Kornimate/medical-research-clean huggingface dataset:
a non-interventional study of revlimid® (lenalidomide) treatment of ipss low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q or refractory/relapsed mantle cell lymphoma in korea

Conditions: Myelodysplastic Syndromes; Lymphoma, Mantle-Cell; Lymphoma, Follicular

Summary: the drug use examination (due) is planned and designed for the safety evaluation of new indications after the approval of a new drug in korea. this due is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of revlimid® for new indications in routine clinical practice in korea. six-hundred (600) adult patients, who start with revlimid® treatment based on the approved local package insert (pi) of revlimid® during routine clinical practice in korea and have indications noted below. 1. patients with transfusion-dependent anemia due to ipss low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality (del \[5q\] mds) 2. patients with mantle cell lymphoma who have received at least one prior therapy (rrmcl) 3. previously treated follicular lymphoma (fl), in combination with rituximab (an anti-cd20 antibody)


Eligibility criteria:
inclusion criteria: * treatment of patients with transfusion-dependent anemia due to ipss low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality according to international scoring system for evaluating prognosis in myelodysplastic syndromes according to ipss or * treatment of patients with mantle cell lymphoma who have received at least one prior therapy * previously treated follicular lymphoma (fl) * patients who are registered in celgene risk management program" in korea exclusion criteria: pregnancy or females of childbearing potential * hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, stevens-johnson syndrome, toxic epidermal necrolysis, dress) * patients with genetic disorder (e.g., galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption)

Keywords: revlimid® lenalidomide observational korea post marketing surveillance[pms] relapsed and refractory mantle cell lymphoma ipss low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q previously treated follicular lymphoma (fl) in korea
a long term study of alks 5461 in the treatment of refractory major depressive disorder (mdd)

Conditions: Refractory Major Depressive Disorder

Summary: this study will assess the long-term safety and tolerability of alks 5461 as an adjunctive treatment for refractory mdd.


Eligibility criteria:
inclusion criteria: * completed study alk5461-217 * be willing to abide by the contraception requirements as outlined in the study protocol * be willing and able to follow the study procedures and visits as outlined in the protocol * additional criteria may apply exclusion criteria: * pregnant, planning to become pregnant, or breastfeeding * a positive urine drug test for drugs of abuse * poses a current suicide risk * additional criteria may apply

Keywords: alkermes major depressive disorder depression alks 5461
comparison of two marketed silicone hydrogel lenses

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate cholesterol sorption by air optix® aqua lenses compared to ultra lenses after 30 days of wear.


Eligibility criteria:
inclusion criteria: * sign informed consent document; * vision correctable to 20/40 snellen (feet) or better in each eye at distance with both study contact lenses; * willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits; * successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (note: monovision is included); * other protocol-specified inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current); * history of herpetic keratitis, corneal surgery or irregular cornea; * any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator; * monocular (only 1 eye with functional vision) or fit with only one lens; * current or past air optix® aqua or ultra lens wearers; * other protocol-specified exclusion criteria may apply.
database of pulmonary hypertesion in polish population - bnp-pl

Conditions: Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Arterial Hypertension

Summary: the bnp-pl is a multicenter, observational study in which patients are prospectively followed in order to investigate clinical course and management of pulmonary hypertension in poland. all patients diagnosed with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension confirmed in right heart catheterization, will be eligible to participate in the study.

the bnp-pl registry is an initiative of the polish cardiac society task force for pulmonary vascular diseases this study is conducted by the polish cardiac society. all centers of pulmonary hypertension in poland which are accredited by the national health fund have been invited to join the study. the data is administrated by the jagiellonian university medical college on the basis of an agreement between the polish cardiac society, jagiellonian university medical college and pulmonary hypertension centres. the goal is to describe current practice and outcomes in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. the data collection will have no impact on the way the patient is diagnosed and treated. collection of data on patients with pulmonary hypertension is carried out via the electronic platform. no personal data is entered into the project database.

Eligibility criteria:
inclusion criteria: patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed after 1st march 2018 (incident cases) who: * are aged \> 3 months at the time of enrollment * fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mpap) of 25 mm hg or more, mean pulmonary arterial wedge pressure (pawp) or left ventricular end-diastolic pressure (pvedp) of 15 mm hg or less, pulmonary vascular resistance (pvr) of 3 woods. patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension diagnosed before 1st march 2018 (prevalent cases) who: * are aged \> 3 months at the time of enrollment * fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mpap) of 25 mm hg or more, mean pulmonary arterial wedge pressure (pawp) or left ventricular end-diastolic pressure (pvedp) of 15 mm hg or less, pulmonary vascular resistance (pvr) of 3 woods

Keywords: pulmonary hypertension, cteph pulmonary arterial hypertension registry data base polish patients
exercise intervention combined with metformin in the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: background: both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (t2dm), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in t2dm patients. this study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in t2dm patients.

background: both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (t2dm), while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in t2dm patients. this study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in t2dm patients. methods: a total of fifty-seven t2dm patients with a mean age of 46.2±8.3 years were randomized to three study groups; each group included nineteen patients. the first group conducted a resistance exercise program (rep, 50-60% of 1rm, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (aep, 50-70% maxhr, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (met group). the study program was conducted thrice weekly for consecutive twelve weeks. fasting blood glucose (fbg), glycated hemoglobin (hba1c), homeostatic model assessment of insulin resistance (homa-ir), and maximal oxygen uptake (vo2max) were evaluated before and after study intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm * glycated hemoglobin (hba1c) ≥8.0% * a previous inactive lifestyle * not receiving insulin or diabetic medications except for metformin * metformin dosage of 1000-1500 mg daily. exclusion criteria: * cancer * pregnancy * corticosteroid medications * uncontrolled systemic diseases * any physical limits that affect exercise training

Keywords: resistance exercise aerobic exercise metformin insulin resistance
tmtp1-icg mapping in laparoscopic sln detection in cervical cancer

Conditions: Cervical Cancer

Summary: investigators aimed to determine the validity of our novel tumor targeted fluorescent tmtp1-icg to increased accuracy of laparoscopic sln mapping


Eligibility criteria:
inclusion criteria: * at least 18 years of age, married, without childbearing requirements at the time of consent. * figo stage ia1-iib cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan. * subject has provided written informed consent. exclusion criteria: * breast-feeding or pregnant * ongoing participation in another clinical trial with an investigational drug with 3 months * own allergy towards icg and/or alcohol * diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases * patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
aprepitant versus gabapentin prophylaxis for postoperative nausea and vomiting in laparoscopic gynecological surgeries

Conditions: Postoperative Nausea and Vomiting

Summary: to evaluate the efficacy of pre-empetive administration of aprepitant, versus gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in laproscopic gynacological surgeries.

postoperative nausea and vomiting (ponv) is frequently encountered in the surgical recovery room. laparoscopic surgery is one important risk factor for increased incidence of ponv. gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against ponv. results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting. aprepitant, a neurokinin-1 (nk1) receptor antagonist, blockades the central effects of substance p. substance p is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.

Eligibility criteria:
inclusion criteria: • asa physical status i and ii aged between 18 and 45 yrs. they undergo laproscopic gynacological surgeries under general anesthesia. exclusion criteria: * central or peripheral neurological pathologies. * history of drug abuse, chronic pain, or psychiatric disorders. * pregnant women * patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.
effectiveness of prazosin in bulimic patients experiencing nightmares due to ptsd

Conditions: Stress Disorders, Post-Traumatic; Bulimia Nervosa

Summary: this research is being done to find out how effective prazosin is in the treatment of bulimic patients experiencing distressing nightmares using subjective and objective measures.

to the investigators knowledge, there is no treatment trial for prazosin use in patients with bulimia nervosa struggling with nightmares, looking at either objective or subjective measures. the investigators plan to probe the effectiveness of prazosin in bulimic patients experiencing nightmares due to ptsd using both subjective and objective measures in order to improve future clinical care. the effects of prazosin on decreasing nightmares and bulimic symptoms on subjective scales and effects on sleep architecture using objective polysomnogram (psg) measurements will help inform targeted psychopharmacologic and psychotherapeutic strategies to improve clinical care of bulimic patients struggling with distressing dreams secondary to ptsd. this study will be performed in two phases. phase a will involve eight participants who will be tested using subjective scales (mentioned below). if phase a data analysis leads to detection of a signal of efficacy 2 more participants will be recruited to participate in phase b of this trial using objective polysomnogram measurements. the results from this project will aid in establishing a fully powered clinical trial for treatment of nightmares in bulimic patients and improve outcomes in this high risk population.

Eligibility criteria:
inclusion criteria: * age 18-45 * clinical diagnosis of bulimia nervosa with complaint of nightmares secondary to ptsd exclusion criteria: * restless leg syndrome * narcolepsy * sleep apnea * neurological disorders * pregnancy * cardiac abnormalities * significant electrolyte abnormalities * use of steroids, beta blockers, prazosin * alcohol/substance abuse

Keywords: eating disorders bulimia nervosa nightmares post traumatic stress disorder
acupuncture vs tens for gag reflex

Conditions: Gagging

Summary: this study examines if acupuncture or tens of p-6 and st-36 acupoints has a measurable effect on gag tolerance.

the gag reflex is a normal protective mechanism, and portion of the population has an exaggerated reflex that can present major problems in dentistry as well as endoscopy. early studies with acupuncture have been promising, but these studies are limited as has not been a way to objectively measure the response to gag reflex. recent work by drs. karibe and goddard has determined a novel way of measuring gag reflex in healthy subjects, which makes it possible to study the effects of an intervention on gag reflex. acupuncture has been demonstrated to be effective for treating gag reflex, but this effect has not been objectively demonstrated using this novel method. as such, this study investigates the effect of acupuncture against placebo on gag reflex. practically speaking, these findings are unlikely to be of high value since the availability of acupuncturists at dental offices is limited. for this reason, the investigators added a third arm to evaluate the use of a transcutaneous electrical nerve stimulator (tens) device on the same acupuncture points as a treatment intervention to see if this is non-inferior to acupuncture. tens is an fda regulated treatment for the treatment of pain, and has been 510k cleared for other uses including nausea. the placebo arm uses a tens device that has the wire severed, so that the light will continue to blink but no current will be applied. 60 total subjects will be recruited and randomized into one of these three groups: acupuncture, tens and sham-tens. passive ekg readings will be collected using the firstbeat bodyguard 2, which is a 2-lead ekg device that the subject will wear during the study. this is to later evaluate vagal tone by analyzing the spectral analysis of heart rate variability. once this device is affixed to the front of the patient's chest, the gag reflex will be measured. the subject will then undergo the appropriate treatment (acupuncture, tens or sham-tens for a total of 20 minutes, with a subsequent gag reflex measurement. the subject will then rest for at least 5 minutes at the end of the study to collect final ekg data, then given a gift card for her time. it is the hypothesis of the investigators that the treatments will increase gag tolerance in the following stepwise manner: sham-tens \< tens \< acupuncture

Eligibility criteria:
inclusion criteria: * english speaking exclusion criteria: * bleeding dyscrasias * severe needlephobia * pacemaker or other implanted electrical device

Keywords: acupuncture tens acupressure acupoint gag
study on the development of neonatal cerebral blood flow based on ultrafast ultrasound doppler imaging

Conditions: Premature Birth

Summary: recently, with the development of perinatal medicine in china, the establishment of neonatal intensive care unit (nicu) and the improvement of respiratory support technology, the survival rate of preterm and term neonates has been significantly improved. however, the brain development of preterm neonates is incomplete compared with that of full-term neonates. therefore, during the extrauterine cultivation of preterm neonates, clinical intervention should be carried out according to their brain development to achieve the same development status as that of full-term neonates. there are many clinical inspection methods to monitor the brain development of preterm neonates, such as eeg, functional near-infrared spectroscopy imaging, etc. however, these technologies cannot assess the brain development of premature infants systematically and completely. because of the existence of neurovascular coupling, brain function and cerebral blood flow are closely related, so the detection of cerebral blood flow can reflect brain development and brain function. ultrafast ultrasound power doppler imaging technology is an emerging, real-time, high-resolution microvascular imaging technology. in this study, we first used ultrafast ultrasound power doppler imaging technology to image the cerebral blood flow of preterm neonates at different gestational ages to evaluate the development of cerebral blood flow of preterm and term neonates and provide guidance for the clinical intervention of preterm neonates.


Eligibility criteria:
inclusion criteria: * neonates without cerebral diseases exclusion criteria: * neonates with cerebral diseases
a study of belcesiran in patients with aatld

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, pk, and pd in adult patients with pizz aatd-associated liver disease (aatld). the study will be conducted in 3 separate cohorts. a total of up to 16 participants may be enrolled in cohort 1 and 2. a total number of 30 subjects will be enrolled in cohort 3. the 3 cohorts are differentiated by the duration of the treatment period, the number of doses administered, and the timing of the second liver biopsy.

aatd-associated liver disease is a progressive condition resulting in liver fibrosis, cirrhosis, and in some cases hepatocellular carcinoma. the lack of functional alpha-1 antitrypsin (aat) in individuals with the pizz genotype, in conjunction with other precipitating factors, can lead to unchecked activity of neutrophil elastases in the alveoli; causing emphysema and chronic obstructive pulmonary disease (copd). this loss-of-function mechanism may be addressed by use of intravenous augmentation therapy, which aims to substitute the missing aat by infusing alpha-1 proteinase inhibitor (a1pi), purified from pooled human plasma. while augmentation therapy can address the loss of aat in the lung, no treatment exists for the associated liver disease. given the severity of the disease, with approximately 10% of affected patients developing liver cirrhosis and a subgroup of those patients in need of liver transplantation, and the lack of an effective treatment that addresses the toxic hepatic "gain-of-function" mechanism, there is an urgent unmet medical need to develop a therapy that can help this particular patient population.

Eligibility criteria:
inclusion criteria: * 18 to 75 years, inclusive, at the time of consent. * documented diagnosis of pizz-type alpha-1 antitrypsin deficiency, confirmed by genotyping. historical genotyping data may be used, if available. * aatd-associated liver disease documented by liver biopsy at screening. * consent to undergo paired liver biopsies. * lung, renal and liver function within acceptable limits * capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the icf and in this protocol. exclusion criteria: * history of chronic liver disease other than non-alcoholic fatty liver disease from any cause other than pizz-type alpha-1 antitrypsin deficiency. * child-pugh score b or c. * history of one single severe exacerbation of underlying lung disease in the year prior to randomization. * history of clinically significant respiratory infections (including pneumonia and lower respiratory tract infections), as determined by the investigator, in the 3 months prior to screening * use of an rnai drug at any time.
functional mri during resting state in patients with eating disorders

Conditions: Anorexia Nervosa; Bulimia Nervosa

Summary: the goal of this observational study is to learn if clinical and neurophysiological characteristics dynamics may follow similar trends in a longitudinal characterization of patients with a diagnosis of an eating disorder. the primary hypothesis is that the reversal of functional magnetic resonance imaging (fmri) baseline alternations is positively associated with symptomatic amelioration. the secondary hypothesis is that the degree of (f)mri baseline alternations is positively associated with symptoms. participants will be asked to complete psychometric questionnaires, perform a fmri and be recalled at 12 months for a follow-up.


Eligibility criteria:
inclusion criteria: * female sex * age between 12 and 40 years old * current diagnosis of anorexia nervosa or bulimia nervosa according to dsm-5-tr. exclusion criteria: * previous or current diagnosis of schizophrenia or bipolar disorder, * acute psychosis * substance abuse * severe medical comorbidities (hypercapnia, severe hypertension, cardiac arrhythmia, organ failure) * incapacity to grant written or verbal consent

Keywords: resting state fmri longitudinal evaluation
inhaled sevofluran vs endovenous propofol for colonoscopy

Conditions: Anesthesia

Summary: to compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy. a longitudinal, randomized clinical study of 32 patients of both sexes asa i-iii, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. in both, intravenous induction with propofol (2-2.5 mg / kg) was performed, group a remained sedated with propofol infusion (1-2 mg / kg / min); group b by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * physical status i, ii and iii according to the criteria of the american society of anesthesiology (asa) * patients who are going to undergo diagnostic colonoscopies * patients who signed the informed consent exclusion criteria: * allergy or hypersensitivity to some of the reference drugs in the study * patients with proven liver disease * suspicion or confirmation of pregnancy * antecedent or risk of malignant hyperthermia * fasting less than 8 hours * patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study * patients who have acute illnesses that compromise their health for which the study cannot be performed

Keywords: sedation colonoscopy