Kornimate/medical-research-clean huggingface dataset:
adme study of [14c]-ibrexafungerp in healthy male subjects

Conditions: Fungal Infection

Summary: this is a phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (adme) of an oral solution of \[14c\]-ibrexafungerp following administration in healthy male subjects. each subject will receive a single dose of \[14c\]-ibrexafungerp and will be followed for up to 20 days. during this period total radioactivity will be measured in blood, urine and faeces.

this is a phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (adme) of an oral solution of \[14c\]-ibrexafungerp following administration in healthy male subjects. each subject will receive a single dose of \[14c\]-ibrexafungerp and will be followed for up to 20 days. during this period total radioactivity will be measured in blood, urine and faeces. all subjects will undergo preliminary screening procedures for the study at the screening visit. subjects will be admitted to the clinical unit on the evening prior to dosing (day -1). a single oral dose containing \[14c\]-ibrexafungerp oral solution will be administered to subjects. individual subjects will be released from the clinical unit following study-related procedures on days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.

Eligibility criteria:
key inclusion criteria: * healthy males * age 30 to 65 years of age at the time of signing informed consent * must be willing and able to participate in the whole study * must provide written informed consent * must agree to adhere to the contraception requirements key exclusion criteria: * subjects who have received any investigational drug in a clinical research study within the 90 days prior to day 1 * current smokers * recent radiation exposure * subjects who have been enrolled in a 14c adme study in the last 12 months * an acute or chronic disease determined by the investigator to be clinically significant * clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator * evidence of renal impairment at screening * history of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder

Keywords: scy-078 ibrexafungerp adme
reliability and validity of the dutch language version of the cfcs-nl and the vss-nl in flanders, belgium

Conditions: Cerebral Palsy; Communication

Summary: the study aims to determine the reliability and validity of the cfcs-nl and vss-nl (both speech and language-related classification scales for children with cerebral palsy) for flanders so they can be implemented within the cp-referencecentre at uz leuven, amongst the classification scales that are already being used.

within the cp-referencecentre, the gross motor (gmfcs), fine motor (macs) and swallowing (edacs) skills have of children witch cerebral palsy (cp) have long been classified. in the speech and language pathology field, the communication function classification scale (cfcs) and the viking speech scale (vss) were recently developed. the cfcs maps communication as a whole and is a five-point scale. the cfcs is analogous to the aforementioned scales. the vss focuses on speech intelligibility and is a four-point scale. this research is based on determining the reliability and validity of the above scales for flanders so that they can be implemented within the cp-referencecentre. in addition, the mutual relationship between the scales and the relationship between the cfcs-nl and the other classification scales for cp (gmfcs, macs \& edacs) will be determined. the vss will also be translated into dutch beforehand, this is a collaboration with the vu university amsterdam (dr. joke geytenbeek). the study is a cross-sectional study. the patients (n = 20) will be recruited during the consultations at the cp-referencecentre between february 1, 2019 and april 30, 2019. the selection criteria consist of: diagnosis of cp, age of 4 t.e.m. 10 years, single language education in dutch, no diagnosis of asd and a signed informed consent form. a questionnaire bundle will be given to the parents of the participating patients (completion time approx. 30 to 45 minutes). this includes a few questionnaires about characteristics of the child / filler, two questionnaires about the social communication skills and the social interaction skills of the child, and the cfcs and vss scales which the parents have to score. this questionnaire bundle (with the exception of the questionnaires concerning social communication skills and social interaction skills) will also be given to the child's teacher and a treating paramedic. in addition, an appointment will also be made at the patients house where a video recording (2x15min) will be made in which the child interacts with a trusted person and an untrusted person (the researcher) so that the cfcs- nl and the vss-nl scores of the child can be determined by the student and the speech therapists of the cp-referencecentre. during that appointment one of the parents will also be interviewed using the subdomain "social functioning" of the pedi-nl. after data collection, a quantitative data analysis is performed to obtain an answer to the research questions.

Eligibility criteria:
inclusion criteria: * cerebral palsy * gmfcs i-v exclusion criteria: * bi- or multilinguism * diagnosis of autism

Keywords: cfcs vss cerebral palsy
prevalence of wild type transthyretin cardiac amyloidosis in patients operated for idiopathic carpal tunnel syndrome

Conditions: Amyloidosis Cardiac; Carpal Tunnel Syndrome

Summary: wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction. before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. this study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.


Eligibility criteria:
inclusion criteria: * patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the region of central denmark (region midtjylland) the last five years. * informed written and verbal consent exclusion criteria: * operation by different indication such as * fracture * ganglion * tumors * osteophytes * rheumatoid arthritis * persistent medial artery * metabolic causes * alcoholism * hyperthyroidism * myxedema * hereditary cardiac amyloidosis * known wt attr * al amyloidosis * myelomatosis * mgus and morbus waldenström
study of ono-4685 in patients with relapsed or refractory t cell lymphoma

Conditions: Relapsed or Refractory T Cell Lymphoma

Summary: this study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ono-4685 in patients with relapsed or refractory t cell lymphoma


Eligibility criteria:
inclusion criteria 1. patients aged ≥ 18 years at time of screening 2. written informed consent by the patient or the patients' legally authorized representative prior to screening 3. patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of t-cell lymphoma: 1. peripheral t-cell lymphoma (ptcl): angioimmunoblastic t-cell lymphoma (aitl), ptcl, not otherwise specified (ptcl-nos), nodal ptcl with t-follicular helper (tfh) and follicular t-cell lymphoma (ftcl) 2. cutaneous t-cell lymphoma (ctcl) (stages ii-b, iii, and iv): mycosis fungoides (mf) and sezary syndrome (ss) 4. patients must have received at least 2 prior systemic therapies 5. patients with ptcl must have at least 1 measurable lesion (cheson bd, 2014) 6. patients with ctcl must have assessable disease by response criteria for ctcl (olsen ea, 2011) 7. eastern cooperative oncology group performance status (ecog ps) = 0-2 8. life expectancy of at least 3 months 9. adequate bone marrow, renal and hepatic functions exclusion criteria: 1. patients with central nervous system (cns) involvement 2. patients with adult t-cell leukemia/lymphoma (atll) 3. prior allogeneic stem cell transplant 4. prior treatment with ono-4685, anti-pd-1, anti-pd-l1, anticytotoxic t lymphocyte associated protein 4 (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways 5. prior allogeneic and autologous chimeric antigen receptor (car) t-cell therapy 6. patients with malignancies (other than t-cell lymphoma) except for completely resected basal cell carcinoma, stage i squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years 7. history of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone) 8. history of infection with mycobacterium tuberculosis within 2 years prior to the first dose of study treatment 9. patients with systemic and active infection including human immunodeficiency virus (hiv), hepatitis b or c virus infection 10. patients not recovered to grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies 11. women who are pregnant or lactating

Keywords: ono-4685 pd-1 cd3 bispecific antibody ptcl aitl ptcl-nos nodal ptcl with tfh ftcl ctcl mf ss
the effect of caudal block on the postoperative complications in pediatric patients after hypospadias repair

Conditions: Hypospadias

Summary: hypospadias refers to a disease represented by a congenital defect in the urethra meatus (urinary opening) in male children. due to the postoperative pain, symptoms such as discomfort, agitation, and restlessness are generally found. in particular, young children with restlessness often express their pain or discomfort with their bodies because they are unable to express it in words. this severe restlessness may make an operated region unstable, accompanying bleeding, infection, or other surgery-related complications. because postoperative pain control is very important, neuraxial block techniques such as epidural block or caudal block have been employed in addition to a penile dorsal nerve block. although the neuraxial block technique including the caudal block is an easy and safe method and has an excellent effect, the neuraxial block technique poses a potential risk in the procedure. in addition, with respect to the surgical prognosis, it has been reported that penile engorgement may cause penile vasodilation, resulting in oozing at the surgical region or other surgical complications. however, there has not been a report on the increase of postoperative complications by penile vasodilation or on the difference in the recovery or surgical prognosis according to the types of pain control for young patients.


Eligibility criteria:
inclusion criteria: * pediatric patients who underwent the tubularized incised plate (tip) repair under hypospadias at our institution between january, 2010 and december, 2014 exclusion criteria: * patients whose medical records could not be analyzed for having undergone the first hypospadias surgery at another institution. other exclusion criteria were as follows: over the age of 8 years, planned two-stage hypospadias repair, receiving continuous epidural analgesia, and without hypospadias as the final diagnosis.

Keywords: hypospadias repair caudal block postoperative complications
osteoarthritis and body composition: evaluation of systematic mediators

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to examine the relationship between body composition and knee osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.

banked serum and urine specimens obtained from nia baltimore longitudinal study on aging (blsa) participants with and without knee oa will be used to determine inflammatory, metabolic, bone and joint biomarkers in an observational, case-control study. this study will be limited to blsa data and samples that have already been acquired and stored. the specific aims of this study are to: 1. examine the association between prevalent radiographic osteoarthritis (oa), concurrently obtained inflammatory and metabolic mediator levels and change in bone density and bone markers over time subsequent to radiographic classification. 2. determine levels of inflammatory, metabolic and bone markers, and body composition when radiographic oa was absent, and examine their relationship to the development of radiographic knee oa. adjustments will be made for age, gender, body mass index and level of physical activity.

Eligibility criteria:
inclusion criteria: * participants of the blsa who have had 1 or more dxa scans and who were either classified as having radiographic knee oa (kellgren \& lawrence 2 or higher) or as having no radiographic knee oa on two or more xrays (kl 0-1) exclusion criteria: * diagnosis of rheumatoid arthritis * diagnosis of malignancy * reported use of prednisone and other immunosuppressive medications or insulin

Keywords: inflammatory markers bone markers oa
therapeutic hypothermia with intravascular temperature management (ivtm) in post-cardiogenic cardiac arrest and post-return of spontaneous circulation patients in japan

Conditions: Cardiac Arrest

Summary: a multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (ivtm) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (rosc) patients in japan. the objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (ivtm) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-rosc patients.


Eligibility criteria:
inclusion criteria: 1. non-traumatic in-hospital or out-of-hospital cardiac arrest 2. unwitnessed cardiac arrest (ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset) 3. patient is at least 20 years of age and less than 80 years of age with consent is given 4. in the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions 5. therapeutic hypothermia using the investigational device can be initiated within six hours of return of spontaneous circulation (rosc) 6. written consent can be obtained from a legally acceptable representative exclusion criteria: 1. traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc) 2. accidental hypothermia with core body temperature less than 35.0°c 3. pregnant or of child bearing potential 4. patient has given or indicated a do not resuscitate (dnr) order 5. femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like 6. an inferior vena cava filter is in place 7. patient has severe bleeding (pulmonary hemorrhage, gastrointestinal hemorrhage, etc.) 8. intracranial hemorrhage as confirmed by ct scanning 9. hemodynamic instability despite use of vasopressor agents and cardiac stimulants 10. heparin hypersensitivity 11. serious systemic infectious diseases (sepsis, etc.) 12. platelet count less than 30,000/mm3 13. serious hepatic dysfunction 14. serious renal impairment 15. using percutaneous cardiopulmonary support (pcps) 16. using continuous hemodiafiltration (chdf) 17. therapeutic hypothermia has been otherwise implemented between rosc and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander) 18. the patient's core body temperature cannot be monitored 19. currently participating in another clinical trial or has participated in another clinical trial within the past six months 20. in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient

Keywords: cardiac arrest return of spontaneous circulation (rosc) intravascular temperature management (ivtm) therapeutic hypothermia japan
calcipotriol as a novel treatment for central centrifugal cicatricial alopecia (ccca)

Conditions: Central Centrifugal Cicatricial Alopecia

Summary: the purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for central centrifugal cicatricial alopecia (ccca). this study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.

calcipotriol, a vitamin d analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. it is possible that vitamin d plays a role in sustaining the hair follicle's immune privilege through anti-inflammatory effects such as controlling interferon gamma (ifn-γ) production. a recent study showed a significant decrease of vitamin d in black patients with central centrifugal cicatricial alopecia (ccca)"

Eligibility criteria:
inclusion criteria: * women who are eighteen years of age or older * biopsy-proven and/or clinical diagnosis of ccca stage ii-iv * must be on stable treatment without changes for at least 3 months * subjects will be recruited from outpatient dermatology clinics at the wake forest baptist health department of dermatology. exclusion criteria: * males

Keywords: hair loss hair follicle regrowth
comparison between two types of meshes used in pelvic organs prolapse procedures

Conditions: Postoperative Complications

Summary: using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.

weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. it was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. the degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones. during the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. the cases will be divided according to the mesh type being used. a polypropylene mesh (single strand and tunneling wide) trade name "prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "prolift +" m. the number of participants in each group is 120 women. the post-operative follow-up examination will include three points in time. after a month, six months and a year later. in addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.

Eligibility criteria:
inclusion criteria: * women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall. exclusion criteria: * women with significant pre-operative pain * women with collagen diseases * women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall

Keywords: absorbable mesh partially absorbed mesh prolift prolift + m mesh related complications
outcome for patients with war-associated extremity wound infection

Conditions: Wounds and Injuries

Summary: extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians and combatants. war-associated injuries are often contaminated with foreign material, leading to infection. wound infections is considered a major risk to life and restoration of function in war-wounded patients surviving past the first hours. in a cohort study the investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

armed violence has occurred intermittently in northwestern pakistan and neighboring afghanistan since the beginning of the 1980s. in 1981 the international committee of the red cross (icrc) opened a hospital in peshawar, pakistan, to care for the injured from the armed conflict in afghanistan. in 2004 the number of patients increased as a result of the emerging divergence between the state of pakistan and militant groups in the northwestern pakistan. yearly about 1000 patients with war-associated injuries, predominantly caused by gunshots and explosive devices have been treated for free at the icrc hospital in peshawar. the hospital is now closed. war-associated injuries are generally treated according to the icrc war surgical protocol. research on the epidemiology of and risk factors for wound infection in patients with war-associated injuries is limited and primarily include military combatants, leading to a selection of young males. due to the use of body armor and forward surgical teams this data may not be applicable to a civilian setting. it is unknown to what extent wound infection itself is a factor contributing to serious complications such as amputation and death. knowledge is needed to gear resources towards those most in need. this research makes use of a unique database that contains both civilians and combatants of both sexes and all ages. the investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

Eligibility criteria:
inclusion criteria: * patients that have received treatment for war-associated extremity wounds * patients that present at the hospital within 72 hours of injury * patients with valid data on baseline wound status. exclusion criteria: • patients that are re-admitted during the study period, i.e. patients that received treatment during the study period and are later re-admitted will only be counted as one patient.