Kornimate/medical-research-clean huggingface dataset:
diamel in the treatment of type 2 diabetic patients receiving insulin therapy

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the efficacy of diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. the duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. the estimated number of patients to be recruited and randomized for the study is 116. daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (hba1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes with insulin therapy regimen of two daily doses. * signed informed consent. exclusion criteria: * type 1 diabetes. * type 2 diabetes with glibenclamide treatment. * nephropathy or liver condition diagnosed by clinical and/or biochemical examination. * sepsis. * pregnancy. * hba1c values greater than 10%.

Keywords: type 2 diabetes diamel dietary supplement
hospital management and 1-year outcome of patients aged 70 years and older with severe covid-19

Conditions: COVID-19; Elderly Patient

Summary: sars-cov-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the icu in 5-20% of affected patients. age is a major risk factor for developing a severe form and for death. ards related to sars-cov-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. these specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). to investigator's knowledge, no study has evaluated the prognosis in the icu and the long-term functional outcome of elderly people admitted for a severe or critical form of covid-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...). investigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of covid-19. the objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe covid-19.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years on admission to hospital * diagnosis of sars-cov-2 infection defined by a positive rt-pcr test * medical or critical care hospitalisation between 1 july 2020 and 31 august 2021 * who experienced severe hypoxaemic acute respiratory failure defined as at least 4l/min of oxygen during hospitalisation exclusion criteria: * oxygen therapy \< 4l/min during hospitalisation * mc cabe score 3 (chronic disease fatal at 1 year such as stage iv heart failure, ventilated respiratory failure, metastatic cancer, child c cirrhosis) * dementia or cognitive disorders before hospitalisation reported in the medical record * patient gir 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle * patient with an adl score \< 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle * patient living in ehpad before hospitalisation * non-french speaking patient * patient under guardianship or curatorship * refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person

Keywords: covid-19 elderly patient
a study to evaluate the effect of genetic variation on beta-cell function during fasting and hyperglycemia in nondiabetics

Conditions: Healthy

Summary: the glp-1 receptor (glp1r) gene is found on the beta cells of the pancreas. its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. the purpose of this research study to find out how genetic variations in glp1r alter insulin secretion, in the fasting state and when blood sugars levels are elevated.


Eligibility criteria:
inclusion criteria: * 40 nondiabetic subjects will be recruited. * 20 subjects with the aa genotype at rs3765467 and remainder will have the gg genotype. * individuals encompassing the age span of 25-65 years. exclusion criteria: * individuals under 25 and over 65 years of age.
expanded access to provide arq 092 for the treatment of overgrowth diseases and/or vascular anomalies

Conditions: Proteus Syndrome; PIK3CA-Related Overgrowth Spectrum (PROS); Growth Disorders

Summary: arq 092 is being investigated for patients with overgrowth diseases and/or vascular anomalies with genetic alterations of the pi3k/akt pathway and may be available for patients who are ineligible for an ongoing arq 092 clinical trial or have other considerations that prevent access to arq 092 through an existing clinical trial.


Eligibility criteria:
inclusion criteria: 1. severe overgrowth diseases and/or vascular anomalies with confirmed somatic genetic alterations of pik3ca or akt 2. are unable to participate in an ongoing arq 092 clinical trial 3. willing and able to provide written, signed informed consent. in the case of a minor, a parent or legal guardian must sign an informed consent form. 4. medically suitable for treatment with arq 092 5. not eligible for any other available therapy for the diagnosed overgrowth disease and/or vascular anomaly with confirmed somatic genetic alterations of pik3ca or akt exclusion criteria: 1. currently enrolled in an ongoing clinical study of arq 092 or other investigational drug 2. currently being treated with any inhibitor of the pi3k/akt/mtor pathway

Keywords: arq 092 arqule akt pik3ca overgrowth congenital malformations
possible immuno-modulatory effect of tocilizumab in patients with refractory status epilepticus.

Conditions: Epilepsy

Summary: recently, the pathogenesis of epilepsy is immuno-modulatory and neuro-inflammatory which is commonly activated in epileptogenic brain regions in humans and is clearly involved in animal models of epilepsy. inflammatory mediators in the blood and molecular imaging of neuro-inflammation could provide diagnostic, prognostic, and predictive biomarkers for epilepsy, which will be instrumental for patient stratification in future clinical studies. dysfunction of the blood-brain barrier (bbb) may be responsible for abnormal neuronal firing. disruption of the bbb causes the leakage of serum protein and leucocyte invasion into the brain. these exogenous inflammatory mediators have the potential to lower seizure thresholds, which could alter channel sensitivity, neurotransmitter uptake or release, and glia-associated regulation of extracellular environments, such as potassium concentration.


Eligibility criteria:
inclusion criteria: * age: 15-75 years old. * gender: male and female. * newly diagnosed refractory status epilepticus patients who are scheduled to receive anti-epileptic drugs. * patients with normal renal and hematological functions. exclusion criteria: * old age \>75 years old. * pregnant or lactating females. * severe renal impairment when gfr\<30 ml/min. * hepatic patients ( not recommended with active hepatic disease or hepatic impairment specially when alt or ast \>3 times uln). * neutropenia when neutrophil count \<500 cells/mm3 due to increase the risk of infection. * thrombocytopenia when platelet count \< 50000 cells/mm3. * patients take immunosuppressant drugs. * cancer patient who taking chemotherapy. * patients with a known hypersensitivity to any of the used drugs.
proof of concept study with an endothelin receptor b inhibitor (bq-788) for human melanoma

Conditions: Melanoma

Summary: intra-lesion administration of an endothelin receptor b inhibitor (bq-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.


Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed melanoma * disease stage iii or iv * at least 2 injectable and surgically removable cutaneous metastasis * age \> 18 years * clinically stable medical condition exclusion criteria: * primary ocular melanoma * symptomatic intracranial melanoma * history of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (hiv) disease * pregnancy or lactation
transdiagnostic internet-delivered intervention for adolescents with anxiety and depression

Conditions: Anxiety Disorders; Depressive Disorder; Social Anxiety Disorder; Major Depressive Disorder; Dysthymia; Generalized Anxiety Disorder

Summary: the goal of this clinical trial is to test the efficacy of a transdiagnostic internet-delivered interventions for romanian adolescents with anxiety and/ or depression. the main questions it aims to answer are: * what is the clinical efficacy of the internet-delivered intervention? * how accurate is the prediction model in predicting who will respond to treatment? participants will undergo non-invasive fmri to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the internet-delivered intervention or control group.

to the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fmri to investigate participants' response to a transdiagnostic internet-delivered intervention.

Eligibility criteria:
inclusion criteria: * elevated symptoms of anxiety or depression/ internalizing problems (t score\> 60) at intake (based on youth self-report completed by adolescents) * primary diagnosis of an anxiety/depressive disorder based on dsm-5 criteria according to adis-5-c/p interview * age 13-17 * able to read and understand romanian language * currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset * internet access exclusion criteria: * severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview) * any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months), * active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month * currently following cbt/ psychotherapy for anxiety/depression, in the last 6 months * fmri incompatible (based on safety questionnaire) * being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview). * current treatment with benzodiazepines

Keywords: internet-delivered intervention transdiagnostic adolescents internalizing anxiety depression
effects of early exercise rehabilitation on long-term functional recovery in patients with severe sepsis

Conditions: Severe Sepsis or Septic Shock

Summary: we hypothesized that early exercise rehabilitation for patients with severe sepsis or septic shock would decrease their functional disability and cognitive impairment. we plan to enroll patients with severe sepsis and septic shock who admitted an urban teaching hospital in seoul, south korea via er. we will randomize those subjects into the intervention group which will take a standardized rehabilitation with routine clinical care for sepsis and the control group which will take routine clinical care for sepsis. and, we plan to assess their functional activity using adl, iadl and sf-36, and cognitive function using mmse at the time of enrollment, 28 days, and 6 months later.


Eligibility criteria:
inclusion criteria: 1. age ≥20; 2. confirmed or suspected infection; 3. two or more among 1)-4) 1) body temperature \>38˚c or \ 90/min 3) respiratory rate \>20/min or paco2\ 12000/mm3, \ 10%; 4. within 48 hours after arriving er exclusion criteria: 1. severe functional disability before admission; 2. central nervous system infection; 3. contraindication for exercise rehabilitation according to the investigators' decision; 4. severe medical illness or mental problem or laboratory abnormality which can confound the results; 5. pregnancy

Keywords: sepsis, septic shock, rehabilitation, exercise
a study of flurbiprofen 8.75 mg lozenge in patients with pharyngitis

Conditions: Pharyngitis

Summary: the purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study. after the initial 2 hours in the research center, patients were discharged with an outpatient diary to continue (while awake) to document hourly assessments of sore throat pain intensity scale (stpis), difficulty swallowing scale (dss), and swollen throat scale (swots) through 24 hours. they used the assigned lozenges as needed every 3-6 hours, up to 5 lozenges over 24 hours. a follow-up visit was conducted for the 24-hour assessments. patients received additional study lozenges for use as needed (up to 5 lozenges per 24 hours) over the following 6 days, rescue medication (acetaminophen 650 mg) and a diary to document their safety and efficacy assessments immediately before and postdose after each as-needed use of a lozenge for the remaining days in the 7-day treatment period. at the end of the 7-day trial, patients returned to the research center for final assessments, review of adverse events over the week, and discharge from the study.

Eligibility criteria:
inclusion criteria: 1. the patient has a complaint of sore throat. 2. if the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. 3. if the patient is a female of childbearing potential, the patient must have a negative urine pregnancy. 4. the patient has provided written informed consent prior to any study-related procedures. exclusion criteria: 1. the patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week). 2. the patient has a history of any hepatic disease or renal dysfunction. 3. the patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)

Keywords: pharyngitis swollen throat difficulty swallowing
the attitudes, communication, treatment and support intervention to reduce breast cancer treatment disparity

Conditions: Breast Cancer

Summary: the acts (attitudes, communication, treatment, support) intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about treatment and its rationale. the support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community.

the 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in white american women, an alarming disparity that cannot be explained by stage of disease at presentation. nonadherence to breast cancer treatment and treatment delays from diagnosis to initiation of treatment may be among the reasons for worse breast cancer outcomes in black women. this recognition is critical because it suggests that breast cancer survival disparity can be decreased through clinical interventions that increase adherence to chemotherapy. the acts (attitudes, communication, treatment, support) intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about treatment and its rationale. the support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community. this study is a randomized controlled trial that will test the efficacy of the acts intervention vs. usual care on the primary outcomes of adherence to recommended breast cancer chemotherapy.

Eligibility criteria:
inclusion criteria: * african american, as determined by patient self report on their demographic form completed at first medical oncology visit * female * age 18 or older * diagnosed with invasive breast cancer * recommended (prescribed) chemotherapy by participating medical oncologists exclusion criteria: * impaired cognition, as determined by a score of less than 22 on the mini mental status exam * an inability to understand english

Keywords: chemotherapy patient adherence african americans cancer survivor decision making communication quality of life social support patient education
apple hearing study

Conditions: Hearing Loss, Noise-Induced; Hearing Loss; Tinnitus

Summary: the apple hearing study is a partnership between the university of michigan and apple to study sound exposure and its impact on hearing health. this groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. the investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. us residents who own an iphone, download the apple research app and consent to participate will be randomly assigned to two groups, one with a "basic" user interface in the research app, and one with an "advanced" user interface. users in the "advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. the study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. this information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the us and globally.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of eligibility screening, ascertained from self-reported date of birth. potential subjects in the states of alabama and nebraska must be 19 or older (legal age of consent in these states), and 21 and older for any subjects in puerto rico. * live in the united states of america at time of eligibility screening, ascertained from self-report. * proficient in written and spoken english, defined by self-report. * participants must not share their icloud account, iphone or other devices such as apple watch with anyone else as this would make it challenging for researchers to use their information. * possession of the following, ascertained from automatic hardware/software/device pairing check: * iphone with ios versions capable of supporting the research app used to complete screening eligibility. * optional: apple watch (any model) paired with iphone; an apple watch series 4 or later is required to share environmental sound levels.

Keywords: hearing loss noise exposure noise induced hearing loss listening volume environmental noise music audiometry speech-in-noise hearing ability headphones headphone audio level ambient noise occupational noise heart rate tinnitus
optimizing a multi-modal intervention to reduce health-risking sexual behaviors: component selection

Conditions: Sexually Transmitted Infections; Pregnancy, Unplanned; Military Personnel

Summary: the goal of this project is to evaluate the components of the app-based intervention mission wellness to reduce health-risking sexual behaviors (hrsbs; e.g., condom non-use, multiple sexual partners) in active-duty members of the us military to improve their sexual and reproductive health (srh) and readiness to serve. following the multiphase optimization strategy (most) framework, factorial component selection experiments (cses) will be conducted to evaluate which five experimental intervention components (i.e., narratives, skills, scenarios, future, and risk) elicit the greatest improvements in the outcomes of interest given key constraints.

negative srh outcomes (e.g., sexually transmitted infections \[stis\], unintended pregnancy, sti-related cancers) reduce human performance and undermine military readiness. service members face unique challenges to maintaining srh during their military service. hrsbs (e.g., multiple sexual partners, unprotected sexual behavior) offer potential intervention targets to improve srh. electronic-health interventions are cost-effective and dynamic, and have the potential to reach millions of users as part of an overall strategy for individual behavior and systems change. in civilian populations, e-health interventions have demonstrated success in reducing hrsbs. however, effective hrsb-prevention interventions must consider the specific values, mission, and context of military populations and settings. the most framework is used to develop highly effective, efficient, and economic behavioral interventions that is particularly well suited to be used in this context. this project aims to address this problem by delivering an optimized app-based prevention intervention package ready for evaluation via a subsequent randomized controlled trial (rct). the specific purpose of this project is to determine which component(s) should be included in the packaged app-based intervention mission wellness for us service members based on their effects on the outcomes of interest (i.e., improved knowledge, motivation, and behavior skills related to srh and reduced hrsbs) in no more than 25 minutes of content. the components tested in the factorial cses include: narratives; skills; scenarios; future; and risk. each component has two levels: "on" (included) or "off" (not included). main and interaction effects of components will be measured to determine the components constituting the packaged intervention.

Eligibility criteria:
inclusion criteria: 1. age 17 or older, 2. currently serving as active duty in the us military, and 3. willing to participate in all study activities if eligible and enrolled exclusion criteria: 1. does not meet eligibility criteria, 2. unable to read, speak, or comprehend english, or 3. unable or unwilling to give informed consent

Keywords: women's health sexual and reproductive health military multiphase optimization strategy