Kornimate/medical-research-clean huggingface dataset:
food and education effects on diabetes study

Conditions: Diabetes Mellitus, Type 2

Summary: low-income adults are disproportionately affected by diabetes, experiencing greater rates of diabetes, diabetes-related complications, and mortality. dietary habits play an important role in achieving and maintaining glycemic control to improve health outcomes. however, low-income adults are less likely to adopt the necessary dietary changes to improve glycemic control largely due to poor access to care, limited knowledge and skills to facilitate lifestyle change, and financial and environmental constraints that limit access to healthy foods. nutrition interventions that target key barriers to healthy dietary habits among low-income adults with diabetes may have a profound impact on improving glycemic control. the provision of home-delivered, medically-tailored meals in addition to individualized medical nutrition therapy is a promising approach to improve dietary habits in socially disadvantaged populations with diabetes. evidence suggests the provision of medically tailored meals may be beneficial in improving health outcomes and health care costs among socially disadvantaged adults with chronic illnesses, however rigorous studies specifically exploring the benefits of meal provision and medical nutrition therapy among adults with type 2 diabetes are lacking. the investigators aim to conduct a randomized-controlled clinical trial examining the impact of medically-tailored meals and medical nutrition therapy on health-related outcomes and health care costs among low-income adults with type 2 diabetes.

the investigators will recruit 100 individuals age 18 and over with uncontrolled diabetes (defined as a hemoglobin a1c (hba1c) \>8%) and enrolled in priority partners medicaid insurance. participants will be randomized to one of two groups: 1) 3 months of home-delivered, medically-tailored meals combined with monthly individual medical nutrition therapy sessions for 6 months or 2) usual care. the investigators will follow participants for up to 12 months to assess for changes in hemoglobin a1c.

Eligibility criteria:
inclusion criteria: * age 18 and over * diabetes with a hemoglobin a1c\>8% * medicaid beneficiary * enrolled in medicaid insurance exclusion criteria: * medical conditions that are indications for additional dietary requirements (e.g., advanced chronic kidney disease, end-stage renal disease, chronic wounds, or severe alcohol use disorder) * swallowing difficulties * food allergies * non-english speaking * language or hearing impairment * currently pregnant or breast feeding * does not have a refrigerator/freezer in the home to store meals * has plans to move out of the meal delivery service area in the next 12 months

Keywords: nutrition medically-tailored meals
cervical capsaicin for labor induction and pain relief

Conditions: Labor Pain; Pregnancy Loss; Labor Induction

Summary: in the setting of fetal demise it is important to help the mother deliver the fetus expeditiously and with as little physical trauma as possible. this study hypothesizes that application of capsaicin to the uterine cervix will enhance cervical ripening and desensitize pain fibers such that delivery is less painful.

induction of labor is associated with increased risk of cesarean section and elevated pain when compared to labor of spontaneous onset. in the setting of intrauterine fetal demise (iufd), it is desirable to induce labor in order to achieve a successful vaginal delivery for the health and well being of the mother, thereby avoiding operative fetal extraction. the current protocol for midtrimester labor induction prior to 24 weeks gestational age includes intravaginal cytotec(misoprostol) 200 mcg every 6 hours for up to 24 hours, occasionally followed by oxytocin infusion. when an iufd occurs at 24 or greater weeks gestational age, labor is induced with cytotec 25 or 50 mcg every 4 hours and/or oxytocin infusion. the investigators hypothesize that application of lidocaine to the uterine cervix followed by 0.1% capsaicin cream will facilitate cervical ripening and decrease the pain of labor induction when compared to use of a placebo cream. capsaicin 8methylnvannilyl6nonenamide) activates trpv1, a nonselective cation channel activated directly by heat, and low ph, and indirectly by a number of inflammatory factors, including nerve growth factor (ngf), bradykinin, lipids, and prostaglandins. activation of trpv1 by capsaicin results in an influx of ca2 and na ions, depolarization, exocytosis of neuropeptides and excitatory amino acids, and induces a burning sensation. this initial phase is followed by prolonged desensitiztion that is dose dependent. once the trpv1 receptor is desensitized, pain transmission through ctype primary afferent receptors is reduced. the pain relief from capsaicin is due to desensitization of the trpv1 receptor. the enhancement of cervical ripening is due to activation of primary afferent cfibers, release of neuropeptides substance p, neurokinin a, calcitonin generelated peptide, secretoneurin and nitric oxide to help orchestrate a series of local inflammatory responses including vasodilation, vascular permeability with tissue edema and protein extravasation, and migration of inflammatory immune cells. in a study of pregnant rats, vaginal lidocaine gel was applied followed by capsaicin sham cream. a blinded observer monitored behavior via video over the next 72 hours. all animals treated with capsaicin delivered on day 22 with minimal pain behaviors while 90% of sham treated animals delivered as expected on day 23 with normal pain related behavior. all pups were delivered live and rearing and suckling behavior was normal.

Eligibility criteria:
inclusion criteria: * iufd after 20 weeks gestation exclusion criteria: * chorioamnionitis * chronic pain syndrome * current pain meds during pregnancy
effect of short-term motor training on accuracy and precision of knee movement in human with and without knee pain

Conditions: Isotonic Saline; Hypertonic Saline; Healthy Eld Human; Knee Pain Chronic

Summary: the objects of this research are to investigate the ability of the motor learning and test the possible differences between younger and older healthy human, and between non-pain and acute experimental pain and chronic clinical pain conditions.

the project consists of four experimental studies. in the first experiment, younger and older healthy human subjects are involved in a short-term neuromuscular training on the accuracy and precision of knee movement to investigate the possible age effect of the motor learning. the second experiment focuses on the experimental pain on the learning effect of the younger subjects. the third experiment will investigate a group of knee osteoarthritis patients to show the influence of chronic pain on the motor training compared with age-, gender-matched pain free subjects. 3d camera tracking system will be used to record the knee movements at the baseline and after 6-day motor task training. the variability in amplitude of the values of knee movements was transformed to percentage in relation to the target position (accuracy) or to the mean position (precision). the results of the study will contribute to both basic and clinical understanding of the mechanisms related to knee movement control and influences of varies painful conditions.

Eligibility criteria:
inclusion criteria: * • aged 18-30 or 50-65 years * free from ongoing or chronic pain * right dominant leg * speak and understand english * aged 50-65 years. * diagnosed with knee oa (according to american college of rheumatology classification) with pain in left or both knees for more than six months * have ongoing pain rated above 2 on a 0-10 visual analogues scale (vas) in the previous week. * right dominant leg * speak and understand english * aged 50-65 years * diagnosed with knee oa * have had total knee arthroplasty on left or both knees * right dominant leg * speak and understand english exclusion criteria: * • pregnancy or intent to become pregnant, breast feeding * regular use of analgesics, including simple analgesia and nsaids * frequent recreational drug or alcohol use * history of knee joint pathology or injury * previous neurologic, musculoskeletal or mental illnesses * practicing sport activities on a regular basis * lack of ability to cooperate * regular use of analgesics, including analgesia and nsaids for the last 24 hours * frequent recreational drug or alcohol use * previous neurologic, musculoskeletal or mental illnesses * practicing sports activities on a regular basis * lack of ability to cooperate * regular use of analgesics, including analgesia and nsaids for the last 24 hours * frequent recreational drug or alcohol use * other disorders or injuries in the knee joints * previous neurologic, musculoskeletal or mental illnesses * practicing sports activities on a regular basis * lack of ability to cooperate
hf10 treatment of chronic knee pain

Conditions: Chronic Pain Post-Procedural

Summary: this is a multi-center study where patients who meet the eligibility criteria will be treated with hf10 therapy for their chronic knee pain post-orthopedic surgery. the primary endpoint will be assessed at 3 months, but observational assessments will continue until study completion at 12 months following implant.


Eligibility criteria:
key inclusion criteria: 1. have been diagnosed with chronic, focal, neuropathic pain following orthopedic surgery(ies) of the knee(s). 2. average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the visual analog scale (vas) in the primary area of pain at enrollment. 3. have a score of at least 4 out of 10 in douleur neuropathique 4 (dn4) questionnaire at the time of enrollment or eligibility verification. 4. deemed not to have surgical loosening or other complications from the surgery that affect the stability of the knee. 5. have stable neurological status measured by motor, sensory and reflex function as determined by the investigator. 6. be on stable pain medications, as determined by the investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted scs device. key exclusion criteria: 1. have radiculopathy or radicular leg pain resulting from failed back surgery. 2. have a medical condition or pain in other area(s), not intended to be treated with scs, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia). 3. have a current diagnosis of a progressive neurological disease such as multiple sclerosis (ms), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the investigator. 4. have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator. 5. have any prior experience with scs. 6. have objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator. 7. be benefitting from an interventional procedure to treat their trunk or limb pain (subjects should be enrolled at least 30 days from last benefit). 8. have an existing drug pump and/or another active implantable device such as a pacemaker. 9. be involved in an injury claim under current litigation. 10. have an active or unsettled worker's compensation claim.
a timeline study of alcohol use and its relationship to insomnia

Conditions: Insomnia; Alcohol Problem

Summary: this study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.


Eligibility criteria:
inclusion criteria: * subjects must be between the ages of 18-70, may be male or female, and from any ethnic background. * individuals must have the capacity to give irb-approved study consent. * subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence. * subjects must have a complaint of chronic insomnia, reporting either six or less hours tst, on average at least three times per week. exclusion criteria * potential subjects with a lifetime diagnosis of bipolar affective disorder, schizophrenia, borderline personality disorder, dementia of any type, or epilepsy will not be admitted to the study. * subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. however, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy. * any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the pi.
a long-term (12 months) safety, tolerability and efficacy study of lcz696 in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to assess the long-term safety, tolerability and efficacy of lcz696.


Eligibility criteria:
inclusion criteria: * patients who have successfully completed protocol no. clcz696a2219 and who, as judged by the study investigator, are able to continue in the current study. * ability to communicate and comply with all study requirements and demonstrate good medication compliance during clcz696a2219. exclusion criteria: * patients who did not complete clcz696a2219. * presence of significant protocol violation in clcz696a2219. * patients who are deemed to be unable to comply with the protocol by the investigator. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension blood pressure lcz696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (arni)
validation of pulse waveform analysis-based continuous noninvasive blood pressure measurement sensor

Conditions: Blood Pressure

Summary: the study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

a novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. monitor captures also saturation and ecg, which are compared to traditional monitoring.

Eligibility criteria:
inclusion criteria: * subjected to operative treatment with the need for invasive blood pressure measurement * spontaneous ventilation * able to give informed consent exclusion criteria: * denial by patient * pacemaker

Keywords: sensitivity specificity novel blood pressure monitor saturation
directly observed hepatitis c treatment in methadone clinics

Conditions: Hepatitis C; Medication Adherence

Summary: drug users account for a disproportionately large burden of hepatitis c virus (hcv) infection. however, hcv treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during hcv treatment. because hcv treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve hcv treatment adherence need to be developed and evaluated. the investigators designed the hcv dot trial to test the efficacy of two versions of modified directly observed hcv therapy provided on-site at a methadone clinic. the primary objective of this trial is to determine whether enhanced dot with both pegylated interferon alfa-2a plus ribavirin (peg/rbv-dot) is more efficacious than standard dot with weekly provider-administered pegylated interferon (peg-dot) and self-administered ribavirin for increasing adherence and improving hcv treatment outcomes. the investigators hypothesize that peg/rbv-dot is associated with increased adherence and rates of sustained viral response compared with peg-dot.


Eligibility criteria:
inclusion criteria: * hcv-infected * receive hcv medical care at the methadone clinic * plan to initiate hcv treatment on-site within the next 3 months * psychiatrically stable as determined by hcv treatment provider and/or on-site psychiatrist * attend the methadone clinic between three and six days per week to receive methadone * stable dose fo methadone for two weeks prior to the baseline visit exclusion criteria: * unable or unwilling to provide informed consent * currently receiving hcv treatment * primary hcv care provider does not agree to their participation in the trial * psychiatrically unstable

Keywords: hepatitis c virus chronic hepatitis c methadone injection drug user adherence directly observed treatment
lille covid research network (covid-19)

Conditions: Sars-CoV2

Summary: the lille university hospital developped a research objective common to all the services which took care of patients, "suspected patient", "possible case", "probable case" or "confirmed case" infected with sars-cov-2 by constituting a prospective and a retrospective observational cohort which allowed pooling and sharing the resources and data collected. in the next two years the prospective cohort will allow to continue inclusions in a standardized way mainly for the constitution of a negative control group (excluded cases), to collect biological samples which had not been collected in the retrospective cohort so that the pathophysiology of the covid-19 will be better apprehended as for example the inflammatory response to the viral infection. finally in case of a second epidemic wave in the hauts de france, it seems essential to have a defined research protocol which had already received all the necessary authorizations to guarantee cutting-edge (or quality ) research in a center like the lille university hospital.the aim objective of this study is to identify predictive factors of mortality to day 28 infection to sars-cov-2 for patients under medical care for the covid-19 in the lille university hospital thanks to the constitution of an epidemiological, clinical, biological, immunological, genetic, microbiological, anatomopathologic, radiological, therapeutic database and so record the results of functional exploration exams.

this is a retrospective and prospective observational monocentric cohort study designed to identify predictors of mortality on day 28 in patients treated at the lille university hospital for covid-19.

Eligibility criteria:
inclusion criteria: * all adult "suspect patient", "possible case", "probable case" or "confirmed case" of an sars-cov-2 infection admitted to lille university hospital. exclusion criteria: * minor patient patient under guardianship or curatorship refusal to participate in the study patient for whom the collection of genetic non-opposition or consent is impossible because of a language barrier with the patient himself or herself or with his or her trusted person or close family. patient for whom the collection of genetic non-opposition or consent is impossible because of his or her state of health at the time of inclusion in the study and for whom the trusted person or close family member opposes participation in the study. translated with www.deepl.com/translator (free version)

Keywords: covid-19 fatality rate inflammatory and autoimmune processes severity clinical features diagnostic (qrt-pcr or serology) methods thrombosis co-infection
inflammatory and metabolic prognostic assessment in critically ill neurological patients

Conditions: Stroke Acute; Encephalitis; Non-traumatic Brain Injury

Summary: the study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. this model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.

a multi-center, prospective case data collection study will be conducted across 19 tertiary hospitals in china. based on this, a predictive assessment model for poor prognosis in neurocritically ill patients receiving enteral nutrition support will be developed and validated, using key inflammatory and metabolic markers. during the data collection process, comprehensive clinical information will be extracted, including patient demographic data, clinical indicators, and hematological markers. by conducting in-depth analysis and processing of this vast and detailed clinical and laboratory data, a nomogram for predicting poor prognosis in neurocritical care patients receiving enteral nutrition support will be constructed using statistical methods and data analysis techniques in r. once the model is built, it will undergo rigorous validation on an independent external dataset to ensure its accuracy and reliability. the goal is to create a precise assessment tool for clinicians, helping them to quickly and accurately identify high-nutritional-risk patients, thereby providing a solid scientific foundation for the formulation of individualized nutrition support strategies, ultimately improving the prognosis of neurocritical patients.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years, no gender restrictions. 2. within 7 days of disease onset and expected nicu stay of at least 7 days. 3. eligible for enrollment within 24 hours of nicu admission, with enteral nutrition (en) initiated and continued for at least 7 days. 4. non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a glasgow coma scale (gcs) score ≤12. 5. nrs 2002 score ≥3. 6. kuwata drinking test ≥ grade 3. 7. acute gastrointestinal injury (agi) grade 1 or 2. 8. signed informed consent obtained from the patient or their legal representative. exclusion criteria: 1. severe malnutrition prior to admission, defined as bmi \< 16 kg/m². 2. pregnant or lactating women. 3. receiving hypothermia treatment or core body temperature \< 36°c. 4. end-stage disease with an expected survival time of \< 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability. 5. malignant tumors.

Keywords: enteral nutrition adverse prognosis prediction model non-traumatic severe brain injury