Kornimate/medical-research-clean huggingface dataset:
nexus compliance study

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnoea (osa) is characterised by a partial or complete collapse of the upper airway during sleep. the treatment of choice for osa is continuous positive airway pressure (cpap). cpap acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. humidification is used during cpap therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion. the latest design of a cpap device, known as nexus (s9), encompasses new features including an improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing, and a new user interface. this study will assess whether compliance on cpap therapy is improved on the nexus (s9) cpap, and will assess the usability of the nexus (s9) cpap

obstructive sleep apnoea (osa) is a condition characterised by the partial or complete collapse of the upper airway during sleep. osa comprises a continuous spectrum of severity ranging from simple snoring and upper airway resistance through mild to severe symptomatic obstructive hypopnoea and apnoea. the prevalence of sleep disordered breathing in the adult population is 24% males and 9% for females. the prevalence of symptomatic osa in the adult population has been estimated to be 4% in males and 2% in females. these patients demonstrate behavioural and neuropsychological consequences to varying degrees, including excessive daytime sleepiness, intellectual deterioration and depression. more serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and heart disease. the treatment of choice for osa is continuous positive airway pressure (cpap). cpap acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. humidification is used during cpap therapy to improve comfort of the delivered air and alleviate nasal dryness/congestion. compliance with cpap is a known issue which is affected by many things, including negative side effects and issues with the equipment. the most common complaints involve nasal dryness/congestion and noise from the machine. the purpose of this study is to assess whether the improved humidification system, reduced noise, improved comfort of breathing and new user interface on the nexus (s9) cpap will improve compliance. aims: 1. to determine if compliance on the new nexus (s9) cpap is improved over the patient's usual cpap 2. to assess the usability of the nexus (s9) cpap.

Eligibility criteria:
inclusion criteria: * willingness to provide written informed consent * patients who are using a resmed mask system * patients who are at least 18 years of age * patients who use a resmed cpap device exclusion criteria: * patients currently using bilevel pap * patients who are pregnant * patients who the researcher believes are unsuitable for inclusion because either: * they do not comprehend english * they are unable to provide written informed consent * they are physically unable to comply with the protocol

Keywords: cpap compliance
opioid sparing pain management strategy

Conditions: Cardiac Surgical Procedures

Summary: the purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort.

retrospective data will be collected on patients admitted to prisma health-upstate greenville memorial hospital in the cardiovascular intensive care unit following cardiovascular surgery. they will be divided into two cohorts, a control cohort from september 1, 2018 - october 31, 2018 and an intervention cohort from march 1, 2019 - april 30, 2019. a study investigator will assess each participant's electronic medical record through the electronic medical record database - epic to determine eligibility per the protocol. demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs.

Eligibility criteria:
inclusion criteria: * adult patients 18 and over * patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during september 1, 2018 - april 30, 2019 exclusion criteria: * patients being placed on extracorporeal membrane oxygenation
risk for ketonaemia in type 1 diabetes pregnancies with sensor-augmented pump therapy

Conditions: Pregnant Women With Type 1 Diabetes

Summary: the roksana study is an open-label crossover rct with the aim to evaluate whether sensor-augmented pump therapy (sap) with predictive low glucose suspend technology is associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.

10 pregnant women with type 1 diabetes will be included . participants will be randomized 1/1 between 12-30 weeks of pregnancy to sap with predictive stop before low during two weeks or predictive stop on low. participants will be cross-over to the other group after two weeks (from stop before low to stop on low or vice versa). during the study, participants will be asked to measure blood ketones three times per day.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * age 18-45 years * a singleton pregnancy with ultrasound-confirmed gestational age between 12- 30 weeks. * treated with 640 insulin pump and have a baseline hba1c level ≤10%. exclusion criteria: * a physical or psychological disease likely to interfere with the conduct of the study * medications known to interfere with glucose metabolism
resistance and aerobic exercise with nutritional supplementation in men and women

Conditions: Obesity

Summary: the purpose of this study is to identify the influence of resistance and aerobic exercise with different nutritional supplements in middle-aged men and women on various physiological measures. throughout the study, the investigators examine body composition, body weight, food intake, fitness level, metabolism, and blood hormones.


Eligibility criteria:
inclusion criteria: * men and women age 35-65 yr * body weight \<300 lbs (136 kg) * body mass index between 28 kg/m2 and 35 kg/m2 * fasting glucose \<110 mg/dl * blood pressure \<160/100 mm hg * plasma total cholesterol \<260 mg/dl * ldl-cholesterol \<160 mg/dl * triacylglycerol \<400 mg/dl * not currently or previously following a weight loss diet or other special/non-balanced diet (in the past 6 months) * \<1 hour/week of habitual aerobic exercise training and no resistance * exercise training (in the past 6 months) exclusion criteria: * men and women age \ 65 yr * body weight \>300 lbs (136 kg) * body mass index between \ 35 kg/m2 * fasting glucose \>110 mg/dl * blood pressure \>160/100 mm hg * plasma total cholesterol \>260 mg/dl * ldl-cholesterol \>160 mg/dl * triacylglycerol \>400 mg/dl * currently or previously following a weight loss diet or other special/non- balanced diet (in the past 6 months)

Keywords: measuring markers of metabolic syndrome in overweight and obese adults.
effect of l-carnitine on biomarkers of myocardial reperfusion injury in patients with stemi

Conditions: Reperfusion Injury, Myocardial; Myocardial Infarction

Summary: the study aims is to evaluate the efficacy and tolerability of l-carnitine on biomarkers of myocardial reperfusion injury in patients with st-segment elevation myocardial infarction (stemi) undergoing primary pci by the assessment of nitrotyrosine as an oxidative stress marker and matrix metallopeptidase-2 (mmp-2) as a cardiac fibrosis marker

this study aims to investigate the effects of l-carnitine on biomarkers of myocardial reperfusion injury in patients with st-segment elevation myocardial infarction (stemi) undergoing primary pci by the assessment of the following: 1. measurement of nitrotyrosine as an oxidative stress marker and matrix metallopeptidase-2 (mmp-2) as a cardiac fibrosis marker. 2. assessment of the timi (thrombolysis in myocardial infarction) grade and myocardial blush grade (mbg). 3. echocardiography parameters patients and methods: design: prospective, randomized, open label, controlled clinical trial patients: a total of 76 stemi patients undergoing primary pci will be enrolled in the study and will be randomly assigned into one of 2 arms: group 1 (control group) (n=38): stemi patients undergoing pci who will receive the standard of care group 2 (test group) (n= 38): stemi patients undergoing pci who will receive the standard of care in addition to l-carnitine 5 g intravenous administered as slow iv push over 2-3 minutes (l-carnitine 1 gm / 5 ml injection®, mepaco, egypt) prior to pci and then 2 g orally (carnitol 500 mg®, global napi, egypt) daily for 4 weeks after pci

Eligibility criteria:
inclusion criteria: * female or male aged \>18 and \< 75 years. * stemi patients undergoing pci. exclusion criteria: * patients with a recent history of myocardial infarction (mi), a previous pci, a previous coronary artery bypass graft, or any cardiac surgery. * a late presentation (\>12 h), unsuccessful primary pci (residual stenosis \>50% in the culprit lesion after procedure), * pretreatment with thrombolytic or glycoprotein iib/iiia inhibitor therapy before primary pci, * concurrent infectious or active inflammatory disease, * severe liver or renal disease, (aspartate aminotransferase (ast) or alanine transaminase (alt) \> 3x uln or total bilirubin \> 3 x uln), (crcl \< 60 ml/min (based on the cockroft-gault equation) * neoplasm, or hematological disorders * pregnant or breast-feeding patients * active participation in another clinical study * patients taking antioxidant drugs. * history of or known allergy or intolerability to the study medications
efficacy of androgen substitution for hypogonadism in men with type 2 diabetes mellitus

Conditions: T2DM (Type 2 Diabetes Mellitus); Hypogonadism

Summary: the purpose of the study is to get data of prevalence of testosterone deficiency in patient with t2dm in russian federation

clinical and epidemiological characteristics and efficacy of androgen substitution for hypogonadism in men with type 2 diabetes mellitus under routine clinical practice (destiny)

Eligibility criteria:
inclusion criteria: * male 45-60 years old * diagnosis of t2dm according to approved standards * signed informed consent form exclusion criteria: * prepubertal hypogonadism of any genesis; * sexual and developmental disorders; * absence of at least one of the testicles; * cryptorchidism, including in the anamnesis; * injuries and / or surgical interventions on the genitals with loss of at least one of the testicles; * established diagnosis of panhypopituitarism in accordance with current recommendations / standards; * androgen therapy, administered at the time of the study or in the anamnesis; * admission of anabolic steroids; * alcoholism or drug addiction; * insolvency.
the effect of synbiotic and diet modification among overweight or obese hong kong chinese

Conditions: Obesity

Summary: synbiotic is a nutritional supplement that contains both prebiotic and probiotic. probiotics are beneficial microorganisms, while prebiotics are foods that help the growth of beneficial microorganisms in the gut. in the study, dietary intervention with fruits and vegetables and/or synbiotic supplementation with be administered to hong kong chinese subjects for eight weeks. changes in the composition and diversity of intestinal microbiota, and markers indicative of obesity, chronic inflammation and metabolic dysfunction will be assessed throughout the whole period. this study will further provide a scientific basis for the intake of synbiotics for reducing the risk of overweight and obesity among hong kong chinese. furthermore, the results will bridge to further research into the most desirable gut microbiome profile, hence facilitating personalised nutrition for optimal health.

this is an 8-week randomized controlled dietary interventional trial.the objectives of this study include: * to investigate the effects of synbiotic supplementation and/or dietary intervention with fruits and vegetables on gut microbial diversity and composition, and on inflammation, metabolic functioning, overweight and obesity among hong kong chinese * to study whether the changes in gut microbial diversity and composition upon the interventions in hong kong chinese are correlated with metabolic functioning and inflammation, as well as overweight or obesity

Eligibility criteria:
inclusion criteria: * waist circumference ≥90cm in men and ≥80cm in women * bmi \>23.0kg/m2 exclusion criteria: * practicing dietary restrictions * using cholesterol-lowering, antihypertensive, anti-inflammatory drugs or chinese medicines * consuming laxatives, any gastrointestinal medication, probiotics, prebiotics, synbiotics or antibiotics * smokers * alcohol abuser * currently pregnant or lactating

Keywords: obesity overweight synbiotic diet metabolic dysfunction
xpress registry study

Conditions: Sinusitis

Summary: this is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the xpress device per the device indication for use (ifu).

endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients. one-month follow-up was required for all patients. the first 50 patients enrolled also consented to a 1-year follow-up. complications and sinus symptom severity were assessed at the 1-month visit. symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * scheduled to undergo sinus surgery with planned use of the xpress balloon device consistent with the tool's indication for use * willing and able to provide consent exclusion criteria: * known samter's triad * history of primary ciliary dysfunction * history of cystic fibrosis * known to be immunosuppressed * hemophilia * currently enrolled in another pre-approval investigational study

Keywords: sinusitis
specialized clozapine clinic for bipolar and schizoaffective disorder

Conditions: Bipolar Affective Disorder; Schizoaffective Disorder

Summary: bipolar disorder (bd) and schizoaffective disorder (sa) clients. * determine if after 12 months of treatment with clozapine, the bmi changes with clients who are councelled as usual regarding weight gain while on clozapine. * determine if after 12 months of treatment with clozapine, the bmi changes with intense, structured councelling about diet and exercise.

to determine whether the changes in bmi produced in subjects with bipolar disorder (bd) and schizoaffective disorder (sa) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.

Eligibility criteria:
inclusion criteria: * clients diagnosed with bipolar disorder or schizoaffective disorder * clients who respond poorly to treatment * males and females ages 18 years or older * clients who have had a trial of antipsychotics, incl. at least one atypical antipsychotic plus at least 2 mood stabilizers * clients who are capable of providing informed consent exclusion criteria: * clients who take carbamazepine * clients with a history of extremely low white blood counts * clients with severe kidney, liver or heart disease, or heart operation * clients are hypersensitive to clozapine * clients who have a history of serious side effects after previous treatment with clozapine * clients with alcohol or drugs abuse within the last 3 months * clients who have a seizure disorder * clients who have metal in the head, neck or eyes, shrapnel, bullets, or body piercing, a pacemaker, brain aneurism clips, cochlear implant, hearing aid, tens unit, spinal implant, or pregnancy. these safety measures are necessary because of the magnetic fields of the mri scan.

Keywords: bipolar and schizoaffective disorder clozapine metabolic side effects diet & exercise bmi
community outreach-based study to increase cervical cancer screening among hispanic women in cleveland

Conditions: Cervical Cancer

Summary: this study offers hispanic women who are eligible for cervical cancer screening residing in the cleveland metropolitan area one of two possible community outreach-based cervical cancer screening modalities, self-collection home hpv test or clinic-based pap test, which is the current standard of care, to assess if these strategies improve cervical cancer screening rates in this population group.

this study is an observational community outreach-based feasibility study. the study intervention that is being evaluated includes two different strategies of cervical cancer screening: 1) a self-collection home hpv test and 2) an in-office pap test. study subjects who choose the self-collection home hpv test will be provided with the following materials: 1) research information sheet that explains the study objective, the expected timeline of the results, 2) a letter recommending a routine pap test regardless of whether they chose to complete the self-sampling hpv test, 3) educational materials on how to self-collect and return a sample, and 4) a fda-approved self-sampling kit. self-collected samples will be tested by the fda-approved procedure. study subjects will be asked to choose the screening method of their preference: a self-collection hpv testing kit at home and return the kit within 1 month to the study team or a pap test at a local clinic, which is scheduled within a month. the at-home test only includes vaginal swab and not collection from the cervix. the study team will be notified of the results of hpv test or of pap test and inform the study subjects. if the study subject reports the study team of the loss of her home hpv test kit, it will be recorded as a study outcome of "loss of home hpv test kit". study subjects who do not return their hpv test kit within 4 weeks will receive 3 reminder calls within a week. study subjects who choose an in-office pap test will be scheduled for an annual gynecological exam that includes a pap test at a local clinic that the participant prefers by the study team. the standard-of-care in gynecology at the local clinic involves annual gynecological exam. study subjects who choose an in-office pap test will receive two appointment reminder calls by the study team a week and three days prior to the scheduled appointment, respectively. no returning of the self-sampling home hpv kit and no show to the scheduled appointment for pap test will be recorded as study outcomes, and these study subjects will be considered enrolled in the study.

Eligibility criteria:
inclusion criteria: * hispanic women aged 30 and 65 years * residing in the city of cleveland exclusion criteria: * women who are pregnant * had a hysterectomy * women who had pap test in the past three years or hrhpv test in the past five years or co-testing (hrhpv + pap test) in the past five years.

Keywords: cervical cancer screening home hpv self-test in-office pap test hispanic women cleveland
retrospective chart review study of korlym for the treatment of acth independent cushing's syndrome

Conditions: Cushing's Syndrome

Summary: chart review study to collect patient data from medical charts of patients who have been treated with korlym® for the treatment of acth independent adrenal cushing's syndrome.

a retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with korlym® for the treatment of acth independent adrenal cushing's syndrome. treatment with korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Eligibility criteria:
inclusion criteria: * diagnosed with acth independent endogenous cushing's syndrome * available adrenal imaging prior to being treated with korlym® * treated with korlym® and followed for at least 3 months (follow-up data should be available) exclusion criteria: * diagnosed with adrenocortical carcinoma * participant in any clinical trial(s) during the observational period

Keywords: cushing's syndrome mifepristone adrenal retrospective chart review
efficacy of bifeprunox in patients with schizophrenia

Conditions: Schizophrenia

Summary: the primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. there are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. in particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. in the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. the study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. after this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. in the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11915a).

Eligibility criteria:
inclusion criteria: main inclusion criteria * the subject has a primary diagnosis of schizophrenia * the subject experiences clinically significant symptoms * the subject's medication remained stable for 8 weeks prior to screening * the subject is currently in the post-acute maintenance phase of his/her disease exclusion criteria: main exclusion criteria * the subject is at significant risk of suicide * the subject is treatment resistant * the subject has experienced an acute exacerbation within 8 weeks prior screening * the subject is unlikely to comply with the protocol * the subject has a current diagnosis or a history of substance abuse

Keywords: schizophrenia antipsychotic bifeprunox