Kornimate/medical-research-clean huggingface dataset:
neuromodulation for central post-stroke pain: mechanism, safety and outcome

Conditions: Central Post-stroke Pain; CPSP

Summary: central post-stroke pain (cpsp) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. cpsp has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (vc-dbs), motor cortex repetitive transcranial magnetic stimulation (m1-rtms), and motor cortex stimulation (mcs)), but the level of evidence for these procedures is very low. moreover, data on the changes in pain brain circuitry in cpsp, and the effect of neuromodulation on this circuitry is very limited.

in this project, we propose a prospective double-blind randomized crossover on/off study in 32 cpsp patients. these patients will undergo m1-rtms and either mcs or vc-dbs. before and after active and inactive stimulation they will be assessed with clinical scales for pain, function, quality of life and depression. adverse events will be monitored. this allows to measure the outcome and safety of neuromodulation in cpsp. in addition, we will have functional magnetic resonance imaging (fmri) and positron emission tomography (pet) use. this will provide insight into the pathological changes in the pain circuitry, and the influence of neuromodulation.

Eligibility criteria:
inclusion criteria: 1. able to provide voluntary written informed consent of the participant prior to any screening procedures 2. male or female patients 3. aged 18-70 years 4. diagnosed with definite cpsp (treede-klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in \<50% vas reduction and/or intolerable side-effects) exclusion criteria: 1. aphasia 2. pregnancy or intention to become pregnant in the following year 3. medical inoperability 4. impossibility to temporarily withhold anticoagulation or anti-platelet medication 5. impossibility to undergo mri, fmri and/or pet imaging 6. complete destruction of the stimulation target region (m1 or vc) 7. uncontrolled seizures 8. expected relocation in the following year.

Keywords: neuromodulation dbs rtms mcs
clinical trial of cinobufacini combined with transarterial chemoembolization (tace) on primary liver cancer

Conditions: Liver Cancer

Summary: the clinical trail of cinobufacini combined with tace on primary liver cancer.the trail is randomized controled.patients are diagnosed primary liver cancer based on pathology or cell biology.they are randomized into 2 groups:both groups receive tace.the treatment group receives cinobufacini injection 20ml via hepatic artery during transarterial chemoembolization(tace) operation , cinobufacini injection 20ml+5% glucose injection 500ml from the second day of tace until 7th day, and cinobufacini tablet 3 tablets tid for 2 months..the control group only receives tace.mainly to study cinobufacini leads to the influence of the immunologic function after tace.immunological examination and blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(cd3、cd4、cd8,etc),tumor marker(cea、afp),etc.clinical evaluation includes image data(ct/mri),drug toxicities,quality of life(qol),etc.

the clinical trail of cinobufacini combined with tace on primary liver cancer.the trail is randomized controled.patients are diagnosed primary liver cancer based on pathology or cell biology.they are randomized into 2 groups:both groups receive tace.the treatment group receives cinobufacini injection 20ml via hepatic artery during transarterial chemoembolization(tace) operation , cinobufacini injection 20ml+5% glucose injection 500ml from the second day of tace until 7th day, and cinobufacini tablet 3 tablets tid for 2 months..the control group only receives tace.mainly to study cinobufacini leads to the influence of the immunologic function after tace.immunological examination and blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(cd3、cd4、cd8,etc),tumor marker(cea、afp),etc.clinical evaluation includes image data(ct/mri),drug toxicities,quality of life(qol),etc.

Eligibility criteria:
inclusion criteria: * age:18-70 years. * male and female. * signed the informed consent form. * diagnosis:primary liver cancer diagnosed by imaging、cell and pathology report. * eastern cooperative oncology group (ecog) :0-2;life expectancy more than 3 months. * indication for tace,no contraindication. * first time chemotherapy or at least 6 months after last chemotherapy and radiotherapy. * at least 8 weeks after last biotherapy. * surgery：had not received transplantation surgery,at least 2 weeks after last major surgery. exclusion criteria: * chemotherapy is contraindicated. * have the primary disease can cause the neuropathy. * a history of other malignant tumor in recent 5 years. * less than 6 months after last chemotherapy or radiotherapy. * less than 8 months after last. * cinobufacini allergy. * had received transplantation surgery ,less than 2 weeks after last major surgery. * other researchers think is not suitable for this clinical trail.

Keywords: cinobufacini
synbiotic treatment of ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is one of the two main forms of inflammatory bowel disease. uc is associated with high morbidity and incurs significant social, commercial and nhs costs. for a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. however, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. a synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. the aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in uc patients with active disease. it is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. if the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for uc, making a significant contribution to relieving the clinical and financial burdens of this disease.


Eligibility criteria:
inclusion criteria: * ulcerative colitis * stable doses of medications for uc for the preceding three months * mayo score of 6 to 12 * sigmoidoscopy subscore of 2 * stable doses of medication exclusion criteria: * pregnancy * lactation * antibiotic therapy in the last three months * probiotic or prebiotic therapy in the last month * crohn's disease, indeterminate colitis * alterations to medications in the last three months
hospital-based phthalate exposure in very low birth weight neonates

Conditions: Low Birth Weight Neonates

Summary: in this observational pilot project, the investigators plan to document duration and sources of exposure to plasticizers in infants born at birth weights less than 1500 grams. the investigators will examine the association between exposure to plasticizers and outcomes such as performance on a neurological screening tool, extrauterine growth, and thyroid function.

high levels of exposure to certain plasticizers, specifically, phthalates and bisphenol-a (bpa) have been shown to affect intelligence and behavior in school-age children, as well as to disrupt growth and some endocrine functions. items used in the care of infants in the neonatal intensive care unit (nicu) contain phthalates and bpa. babies admitted for long periods of time to the nicu, could be exposed to high levels of these potentially harmful plastics. in this study, the investigators are interested in documenting duration and sources of exposure to plasticizers during the nicu admission of infants born weighing less than 1500 grams. the investigators will examine the association between nicu exposure to plasticizers and performance on a neurological screening test that predicts future behavior, growth after birth, and the presence of any thyroid dysfunction. the investigators plan to enroll 50 neonates in our study. the investigators will catalog all exposure to plasticizers during the infant's nicu admission and assign each baby a risk level of exposure. the investigators will then test each infant's performance on a neurological screening tool, measure growth from birth and assess whether or not each infant has thyroid dysfunction and correlate each outcome with exposure risk level. the investigators will also collect urine samples from each baby to store for possible future analysis. the investigators hypothesize that neonates with higher levels of exposure will demonstrate worse performance on the neurological screening tool, poor growth, and abnormal thyroid function.

Eligibility criteria:
inclusion criteria: * neonates born less than 1500 grams that are admitted to the mount sinai hospital nicu exclusion criteria: * chromosomal abnormality or other genetic disorder * diagnosis of hypoxic-ischemic encephalopathy * inborn error of metabolism * congenital renal disease

Keywords: low birth weight neonates neurodevelopmental outcome thyroid dysfunction extrauterine growth plasticizers
a parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department

Conditions: Informed Consent Process

Summary: this study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ed) about risks, benefits, and alternatives to receiving procedural sedation for their children.


Eligibility criteria:
inclusion criteria: * parents with patients under 18 years of age * patients receive the procedural sedation and anesthesia in the emergency department exclusion criteria: * clinically unstable * refuse to participate * unable to understand the consent process for this study
levineconservationmodelandcolorectalpatients

Conditions: Fatigue; Peripheral Neuropathy; Anxiety

Summary: colorectal cancer is one of the most common types of cancer in the world, ranking 3rd among cancers that cause death in men and women. in patients diagnosed with colorectal cancer, chemotherapy treatment is planned to prolong survival as in all other cancer patients. among the side effects of chemotherapy treatment, it is known that fatigue develops between 50-90%, which is mild for one week in 45% of patients and persists for two weeks in 33%. in the literature, the incidence of chemotherapy-induced peripheral neuropathy is reported to be between 10-100% depending on the type and dose of the drug taken. alejandro et al. (2013) reported that the incidence of oxaliplatin-related peripheral neuropathy was 84%, which was acute in 74% of patients and permanent in 48%. in addition, anxiety disorders are among the common mental symptoms in cancer patients and their prevalence has been reported to be 10-30%. in this study, it is aimed to reveal the effect of nursing interventions based on levine's conservation model on fatigue, peripheral neuropathy and anxiety levels in colorectal cancer patients receiving chemotherapy treatment.


Eligibility criteria:
inclusion criteria: * between the ages of 18-75 * diagnosed with primary and new colorectal cancer (stage ii and iii), * the decision to start the folfox treatment protocol has been taken, * having a smartphone, * being literate, * ability to speak and understand turkish, * open to communication and cooperation. exclusion criteria: * history of neuropathy or diabetes, * history of hypothyroidism, renal failure, * hearing, speech and vision problems, * receiving radiotherapy or immunotherapy, * psychiatric diagnosis or ongoing treatment.

Keywords: colorectal cancer, levine's conservation nursing model, nursing intervention
does the use of fiasp vs. asp lead to the prolonged tir in children with type 1 diabetes?

Conditions: Diabetes type1; Diabetes Mellitus, Type 1

Summary: the aim of the study is to assess whether the implementation of faster insulin aspart in children with type 1 diabetes treated with intensive insulin therapy with the use of an insulin pump and using real time continuous glucose monitoring (rt-cgm) systems leads to prolonged time in range (tir) compared to insulin aspart.


Eligibility criteria:
inclusion criteria: * ≥1 year of a history of type 1 diabetes; * treatment with intensive insulin therapy with the use of an insulin pump (continuous subcutaneous insulin infusion, csii) ≥3 months; * using continuous glucose monitoring system for at least 1 month; * hba1c\<8%; * consent to participate in the study obtained from the parent and the patient (\>16 years of age). exclusion criteria: * diabetes treated with multiple insulin injections with insulin pens (multiple daily injections, mdi); * concomitant medical problems which might significantly affect glucose levels; * the withdrawal of the consent to participate in the study.

Keywords: cgm continuous glucose monitoring system tir time in range insulin aspart insulin faster aspart
postnaps: fi, nutrition, and psychosocial health among women of mixed hiv status and their infants in gulu, uganda

Conditions: Food Insecurity; HIV; Maternal and Child Health; Nutrition; Psychosocial Health

Summary: postnaps was a continuation of the prenaps study. 246 women were enrolled in the postnatal period with the primary scientific objective of determining whether food insecurity was an independent risk factor for poor maternal nutritional or psychosocial outcomes or for sub-optimal infant feeding practices.


Eligibility criteria:
inclusion criteria: * postpartum women \>18 years of age * attended antenatal care at gulu regional referral hospital * participated in the prenaps study * infants that were born to women participating in the prenaps study exclusion criteria: * women \<18 years of age * women not participating in the prenaps study
evaluation of genetic markers as explanations for the observed differences in disease progression in hiv+ youth

Conditions: HIV Infection

Summary: this protocol is a study of hiv+ young people who were identified as having certain hiv-1 specific t-cell responses and genetic markers while previously enrolled in the 5-year longitudinal adolescent study, "reach." blood samples will be collected, a medical and medication history and physical examination will be performed every 6 months for a total of 2 years.

numerous studies have demonstrated an association between hla class i genotypes with differing progression to aids in individuals who are followed after being off antiretroviral therapy. these studies do not always associate the same hla class i alleles with the risks of hiv-1 disease progression; however they consistently demonstrated that hla-b\*35 and b\*53 portend a bad outcome compared to the better outcome observed in hla-b\*27 and b\*57 carriers. despite this information, very little data exists to explain the mechanism of this association. this longitudinal study will look at the hiv-1 specific cd8+ t-cell responses and the dominant hiv-1 genotype among individuals identified as hla-b\*27, b\*35, b\*53 and b\*57 positive through studies done in collaboration with the reach project.

Eligibility criteria:
inclusion criteria: * hla-class i hla-b\*27, b\*35, b\*53 and/or b\*57 positive identified through the reach study * subject's ability and willingness to provide written informed consent * subject's ability and willingness to be followed at least one year on this atn 026 study exclusion criteria: * on chronic immunosuppressive therapy, not including topical or inhaled steroid use. * any prohibited medication listed in protocol within 2 weeks prior to the entry visit labs

Keywords: hiv infection cd8+ t-cells hiv-1 genotype
open-label extension study to assess safety and tolerability of lyc-30937-ec in subjects with active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to allow subjects completing study lyc-30937-2001 the opportunity to receive lyc-30937-ec 25 mg.

subjects who complete the 8 week treatment period of the double-blind, placebo-controlled study lyc-30937-2001 will have the option of receiving lyc-30397-ec 25 mg po qd in this open-label extension study (lyc-30937-2002). subjects meeting eligibility criteria will enter this open-label extension trial upon completion of the lyc-30937-2001 week 8 study procedures. this open-label extension study will consist of 44 weeks of treatment followed by a 2 weeks post-treatment follow-up.

Eligibility criteria:
inclusion criteria: * completed the 8-week double-blind treatment period of study lyc-30937-2001 * male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug * non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study * investigator considers it safe and potentially beneficial to participate * ability to provide written informed consent and to be compliant with study schedule exclusion criteria: * subjects who completed study lyc-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study
nasal and peripheral blood biomarkers of crs patients before and after surgical intervention

Conditions: Sinusitis, Chronic

Summary: to characterize inflammatory cells in the nose of patients with chronic rhinosinusitis (crs) before and after sinus surgery.

rhinosinusitis (rs) is a heterogenous disease, with variable etiologies, manifestations, and progression. generally, rs can be divided into acute, subacute, and chronic rs, depending on the symptoms and duration of the disease. most commonly, acute rs is caused by a viral infection (viral rs), which starts in the nasal passages and progresses to inflammation of the sinuses. when this inflammation of the paranasal sinuses does not resolve and lasts for at least 12 weeks, the disorder is broadly defined as chronic rs (crs), which is usually accompanied by bacterial infections. this inflammatory disease pathophysiology is further subdivided into crs with (crswnp) and without (crssnp) nasal polyps. recently, several studies aimed at phenotyping the diverse pathophysiology among patients suffering from crs characterized subgroups based on the presence of inflammatory clusters. crssnp is marked by pro-inflammatory neutrophilic inflammation of the nasal mucosa and a nasal cytokine profile that is characterized by increased levels of tgfβ1 and ifnγ and low or undetectable levels of il-5. in contrast, patients with crswnp demonstrate eosinophilic inflammation of the nasal mucosa, low levels of tgfβ1, but high levels of th2/th17-type cytokines such as il-17 and il-5, higher levels of eosinophil cationic protein (ecp) and mast cell tryptase, and lower levels of il-10. currently biomarkers associated with physician diagnosed disease severity and patient-perceived quality of life impairments are lacking. analysis of markers of inflammation in the nasal mucosa and peripheral blood leukocytes in combination with quality of life symptom scoring will enable us to identify biomarkers associated with crs disease severity. this study will determine if biomarkers identified in the nasal mucosa and peripheral blood leukocytes correlate with physician diagnosed and patient-perceived disease severity.

Eligibility criteria:
inclusion criteria: * physician diagnosed crs with surgical requirement for treatment exclusion criteria: * subjects with physician-diagnosed: * cystic fibrosis, * vasculitis, * any type of nasal tumor * receiving ongoing immunosuppressant therapy
evaluation of apap with sensawake in osa and insomnia patients

Conditions: Obstructive Sleep Apnea; Insomnia

Summary: the hypothesis is that apap with sensawake improves wake-after sleep onset compared to apap without sensawake in a patient population with obstructive sleep apnea syndrome (osas) and insomnia.

patients with osa and insomnia will be enrolled into this randomized study to receive treatment with apap with and without sensawake. baseline data will be collected for one week prior to cpap initiation, followed by two treatment periods on each study arm of four weeks each.

Eligibility criteria:
inclusion criteria: * older than 18 years of age. * diagnosed with osa and eligible for cpap treatment under local requirements (ahi\>30 with no more than 20% of central respiratory events) * naïve to cpap therapy, i.e. have not been prescribed, or used cpap in the last 5 years. * fluent in spoken and written french exclusion criteria: * significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or left ventricular ejection fraction (lvef) \< 45% * co-existing lung disease, as per the principal investigator's discretion * co-existing sleep disorder, such as predominant central sleep apnea * previous or current diagnosis of sleep phase delay * pregnancy * participants that are unable or unwilling to give informed consent * receiving cognitive behavioral therapy or other intervention to treat insomnia. subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study. * diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months. * hospital anxiety or depression score \> 11 * participating in another research study for the duration of participation in this study. participation in an observational study or genetic study is permitted at the discretion of the investigator. * patient protected by the law, under guardianship or curators, as defined in public health code in articles from l1121-5 to l1121-8. * patient not covered by a health insurance

Keywords: obstructive sleep apnea osa insomnia cpap sensawake