Kornimate/medical-research-clean huggingface dataset:
australasian resuscitation in sepsis evaluation randomised controlled trial

Conditions: Severe Sepsis

Summary: the arise rct is a multi-centre, randomised, controlled trial of egdt compared to standard care in patients with severe sepsis presenting to the ed. the study will be conducted in multiple sites with 1600 patients enrolled into the study. hypothesis to be tested: egdt, compared to standard australasian resuscitation practice, reduces 90-day all-cause mortality in patients presenting to the ed with severe sepsis.

the primary aim of the study is to determine whether providing egdt, compared to standard care, reduces 90-day mortality in patients presenting to the ed of hospitals in australasia with severe sepsis. each patient meeting all of the exclusion criteria and none of the exclusion criteria will be randomised in the ed to receive either egdt for a total of 6 hours post-randomisation, or standard care. patients assigned to receive egdt will be cared for by the dedicated arise study team. the patient will receive treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, then receive standard care. patients assigned to receive standard care will continue to be cared for by the hospital team in accordance with current best practice. patients in both groups will also receive any additional treatment needed, such as antibiotics or surgery. this study will involve 1600 patients with severe sepsis admitted to the ed from multiple hospitals.

Eligibility criteria:
inclusion criteria: * suspected or confirmed infection * the presence of two or more of the following sirs criteria: * core temperature \ 38.0 degc * heart rate \> 90 beats/minute * respiratory rate \> 20 breaths/minute or paco2 \< 32 mmhg or the requirement for mechanical ventilation for an acute process * white blood cell count \> 12.0 or \ 10% immature band forms * evidence of either refractory hypotension or hypoperfusion: * refractory hypotension is confirmed by the presence of a systolic blood pressure (sbp) \< 90 mmhg or mean arterial pressure (map) \< 65 mmhg after a 1000ml intravenous (iv) fluid challenge within 60 minutes (including iv fluids administered pre-hospital) * hypoperfusion is confirmed by the presence of a blood lactate concentration greater than or equal to 4.0 mmol/l * first dose of iv antimicrobial therapy commenced prior to randomisation exclusion criteria: * age \< 18 years * contra-indication to superior vena cava (svc) cvc insertion * contra-indication to blood products (e.g. jehovah's witness) * inability to commence delivery of the egdt protocol within 1 hour of randomisation or complete 6 hours of egdt * haemodynamic instability due to active bleeding * pregnancy (confirmed or suspected) * in-patient transfer from another acute health care facility * an underlying disease process with a life expectancy of \< 90 days * death is deemed imminent and inevitable * a "limitation of therapy" order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable

Keywords: sepsis severe sepsis septic shock
role of ptk-7 in acute myeloid leukemias

Conditions: Acute Myeloid Leukemia

Summary: the pseudo tyrosine kinase receptor 7 (ptk7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. ptk7 is expressed in normal myeloid progenitors and cd34(+) cd38(-) bone marrow cells in humans. it is also expressed in acute myeloid leukemia (aml) and is mostly assigned to granulocytic lineage differentiation. in aml, ptk7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. this study aims at: * evaluating the impact of ptk7 expression on primary aml cells ex vivo * evaluating the diagnostic and prognostic value of a soluble form of ptk7


Eligibility criteria:
inclusion criteria: * age\> 18 years * aml at diagnosis, not previously treated * treatment by induction chemotherapy * signed informed consent * affiliation to the french social security system exclusion criteria: * pregnant woman(or of childbearing potential) or breastfeeding woman * emergency * patients deprived of liberty or placed under the authority of a tutor

Keywords: ptk7 acute myeloid leukemia
biological image guided antalgic stereotactic body radiotherapy of bone metastases

Conditions: Bone Metastases

Summary: in various common cancers, the skeleton is a preferred site of metastasis. these bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. it is postulated that the clinical target volume (ctv) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. advances in biological imaging (positron emitting tomography pet) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. these findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. the hypothesis is that fluorodeoxyglucose positron emitting tomography (fdg-pet) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. the primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.


Eligibility criteria:
inclusion criteria: * painful bone metastasis of solid tumors * pain score minimum of 2 on a scale of 10 * a maximum number of painful bone metastases: 3 or more * life expectancy \> 3 months * age minimum 18 years old * signed informed consent exclusion criteria: * tumor histology (renal cell and melanoma vs. other solid tumors) * vas pain score (\<5 vs. 6-10). * bisphosphonate use (yes vs. no) * opioid analgesics (yes vs. no) * corticosteroid use (yes vs. no) * spine vs non-spine localisation
incidence/magnitude-haemorrhagic progression-cerebral contusions and identification (id) of safety issues after traumatic brain injury

Conditions: Acquired Bleeding Disorder; Trauma

Summary: this study is conducted in north america. the purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.


Eligibility criteria:
inclusion criteria: * ages eligible for study: 18 years - 85 years
preoperative oral hydration in the ambulatory arthroplasty population

Conditions: Same-day Discharge; Length of Stay

Summary: the purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.

the way total joint arthroplasty is practiced continues to evolve as cms removed total hip arthroplasty (tha) from the inpatient-only list and added total knee arthroplasty (tka) to the asc covered surgical procedures list (cpl) in 2020. thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.

Eligibility criteria:
inclusion criteria: * candidates for ambulatory total knee arthroplasty * candidates for ambulatory total hip arthroplasty * candidates for ambulatory revision knee arthroplasty (liner exchange only) * candidates for ambulatory revision hip arthroplasty (liner exchange only) * case scheduled before noon (12 pm) * patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge exclusion criteria: * bmi less than 18.5 or greater than 37.0 * patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb. * pregnant women * patients scheduled as ambulatory due to insurance mandates * patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per hospital for special surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate \< 60ml/min.

Keywords: carbohydrate drink perioperative fluids same-day discharge total joint arthroplasty nausea vomiting same-day total hip arthroplasty same-day total knee arthroplasty
efficacy of rts,s/as01 vaccine against episodes of malaria due to p. falciparum infection in children.

Conditions: Malaria

Summary: this phase iib trial is being done to find out if the rts,s/as01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * a male or female child of between 5 months and 17 months of age at the time of first vaccination. * written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. exclusion criteria: * acute disease at the time of enrolment. * serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. * laboratory screening tests for haemoglobin, total white cell count, platelets, alt and creatinine out of acceptable limits. * planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine. * use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose * previous participation in any other malaria vaccine trial. * simultaneous participation in any other clinical trial. * same sex twin. * history of allergic reactions (significant ige-mediated events) or anaphylaxis to previous immunizations. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Keywords: malaria plasmodium rts s/as01 falciparum
recent-onset type 1 diabetes extension study evaluating the long-term safety of teplizumab (protect extension)

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the protect study.

this study is the long-term extension of the prv-031-001 (protect) study. protect is a phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-cd3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose. participants who complete the protect study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. the decision to participate can be made within 12 months of completing the protect study. no study drug will be administered during this extension study. participants will continue to receive standard care for type 1 diabetes from their primary physicians. participants will return to the study sites for assessments once every 6 months through month 42. therefore, the combined duration of the protect and protect extension studies will be 60 months.

Eligibility criteria:
inclusion criteria: 1. completion of the prv-031-001 (protect) study by completing the week 78 visit in that study, regardless of how many doses of study drug were administered. 2. provide written informed consent within 12 months of the week 78 in the prv-031-001 study. written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. if possible, written informed consent and/or assent for the current protect extension study (prv-031-003) should be obtained at the final (week 78) visit in the protect study. exclusion criteria: 1. premature discontinuation from the prv-031-001 (protect) study for any reason.

Keywords: recent-onset type 1 diabetes teplizumab t1d stage 3 type 1 diabetes new onset type 1 diabetes
to evaluate the safety, tolerability and efficacy in male and female with aga treated with hmi-115 over a 24-week treatment period

Conditions: Androgenetic Alopecia

Summary: an open label study, to evaluate safety, tolerability, and efficacy study in male and female with androgenetic alopecia treated with hmi-115 over a 24-week treatment period.


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. male and female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent. 3. clinical diagnosis of androgenetic alopecia. male subjects who meet norwood-hamilton scales 3v, 4 and 5. female subjects who meet sinclair scales 2-4. exclusion criteria: 1. subject with clinical diagnosis of non-aga 2. subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment 3. subject has used therapies associated with hair growth or may affect prl levels, within defined time window before screening 4. subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction 5. subject has clinically significantly abnormal laboratory tests at screening 6. known hypersensitivity to any of the imp ingredients 7. any other conditions in the investigator's opinion that prevent the subject from participating
recover-autonomic: platform protocol, appendix a (ivig)

Conditions: Long COVID; Long Coronavirus Disease 2019 (Covid19); Long Covid-19

Summary: this study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into covid-19 programs and subsequent treatment plans. this protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (pots), in post-acute sequelae of sars-cov-2 infection (pasc) participants. the interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

the hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms. interventions will be added to the platform protocol as appendices. each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

Eligibility criteria:
inclusion criteria: * see nct06305780 for recover-auto: platform protocol level inclusion criteria which applies to this appendix (or sub-study) additional appendix a (ivig sub-study) level inclusion criteria: 1. abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in hr within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms 2. compass-31 score \> 40 exclusion criteria: * see nct06305780 for recover-auto: platform protocol level exclusion criteria which applies to this appendix (or sub-study) additional appendix a (ivig sub-study) level exclusion criteria: 1. current or previous ivig treatment 2. contraindication to intravenous immunoglobulin. 3. known allergic reactions to blood products including ivig and/or subcutaneous immunoglobulin (scig), such as history of clinically relevant hemolysis after ivig infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reactions 4. selective iga deficiency 5. current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-tnf-alpha inhibitors 6. use of immunosuppressants such as plaquenil, or low-dose steroid (prednisone, no more than 10mg a day) will be excluded unless the participant is on stable (\>4 weeks) dose 7. significant thrombotic events after the acute phase of covid-19 and/or within 6 months of enrollment 8. veins that are not viable for infusions 9. not willing to adhere to dosing schedule for ivig infusions for 9 months

Keywords: pasc pots
noninvasive positive pressure ventilation for ali/ards:a multicentre randomized controlled trial

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: with appropriate inspired oxygen concentrations, nppv would prevent intubation and hence avert the poor outcome associated with the need of invasive ventilation in patients with ali/ards.

noninvasive positive-pressure ventilation (nppv) is increasingly being used in the care of patients suffering acute respiratory failure. high-level evidence supports the use of nppv to treat exacerbation of chronic obstructive pulmonary disease (copd). more recently, niv has shown to reduce the need for intubation in selected groups of patients with severe cardiogenic pulmonary edema, immunosuppression, and respiratory failure after lung resection. in their subgroup analysis of the five randomized control trials, however, patients with acute lung injury (ali) or ards still couldn't avoid intubation and death even treated with nppv. till now, there has been no randomized controlled study of nppv in patients with ali or ards. we hypothesized that in patients with ali/ards, early use of nppv, providing appropriate inspired oxygen concentrations, would prevent intubation as the primary end-point variable, hence avert the poor outcome associated with the need of invasive ventilation. accordingly, we conducted a prospective, randomized controlled trial to assess the efficacy of nppv compared with a standard regime consisting of high-concentration oxygen therapy.

Eligibility criteria:
inclusion criteria: * meet the ali/ards criteria exclusion criteria: * age \> 85 * ph \ 50mmhg * glasgow coma scale (gcs)\<11 * airway or facial deformity * pneumothorax or pneumomediastinum * unable to spontaneously clear secretions from their airway * respiratory arrest * shock or hemodynamic instability (systolic blood pressure \<90 mmhg associated with decreased urinary output (\<20 ml.h-1) despite fluid repletion and use of vasoactive agents) of other causes * severe ventricular arrhythmia or active myocardial ischemia * severe organ dysfunction (including gastrointestinal hemorrhage, disseminated intravascular coagulation, hepatic and renal dysfunction, sofa score\>1) * end-stage patients who are expected to survive less than six months * severe abdominal distension * refuse to receive nppv * unable to cooperate with the application of nppv

Keywords: noninvasive positive pressure ventilation acute lung injury acute respiratory distress syndrome
echocardiography sub-study of the umbilical cord milking in non-vigorous infants trial (minvi)

Conditions: Birth Asphyxia

Summary: non-vigorous infants enrolled in the minvi trial will be approached for consent for ongoing data collection. as part of the data collection, an optional echocardiogram will be performed if the parent consents.

non-vigorous infants enrolled in the minvi trial will be approached for consent for ongoing data collection. as part of the data collection, an optional echocardiogram will be performed if the parent consents. the consent will have a check box to indicate if they consent to the additional test. echocardiographic measurements will be performed on all infants at 12 hours +/- 6 hours of age by our research sonographers who are blinded to infant randomization. measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (svc) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (lvo) (ml/kg/min), measures of left and right ventricular tissue doppler and strain imaging. these measurements will be performed offline at a later time. data will be entered into redcap. if any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. the consent will clearly state that this echo is not for diagnostic purposes. any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary

Eligibility criteria:
inclusion criteria: • non-vigorous newborns born between 35-42 weeks gestation. exclusion criteria: * known major congenital or chromosomal anomalies of newborn. * known cardiac defects other than small atrial septal defect (asd), ventricular septal defect (vsd) and patent ductus arteriosus (pda). * complete placental abruption/cutting through the placenta at time of delivery. * monochorionic multiples * cord anomaly (i.e. cord avulsion or true knot) * presence of non-reducible nuchal cord * perinatal providers unaware of the protocol * incomplete delivery data * infants born in extremis, for whom additional treatment will not be offered.

Keywords: umbilical cord milking immediate cord clamping resuscitation