Kornimate/medical-research-clean huggingface dataset:
pioglitazone add-on study in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus (t2dm) * patient is 18 years of age (or older) * patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period exclusion criteria: * patient has a history of type 1 diabetes mellitus or a history of ketoacidosis * patient required insulin within the prior 8 weeks * patient is on a weight loss program and is not in the maintenance phase * patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks * patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate) * patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease * patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis) * patient has any of the following disorders within the past 6 months: acute coronary syndrome (e.g., mi or unstable angina), coronary artery intervention, stroke or transient ischemic neurological disorder. * patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months * patient has severe peripheral vascular disease * patient has congestive heart failure * patient is hiv positive * patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) * patient has a history of neoplastic disease * patient has a history of alcohol or drug abuse within the past 3 years * patient has viral hepatitis (hepatitis b or c)
digital single session intervention for youth mental health

Conditions: Anxiety; Depression; Conduct Disorder; Stress

Summary: the aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.

there is a massive unmet need for youth mental health care in america; only ¼ of youth in need receive services. the problem has been underscored and exacerbated by the pandemic. the need for child and adolescent mental health care, particularly for depression and anxiety, has surged while clinician availability and clinic funding have shrunk. one result is that clinic waitlists, always lengthy, have stretched, with youths and families who seek care waiting for up to 12 months for a first appointment, and many giving up and dropping out before the much-delayed appointment. there is a clear need-in both pandemic and normal times-for efficient mental health support that can be provided when need is acute, to sustain young people through periods of delayed access, and to reduce burden for professionals. fortunately, recent evidence shows the surprising potential of brief, low-cost, digital interventions that could go a long way toward bridging the need-to-access gap. single-session interventions have substantial effects, in some cases rivaling effects of full-length in-person psychotherapy. remote therapies for youth mental health problems are beneficial on average and approximately as beneficial as in-person psychotherapy. the current trial will test a brief (one 30-45-minute session), online, interactive mental health and behavior change intervention for adolescents (9-17 years old), who have been placed the waitlist for outpatient treatment at participating mental health clinics in the united states. previous rcts show beneficial effects of the principle of practicing the opposite (pto) on youth mental health when using the therapeutic elements present in pto (e.g., exposure, to overcome anxiety; behavioral activation, to overcome depression). the single-session pto intervention uses stories, interactive activities, and engaging graphics to teach youths a key principle: by practicing the positive opposite of unhelpful behaviors, one can, over time, change their emotions thoughts, and actions.

Eligibility criteria:
inclusion criteria: * youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist. * youth is between the ages of 9-17 years (inclusive) at the time of study enrollment. * youth and at least one guardian consent to the youth's participation in study. * youth reads english well enough to effectively complete the digital programs (defined as taking classes in english, as opposed to esl classes). * youth has access to a digital device. exclusion criteria: * youth is non-english speaking, as the program is only available in english. * youth does not have access to a digital device.
serum s100b protein assay in mild head injury

Conditions: Light Head Injury

Summary: head injuries are a major public health issue, with an estimated annual incidence in europe of 262 per 100,000 population. light head injury (sci), defined by a glasgow score between 13 and 15, constitutes the majority (71% to 98%) of head injury cases. despite a generally good prognosis, patients with tcl have a low but real risk of brain damage, whose prevalence is estimated at 5%. cerebral computed tomography (ct) because of its high sensitivity for the detection of posttraumatic intracranial lesions (lic), is currently considered the gold standard for the diagnosis of these lesions in patients considered at risk after clinical evaluation. the number of ctcts performed is high with no lesion in more than 90% of cases. the s100b protein, a marker of brain tissue damage, is reported to reliably exclude the presence of brain lesions in adults as well as antiaggregants. these numerous studies show that its serum assay in combination with the clinical decision algorithms allows, thanks to a sensitivity close to 100% for brain lesions, to reduce the number of ctmc currently prescribed by approximately 30%, and therefore to decrease unnecessary exposure to radiation. although there is no study on the subject, a gain on the duration of care in emergencies can be expected as well as a reduction on the cost of care by a dosage price three times less higher than the tdmc. expert opinion for the use of this assay in the management of moderate-risk tcl at threshold ≤ 0.10 μg / l in 3h post-tc to ensure sensitivity of 100%, was published in 2014 in the annales françaises de médecine d'urgence. the use of anticoagulants has continued to increase in recent years. in 2013, it is estimated that 3.12 million patients received at least one anticoagulant in france. currently, the international and french recommendations indicate the achievement of ctct in anticoagulated tcl because it is an independent risk factor for cerebral injury and is therefore considered to be a high risk tcl. lic. the hypothesis of this study is that the s100b protein assay could also exclude the presence of brain lesion after tcl under anticoagulation in adults


Eligibility criteria:
inclusion criteria: * major patient * emergency department patient with mild head trauma (13 ≤ glasgow score ≤ 15) * affiliated to the social security scheme * patient having been informed about the study and do not disagree to participate * patient on anticoagulant therapy (enteral or parenteral route) exclusion criteria: -
decitabine in patients with chronic myelomonocytic leukemia (cmml)

Conditions: Chronic Myelomonocytic Leukemia

Summary: the aim of this study is to determine the therapeutic efficacy of decitabine in patients with chronic myelomonocytic leukemia (cmml) diagnosis according to who criteria either untreated or previously treated with hydrea or etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.


Eligibility criteria:
inclusion criteria: * age 18 or older * cmml diagnosis according to who criteria * stable excess in blood monocytes,\>1x10g/l and \>10% of wbc * bone marrow blasts \<20% * dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation * with: * if wbc \< or= 12 000/mm3: ipss high or intermediate 2 * if wbc \> 12 000/mm3: at least two of the following criteria: blast cells \> 5% in the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13), anemia (hb \ 5 cm below costal margin, extramedullary localization * either untreated or previously treated with * hydrea or etoposide given orally * non intensive chemotherapy * intensive chemotherapy given more than 3 months before inclusion * with performance status 0-2 on the ecog scale * with estimated life expectancy of at least 12 weeks * with adequate organ function including the following: * hepatic: total bilirubin \< 1.5 times upper limit of normal (uln), alanine transaminase (alt) and aspartate transaminase (ast) \< 3 times uln * renal: serum creatinine \ 30 ml/min * with informed consent * negative pregnancy and adequate contraception if relevant exclusion criteria: * myeloproliferative/myelodysplastic syndrome other than cmml * acute blastic transformation of cmml with bone marrow blasts\>20% * patients eligible for allogenic bone marrow transplantation with identified donor * cmml with t(5;12) or pdgfbetar rearrangement that could receive imatinib * previous treatment with a hypomethylating agent * age \< 18 years old * pregnancy or breastfeeding * performance status\> 2 on the ecog scale * estimated life expectancy \< 12 weeks * serious concomitant systemic disorder, including active bacterial, fungal or viral infection, that in the opinion of the investigator would compromise the safety of the patient and/or his/her ability to complete the study

Keywords: decitabine, chronic myelomonocytic leukemia
epidemiology study of malaria transmission intensity in africa

Conditions: Malaria; Malaria Vaccines

Summary: the aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (nct00866619).

this study is a multicenter epidemiology study at centers that are participating in gsk's pivotal phase iii candidate malaria vaccine 110021 ( nct00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission. there will be no study vaccine administered in this epidemiology study.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * a male or female 6 months or older at the time of survey. * written informed consent obtained from the subject/from the parent(s)/ legally acceptable representative(s) of the subject. exclusion criteria: * child in care. * previous or current participation in any malaria vaccine trial.

Keywords: malaria plasmodium falciparum
data analysis for drug repurposing for effective alzheimer's medicines (dream) - tnfi vs abatacept

Conditions: Rheumatoid Arthritis

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/11fiivboto16gyb_1xm8axnhn-ec4v7tilzcjpbbxf0q/edit?usp=sharing or appendix a for full code and algorithm definitions. medicare timeframe: 2007 to 2017 (end of data availability). inclusion criteria: * 1. no prior use of tumor necrosis factor inhibitors or abatacept anytime prior to cohort entry date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. no prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date * 3. prior history of nursing home admission in the 365 days prior to the cohort entry date
the efficacy of oregano essential oil in reducing oral halitosis

Conditions: Halitosis

Summary: the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and bana test scores compared to placebo

the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis

Eligibility criteria:
inclusion criteria: 1. organoleptic score was \>2 at baseline. 2. participants between 18-23 years of age. 3. the subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy. 4. the subjects did not receive the same time treatment for their halitosis. exclusion criteria: 1. smokers, alcoholics and drug addicts. 2. patients with periodontitis or pocket depth \>6 mm. 3. patients taking drugs which induced xerostomia. 4. subjects consuming spicy food: garlic or onions two days before examination. 5. patients with orthodontic appliances or removable dentures. 6. pregnancy

Keywords: oral halitosis oregano essential oil mouthwash
"efficacy of hybrid systems ("topping off") versus rigid spinal fusion in lumbar fusion surgery: a dual-center, prospective, randomized pilot study ("cd horizon balanc")"

Conditions: Spine Surgery

Summary: effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: a prospective, randomized, bicentric pilot study ("cd horizon balanc™)

posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (cd horizon balanc™ manufacturer: medtronic) control: posterior spondylodesis and monosegmental intervertebral cage

Eligibility criteria:
inclusion criteria: * informed consent * legal capacity * age ≥ 30 years * indication for monosegmental lumbar spine fusion (plif or "topping-off ") l2-s1 with osteochondrosis modic grades i-iii \[20\]\[21\]\[22\] or spondylolisthesis meyerding grades i-iii. * radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability exclusion criteria: * motor deficit * cauda equina syndrome * previous surgical intervention of the lumbar spine * relevant peripheral neuropathy * acute denervation subsequent to a radiculopathy * scoliosis with cobb angle greater than 25° * spondylolisthesis \> meyerding grade iii * radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria) * no radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria) * radiologic signs of degeneration in the adjacent segment of the intended fusion with \>fujiwara grade ii \[15\] or \>pfirrmann grade iv \[14\] * signs of instability in any lumbar spine segment other than that undergoing fusion * general contraindication for elective lumbar spine surgery * pathologic fracture * osteoporosis with pathologic fracture * active systemic infection * rheumatic disease * disease of bone metabolism (e.g. paget's disease) * bone metastasis * local infection focus lumbar spine * seizure disorder * chronic ischemia fontaine classification iib-iv * severe heart insufficiency (nyha iii-iv) * blood coagulation disorder or blood thinning therapy * cortisone intake more than one month in the last 12 months before randomization * simultaneous participation in another clinical trial in the 30 days before randomization * known allergy or intolerance to the implants * dependency on investigator * lack of familiarity with the german language * placement in an institution by governmental or juridical advice * absent legal capacity * pregnancy
postoperative pain management in patients undergoing intramedullary nail fixation after tibia and femoral fractures

Conditions: Femur Fracture; Tibial Fractures

Summary: the purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. this study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

the data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (group 1 vs. group 2). likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (group 3 vs. group 4).

Eligibility criteria:
inclusion criteria: 1. patients with tibial and femoral shaft fractures 2. patients undergoing intramedullary nailing 3. willing to participate in the protocol exclusion criteria: 1. chronic pain disorder (daily use of oral opioids) 2. allergy or hypersensitivity to non steroid anti-inflammatory drug 3. impaired renal, cardiac, or hepatic function 4. history of gastrointestinal bleeding or substance abuse

Keywords: opioid use post-operative pain analgesic use femur fracture tibia fracture intramedullary nailing
oral glyceryl triacetate (gta) in newborns with canavan

Conditions: Canavan Disease

Summary: canavan disease is caused by aspartoacylase deficiency. there is no treatment for the disease, but there is a food additive that includes acetate . we suggest an early treatment with acetate and a neurologic evaluation, including mri, after 4 months of treatment. in any case the treatment will be stopped at the age of 22 months, when myelinization is ended.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of canavan disease exclusion criteria: * age above 18 months

Keywords: babies with canavan disease
white matter hyperintensities burden in adult patients with cyanotic congenital heart disease: a pilot study

Conditions: Aging, Premature; Congenital Heart Disease; White Matter Hyperintensities

Summary: the study aims at investigating the role of cyanotic congenital heart disease (cchd) on brain aging. the investigators assume that due to congenital and acquired cardiovascular abnormalities, cchd patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.

white matter hyperintensities burden will be quantified through a semi-autamated software (itk-snap)

Eligibility criteria:
inclusion criteria: * for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not. * for the control group, being an healthy subject. exclusion criteria: * any contraindication to magnetic resonance imaging; * any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which: * inflammatory, infectious, demyelinating or dysmyelinating diseases of the cns; * ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae; * genetic diseases (whether mendelian or mitochondrial) of the cns; * cerebral amyloid angiopathy; * cadasil; * cerebral arteriovenous malformations; * primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision; * patent oval foramen; * being pregnant; * migraine with aura (bashir, lipton, ashina, \& ashina, 2013).
ultrasound versus fluoroscopy guided superior hypogastric plexus block in cancer bladder patients

Conditions: Pain, Chronic

Summary: pelvic cancer pain is a chronic condition related to the involvement of viscera, pelvic muscular structures or neural structures by tumor. the superior hypogastric plexus block is a sympathetic block used to treat pelvic visceral pain that is unresponsive to oral or parenteral opioids different approaches for superior hypogastric block as transdiscal approach, classic approach, posteromedial approach, ct guided approach and ultrasound anterior approach the ultrasound-guided superior hypogastric plexus neurolysis technique (anterior approach) is simple to perform. we believe this block can be useful in cancer patients who are having difficulty in lying prone, because it is a procedure performed in the supine position and it is less time-consuming. it also avoids the radiation exposure involved with a computed tomography-guided and fluoroscopy posterior approach.

aim of the study: to compare fluoroscopic guided transdiscal superior hypogastric block and ultrasound guided superior hypogastric block regarding their efficacy to control pelvic pain and statistical analysis: data will be described as mean ±sd or as frequencies (number of cases) and percentages when appropriate. comparison of numerical variables between two study groups will be carried out using parametric and non-parametric t- tests for independent samples. within group comparison of numerical variables was carried out using repeated measures anova. p values of less than 0.05 will be statistically significant. all statistical calculations are performed using statistical package for the social sciences (spss, version 23 for microsoft windows; spss inc., chicago, illinois, usa)

Eligibility criteria:
inclusion criteria: * age \> 20 years. * patients with advanced stage cancer bladder. * patient with severe pain (vas) 7 or more . * patients don't receive any strong opioids for pain at least 2 weeks exclusion criteria: * patient refusal. * local infection at the puncture site. * coagulopathy. * cognitive disorders. * unstable cardiovascular disease. * history of psychiatric disorders. * history of drug abuse. * patients allergic to medication used. * patients with any contraindications to drugs and dye used.

Keywords: fluroscopy and ultrasound shpb in cancer bladder
haloperidol prophylaxis in cardiac surgery for patients at risk for delirium

Conditions: Postoperative Confusion

Summary: will the use of prophylactic haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo bid administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by mrp.

Eligibility criteria:
inclusion criteria: * greater than or equal to 70 years of age, undergoing a median sternotomy or 60-69yrs of age with one or more of the risk factors: * tia/stroke; * euroscore greater than or equal to 5; * abnormal clock draw. exclusion criteria: * parkinsonism, * on any antipsychotic medications pre-op, * active delirium, * emergent surgery, * haloperidol allergy, * schizophrenia, * prolonged qtc.

Keywords: prevention delirium cardiac surgery