Kornimate/medical-research-clean huggingface dataset:
bioequivalence study for acarbose / metformin fdc

Conditions: Diabetes Mellitus, Type II

Summary: to establish the bioequivalence between acarbose / metformin fdc (50mg / 500mg) and loose combination of acarbose (glucobay) (50mg) and metformin (glucophage) (500mg).


Eligibility criteria:
inclusion criteria: * body mass index (bmi): 18 to 28 kg/m2 (inclusive) * results of glycosylated hemoglobin a1c (hba1c) value are within the normal range (4.3-5.6%, inclusive) * results of the 75 g oral glucose tolerance test (ogtt) during screening show: * blood glucose before ogtt \<110 mg/dl. * blood glucose 1 hour after glucose loading \<180 mg/dl * blood glucose 2 hours after glucose loading \<140 mg/dl exclusion criteria: * a history of relevant diseases of internal organs (diabetes mellitus, ileus, ileus-like symptoms, diseases that may significantly jeopardize body systems * febrile illness within 1 week before drug administration * family history of diabetes (within the second degree of relationship) * known drug hypersensitivity or idiosyncrasy * known severe allergies, non-allergic drug reactions, or multiple drug allergies * habitual medication including chinese herbal drugs * intake of any drugs within 2 weeks of drug administration of period 1 * regular daily consumption of more than 1 l of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form * donation of more than 150 ml of blood within 4 weeks before the screening examination * participation in another clinical trial within 4 weeks before the screening examination

Keywords: bioequivalence acarbose metformin fdc
transdiagnostic group cognitive behavioral therapy (psicap-a) for adolescents with emotional disorders

Conditions: Emotional Disorder

Summary: emotional disorders such as anxiety and depression are highly prevalent during adolescence and associated with functional impairment that commonly extends into adulthood. in the primary care (pc) setting, these disorders are frequently underdiagnosed and undertreated. objective: to carry out a prospective, randomized controlled trial (rct) to test the efficacy of a new transdiagnostic cognitive behavioural group therapy (td-cbt) protocol for adolescents (age 12 to 18 years) compared to group relaxation therapy (rt). methods: two-arm, single-blind, rct (expected n=160) to compare group td-cbt for emotional disorders to group rt. the group td-cbt will be administered in seven sessions (90 min/session) over 12 weeks. psychological assessments will be carried out at baseline, post-treatment, and at months 3, 6, and 12 after treatment. the assessments will include measures of depression, anxiety, somatization, quality of life, disability, and cognitive-emotional factors. the study will be conducted in two pc centres located in cantabria, spain. discussion: this is the first rct to evaluate the efficacy of group td-cbt for emotional disorders in adolescents in the pc setting in spain. if, as expected, the results confirm the superiority of td-cbt to conventional rt, the widespread implementation of this new approach-based on scientific evidence obtained in a real-world, primary care setting-could improve treatment outcomes and quality of life in adolescents suffering from anxiety or depression.


Eligibility criteria:
inclusion criteria: * patients aged 12 to 17, inclusive, who present to the pc centre seeking treatment for symptoms of anxiety or depression. * scores above the predetermined cut-off points on the gad-7 (\>= 5) and phq-9 (\>= 5). * agreement to participate in the study, with written informed consent provided by both patients and parents/guardians. exclusion criteria: * presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder, and major depressive disorder (phq-9\> 20). * presence of severe or recent suicide attempts * moderate or severe behaviour disorder that could interfere with the dynamics of the therapy groups. * presence of a mental disability (iq \< 75). * be receiving psychological treatment or any type of specialized care related to mental health. * receiving any psychopharmacological treatment. * parents involved in legal litigation due to separation or divorce.

Keywords: emotional disorders cognitive behavioural therapy adolescents
improving transition outcomes for youth with asd in a medicaid accountable care organization

Conditions: Autism Spectrum Disorder

Summary: despite an increasing number of children with autism spectrum disorder (asd), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (tay). the investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large medicaid accountable care organization (aco). the investigators will conduct a randomized pilot study of 40 families of tay with asd. all families will receive care by providers trained in the got transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. families in the 'intervention refinement' arm will also receive a family-based problem solving education (pse) intervention.

this is a randomized pilot study of 40 families of tay with asd. families will be randomly allocated to study arms - not for the purpose of maximizing internal validity; but rather, to allow us to refine recruitment techniques that maximize the acceptability of randomization. twenty families in the 'intervention refinement' arm will receive a pse-based intervention; among this group, the model will be refined in real time - based on both experience delivering the intervention and ongoing qualitative data collection. refinement arm participants will receive a pse prototype based on prior initial adaptations. each pilot family will also be asked to participate in a semi-structured interview. the interviews will be conducted after families have experienced at least 3 pse sessions and use their data to further refine the model and develop hypotheses concerning testable intervention targets. among 20 families in a control-like 'parameter estimation' arm, empiric estimates will be obtained of study parameters key to the design of a future trial. all families in this arm will receive care from providers trained in the got transition toolkit, and will have access to web-based resources for creating a young adult vision statement and for accessing multiple service sectors. participants will be tracked over six-months. consistent with pilot methods, the analysis will not emphasize comparisons across study arms

Eligibility criteria:
caregivers 18+ and transition aged youth with autism ages 14-20 inclusion criteria: * speak english or spanish exclusion criteria: * foster families * families in which a parent has either serious mental illness or limited cognitive capacity

Keywords: transition-aged youth (tay) medicaid aco got transition toolkit problem solving education (pse)
investigation of contralateral arytenoid sparing imrt for t1a & t2a larynx cancer & analysis of post-treatment laryngeal function

Conditions: Laryngeal Neoplasms

Summary: the aim of this study is to define a new treatment technique for t1a larynx cancer that maintains excellent local control with less extensive radiation fields. it is thought that this will lead to patients having fewer changes to their voice and a higher quality of life after treatment when compared to the current standard treatment.

parallel opposed portal external beam radiation is the standard nonsurgical treatment for t1-2n0 glottic cancer. this technique involves treatment of the entire larynx for tumors that are small and limited. although technological advances now allow radiation oncologists selectively to target and avoid adjacent sub-portions of any organ, these tools have not been applied t1-2n0 glottic cancer due to the perceived low toxicity of standard therapy. however, radiotherapy for early glottic cancer is not without functional side effects and it is not known whether post-treatment function after whole larynx radiation is superior to a more targeted surgical approach. this is a phase ii study to treat unilateral glottic cancer (stage t1a and t2an0) with intensity modulated radiation therapy (imrt). in view of the anticipated small volume of disease at presentation and need to limit the potential for a "marginal miss", treatment will include the entire involved vocal fold, anterior commissure, and the anterior 1/3 of the contralateral vocal fold thus sparing the contralateral arytenoid cartilage and musculature ("contralateral arytenoid sparing imrt"). in addition, we propose to perform sophisticated objective and patient reported measures regarding speech outcomes for two years after the completion of therapy at specified intervals, to better gain an understanding of the effects of therapy. our findings will have the potential to dramatically advance the field of early larynx cancer therapy by demonstrating the efficacy of limiting the volume of uninvolved larynx that receives radiation and comprehensively assessing the functional outcomes of said therapy.

Eligibility criteria:
* inclusion criteria: * patients with t1a or t2a squamous cell carcinoma of the glottic larynx (tumor limited to one vocal cord with normal cord mobility). * patients must be able to read and write english to comply with the questionnaire portions of the protocol. * ecog performance status of 0 or 1. * exclusion criteria: * patients with verrucous or adenocarcinoma * patients with t1 tumors on both cords (t1b) * patients with t2b-t4 true larynx tumors * patients with primary supraglottic tumors that involve the true larynx * patients with a prior or concurrent malignancy (other than nonmelanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless the previous cancer was treated 5 years or more prior to the current tumor and the patient has remained continually disease free * patients who have received prior radiation to the head and neck * pregnant or breastfeeding women

Keywords: t1a larynx cancer t2a larynx cancer
is covid-19 transmitted through human milk? implications for breastfeeding and human milk banking-study 1c

Conditions: COVID-19 Vaccine; Breastmilk

Summary: this will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against sars-cov-2 (covid-19 vaccine). mothers may have delivered at mount sinai hospital or may be from the general public recruited by social media or word of mouth. as the study participants will be lactating mothers, they will not be under the care of the investigators. due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mrna vaccines (e.g. pfizer-biontech and moderna covid-19 vaccines) and in the future at least two other vaccines (e.g. oxford-astrazeneca) as they are approved and become available. milk samples will be analyzed for the presence of antibody to sars-cov-2 using the anti-sars-cov-2 elisa (igg and iga). these analyses will be conducted in the department of microbiology at sinai health following validation of the procedures in human milk.


Eligibility criteria:
inclusion criteria: * lactating birthing persons from the general public or sinai health system exclusion criteria: * none
a comparison of chlorhexidine and green tea mouthwash in patients with gingivitis and their salivary neutrophil and tac levels

Conditions: Periodontal Diseases

Summary: a comparison of chlorhexidine and green tea mouthwash in patients with gingivitis and their salivary neutrophil and tac levels.

this research was structured as a double-blind, randomized clinical trial to assess the effectiveness of chx and green tea mouthwash on periodontal health in patients with gingivitis. 84 patients from the department of periodontics at broujerd dental school of the islamic azad university of medical sciences were chosen for the study. before the commencement of the trial, various clinical periodontal parameters, such as plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level, were measured in six different areas of the tooth surface. subsequently, scaling and root planning were carried out, and oral hygiene practices were enhanced for all participants. the participants were then randomly divided into three groups: group a, chx, and group b, which was provided with green tea mouthwash two times daily. after three months, the clinical periodontal parameters were reevaluated. furthermore, to compare the total pmn and tac levels in saliva before and after the administration of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using uv-spectrophotometric methods. the selection criteria for eligible participants in this study were also clearly defined.

Eligibility criteria:
inclusion criteria: a minimum of 20 natural teeth; a mean plaque index (pi) of at least 1.5, (10); a mean gingival index (gi) of at least 1.0 (patients with a gingival index score of ≥1 at more than 60% of sites exclusion criteria: with systemic diseases, those who had undergone antibiotic therapy in the past three months, and anyone who had received periodontal treatment within the last six months. participants diagnosed with aggressive periodontitis, individuals with known allergies to statin medications, and those currently undergoing statin treatment or using medications that may affect periodontal health were also not eligible. furthermore, individuals who are immunocompromised, those who use tobacco products, and lactating or pregnant women were excluded from participation.

Keywords: gingivitis, saliva, green tea, chlorhexidine, neutrophil
a study of ly900014 in a medtronic pump

Conditions: Type1 Diabetes Mellitus

Summary: the purpose of this study is to compare the study drug ly900014 to insulin lispro (humalog) when both are delivered by the medtronic minimed 670g system in adults with type 1 diabetes (t1d). the study will consist of two treatment periods of 4 weeks.


Eligibility criteria:
inclusion criteria: * participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months * participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days * participants must have hemoglobin a1c (hba1c) values ≥6.0% and ≤8.0% * participants must have been using the minimed 670g insulin pump for at least the past 90 days * participants must use their guardian (3) sensor at least an average of 75% of the time and remain in auto mode an average of 70% of the time exclusion criteria: * participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months * participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening * participants must not have a total daily insulin dose \>100 units * participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via csii in the 30 days prior to screening * participants must not have major problems with their heart, kidneys, liver, or have a blood disorder
pa-824-cl-007: phase iia evaluation of early bactericidal activity in pulmonary tuberculosis

Conditions: Pulmonary Tuberculosis

Summary: the trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of pa-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. a control group will receive standard tb treatment.


Eligibility criteria:
inclusion criteria: * informed consent * m/f 18-64 yo * newly diagnosed pulmonary tb * sputum positive * adequate contraception exclusion criteria: * poor health * rifampicin resistance * treatment with other anti tb agents in last 3 mos. * extrapulmonary tb * copd * neuropathy * ecg wih qrs prolongation ove 120 msec * cv disorder * diabetes requiring insulin * metabolic disease * drug/alcohol abuse * pregnancy * use of substances that are strong inhibitors/inducers of cyp450 * use of arv

Keywords: early bactericidal activity eba pulmonary tuberculosis pa-824 pretomanid cl-007
effect of cinnamon on glucose and lipid levels in non-insulin dependent type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Adult Onset

Summary: the purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.

forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. the dose of cinnamon will be one gram daily. fasting serum glucose, triglyceride, total cholesterol, ldl, hdl, and insulin levels will be measured at baseline and at 1, 2, and 3 months. hba1c levels will be measured at baseline and at 3 months. patients will be monitored for compliance, adverse effects, and dietary changes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * hba1c \> 6.0% * age 18 and above * able to obtain consent exclusion criteria: * currently taking insulin * pregnancy * end-stage renal disease * hemolytic anemia * cinnamon intolerance * inability or unwillingness to adhere to study protocol

Keywords: cinnamon diabetes mellitus hyperlipidemia insulin resistance
reliability and validity of mediterranean colorectal cancer registry

Conditions: Registries

Summary: the study will examine the validity and reliability of the mediterranean colorectal cancer registry. aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the mediterranean colorectal cancer registry.

although central cancer registry programs have many benefits (the determination of national cancer incidences, strategic planning of health care systems etc.) data entry in such programs is often collected in restricted variables and physicians participating in the registration process may not be able to interact with each other during the management of their patients. for these reasons, a complete record in national general cancer registries can only be established retrospectively and the direct contribution to patient-specific diagnosis / treatment is limited. on the other hand, local registries have many advantages like easy integration of the data into the hospital electronic systems and multidisciplinary proactive enrollment. thus, characteristics of ongoing colorectal cancer registries (swedish, south australian, oregon, lublin, ontario etc.) reported previously in the english medical literature are reviewed and an electronic form is tabulated for the mediterranean colorectal cancer registry. this study will examine the validity and reliability of this registry. aspects of the analysis will cover construct validity, content validity, parallel forms reliability, test-retest reliability, split half internal consistency and face validity.

Eligibility criteria:
inclusion criteria: * adult patients with colorectal cancer. exclusion criteria: * patients reluctant to participate in the study.
observatory of screening aneurysms of the abdominal aorta during echocardiography. national epidemiological survey

Conditions: Abdominal Aortic Aneurysms

Summary: study of the prevalence of abdominal aortic aneurysms (aaa) (\> 3 cm) in patients with echocardiography (transthoracic or) during a specific day, with cardiologists in france. this is a cross-sectional epidemiological investigation, assembling evidence from a routine ultrasound screening for aaa at the waning of echocardiograms performed during a specific day. the study will be offered a list of centers selected by the scientific committee in the complete list of locations being in france, the subsidiary of echocardiography echocardiography of french society of cardiology. these centers will be 500 in number representative of the french centers, geographically and by type of centers.

multicenter observational study collecting data from a routine ultrasound screening for aaa at the waning of echocardiograms performed during a specific day. all of the cardiologists practicing echocardiography are invited to participate in this study, each cardiologist should include echocardiography in 10 patients examined for any reason and will be considered referring cardiologist. there will be no follow-up, the idea is to have a database with measures of abdominal aortic aneurysms and therefore.

Eligibility criteria:
inclusion criteria: * any patient \> 65 years, * have an echocardiogram, whatever the reason, * having agreed to participate in the study. exclusion criteria: * patients already operated in the aorta (aaa, pad, stent, ...) * patient refusal to participate in the study

Keywords: transthoracic echocardiography
general exercises with and without ta contraction in patients with nonspecific acute lbp

Conditions: Low Back Pain

Summary: purpose: to evaluate the effectiveness of adding transversus abdominis contraction to general exercises to treat patients with nonspecific acute low back pain. background: non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. the clinical course of low back pain is often favourable; thus, many patients require little if any formal medical care. two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. motor control exercises, which advocate the contraction of the tra have shown some efficacy for patients with chronic low back pain. however, the validity of this strategy for patients with acute lbp is unclear. hypotheses: there will be no significant effect of adding transversus abdominis contraction to general exercise than general exercise alone in patients with non-specific acute low back pain. research question: is there a statistically significant effect of adding transversus abdominis contraction to general exercise on outcomes of patients with non-specific acute low back pain?


Eligibility criteria:
inclusion criteria: 1. individuals of both sexes 2. aged between 18 and 50 years 3. acute nonspecific low back pain according to the most recent guidelines for the diagnosis and management of nslbp come from the american college of physicians and were published in 2017. according to these guidelines, the diagnosis of acute nslbp should be made based on the following criteria: acute onset of low back pain, defined as pain lasting for less than 12 weeks no specific identifiable cause of the pain (e.g., infection, malignancy, fracture, inflammatory disorder) no radicular symptoms (e.g., pain radiating down the leg) no significant neurological deficits or findings on physical examination (e.g., loss of reflexes or muscle strength) exclusion criteria: 1. serious low back pathology 2. contraindications to exercise therapy 3. neurological signs (leg weakness) 4. specific spinal pathology (e.g., malignancy, or inflammatory joint or bone disease) 5. prior back surgery