Kornimate/medical-research-clean huggingface dataset:
exhaled breath analysis to predict risk of symptomatic pneumonitis

Conditions: Pneumonitis; Nonsmall Cell Lung Cancer Stage III

Summary: this is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

primary objective: • to quantify the intra-person variability of concentrations of tgf-β1, il-6, il-1α, and il-10 measured in exhaled breath condensate. secondary objectives: * to examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of tgf-β1, il-6, il-1α, and il-10 and the development of ctcae grade 2+ symptomatic pneumonitis. * to examine the associations between serum measures of tgf-β1, il-6, il-1α, and il-10 and: * exhaled breath condensate measures of the same biomarkers, and * the development of ctcae grade 2+ symptomatic pneumonitis. * to examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of ctcae grade 2+ symptomatic pneumonitis.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old. * clinically diagnosed or suspected stage iii non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician. * plan for treatment with definitive radiotherapy (≥60 gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists. * willing and able to tolerate exhaled breath collection. * able to provide informed consent. exclusion criteria: * systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration. * prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly). * any systemic antibiotic use within 2 weeks of registration.
impact of maternal covid-19 disease on breast milk and infant health

Conditions: Covid19

Summary: prospective multicenter study the main aim is to study the impact of maternal covid-19 on breast milk immune, microbiological, and metabolic profile and infant growth and development


Eligibility criteria:
inclusion criteria: * pregnant or nursing women with positive pcr for sars-cov-2 in nasopharynge and/or presence of sars-cov-2 antibodies in serum determined in hospitals exclusion criteria: * aggravation of symptomatology requiring specific treatment and/or hospitalization

Keywords: breast milk microbiota sars-cov-2 metabolites immune compounds infant growth and development
rapid diagnostic test for septic arthritis

Conditions: Juvenile Idiopathic Arthritis; Arthritis, Septic; Arthritis, Unspecified

Summary: diagnostic validation study of a test based on the analysis of the proteome by mass spectrometry for the diagnosis of septic arthritis in children under 16 years of age

arthritis is an inflammation of the joints that can have many causes. in children, septic arthritis (sa) is the most common cause of acute arthritis (around 45% of cases). juvenile idiopathic arthritis (jia) is a disease characterized the presence of arthritis in one or more of unknown origin in children under 16 years of age, lasting more than 6 weeks. it is the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per 100,000 children. finally, in approximately 40% of children the origin of acute arthritis remains undetermined (nd arthritis). in this group, all the examinations performed are not in favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of jia to be retained and no other disease is found. during the first few days of arthritis, differentiation between as and non-septic arthritis is difficult. the available clinical and biological parameters do not allow for easy and rapid differentiation between as and non-septic arthritis. this project aims to develop a new diagnostic technique based on molecular analysis of the proteome in the joint puncture fluid.

Eligibility criteria:
inclusion criteria: * patients \>3 months of age \<16 years of age * hospitalized for arthritis that started less than 6 weeks ago or patients with diagnosed inflammatory arthritis whose clinical course suggests bacterial superinfection * indication of a joint puncture for diagnostic purposes, confirmed by a senior physician after study of all available clinical and biological elements. * holders of parental authority who have accepted the participation of their children * patients benefiting from a social security scheme (excluding ame) exclusion criteria: * contraindications to joint puncture
clinical study of pregnant women with covid-19

Conditions: Covid-19

Summary: a new pandemic, covid-19, has spread rapidly around the world. she does not spare pregnant women. little is known about the clinical course of pregnant women infected with covid-19. as of april 1, 2020, six case series and one case report for a total of 61 pregnancies affected by covid-19, all from the pandemic epicenter in china, except for one state case report -unis, have been published. these preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at hus. for these reasons, additional information, especially from parts of the world other than china, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of covid-19 will not present with severe pneumonia to covid-19.


Eligibility criteria:
inclusion criteria: * adult woman (≥18 years old) * pregnant woman * suffering from a confirmed or suspected covid-19 infection * patient who has been medically treated at strasbourg university hospitals as well as for his newborn baby, between 03/01/2020 and april 30, 2020 * woman having given, after information, her agreement for the reuse of her data for the purposes of this research exclusion criteria: * patient who expressed her opposition to participating in the study * patient under guardianship or under guardianship * patient under legal protection

Keywords: covid-19 covid-19 pandemic sars-cov-2 pregnant women
electrocorticography in mapping functional brain areas during surgery in patients with brain tumors

Conditions: Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain; Recurrent Brain Neoplasm

Summary: this pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.

primary objective: i. to record electrocorticogram (ecog) data intraoperatively with surface electrode grids during various motor, sensory (tactile) and speech tasks, and identify functional brain areas through the spectral analysis, and compare the preliminary data with our current pre-surgical mapping methods: functional magnetic resonance imaging (fmri) and transcranial magnetic stimulation (tms), and the gold standard, intraoperative direct electrical stimulation (des). secondary objective: i. to perform a preliminary assessment of the utility of using ecog data in these patients to quantify new neurological and language/speech deficits in the short term (24 hours) and long-term (1, 3, and 6 months), and achieve a safe maximal tumor resection. outline: patients undergo tumor resection. during surgery, patients also undergo electrocorticography with either the cortec high resolution hybrid grid, the pmt high-resolution grid, or the ad-tech grid followed by direct electrocortical stimulation. following completion of study, patients are followed up within 24 hours from surgery and at 1, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * patients undergoing a tumor resection at the university of texas m. d. anderson cancer center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and/or speech brain areas * patients \>= 18 years of age * signed informed consent exclusion criteria: * patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (pi) * patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the pi
empa/lina fdc food effect study (japan)

Conditions: Healthy

Summary: the trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (fdc) tablet.


Eligibility criteria:
inclusion criteria: * healthy male subjects age \>=20 and \ =50 kg and \ =18.0 and \<=25.0 kg/m2 * without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (bp), pulse rate (pr), body temperature) * signed and dated written informed consent prior to admission to the trial in accordance with the good clinical practice (gcp) and the local legislation exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance * further exclusion criteria apply
preoperative maximum inspiratory pressure and outcomes after interscalene block in obese patients

Conditions: Dyspnea After Interscalene Nerve Block

Summary: the study aims to explore if maximum inspiratory pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery. the main question is: does baseline maximum inspiratory pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (bmi\>35). preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.


Eligibility criteria:
inclusion criteria groups 1 and 2 * adults \>18 years of age receiving shoulder surgery with preoperative interscalene block and general anesthesia; * speak english; group 3 · adults \>18 years of age receiving cystoscopy or lower extremity procedures receiving general endotracheal anesthesia exclusion criteria all groups * less than 18 years of age; * currently pregnant; * currently incarcerated; * those with significant neuromuscular disease, tracheo-bronchial structural abnormalities, severe respiratory or severe cardiovascular comorbidity; * those undergoing intra-abdominal or intrathoracic surgeries due to the potential to independently effect breathing
serum sclerostin level & treatment of vitamin d deficiency

Conditions: Endocrine System Diseases; Vitamin D Deficiency

Summary: the aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with vitamin d deficiency treated with calcium and vitamin d. healthy premenopausal patients with vitamin d deficiency diagnosed and routinely treated with calcium and vitamin d will be included in the study. this is an observational study. the serum sclerostin levels will be measured before and after vitamin d treatment.

this study is a prospective, observational, single-center study. ethical approval was obtained from the institutional review board. this study will be completed with patients with vitamin d deficiency. an intravenous cannula will be inserted into the antecubital vein. blood samples will be obtained before and after treatment. serum will be collected and will be centrifuged for 15 minutes at 1000xg within 30 minutes of collection. aliquots of serum will be added to eppendorf tubes and stored at -20°c. serum sclerostin levels will be measured using a human sclerostin elisa kit (cusabio, catalog no: csb-e13146h, newark, de, usa). all assays will be performed according to the manufacturer's instructions. the minimum detectable concentration of human sclerostin is typically \<0.012 ng/ml. intra-assay precision is less than 8%.

Eligibility criteria:
inclusion criteria: * premenopausal * serum 25(oh)d \< 10 ng/ml exclusion criteria: * anemia * tumor-induced osteomalacia (hypophosphatemia) * hypothyroidism * hepatic / renal disease * primary hyperparathyroidism * fibromyalgia * polymyalgia rheumatica * serum 25(oh)d \> 10 ng/ml * vitamin d and calcium treatment commenced prior to study participation

Keywords: sclerostin osteomalacia vitamin d deficiency
efficacy of extended release tramadol for treating prescription opioid withdrawal

Conditions: Substance Withdrawal Syndrome

Summary: prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. this study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.


Eligibility criteria:
inclusion criteria: * addicted to opioids exclusion criteria: * any major medical or psychiatric disorder that would be contraindicated for participation
the effect of educational program on teachers' knowledge self-reported practice towards tdis

Conditions: Dental Trauma

Summary: the study aims at evaluating the effect of an oral health educational program on the knowledge and self-reported protocol of primary school teachers in beni-suef towards traumatic dental injuries.

traumatic dental injuries (tdis) are considered a public health concern representing 5% of all injuries. according to the world health organization (who) about 16-40% of children across the world are subjected to tdis with the most susceptible age group between 6-12 years old. dental trauma may be caused by falls, blows to the face and sports which could be mild as concussion or subluxation, or complicated as avulsion ). the majority of the injuries took place at home followed by school, so teachers are one of the first to be present at the site of action, making their knowledge of emergency management essential to the provision of proper care to an injured child . for example, in cases of avulsion of permanent tooth the proper management is to find the missing tooth and immediately replant, or transport the tooth in suitable transportation media, then referral to the dentist for treatment and follow up. the prognosis of such case mainly depends on the time between the injury and the replantation and the media of transportation . the unnecessary negative consequences of not providing proper first aid management in such case could lead to more time consuming and costly treatment and in a worst-case scenario permanent loss of one or more tooth . this could cause pain and have significant functional, esthetic, speech, and psychological effects on children thus affecting their quality of life . a number of studies have evaluated the knowledge level of schoolteachers with respect to dental trauma and its emergency management concluded that teachers lack knowledge towards traumatic dental injuries. they recommended establishing oral health educational programs to raise the teachers' knowledge and improve their attitude towards tdis . other educational studies showed remarkable increase knowledge after oral health educational program and that is why educational programs and training are needed to improve proper management of traumatic injuries by schoolteachers and avoid unnecessary negative consequences.

Eligibility criteria:
inclusion criteria: * both males and females teachers. * all ages and different periods of experience. * from both private and public schools. * teachers in beni-suef district exclusion criteria: * primary school teachers who refuse to participate. * teachers who attended any previous first aid course.
safety and tolerability of tng456 alone and in combination with abemaciclib in patients with solid tumors with mtap loss

Conditions: Non Small Cell Lung Cancer; Glioma Glioblastoma Multiforme; Glioma, Malignant; Solid Tumor; Non-Small Cell Adenocarcinoma; Lung Cancer; Brain Tumor

Summary: this is a first in human study of tng456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an mtap loss. the first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific solid tumor types with a confirmed mtap loss. the study drug, tng456, is a selective prmt5 inhibitor administered orally. the study is planned to treat up to 191 participants.

this is a phase 1/2 multi-center, open label study in solid tumor patients who have a confirmed mtap loss in their tumor. the phase 1 portion is a dose escalation study of oral tng456 administered as a single agent and in combination with oral abemaciclib in solid tumor patients with confirmed mtap loss. in the phase 2 expansion part of the study, 6 arms defined by confirmed tumor types will enroll in parallel at the rp2d(s) of tng456 and in combination. in both parts of the study participants who tolerate the drug may continue treatment until disease progression.

Eligibility criteria:
inclusion criteria: * has a tumor with a confirmed mtap loss * is ≥18 years of age at the time of signature of the main study icf * has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care therapy is not appropriate. * is able to swallow tablets * adequate organ function/reserve per local labs * negative serum pregnancy test result at screening * has an ecog performance status score of 0 to 1 * has measurable disease based on recist v1.1 or a confirmed glioblastoma (idh-wildtype) with radiographic evidence of disease progression or recurrence defined by rano 2.0. * has an ecog performance score of 0 to 1 or for gbm has a karnofsky performance status score ≥70. exclusion criteria: * a female patient is who is pregnant or breastfeeding * has impaired gi function or disease that may significantly alter the absorption of oral study treatment(s) * has an active infection requiring systemic therapy * has received prior treatment with a prmt5 inhibitor or a mat2a inhibitor * patients in the expansion receiving the combination therapy that have received prior treatment with a cdk4/6 inhibitor * clinically relevant cardiovascular disease * has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol

Keywords: mtap prmt5 inhibitor cdk 4/6 abemaciclib tango
client-centered care coordination for black men who have sex with men

Conditions: HIV Prevention; HIV Pre-exposure Prophylaxis

Summary: the goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (c4) in improving pre-exposure prophylaxis (prep) adherence in black men who have sex with men (msm). the main aims of the study are: 1. determine the efficacy of c4 for increasing prep adherence among black msm. 2. identify the optimal dose of c4 implementation for maximizing its effect on prep adherence. 3. describe the acceptability and feasibility of c4 implementation in community settings. participants in the clinical trial will be randomized to receive the intervention or standard of care for prep in two sites. researchers will compare administration of c4 to standard of care to see if c4 improves adherence to prep. c4 is a longitudinal intervention which provides individualized client-centered hiv prevention and support services designed to address health and psychosocial needs that impact the success of prep use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). the intervention pulls from the centers for disease control and prevention (cdc) comprehensive risk counseling and services (crcs) and self-determination theory (sdt) to support client-identified hiv prevention goals to promote, adopt, and maintain prep use. crcs is a public health strategy to assist persons in developing behavioral goals to reduce hiv acquisition and transmission. in this intervention, the hiv prevention plan element of crcs will be the foundation of the c4 intervention. after the initial prevention plan is developed, elements of sdt will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful prep adherence.


Eligibility criteria:
inclusion criteria: * age of 18 years of age * identify as black, african american, black african, afro-caribbean, or black-latino * cisgender male * prep naïve or who prematurely stopped prep * no prior hiv diagnosis confirmed through hiv testing * self-reported high risk for acquiring hiv * currently not enrolled in another hiv prevention study exclusion criteria: * black msm who received a reactive or positive hiv test at screening or self report hiv-positive * identifying as transgender * current participation in any research study via self-report * use of prep or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment
covid-19 and venous thromboembolism risk

Conditions: Venous Thromboembolism; Covid19

Summary: coronavirus disease 2019 (covid-19) is now a leading cause of death among u.s. adults. in addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (vte) have been increasingly reported in patients with severe covid-19. the aim of this study is evaluate the risk of vte related to covid-19 infection in a real-world community-based population.

this is an observational study of adult (age ≥18 years) members enrolled in the kaiser permanente northern california (kpnc) or kaiser permanente southern california (kpsc) integrated healthcare delivery systems during the time period january 1, 2020 through january 31, 2021, (representing the first year of the covid-19 pandemic) and diagnosed with incident covid-19. the outcomes will be incident vte and all-cause death, assessed through february 28, 2021. the primary analysis will describe the rate of post-covid-19 vte after index diagnosis. a second analysis will compare the risk of vte in hospitalized patients with covid-19 compared with matched hospitalized controls without covid-19.

Eligibility criteria:
inclusion * covid-19 diagnosis (defined as date of a positive laboratory test for sars-cov-2 virus) during the time period january 1, 2020 to january 31, 2021 * age \>=18 years * continuous pharmacy benefits and health plan membership for at least 12 months before the index date exclusion • incomplete information on age and sex