Kornimate/medical-research-clean huggingface dataset:
pcr (polymerase chain reaction) assay for diagnosis of sarcoptes scabiei

Conditions: Scabies

Summary: the main objective of this study is to identify unique dna sequences within the genome of human scabies that can be utilized to identify the parasite through pcr.

the main objective of this proposed study is to identify unique dna sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or pcr. the goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain sarcoptes scabiei. we hypothesize that specifically amplifying the unique regions of the scabies genome using pcr can serve as a means to diagnosis infestations in humans. to address this question, we will optimize pcr amplification of known scabies samples then apply our procedure to dna extracted from patient samples.

Eligibility criteria:
inclusion criteria: * 1. male/female of all ages whose standard clinical treatment produces one or more of the following: * slides from skin scrapings containing scabies mites, eggs, and/or fecal material * slides from skin scrapings of suspected tinea * slides from skin scrapings of demodex mites exclusion criteria: * 1. patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. subjects or guardians who cannot understand and read english and so are unable to consent to participation.
palonosetron plus aprepitant versus palonosetron in preventing nausea and vomiting in leukemic patients

Conditions: Chemotherapy Induced Nausea and Vomiting

Summary: the aim of present study is to evaluate if the addition of aprepitant to multiple doses of palonosetron iv enhances the efficacy of multiple doses of palonosetron iv alone, in preventing cinv in aml or high risk mds patient, treated with multiple days chemotherapy.

this is an open-label, randomized, comparative, multicenter phase ii study in patients with aml scheduled to receive multiple days chemotherapy. patients will receive either palo+apr or the palo regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. below are described the details for both antiemetic regimens: palo+apr regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment. palo regimen: multiple intravenous bolus of palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukaemia or high-risk mds according to ipss * patient eligible for aml-like induction therapy * candidate for multiple-days chemotherapy (minimum 3 days) * age more, equal18 years * ecog 0-2 * not pregnant or nursing * must be able to complete the patient's diary * provide written informed consent exclusion criteria: * aml or hr-mds therapy-related * active infection requiring intravenous antibiotics * prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years * unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related * myocardial infarction within the past 6 months * psychiatric or cns disorders interfering with ability to comply with study protocol * known hypersensitivity to 5-ht3 antagonists and their components csf involvement * pre-existing nausea or vomiting

Keywords: palonosetron aprepitant cinv aml multiple-days
endoscopic ultrasound-guided portosystemic pressure gradient measurements

Conditions: Liver Cirrhosis; Liver Diseases; Hypertension, Portal

Summary: the objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with echotip® insight™ in patients with cirrhosis who are referred for an egd and/or eus.


Eligibility criteria:
inclusion criteria: patient who has been referred for an egd and/or eus procedure and direct pressure measurement. general exclusion criteria: * patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study. * patient is unwilling or unable to sign and date the informed consent. * patient is unwilling or unable to comply with the follow-up study schedule. * patient for whom endoscopic procedures are contraindicated

Keywords: fatty liver portal pressure measurement portal pressure gradient
cardiovascular fellow-in-training feedback on virtual and simulator-based learning experience in a low to middle income country

Conditions: Educational Problems

Summary: virtual and simulatorbased learning is not widely available in lmic. it is imperative to analyze feedback of cv fellow-in-training regarding this mode of learning before large scale implementation.

covid-19 pandemic has introduced us to a greater need of virtual learning platforms and has resulted in less clinical exposure for fellows-in-training. virtual and simulatorbased learning is not widely available in lmic. it is imperative to analyze feedback of cv fellow-in-training regarding this mode of learning before large scale implementation. this was an observational study conducted between july-august 2020. a multicentered survey was conducted. survey questionnaire was disseminated to fit via google forms. the questionnaire contained total of 24 questions about virtual and simulator-based learning during the pandemic.

Eligibility criteria:
inclusion criteria: * cardiovascular fellow-in-training currently under training at the institute. exclusion criteria: * none.

Keywords: cardiovascular education, virtual education, simulator, lmic
evaluating the potential of probiotic supplementation sleep quality

Conditions: Sleep Disorder; Anxiety; Depression; Stress; Probiotics

Summary: this study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. previous animal experiments have confirmed that limosilactob acillus fermentum ps150 and heat-treated lactobacillus fermentum ht-ps150 strains have the effect of improving sleep. 90 subjects will be recruited, 45 in each group. they will be given either ht-ps150 or placebo for 8 weeks and their blood, urine, saliva and questionnaire will be evaluated.

the most important function of sleep is to restore physical energy lost after activities during the day, and to adjust and reorganize people's emotions, behavior, and cognitive memory. the average adult sleeps about 7 to 8 hours. good sleep quality has a great impact on the performance of work and study during the day. if a person does not get enough sleep for a long time, it is easy to suffer from memory loss, emotional instability and other phenomena. it will also affect the operation of the immune system and easily lead to colds and illnesses. the following statements are often complained by sleep disorder patient: 1. difficulty falling asleep. 2. difficulty maintaining sleep, often waking up suddenly in the middle of sleep or having difficulty falling back to sleep once woken up. 3. waking up too early and having trouble falling back to sleep. this study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. previous animal experiments have confirmed that limosilactob acillus fermentum ps150 and heat-treated lactobacillus fermentum ht-ps150 strains have the effect of improving sleep.

Eligibility criteria:
inclusion criteria: * age 20 to 60 years old * pittsburgh sleep quality scale score is greater than or equal to 5 * insomnia severity scale (isi less than 22 points) * subjects need to have a regular daily routine (no night shift work) exclusion criteria: * have used antibiotics or probiotic products in powder, capsule or tablet form within one month * are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills) * those who are taking traditional chinese medicine or western medicine to treat serious acute diseases * patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness * those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.) * people who are allergic to probiotic products * pregnant or breastfeeding * alcohol, tobacco and coffee addicts * have carried out long-distance travel or work across time zones in the past month and the next two months * those who have participated in other interventional clinical studies in the past three months * those who are judged by the moderator to be unsuitable to participate in the research
personalized viscoelastic testing-guided bleeding management in liver surgery, neurosurgery and obstetrics

Conditions: Thrombelastography; Liver Transplant; Postpartum Hemorrhage; Bleeding Disorder; Intracranial Hemorrhages

Summary: the clotpro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. this study aims to assess the agreement of clotpro 6.0, rotem delta, and teg 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. the obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.

the primary research question is therefore to compare various parameters of standard clotpro measurements with corresponding rotem delta and teg 6s parameters. additionally, this study aims to close the following clinically important knowledge gaps: do vet results mirror measurements obtained by more holistic, in-depth analyses of the hemostatic system that are currently not available in clinical practice, such as tga-tm and pg? which of the three investigated vet devices offers the most rapid availability of diagnostic results? do vet results have a predictive ability for the occurrence of perioperative bleeding and/or thromboembolic events? do vet results depict sex-specific differences in perioperative coagulation management? furthermore, by including a large number of patients from three distinct patient cohorts, this study intends to examine whether cohort-specific reference ranges need to be established for clotpro. thereby, this study aims to provide the foundation for an evidence-based clotpro-guided perioperative coagulation management algorithm, which could upscale current opportunities of personalizing perioperative coagulation management.

Eligibility criteria:
inclusion criteria: 1. vulnerable patient cohorts * patients undergoing elective liver surgery defined as one of the following invasive procedures: * liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy), * orthotopic liver transplantation, * pregnant women undergoing an elective caesarean section, and * patients undergoing an elective intracranial neurosurgery. 2. written informed consent exclusion criteria: none

Keywords: viscoelastic testing personalized bleeding management
early tranexamic acid and modulating the inflammatory response in sepsis

Conditions: Sepsis

Summary: in this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.

a written informed consent will be taken from the patients or their relatives.patients will be assigned randomly to two groups (40 subjects each) with qsofa ≥2. in (group t) administer 1 gram of tranexamic acid (txa) in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of tranexamic acid (txa) iv over 8 hours in 0.9% normal saline for the first 3 days. in (group c) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.

Eligibility criteria:
inclusion criteria: * adults (age 18-65 years) of american society of anesthesiologists (asa) i-ii who will be diagnosed with sepsis by qsofa ≥2 * \& needed icu admission. exclusion criteria: * chronic renal failure * liver cirrhosis * bleeding disorders or current anticoagulant therapy * pregnancy or breastfeeding * impaired color vision * severe vascular ischemia, history of venous thrombosis \& pulmonary embolism * long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before icu admission * allergy to tranexamic acid (txa)
tonsillectomy and primitive iga nephropathy in children: strasbourg cohort and assessment practices in inter north east region

Conditions: Tonsillectomy

Summary: primitive kidney disease iga, represented by berger's disease and rheumatoid purpura nephropathy, are the first cause of kidney failure from chronic glomerulonephritis: changes in 20 years to end-stage renal failure is described in 10 to 30 % of cases in berger's disease and in 15 to 20% of cases in nephropathy hsp. these two pathological entities share biological and histological characteristics, as well as common pathophysiological mechanisms, particularly the production of abnormally glycosylated iga1 promoting their proliferation in the mesangium. tonsils part of iga abnormal production sites that would be associated with an infectious stimulus, tonsillectomy has been studied as a possible treatment in primitive iga nephropathy. the benefit of tonsillectomy is controversial: many japanese studies demonstrate its effectiveness in terms of reduction of proteinuria, improved renal function in the long term regression of histological lesions and reduced risk of relapse following clinical remission whereas european studies do not suggest its effectiveness in treating iga nephropathy. in this context, the aim of our study is to describe the scope of practice of tonsillectomy in the treatment of primary renal disease in iga child in the inter east region and describe the short renal become strasbourg end of the cohort that received this treatment.


Eligibility criteria:
inclusion criteria: * children with a clinical diagnosis and / or histological evidence of primary iga nephropathy * follow the university hospital of strasbourg since 2009 * having received a tonsillectomy in their care * children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes exclusion criteria: * children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Keywords: tonsillectomy primary iga nephropathy primary nephropathy iga berger's disease purpura rheumatoid kidney failure
pathology of skin, nerve and vasculature in the amputated limb of diabetes

Conditions: Wound; Diabetes; Amputation

Summary: 1. to explore the pathology of nerve, vascular, and skin in the amputated leg 2. to diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention 3. to search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb

diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem. peripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. all these predict foot ulceration to some degree(1). motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population. for more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. skin biopsy with pgp9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis . intra-epidermal nerve fiber (ienf) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes . previous ienf density study was performed in diabetic patients with sensory symptom but no foot ulcer. now we tried to evaluate ienf density in severe diabetic foot patient who received below knee amputation. skin biopsy willl be performed at amputated leg. the skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group . underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study. the result will be compared to the control group which were recruited from a previously described cohort matched by gender and age.

Eligibility criteria:
inclusion criteria: * diabetic foot wound patient who underwent below-knee amputation exclusion criteria: * diabetic foot wound patient who couldn't receive below-knee amputation due to severe heart disease, high anesthetic risk.

Keywords: small-fiber sensory neuropathy nerve pathology vasculature pathology amputation diabetic foot wound sensory neuropathy below knee amputation
laser assisted sperm selection of viable immotile testicular sperm in azoospermic infertile men

Conditions: Azoospermia; IVF

Summary: this study aims to investigate the outcome of icsi after using laiss for selection of viable immotile testicular sperm in azoospermic infertile men. patients will be randomly assigned to 2 groups. in (laiss) group, viable immotile testicular sperms will be selected before icsi using laser assisted immotile sperm selection (study group). in (host) group, viable immotile testicular sperms will be selected before icsi using hypo-osmotic swelling test (control group).


Eligibility criteria:
inclusion criteria: * eligible couples are those undergoing icsi due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (tese) or aspiration (tesa). exclusion criteria: * cases with female factor infertility or woman age above 35 years will be excluded.

Keywords: laser assisted immotile sperm selection hypo-osmotic swelling test icsi testicular sperm
safety, tolerability and pk of ensovibep (mp0420 - a new candidate with potential for treatment of covid-19)

Conditions: COVID-19

Summary: this study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male or female subjects between ages of 18-65 years * body mass index of 18.0-35.0 kg/m2 * non-smokers for at least 3 months * deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine * agree to follow the contraception requirements of the trial * able to give fully informed written consent. exclusion criteria: * positive tests for hepatitis b \& c, hiv * severe adverse reaction to any drug * drug or alcohol abuse * use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication * any vaccination within 4 weeks before dose of trial medication * participation in other clinical trials of unlicensed medicines within the previous 3 months * loss of more than 400 ml blood within the previous 3 months * vital signs outside the acceptable range * clinically relevant abnormal findings at the screening assessment * acute or chronic illness * clinically relevant abnormal medical history or concurrent medical condition * possibility that volunteer will not cooperate * females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.

Keywords: ensovibep covid-19 treatment sars-cov-2 corona designed ankyrin repeat protein (darpin®) angiotensin-converting enzyme 2 (ace2)
breestim for motor recovery in chronic stroke with severe impairment (pilot)

Conditions: Motor Recovery

Summary: the overall goal is to investigate the effectiveness of a novel intervention - breathing-controlled electrical stimulation (breestim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.


Eligibility criteria:
inclusion criteria: * has post stroke ≥ 6 months , medically stable; * unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke); * mas score ≥ 1, i.e., detectable finger flexor hypertonia; exclusion criteria include: * patients with visual deficit/neglect; hearing or cognitive impairment; * patients with history of pulmonary disease (asthma, chronic obstruction pulmonary disease, copd); * patients that are currently adjusting tone alternating medications (e.g., baclofen), or * patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years; * patients with a pacemaker; * women who are pregnant.

Keywords: finger flexor spasticity motor recovery breestim
cefid-ii (cera flow improves dvt-ii)

Conditions: Blood Circulation Disorder; Deep Vein Thrombosis

Summary: for deep vein thrombosis (dvt) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name cgm mb-1701).

the investigator applies the test device to the appropriate subjects for a total of 10 days (+1 days) at the institution and nursing hospital, and upon discharge for long-term follow-up investigation, the investigational device is applied at subjects' home according to the subject's consent for about 3 months.

Eligibility criteria:
inclusion criteria: 1. adult men and women over 19 years of age 2. subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices. (1) subjects diagnosed by doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) d-dimer negative test result (even if d-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.) 3. subjects have 2 or more points of venous thromboembolism (hereinafter referred to as vte) clinical prediction score (two-level wells score) at the time of screening. 4. subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent exclusion criteria: 1. subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain 2. subjects have inflammation or trauma on the skin that directly touches the device