Kornimate/medical-research-clean huggingface dataset:
myometrial biopsy for the detection of infection

Conditions: Infection

Summary: this study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.

the infection is a dynamic process probably beginning shortly after the onset of labor. this process continues and is enhanced during active uterine contractions, which result in bacteria from the vagina being drawn up into the uterine cavity. during labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.

Eligibility criteria:
inclusion criteria: 1. patients must be afebrile throughout labor. 2. amniotic fluid must be not purulent; presence of meconium is not an exclusion. 3. patients undergoing an elective cesarean section. 4. patients who have labored with intact or ruptured amniotic membranes. exclusion criteria: 1. patient with a temperature of ≥ 100.4o f. 2. white blood cell count ≥ 24,000. 3. suspicion of chorioamnionitis. 4. suspicion of a urinary tract infection. 5. presence of diarrhea (defined \> 4 liquid stools in a 24 hour period). 6. patient currently taking therapeutic antibiotics.

Keywords: postoperative infection c-section
observational study of iron overload in stem cell transplantation

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

Summary: recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. however, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. therefore, the investigators are conducting a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.

as above.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histologically confirmed acute myeloid leukemia (aml), acute lymphoblastic leukemia (all), or myelodysplastic syndrome (mds) * planned allogeneic stem cell transplantation with myeloablative conditioning regimen (regardless of stem cell source or donor hla match) * patients will be eligible even if they have had prior stem cell transplantation (autologous or allogeneic) exclusion criteria: * contraindication to magnetic resonance imaging (mri): * patients with cardiac pacemakers, implanted cardiac defibrillator (icd), cardiac electrodes, pacing wires, internal electrodes, cochlear, otologic or other ear implants, metallic fragments or foreign body, metallic prosthesis. patients with surgical staples should not be imaged until 7 days post-op unless approved by a radiologist; * severe claustrophobia * note: a history of allergic reaction to gadolinium is not a contraindication to enrollment, as contrast will not be used. * inability to provide informed consent

Keywords: aml all mds iron overload
a study of bind-014 (docetaxel nanoparticles for injectable suspension) as second-line therapy for patients with kras positive or squamous cell non-small cell lung cancer

Conditions: KRAS Positive Patients With Non-small Cell Lung Cancer; Squamous Cell Non-small Cell Lung Cancer

Summary: bind-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-ki-ras2 kirsten rat sarcoma viral oncogene homolog (kras) mutation positive or squamous cell non-small cell lung cancer (nsclc) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.


Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age * diagnosis of nsclc with locally advanced or metastatic disease * positive for kras mutation or squamous cell histology * previously treated with one platinum-based chemotherapy * disease status must be that of measurable and/or evaluable disease * performance status of 0 to 1 on the ecog scale * prior chemotherapy completed at least 3 weeks prior to study enrollment * prior radiation therapy allowed to \< 25% of the bone marrow * patient compliance and geographic proximity that allow adequate follow-up * adequate organ function * patients with reproductive potential must use contraceptive methods * signed informed consent from patient exclusion criteria: * active infection * pregnancy or planning to become pregnant * breast feeding * serious concomitant systemic disorders * second primary malignancy * patients who are symptomatic from brain metastasis * presence of detectable (by physical exam) third-space fluid collections * more than 1 prior cytotoxic chemotherapy regimen for advanced disease * prior treatment with docetaxel * history of severe hypersensitivity reaction to polysorbate 80 * peripheral neuropathy at study entry * patients known to be hiv positive * patients known to be seropositive for hepatitis c hepatitis b * congenital long qt syndrome, congestive heart failure, or bradyarrhythmia
emotion regulation in preschoolers with autism and their parents

Conditions: Autism Spectrum Disorders

Summary: in the proposed study, the investigators would like to investigate the emotion regulation (er) strategies children with autism spectrum disorders (asd) demonstrate, and the influence parents have on their children's er. more specifically, the investigators would like to examine what are the er mechanisms that parents use, what mechanisms of self regulation children with autism internalize, and how parents support and improve the er capabilities of their child with asd. these will be studied in a behavioral level, using micro-analysis of parent-child interaction, and in a physiological level, using indexes of stress control and affiliation. in addition, in order for parental er support to be effective, it is important to consider more innate neuro-developmental difficulties children with asd demonstrate that strongly affect their ability to regulate themselves. these include sensory regulation difficulties, temperament, attention disorders and poor executive functioning. hypotheses: 1. er strategies used by children with asd will be more poorly developed and less effective, compared to those of children in the control groups. 2. difficult temperament and sensory regulation difficulties will hamper er in children with asd. 3. er strategies of parents of children with asd will be more poorly developed and less effective than those of parents in the control groups. 4. good parental self-er and parental attunement to the child will be predictive of improved er in children with asd, and in parent-child synchrony, both in the behavioral and in the physiological levels.


Eligibility criteria:
inclusion criteria: * for the study group:children diagnosed with asd * for the comparison group:children with typical development exclusion criteria: * for the study group:non verbal children. * for the comparison group: any major developmental disability.
evaluating the effects of information leaflets in adult aural rehabilitation

Conditions: Hearing Impairment

Summary: knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients. the primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations.


Eligibility criteria:
inclusion criteria: * adults (18-80 years old) with hearing aids from 2012 or later exclusion criteria: * hearing aids without possibility to have activated directional microphones and telecoil * non-swedish speaking (e.g. need interpreter)

Keywords: aural rehabilitation hearing aid functions hearing aid knowledge information leaflet visual aids
measurement of cerebral oxygen extraction fraction using mri technique

Conditions: Stroke

Summary: all images in this study were acquired on a 1.5 t sonata whole body scanner (siemens medical inc., erlangen, germany) using 2d multi-echo gradient echo/spin echo sequence and 2d single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. the quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

all images in this study were acquired on a 1.5 t sonata whole body scanner (siemens medical inc., erlangen, germany) using 2d multi-echo gradient echo/spin echo sequence and 2d single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. the quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Eligibility criteria:
inclusion criteria: * normal volunteer * stroke exclusion criteria: * who is unable receiving mri examination * pregnancy
an observational study of tarceva (erlotinib) in previously treated patients with advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (egfr) gene (wilt)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this prospective observational study will evaluate the efficacy and safety of second-line tarceva (erlotinib) in patients with previously treated advanced non-small cell lung cancer with confirmed wild-type epidermal growth factor receptor (egfr) gene. the aim of the study is to identify from baseline clinical and demographic patient characteristics prognostic factors related to overall survival with second-line tarceva treatment. data will be collected from eligible patients for up to 2 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (nsclc) * patients with known wild-type egfr gene; patients with unknown egfr mutation status are allowed if they fulfil the following criteria: * squamous cell carcinoma lung cancer histology, and * current smoker, or former smoker who has stopped smoking less than 10 years ago and has had a total of \>15 pack-years of smoking * eastern cooperative oncology group (ecog) performance status 0 to 2 * patients having failed one prior chemotherapy regimen and eligible for a second-line treatment with tarceva exclusion criteria: * current treatment with an investigational drug or participation in another investigational study * severe or uncontrolled systemic disease, active infection, concomitant malignancy or a second primary malignancy except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin * clinically active interstitial lung disease * recent myocardial infarction or unstable angina * progressive or uncontrolled brain metastases
nad-supplementation in drug naïve parkinson's disease

Conditions: Parkinson Disease; Neurodegenerative Diseases

Summary: 1. primary objective: determine if nr has an impact on the neurometabolic profile of patients with pd as measured by \[18f\]fluorodeoxyglucose (fdg)-positron emission tomography (fdg-pet). 2. secondary objective: determine whether high dose oral nr improves motor symptoms associated with pd. 3. tertiary objectives: determine whether high dose oral nr rectifies nad metabolism and increases nad levels in body fluids and muscle tissue.

individuals with pd (n=30) will be recruited starting 14/02/2019 from the department of neurology, haukeland university hospital. only newly diagnosed and drug naïve pd patients are eligible for inclusion. after initial assessment at baseline, the participants will be randomly assigned (1:1) to one of two study groups (n = 15 per group): nicotamide riboside (nr) 500 mg x 2/day, or placebo. participants and investigators will be masked to treatment group. participants and investigators will be blinded (double blinded). the study will have a 4 week exposure period, during which patients will self-administer nr 500 mg x 2/day, or placebo per os. patients will not be using any dopaminergic treatment during the study period. during baseline and 4 week follow-up, mds-updrs will be performed as clinical measure. we will also collect blood, cerebral spinal fluid and muscle biopsy from all subjects at baseline and 4 week follow-up. imaging will be performed using mri, dat scan and fdg-pet at baseline and 4 week follow-up.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed with pd 2. drug naïve with respect to dopaminergic treatment 3. have a clinical diagnosis of idiopathic pd according to the mds clinical diagnostic criteria for pd exclusion criteria: 1. \[¹²³i\]fp-cit single photon emission ct (datscan) does not show nigrostriatal degeneration. 2. magnetic resonance imaging (mri) suggestive of atypical parkinsonsism. 3. dementia or other neurological disorder at baseline visit 4. metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit

Keywords: clinical pilot, nicotamide riboside, parkinson's disease
introduction of the vi polysaccharide typhoid vaccine in hue city, central vietnam

Conditions: Typhoid; Paratyphoid Fever

Summary: this study is part of international vaccine institutes (ivi)'s typhoid vi demonstration project that aims to accelerate the rational introduction of vi vaccines in typhoid endemic countries. the primary objectives of the study are to evaluate the logistic feasibility of a mass typhoid fever immunization campaign program targeting school age children in hue city, vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and healthcare providers in hue city regarding typhoid fever prevention and treatment.

typhoid fever is a major cause of morbidity worldwide. the disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. management of this disease is further complicated by the emergence of multi-drug resistant strains. vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. the vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements. a cluster-randomized trial involving the vi polysaccharide vaccine and an active control (hepatitis a) was designed to determine the logistic feasibility of providing vi vaccine under actual programmatic conditions among school students in hue city. the vaccines used in this study are internationally produced and locally licensed. secondary objectives of this trial are: * to estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine delivery costs, private vaccine costs, etc) of vi vaccination * to determine the effectiveness of the vi polysaccharide vaccine following routine administration of a 1-dose schedule to school students (aged \>=6 years) * to determine the safety and immunogenicity of the vi vaccine * to study typhoid risk factors among students a nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in hue city.

Eligibility criteria:
inclusion criteria: * local students whose parents/guardians provide written consent to receive vi vaccine * attending any of the 66 registered schools in hue * registered in the project census * lives in hue city exclusion criteria: * fever (\>37.5 degrees celsius, axillary) * pregnancy * lactating

Keywords: salmonella typhoid vaccine enteric fever socioeconomic costs
atrial fibrosis in obstructive sleep apnea patients: a pilot study

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea

Summary: the investigators hypothesize that obstructive sleep apnea (osa) is an independent risk factor for atrial fibrosis development. the investigators aim to prove the presence of atrial fibrosis on delayed enhancement magnetic resonance imaging (de-mri) in osa patients without atrial fibrillation (af).

this is a cross sectional pilot study. sixty mild to severe osa patients and five age- and body mass index (bmi)-matched controls will undergo a de-mri. demographics, medical history and polysomnography results will be collected. patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. the investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true osa diagnosis for their inclusion in the study.

Eligibility criteria:
inclusion criteria: group a: 10 patients 18-75-year-old with mild osa (5\<ahi\<15), confirmed by polysomnography. no previous af diagnosis on the medical chart group b: 10 patients 18-75-year-old with moderate osa (15\<ahi\<30), confirmed by polysomnography. no previous af diagnosis on the medical chart group c: 10 patients 18-75-year-old with severe osa (ahi\>30), confirmed by polysomnography. no previous af diagnosis on the medical chart group d (mild osa+ af): 10 patients 18-75-year-old with mild osa (5\<ahi\<15), confirmed by polysomnography. previous af diagnosis * in this group, patients with af and osa who already have done mri might be included. group e (severe osa +af): 10 patients 18-75-year-old with severe osa (ahi\>30), confirmed by polysomnography. previous af diagnosis \*in this group, patients with af and osa who already have done mri might be included. group f (control): 10 patients 18-75-year-old no previous osa and/or af diagnosis on the medical chart exclusion criteria: * history of chronic heart failure (lvef \< 50%), af, myocardial infarction, valvular disease. * prior cardiac or chest surgery. * other advanced pulmonary disease (severe chronic obstructive pulmonary disease (copd) or asthma, pulmonary hypertension) or central sleep apnea. * contraindications to de-mri (e.g. allergy to gadolinium, pacemakers, defibrillators (icd's), other devices/implants contraindicated for mri, glomerular filtration rate \<30 ml/min, etc.). * pregnancy. * inability to give informed consent.

Keywords: ablation atrial fibrosis delayed enhancement magnetic resonance imaging electrocardiogram
a study in adolescent females to explore cytomegalovirus infection

Conditions: Infections, Cytomegalovirus

Summary: the purpose of this study is to estimate the incidence of cytomegalovirus (cmv) secondary infections (re-infections/re-activations) and the incidence of cmv primary infections in adolescent females.


Eligibility criteria:
inclusion criteria: * a female adolescent between, and including 10 and 17 years at the time of enrolment regardless of pregnancy status and contraception method used or not used. * subjects who the investigator believes that the subject and/or the subject's parent(s)/legally acceptable representative(s) (lar\[s\]) can and will comply with the requirements of the protocol. * written informed assent and/or consent obtained from the subject and/or the parent(s)/lar(s) of the subject. * subject is likely to remain in the area and/or return for required study site visits and complete sample collection visits. exclusion criteria: * child in care. * use or planned use of any investigational or non-registered antiviral drug or vaccine during the study period. * known medical history of any recurrent clinical herpes episodes requiring episodic or chronic suppressive treatment with oral or parenteral antiviral treatment such as acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during the year preceding enrolment. topical anti-viral are allowed. * subjects with history of previous vaccination against cmv. * chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to visit 1 or planned administration during the study. inhaled and topical steroids are allowed. * administration of immunoglobulins and/or any blood products within 3 months prior to visit 1 or planned administration during the study. * any confirmed or suspected immunosuppressive or immunodeficient condition including hiv-infection, based on medical history and physical examination (no laboratory testing required). * any major congenital defects, serious chronic illness or organ transplantation.

Keywords: adolescent females cytomegalovirus (cmv)
a study of venetoclax and dinaciclib (mk7965) in patients with relapsed/refractory acute myeloid leukemia

Conditions: Cancer - Acute Myeloid Leukemia

Summary: an open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory acute myeloid leukemia (r/r aml).


Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia (aml) by world health organization criteria excluding acute promyelocytic leukemia (apl)-m3. * eastern cooperative oncology group (ecog) performance status ≤ 2. * participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol. exclusion criteria: * known central nervous system leukemia * severe chronic obstructive pulmonary disease (copd) with hypoxemia * history of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment. * prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * history of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study. * known active infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c. * history of tumor lysis syndrome (tls) due to previous exposure to venetoclax.

Keywords: cancer, acute myeloid leukemia (aml), venetoclax, dinaciclib, relapsed/refractory aml, pharmacokinetics, venetoclax, dinaciclib