Kornimate/medical-research-clean huggingface dataset:
sperm separation efficiency to maximize pregnancy rates: macs vs. fertile chip

Conditions: Infertility, Male

Summary: the goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (macs) technique, in males with high dna fragmentation within an assisted reproductive treatment. the main questions it aims to answer are: * does microfluidic sorting improve pregnancy rate compared to macs? * does microfluidic sorting improve fertilization rate compared to macs? * does microfluidic sorting improve implantation rate compared to macs? * does microfluidic sorting improve blastocyst development rate compared to macs? participants will deposit an eyaculate sample that will be analyzed for dna fragmentation using a aliquot, then split in two to perform macs and the microfluidic sorting. both will be tested for dna fragmentation (aliquotes) and used for the icsi treatment with donor oocytes. researchers will compare both techniques to see if the selection of the best functional spermatozoa with less dna fragmentation and clinical outcomes improve.

in assisted reproductive technology (art), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. any type of damage present in sperm dna can lead to art failure. sperm dna fragmentation might be the most frequent cause of paternal dna anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. such dna fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal dna integrity as possible from ejaculated semen. because of centrifugation steps associated to swim-up or density-gradient can induce sperm dna fragmentation via reactive oxygen species (ros), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. it seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. hence, this new technology has been proposed to minimize dna damage. in this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower dna fragmentation spermatozoa when compared to magnetic activated cell sorting (macs) in split semen samples, and increases clinical outcomes.

Eligibility criteria:
inclusion criteria: * oocyte recipient patients exclusion criteria: * sperm concentration \< 5 mill/ml * percentage of motile sperm \< 15%

Keywords: macs dna fragmentation sperm selection
a fourteen-week placebo-controlled dose-response efficacy and safety study of ns 2330 in early parkinson's disease patients (study for proof of concept in early parkinson's disease of a triple reuptake inhibitor, ns 2330 / sceptre)

Conditions: Parkinson Disease

Summary: to demonstrate efficacy and dose-response of ns 2330 versus placebo in patients with early parkinson's disease in 14 weeks of treatment, and to investigate the safety and tolerability of ns 2330 in these patients.


Eligibility criteria:
parkinson's disease for \<5 years, non-demented, no or \<6 months of levodopa and none during trial. off levodopa, da agonists, and psychotropics for 30 days before screening. amantadine, anticholinergics allowed if at stable dosage. hoehn \& yahr stage i-iii. depression allowed, but no other chronic disease that is unstable or might interfere with ability to participate.
covid-19 - implications on surgeons' burnout and career satisfaction

Conditions: Physical Stress; Career Burnout; Satisfaction

Summary: this is a cross-sectional survey which will be distributed online between surgeons. the survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. it consists of a semi-structured questionnaire that is provided in english language. the survey will be conducted online through an online survey development cloud-based software (surveymonkey®; san mateo, ca, usa). participants will be aware of the nature of the survey and informed that they will be listed as co-authors. collected data will be confidential and anonymous. the first sector of the questionnaire includes trainee demographics and baseline characteristics. then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.

this is a cross-sectional survey which will be distributed online between surgeons. the survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. it consists of a semi-structured questionnaire that is provided in english language. a subsequent translation in different language will provided based on geographical distribution. the survey will be conducted online through an online survey development cloud-based software (surveymonkey®; san mateo, ca, usa). participants will be aware of the nature of the survey and informed that they will be listed as co-authors. collected data will be confidential and anonymous. the first sector of the questionnaire includes trainee demographics and baseline characteristics. then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice. statistical analyses will be performed using spss v. 20. data distribution will be tested for normality using the kolmogorov-smirnov test and the shapiro-wilk test. categorical variables will be expressed as group percentages and will be compared for independent samples using the chi-square test. continuous data of the survey will be presented as medians with ranges or means and standard deviations. a comparison of continuous data will be compared for independent samples using the t-test or mann-whitney test according to the data distribution. spearman correlation coefficient will be used for further assessment of the strength of the association between variables. the statistical significance level will be set at \<0.05.

Eligibility criteria:
inclusion criteria: * the survey is targeting surgeons of all specialities; cardiothoracic, general, neurosurgery, oral and maxillofacial, otolaryngology, pediatric, plastic, trauma and orthopedic, urology, and vascular surgery. furthermore, gynecological oncology and urogynecology surgeons are invited. exclusion criteria: * other specialities other than surgery
a study in non-squamous non small cell lung cancer in asian patients

Conditions: Non Small Cell Lung Cancer

Summary: to investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous non small cell lung cancer (nsclc) who receive at least one dose of the induction therapy.


Eligibility criteria:
inclusion criteria: * non-squamous cell non small cell lung cancer (nsclc) disease * clinical stage iiib/iv or recurrent disease after surgery * no prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy * prior radiation therapy is allowed to less than 25% of the bone marrow * measurable disease as defined by response evaluation criteria in solid tumors (recist) * the eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate organ function * estimated life expectancy of at least 12 weeks exclusion criteria: * clinically significant third-space fluid collections * central nervous system disease other than stable and treated brain metastasis * more than 3 weeks interval between the surgery and enrollment request date * unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids), for a 5 days period * unable or unwilling to take folic acid or vitamin b12 supplementation * unable to take corticosteroids. * serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol * currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest x-ray or computed tomography (ct)

Keywords: non-squamous
intervention to reduce sedentary time

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to determine whether the researchers can help people change the amount of time they spend in sitting activities and whether this change might improve health outcomes.

specific aim 1: determine feasibility of a 12-week home and telephone based intervention in older adults with mild cognitive impairment targeting both the impaired individual and their study partner to help initiate and maintain behavior change. we will recruit kuadc registry participants with mci and their caregivers (as study partners). behavioral interventions are more effective when there is built in social support. we will evaluate feasibility in terms of successful recruitment and retention of participants, 10% or less of technological failures, rate of participant concerns addressed by phone and at home visits, acceptability of the intervention to participants (measured by questionnaires during home visits). specific aim 2: determine whether a 12-week home and telephone based intervention results in reduced total sitting time and shorter bouts of sitting in older adults with mci and their caregivers. electronic postural monitors will record sitting time for a duration of one week at three time points (pre-intervention, mid-intervention, and post-intervention). the intervention includes 1) feedback from baseline monitoring, 2) educational and goal setting session with the participants and research staff, 3) wrist worn monitors that alert wearers to sitting times \>30 minutes, 4) home and telephone visits to address physical, psychological, and home environment barriers to behavior change. changes in sitting time and breaks from sitting will be compared between baseline, mid-intervention, and post-intervention measurement occasions. specific aim 3: determine whether sedentary behavior intervention results in improved insulin sensitivity and glycemic control. to evaluate whether reduced sitting results in meaningful metabolic changes, we will measure postprandial insulin and glucose, and body composition, and evaluate changes from pre- to post- intervention adjusting for relevant covariates.

Eligibility criteria:
inclusion criteria: * enrolled in the university of kansas (ku) alzheimer's disease center (adc) registry * clinical dementia rating (cdr) = 0.5 * inactive status as determined by the measure of older adults' sedentary time (most) questionnaire * retired or \<20 hours/week in an office * lives with partner in a community dwelling setting exclusion criteria: * unable to stand or walk unassisted * inadequate visual, auditory, or english language capacity * adhesive allergy * current uncontrolled type 2 diabetes * unwilling to change sitting behavior

Keywords: physical activity alzheimer's disease cognitive impairment sedentary behavior insulin sensitivity
dd-study: diet or diuretics for salt-sensitivity in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: in this clinical study the anti-hypertensive response to dietary salt restriction is compared with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in adult patients with chronic kidney disease.

patients with chronic kidney disease (ckd) are exquisitely salt-sensitive. salt-sensitivity in ckd is linked to hypertension and cardiovascular outcomes. dietary salt restriction is an accepted intervention for salt-sensitivity in ckd. another strategy, however, could be to block sodium uptake by the kidney pharmacologically by diuretics. especially diuretics acting on the distal tubule may be effective, because this appears to be the site of increased sodium reabsorption in ckd. it is currently unknown how these two strategies, diet or diuretics, relate. the investigators hypothesize that diuretics are non-inferior to diet.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * ckd stage 3 or 4 (mdrd-gfr 15-60 ml/min) * use of any anti-hypertensive drugs * no anti-hypertensive drugs but an average office systolic blood pressure \> 140 mmhg (as measured by datascope) exclusion criteria: * salt-wasting ckd * nephrotic syndrome * pregnant or breastfeeding women * life expectancy \< 6 months * severe heart failure (nyha iii or iv) or liver cirrhosis with ascites and the inability to withdraw diuretics * rapidly declining kidney function with high likelihood of dialysis or kidney transplantation in the coming 4 months * kidney transplant recipients * use of immunosuppressive drugs * use of non-steroidal anti-inflammatory drugs * previous intolerance or allergy to hydrochlorothiazide or amiloride * serum sodium \< 135 mmol/l * serum potassium \ 5.0 mmol/l * inability to adhere to the study protocol (due to language, incapacitated subjects, subjects with intellectual disability)
confirmmdx assay in multiparametric mri (mpmri) pirads scored lesions after a negative mr/us fusion biopsy

Conditions: Prostate Disease

Summary: the purpose of this study is to see if the confirmmdx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated psa and prostate lesion identified on mpmri.


Eligibility criteria:
inclusion criteria: * prior documented elevated psa (\> 4.0 ng/ml) * mri lesion based on pirads scoring within the past 3 years * completed mr/us fusion prostate biopsy with concurrent systematic biopsy for pirads score 2-5 with negative pathological findings completed subsequent confirmmdx assay (regardless of result). the most recent biopsy can be within 4 years if confirmmdx already completed. * may have had prior negative biopsy sessions prior to the most recent mr/us fusion biopsy * must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy * ability to give informed consent exclusion criteria: * any metastatic cancer * any prostate cancer * active infection: urinary tract infection or prostate infection precluding prostate biopsy * anal stenosis or severe anal disease preventing prostate biopsy
laparoscopy in complicated groin hernia

Conditions: Inguinal Hernia

Summary: this study assessed the outcomes of laparoscopic repair in complicated groin hernia. laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. this study provides an insight to the outcomes from the procedure in low resource setting of nepal.


Eligibility criteria:
inclusion criteria: * patients with age greater than 18 years with diagnosis of complicated groin hernia exclusion criteria: * patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia

Keywords: complicated groin hernia totally extra-peritoneal repair transabdominal preperitoneal repair
intervention targeting medication adherence and methamphetamine use in hiv positive men (ace)

Conditions: HIV Medication Adherence; Methamphetamine Use; Sexual Risk; Poly-substance Use; HIV Infections

Summary: the primary aim is to test an innovative 8-session intervention, based on motivational interviewing and cognitive behavioral skills-training for the co-occurrence of methamphetamine use and highly active antiretroviral therapy (haart) non-adherence among methamphetamine using hiv+ msm in nyc, compared to an 8-session educational (ed) condition. participants in the intervention condition will report greater reductions in the number of days of methamphetamine use and viral load, and greater increases in cd4 counts and self-reported and objectively measured adherence than those in the education condition.


Eligibility criteria:
inclusion criteria: * hiv+ (confirmed at baseline through documentation) * biologically male * report sex with another man at least once * report methamphetamine use at least three times in the past three months * report less than 90% haart medication adherence, as measured by the total number of days a participant missed an hiv medication in the last 30 * able to communicate with staff and complete a survey that is in english. exclusion criteria: * unstable, serious psychiatric symptoms * currently suicidal/homicidal * evidence of gross cognitive impairment * self-reported current enrollment in a drug or hiv-related intervention or research study. * methadone use

Keywords: medication adherence methamphetamine use sexual risk poly-substance use hiv treatment motivational interviewing cognitive behavioral skills training men who have sex with men
role of magnetic resonance imaging (mri) perfusion to detect disease in prostate carcinoma

Conditions: Prostatic Neoplasms

Summary: this is a pilot study of 50 patients to establish whether there is a potential role for mri perfusion in the detection of locally recurrent or persistent prostate carcinoma after previous treatment with radiotherapy. all subjects will be patients who have had localised prostate cancer treated with radiotherapy and have already agreed to undergo a biopsy of the prostate to look at local control within the prostate as part of their management. the objective of the study is to establish whether there is a relationship between recurrent or persistent disease within the prostate and increased perfusion on mri at these sites.


Eligibility criteria:
inclusion criteria: * previously have had radical radiotherapy for localised prostate cancer * due to undergo routine post-treatment prostatic biopsies * suitable for mri scan * adequate renal function * no previous reaction to gadolinium * able to give informed consent * no recent prostate biopsy within 6 weeks of enrolment * performance status (eastern cooperative oncology group \[ecog\]) 0 or 1 exclusion criteria: * not suitable for mri scan * previous reaction to gadolinium * impaired renal function * inability to give informed consent
matrix metalloproteinases and diabetic nephropathy

Conditions: Diabetes Mellitus, Type 1; Diabetic Nephropathy

Summary: matrix metalloproteinases (mmps) are a family of protein-degrading enzymes that are involved in the breakdown and remodeling of many tissues and organs. abnormal activity of these enzymes has been implicated in many disease processes including rheumatoid arthritis, dental disease and metastatic cancer. recent studies also suggest that elevations in blood sugar may abnormally effect mmp enzyme activity. decreased activity of some of these mmp enzymes may be a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the start of diabetic kidney disease (nephropathy). preliminary clinical data from our laboratory confirm that children with newly diagnosed type 1 diabetes mellitus (dm) have lower blood levels of some of these enzymes at the time of very high blood sugar readings. however, these enzyme levels become normal again as blood sugar levels improve with insulin treatment. in the present study, we propose to investigate the hypothesis that mmps are involved in the cause of diabetic kidney disease by measuring concentrations of specific mmps and some related proteins in the blood and urine of patients with type 1 dm who are between the ages of 14-40 years. we will enroll some patients who are recently diagnosed with diabetes, some who have had diabetes for several years, but without signs of kidney disease, and some with long-term diabetes and various degrees of kidney disease. continuous subcutaneous glucose monitoring, conducted for 3-4 days, will also be provided as a part of this study, to determine how different levels of blood sugar control might relate to different levels of mmp enzyme activity in the blood. we anticipate that this study will help to establish a link between abnormal mmp activity and the cause of nephropathy in type 1 dm, allowing scientists to design better therapies for the prevention and treatment of diabetes-related kidney problems.


Eligibility criteria:
type 1 diabetes with or without kidney disease and past puberty.
an interventional study to compare the efficacy and tolerability with targin® in non-malignant chronic pain (glory)

Conditions: Chronic Pain

Summary: objectives: 1. objective of main interest - to assess the drop-out rate caused by adverse event\* after 6 weeks treatment 2. further objectives * to assess the drop-out rate caused by adverse event\* after 1 week treatment * to assess the pain reduction rate after 6 weeks treatment from baseline * to assess the euroquol (eq-5d) quality of life * to assess physician's overall satisfaction * to assess subject's overall satisfaction * to assess safety

study design (methodology): this will be a single center, open-label, randomised, phase iv, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with targin® (oxycodone/naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication world health organisation (who) step ii analgesics). upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. if the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in group a or group b. re-screening, study drug dose interruption is not allowed.

Eligibility criteria:
inclusion criteria: * male or female ≥ 20 and \<80 years of age * patients who have non-malignant chronic pain(≥90 days) * patients who have moderate to severe pain intensity which is not controlled with non-strong opioid * naïve patients for oxycodone/naloxone (naïve patient defined as who did not treated for 90 days) * naïve patients for strong opioid (naïve patient defined as who did not treated for 90 days) * patients who signed a written informed consent form exclusion criteria: * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test * patients with known hypersensitivity to oxycodone/naloxone or to any of the excipients * patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment * having used other investigational drugs at the time of enrollment, or within 30 days of enrollment

Keywords: moderate to severe non-malignant chronic pain