Kornimate/medical-research-clean huggingface dataset:
the effect of plantar vibration on the progression of peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: the purpose of this study is to assess the effect of vibration of the plantar surface of the foot on peripheral neuropathy.

background: peripheral neuropathy has a prevalence approaching 10% in the general population. the pathophysiology of peripheral neuropathy is poorly understood or undetermined. while many causes of peripheral neuropathy are known, a significant number of cases are idiopathic. the most common cause of neuropathy relates to glucose intolerance or overt diabetes. exogenous factors such as smoking constrict small cutaneous blood vessels, thereby inhibiting small nerve fiber nutrition. symptoms of neuropathy include numbness, pain, difficulty with balance, lack of temperature perception, and weakness which can lead to significant disability. classification of neuropathies can be made based on nerve fiber size: large fiber, small fiber and mixed large and small fiber types. plantar vibration which affects large fibers has been demonstrated to enhance peripheral and systemic blood flow, peripheral lymphatic and venous drainage (stewart, karman, montgomery, \& mcleod, 2005). since fluid retention in axons, nerve sheaths and surrounding connective tissues may contribute to neuropathy, it is hypothesized that plantar vibration may repair the small peripheral fibers, thereby improving the symptoms of neuropathy. purposes: 1. to assess the effect of plantar vibration on regeneration of small peripheral nerve fibers, peripheral neuropathy and quality of life in patients with diagnosed peripheral neuropathy. 2. to assess the correlation of health history, demographic variables, diet, alcohol and smoking history with small fiber neuropathy analysis by skin biopsy and plantar vibration. design: the study will employ a cross-over experimental design with subjects acting as their own controls. independent variables are the plantar stimulation (intervention), and the characteristics of the subjects that include health history, demographic variables, self reported diet, alcohol, and smoking history, as well as urinary cotinine (a quantitative measure of smoking history). the dependent variables are the assay of intraepidermal nerve fibers in small-fiber neuropathy, clinical assessment of peripheral neuropathy, serum levels of hgb a1c, and quality of life measurement.

Eligibility criteria:
inclusion criteria: * clinical evidence of neuropathy * normal to moderate evidence of neuropathy on nerve conduction studies exclusion criteria: * currently on medications with a known risk of neuropathy * pregnant * evidence of peripheral vascular disease

Keywords: peripheral neuropathy diabetes plantar vibration
a study of shr6390 in combination with letrozole or anastrozole in patients with hr positive and her2 negative advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a phase iii clinical trial to evaluate the efficacy and safety of shr6390 in combination with letrozole or anastrozole versus placebo in combination with letrozole or anastrozole in patients who have hr positive and her2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.


Eligibility criteria:
inclusion criteria: 1. has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, her2 negative breast cancer. 2. age: 18 - 75 years old 3. no prior systemic anti-cancer therapy for advanced hr+ disease. 4. eastern cooperative oncology group \[ecog\] 0-1 exclusion criteria: 1. patients who received prior treatment with any cdk4/6 inhibitor. 2. clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, congestive heart failure (new york heart association (nyha) class \> 2), or ventricular arrhythmia which need medical intervention.
coronary care caffeine: influence of coffee on heart rate post myocardial infarction

Conditions: Myocardial Infarction

Summary: sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial infarction) is a common cause of death. it is well documented that sudden cardiac death after a myocardial infarct (mi) is associated with low or poor heart rate variability (hrv). hrv is a measure of beat-to-beat changes in heart rate, with a greater variation associated with a "healthier" heart. the effect of caffeine on hrv in patients at high risk for sudden cardiac death is unknown. we, the investigators at the royal bournemouth hospital, aim to study the effect of coffee or tea on hrv after mi.

120 post mi patients on ccu will be studied during the first week of admission. patients will be categorised using the following criteria: infarct size and site; pmh; co-morbidities; drugs; regular caffeine ingestion. patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea during admission. hrv will be assessed by non-invasive holter-monitoring on the fifth day. salivary caffeine concentration will be assessed concurrently to assess compliance.

Eligibility criteria:
inclusion criteria: * st-segment elevation (trans-mural) mi; sinus rhythm. * age \< 80 years. exclusion criteria: * cardiogenic shock * nothing by mouth (nbm) * caffeine intolerance * atrial fibrillation, temporary or permanent pacing * complete heart block, bundle branch block, severe left ventricular impairment, non-st segment mi/acute coronary syndrome
physiological responses to exercise tests in primary ciliary dyskinesia compared with healthy individuals

Conditions: Primary Ciliary Dyskinesia

Summary: the individuals with primary ciliary dyskinesia (pcd) have lower aerobic fitness and anaerobic performance than healthy individuals. cardiopulmonary exercise test (cpet) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. maximum oxygen consumption is measured by performing gas exchange analysis with cpet, offering an objective measure of cardiorespiratory fitness. the six-minute walk test (6mwt) and the shuttle walk test (swt) are field tests that produce oxygen consumption results similar to those during cpet. there is a need to determine the physiological responses to cpet, swt and 6mwt in individuals with pcd. additionally, the physiological responses of individuals with pcd to different exercise tests will be compared with the responses of healthy individuals. low aerobic capacity in individuals with pcd may affect the physical, emotional, and social lives of individuals. this influence may cause a decrease in the quality of life of individuals with pcd. the relationship between exercise capacity and quality of life in individuals with psd will be investigated with this study.


Eligibility criteria:
inclusion criteria: * having been diagnosed with pcd in the pediatrics department, pediatric chest diseases unit of hacettepe university faculty of medicine and being routinely referred to hacettepe university, faculty of physical therapy and rehabilitation, cardiopulmonary rehabilitation unit for physiotherapy applications and pulmonary rehabilitation program, * being clinically stable, * being between 8-18 years old, * having a forced expiratory volume in the first second (fev1) ≥ 40%, the healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. for healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study. exclusion criteria: * having unstable clinical condition * having severe neuromuscular and musculoskeletal problems, * having any congenital heart diseases other than situs inversus, * unable to cooperate
clinical trial to evaluate the efficacy and safety of ckd-391

Conditions: Hyperlipidemia

Summary: a multicenter, randomized, double-blind, active-controlled, parallel group, factorial design, phase iii clinical trial.

the aim of this phase 3 study was to evaluate the efficacy and safety of ckd-391 once daily for 8 weeks in patients with primary hypercholesterolemia. furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of ckd-391.

Eligibility criteria:
inclusion criteria: * adult, at least 19 years of age. * hyperlipidemia patient of ldl-c≤250 mg/dl and tg ≤400 mg/dl * patients requiring anti-dyslipidemia drug therapy \[based on the ncep atp iii(2002)\] * drug compliance during run-in period ≥70% * patients must willing to the study and signed an informed consent exclusion criteria: * patients with myopathy included rhabdomyolysis or cpk level≥2xuln * patients with acute arterial disease * patients with renal dysfunction or serum creatinine level ≥2x uln * patients with liver dysfunction or alt, ast level \> 2xuln * patients with medical history within 6 months prior to screening visit (heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease) * patient with uncontrolled disease (diabetes mellitus as hba1c level of \> 9.0%, hypertension as sbp≥180mmhg or dbp≥110mmhg, hypothyroidism as tsh≥1.5xuln) * patients who have a history or presence of active malignancy within 5 years * patients with difficulty of stop taking lipid-lowering agents during run-in period. * patients who have taken another investigational drug within 4 weeks prior to screening visit.
diet and exercise in type 2 diabetes - a randomized controlled trial

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. the investigators randomize 40 participants to two groups: 1) modified paleolithic diet and exercise under observation 3 sessions/week, 2) modified paleolithic diet and general advice about exercise. the investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.


Eligibility criteria:
inclusion criteria: * type 2 diabetes less than 10 years * bmi 27-35 * women only after menopause * diabetes treatment with diet and/or metformin * hba1c between 45 and 94 exclusion criteria: * nicotine use * insulin * betablockers * estrogens orally * blod pressure \>160/100 * macroalbuminuria * malignancy during the past 5 years * alcoholism * depression * cardiovascular disease/stroke * liver disease * serious lung disease, gi disease or kidney disease * more than 30 minutes/5 days a week of moderate exercise during the last 6 months * resistance training during the past 6 months * official weight loosing program during the past year * obesity surgery * night work * madrs-s (montgomery asberg depression rating scale) \>20 points * audit \>14 points for women, \>16 points for men * not possible to obtain venous sampling

Keywords: diet therapy exercise therapy insulin resistance
auragaintm and i-gel® laryngeal masks in general anesthesia for laparoscopic cholecystectomy

Conditions: Respiratory Aspiration of Gastric Content

Summary: the standard procedure used for airway control in general anesthesia for lc (laparoscopic cholecystectomy) is endotracheal intubation (ei). auragain and i-gel are supraglottic airway devices (sads) used for airway control for certain types of surgeries. the aim of this study was to evaluate and compare the performances of new types of sads with ei regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (paw) in lc as well.

the standard procedure used for airway control in general anesthesia for lc (laparoscopic cholecystectomy) is endotracheal intubation (ei). auragain and i-gel are supraglottic airway devices (sads) used for airway control for certain types of surgeries.previous studies have investigated and/or compared the performance of proseal™ lma (intavent orthofix, maidenhead, uk) during lc. but the performances of i-gel and auragain have not been studied well yet. the main aim of this study was to evaluate and compare the performances of new types of sads (i.e. auragain and i-gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. the secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.

Eligibility criteria:
inclusion criteria: * (asa) 1-2 physical status scheduled for elective lc exclusion criteria: * under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (bmi) \> 30 kg m-2, asa physical status 3 or over and patients who met the difficult intubation criteria

Keywords: laringeal masks cholecystectomy, laparascopic intubation, intratracheal
effect of upright patient positioning on intubation success

Conditions: Intubation

Summary: endotracheal intubation is most commonly taught and performed with the patient supine. recent literature suggests that elevating the patient's head to a more upright position may decrease peri-intubation complications. however, there is little data on success rates of upright intubation in the emergency department. the goal of this study was to measure the association of head positioning with intubation success rates among emergency medicine residents.

endotracheal intubation is most commonly taught and performed with the patient supine. recent literature suggests that elevating the patient's head to a more upright position may decrease peri-intubation complications. however, there is little data on success rates of upright intubation in the emergency department. the goal of this study was to measure the association of head positioning with intubation success rates among emergency medicine residents. study design was a prospective observational study. residents performing intubation recorded the angle of the head of the bed, and the number of attempts required for successful intubation was recorded by faculty and respiratory therapists. the primary outcome of first past success was calculated with respect to three groups: 0-10 degrees (supine), 11-44 degrees (inclined), and ≥45 degrees (upright); first past success was also analyzed in 5 degree angle increments.

Eligibility criteria:
inclusion criteria: * adult medical intubations in which the intubating resident and supervising faculty both consented to study participation. exclusion criteria: * pediatric patients * obstetric patients * trauma patients
study to assess drug levels and safety of bms-986278 in healthy participants and participants with different degrees of hepatic impairment

Conditions: Hepatic Impairment; Healthy Participants

Summary: the purpose of this study is to assess the drug levels and safety of bms-986278 in participants with mild, moderate, and severe hepatic impairment (hi), and in matched healthy control participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: all participants: * must have a body mass index (bmi) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg. mild, moderate, or severe hepatic impairment participants: * mild, moderate, or severe hepatic impairment (hi) or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * mild, moderate, and severe hi participants will be enrolled according to the child-pugh classification score. matched healthy participants: * free of any clinically significant disease that would interfere with the study evaluations. * normal hepatic function participants will be enrolled and matched individually with hi participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (japanese and chinese participants vs non-japanese and non-chinese participants). exclusion criteria: all participants: * history of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 ml of beer 5%, 140 ml of wine 12%, or 45 ml of distilled alcohol 40%). * must not have had any prior exposure to bms-986278. mild, moderate, or severe hepatic impairment participants: * acute liver disease (eg, caused by an acute infection or drug toxicity). * history of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant. matched healthy participants: * any significant medical condition, or psychiatric illness that would prevent participant from participating in the study. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: healthy volunteers pharmacokinetics liver diseases mild, moderate and severe hepatic impairment bms-986278
neotililty trial: effect of coenzyme q10 on semen parameters in men with idiopathic infertility

Conditions: Idiopathic Infertility

Summary: to study the effect of coenzyme q10 on semen parameters in men with idiopathic infertility

decreased serum coq10 concentrations as well as a decrease in the coq10h2 to-ubiquinone ratio have been demonstrated in diseases associated with os. a strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported. the aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in pakistani men population. patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. patient will start to take medication and will take it for 26 weeks. all men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. a questionnaire will be used to collect information on demographic characteristics. two semen samples 1 and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. the mean of the two will be used for statistical analysis. semen analyses will be performed using who recommended methods. 3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters. sponsor will bear the test cost of patient during the study treatment period.

Eligibility criteria:
inclusion criteria: * to sign the informed consent form * patients will be recruited in the study if they will fulfilled the criteria of history of primary infertility of more than 2 years, abnormal sperm count and motility * age between 20 and 50 years * no known medical or surgical condition which can result in infertility exclusion criteria: * voluntary withdrawal * poor compliance of visit/treatment * a history of cancer chemotherapy or radiotherapy * a history of genital disease such as cryptorchidism and varicocele; a history of genital surgery * body mass index 30 kg/m or greater; any endocrinopathy * ychromosome microdeletions or karyotype abnormalities * leukocytospermia * drug or substance abuse; tobacco use; * use of anticonvulsants, androgens or antiandrogens * significant liver (serum bilirubin greater than 2.0 mg/dl) * renal function (serum creatinine greater than 2.0 mg/dl) impairment * patients with severe oligozoospermia (less than 5 x 106/ml), azoospermia and testicular volume less than 12 ml will also excluded from study.

Keywords: idiopathic infertility coenzyme q10 pakistan
a prospective pharmacodynamic study of rivaroxaban

Conditions: Blood Clot

Summary: the ability to explain bleeding or clotting complications in patients treated with rivaroxaban remains challenging. in addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of rivaroxaban. predicted responses of coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding abnormal responses to rivaroxaban. the purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking fda approved doses of rivaroxaban and to determine which tests may be most clinically useful for monitoring rivaroxaban.


Eligibility criteria:
inclusion criteria: person taking therapeutic dose of rivaroxaban exclusion criteria: * crcl \< 15 ml/min * non-fda approved dose based on calculated crcl with most recent scr * age \< 18 years * inability to communicate in the english language * decisionally-impaired individuals * incarcerated * pregnant/lactating (pregnancy category: c, unevaluated effects in lactation)
piloting prohealth: a program for male soldiers on sex, dating and alcohol-use at fort bragg

Conditions: Sexual Assault and Rape; Risk Behavior; Alcohol Abuse

Summary: the proposed project will provide data concerning dating and sexual interactions that occur on fort bragg, north carolina, in addition to piloting a sexual assault prevention program through the use of social norms and bystander intervention concepts. the investigators will be able to use data and feedback gained from this research to help reduce rates of sexual assault in the military by providing a sexual assault prevention program tailored to at risk male soldiers that can be disseminated across military posts.

research has shown that one beneficial preliminary step to sexual assault prevention is the examination of a population's social norms pertaining to sex, dating, and alcohol- use. studies show that the social norms surrounding these behaviors can be risk factors that increase the likelihood that certain high-risk men will perpetrate sexual assault. among college-age men, research on social norms has been used to inform the development of a sexual assault prevention program that positively impacts high-risk men. a hallmark of this approach is its exploration of the climate of a given population with regard to sex, dating and alcohol-use, and its use of data gathered to inform the development of a sexual assault program. researchers have yet to study the effectiveness of this approach in the u.s. army. it has been well documented that sexual assault in the army carries a significant threat to the readiness of the force. as such, the army continues to make strong and laudable efforts to reduce sexual assault. however, there remains a need to better understand how young at-risk men behave in the social situations where sexual assault can occur and what they subjectively believe about these behaviors in order to effectively reduce perpetration. in order to fill this gap, the investigators propose to implement a sexual assault prevention program by using social norms and bystander approach concepts via surveys, interviews and group workshops. the data and feedback from this research have the potential to produce insight that could help leaders and the investigators more effectively promote health in male soldiers' dating and sexual relationships.

Eligibility criteria:
inclusion criteria: * male * active-duty soldier (active-duty army, activated reservist or national guardsmen) at fort bragg, nc * between the ages of 18 and 26; usage of "18-26" means at least 18 years of age but less than 27 years of age * reported having engaged in oral, vaginal, or anal sex within previous 4 months * able to speak and comprehend english sufficiently to complete the study procedures * indicate at risk-drinking via an audit-c score \>4 exclusion criteria: * screen positive for alcohol withdrawal on the aswc (score of \> 23) * report or indicate suicidal or homicidal ideation

Keywords: military personnel sexual assault military sexual trauma alcohol and substance abuse