Kornimate/medical-research-clean huggingface dataset:
feasibility of risk-adapted therapy in young adult acute lymphoblastic leukemia: a multicenter trial

Conditions: Acute Lymphoblastic Leukemia

Summary: several prognostic predictors, including baseline all features and response to initial therapy, have been described in adult all raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification. in the graall-2003 prospective phase 2 study, we aim to hierarchize the following high-risk factors in ph-negative all patients.

1) baseline (bl) : wbc30g/l in b-lineage, cns involvement, mll-af4 and e2a-pbx fusions, haploidy/near-triploidy; 2) early response (er) : corticoresistance after prophase (csr), chemoresistance at day 8 (chr); all csr and/or chr patients are planned to receive higher doses of cyclophosphamide (hyperc) at day 15 of induction; 3) induction response (ir) : no cr or ig-tcr minimal residual disease (mrd) 10-2 after standard or hyperc induction. allogeneic stem cell transplantation is proposed to patients with a donor and at least one bl, er, or ir factor.

Eligibility criteria:
inclusion criteria: * 15-59 years * acute lymphoblastic leukemia newly diagnosed * signed written informed consent exclusion criteria: * lymphoblastic lymphoma * acute lymphoblastic leukemia 3 * chronic myeloid leukemia acutisation * sever organ condition

Keywords: acute lymphoblastic leukemia adult patient chemotherapy stem cell transplantation young adult patients
retrospective evaluation of commercial spacers in prostate cancer patients

Conditions: Prostate Cancer

Summary: assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the bioprotect balloon implant system

Eligibility criteria:
inclusion criteria: - males at least 18 years of age, who have undergone radiation therapy with implantable spacers exclusion criteria: * patients whose clinical and pathological data are not available. * patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension
controlling rapid atrial fibrillation with dexmedetomidine

Conditions: Rapid Atrial Fibrillation; Heart Rate Control

Summary: the purpose of this study is to assess the effects of dexmedetomidine (dex), on heart rate control in patients with rapid atrial fibrillation (af) through a pragmatic, randomized, double blinded study comparing the addition of dex or placebo to standard of care (soc) treatment.

dexmedetomidine is a commonly used sedative/anxiolytic agent in the icu with sympatholytic properties that can cause a decrease in heart rate. eligible patients will be randomized into one of two groups: soc plus dex arm or soc plus placebo (normal saline) arm. study drug infusion will be administered at an infusion rate of 1μg/kg/hr via iv, and will not include a loading dose. four 6-second telemetry rhythm strips will be collected per hour, starting one hour prior to study drug infusion, during the eight hour infusion period, and two hours post infusion cessation). degree of heart rate control and time to heart rate control for both groups will be analyzed.

Eligibility criteria:
inclusion criteria: * adult patients in a sbu hospital icu with rapid-af (with ventricular rates \>100 bpm). * patient screening will be conducted prior to patient or lar consent. exclusion criteria: * patients age \<18yrs; * anticipated icu stay \<11hrs; * permanently paced heart rhythm; * known 2nd or 3rd degree heart block; * junctional rhythms; * known pregnancy; * known allergy to dexmedetomidine; * receiving dexmedetomidine prior to study onset; * non-intubated patients w/ glasgow coma scale \<8; * weight \>400lbs (protocol dosing restriction); * untreated, symptomatic hypotension (sbp\<90mmhg); * received amiodarone, lidocaine, or mexiletine w/in 4hrs prior to consent.

Keywords: dexmedetomidine critical care atrial fibrillation
the drug-drug interaction of shr3824 and metformin

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the potential interaction between multiple oral doses of shr3824 and a single oral dose of metformin in healthy adult volunteers.

this is an open-label (volunteers will know the names of treatments they are assigned) single-center study of shr3824 and metformin in healthy adult volunteers. shr3824(a sodium-glucose cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (t2dm) and metformin is an approved treatment for patients with t2dm. shr3824 will be administered orally (by mouth) as 25 mg on days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on days 1 and 8. both shr3824 and metformin tablets will be taken with 8 ounces (240 ml) of water.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index (bmi, a measure of a person's weight in relation to height) between 19 and 24 kg/m2. exclusion criteria: * history of diabetes * history of heart failure or renal insufficiency * urinary tract infections, or vulvovaginal mycotic infections * history of or current clinically significant medical illness as determined by the investigator * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * known allergy to shr3824 or metformin or any of the excipients of the formulation of shr3824 or metformin

Keywords: shr3824 metformin drug-drug interaction
ventilator associated pneumonia multiplex pcr for anti-infective regimens

Conditions: Ventilator Associated Pneumonia

Summary: ventilator-associated pneumonia (vap) remains one of the main nosocomial infections acquired in the intensive care unit (icu). vap is pneumonia occurring 48 hours after intubation. today, bronchoalveolar lavage (bal) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. multiplex pcr can detect dna of a number of bacteriae, as well as the presence of resistance genes. however, its clinical value in the icu remains to be demonstrated. we think that the use of multiplex pcr with a panel adapted to the microbiology of vap, could be an interesting method for clinicians in icu.

ventilator-associated pneumonia (vap) remains one of the main nosocomial infections acquired in the intensive care unit (icu). vap is pneumonia occurring 48 hours after intubation. today, bronchoalveolar lavage (bal) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. multiplex pcr can detect the bacterial dna of a number of bacteria, as well as the presence of resistance genes. however, its clinical value in the icu remains to be demonstrated. we think that the use of multiplex pcr with a panel adapted to the microbiology of vap, could be an interesting method for clinicians in icu. the aim of our study is to compare the percentage of appropriate empirical antibiotic therapy in the group benefiting from multiplex pcr on bal prior to bacterial culture results compared to control group (bacterial culture alone=usual management) in patients with culture-confirmed vap. this is a multicenter, randomized, controlled, french study conducted in 8 university intensive care units (2 surgical units, 6 medical units) in the grand-est region of france. the multiplex pcr tested here is biofire's filmarray pneumonia panel plus. it is performed solely on per-fibroscopic bronchoalveolar lavage (bal) fluids in cases of suspected vap.

Eligibility criteria:
inclusion criteria : * adult patients, hospitalized in intensive care unit * on mechanical ventilation for at least 48 hours * suspected vap * with an indication for bronchoalveolar lavage (bal) exclusion criteria : * patients under legal protection or without social security coverage * pregnant women * previous episode of vap during the same hospitalization

Keywords: ventilator associated pneumonia intensive care unit empirical antimicrobial therapy multiplex pcr diagnosis antibiotic stewardship bronchoalveolar lavage
rehabilitation exercise using digital healthcare system in patients with anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injuries

Summary: the study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (uincare homeplus) in the patients with anterior cruciate ligament reconstruction. the study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. limb symmetry index (lsi), pain (using numerical rating scale), knee joint range of motion (rom), lower extremities motor power (using manual muscle test), international knee documentation committee (ikdc) and quality of life using eq-5d-5l will be evaluation on enrollment, 2-weeks, 6-weeks, 12-weeks and 24-weeks after enrollment.

anterior cruciate ligament(acl) is a vital structure in the knee maintaining the stability and due to increased population engaging in sports activities, the acl injury is becoming more prevalent among young adults. rehabilitation after acl reconstruction is essential to restore knee function and many factors including age, degree of sports activities engagement, weight bearing should be considered when organizing rehabilitation programs. knee joint stiffness and weakness of knee flexor/extensor muscles are common problems following the surgery which are related to improper rehabilitation after acl reconstructions. current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance. with development of technologies using multi-motion sensor and ar(augmented-reality) system, the investigators have developed a digital healthcare system(uincare homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback. in this prospective randomized controlled study, the investigators aim to compare the efficacy of the newlydeveloped digital healthcare system with conventional rehabilitation program.

Eligibility criteria:
inclusion criteria: * patient who had anterior cruciate ligament reconstruction surgery * patient who is discharged to home after surgery exclusion criteria: * patient who had previous history of anterior cruciate ligament reconstruction surgery in the past 6 months. * patient who had undergone bilateral anterior cruciate ligament reconstruction surgery. * patient who has knee joint disorders (rheumatoid arthritis, osteoarthritis) other than anterior cruciate ligament injury. * patient who has neurological deficit or infection in the affected knee joint. * patient who has severe comorbidity that inhibits exercise. * patient who cannot participate in post surgery rehabilitation

Keywords: anterior cruciate ligament reconstruction post-operative rehabilitation digital healthcare system
repair of multiple finger defects using the dorsal homodigital island flaps

Conditions: Finger Injuries; Soft Tissue Injuries

Summary: multiple finger defects are common in hand trauma and result in functional disability. these injuries are often complex and severe, and thus reconstructive alternatives are limited. in this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. at the final follow-up, we would evaluate the efficacy of this technique.

at final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and semmes-weinstein monofilament testing. the range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. the cold intolerance of the injured finger is measured using the self-administered cold intolerance severity score questionnaire that is rated into mild, moderate, severe, and extreme. the pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Eligibility criteria:
inclusion criteria: 1. a patient who had separate soft tissue defects in different fingers in same hand; 2. the defect ≥ 1.5 cm and ≤ 3.5 cm in length; 3. local tissue near the defect is uninjured; and 4. a patient between 15 and 60 years of age. exclusion criteria: 1. concomitant injuries to local tissue around the defect that precluded its use as donor site; 2. a defect \< 1.5 cm and ≥ 3.5 cm in length; 3. a finger degloving injury; 4. the defect of the thumb.

Keywords: surgical flap; dorsal branch of the digital artery
guiding aging long-term opioid therapy users into safer use patterns

Conditions: Pain; Opioid Use

Summary: patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. these increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. the dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. by focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care. the objective of this study is to assess the comparative effectiveness of paintracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 300 northwestern medicine clinicians treating chronic opioid use registry patients (n=5159).

using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. this system will be used to evaluate paintracker, delivered to half of the sample (approximately 2,579 patients). clinicians treating chronic opioid use registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) current opioid misuse measure \[comm\] \[standard clinical care\] or 2) comm + paintracker. surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in epic.

Eligibility criteria:
inclusion criteria: • patients age 65 or older on long-term opioid therapy within the northwestern medicine chronic opioid use registry system with at least one primary care encounter in the past 12 months. exclusion criteria: • patient visits with active cancer diagnoses
all reconstruction versus modified lemaire's let in combination with acl reconstruction with a minimum follow up of 2 years

Conditions: Anterior Cruciate Ligament Injuries

Summary: anterior cruciate ligament (acl) tears are associated with concomitant lesions of the anterolateral ligament (all), which increase rotatory instability of the knee. if untreated, all insufficiency can compromise the results of acl reconstruction, with higher risk of iterative acl tear or additional meniscal lesion. several surgical techniques have been described to reconstruct the all. indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. to date, the two most popular techniques are the lemaire technique (use of a fascia lata strip) and lal reconstruction plasty (use of part of an accessory hamstring tendon). the older lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. more recently, following a new, precise anatomical description, anterolateral ligament plasty (all) has been developed, which is intended to be more anatomical than lemaire's technique, but whose clinical superiority has not yet been demonstrated. both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion. to date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up. the aim of this study was to compare graft survival of all reconstruction versus modified lemaire let in combination with acl reconstruction with a minimum follow up of 2 years. secondary aim was to compare functional outcomes between both groups.


Eligibility criteria:
inclusion criteria: * man or woman with age between 18 and 50 years old * disabling anterior chronic laxity * 1 criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test * patient who signed the informed consent form. exclusion criteria: * any associated procedure (excluding meniscal resection or repair) like osteotomy or meniscus graft * pregnant patient * persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care * adults under legal protection

Keywords: acl reconstruction lateral extra-articular tenodesis modified lemaire tenodesis anterolateral ligament
chiropractic dosage for lumbar stenosis

Conditions: Lumbar Spinal Stenosis

Summary: this randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. subjects will be evenly randomized into four groups of either flexion distraction (fd) care or a control: group 1 with 8 total fd treatment visits, group 2 with 12 total fd treatment visits, group 3 with 18 total fd treatment visits, or group 4 with 8 total placebo control visits. the study is designed: (1) to determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) to determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.


Eligibility criteria:
inclusion criteria: * males and females at least 50 years old with lumbar spinal stenosis * impingement of the cord and/or exiting nerve roots evidenced on spine imaging studies * symptomatic with current pain in the back and/or one or both of the legs. * symptoms must have been present for at least six months with an insidious onset exclusion criteria: * congenital stenosis or other spine deformities such as current spinal fractures, spinal infections, or tumors of the spine * prior lumbar spine surgery such as laminectomy, spinal fusion, or discectomy that lacks stability or occurred within the past 3 months. * currently pregnant or nursing * co-morbid conditions that may preclude a person from participating in active care (laying prone on a treatment table or completing exercises) and outcome measures (treadmill testing, completion of questionnaires), such as severe cardiopulmonary disorders (i.e.: severe coronary artery disease, recent myocardial infarction, or vascular claudication), neuromusculoskeletal disorders (i.e.: disabling hip or knee arthritis; trochanteric bursitis; piriformis syndrome; need for assisted ambulation), or brain disorders (i.e.: dementia or alzheimer's disease) * active conservative care such as physical therapy or chiropractic care for lumbar stenosis (excluding the use of oral medications or daily at-home exercises for general well-being) * cauda equina symptoms (i.e.: perianal numbness; loss of bowel and/or bladder control) * not fluent or literate in the english language. we will not be able to provide multiple translators within this pilot study * current or future litigation for low back or leg pain
subarachnoid block with ultrasound-guided transversalis fascia plane block for cesarean section

Conditions: Caesarean Section; Pain, Acute

Summary: postoperative pain management is critical for the fulfillment of the maternal duties. the transversalis fascia plane (tfp) block provides adequate postoperative analgesia in the t12 and l1 dermatomes. the aim of this study was to investigate the effect of the tfp block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (cs) under spinal anesthesia.


Eligibility criteria:
inclusion criteria: * aged between 18 and 45 * american society of anesthesiologists (asa) physical score i or ii exclusion criteria: * patients who received general anesthesia * hypersensitivity to the agents to be used * body mass index (bmi) greater than 35 kg/m2 * coagulopathy * local infections * opioid addiction * pregnancy-related hypertension or diabetes mellitus
fentanyl or esketamine for traumatic pain (fore-pain) trial

Conditions: Acute Pain Due to Trauma; Analgesia; Fentanyl; Esketamine; Emergency Medical Services

Summary: fentanyl and esketamine are both standard of care for treatment of acute severe traumatic pain in the prehospital setting in the netherlands. however, it is not known whether they are equally effective and safe. it is also not known whether intranasal (in) administration of fentanyl or esketamine is equally effective and safe as intravenous (iv) administration. the fore-pain trial is a double-blind multi-arm randomized non-inferiority trial comparing fentanyl in, esketamine iv and esketamine in (intervention arms) to fentanyl iv (comparator arm) for prehospital management of traumatic pain. the investigators hypothesize that all intervention arms provide analgesia that is non-inferior to the comparator arm, and that all study arms are equally safe.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * pain has been caused by a trauma (any trauma mechanism) that occurred on the same day * emergency medical services personnel determines that administration of a strong opioid or esketamine for analgesia is required * patient will be transported to a hospital exclusion criteria: * (estimated) weight \ 100 kg * subject does not understand dutch or english * inability to report pain score * inability to give in or iv medication * known severe cardiovascular disease * pre-eclampsia * glasgow coma scale score \< 11 * subject is known to have previously declined participation in medical research

Keywords: analgesics ketanest administration, intranasal administration, intravenous pain management drug-related side effects and adverse reactions anesthetics