Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of atenas association in the treatment of type ii diabetes mellitus and hypertension

Conditions: Hypertension Associated; Type II Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of atenas association in the treatment of type 2 diabetes mellitus and hypertension


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years; * participants presenting the diagnosis of type ii diabetes mellitus, and who did not reach the therapeutic goals of hba1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months; * participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * history of alcohol abuse or illicit drug use; * participation in a clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * known hypersensitivity to any of the formula compounds; * type 1 diabetes mellitus; * known or suspected secondary hypertension.

Keywords: hypertension type ii diabetes mellitus
the change club study: evaluation of civic engagement for built environment change and health improvement

Conditions: Heart Diseases

Summary: this is a community randomized controlled trial to evaluate a civic engagement curriculum through which residents will identify barriers and facilitators to healthy eating and physical activity and then implement a project in their communities.

the purpose of this research is to better understand how resident-led activities to change the community environment affect health. the change club is a small group of residents who will try to change their community environment relative to food (for example, foods in restaurants or schools) or physical activity opportunities (for example, parks or walking trails) by following a step-wise process facilitated by an extension educator. the purpose of this research is to better understand if and how these activities affect individual behaviors (for example physical activity) and health outcomes (for example bmi) of adults in rural communities. this study will take place in designated rural communities in texas and new york. it is planned that about 2,260 people will participate in this study. some will participate as change club members; some will participate as family and friends of change club members; and others will participate as community residents.

Eligibility criteria:
inclusion criteria: we will be recruiting change club members (ccm), friend and family members (ffm) of ccm, and community residents (cr). common inclusion criteria include: * age 18-99 * english-speaking ccm also must: * provide consent electronically * be willing to be randomized to either group * score "poor" or "intermediate" on at least one of the simple 7 composite score items (e.g. not meeting physical activity guidelines for americans) * live in one of the designated towns in ny and tx ffm also must: * provide consent electronically * be family members or friends identified by a ccm cr also must: * provide consent electronically * live in one of the designated towns in ny and tx exclusion criteria: * cognitive impairment (if it precludes completion of assessments and/or intervention) * inability to communicate due to severe, uncorrectable hearing loss or speech disorder (if it precludes completion of assessments and/or intervention) * severe visual impairment (if it precludes completion of assessments and/or intervention) * inability to read (as it precludes completion of assessments and/or intervention) * already included in another study sample (e.g. cr cannot also be ccm)

Keywords: physical activity built environment eating habits
sham lasercap vs. lasercap sd vs. lasercap hd+

Conditions: Androgenetic Alopecia

Summary: androgenetic alopecia (aga) is a prevalent disease, occurring in 80% of caucasian men and 50% of caucasian women by age 701. treatments for aga are limited, and presently the only fda-approved medications for aga are topical minoxidil and oral finasteride1. in addition to medical therapies, fda-cleared medical devices are now utilized for the treatment of aga as of 20072. these devices, termed low level laser therapy (lllt), come in multiple forms including combs, helmets and sports cap wearable devices2. these home-use, wearable devices utilize the \~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3. recent meta-analyses investigating photobiomodulation and lllt for aga have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. however, randomized control trials (rct) with direct comparison of lllt devices of different fluences has yet to be performed. accordingly, in the present study we aim to investigate if increasing fluence in lllt devices is associated with increased hair density by comparing sham lasercap to lasercap sd (1.15 j/cm2, low fluence) and lasercap hd+ (3.93 j/cm2, high fluence) in rct.


Eligibility criteria:
inclusion criteria: * 25 years and older * men and women with aga, untreated or with 6-month washout of previous treatments * men: norwood stage iia - v * women: ludwig i-1 - ii-2, or frontal pattern * all patients: fitzpatrick skin types i to iv exclusion criteria: * men: norwood stage va, vi, vii * women: ludwig stage iii, advanced * all patients: fitzpatrick skin types v, vi * current use or within the past six month of other treatment for aga, including topical and oral minoxidil, topical and oral finasteride and dutasteride * age 0-25 years
efficacy mechanism of n-acetylcysteine in patients with posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: it has been suggested that n-acetylcysteine exerts neuroprotective effects by regulating neurotransmitters and cell signaling pathways. we hypothesize that oral n-acetylcysteine augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well as improve cognitive functions. we also expect that the n-acetylcysteine augmentation will induce change in structural, functional, and neurochemical aspects of the brain. in this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation study with n-acetylcysteine in addition to escitalopram. we will assess the efficacy and safety of the n-acetylcysteine augmentation.


Eligibility criteria:
inclusion criteria: * 20-65 year-old male or female * posttraumatic stress disorder diagnosed by scid-iv * written informed consent exclusion criteria: * medication treatment for posttraumatic stress disorder within 2 weeks * neurologic disease (eg., penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, cerebrovascular diseases) * any other axis i psychiatric disorder * iq below 80 * contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.) * any psychotropic medication within 2 weeks * unstable medical illness or severe abnormality in laboratory test at screening assessment * women who are pregnant, breastfeeding, or planning pregnancy * history of myocardial infarction within 6 months * current diagnosis of duodenal ulcer or asthma * contraindications to drugs used in the study (e.g., epilepsy, uncontrolled narrow-angle glaucoma, etc.) * allergy or intolerance to the study drug

Keywords: posttraumatic stress disorder n-acetylcysteine magnetic resonance imaging
a comparison of nivolumab-based treatments in a real-world pd-l1 positive metastatic melanoma population in the us

Conditions: Melanoma

Summary: the goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for pd-l1 expression treated first line (1l) with either nivolumab and ipilimumab in combination (nivo + ipi) or nivolumab (nivo) monotherapy


Eligibility criteria:
inclusion criteria: * adults 18 years or older * first advanced of diagnosis of metastatic/stage iv) melanoma * tested for pd-l1 expression with a tumor proportion score (tps) greater than or equal to 1% (phase 1 data collection) * initiating a first line of therapy during the index period between october 1, 2015 through july 1, 2017 * medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) exclusion criteria: * patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/stage iv) melanoma other protocol defined inclusion/exclusion criteria could apply
objective choroidal thickness measurements in uveitis

Conditions: Uveitis

Summary: optical coherence tomography (oct) machines are non-contact instruments that can provide micrometer scale imaging of biological tissue. applying the image processing allows us to automatically measure the choroidal thickness with good interclass correlation coefficient to the manual measurements.


Eligibility criteria:
inclusion criteria: * to the control group - ability to perform oct examination * to the uveitis group - with one or more of the following clinical features (as indicators for active state of the disease): 1. \>1+ anterior chamber cells; 2. \>1+ vitreous haze; 3. presence of vitreous cells; 4. presence of blood in anterior chamber; 5. presence of blood in vitreous; 6. presence of aqueous or vitreous pigment. exclusion criteria: * to the control group - diagnosed uveitis * in case of all groups: 1. inability to give informed consent; 2. inability to maintain stable fixation for oct imaging.
impact of the geographical factor on the prostate cancer stage at hormonal therapy initiation

Conditions: Prostate Cancer

Summary: french epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. the main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).


Eligibility criteria:
inclusion criteria: * patients with histologically demonstrated prostatic adenocarcinoma. * patients never previously treated with hormonal therapy for prostate cancer. * patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment). * patients agreeing to the collection of personal health data for the purposes of the study. * patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment. exclusion criteria: * patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation. * patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including gnrh receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).
gb001 in adult subjects with moderate to severe asthma

Conditions: Asthma

Summary: a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of gb001 when added to standard-of care (soc) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.


Eligibility criteria:
inclusion criteria * a diagnosis of asthma by a physician at least 12 months before screening visit. * treated with medium or high dose inhaled corticosteroid (ics) plus additional controller for at least 12 months prior to screening visit. subjects must maintain a stable ics dose regimen during the 4 weeks prior to the screening visit. * forced expiratory volume in 1 second (fev1) of ≤ 85% of predicted normal * demonstrated reversibility of at least 12% in fev1 * evidence of uncontrolled asthma * eosinophilic asthma * no changes in ics dose and compliant with standard of care asthma therapy during run-in period. exclusion criteria * current smokers (any substance) * serious co-morbidities * fridericia's correction qt factor (qtcf) ≥450 msec (male) or ≥470 msec (female) * use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to screening visit * regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal antibodies for asthma * pregnant or breastfeeding other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gb001 eosinophilic asthma moderate asthma severe asthma
responding to children and adolescents with tyrannical behaviour

Conditions: Oppositional Defiant Disorder

Summary: this was a randomized controlled trial that compared the nvr intervention group with a tau group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (stb).


Eligibility criteria:
inclusion criteria: 1. being the parent of a child aged 6 - 20 years who endorses the dsm-5 criteria of iodd. in fact, odd is considered a necessary but not a sufficient condition for tyranny behavior 2. two or more positive answers to the custom quetions routinely used to identify stb in children/adolescents at the university hospital of montpellier), related to a 12 month period : * are you afraid of your child? * is your child physically or psychologically violent toward you? * do you think that your child is the decision maker in the family? * do you feel ashamed by your situation at home? 3. being able to attend half of the sessions. exclusion criteria: 1. predicted absence from at least half of the sessions 2. subject deprived of liberty 3. subject under guardianship or curatorship.

Keywords: child-to-parent violence severe tyrannical behaviour nvr parental training program
dose-response enteral citrulline for normal healthy volunteers and surgery patients

Conditions: Nutritional Deficiency

Summary: to determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.


Eligibility criteria:
inclusion criteria: * adults, male \& female, non-pregnant * bmi 18.5-29.9 exclusion criteria: * cancer * hiv positive
the effect of childhood dyslipidemia on endothelial and renal function

Conditions: Dyslipidemias; Children, Only; Endothelial Dysfunction; Renal Dysfunction; Hypercholesteremia in Children

Summary: the aim of the study is to assess if abnormal lipid levels in childhood could cause early damage of the inner layer of the vessels, the endothelium. dysfunction of the endothelium is the first event in the development of atherosclerosis, is present at all stages of atherosclerosis and is potentially reversible in childhood. it has been suggested that dyslipidemia, via its detrimental effects on endothelium, could impair renal function. this study will assess the dysfunction of the kidneys in children with dyslipidemia.

in children recruited in the study, family history of dyslipidemia or premature cardiovascular disease will be recorded. furthermore, anthropometric and clinical characteristics will be noted and lipid measurements will be obtained at recruitment after a fasting period. the investigators will test in children the flow-mediated dilation (fmd) which assesses the vasodilation due to the production of nitric oxide from the endothelium in response to occlusion-induced hyperaemia of the branchial artery and the carotid intima-media thickness (cimt). these non-invasive ultrasound indices detect early vascular damage. renal function will be assessed in children with dyslipidemia by a new marker in serum, cystatin c, which is more accurate and reliable than creatinine. also, creatinine serum levels and estimated glomerular filtration rate (egfr) will be evaluated. additionally, total protein, albumin, electrolyte and β2-microglobulin excretion in urine will be measured.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 7 to 17 years * dyslipidemia (serum levels of ldl-cholesterol ≥95th percentile or serum levels of triglycerides ≥95th percentile or serum levels of hdl-cholesterol ≤5th percentile for age and sex) exclusion criteria: * history of renal disease * dyslipidemia caused by nephrotic syndrome or chronic kidney disease * chronic use of medication * acute or chronic inflammatory process
a study evaluating the efficacy and safety of adjuvant platinum-doublet chemotherapy, with or without atezolizumab, in patients who are ctdna positive after complete surgical resection of stage ib to select iiib non-small cell lung cancer

Conditions: Carcinoma, Non-Small Cell Lung

Summary: this is a phase ii, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with stage ib to iiib (t3n2) nsclc following surgical resection who are positive for ctdna.


Eligibility criteria:
inclusion criteria: * complete resection (r0) and pathologically confirmed stage ib to select iiib nsclc (8th edition) * submission of pre-surgery blood sample and surgically resected tumor tissue slides or block * eastern cooperative oncology group (ecog) performance status of 0 or 1 * normal life expectancy excluding lung cancer mortality risk * positive ctdna status in plasma confirmed by central laboratory testing after surgical resection and prior to start of adjuvant therapy. exclusion criteria: * resected nsclc with positive margins (r1 or r2) * nsclc with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma * mixed nsclc and sclc histology * any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy * nsclc with an activating egfr mutation or alk fusion oncogene * prior treatment with cd137 agonists or immune checkpoint blockade therapies, including anti-ctla-4, anti-pd-1, and anti-pd-l1 therapeutic antibodies
effectiveness of an anti-bullying intervention for adolescent perpetrators

Conditions: Conduct Disorder

Summary: the investigators recruited school bullying perpetrators from the age of 12 to 17 by referral from the local police department. an anti-bullying intervention based on cognitive-behavioral therapy (cbt) principles was conducted, and addressed issues related to impulse control, empathy and communication enhancement. all participants completed brain magnetic resonance imaging, neurocognitive tests, and questionnaires before and after the intervention.

the present study included previous perpetrators of school bullying who were convicted for a minor offense, including physical or verbal assaults or theft, and who were referred by the police to participate in an anti-bullying intervention. the program consisted of 8 sessions over 4 weeks and was conducted by a board-certified psychiatrist and a therapist with previous training in psychosocial treatments. the intervention was based on cbt principles and addressed various factors that have been associated with perpetrators of school bullying, including impulse control, perspective taking (empathy), and the enhancement of communication skills. all participants completed the korean kiddie schedule for affective disorders and schizophrenia-present and lifetime version (k-sads-pl) administered by board-certified child and adolescent psychiatrists. the validity and reliability of the original and korean versions of the k-sads-pl have been established. intelligence quotient (iq) was measured using the korean educational developmental institute's wechsler intelligence scale for children. prior to and after participation in the program, all participants underwent brain magnetic resonance imaging (structural and functional) and completed neurocognitive tests that included the continuous performance test (cpt), the stroop word and color test, and the wisconsin card sorting test (wcst). the parents of the participants completed questionnaires including the child behavior checklist (cbcl). written informed consent was obtained from the parents and the participants after sufficient explanation of the study. the study protocol was approved by the institutional review board of the seoul national university hospital.

Eligibility criteria:
inclusion criteria: * no psychiatric diagnosis or psychiatric diagnoses including conduct disorder, depressive disorder, oppositional defiant disorder, attention-deficit hyperactivity disorder, and adjustment disorder. * iq \> 70 * agreement to participate * ability to cooperate in group therapy exclusion criteria: * any psychotic disorder * severe impairment in impulse control * not cooperating with program participation * iq \< 70 * current or past history of brain trauma or organic brain disorder, seizure disorder, or any neurological disorder.
the iressa novel head and neck chemotherapy evaluation study

Conditions: Squamous Cell Cancer; Cancer of Head and Neck

Summary: the purpose of this study is to compare the objectie tumour response rate between the cisplatin/5fu and cisplatin/5fu plus zd1839 combination


Eligibility criteria:
inclusion criteria: * provision of written informed consent * patients with histologically proven primary scchn * aged 18 or over exclusion criteria: * patients eligible for surgery with curative intent * other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * exclude ucnt