg/min or norepinephrine \>0.1 µg/kg/min (cardiovascular sofa-score of 4) 5. patients with creatinine ≥5 mg/dl or urine output \<200 ml/day (renal sofa-score of 4) 6. patients on kidney dialysis 7. patient with meld-score of 40 8. mean arterial pressure ≤ 50 mmhg despite conventional medical treatment 9. patient testament excludes the use of life-prolonging measures 10. post-operative patients whose liver failure is related to liver surgery 11. uncontrolled seizures 12. active or uncontrolled bleeding 13. weight ≥ 120 kg 14. pregnancy 15. patient diagnosed with creutzfeldt-jakob disease 16. participation in another clinical study

Keywords: liver failure hepatic insufficiency liver cirrhosis artificial liver albumin dialysis
effect of inferior alveolar and gow-gates nerve block techniques for symptomatic mandibular molars

Conditions: Symptomatic Irreversible Pulpitis

Summary: introduction: to evaluate the efficacy of inferior alveolar nerve block (ianb), gow-gates nerve block (ggnb), and their combination in patients with irreversible pulpitis. methods: one hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two ianb injections or two ggnb injections or their combination of 1.8 ml 2% lidocaine with 1:100,000 epinephrine. success was specified as no or mild pain on the basis of heft-parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. data were analyzed by kruskal-wallis, and anova tests.

introduction: to evaluate the efficacy of inferior alveolar nerve block (ianb), gow-gates nerve block (ggnb), and their combination in patients with irreversible pulpitis. methods: one hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two ianb injections or two ggnb injections or their combination of 1.8 ml 2% lidocaine with 1:100,000 epinephrine. success was specified as no or mild pain on the basis of heft-parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. data were analyzed by kruskal-wallis, and anova tests.

Eligibility criteria:
inclusion criteria: * vital mandibular molar tooth * diagnosis of symptomatic irreversible pulpitis exclusion criteria: * younger than 18 years old * history of significant medical conditions * allergies to local anesthetics or sulfites * pregnancy * taking any medications that might influence anesthetic assessment * active sites of pathosis in area of injection * inability to give informed consent

Keywords: gow-gates nerve block inferior alveolar nerve block local anesthesia molar pulpitis
metabolic changes induced by a very low carbohydrate diet in youth with type 1 diabetes

Conditions: Type1diabetes, Low Carbohydrate Diet

Summary: as more adolescents with type 1 diabetes (t1d) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric t1d population. this work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with t1d.

the primary objective of this randomized crossover study is to determine whether a very low carbohydrate diet improves glycemic changes (measured by continuous glucose monitors) when compared to a standard carbohydrate diet in youth with type 1 diabetes. the secondary objectives of the study are to compare metabolic changes after 2 weeks on each diet using the 2-step hyperinsulinemic euglycemic-hypoglycemic clamp and stable isotope infusions. the euglycemic portion of the clamp will allow us to determine the hepatic glucose production and adipose tissue lipolysis. secondary objectives also include measuring the neurohormonal response to hypoglycemia after 2 weeks on each diet.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes for at least 1 year * hemoglobin a1c level \< 10% within the past 2 months * provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is \<18 years old. * stated willingness to comply with all study procedures and availability for the duration of the study * all sexes are eligible * diagnosis of type 1 diabetes for at least 1 year * insulin pump use for at least 2 months. * ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal. * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention. * for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner exclusion criteria: * current use of glucose-lowering agents other than insulin * unstable psychiatric disorders, including eating disorders * weight loss medications within the last 6 months * pregnancy or lactation, or planning pregnancy within the next 6 months * bmi \< 19 kg/m2 for individuals 18 years of age or older * bmi \< 5%ile for individuals under 18 years * weight less than 49 kg or 108 pounds * other medical conditions that may interfere with glucose metabolism and insulin sensitivity
transient circulatory support in cardiogenic shock

Conditions: Acute Cardiogenic Shock

Summary: the purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (tcs) in cardiogenic shock is relevant. tcs is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. some studies described patients with tcs in order to establish mortality predictive scores (encourage, save), but no study has assessed the clinical relevance of the tcs decision yet. therefore, the investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once tcs implantation was decided or not by the heart team.

this french multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (tcs) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment. all patients with cardiogenic shock for whom indication of tcs was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study. two groups of patients are defined: * patients with cardiogenic shock treated by medical treatement * patients with cardiogenic shock treated by tcs (extracorporeal circulatory life support and/or impella). the main objective is to compare mortality between the 2 groups. secondary objectives are icu follow-up characteristics and quality of life questionnaire at day 180. statistical analysis will include a propensity-matched method to compare the groups to avoid confounding factors. the number of necessary subjects (n=240, 120 in each group) was calculated assuming that tcs has a superiority of 20% in comparison with medical treatment in severe cardiogenic shock, with a study power of 80%, and an alpha risk of 5%.

Eligibility criteria:
inclusion criteria: * cardiogenic shock : • systolic bp\<90mmhg despite adequate filling pressure * or need of cathecolamines to maintain sbp \> 90mmhg * signs of right-sided and/or left-sided congestion * signs of tissue hypoperfusion : oliguria, cold sweated extremities, mental confusion, dizziness, narrow pulse pressure, blood lactate \> 2 mmol/l * short-term mechanical circulatory support discussed by the multidisciplinary heart team exclusion criteria: * post cardiotomy cardiogenic shock * refractory cardiac arrest * cardiac arrest with no flow \>3 min and/or non shokable rythm * contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation * pregnant or brest-feeding women, * age \< 18 year-old

Keywords: human, adult, intensive care unit, cardiogenic shock, transient circulatory support, extra corporeal life support impella
exercise intensity, metabolic rate and insulin sensitivity

Conditions: Healthy Women

Summary: the primary goal is to test the hypothesis high interval exercise increases energy expenditure and insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. secondary goals are to evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise. a secondary study is designed to evaluate potential mechanism. hypotheses are that changes in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be increased following the high intensity interval exercise. in addition, these changes will be related to changes in insulin sensitivity and increases in protein metabolism and muscle damage.


Eligibility criteria:
inclusion criteria: * healthy premenopausal african-american or caucasian women ages 19 - 42 exclusion criteria: * subjects cannot be smoking, * taking medications which alter energy expenditure or fuel utilization, * be diabetic or have a body mass index (bmi) less than 18 or more than 35. * also subjects cannot be pregnant or have cardiopulmonary disease.

Keywords: exercise intensity metabolism insulin
adjuvant acupuncture for severe head injury

Conditions: Head Injury

Summary: the purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. a double-blind clinical trial is conducted up to 6 weeks and the change of subjects' glasgow coma scale (gcs) and muscle power is measured.

objective: to investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment. methods: 90 subjects aged 12 to 70 years with severe head injury (glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. we use restoring consciousness acupuncture (gv26 and 12 well points) to treat the subjects 3 sessions per week under conventional treatment at department of neurosurgery. a double-blind clinical trial is conducted up to 6 weeks and the change of subjects' gcs and muscle power is measured.

Eligibility criteria:
inclusion criteria: * subjects aged 12 to 70 years with severe head injury (glasgow coma scale score 8 or less) * with informed consent exclusion criteria: * dilated pupils without light reflex * serious complications during therapeutic course * interruption of therapeutic course * unfavored condition assessed by physician in charge * without informed consent

Keywords: acupuncture; laser acupuncture; traumatic brain injury
prospective trial to reduce morbidity and mortality after lung surgery in patients with reduced pulmonary capacity

Conditions: Respiration Disorders

Summary: a fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with fev1 \< 70% of expected value or \< 1.5l who undergo resections of the lung.


Eligibility criteria:
inclusion criteria: * resection of the lung * fev1 \<70% of expected value or below 1.5l * 18-80y * given written informed consent exclusion criteria: * contraindication for epidural anesthesia * prio ipsilateral thoracotomy * chemotherapy \<6 weeks prior to study enter * existing pneumonia (fever, elevated wcc, elevated crp)

Keywords: lung resection reduced pulmonary function
no treatment versus oral ibuprofen treatment for patent ductus arteriosus in preterm infants

Conditions: Bronchopulmonary Dysplasia (BPD)

Summary: the purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. the study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)

this study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.

Eligibility criteria:
inclusion criteria: 1. gestational age of 30 weeks or less or birth weight of 1250 g or less 2. born in samsung medical center 3. confirmed to have hemodynamically significant patent ductus arteriosus (pda) during day of life (dol) 5 to 14 4. definition of hemodynamically significant pda: ductal size ≥ 1.5 mm with left-to-right shunt (or bidirectional shunt with dominant left-to-right blood flow) on the initial echocardiography plus at least one of clinical criteria. * clinical criteria * respiratory signs, including tachypnea, chest retraction, increased respiratory support, unable to wean respiratory support * physical signs, including a murmur, hyperdynamic precordium or bounding pulses * blood pressure problems, including decreased mean or diastolic pressure or increased pulse pressure * signs of congestive heart failure, including cardiomegaly, hepatomegaly or pulmonary congestion exclusion criteria: * mortality within the first 48 hours of life * ductal size \< 1.5 mm on the initial echocardiography * right-to-left shunt or bidirectional shunting with dominant right-to-left shunt through pda * congenital anomaly * bilateral intraventricular hemorrhage of grade 4 * contraindication of ibuprofen (bleeding diasthesis, platelet count 10,000/mm3 or less, serum creatinine 2.0 mg/dl or greater, necrotizing enterocolitis stage 2 or greater

Keywords: patent ductus arteriosus ibuprofen bronchopulmonary dysplasia
trauma-informed procedural pain intervention: refinement of an evidence-based protocol

Conditions: Procedural Pain; Cancer-related Pain

Summary: the trauma-informed procedural pain intervention (tippi-r) has been developed as a standardized way to provide education and teach evidence-based strategies for managing pain and distress that may occur during pediatric cancer treatment. the purpose of this clinical trial study is to test how helpful tippi-r is in supporting children and families manage pain and distress during the initial stages of cancer treatment. the main questions this study aims to answer are: * does tippi-r increase use of helpful pain coping strategies for pediatric cancer patients? * does tippi-r help lower perceived pain intensity during initial stages of cancer treatment? * does tippi-r increase patient and family confidence in coping with pain and distress during cancer treatment? researchers will compare pain experiences and use of pain coping strategies for families who receive the tippi-r intervention and families who receive standard of care to see if tippi-r decrease pain and distress during the initial stages of cancer treatment. participants will: * complete surveys to measure pain and distress within 5 weeks of initial diagnosis (time 1) * either receive the tippi-r intervention or standard of care * complete surveys to measure pain and distress 4 weeks after initial consent or tippi-r intervention delivery (time 2)


Eligibility criteria:
inclusion criteria: * patient is receiving treatment at norton children's cancer institute, norton children's hospital, university of kentucky children's hospital or danceblue clinic. * patient has been diagnosed with an oncology diagnosis. * patient and family are english-speaking. * patient is between the ages 0-18. exclusion criteria: * families not proficient in english. * patient is 19 years or older. * patient is not receiving treatment at norton children's cancer institute, norton children's hospital, university of kentucky children's hospital or danceblue clinic. * patient does not have an oncology diagnosis. * patient and family have any cps involvement.
hiv prevention for youth with severe mental illness

Conditions: HIV Infections

Summary: this 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a randomized interventions trial, project style: "hiv prevention for youth with severe mental illness" (r01, mh 63008). extending the follow-up from one year to 36 months will 1) discern the long-term impact of the project style interventions and 2) permit complex modeling of the predictors and trajectories of sexual health (delay of sex) and risk (incident stis). adolescents, particularly those in mental health treatment, are at risk for hiv because of sexual and substance behaviors. parent-child communication about sexual topics and parental supervision are associated with delays in the onset of sexual activity and more responsible sexual behavior; thus, the parent project, project style, is a randomized trial that is evaluating the comparative efficacy of three interventions: a) family-based hiv prevention intervention, b) adolescent-only hiv prevention intervention, and c) general health promotion intervention. this multi-site project (rhode island hospital, emory university, and the university of illinois at chicago) is enrolling an ethnically/racially/geographically diverse group of 750 adolescents in outpatient mental health treatment and their parents. subjects receive a full day group intervention on the day of randomization, return in two weeks for an individual session, participate in a half day booster session three months later, and are assessed six and 12 months after the intervention. this application offers a unique opportunity to assess this already ascertained sample at three additional points (24,30, and 36 months). this is important because few studies have examined the longer-term predictors of the delay of sex and incident stis over 36 months using a comprehensive array of family functioning, family monitoring/communication, and trauma history. additionally, this continuation will provide important data concerning the long-term impact of project style's theoretically based hiv prevention programs which are designed to maintain safe sexual behaviors. the family-based program has increased parent/adolescent sexual communication and reduced adolescent unprotected sex after six months and extended assessment will determine whether these benefits are maintained over time.


Eligibility criteria:
inclusion criteria: * adolescent in mental health treatment * living with parent/caregiver past 3 months exclusion criteria: * adolescent is hiv positive * adolescent is pregnant

Keywords: hiv prevention hiv seronegativity
arthroscopic partial trapezictomy with hematoma distraction in basal thumb arthritis

Conditions: Orthopedic Disorder

Summary: the basal joint, also referred to as the carpometacarpal (cmc) joint, of the thumb is one of the joints most commonly affected by arthritis. cmc joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living

the thumb cmc joint has been reported as the most painful joint when compared to other hand joints affected by oa. it is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door knob, this pain may be reproduced by resisted pinch and grip . on physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal cmc dislocation subluxation .

Eligibility criteria:
inclusion criteria: * age: adult patient \> 20years. * gender: males \& females. * symptomtic patient. * failed conservative treatment of 6 months duration * eaton stage ii, iii and iv of base thumb arthritis exclusion criteria: * patient presenting with flexor carpi radialis rupture * previous zancolli arthroplasty * associated comorbidity as: ra,dm with joint destruction * infection * poor skin condition * active pateint with high joint demand