Kornimate/medical-research-clean huggingface dataset:
a trial of telemonitoring in adults with heart failure

Conditions: Heart Failure

Summary: this is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure. the study hypothesis is that telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, emergency room visits in patients with heart failure over the 60 day post hospitalization period.

a 60 day stratified, randomized clinical trial of a home-based telemonitoring system (tep) vs. usual home-care with educational package (ep). both groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. the study will be conducted on 100 patients receiving home care nursing services post-hospital discharge. each participant will be randomized in equal amounts to treatment (tep) or no treatment (ep).

Eligibility criteria:
inclusion criteria: * heart failure (primary or secondary) diagnosis regardless of ejection fraction (ef) and new york heart association (nyha) class ii- iv at the time of home health care (hhc) admission and hhc services initiated following a hospital stay exclusion criteria: * inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence. * additional exclusion criteria were: patients with severe ischemic heart disease, myocardial infarction (mi) and/or coronary artery bypass graft surgery(cabg) in the last 6 weeks, severe uncorrected valvular disease, home inotropic therapy, severe lung disease (oxygen dependent), active cancer, uncorrected thyroid disease, aids, or end stage renal disease on dialysis.
simultaneously integrated dose escalation for locally advanced cervical cancer

Conditions: Squamous Cell Carcinoma of Cervix

Summary: the purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.

concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. while there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, imrt, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. this protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to biological target area defined by pet scan. this dose escalation is to downstage disease for minimal invasive surgical resection.

Eligibility criteria:
inclusion criteria: * biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy. good performance status. negative pregnancy test in women of child-bearing potential. signed study-specific informed consent. lab results within study specific limits exclusion criteria: * prior radiation to the abdomen or pelvis. a history of scleroderma or inflammatory bowel disease. contraindication to chemotherapy or radiation
systematic efficacy replication study of conjoint behavioral consultation in elementary schools

Conditions: Emotional Disturbances

Summary: the purpose of this project is to conduct an impact evaluation of the conjoint behavioral consulting (cbc) intervention under real-world conditions as an ies efficacy replication trial. cbc is a family-school partnership intervention proven efficacious for children with serious emotional and behavior problems. the investigation will conduct a systematic efficacy replication of cbc to identify important process and context variables in need of attention prior to a cbc effectiveness study. school-based specialists (sbss) will implement cbc and will be responsible for working directly with parents and teachers who have a student with or at risk for severe emotional disturbance, with more implementation support (i.e., non-routine conditions) than would be expected under routine conditions to ensure adequate fidelity of implementation. the research questions examine the impact of cbc, when implemented by sbss, on student, parent, and teacher outcomes, as well its effect on mediational pathways. in addition, the research team will gather stakeholder feedback in focus groups to provide information about factors that stakeholders perceive as impeding or promoting cbc adoption, implementation, and sustainability.

sixty schools will be recruited for this impact evaluation (20 from madison metropolitan school district, and 40 from milwaukee public schools). the population for this evaluation will consist of the 12 children from grades k-4 in each participating school who demonstrate the highest levels of behavioral and/or emotional difficulties in school, based on teacher ratings on the basc3-bess screening (and whose families consent to participate in the evaluation). the total population for this evaluation will include 720 students. baseline will take place at the beginning of the intervention school year, outcome 1 at the end of the intervention school year, and outcome 2 at the end of the subsequent school year. at all three timepoints, the research team will gather parent questionnaires (covering competence in problem solving, parenting strategies, parent-teacher relationships, and their child's social and behavioral functioning), teacher questionnaires in relation to each study child (covering the parent-teacher relationship, teacher competence in problem solving, and the student's social and behavioral functioning), direct observations of teacher and student behavior in the classroom, and student records related to discipline.

Eligibility criteria:
inclusion criteria: * enrolled in kindergarten, grade 1, grade 2, grade 3, or grade 4 at recruitment * among the 12 students with the highest risk score on the behavioral and emotional screening system 3 behavioral and emotional screening system (basc3-bess) in the above grade span in their school (among those with parental consent for screening). exclusion criteria: none
treatment and outcomes of stage iii colon cancer in patients 80 years of age and older

Conditions: Colon Adenocarcinoma

Summary: the objective of this study was to assess survival trends in elderly patients with stage iii colon cancer

this retrospective population-based study included patients aged 80 years and older with stage iii colon adenocarcinoma who underwent surgery between 2007 and 2014.

Eligibility criteria:
inclusion criteria: • stage 3 colon adenocarcinoma exclusion criteria: * rectal tumors * patients receiving neo-adjuvant chemotherapy or radiotherapy * tumours of the appendix * tumours with histology other than adenocarcinoma

Keywords: stage 3 colon cancer elderly survival surgery chemotherapy
prospective comparison of 18f-choline pet/ct and 18f-fdg pet/ct in the initial work-up of multiple myeloma

Conditions: Myeloma Multiple

Summary: multiple myeloma (mm) survival has been improved during the last decade owing to new treatments. hence, it has become a matter of importance to precisely define the depth of mm response to therapy. 18f-fdg pet/ct (fdg-pet) has proved to be superior to x-rays for the initial staging of mm. it is now recommended by the international myeloma working group (imwg) during the initial work-up and for response evaluation, as it is superior to mri in that setting. however, sensitivity of fdg-pet remains inferior to that of mri for the initial staging of mm. indeed, fdg-pet remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of mri at diagnosis, and could bring better baseline information than fdg pet for therapy evaluation. ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18f-choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18f-fdg in a recent retrospective study, with about 70% more lesions detected in mm patients with suspected relapsing disease. following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed mm, the detection rate of mm lesions by 18f-choline pet/ct (fch-pet) vs. fdg-pet. our secondary objectives will be to compare the performance of both pet modalities as regard to mri as well as the detection rate of extra-medullary lesions. patients with mm will proceed to fch-pet, fdg-pet and then whole-body mri within 3 weeks.


Eligibility criteria:
inclusion criteria: * symptomatic multiple myeloma on first-line treatment as defined by 2014 international myeloma working group criteria * measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay * age \> 18 years old at time of signed consent * beneficiary of social security insurance * signed informed consent exclusion criteria: * previous multiple myeloma treatment * previous cancer with less than 5 year of complete remission (including plasmacytoma) * chemotherapy in the 6 months preceding the inclusion * uncontrolled diabetes mellitus * medullary growth factor injection less than 48 hours before imaging procedures * ongoing corticosteroid therapy, or given less than 72 hours before pet-ct imaging * pregnant or nursing (lactating) women * childbearing potential woman without adequate barrier contraception method (has criteria) * freedom deprivated patient by judiciary or administrative decision * patient under legal protection or unable to express its own consent * pet contraindication (known allergy to 18f-fch or 18f-fdg or excipient) * mri contraindication

Keywords: multiple myeloma pet/ct 18f-fdg 18f-fch
the ability of songha night ® to improve sleep in patients with mild to moderate sleep disturbances

Conditions: Sleep Initiation and Maintenance Disorders

Summary: to evaluate the effect of songha night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.


Eligibility criteria:
inclusion criteria: * psychophysiologic insomnia * severity: mild to moderate * duration: subacute to chronic * subjects age \> 18 and \< 65, men or women * subject had to give written informed consent exclusion criteria: * regular use of psycho-active drugs * work in shifts * use of psychoactive drugs during the past 30 days * any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.) * known hypersensitivity to any of the ingredients of the study drug * pregnancy, lactation, women of childbearing potential not using an established contraceptive * drug and alcohol abuse * participation in another trial within the past 30 days
end-expiratory lung volume in children awakening from propofol anesthesia

Conditions: Atelectasis, Postoperative Pulmonary

Summary: the goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery. the main question\[s\] it aims to answer are: * high flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients? * head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients? researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia. and in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing airway surgery with high flow nasal oxygen exclusion criteria: * loss of spontaneous ventilation during surgery * less than 1 months * cyanotic patients
classification of benign and malignant lung nodules based on ct raw data

Conditions: Lung Cancer; Image, Body

Summary: the employ of medical images combined with deep neural networks to assist in clinical diagnosis, therapeutic effect, and prognosis prediction is nowadays a hotspot. however, all the existing methods are designed based on the reconstructed medical images rather than the lossless raw data. considering that medical images are intended for human eyes rather than the ai, we try to use raw data to predict the malignancy of pulmonary nodules and compared the predictive performance with ct. experiments will prove the feasibility of diagnosis by ct raw data. we believe that the proposed method is promising to change the current medical diagnosis pipeline since it has the potential to free the radiologists.

the routinely used diagnostic scheme of cancers follows the process of signal-to-image-to-diagnosis. it is essential to reconstruct the visible images from the signal of medical device so that the human doctor can perform diagnosis. however, the huge amount of information inside the signal is not optimally mined, which causes the current unsatisfactory performance of image based diagnosis. in this clinical trial, we will develop an ai based diagnostic scheme for lung nodules directly from the signal (raw data) to diagnosis, skipping the reconstruction step. in this trial, we will focus on the discrimination of malignant from benign lung nodules. we will collect a dataset of patients who are screened out lung nodules. all patients undergo preoperative ct scan (raw data and ct images available) and have pathologically confirmed result of the nodules. we will build a model using only raw data for diagnosis of the lung nodules. moreover, another model from ct image will be built for comparison. furthermore, we will perform follow-up on these patients and build a model based on ct raw data for prognosis analysis of lung cancer.

Eligibility criteria:
inclusion criteria: 1. patients who are screened out lung nodule. 2. the ct data and corresponding ct raw data are available before the surgery. 3. final pathology diagnosis of the malignancy of the nodule is available. exclusion criteria: 1. previous history of lung malignancies. 2. artifacts on ct images seriously deteriorating the observation of the lesion. 3. the time interval between ct scan and pathology diagnosis is more than 4 weeks.

Keywords: radiomics lung cancer classification ct raw data
a study of gdc-0134 to determine initial safety, tolerability, and pharmacokinetic parameters in participants with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this first-in-human, double-blind, placebo-controlled phase i study will be conducted in participants with amyotrophic lateral sclerosis (als) to explore safety, tolerability, and pharmacokinetic (pk) properties of gdc-0134. it will include three components: a single-ascending-dose (sad) stage, a multiple-ascending-dose (mad) stage, and an open-label safety expansion (ose) stage.


Eligibility criteria:
inclusion criteria: * male or female participants with a diagnosis of possible, laboratory-supported probable, probable, or definite als according to modified el escorial criteria * upright forced vital capacity of at least 50 percent (%) * ability to fast from food for 8 hours prior to dosing and 2 hours after dosing exclusion criteria: * currently taking riluzole unless on a stable dose for the 3 months prior to day -1 and without current liver enzyme or liver function abnormalities * currently taking edaravone unless after completion of at least the second 14-day drug-treatment period, as long as day 1 occurs during a drug-free period at least 24 hours after the last edaravone dose and at least 5 days prior to the first dose of the next cycle * positive for hepatitis c antibody, hepatitis b surface antigen, or human immunodeficiency virus (hiv) antibody * clinically significant thrombocytopenia * currently taking nutritional/herbal supplements, except for over-the-counter vitamins that are within recommended dietary allowance (rda), unless discontinued at least 7 days prior to day -1, except upon approval of both the investigator and sponsor * for participants participating in a designated drug-drug interaction (ddi) cohort in the mad stage of the study, who require midazolam/caffeine administration: known allergy, religious prohibition, or other condition limiting midazolam or caffeine administration
nc young women's coop

Conditions: Condomless Sex; Human Immunodeficiency Virus (HIV); Sexually Transmitted Infection (STI); Alcohol and Drug Use

Summary: this three-arm cross-over randomized trial will develop, test, and compare the efficacy of two delivery formats of the young women's coop (ywc), which is designed to provide risk reduction and empowerment skills, as well as linkages to healthcare services for women who use substances. the current study will develop a revised version of the ywc and evaluate the relative efficacy of a face-to-face (face-to-face ywc), mobile health application (mhealth ywc) delivery format, and hiv counseling and testing (hct) as a control to reduce risky sexual behaviors and reduce substance use among young (18-25) african american women who use substances and are sexually active and have not recently been tested for hiv in three nc counties.

the purpose of this study is to use the seek, test, treat, and retain framework to develop and test the efficacy of a clinic-based, age-appropriate, woman-focused hiv risk-reduction intervention to reduce sexual risk among up to 700 young sexually active african american women aged 18 to 25 who use drugs in three north carolina counties. the researchers will test the delivery of the woman-focused intervention conducted in two formats, face-to-face ywc and mhealth ywc, using a three-arm cross-over randomized design in which counties are randomized to (1) hct as the control, (2) face-to-face ywc; and (3) mhealth ywc that will be delivered on tablets using an interactive app. the researchers will fulfill the purpose of this study through the following aims: (aim 1) to develop a new ywc intervention and recruitment strategies using formative methods to engage young african american women who use substances and have not recently been tested for hiv, clinic staff, and stakeholders to ensure age appropriateness, to identify barriers to reaching these young women and the challenges in conducting the intervention in the clinics, and to develop the mhealth ywc; (aim 2) to test the efficacy of two formats of the woman-focused intervention program (face-to-face ywc and mhealth ywc) relative to hct with up to 700 young women aged 18 to 25 in three north carolina county health departments for primary outcomes at 6-, and 12-month follow-up assessments; (aim 3) to estimate the total costs of implementing the face-to-face ywc and mhealth ywc interventions, and to assess the resource components that drive these costs; and (aim 4) to examine the extent to which the face-to-face ywc and mhealth ywc are perceived by collaborating health clinic staff and participants as being acceptable and sustainable.

Eligibility criteria:
selected inclusion criteria: * identify as female * identify as black or african american * 18-25 years of age * have used alcohol or drugs in greater quantity or for a longer period of time than intended within the past 30 days exclusion criteria: * participants may not be non-black/african american

Keywords: human immunodeficiency virus (hiv) sexually transmitted infections (sti) mhealth substance abuse violence victimization sexual risk
examining community-based effectiveness of a substance use and hiv risk reduction intervention for young men of color

Conditions: Substance Use; Sexual Risk

Summary: this study will conduct an effectiveness trial of the 4-session evidence-based ymhp intervention for young men who have sex with men (ymsm) of color ages 15-29 at two cbos in new york city, compared to usual care.

we will conduct a comparative effectiveness trial (cet) with two intensities of treatment to be offered following field-based hiv counseling and testing (c\&t) - the young men's health project (ymhp) intervention and an enhanced "treatment as usual" (etau) condition involving hiv prevention services provided at two community based organizations (cbos) to test their relative effectiveness in reducing substance use and sexual risk behavior among hiv-negative ymsm. in collaboration with two cbos, our goals are to better understand substance use and sexual health-related outcomes among hiv-negative ymsm who are unlikely to be treatment seeking and to implement the ymhp intervention in a way that will maximize portability and scalability. working together with our collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and hiv infection among ymsm.

Eligibility criteria:
inclusion criteria: * hiv-negative test result from the past 90 days * 15-29 years of age * born biologically male or currently identifying as male * sex with men in the past 90 days * ≥ 5 days of illicit drug use in the past 90 days * ≥ 1 episode of condomless anal sex (cas) in the past 90 days, or a positive sexually transmitted infection test result in the past 90 days. * living in the new york city area * able to communicate in english exclusion criteria: * serious cognitive or psychiatric impairments * ≥5 days of injection drug use in the past 90 days * currently taking truvada as pre-exposure prophylaxis (prep)