Kornimate/medical-research-clean huggingface dataset:
an alternative culture medium to better support preimplantation embryo development in vitro

Conditions: Infertility; Reproductive Techniques, Assisted

Summary: the purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in art.

egg retrieval will be performed as per standard operating procedures. eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. the single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. all mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. after fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. after confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). on day 3, embryos are evaluated and moved from step one to step two culture medium. on day 5 and day 6, embryo development will be assessed. good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.

Eligibility criteria:
inclusion criteria: * adult women of any age who come to colorado center for reproductive medicine for fertility treatment using ivf. * patients can be of any race, culture, sexual orientation or ethnicity. exclusion criteria: * minors are excluded from the study

Keywords: embryo culture techniques embryonic development
evaluation of regret in kidney transplantation

Conditions: Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney

Summary: decisional regret is a negative feeling, involving distress or remorse following a decision. this has been studied in several areas such as psychology, economy or marketing. patients suffering from end-stage renal disease may choose between dialysis and transplantation. this decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. the donor study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. the decisional regret will be assessed by the drs ("decisional regret scale"), associated with the retransqol, a quality of life questionnaire.


Eligibility criteria:
inclusion criteria: * kidney transplantation in the lille university hospital * functional kidney graft after 28 days post transplantation exclusion criteria: * previous other solid organ transplant * combined transplantation (kidney and liver for example) * cognitive disorders * lack of french language skill

Keywords: decisional regret kidney transplantation quality of life
movement enhancing device for children

Conditions: Upper Extremity Dysfunction

Summary: the purpose of this study is to assess: 1) how infants move their bodies to explore, play, and solve problems, 2) if this is different in a high-risk group of infants, and 3) if these abilities can be advanced in a high-risk group through the use of a movement assisting device.

certain conditions or diagnoses identified soon after birth are known to put infants at risk for having problems with their motor (movement) development as they get older. infants with these diagnoses are at risk for additional developmental problems due to their inability to move their bodies to explore, learn, and play. this study tests how a device that assists movement can help exploration, learning, and play in children. the information gathered in this study will help us better understand how early learning happens and how we can help individuals become better movers, learners, and problem-solvers so they can increase their participation in everyday play activities.

Eligibility criteria:
inclusion criteria: • infants will be invited to participate if they are between 1 month and 6 years and: * were born \< 36 weeks of gestational age with periventricular leukomalacia or grade iii or iv intraventricular hemorrhage * were born \> 36 weeks of gestational age with encephalopathy related to perinatal asphyxia * have the diagnosis of neonatal stroke or intracranial hemorrhage * have brachial plexus palsy * have arthrogryposis multiplex congenital * have down syndrome * have congenital hypotonia exclusion criteria: • blindness or severe sensory motor impairments that would prohibit the child from completing the study assessment.

Keywords: wilmington robotic exoskeleton reaching upper extremity function preterm infants brain injury pediatrics early intervention arthrogryposis
study of glycopyrronium in axillary hyperhydrosis

Conditions: Hyperhidrosis

Summary: the study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

this is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis. safety will be assessed through lab tests, ecg, physical exams and vital signs.

Eligibility criteria:
inclusion criteria: * male or female ≥ 9 years of age. * primary, axillary hyperhidrosis of at least 6 months duration * hyperhidrosis disease severity scale (hdss) of 3 or 4 at baseline * axillary sweating daily diary (asdd) ≥ 4 at baseline * sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically exclusion criteria: * prior surgical procedure for hyperhidrosis. * prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational). * prior treatment with botulinum toxin (e.g., botox®) for axillary hyperhidrosis within 1 year of baseline/day 1. * previous active treatment in the dermira drm04-hh01 or drm04-hh02 clinical trials. * axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of baseline. * subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline. * treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months. * other treatment with glycopyrrolate within 4 weeks prior to baseline. * secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis. * history of sjögren's syndrome or sicca syndrome. * history of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness. * men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy. * history or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. * other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
brain death diagnosis at an academic tertiary medical care center

Conditions: Brain Death

Summary: the aim of this study is to assess and survey the quality of the process required to diagnose brain death in adult patients. this study of adult patients diagnosed brain dead or suspected of having brain death on the icus at the university hospital basel will be purely observational.


Eligibility criteria:
inclusion criteria: * patients with suspected and/or diagnosed brain death * adults 18 years and over

Keywords: diagnosis of brain death
early detection and post-operative monitoring of gastric cancer

Conditions: Gastric Cancer

Summary: this study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.

this study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. sensitivity, specificity, accuracy, roc curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers ca19-9, cea, and ca72-4. blood will also be collected at various time points post-operatively. the investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. the investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers ca19-9, cea, and ca72-4. this study is a prospective and multi-center study.

Eligibility criteria:
inclusion criteria: 1. subject age over 18. 2. subject has stomach discomfort, and seek medical attention at the gastric surgery department of our center. 3. subject has or will have gastroscopy and/or pathological examination results at this center. 4. subject must be able to fully understand the informed consent form and be able to personally sign it. exclusion criteria: 1. subject has serious heart, liver, kidney dysfunction, or mental illness. 2. subject diagnosed previously with any kind of malignant tumor. 3. subject is known to be infected with hiv or other related diseases (considering interference from the use of immune drugs). 4. subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies. 5. researchers believe that subject is not suitable for enrollment. 6. subject can not supply sufficient sample to complete this experiment.
longitudinal surveillance study of the 4-site lead/header system

Conditions: Primary Prevention of Sudden Cardiac Arrest; Secondary Prevention of Sudden Cardiac Arrest

Summary: post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. the goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the boston scientific endotak reliance® 4-site™ lead and the pulse generator 4-site header.

the objective of the lss of 4-site study is to prospectively determine the chronic complication-free rate of the 4-site lead/header system in order to verify its clinical performance, long-term reliability and functional integrity. the lss of 4-site study is a non-randomized, multi-center, global clinical investigation of subjects implanted with the 4-site lead/header system. the study is designed to collect product performance information, any reportable adverse events and withdrawal data. the primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-site lead/header system. this 4-site lead/header system consists of a 4-site endotak® reliance defibrillation lead connected to a 4-site header (which is the only pg component under study) of a single or dual chamber (vr and dr) implantable cardioverter defibrillator (icd) or a cardiac resynchronization therapy icd (crt-d) bsc pulse generator. additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.

Eligibility criteria:
inclusion criteria: * medically indicated for icd/crt-d * received/plan to receive study lead * willing for long-term follow-up exclusion criteria: * unwilling to comply with protocol

Keywords: icd crt-d defibrillation lead
effects of sevoflurane in subanesthetic concentrations on the forearm perfusion

Conditions: Ischemia/Reperfusion Injury

Summary: sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury. study hypothesis: the volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation

healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations. forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design.

Eligibility criteria:
inclusion criteria: male * non-smoker * no asthma * npo * volunteer exclusion criteria: * female * chronic medication * asthma * smoking

Keywords: ischemia/reperfusion organ protection anesthetics
ptsd mobile app for cancer survivors

Conditions: Posttraumatic Stress Disorder; Cancer

Summary: the purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (ptsd). the information learned by doing this study may help us to develop some target treatments for ptsd symptoms in survivors of stem cell transplant. participants in this study will be randomized to a mobile app or usual care. an assessment will be made after 4 weeks and a determination made of adding more intensive treatment. participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.


Eligibility criteria:
inclusion criteria: * completion of autologous or allogeneic hct 1-5 years previously * partial or complete remission (ned), may be receiving chemoprevention * absence of severe psychological impairment (eg hospitalization for suicidality) * approved for contact by oncologist * able and willing to participate in a one-hour baseline interview * no prior cbt for ptsd * owns a smart device with internet and email access * able to read and write english * significant ptsd symptoms as indicated by at least one of the following two criteria: probable cancer-related ptsd on the pcl5 by using the symptom cluster criteria; subthreshold or partial ptsd symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster exclusion criteria: * if the participant does not fulfill the inclusion criteria

Keywords: ptsd depression anxiety distress digital health mhealth
niapsan as add -on therapy to antipsychotic treatment in first episode psychosis

Conditions: Psychosis

Summary: the purpose of this study is to help understand if by adding niaspan fct (study drug) to antipsychotic medications will it help maintain or improve cognitve functioning.


Eligibility criteria:
inclusion criteria: all subjects 1. must understand the nature of the study, must provide written informed consent prior to the conduct of any study procedures/assessments and are willing/able to participate in study procedures/assessments as specified in this protocol. 2. must be between the ages of 18 - 35 patients 1. within one year of initial dsm 1v tr diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder nos 2. outpatients 3. females of child bearing potential who have a negative serum pregnancy test prior to enrolment and agree to use a reliable method of birth control (use of oral contraceptives or norplant; contraceptive injections; contraceptive patch; double barrier method; intrauterine devices; partner with vasectomy or abstinence) during the study and for one month following the last dose of study drug. healthy controls 1. age-matched to experimental groups exclusion criteria: 1. due to their underlying mental disorder are considered by the investigator(s) to be unable to provide informed consent and/or unwilling or unable to participate in study procedures/assessments 2. are judged by the investigator(s) (based on history, mental status examination or clinical impression) as being at significant risk of self-injurious/suicidal or violent/homicidal behaviour 3. meet criteria for substance abuse or dependence (excluding nicotine and caffeine) as defined by dsm iv-tr at the time of screening and/or within the preceding 6 months 4. have unstable medical, psychiatric, neurological or behavioural disorders that may interfere in the conduct or interpretation of the study. 5. have a history of pre-existing liver dysfunction and/or at screening have abnormal liver function tests (alt\>2x upper limit of normal; ast\>3x upper limit of normal; bilirubin\>1.5x upper limit of normal) 6. have a past or current history of peptic ulcer, gout or bleeding problems 7. have a past or current history of hypophosphatemia 8. have a history of head injury resulting in loss of consciousness of \> 5 minutes or other neurological disorder (e.g., seizures, stroke, ms) 9. are currently taking a vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 100 mg/day. 10. are currently receiving treatment with any of the following medications: 1. anticoagulants 2. statins 3. antihypertensives 11. are currently receiving treatment for type 1 or type 2 diabetes 12. have a history of allergic reactions to niaspan or any of its non-medicinal ingredients (methylcellulose, povidone, stearic acid), niacin or nicotinic acid 13. are currently participating in any other investigational drug study 14. are a professional or staff member affiliated with the nova scotia early psychosis program or are an immediate family member defined as spouse, parent, child, sibling, grandparent or grandchild
effect of lu af35700 in patients with treatment-resistant schizophrenia

Conditions: Schizophrenia

Summary: to evaluate the efficacy of 10 and 20 mg/day of lu af35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (trs)

the study consists of a screening period (3 weeks), a single-blind prospective confirmation (pc) period (6 weeks), a double-blind treatment (dbt) period (10 weeks), and a safety follow-up period (6 weeks). patients who did not fulfil the randomization criteria for the dbt period, were withdrawn from the study after the pc period. patients who fulfilled the randomization criteria for the dbt period, continued into the dbt period and were randomized into one of 3 treatment arms (1:1:1) with either lu af35700 10 mg/day, lu af35700 20 mg/day or to continue the treatment allocated in pc period (olanzapine or risperidone) at the dose set at last visit of pc period. this mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the pc period. data was not collected separately for the dbt olanzapine and dbt risperidone participants, and there was no intent to compare lu af35700 to each drug separately.

Eligibility criteria:
inclusion criteria: * the patient has schizophrenia, diagnosed according to dsm-5(tm) (diagnostic and statistical manual of mental disorders) and confirmed by the mini international neuropsychiatric interview for schizophrenia and psychotic disorders * the patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist. * patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to screening * the patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to screening. the failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s) * the patient has a panss total score of ≥80 and a score of ≥4 on at least 2 of the following panss items (at screening and at the first visit of period a) * the patient has a cgi-s score of ≥4 at screening and at the first visit of period a exclusion criteria: * the patient has any current primary psychiatric disorder other than schizophrenia as assessed by the mini international neuropsychiatric interview (mini) * the patient is experiencing an acute exacerbation of his/her psychotic symptoms * the patient has not responded to treatment with clozapine other protocol defined inclusion and exclusion criteria may apply
pectus esc outcomes and comparative effectiveness study

Conditions: Pectus Excavatum; Pain, Postoperative

Summary: investigators hypothesize that erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. the aims are to compare los between the two groups (epidural and es groups). secondary aims are to compare recovery outcomes (mobilization time), time required to do the blocks, pain scores and opioid use during hospitalization and on follow up after discharge until pain clinic visit, side effects, family satisfaction and readmissions among the two groups. in addition, in-hospital and post-discharge outcomes in subjects who received esp protocol will be studied.

retrospective study - electronic medical records of consecutive patients who underwent pectus surgery between january and december of 2019 (epidural protocol) and those who underwent same procedure between june 2020 to may 2021, will be evaluated. covariates and outcomes described in sections below will be recorded from emr. the data included records from flowsheets, pain team notes based on follow up questionnaires administered by phone after discharge until after esp catheters were removed, as well as pain clinic notes.

Eligibility criteria:
inclusion criteria: * age\>8 years * diagnosis of pectus excavatum who underwent nuss procedure * pain regimen included either epidural catheter or es catheters exclusion criteria: * developmental delay * prior pectus repair * concomitant procedures