Kornimate/medical-research-clean huggingface dataset:
health and faith (salud y fe): community-based diabetes pilot intervention

Conditions: Diabetes

Summary: main objective: to improve diabetes outcomes among mexican-americans with diabetes through church-based, culturally tailored, diabetes self-management interventions linked to the local healthcare system. specific aim: to pilot test a church-based, culturally tailored diabetes self-management intervention to improve diabetes outcomes among low-income mexican-american with diabetes h1 a church-based diabetes self-care management curriculum partnered with the local healthcare system will improve glycosylated hemoglobin. h2 a church-based diabetes self-care management curriculum partnered with the local healthcare system will improve systolic blood pressure and low-density lipids. h3 a church-based diabetes self-care management curriculum partnered with the local healthcare system will improve diabetes related self-efficacy, self-empowerment and self-care management.

diabetes is a very prevalent and morbid condition affecting latinos, especially mexican-americans in the united states. south lawndale, a predominately-mexican neighborhood of chicago, has a disproportionately high diabetes related mortality rate in comparison to the rest of chicago and the u.s. many church-based interventions have shown promise improving health outcomes among minority populations; but data on church-based interventions for latino populations is scarce. mobilizing community resources to develop church-based, diabetes self-management interventions may lead to sustainable, culturally tailored interventions, and improve outcomes in latinos with diabetes. considering the growth of the hispanic population and their disproportionate burden of chronic diseases, developing programming aimed at decreasing the health disparities in this population is crucial. our study proposes to fill this gap.

Eligibility criteria:
inclusion criteria: * over the age of 18 * able to speak either english or spanish * self-report of diagnosis of diabetes by a doctor exclusion criteria: * cannot give informed consent (e.g. due to intoxication or dementia) * do not speak english or spanish * younger than 18 years old. * pregnant women * undergoing hemodialysis or treatment for cancer * unable to attend 3- and 6-month follow up appointments
instrument-assisted soft tissue mobilization versus integrated on mechanical neck pain

Conditions: Non-specific Chronic Mechanical Neck Pain

Summary: the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain

mechanical neck pain is a prevalent condition in various populations. neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. the neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. it has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. myofascial trigger point (mtrp) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band. iastm and integrated play an important role in the treatment of mechanical neck pain.this trial has three groups; one will receive iastm+ conventional, the second will receive integrated + conventional and the third will receive conventional treatment for four week

Eligibility criteria:
inclusion criteria: 1. diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern 2. body mass index from 18 to 25 kg/m2 3. their ages from 18-35 exclusion criteria: 1. if they had trigger point injections within the past 6 months 2. history of neck or upper back surgery, trauma or fracture 3. history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities 4. cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases

Keywords: instrument-assisted soft tissue mobilization integrated neuromuscular inhibition technique
anxiety and symptom burden in hemodialysis patients

Conditions: Anxiety; ESRD

Summary: anxiety has been identified as a prevalent and significant co-morbid condition in patients with end stage renal disease (esrd) being treated with hemodialysis. in particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life. the proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. the primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.

additional analyses will examine the relationship of elevated anxiety and depression scores on symptom burden, qol, and other measures of dialysis adherence. retrospective data of the preceding three months will be used to calculate measures of dialysis adherence (shortening and skipping) and clinical parameters.

Eligibility criteria:
inclusion criteria: * receiving in-center hemodialysis exclusion criteria: * non-english speaking
first in human safety study of fx-345 in adults with sensorineural hearing loss

Conditions: Hearing Loss, Sensorineural

Summary: this single-blind, placebo-controlled trial will be conducted to evaluate the safety of fx-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. the primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (pk) profile to determine systemic exposure.

this study will enroll two cohorts. cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. after the sponsor completes an unblinded safety review, cohort 2 (n=27) will be enrolled to continue safety evaluation of fx-345.

Eligibility criteria:
inclusion criteria: * adult aged 18-67 years (inclusive) * documented medical history consistent with acquired, adult onset, sensorineural hearing loss * at the screening, lead-in (visit 2) and treatment (day 1) visits, a pure tone average of 40- 80 dbhl at 500hz, 1000hz, 2000hz, and 4000hz in the potential study ear to be injected * female participants must not be pregnant, breastfeeding, or lactating. women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test. * male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception exclusion criteria: * randomization in a fx-322 (laduviglusib and sodium valproate) clinical trial * perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. this includes a current tympanostomy tube. * any conductive hearing loss of greater than 15 db at a single frequency or greater than 10 db at two or more contiguous octave frequencies in the study ear at the screening, lead-in (visit 2) or treatment (day 1) visits, based on the investigator's judgment. * active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected. * within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss * evidence of or previous diagnosis of traumatic brain injury, meniere's disease, or genetic hearing loss * history of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms * exposure to another investigational drug within 28 days prior to screening visit

Keywords: hearing loss intratympanic injection
study to evaluate efficacy and safety of imiglucerase treatment in chinese patients with gaucher disease type ⅲ

Conditions: Gaucher's Disease

Summary: primary objective * to evaluate the efficacy on hematologic manifestations of imiglucerase treatment in chinese patients who are diagnosed as gaucher disease type ⅲ * to evaluate the safety profile of imiglucerase in maximum dose in the label (60u/kg, iv biweekly) in chinese patients. secondary objective * to evaluate the efficacy on viscera manifestations of imiglucerase treatment in chinese patients who are diagnosed as gaucher disease type ⅲ * to evaluate the efficacy on bone disease of imiglucerase treatment in chinese patients who are diagnosed as gaucher disease type ⅲ * to evaluate the effect on quality of life of imiglucerase treatment in chinese patients who are diagnosed as gaucher disease type ⅲ

approximatively 14 months including a 12 months treatment period

Eligibility criteria:
inclusion criteria: * capable of giving signed informed consent. * participant is diagnosed with gd type ⅲ * participant with neurological manifestations * participant whose age is \> 2 years old. * participant whose spleen and/or liver volume is \> uln at screening. exclusion criteria: * major congenital anomaly * clinically significant intercurrent organic disease unrelated to gaucher disease, which means the disease or condition that may have impact on the parameters chosen for primary endpoints (e.g. level of hemoglobin platelets, liver/spleen enlargement and bone pains) * prior treatment with ert. * physical conditions that cannot tolerate regular treatment or follow-up visit. * pregnant or lactating women * participant is participating in or has participated in another clinical study using any investigational therapy in 3 months * participant has been diagnosed with central nervous system disease unrelated to gaucher disease, or mri result of the participant indicates space-occupying lesion in central nervous system * the patient has a documented hemoglobinopathies, deficiency of iron, vitamin b-12, or folate that requires treatment not yet initiated or, if initiated, the patient has not been stable under treatment for at least 6 months prior to administration of the first dose of cerezyme in this study * participant not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * any specific situation during study implementation/course that may rise ethics considerations * sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
onco-genomas brasil: mapping breast and prostate cancer in the brazilian public health system

Conditions: Breast Cancer; Prostate Cancer

Summary: this project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the brazilian unified health system to generate genomic and phenotypic data for the brazilian ministry of health's national precision genomics and health program, called genomas brasil, as well as to collect data on the population's ancestry.

in brazil, the most frequent types of neoplasm are prostate cancer in men and breast cancer in women. understanding the molecular variants in tumors, which result from mutations and variants that occur during carcinogenesis, can affect treatment response and disease prognosis and is an important target of oncology research. detecting hereditary genetic syndromes also helps in oncological follow-up, allowing prediction of the risk of new neoplasms. this project aims to perform complete sequencing of the somatic (tumor) and germline exomes during clinical investigation of cancer patients treated through the brazilian unified health system to generate genomic and phenotypic data for the brazilian ministry of health's national precision genomics and health program, called genomas brasil, as well as to collect data on the population's ancestry.

Eligibility criteria:
inclusion criteria for breast cancer patients (arm 1): * women aged ≥ 18 years; * brazilian nationality; * after review at the hospital moinhos de vento, confirmed histological diagnosis of breast carcinoma with overexpression of her2 (classified by immunohistochemistry as 3+ or 2+ with positive in-situ hybridization) or triple-negative (estrogen and progesterone receptors \<1% and no overexpression of her2); * clinical stage ii or iii for her2-positive and i, ii and iii for triple-negative patients - american joint committee on cancer (ajcc) 8th edition; * her2- positive patients: must undergo neoadjuvant chemotherapy plus trastuzumab in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel), combined with trastuzumab, or a non-anthracycline option consisting of taxane (docetaxel or paclitaxel) combined with carboplatin and trastuzumab; * triple-negative patients: must undergo neoadjuvant chemotherapy without immunotherapy in the following regimens: anthracycline (doxorubicin or epirubicin) followed by taxane (docetaxel or paclitaxel) with/ without platins (carboplatin ou cisplatin) or a regimen without anthracycline (taxane with/without platins) * patients must provide written informed consent prior to inclusion inclusion criteria for patients with prostate cancer (arm 2): * men aged ≥ 18 years; * confirmed histological diagnosis of prostate adenocarcinoma; * ajcc 8th edition clinical stage iv; * patients must provide written informed consent. exclusion criteria for arms 1 and 2: * no available paraffin-embedded tumor tissue for genomic analysis; * inability to collect blood for genomic evaluation.

Keywords: breast cancer prostate cancer exome
a pharmacokinetic, safety and tolerability study in healthy adult males

Conditions: Healthy

Summary: the primary objective of this study is to evaluate the pharmacokinetics of various trv734 formulations in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy as determined by a responsible physician or trained qualified designee * males: 18 - 55 years inclusive at screening * capable of giving written informed consent exclusion criteria: * clinically significant conditions or history of fainting or syncope * medical or psychiatric illness that could interfere with the completion of treatment and follow up * major surgery within 4-weeks of screening * known difficulty with obtaining intravenous access * history of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation * use of prescription or non-prescription medications * history of excessive alcohol use * history of drug abuse within 6 months of screening * use of any illegal drug within 30 days of screening and throughout participation in the study * history of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study * donation of blood or plasma 4 weeks prior to dosing * participation in a clinical trial and has received medication within 30 days * weight \<50 kg or bmi outside range of 18-32 kg/m2 * positive for hiv antibody, hepatitis b virus surface antigen, or hepatitis c virus * unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation

Keywords: healthy male pharmacokinetics
trial of chewing gum to reduce post operative ileus in elective colorectal surgery

Conditions: Colorectal Cancer; Surgery

Summary: it is unknown whether post operative chewing gum will reduce post operative ileus. this study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. time to passage of flatus will be used to determine that incidence of ileus.

patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care. the primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes). the trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

Eligibility criteria:
inclusion criteria: * undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent exclusion criteria: * emergency colorectal surgery, unable to consent
a study of standard and individualized prophylactic treatment with advate in men and boys with severe hemophilia a

Conditions: Hemophilia A

Summary: the main aim of this study is to learn about changes in the lowest blood levels of factor viii in men and boys when upgraded from standard prophylaxis with advate to individualized prophylaxis with advate. no study medicines will be provided to participants in this study. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. participants will need to visit the study doctor 3 times in total during the study. during these visits, study data will be collected by the study doctor.

local, multicenter, non-interventional, ambispective study in severe hemophilia a patients on standard and pk-tailored prophylaxis with octocog alfa (advate®) in the russian federation

Eligibility criteria:
inclusion criteria: * male participants of all ages with severe hemophilia a (fviii ˂1%) or moderate hemophilia a with severe bleeding phenotype who: * had been on standard prophylaxis or pk-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment (150 participants) or who started advate® treatment in 2021 (20 participants), * is being treated with octocog alfa at the moment of enrolment with any of the above mentioned treatment modalities, and * had been assigned octocog alfa provision in federal reimbursement program 2021 * availability of participants' records sufficient for data collection according to the study objectives during the retrospective period of the study for participants who had been on standard prophylaxis or pk-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment * written informed consent provided by the participant or, in case of children below 14 years of age, by participant's parent or participant's legally acceptable representative. exclusion criteria: * failure to obtain the participant's written informed consent * participation in any interventional study of products for hemophilia or other hemostasis disturbances treatment during 12 months prior to the study enrollment for participants who has retrospective data collection period and during 12 months after the study enrollment for all participants.
arterial oxygen saturation on ventilatory stability in extremely premature infants

Conditions: Apnea of Prematurity; Desaturation of Blood; Central Apnea; Periodic Breathing; Obstructive Apnea of Newborn

Summary: this is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (spo2), both within the clinically recommended range of 90- 95%. the specific objective of this study to evaluate the impact of targeting spo2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (ga).


Eligibility criteria:
inclusion criteria: * 23 0/7- 29 6/7 weeks gestational age * postnatal age ≥ 14 days * requiring fio2 ≥ 0.25 to keep spo2 90-95% * parental informed consent exclusion criteria: * severe congenital anomalies that may affect pulmonary or neurosensory development * severe cns pathology that may alter respiratory control function
daily bitemporal low-frequency transcranial random noise stimulation in tinnitus (trns2-tin)

Conditions: Chronic Tinnitus

Summary: stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (trns) is used to modulate the neural pathways involved in chronic tinnitus.

tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. it is a frequent problem which can interfere significantly with the ability to lead a normal life. tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. these changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. treatment remains difficult. non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. first data suggest the use of transcranial random noise stimulation (trns) over both auditory cortices as new and highly effective treatment. low-frequency (lf; \<100hz) trns might be highly effective in tackling hyper-synchronised cell assemblies. daily lf-trns (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.

Eligibility criteria:
inclusion criteria: * diagnosis of bothersome, subjective chronic tinnitus * diagnosis: duration of tinnitus more than 6 months exclusion criteria: * objective tinnitus * irregular head shap below the electrodes * eczema on the head * treatable cause of the tinnitus * involvement in other treatments for tinnitus at the same time * clinically relevant psychiatric comorbidity * clinically relevant unstable internal or neurological comorbidity * history of or evidence of significant brain malformation or neoplasm, head injury * cerebral vascular events * neurodegenerative disorder affecting the brain or prior brain surgery * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse

Keywords: tinnitus transcranial random noise stimulation trns auditory cortex non-invasive brain stimulation