Kornimate/medical-research-clean huggingface dataset:
the epic study: exploring paternal age and the influence on blastocyst culture

Conditions: Infertility (IVF Patients); Oocyte Competence; Sperm DNA Fragmentation; Paternal Age; Sperm Selection

Summary: this study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (zymot) compared to routine embryologist selected sperm after density gradient centrifugation (dgc) preparation for intracytoplasmic sperm injection (icsi) in patients undergoing in vitro fertilization treatment (ivf) of their infertility.

in this study, we aim to determine the clinical utility of the zymot sperm selection methodology for icsi, while also accounting for paternal age. this study will be a prospective, split cohort, randomized, control trial comparing the routine standard of dgc sperm preparation for icsi versus sperm prepared via zymot for icsi. embryology parameters, ploidy status, dna fragmentation and clinical pregnancy outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * undergoing first ivf cycle * electing single embryo transfer * electing pgt-a of their embryos * female partners age \ 18 years old. * amh ≥ 1.2 ng/ml * afc ≥ 8 * fsh ≤ 12iu/l * at least 4 mature oocytes (m2s) retrieved at the vor procedure in order to randomize * intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure exclusion criteria: * contraindication to ivf * clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis) * male partner with azoospermia or oligozoospermia (\<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment) * planned for previously cryopreserved sperm to be used for icsi * donor sperm * male partner with y-chromosome microdeletion * male partner with any karyotype other than 46,xy * male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures * uncorrected hydrosalpinges that communicate with the endometrial cavity * endometrial insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid * donor oocyte or embryo cycles * gestational carriers

Keywords: microfluidic density grade centrifugation sperm selection paternal age sperm dna fragmentation zymot
presurgical evaluation of skin cancers using hifu

Conditions: Skin Cancer, Non-Melanoma

Summary: 1. to ensure complete elimination of lesions with maximum preservation of function and aesthetics. 2. to elaborate the ultrasonographic features of skin cancers. 3. to determine the accuracy of hifu to assess the margins of skin lesions and its safety margins by histopathiological examination.. 4. to follow up the patient postoperatively for incomplete excision or recurrence by clinical and hifu examination.

the skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures. of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (bcc) and squamous cell carcinoma (scc). techniques such as high frequency ultrasound (hfus) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability. high frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues. high frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area. high frequency ultrasound examination of each lesion should consist of: 1. a morphologic study analyzing the structural sonographic pattern and margins; 2. the measurement of the largest transverse diameter and thickness; 3. color doppler usg for perilesional vessels ; and 4. in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.

Eligibility criteria:
inclusion criteria: * patients between 30 \& 80 years. * lesions clinically apparent locally malignant, or malignant. * lesions with or without visible ulcerations. exclusion criteria: * surgeon unable to visualize tumor on clinical examination. * patients unfit for surgery.
medicolegal aspects of head trauma

Conditions: Head Trauma

Summary: trauma is a critical global health problem. it represents the fifth leading cause of significant disability and is one of the most common causes of mortality in youth and adulthood, as one in 10 deaths worldwide occurred due to trauma. the head is preferred target for criminal acts and is a favorite place for various pathological lesions .traumatic head injury (thi)is one of the prevalent causes of global death and disability. lately, head injury (hi) cases have increased in both developed and developing nations. therefore, it is of great value to evaluate the clinical and pathological features of head injury . every injury that results in harm to the scalp, skull or brain can be sort out as a hi which can be caused by traffic mishap, falls, sports and gunshot wounds. vehicle accidents are one of the most prevalence causes of thi as they are deemed to be one of the main causes of fatality due to road-traffic accidents (rta) .among different type of the rta, motorcycle accidents holds the number one cause of accident in most of the country . skull fracture and hemorrhage are common association, which may be present with head trauma and affect the outcome of the case.the skull fractures, especially by blunt force offer varying diagnostic and medico- legal problems to the medical jurists as well as to the clinicians.


Eligibility criteria:
inclusion criteria: * diagnosed cases of head trauma exclusion criteria: * patients with deficient data i.e. escaped, discharged on demand before period of follow up
a phase 1 study of sail66 in patients with cldn6-positive locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and preliminary efficacy of sail66 in patients with cldn6-positive locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of signing informed consent form * eastern cooperative oncology group (ecog) ps of 0 or 1 * patient must have tumor specimen available for central pathology review and confirmed as cldn6-positive * (for male patients) agreement to stay abstinent or use contraceptive measures with female partners, and agreement to refrain from donating sprerm during the treatment and for 3 months after the final dose of obinutuzumab. exclusion criteria: * intending to become pregnant or breastfeed during the study and within 3 months after the last dose of sail66 or tocilizumab, or within 18 months after the last dose of obinutuzumab, whichever is longer * primary central nervous system (cns) malignancy, symptomatic (seizures etc.) cns metastases or cns metastases required any anti-cancer treatment * history or presence of cns disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, cns vasculitis, neurodegenerative disease, aphasia, dementia or paresis * uncontrolled tumor-related pain * uncontrolled pleural effusion, pericardial effusion, or ascites
hemostatic profile of post covid-19/long covid-19 patients

Conditions: COVID-19; Post-acute COVID-19 Syndrome

Summary: the present study aims at assessing long-term hemostatic profile of patients recovered from covid-19 acute infection that remain asymptomatic (post-covid) versus patients with residual symptoms (long-covid) through the employment of a commercially available new generation point-of-care viscoelastic device. the primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from covid-19.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * recovery from acute covid-19 infection; * covid-19 pneumonia that required hospitalization in our institution; * discharge from the hospital minimum 3 months before the day of the visit; * written consent to participate to the study. exclusion criteria: * none.

Keywords: covid-19 post-acute covid-19 syndrome coagulopathy fibrinolysis thrombosis
the effect of bezafibrate on cholestatic itch

Conditions: Primary Biliary Cholangitis; Primary Sclerosing Cholangitis; Secondary Sclerosing Cholangitis

Summary: randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.


Eligibility criteria:
inclusion criteria: * diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by easl clinical practice guidelines of cholestasis 2009; * itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion. exclusion criteria: * concomitant guideline-recommended as well as experimental antipruritic therapy, e.g. rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-b phototherapy; nb. topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. incidental use of these agents should be noted by patients in the diary, structural use should be noted on the crf (section co-medication); * pregnancy, women of childbearing potential not using contraception, breast feeding; * cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ercp) or surgical removal of a tumor compressing the bile duct; * use of opiates; * renal insufficiency (creatinine clearance \<60ml/min).

Keywords: pruritus itch cholestasis
a study to investigate the effect of probiotics (l. reuteri atcc pta 5289 and l. reuteri dsm 17938) on symptoms of viral upper respiratory tract infections in children

Conditions: Virus Diseases in Children

Summary: this study investigates the effect of lactobacillus reuteri probiotic strains (atcc pta 5289 and dsm 17938) on symptoms of viral upper-respiratory tract infections in children.

lactobacillus reuteri probiotic strains (atcc pta 5289 and dsm 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. the investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.

Eligibility criteria:
inclusion criteria: * children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain) * any gender * age from 4 years to 17 years * signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years * negative strep test exclusion criteria: * use of antibiotics or probiotics in the 10 days prior to study enrolment * use of a probiotic other than the test sample during the study * eight or more otitis media within 12 months * two or more bacterial sinusitis within 12 months * two or more pneumonia episodes within 12 months * history of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia) * chronic diarrhea * recurrent deep skin or organ abscesses * persistent superficial candidiasis * use of antibiotics for two months or more to treat respiratory infections within 12 months * gastroesophageal reflux * perennial (e.g., dust mite or mold) or current seasonal hay fever allergy * primary or secondary ciliary dyskinesia * congenital malformations of the respiratory tract
pressure offloading injectible system with the use of juvederm voluma in the foot

Conditions: Metatarsalgia; Hyperkeratotic Callus; Corns; Fat Pad Syndrome

Summary: the current use of juvederm voluma xc is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21. in this particular setting, the intended use of the product juvederm voluma xc is to show that the filler works to alleviate stress in high pressure areas in the foot during gait, thus decreasing foot pain and allowing individuals to walk more comfortably.


Eligibility criteria:
inclusion criteria: * patient's 40 to 75 years of age * foot and ankle disability index of at least 55 (based on the majority of people having moderate difficulty in weight-bearing living) and heavy clinical significance of fat atrophy as evaluated by the principal investigator creating a standard analysis. * atrophy of the heel or the ball of the foot will be evaluated in the step wise approach. * second a clinical exam by the primary investigator exclusion criteria: * patients who do not have high pressure fat pad atrophy * patient is being treated for cancer * skin infections * unhealed or acute foot fractures * patients with a decrease in dorsalis pedis or posterior tibial pulses * pregnant or breast-feeding * patients who have had previous injections with fillers * patients with nerve injury or nerve damage to the foot causing symptoms of numbness, tingling, burning, and sharp shooting or stabbing sensations. this criteria shall be determined by a. direct patient feedback. if the patient verbally states that they have numbness tingling burning sharp shooting or stabbing pains in their feet or ankles they will not be included. b. semmes weinstein monofilament testing - semmes weinstein monofilament testing will be performed on all patients. the semmes weinstein will be performed on the great toe submetatarsal one submetatarsal three submetatarsal five the heel and the dorsum of the foot. if a patient cannot feel the sends weinstein filament in any of those locations they will be eliminated. * active an acute diabetic foot ulceration * patients with severe allergies manifested by history of anaphylaxis * patients with a history or presence of multiple severe allergies * patients with a history of allergies to gram-positive bacterial proteins * patients with a history of allergies to lidocaine.
single ascending dose study with healthy male volunteers and type ii diabetic patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess safety and tolerability of azd6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * part a,healthy male subjects, aged between ≥20 and ≤40 years. * part b,male t2dm patients, aged between ≥20 and ≤65 years. treatment with metformin as single therapy for t2dm for at least 30 days prior to enrollment exclusion criteria: * part a,clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the ip. * part a clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator * part b, history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease. * any clinically significant abnormality identified on physical examination, laboratory tests or ecg, which in the judgment of the investigator would compromise the patient's safety or successful participation.

Keywords: type ii diabetes
duration of immobilization after rotator cuff repair: its clinical impact

Conditions: Rotator Cuff Tear

Summary: the purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff. the investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.


Eligibility criteria:
inclusion criteria: * medium to large sized cuff tear (2-4 cm) * yes subscapular partial fraying or longitudinal split side to side * yes acromioplasty * yes ac arthritis with mumford procedure * yes biceps tenotomy or tenodesis exclusion criteria: * no arthritic changes of glenohumeral joint * no combined infection * no mini-open procedures * no complete subscapularis tear * no incomplete repair * no small tears or side to side repairs without anchors * no pregnancy

Keywords: medium to large tear rotator cuff tear arthroscopic repair repair integrity immobilization
multiple dose study of shr4640 in healthy subjects

Conditions: Gout; Hyperuricemia

Summary: the objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of shr4640 in healthy volunteers.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 55, male; 2. body weight≥50, bmi:19-25kg/m2; 3.4 mg/dl≤screening serum urate level≤7 mg/dl; 4.medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen b-ultrasound and chest x-ray examination at screening. exclusion criteria: 1. serum creatinine\>upper limits of normal(uln); 2. alanine aminotransferase and/or aspartate aminotransferase\>2×uln, total bilirubin\>1.5×uln, glutamyltransferase\>3×uln; 3. history of hyperuricemia or gout; 4. history or suspicion of kidney stones; 5. positive results for hepatitis b surface antigen, hepatitis c antibody, hiv antibody, syphilis antibody test.

Keywords: shr4640 pharmacokinetics pharmacodynamics
supraclavicular versus interscalene block

Conditions: Pain

Summary: we hypothesize that both ultrasound-guided supraclavicular and interscalene block provide similar analgesia after shoulder surgery.

interscalene block provides effective postoperative analgesia after shoulder surgery. however, it can be associated with significant risk including the phrenic nerve palsy. previous study reported that ultrasound-guided interscalene and supraclavicular blocks are effective and safe for shoulder arthroscopy.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists physical status i-iii inpatients undergoing shoulder surgery exclusion criteria: pregnancy, severe respiratory disease, preexisting neuropathy in the operated arm, coagulopathy, allergy to study medication
safety and antiviral activity of idx184 in combination with pegylated interferon and ribavirin (mk-2355-004)

Conditions: Chronic Hepatitis C Infection

Summary: this study will assess short term safety, antiviral activity and pharmacokinetics (pk) of idx184 in combination with peg-interferon (peg-ifn)/ribavirin (rbv) in participants with hepatitis c virus (hcv) genotype (gt) 1 infection. these data will guide dose selection for future, longer term studies.


Eligibility criteria:
inclusion criteria: * has documented chronic hcv gt1 infection * agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy exclusion criteria: * has received previous antiviral treatment for hcv infection * has cirrhosis or decompensated liver disease * is pregnant or breastfeeding * is co-infected with hepatitis b virus (e.g., hepatitis b surface antigen \[hbsag\] positive) and/or human immunodeficiency virus (hiv) * has clinically significant concomitant disease

Keywords: chronic hepatitis c hepc hep c
the pilot study of high-throughput sequencing in neonatal birth defects

Conditions: Birth Defect; Newborn; Fit; Genetic Diseases; Multiple Malformation; Congenital Malformation

Summary: in china, birth defects can reach as high as 5.6%, about 900,000 new cases of birth defects are added each year, making it the second cause of death for infants, with a total death rate of 19.1%. at present, china implements the three-level prevention and control system for birth defects, which is performed before marriage, before birth, and during the neonatal period. newborn screening is the last line of defense against birth defects. early screening diagnosis and timely intervention are extremely important, especially for diseases which can be preventive and treatable. this study aims to evaluate the clinical application of high-throughput targeting sequencing in newborns, and investigate whether this new technology can significantly shorten the time of examination, improve the diagnosis rate, guide the intervention treatments and promote prognosis for these disease.


Eligibility criteria:
inclusion criteria: 1. neonates in one of the study hospitals 2. abnormal laboratory testing or abnormal response to standard therapy suggestive of a genetic disease exclusion criteria: 1. any infant whose genome has been shown to have large chromosomal aberration (trisomy 13, 18, 21 or other) 2. any infant in which clinical considerations preclude drawing 1.0 ml of peripheral blood 3. parents refuse consent
university of michigan youth violence prevention emergency department brief intervention (project sync)

Conditions: Violence

Summary: the purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.

this emergency department (ed) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (ic) on reducing violence in 14-20 year olds who present to the hurley medical center (hmc). eligible adolescents at the hurley medical center (hmc) emergency department (ed) (based on eligibility criteria) will complete a computerized online survey. the goal of the intervention was to examine ways to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. this one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior. at 2-months following their ed visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey. an online survey tool will be used for baseline, follow up and post-test surveys. participants will self-administer the survey at the time of follow up, post-test and baseline.

Eligibility criteria:
inclusion criteria: 1. adolescents (ages 14-20) presenting to the hurley medical center for a medical injury or illness (except exclusions noted below); 2. adolescents will the ability to provide informed assent/consent depending on age; 3. access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work); 4. currently residing in the intervention or control area; exclusion criteria: 1. adolescents who do not understand english; 2. prisoners; 3. adolescents with abnormal vital signs; 4. adolescents deemed unable to provide informed consent by emergency department or research staff (e.g., intoxication, mental incompetence); 5. adolescents treated in the emergency department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by emergency department staff).

Keywords: youth violence