Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of sb1518 for the treatment of advanced myeloid malignancies

Conditions: Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Myelofibrosis

Summary: this study consists of two phases: the first portion of the study is a phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of sb1518 when given as a single agent orally once daily in subjects with advanced myeloid malignancies; the second portion of the study is a phase 2 study to define the efficacy and safety profile of single-agent sb1518 at the recommended dose in subjects with chronic idiopathic myelofibrosis (cimf).


Eligibility criteria:
inclusion criteria * during the dose escalation phase: subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. this includes the following: * subjects with acute myelogenous leukemia (aml) * subjects with chronic myelogenous leukemia (cml) in accelerated phase * subjects with chronic myelogenous leukemia (cml) in blast crisis * subjects with high-risk myelodysplastic syndromes (mds) or chronic myelomonocytic leukemia (cmml) * subjects with advanced myelofibrosis (mf) * in phase 2, subjects with cimf (as well as post et/pv mf) * eastern cooperative oncology group (ecog) performance status 0-2 * all men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists. additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug * able to understand and willing to sign the informed consent form exclusion criteria * subjects with chronic myelogenous leukemia (cml) in chronic phase; * uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. subjects receiving antibiotics for infections that are under control may be included in the study; * concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study; * known hiv-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy); * known active hepatitis a, b, or c; * women who are pregnant or lactating.

Keywords: sb1518 chronic idiopathic myelofibrosis jak2 inhibitor
safety study of intravenous biapenem (rpx2003) and rpx7009 given alone and in combination

Conditions: Healthy Volunteers; Bacterial Infections

Summary: rpx7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

the worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the eskape group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. in particular, the recent dissemination of a serine carbapenemase (e.g., kpc) in enterobacteriaceae in us hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. rempex is developing a fixed combination antibiotic of a carbapenem (rpx2003 or biapenem) plus a new beta-lactamase inhibitor (rpx7009) which has activity against serine beta-lactamases, including kpc. this phase 1 study will assess the safety, tolerability and pharmacokinetics and pharmacodynamics of intravenous biapenem and rpx7009, administered alone and in combination in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * healthy adult males and/or females, 18 to 55 years of age * body mass index (bmi) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). * medically healthy with clinically insignificant screening results * non-tobacco/nicotine-containing product users for a minimum of 6 months prior to day 1. * sexually abstinent or use acceptable methods of birth control exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * history or presence of alcoholism or drug abuse within the 2 years prior to day 1. * hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.). * use of any over-the-counter (otc) medication, including herbal products and vitamins, within the 7 days prior to day 1. up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the pi. * plasma donation within 7 days prior to day 1. * subjects who have any abnormalities on laboratory values at screening or check-in (day -1).
pbase system idiopathic rhinitis clinical investigation

Conditions: Idiopathic Rhinitis

Summary: the purpose of this study is to evaluate the performance of the pbase system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.


Eligibility criteria:
inclusion criteria: * patients with persistent (\>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days * having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3) * male or female 18 - 65 years * judged by the investigator as suitable for participation in the study without safety concerns based on medical history and physical examination. * willing and able to provide written informed consent prior to participation in the clinical investigation * willing and able to comply with all study related procedures exclusion criteria: * patients with allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or rast * ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1) * systemic steroid treatment less than 4 weeks before the inclusion in the study * patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture * history of frequent nose bleeds or a condition that increases the risk of excessive bleeding * pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination * current malignancy of any kind * known allergy to polyvinylchloride or medicinal liquid paraffin * any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk. * any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region. * previous treated with radiation on the face, head or neck regions * female patients who are pregnant or nursing, or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit * female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit * received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
prospective carotid artery stenosis trial

Conditions: Patients With Any Degree of Carotid Artery Stenosis and Vulnerable Features in the Carotid Artery Plaque

Summary: researchers are collecting information and blood from subjects undergoing carotid artery interventions.


Eligibility criteria:
inclusion criteria: * all subjects undergoing carotid artery intervention that presents to our clinic exclusion criteria: * none
vagus nerve stimulation effects on autonomic nervous system activity

Conditions: Vagus Nerve Stimulation

Summary: transcutaneous auricular vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

participants were divided into four groups (figure 1) according to pns and sns indexes as group 1 (pns index \ +2), group 2 (pns index \ -2, sns index \>+2), group 4 (pns index \>-2, sns index \<+2). participants were assessed with blood pressure, pulse rate and hrv before and after tavns stimulation. sympathetic nervous system (sns) index and parasympathetic nervous system (pns) index values were assumed to be between -2 and +2 (95%) in the normal population according to kubios software, and the grouping method was based on this situation.

Eligibility criteria:
inclusion criteria: * age between 18 and 40 years old. * no previous vagus nerve stimulation exclusion criteria: * using of any drug, alcohol or smoking. * pregnancy. * known history of acute or chronic illness. * being in the post or peri-menopausal stage.

Keywords: vagus nerve stimulations diastolic pressure pulse rate systolic pressure
a clinical study to evaluate the safety and effectiveness of the cerene device to treat heavy menstrual bleeding

Conditions: Menorrhagia

Summary: the purpose of the study is to evaluate the safety and effectiveness of the cerene cryotherapy device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.


Eligibility criteria:
inclusion criteria: * refractory heavy menstrual bleeding with no definable organic cause * female subject age 25 to 50 years, inclusive * sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm * sufficient myometrial thickness * documented excessive menstrual blood loss within 3 months of informed consent * premenopausal confirmed by follicle stimulating hormone (fsh) measurement * agrees to use a reliable form of contraception following ablation treatment * provides written informed consent using a form that has been approved by the reviewing ethics committee * agrees to follow-up exams and data collection requirements * demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram * has predictable, cyclic menstrual cycles exclusion criteria: * pregnant or has a desire to conceive * endometrial hyperplasia as confirmed by histology * active endometritis * active pelvic inflammatory disease * active sexually transmitted disease (std) * presence of bacteremia, sepsis, or other active systemic infection * active infection of the genitals, vagina, cervix, or uterus * known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years * known clotting defects or bleeding disorders * abnormal cytology on human papillomavirus (hpv) testing not treated according to local standards. * prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section). * previous low transverse cesarean section where the myometrial wall thickness is insufficient * previous endometrial ablation procedure * clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment * presence of an implantable contraceptive device * currently on medications that could thin the myometrial muscle * currently on anticoagulants * abnormal or obstructed cavity * currently using an intrauterine device (iud) and unwilling to remove the iud * post-partum ≤ 6-months * considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study * any general health or mental, or other situation or condition which, in the opinion of the investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements

Keywords: heavy menstrual bleeding endometrial ablation
efficacy of the domino diet app in ibs

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to evaluate whether the domino diet application is an effective tool in the treatment of irritable bowel syndrome in tertiary care. furthermore, this study aims to determine the response rate of the strict low fodmap diet in non-responders to the domino diet.


Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some iuds, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment(s)) or commitment to a vasectomised partner. 3. patients with irritable bowel syndrome according to rome iv diagnostic criteria 4. patients ages between 18 and 70 years old exclusion criteria: 1. participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years 2. any disorder, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol 3. any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the trial 4. female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 5. participation in an interventional trial with an investigational medicinal product (imp) or device 6. patients presenting with predominant symptoms of functional dyspepsia (fd) and of gastro-oesophageal reflux disease (gerd) 7. patients following a diet interfering with the study diet in opinion of the investigator 8. patients who already followed the low fodmap diet under guidance of a trained dietitian without success

Keywords: domino low fodmap diet irritable bowel syndrome
increasing uptake of evidence-based screening services through chw-led multi-modality intervention

Conditions: Human Papillomavirus; Human Immunodeficiency Virus; Hepatitis C; ColoRectal Cancer

Summary: the purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, hiv, and hepatitis c among under screened hispanic, haitian and african-american individuals in hialeah, south dade, and little haiti. the investigator will compare home testing led by a community health worker (chw) versus clinic testing guided by a chw. community health workers are people who have undergone several weeks of community outreach and health education training. during the study period the participant will continue to receive all of their regular medical care from their regular health care providers. if the participant does not have a health care provider, the community health workers would be able to help in referring the participant for care at a local health care clinic located in their community.


Eligibility criteria:
inclusion criteria: 1. live in one of the three target communities 2. self-identify as haitian, hispanic and/or black. 3. be 50-64 years old 4. need at least one of the four recommended screening services as per us preventive service task force 121 guidelines as follows: never having had a hiv test b) never having had a hepatitis c virus (hcv) test c) not having a pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year. exclusion criteria: 1. plan to move out of the community during the next six months; 2. current or prior enrollment (5 five years) in any research study that involved screening for these conditions. 3. are adults unable to consent 4. are individuals who are not yet adults (infants, children, teenagers) 5. pregnant women 6. prisoners

Keywords: increased screening uptake community health worker medically underserved
sedestactiv project: intervention to reduce diary hours of sitting time in overweight and obese patients

Conditions: Overweight; Obese; Sedentary

Summary: primary care centres are a key setting to treat people with overweight and moderate obesity. there is growing evidence that sitting for a long time is negatively associated with people's health. interventions with the aim of reducing daily time of sedentary activities can be an effective strategy to increase daily energy expenditure. to improve the effectiveness of programmes promoting physical activity in primary care we need some clear action protocols that can be easily integrated in the daily routines of primary care professionals. objective. the objective of the study is to evaluate the effectiveness of a six-moth primary care intervention to reduce diary hours of sitting time in overweight and obese sedentary patients, as well as to increase their weekly caloric spend. methods. the design of the study is a simple randomized controlled trial. ten primary care centers will be invited to participate and will be randomized into control (cg) and intervention group (ig). each professional will randomly invite to participate voluntarily moderate obese or overweight patients (bmi: 25-34,9 kg/m2) of both sexes, aged between 25 and 65 years old, who are 6 or more than 6 hours daily sitting. a total of 400 subjects (200 individuals in each group) are needed. in addition, 50 subjects with fibromyalgia will be included in the study to know the feasibility of the intervention among them. the main dependent variable (sitting times) will be measured with an activpal during first and last intervention week. there will be a follow up after 3, 6 and 12 months of the end of the intervention. other variables included in the study: number of steps walked, subjective level of physical activity, weight, height, bmi, skinfolds, waist circumference, triglycerides, total cholesterol, (ldl and hdl), glucose, sociodemographic variables, blood pressure and quality of life related to health. a descriptive analysis of all variables and a multivariate analysis to assess differences among intervention and control group will be undertaken. multivariate analysis will be carried out to assess time changes of dependent variables. all the analysis will be done under the intention to treat principle.

the intervention will be based on a recommendation to find alternatives to progressively substitute sitting time by doing the regular activities standing or walking. control group will receive minimum advice.

Eligibility criteria:
inclusion criteria: * overweight and moderate obese patients (bmi: 25-34,9 kg/m2). * be 6 or more than 6 hours daily sitting. * able to walk and stand up from a chair unaided. * subjects who can guarantee a year continuity in the study. exclusion criteria: * recommended contradictions to advising physical activity to overweight and obese people. * have an obesity surgical operation.

Keywords: sitting time overweight obese primary health care
study assessing adult subjects affected with upper and/or lower limb spasticity treated with botulinum neurotoxin type a

Conditions: Spasticity

Summary: the aim of the study is to describe the long term use of botulinum neurotoxin type a (bont-a) in adult subjects affected with upper and/or lower limb spasticity who received treatment with bont-a for a minimum of three injections cycles at three italian centers. the study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. time frame for data collection is 12 months from study start.


Eligibility criteria:
inclusion criteria: * adult aged ≥18 years old at the time of the first bont-a injection * diagnosed with spasticity with any cause (excluded cp) * treated with a minimum of three bont-a treatment cycles for upper limb spasticity (uls) and/or lower limb spasticity (lls) * with follow up data available in the subject's medical record * provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study exclusion criteria: * treatments and assessments were performed at more than one centre
applied relaxation (ar) technique versus its modified version for treating menopausal symptoms

Conditions: Hot Flashes; Night Sweats; Sleep Disturbances

Summary: the purpose of this study is to demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms.

applied relaxation (ar) is the most commonly used behavioral methods for treating menopausal symptoms. many clinical trials reported that the technique effectively improved vasomotor and related symptoms. there is a strong evidence to support its continue use in clinical settings. however, the original ar technique is too cumbersome. it involves intensive training once a week for 12 consecutive weeks. each weekly session takes 60 minutes, and subjects are requested to do self-practice at home for at least 15-20 minutes/day. as such, \>25% of recruited subjects drop out from the training course. the investigators have modified the original ar technique by reducing the duration of training to only once, lasting 60 minutes. participants are requested to do self-practice at home for 15-20 minutes/day as in the original technique. instead of coming to a weekly class, the investigators use telephone to communicate with the subjects once a week for 12 consecutive weeks. a preliminary study showed all 10 recruited subjects remained in the study (mr; modified relaxation technique) until completion. they all reported dramatic improvement in their vasomotor symptoms. in this study, the investigators propose to compare our modified version of ar with the original method in a randomized controlled clinical trial. the subjects will be thai menopausal women with vasomotor symptoms. the main outcomes are the reduction in the mrs score (intensity of hot flushes, night sweats and sleep disturbances) among those who remain in the program at the end of the study (efficacy evaluation). as nearly all patients will remain in the mr group, while \>25% of those in the ar group will be expected to drop out from the study, the investigators should be able to demonstrate a superiority of mr over ar in terms of effectiveness as well.

Eligibility criteria:
inclusion criteria: * perimenopausal women and postmenopausal women with either surgical or spontaneous menopause. * women who have at least 5 points of mrs score. exclusion criteria: * women who are taking any hormone therapy for any reason in the past three months prior to entering the trails. * women with uncontrolled hypertension (\>95mmhg diastolic pressure) or daily use of sedatives, tranquilizer or antidepressant medication.

Keywords: perimenopause postmenopause vasomotor symptoms relaxation