Kornimate/medical-research-clean huggingface dataset:
study safety/efficacy of ambisome loading dose regimen versus standard ambisome regimen for initial treatment

Conditions: Invasive Aspergillosis; Other Fungal Infections

Summary: to evaluate and compare two ambisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified eortc criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.

to evaluate and compare two ambisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified eortc criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment. determine and compare the following parameters for the two treatment arms: * safety and tolerability * survival rates and the rates of infection relapse at 4 weeks post treatment. * survival rate at 12 weeks after study entry. * time to favorable overall response and time to end of treatment for patients with favorable overall response. * cumulative dose of study drug given through end of treatment.

Eligibility criteria:
inclusion criteria: * immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, hiv infection, prolonged corticosteroid therapy (greater than or less than 20 mg of prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for ifi. evidence of proven, probably or possible iffi by modified eortc criteria. continued treatment with study drug is contingent upon confirmation of diagnosis of proven or probable ifi within 4 working days after study entry. exclusion criteria: * life expectancy of less than 30 days; chronic ifi (defined as signs/symptoms of ifi present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented ifi. use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (uln), serum alt or ast less than 5 x uln; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.
endoscopic cyclophotocoagulation in normal tension glaucoma

Conditions: Normal Tension Glaucoma; Cataract

Summary: the purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.

subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. all patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.

Eligibility criteria:
inclusion criteria: * signed informed consent * normal tension glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (oct) and possible equivalent visual field defects, iop never more than 21 mmhg, and open anterior chamber angle * glaucoma stable with current medication assessed by a glaucoma specialist * clinically significant cataract exclusion criteria: * secondary glaucoma e.g. due to previous injury or uveitis * exfoliation syndrome * pigment dispersion syndrome * previous transscleral or endoscopic cyclophotocoagulation * previous other glaucoma surgery * cataract due to eye injury or congenital cataract * zonular weakness due to marfan syndrome or other * previous retinal detachment * previous intraocular surgery like vitrectomy and other retinal surgery * wet age-related macular degeneration * diabetic retonopathy * previous corneal transplant or previous refractive surgery * fuchs' dystrophy and other abnormalities compromising corneal clarity like scars * the patient does not want to participate in the study * the glaucoma progresses on current iop * the patient does not speak finnish, swedish or english * dementia * only eye with vision worse than 20/200 or loss of central visual field

Keywords: endoscopic cyclophotocoagulation ecp surgery
diagnosis of sarcopenia in older adults

Conditions: Sarcopenia

Summary: sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. given the aging of the french population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass. in its recommendations, french national authority for health recommends the use osteodensitometry and bioimpedance analysis (bia) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. traditionally, bia assessment is performed while lying down using adhesive electrodes placed on the hands and feet. the biody xpertzm3 is a bia device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. however, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer


Eligibility criteria:
inclusion criteria: * men or women aged 60 or over already receiving care at the day hospital of the rehabilitation, independence and aging center or the frailty platform of the rehabilitation, independence and aging center. * patients affiliated with or covered by a social security system. * patients who have signed an informed consent form in advance. exclusion criteria: * vulnerable persons as defined in articles l1121-5 to -8 * people with pacemakers, implantable defibrillators, or other electronic medical devices * musculoskeletal disorders that prevent bioimpedance measurement in a seated position * any condition of fluid retention or dehydration * absence of a measurement site (muscle resection or amputation)

Keywords: sarcopenia elderly bioimpedance analysis osteodensitometry
frequency of occurrence and risk factors of postoperative nausea and vomiting during elective c-section under spinal anesthesia with preventive medication

Conditions: Nausea and Vomiting, Postoperative; Cesarean Delivery; Spinal Anesthesia; Antiemetic Therapy

Summary: the aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia. the main question it aims to answer is : what are the incidence and risks factors of postoperative nausea and vomiting (nv) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ? patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about nv in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.


Eligibility criteria:
inclusion criteria: any patient requiring elective caesarean section under spinal anesthesia, at a gestational age \>37 weeks of amenorrhea in the context of a single-fetal pregnancy. exclusion criteria: failure to understand the french language; contraindication to locoregional anesthesia; nausea and/or vomiting in the 24 hours preceding the procedure; type 1 or type 2 insulin-requiring non-gestational diabetes; allergy or contraindication to one of the products used in the usual management protocol; severe preeclampsia; height \<150 cm
the effectiveness of biofeedback treatment in constipated patients with idiopathic parkinson's disease

Conditions: Idiopathic Parkinson's Disease; Constipation

Summary: the aims of the investigators' study are to characterize the nature of constipation in idiopathic parkinson's disease (ipd) and to evaluate the usefulness of biofeedback therapy in constipated ipd patients.

the medical treatment of idiopathic parkinson's disease (ipd) alleviates constipation symptoms due to the restoration of autonomic dysfunction. however, additional laxatives are usually needed in these patients. other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. biofeedback therapy (bft) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. however, researchers have not tried to evaluate its usefulness in constipated ipd patients up to now. the aims of our study are to characterize the nature of constipation in ipd and to evaluate the usefulness of bft in constipated ipd patients.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease exclusion criteria: * secondary parkinson's disease

Keywords: biofeedback constipation parkinson's disease
pharmacogenomics of drug safety in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to investigate whether genotypic differences can be identified between ms patients developing 'liver injury' (defined as alt levels five times the upper normal limit and above) compared to those not developing liver injury after exposure to beta-interferon for ms.

purpose: to investigate whether genotypic differences can be identified between ms patients who develop liver injury compared to those who do not develop injury in response to beta-interferon therapy. objective: to determine whether elevated liver enzyme tests (alt \> 5 times the upper limit of normal) in response to beta-interferon therapy in ms patients is associated with genetic polymorphisms. method of recruitment: patients will be identified through a clinic database and chart reviews. an introductory letter will be mailed to potential participants, inviting them to volunteer. a follow-up phone call will be made to determine interest and consent into study. procedures: saliva will be collected for genetic analyses and a questionnaire will be administered

Eligibility criteria:
inclusion criteria: cases and controls must have * definite ms (poser or mcdonald criteria) * relapsing-remitting or secondary-progressive disease course * prescribed a beta-interferon as their immunomodulatory drug for ms exclusion criteria: * primary-progressive ms * an elevated liver test result within 6 months of starting beta-interferon treatment * presence of a co-morbidity that is a known risk-factor for liver injury

Keywords: genetics genomics multiple sclerosis beta-interferons
insulin resistance and hypertensive disorders in pregnancy

Conditions: Hypertension in Pregnancy; Diabetes Mellitus in Pregnancy

Summary: the purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.


Eligibility criteria:
inclusion criteria: * pcos, bmi\>/=30 * previous pregnancy affected by hypertension or gestational diabetes * thrombophilia * type i or ii diabetes mellitus * autoimmune diseases * twin pregnancy * renal diseases * previous pre-eclampsia in relatives

Keywords: pre-eclampsia gestational diabetes insulin resistance hypertension in pregnancy
changes of microbiota in irritable bowel syndrome patients

Conditions: Mucosa Associated Bacteria in Small Intestine

Summary: to investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract


Eligibility criteria:
inclusion criteria: * case group: 20 to 80 years old irritable bowel syndrome patients * control group: 20 to 80 years old healthy subjects exclusion criteria: * without writtent informed consent * contraindications for enteroscopy
genetic association study between single nucleotide polymorphisms (snps) and cognitive performance in young bipolar type i patients: licavalgene

Conditions: Bipolar

Summary: this is a genetic association study of cognitive impairment in young bipolar disease type i patients without medications in mania, depression, hypomania or mixed states.

introduction: cognitive impairment in bipolar disease (bd) patients is common and recent data suggests that it may be an endophenotype of the disease as it differs individually, persists during periods of euthymia and co segregates in families of bd patients. cognition is a complex trait and is therefore likely to be underpinned by many genes, each with a relatively small effect. performance in each domain of the neuropsychological assessment can be statistically linked to the functional activity of particular protein and by extension to the genetic variants accounting for theses functional differences. methods: 80 patients with bd type i (scid dsm-iv), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for comt (val158met, rs165599, -287, rs737865), apoe (epsilon 4) and bdnf (val66met)and 80 healthy controls.

Eligibility criteria:
inclusion criteria: * bd type 1 * non euthymia * 18-35 y.o. exclusion criteria: * pregnancy * organic disease * use of drugs * schizophrenia * mental retardation * illiterate

Keywords: comt apoe bdnf executive function bipolar cognition cognitive deficits and bipolar disease type i
nasal mask kit in gastrointestinal endoscopy

Conditions: Hypoxia; Gastric Cancer; Gastric Polyp; Colon Polyp; Colon Cancer; Esophageal Cancer

Summary: hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. the nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.the aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.


Eligibility criteria:
inclusion criteria: * 18≤ age ≤60 * patients undergoing combined gastroendoscopy and colonoscopy procedure * patients signed informed consent form * asa classification i-ii * estimated procedure time \<=45min exclusion criteria: * coagulation disorders or a tendency of nose bleeding * diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) * diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy) * hypoxia (spo2\< 90 % ) * upper respiratory tract infection * increased intracranial pressure * fever (core body temperature \>37.5 ℃) * pregnancy, breastfeeding, or positive pregnancy test * emergency procedure or surgery * multiple trauma * allergy to propofol or tape and adhesives * bmi\ 30

Keywords: nasal mask hypoxia gastrointestinal endoscopy propofol capnographic monitoring
long term safety and tolerability of sr58611 in patients with major depressive disorder

Conditions: Major Depressive Disorders

Summary: primary objective: - to evaluate the long-term safety and tolerability of sr58611a (amibegron) patients with major depressive disorder (mdd). secondary objective: - to determine plasma concentrations of sr58878 (the active metabolite of sr58611a), for pharmacokinetic population analyses, to evaluate the quality of life (qol) in patients with mdd, and to evaluate the efficacy of amibegron in patients with mdd.


Eligibility criteria:
inclusion criteria: * patients as defined by diagnosis and statistical manual of mental disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of \> 18 on the hamilton depression rating scale (ham-d) 17-items.

Keywords: depression
efficacy of osteopathic treatment on the side effects of curative treatments of lymphoblastic leukemia in pediatrics

Conditions: Lymphoblastic Leukemia

Summary: during the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient. osteopathy is an exclusively manual practice whose goal is to compensate for mobility dysfunctions of the tissues of the human body. it can be used as a complementary treatment for cancer pain when pain medications are not enough. the aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia.

during the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient. osteopathy is an exclusively manual practice whose goal is to compensate for mobility dysfunctions of the tissues of the human body. it can be used as a complementary treatment for cancer pain when pain medications are not enough. the aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia. primary objective : to evaluate the effectiveness of five osteopathy sessions at regular intervals on the characteristics of the pain felt in patients aged 1 to 10 years treated for acute lymphoblastic leukemia using the heden scale (hetero-evaluation pain child).

Eligibility criteria:
inclusion criteria: * patient managed and treated with a diagnosis of acute lymphoblastic leukemia * patient between 1 and 10 years of age * patient with pain at inclusion, or pain at diagnosis related to leukemia * social security affiliation or entitlement * signature of informed consent by both parents exclusion criteria: * no pain reported at the time of management or diagnosis * surgery less than 30 days old * patient with another contraindication to osteopathic treatment (worsening of the condition, bleeding syndrome), or a psychiatric pathology that prevents the scales from being used.

Keywords: osteopathy
the effect of wound irrigation with irrisept™ delivery system on abscess healing in patients presenting to the emergency department

Conditions: Abscess

Summary: the purpose of this study is to determine if wound cleansing and irrigation using the irrisept chlorhexidine gluconate(chg)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.


Eligibility criteria:
inclusion criteria: * immunocompetent individuals 12 years of age or older with an uncomplicated abscess * patient must be able to answer questions and be medically stable as defined by the emergency department physician * patient must voluntarily participate in the study exclusion criteria:patients with any of the following are excluded: * currently receiving antibiotics or received antibiotics within last 72 hours * evidence of systemic infection (fever, aches, chills, nausea) * requires admission to the hospital for infection or for any other reason(s) * abscess caused by a human or animal bite * prior history of hypersensitivity or allergy to chlorhexidine gluconate (chg) * immunodeficiency (examples: hiv positive, crohns disease, systemic lupus erythematosus, addison's disease, psoriasis, splenectomy, leukemia, cancer on chemotherapy) * currently on any immune-modifying medication (examples: prednisone, antivirals) * history of chronic skin infection (3 or more in the past year) * chronic medical problem, for example end-stage heart, liver, kidney, or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant * mental illness including but not limited to substance abuse, dementia, schizophrenia or mentally handicapped or challenged * incarcerated * patient is pregnant or thinks she may be pregnant

Keywords: abscess wound irrigation wound debridement wound healing incision and drainage chlorhexidine
carbon monoxide hyperbaric oxygen with steroid therapy

Conditions: Carbon Monoxide Poisoning; Carbon Monoxide Intoxication; Carbon Monoxide Encephalopathy; Carbon Monoxide-induced Parkinsonism

Summary: hyperbaric oxygen therapy (hbo) is routine treatment of carbon monoxide (co) poisoning to prevent delayed neurological sequelae. this study looking to see if neurologic outcomes are improved with the addition of dexamethasone. co poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. in other demyelinating disorders, steroids are a part of first line treatment. hbo is already used for acute co poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

hyperbaric oxygen therapy (hbo) is routine treatment of carbon monoxide (co) poisoning to prevent delayed neurological sequelae. this study looking to see if neurologic outcomes are improved with the addition of dexamethasone. co poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. in other demyelinating disorders, steroids are a part of first line treatment. hbo is already used for acute co poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes. the control group will receive three hbo treatment sessions plus placebo. the treatment group will receive three hbo treatment sessions plus 10 mg dexamethasone per day during hbo therapy (minimum of two doses, up to a maximum of five doses if participant stays for longer than three days). after three treatment sessions, the participant will be discharged home barring no other medical complications requiring further hospitalization. in two weeks, participants will return for follow-up testing and evaluation. continued hbo therapy plus placebo as well as hbo therapy plus steroids for respective group members will be offered if participants are still dealing with co poisoning sequelae as determined by our outcome measures. in addition, a 6 week and 12 week telephone follow-up will be conducted asking questions regarding memory, emotion, neurologic symptoms.

Eligibility criteria:
inclusion criteria: * acute co poisoning, intentional or non-intentional exposure, receiving hbo treatment during hospitalization * age \>18 years * nebraska medicine admission exclusion criteria: * mechanical ventilation * no hospital admission or admission to hospital critical care medicine service * allergy to dexamethasone * pre-existing neurological condition confounding outcome determination