Kornimate/medical-research-clean huggingface dataset:
efficacy of idarubicin, cytarabine and cyclophosphamide (iac) regimen in relapsed/refractory aml

Conditions: Acute Myeloid Leukemia

Summary: in this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory aml patients will be randomized into 2 groups. in the experimental arm, patients receive iac regimen. in the control arm, patients receive other physician-directed regimen. the primary end point is complete remission rate.

in this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory aml patients will be randomized into 2 groups. patients in the iac arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. in the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(fla±g) regimen,cytarabine plus daunorubicin(da）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus aa) regimen or aa regimen plus granulocyte stimulating factor. all the regimen in the control arm can not contain cyclophosphamide. the primary end point is complete remission. the second end points include overall survival, relapse-free survival and time to treatment failure.

Eligibility criteria:
inclusion criteria: 1. age of less than 60 years old; 2. patients that meet the diagnostic criteria(who 2008 criteria) of aml (except apl subtypes). 3. patients with a confirmed pathologic diagnosis of aml which had relapsed or refractory. 4. patients with ecog score of ≤ 2; 5. adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. patients under 18 years old willing to participate should have their legal guardians sign the informed consent. exclusion criteria: 1. patients who had received reinduction therapy including cyclophosphamide are excluded. however, patients who had received regimens including cyclophosphamide before relapse are eligible. 2. patients with other blood diseases(for example, haemophiliacs) are excluded. 3. relapsed patients with only extramedullary leukemia; 4. after allogeneic hematopoietic stem cell transplantation; 5. with mutation of breakpoint cluster region-abelson(bcr-abl) fusion gene and in need of tyrosine kinase inhibitors therapy; 6. acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 7. had other malignant tumor in need of treatment; 8. had active cardiovascular disease; 9. patients with other factors which were considered unsuitable to participate in the study by the investigators.
effectiveness of a triclosan containing toothpaste in maintaining periodontal health in a type 2 diabetic population

Conditions: Periodontitis

Summary: clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.


Eligibility criteria:
inclusion criteria: * type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of \>200mg/dl. * minimum of 16 teeth * chronic periodontitis as indicated by periodontal probing depths \>4mm on at least 6 teeth exclusion criteria: * any condition requiring antibiotic cover for dental treatment * other serious illness
telehealth physical therapy for chronic back pain - ancillary study to nct03859713

Conditions: Low Back Pain

Summary: this study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.

at the time of the onset of the covid pandemic, the research team was conducting a clinical trial (the optimize trial) investigating different nonpharmacologic treatments for persons with chronic low back pain (nct03859713). one intervention arm in this trial is in-person physical therapy. covid-related restrictions on in-person care prompted suspension of the optimize trial. in order to accommodate persons in the midst of receiving treatment at the time of suspension, the study team adapted the in-person protocol for physical therapy for telehealth delivery using two-way, real-time video sessions. because of the lack of research examining the feasibility of telehealth physical therapy provided in this manner, the study team decided to conduct a pilot study to examine the feasibility of the telehealth protocol. this study was a prospective, longitudinal cohort of persons with chronic lbp seeking care in one of three healthcare systems; university of utah health and intermountain healthcare in salt lake city, utah, and johns hopkins medicine in baltimore, maryland. all participants were offered up to 8 weekly sessions of telehealth physical therapy. outcomes included measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness measures including the oswestry disability index and the promis-29 health domains. assessments occurred at baseline and after 10- and 26-weeks.

Eligibility criteria:
inclusion criteria: * age 18 - 64 years at the time of enrollment. * meets nih task force definition of chronic lbp based on two questions: 1) how long has lbp has been an ongoing problem for you? and 2) how often has lbp been an ongoing problem for you over the past 6 months? a response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the nih definition of chronic lbp. * healthcare visit for lbp in the past 90 days. * at least moderate levels of pain and disability requiring odi score \>24 and pain intensity rating \> 4. exclusion criteria: * evidence of serious pathology as a cause of lbp including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc. * evidence of a specific spinal pathology as the cause of lbp including spine fracture, spinal stenosis, radiculopathy, etc. * knowingly pregnant * unable to participate in telehealth due to lack of technology or internet access * has received physical therapy for lbp in prior 90 days * currently receiving substance use disorder treatment * any lumbar spine surgery in the past year.

Keywords: telehealth physical therapy chronic pain
a nurse-led individualized educational intervention

Conditions: Psoriasis

Summary: 60 newly referred patients with psoriasis at the department of dermatology and allergy, herlev and gentofte hospital, denmark will be consecutive included in the study. in the first phase of the study 30 patients will receive standard treatment (control group) and in the following phase 30 patients will receive the individualized conversational/educational intervention (intervention group).the rationale for using a historical control group instead of a randomised control group is that it in"real-life setting" is unpractical to realize a communicative intervention, because clinicians unintentional can intervene against the control group. the first conversation will take place when the newly referred patient has initiated a new treatment. the rational for this is that the time of transition from private practice to the department of dermatology and allergy is characterised by failed treatment, typically phototherapy or topical. this meaning that newly referred patients current needs is to get their psoriasis under control. when patients have initiated a medical treatment they will be more motivated and have better surplus to engage in the conversational/educational intervention. patients in the intervention group will receive an individual face-to-face conversation with a duration of 45 min. all patients will have access to telephone counselling by their primary nurse when needed and able to arrange a new face-to-face conversation. after 4-6 weeks the face-to-face the nurse will of conversation reach out to the patient by phone to follow up on the earlier conversation. three months after the face-to-face conversation the nurse will offer the patient a closing face-to-face conversation of 15 min at the same time where the patient has a doctor appointment at the department. those who are in the control group will continue standard care and not receive any conversation and be used as the control group. the intervention will be provided by a team of specialized dermatological nurses who have received a formal training on patient-centred communication, self-regulatory model/common sense model interviewing, the life with chronic disease and action plan support.


Eligibility criteria:
inclusion criteria: * newly referred patients with psoriasis at the department of dermatology and allergy, herlev and gentofte hospital, 18 years or older and understand danish. exclusion criteria: * patients younger than 18 years
vascular impairment in type ii diabetes mellitus with co-morbid obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive; Diabetes Mellitus

Summary: the investigators will examine the possible synergistic effects of obstructive sleep apnea (osa) and type ii diabetes mellitus (dm) on vascular functioning by performing a two-part investigation: * a cross-sectional study comparing subjects with osa+dm, osa only, dm only, and healthy controls. * a three-month randomized placebo-controlled trial of continuous positive airway pressure (cpap) in subjects with osa+dm.


Eligibility criteria:
inclusion criteria: * osa subjects: apnea-hypopnea index \>=10 and \<100 * dm subjects: clinical diagnosis of dm and glycated hemoglobin \< 8.0% exclusion criteria: * hematocrit \< 32 * pregnancy * infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
a study to evaluate the use of mobile-phone based patient support in patients diagnosed with myocardial infarction

Conditions: Myocardial Infarction

Summary: the purpose of this study is to evaluate whether the mobile-phone based patient support has an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes that will have a positive impact on the cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: 1. provision of written patient informed consent. 2. patients must have a smart phone at their disposal and use it on a daily basis. 3. female or male aged \>18 years, diagnosed with a st elevation myocardial infarction (stemi) or non st elevation myocardial infarction (nstemi) and treated with ticagrelor prior to inclusion into this study and for which the treating physician intend to continue prescribing ticagrelor according to the prescription recommendation. 4. ability to read, understand and write swedish. exclusion criteria: 1. participation in any clinical trial or device study in the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care. 2. patients not suitable for participation based on the investigators judgment for example: * patients on treatment with triple antithrombotic treatment. * patients on treatment with anticoagulantia. * patients accepted/with a plan for thoracic surgery (cabg) or any other elective surgery that cannot be postponed until after study participation. * patients with a life expectancy of less than 12 months. * patients judged to be unable to follow a structured physical activity program. 3. patients those are pregnant or lactating. 4. patients involved in the planning and/or conduct of the study (applies to astrazeneca staff and/or staff at the study site and application developer).
spsipb and cpb on clavicle surgeries

Conditions: Clavicle Fracture; Postoperative Pain; Analgesia

Summary: clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. this study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. a novel analgesic approach combining two distinct nerve block techniques-serratus posterior superior intercostal plane block (spsipb) and clavipectoral plane block (cpb)-was employed for postoperative pain control. the procedural methodology encompassed the administration of spsipb preceding anesthesia induction, followed by cpb subsequent to induction. spsipb targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas cpb focused on the clavipectoral fascia. standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using numeric rating scores (nrs).


Eligibility criteria:
inclusion criteria: * five american society of anesthesiologists (asa) ⅰ-ii- iii patients scheduled for clavicle surgery will be included in the study exclusion criteria: * patients with bleeding disorders * patients with signs of infection in the block application area * patients with unstable haemodynamics * patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases * patients with vascular disease, * patients with respiratory distress * patients whose consent for the study could not be obtained or who did not accept to participate in the study

Keywords: serratus posterior superior intercostal plane block clavipectoral plane block clavicle fracture pain management
proton therapy research infrastructure- protrait- neuro-oncology

Conditions: Astrocytoma; Ependymoma; Ganglioglioma; Oligodendroglioma; Optic Nerve Glioma; Meningioma; Nerve Sheath Neoplasms; Adenoma; Craniopharyngioma; Hemangiopericytoma; Germinoma; Neurilemmoma

Summary: the first proton therapy treatments in the netherlands have taken place in 2018. due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. in turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. the netherlands has spearheaded the development of the model-based approach (mba) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. in mba, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (δdose), and (2) whether this dose difference translates into an expected clinical benefit in terms of normaltissue complication probabilities (δntcp). to translate δdose into δntcp, ntcp-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. the dutch society for radiotherapy and oncology (nvro) setup the selection criteria for proton therapy in 2015, taking into account toxicity and ntcp. however, ntcp-models can be affected by changes in the irradiation technique. therefore, it is paramount to continuously update and validate these ntcp-models in subsequent patient cohorts treated with new techniques. in protrait, a findable, accessible, interoperable and reusable (fair)data infrastructure for both clinical and 3d image and 3d dose information has been developed and deployed for proton therapy in the netherlands. it allows for a prospective, standardized, multi-centric data from all dutch proton and a representative group of photon therapy patients.


Eligibility criteria:
inclusion criteria: 1. all brain tumors with a favorable prognosis (median survival \> 10 year) 2. age ≥ 18 years 3. ecog performance status 0 - 1 / karnofsky performance status 80 - 100 4. no - minimal neurocognitive impairment 5. dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi) 6. informed consent exclusion criteria: 1. not eligible for chemotherapy 2. eligible for stereotactic radiotherapy
comparison of the risk of surgical site infections between dressings stopped at postoperative day 1 vs dressings stopped at postoperative day 6+/-1 after elective abdominal surgery

Conditions: Elective Abdominal Surgery

Summary: the daily changing of postoperative dressings is a widespread practice, often continuing until the 5th-7th day after surgery. in theory, dressings aim to reduce the risk of superficial surgical site infections (ssis). however, several studies have suggested that early removal of the dressing does not significantly impact the rate of superficial ssis, and this approach is now applied in clinical practice by several teams. a cochrane review indicated that the absence of dressing does not appear to be harmful, though it emphasized the very low level of evidence provided and the need for high-quality randomized controlled trials. in this study, the investigators aim to provide high-level evidence on the effect of stopping dressings from the 1st postoperative day and the lack of impact on the risk of ssis, to standardize practices and enable recommendations.


Eligibility criteria:
inclusion criteria: * patient of legal age (≥18 years) * scheduled for elective abdominal surgery requiring a skin incision of at least 4 cm long listed below: all pancreatectomies, all hepatectomies, all splenectomies, all adrenalectomies, all bariatric surgeries, all gastric surgeries, including gastrectomy and reflux surgery, all parietal surgeries; ventral hernia repairs, inguinal or femoral hernia repairs, with or without mesh placement.. all small bowel resections, laparotomy cholecystectomies, all duodenal surgeries, right, transverse or left colectomy, by laparotomy or laparoscopy, provided that there is a skin incision for extraction of the surgical specimen, but without the presence or creation of a stoma proctectomy but without the presence or creation of a stoma * class i or ii (clean or clean-contaminated) according to the altemeier classification * affiliated in a social security scheme (beneficiary or entitled person, excluding ame) * have signed an informed consent form exclusion criteria: * presence or completion of a stoma * previous abdominal surgery in the month prior to inclusion * emergency surgery * outpatient surgery * trocar holes * closure by biological glue * active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery) * neutrophil count \< 500/mm3 at time of surgery * grade b or c cirrhosis (child-pugh classification) * pregnancy * breast-feeding * patient under guardianship or curatorship * patient deprived of liberty by judicial or administrative decision * patient unable to perform perioperative care

Keywords: surgical site infection dressing elective abdominal surgery postoperative care
zolpidem (myslee) post marketing study in adolescent patients with insomnia - evaluation with polysomnography

Conditions: Insomnia; Sleep Initiation and Maintenance Disorders

Summary: to evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

the study consists of two parts. all patients will receive placebo in one part and zolpidem in the other part in a single blind manner. efficacy will be measured with polysomnography .

Eligibility criteria:
inclusion criteria: * patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in icd10 exclusion criteria: * patients with schizophrenia or manic-depressive illness * patients with insomnia caused by physical diseases * patients having a history of hypersensitivity to zolpidem * patients with attention-deficit hyperactivity disorder

Keywords: polysomnography zolpidem sleep disorders adolescent
prevention of venous thromboembolism following radical prostatectomy

Conditions: Prostate Cancer; Venous Thromboembolism; Lymphocele After Surgical Procedure; Deep Venous Thrombosis; Pulmonary Embolism

Summary: the preventer trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (ipcs) to the use of ipcs alone for the prevention of venous thromboembolism (vte) after radical prostatectomy (rp).

the preventer trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (ipcs) to the use of ipcs alone for the prevention of venous thromboembolism (vte) after radical prostatectomy (rp). currently, there is no standard practice for vte prophylaxis after rp with the american urological association recommending "pharmacological or pneumatic mechanical prophylaxis" for high risk patients. prior studies showed 30% of patients in the united states received no perioperative prophylaxis and less than 20% received pharmacologic agents, compared to 98% of patients receiving pharmacologic prophylaxis in the united kingdom. some urologists prescribe patients low molecular weight heparin (lmwh) after discharge for up to 30 days after surgery. additionally, there are no established risks of pharmacologic prophylaxis for rp patients, but some urologists express concern about the potential impact of prophylaxis on the rate of postoperative lymphoceles or hematomas. at johns hopkins, patients do not routinely receive pharmacologic vte prophylaxis in the perioperative setting for rp. given the lack of standard practice and implications for patient safety, the investigators propose a prospective, stratified randomized controlled trial to evaluate the impact of perioperative pharmacologic prophylaxis on vte following rp hypothesizing that it will prevent vte events without significantly impacting the rate of postoperative bleeding or lymphoceles. the potential impact of surveillance bias with differential imaging between arms, effect of lymphadenectomy (yes/no and number of noted removed) or surgical approach (robotic and open), and differences by patients risk (comorbidity and vte risk based on components of the caprini score) or demographics will be assessed.

Eligibility criteria:
inclusion criteria: * men 18-100 years of age with histologically confirmed prostate cancer of any stage undergoing rp * patients who would have otherwise been eligible to receive routine post-rp care exclusion criteria: * active treatment for vte * patients judged by patients' urologist, primary care doctor, or in the preoperative evaluation center (pec) to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not patients are on systematic anticoagulation for indications other than vte) * known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy) * epidural analgesia * spinal anesthesia * participation in a different trial that increases a patient's risk of vte