Kornimate/medical-research-clean huggingface dataset:
maintenance therapy with histamine dihydrochloride and interleukin-2 in adult acute myeloid leukemia (aml) patients with measurable minimal residual disease (mrd)- a non-interventional study (nis)

Conditions: Acute Myeloid Leukemia

Summary: this is a non-interventional multi-center study (nis) in adult patients with aml in first complete remission with measurable minimal residual disease (mrd). patients are eligible when gene status was already determined for previous induction and consolidation therapy of aml and showed carrier of npm1, cbfβ-myh11, or mll-af9 mutation. the study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (hdc) and interleukin-2 (il-2) with regard to assess leukemia-free survival/time to relapse and to monitor mrd level trend over time. hdc and il-2 are approved drugs for aml patients in first complete remission. therapy is administered for 10 treatment cycles as outlined in the summary of product characteristics.


Eligibility criteria:
patient eligibility criteria in accordance to the summary of product characteristics: * patients with confirmed diagnosis of acute myeloid leukemia according to the world health organization (who) classification (including de novo aml, t-aml and s-aml) in first complete remission (defined as less than 5% blasts in a normocellular bone marrow assessed prior to the treatment start) * amlsg bio participation incl. favourable opinion * presence of npm1 mutation, cbfb-myh11 or mll-af9 fusion genes as assessed in one of the central amlsg reference laboratories. * measurable mrd values (non-negative values after consolidation therapy or increase in values over the threshold during follow-up in complete remission) * the patient must be informed of the observation and written informed consent regarding data privacy obtained. * consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about observation participation * no continuing systemic treatment with clonidine, steroids, and/or h2 receptor blocking agents.

Keywords: acute myeloid leukemia (aml) histamine dihydrochloride interleukin-2
cognitive bias modification (cbm) and internet cognitive behavioural therapy (icbt) for depression- a randomised controlled trial

Conditions: Depression

Summary: cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. one specific bias is the interpretation of ambiguous information. a negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. research has led to the recent development of computerized cognitive bias modification (cbm) techniques to augment such biases and it has been suggested that cbm techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. the fact that cbm procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the internet-based cognitive behavioural therapy (icbt) programs currently offered through st. vincent's hospital and the university of new south wales. therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding cbm procedures to the existing icbt modules offered through st. vincent's hospital and the university of new south wales. it is expected that icbt + cbm will result in superior treatment outcomes as indexed by a standardized clinical battery.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of the american psychiatric association - 4th edition (dsm-iv) criteria for major depressive disorder, * internet access + printer access, * australian resident, * fluent in written and spoken english. exclusion criteria: * current substance abuse/dependence, * psychotic mental illness (bipolar or schizophrenia), * current or planned psychological treatment during study duration, * change in medication during last 1 month or intended change during study duration, * use of benzodiazepines, * suicidal.
preventing preterm birth with a pessary

Conditions: Preterm Birth

Summary: the primary objective of this study, is to determine the effect of a cup pessary, a device that is currently readily available in the usa and similar in design to the arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.


Eligibility criteria:
inclusion criteria: * singleton pregnancies in patients with a history of spontaneous preterm birth (previous delivery between 17 0/7 weeks and 36 6/7 weeks). * women ages 18 to 45 years of age exclusion criteria: * major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, or fetal growth restriction diagnosed before randomization. * presence of prophylactic cervical cerclage * significant maternal-fetal complications (treated chronic hypertension, insulin dependant diabetes mellitus, red cell isoimmunization) * painful regular uterine contractions, or ruptured membranes * visual cervical dilation of 2cm or greater and visible membranes. * patients with a pregnancy dated by an ultrasound after 20 weeks gestation.

Keywords: pessary preterm birth short cervix cervical incompetence
functional capacity in anderson-fabry disease patients

Conditions: Anderson-Fabry Disease

Summary: the goal of this observational study is to observe the relation between excercise parameters - assessed by cpet - and rest/stress hemodynamic parameters - assessed by echocardiogram and cmr - in patients with a genetic diagnosis of anderson-fabry disease. participants will undergo: * baseline evaluation: clinical evaluation, disease staging with fastex and mssi, kccq for quality of life assessment, resting 12-leads ecg, 6mwt, cpet-ese and contrast-enhanced cmr; * before 36 months from baseline: resting 12-leads ecg, 2d rest and stress echocardiogram, cpet-ese, contrast-enhanced cmr, disease staging with fastex and mssi and kccq for quality of life assessment; * up to 7 years from baseline: clinical follow-up.


Eligibility criteria:
inclusion criteria: * patients with a genetic diagnosis of afd, according to current guidelines; * informed written consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care (for patients age \<18 years old, written consent from a caregiver is mandatory). exclusion criteria: * egfr \<30 ml/min and other contraindications for cmr (relative controindication: patients with implantable device); * musculoskeletal limitation for exercise test on the cyclo ergometer; * pregnant or breastfeeding women; * any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a full comprehension of the written consent form.

Keywords: anderson-fabry disease cardiac involvement cmr cpet
incidence and prevention of hypothermia in newborns bonding during caesarean section

Conditions: Thermoregulation Impairment; Hypothermia; Postoperative Shivering

Summary: this study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest. therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. the investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. the investigators will measure core temperature of the newborns and their mothers. the investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.

little is known about the thermoregulatory effects on babies when bonding on the chest of the mother during caesarian section. the aim of our study is to evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest. the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during a 20 min intraoperative bonding period. the investigators plan to enroll 40 parturients scheduled for elective caesarean section under spinal anaesthesia to receive passive insulation or forced-air skin surface warming. the investigators will measure core temperature of the newborns and their mothers. the investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.

Eligibility criteria:
inclusion criteria: * parturients undergoing planned, elective cesarean section under spinal anaesthesia * mothers classified as american society of anaesthesiologists (asa) status i or ii * written informed consent exclusion criteria: * mothers younger than 18 years * mothers classified as american society of anaesthesiologists (asa) status iii or higher * caesarean section planned under general anaesthesia. * any expected problems with the newborn such as: * gestation date \ 42 week * placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (ctg)

Keywords: thermoregulation impairment hypothermia postoperative shivering cesarean section newborn
rise: a remote study of insomnia treatment in crohn's disease

Conditions: Insomnia; Crohn Disease

Summary: the purpose of this study is to assess whether the investigators can treat insomnia in people with crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.

people with crohn's disease often suffer from sleep problems. long term, sleep problems may lead to more flares of crohn's disease or other complications. in general, patients with crohn's disease also report that sleep problems can worsen symptoms of crohn's disease the next day. in people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. in this study, the investigators want to understand if they can treat sleep problems in people with crohn's disease, and what else might improve if sleep gets better. if this study is successful, it will help the investigators understand more about how to treat insomnia in people with crohn's disease and how sleep impacts pain and inflammation. long term, this information will be helpful in understanding how best to take care of people with crohn's disease.

Eligibility criteria:
inclusion criteria: * mild to moderate cd based on pro-3 \& 50% with objective evidence of active disease * insomnia severity index score ≥ 8 and sol or waso ≥ 30 minutes * stability of sleep \& cd meds for ≥ 3 months * access to internet or cell phone service sufficient for telehealth exclusion criteria: * phq-9 depression score ≥ 15 * gad-7 anxiety score ≥ 15 * unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder) * current alcohol or substance abuse * current opioid use for pain control * current systemic corticosteroid use * current pregnancy or nursing * ileostomy or colostomy * diagnosis of seizure disorder * diagnosis of sleep apnea or positive watchpat screen * diagnosis of restless leg syndrome or positive cambridge-hopkins rslq screen * night shift, rotating shift work, or frequent travel outside of time zone
a study to compare safety and efficacy of opt-80(fidaxomicin) with vancomycin in subjects with clostridium difficile-associated diarrhea (cdad)

Conditions: Clostridium Difficile

Summary: the primary objective of this study is to investigate the safety and efficacy of opt-80 versus vancomycin in subjects with clostridium difficile-associated diarrhea (cdad).

this is a multicenter, double-blind, randomized, parallel group study. the subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either opt-80 twice daily or vancomycin powder four times daily for 10 days. a follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.

Eligibility criteria:
inclusion criteria: * inpatients who have symptoms of cdad as defined by; * (1)diarrhea: with ≥4 unformed bowel movements (or ≥200 ml unformed stool for subjects having rectal collection devices) and * (2)presence of either toxin a and/or b of c. difficile in the stool * subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at cdad treatment before the study exclusion criteria: * life-threatening or fulminant cdad * ileus paralytic or toxic megacolon * likelihood of death before the completion of study from any cause * concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of cdad * the anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent * subjects who in the opinion of the investigator require other drugs to control diarrhea * need of change in dosage regimen of opiates during the study period * need of change in dosage regimen of probiotic products during the study period * history/complications of ulcerative colitis or crohn's disease * multiple occurrences of cdad within the past three months * hypersensitivity to vancomycin * previous exposure to opt-80 (fidaxomicin) * female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study * participation in other clinical research studies or post marketing clinical trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer

Keywords: clostridium infections difficile vancomycin fidaxomicin
dario blood glucose monitoring system - android devices altitude evaluation study

Conditions: Diabetes Mellitus

Summary: this study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). the performance is assessed via a reference method for glucose analysis (yellow springs instrument 2300 stat plus glucose analyzer).

this study will be a non-randomized study conducted to assess the accuracy and performance of the dario blood glucose monitoring system at an elevated altitude. 50 subjects will be enrolled in this study. participation includes a 15-20 minute visit to the clinical site where they will be consented. the participant will then receive a fingerstick to obtain capillary blood used to test the performance of the bgms and to obtain a comparative glucose measurement on the reference method, the yellow springs instrument 2300 stat plus glucose analyzer.

Eligibility criteria:
inclusion criteria: * able to speak and read english exclusion criteria: * pregnant * has any condition that the principle investigator believes may interfere in the subject's participation in the trial.
effects of global postural exercises versus specific therapeutic neck exercises in chronic non-specific neck pain

Conditions: Neck Pain; Chronic Pain

Summary: this study is a randomized, parallel, blinded, clinical trial of treatments. the general objective of this study is to analyze and compare the short-term results, during a 4-week follow-up, of two different treatments in patients with chronic nonspecific neck pain. the treatments to be applied are global postural reeducation (gpr) and specific therapeutic exercise, applied during 8 treatment sessions in 4 weeks. these treatments will be applied by a physiotherapist with clinical experience in the treatment of cervical pain. during the study, 4 evaluations will be carried out to assess the effects of the interventions on pain, disability, standing postural control and neuromuscular behavior of the cervical muscles ((1) baseline (pre-intervention); 2) second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) final, 2nd post-intervention (1+4 weeks later))


Eligibility criteria:
inclusion criteria: * non-specific chronic neck pain (neck or upper shoulder pain that is not related to a known pathology or injury, with an evolution of at least 12 weeks) exclusion criteria: * specific cause of cervical pain (systemic, traumatic, rheumatic pathology, discal pathology,...) * central or peripheral neurological signs * cognitive impairment to follow instructions during the evaluations or interventions * history of cervical surgery * treatment of physical therapy in the last 3 months * pharmacologic treatment during the study

Keywords: postural global reeducation exercise chronic neck pain disability postural control cervical muscles
comparison between robotic (rm) and laparoscopic myomectomy (lm)

Conditions: Uterine Leiomyoma; Surgical Procedure, Unspecified

Summary: this is a single-blinded rct evaluating the effect of robotic-assisted (rm) or conventional laparoscopic surgery (lm) in the management of uterine leiomyomas.

uterine fibroids are the most common benign tumors of the uterus and may be presented 20%-40% of women at reproductive age.the uterine fibroids can be asymptomatic without intervention. however, they often are the cause of abnormal uterine bleeding, pelvic pain, infertility, and even miscarriage. myomectomy, rather than hysterectomy can be one option for symptomatic women who wish to preserve their childbearing capabilities or for reasons other than for fertilit. nowadays, patients pursue cosmetic benefit and early recovery and prompted the search for more conservative and minimally invasive surgical methods when surgical intervention is inescapable and surgical devices are improved. the feasibility, safety and advantage of cosmetics of laparoscopic myomectomy (lm) has been confirmed after the improvement of techniques and instruments. however, it is very "unfriendly" for our surgeons because of many disadvantages such as keeping stand for long time, unable to relying on, or swaying visual field by first-assistant, etc. since the approval by the us food and drug administration (fda) in april 2005, robotic surgeries using the da vinci surgical system (intuitive surgical inc., sunnyvale, ca, usa) have been applied widely in many surgical fields including gynecology, urology, orthopedics, general surgery and cardiothoracic surgery. the three-dimensional vision system and the wrist-like structure of endowrist instruments (intuitive surgical inc., sunnyvale, ca, usa) recapitulating the motion of the surgeon's hand make precise procedures easier than in conventional laparoscopy, which allows robotic surgery to overcome some of the shortcomings and limitations of traditional laparoscopy. dr. lai and colleagues had also successfully undergone robotic surgery in many complicated gynecologic diseases in taiwan. however, how to choose or apply robotic-assisted (rm) or conventional laparoscopic surgery (lm) in the management of uterine leiomyomas is still an important issue for our surgeon. we still lack clear definitions about which one kind of myoma may be smoothly performed in rm or lm. the current study is aimed to compare the clinical outcome and efficacy of these 2 minimally invasive procedure in myomectomy, rm and lm, for women with symptomatic uterine fibroids, in this prospective randomised control trial.

Eligibility criteria:
inclusion criteria: * all women who has symptomatic benign myoma. exclusion criteria: * patient is unwilling the scheduled operation after randomization.

Keywords: uterine leiomyoma robot-assisted (rm) conventional lapatoscopic myomectomy (lm)
determine if apparent diffusion coefficient (adc) values can differentiate tumors from normal tissue

Conditions: Brain Cancer; Neck Cancer

Summary: the purpose of this study is to determine normal measurements (adc values) from the head and neck of healthy volunteers using 3t mri.

the purpose of this study is to determine normal measurements (adc values) from the head and necks of healthy subjects using 3t mri.

Eligibility criteria:
inclusion criteria: * healthy subjects 18 years of age or older. exclusion criteria: * under 18 years of age * women of child bearing potential * pregnant or lactating women * all potential volunteers will be pre-screened by mri personnel to determine if there is any medical reason that you should not be included in this study.
redo repair in disrupted hypospadias

Conditions: Hypospadias

Summary: redo hypospadias repair is a challenging situation and its success depends on many factors. several procedures could be used in such situations with variable outcomes. the investigator in this study aimed at comparing the results of these procedures

purpose: our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. methods: the participants were categorized into those who were treated by the tubularized incised plate procedure (group a) and those who were treated by other procedures (group b) and the collected data were compared between the two groups. the patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.

Eligibility criteria:
inclusion criteria: * pediatric patients with disrupted hypospadias repair exclusion criteria: * fresh cases of hypospadias

Keywords: hypospadias redo repair disruption