Kornimate/medical-research-clean huggingface dataset:
fys study: epidemiological, multicentre, cross-sectional study in a clinical practice environment, about the relationship between functioning status and the quality of sleep perceived by schizophrenic outpatients in spain

Conditions: Schizophrenia

Summary: the purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. the secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.

this is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. it is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. these patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. n/a

Eligibility criteria:
inclusion criteria: * patient diagnosed of schizophrenia * reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit * who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study * (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent. exclusion criteria: * patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires * who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome) * or included in another clinical study or trial that can interfere with the normal control of the disease.

Keywords: schizophrenia sleep disturbances quality of sleep functioning level antipsychotic therapy.
complications in hypertension and obesity

Conditions: Metabolic Syndrome; Hypertension; Obesity; Dyslipidemia; Hyperglycemia

Summary: the study in aimed to investigate epidemiology of risk factors in russian federation its prognostic value aimed on acceptance of national specific definition of metabolic syndrome and guidelines for its management.


Eligibility criteria:
inclusion criteria: * age older 18 years * signed informed consent * blood pressure more than 130 and/or 85 mm hg * waist circumference more than 80 sm in females and 94 in males and/or bmi more than 25 kg/m2 * dyslipidemia (elevated tg and/or decreased level of hdlp or therapy for high triglyceride level) * fasting glucose more than 5,6 mmol/l exclusion criteria: * associated clinical conditions (stroke, tia, mi, heart failure, renal disease, diabetes mellitus) * severe concomitant diseases affecting outcome

Keywords: metabolic syndrome hypertension obesity dyslipidemia hyperglycemia cardiovascular complications
comparison of lactobacillus reuteri and nystatin prophylaxis on candida colonization and infection in very low birth weight infants

Conditions: Very Low Birth Weight Infants

Summary: probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. lactobacillus reuteri was shown to reduce candida colonization. the objective of this study is to evaluate the efficacy of prophylactic lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.


Eligibility criteria:
inclusion criteria: * very low birth weight infants \< 1500 gr * gestational age \< 32 weeks exclusion criteria: * genetic anomalies * short bowel syndrome * not willing to participate * allergy to lactobacillus reuteri components

Keywords: lactobacillus reuteri nystatin very low birth weight infants candida colonization
clinical characteristics and medication satisfaction of kanarb tablet in korean hypertensive patient(kanarb-hypertension epidemiology medication satisfaction study)

Conditions: Hypertension

Summary: 1. investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in korean hypertensive patients 2. observe the changes of medication satisfaction and compliance in patients after switchting to fimasartan


Eligibility criteria:
inclusion criteria: step1 * over 20 years old * essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month step2 * patients does not taking fimasartan * patient's medication satisfaction score under 4 exclusion criteria: * patients with secondary hypertension * patients with orthostatic hypotension who has sign and symptom * patients with known severe or malignancy retinopathy * patients with significant investigations; abnormal renal function * childbearing and breast-feeding women * patients with history of allergic reaction to any angiotensin ii antagonist

Keywords: medication satisfaction quality of life drug compliance
cannabis use in cancer patients

Conditions: Solid Tumor, Adult

Summary: the goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.

tightly controlled experimental laboratory studies (e.g., clinical trials with randomization) using cannabis products available in state-regulated markets are simply, at this point, not possible owing largely to federal law and the university requirements related to the controlled substances act and drug free schools and communities act. because a traditional clinical trial design is not possible given the current federal status of cannabis products, this investigator will use a patient-oriented, prospective observational design. specifically, individuals who have already decided to try cannabis for their cancer treatment-related symptoms will initiate use of an orally administered product they have selected. a research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. the participants will then purchase the product and decide how often and how much to use. this approach is consistent with federal law and supported by our preliminary and ongoing studies(1r01at009541-01, 1r01da044131-01, cdphe2902, r01da039707). patients will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks, at which time they will be scheduled for an acute administration session (ta1-tc1) so that we may examine the acute effects of the product. the final follow-up will be one month later via an online survey sent directly to the participant via email.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision to sign and date the consent form. 2. stated willingness to comply with all study procedures and be available for the duration of the study. 3. be a female or male aged at least 21 years. 4. have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment 5. have intent or interest to use cannabis to treat their symptoms. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days 2. actively seeking or in treatment for any substance use disorder 3. acute illness other than cancer that could affect cognition or compliance per the decision of the study m.d. 4. premenopausal females who are pregnant or trying to become pregnant. note that pregnancy testing will not be required. 5. a telephone interview for cognitive status (tics) score indicating moderate or severe cognitive impairment at screening

Keywords: cannabis tumors observational study
mesoglycan for acute hemorrhoidal disease

Conditions: Hemorrhoids

Summary: hemorrhoidal disease (hd) is the most common proctological disease with a prevalence rate that can reach approximately 4.4% of the population, with a particular peak in individuals aged between 45 and 65 years. the most common presentation of hd is painless rectal bleeding occurring during or immediately after defecation. pain is rare in case of uncomplicated hd and may be present in case of external hemorrhoidal thrombosis. the decision-making to treat hemorrhoidal thrombosis usually depends on the timing of the onset of symptoms, with the surgical treatment favored if the onset of symptoms occurs within 72 hours. mesoglycan, a natural preparation of glycosaminoglycans (gags), is a polysaccharide complex rich in sulfur radicals. it is composed of heparan sulphate (47.5%), dermatan sulphate (35.5%), chondroitin sulfate (8.5%) and slow heparin (8.5%). mesoglycan exerts antithrombotic activity (activation of antithrombin iii and heparin cofactor ii) and profibrinolytic (stimulation of the activator tissue plasminogen) decreasing plasma concentrations of fibrinogen without affecting the prothrombin time, the time of partial thromboplastin or the remaining coagulation parameters. the rationale of this double-blind randomized controlled clinical trial is to confirm/evaluate the efficacy and safety of mesoglycan versus placebo in reducing the symptoms of hemorrhoidal disease and their impact on quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of grade i-iii hemorrhoidal disease classified according to goligher classification or diagnosis of external hemorrhoid thrombosis * female patients of childbearing age with a negative pregnancy test * patients able to understand informed consent * signed informed consent. exclusion criteria: * blood coagulations disorders * patients undergoing chemoradiation * intake of anticoagulants * pregnancy
effect of ischemic compression with stretching on patients with upper back pain

Conditions: Myofascial Pain Syndrome

Summary: the purpose of this study is to determine the effect of ischemic compression with stretching on pain related parameters including pain intensity, pressure pain threshold, anxiety, cervical range of motion and patient satisfaction in patients with scapular pain associated with myofascial trigger point.


Eligibility criteria:
inclusion criteria: * the participants have experienced spontaneous upper back pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. * the participants will be able to follow instructions. * good communication and cooperation. exclusion criteria: * fibromyalgia syndrome * cervical radiculopathy or myelopathy) * cervical spine surgery
international registry of thrombotic aps patients treated with direct oral anticoagulants

Conditions: Antiphospholipid Syndrome; Thrombosis; Anticoagulants Causing Adverse Effects in Therapeutic Use

Summary: this registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk aps patients currently on doacs.


Eligibility criteria:
inclusion criteria: * patient receiving a comprehensive information about the study, and not opposed to participate * age ≥ 18 yo * classification of definite aps according to revised sapporo-sydney criteria * direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months exclusion criteria: * incomplete revised sapporo-sydney criteria * no data regarding the recurrent thrombosis * pregnant woman * age \< 18 yo

Keywords: antiphospholipid syndrome direct oral anticoagulants
de novo metabolic syndrome in liver transplant patients after immunosuppression withdrawal

Conditions: Single Transplant; 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS

Summary: evaluate de novo onset of metabolic syndrome, nafld and nash in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").

a retrospective single-center study was conducted aiming to define the incidence of de novo metabolic syndrome (ms) in patients who withdraw immunosoppression (is) drugs after liver transplant (tolerant-group) compared to these who couldn't wean is drugs(non-tol-group).

Eligibility criteria:
inclusion criteria: * single lt recipients with an attempt of is withdrawal * minimum 5 years follow-up exclusion criteria: * liver transplant combined with other organs * presence of metabolic syndrome and/or nash and/or nafld as an indication for liver transplantation * loss of patient to follow-up

Keywords: metabolic syndrome, liver transplantation, immunosoppression, tolerance
effects of an exercise program on bone density

Conditions: Bone Density; Body Composition

Summary: physical inactivity and low adherence to the mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. in addition, exercise in different surfaces or water could affect the bone density specially in women. objective: the purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the mediterranean diet and distribution of macronutrients in the studied population. material \& methods: randomized controlled trial. 63 women from a randomized work environment (ig, n=34) and a control group (cg, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density dual-energy x-ray absorptiometry (dxa) was used and to evaluate diet, the mediterranean diet quality questionnaire (kidmed) and the food frequency questionnaire for macronutrient distribution were used.


Eligibility criteria:
inclusion criteria: * not diagnosed with any disease that contraindicates the practice of physical exercise * do not perform physical activity with continuity exclusion criteria: * diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise * being pregnant before or during the intervention (for intervention and control group)
avatrombopag to promote platelet engraftment after allo-hsct

Conditions: Platelet Disorder

Summary: the purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after allo-hsct.

patients with thrombocytopenia (plt\<20×10\^9/l) after allogenic hematopoietic stem cell transplantation (allo-hsct) who meet eligibility criteria were assigned into the avatrombopag group for 4 weeks' treatment.

Eligibility criteria:
inclusion criteria: * male or female, aged between 18-60 years; * plt\<20×10\^9/l after 14 days of allo-hsct; * expected survival time \> 3 months; * ecog performance status 0-2; * agree to receive the treatment of avatrombopag after allo-hsct and must sign the informed consent form. exclusion criteria: * pregnant or lactating; * with severe and uncontrollable infection; * with graft-versus-host disease (gvhd) with steroid resistance; * with thrombotic microangiopathy; with active thromboembolism requiring anticoagulation * with detected disease recurrence due to chimerism by flow cytometry; * with chronic active hepatitis b and c virus infection; * with secondary or multiple transplantation, or multiple organ transplantation; * with severe heart disease, lung disease, diabetes and metabolic diseases; * hiv positive; * with a history of plt dysfunction or bleeding disorders * with the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (the disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dl); * with progressive solid tumor; * with severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening; * with any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study; * with treatment of thrombopoietin receptor agonist (tpo-ra) one month before enrollment; * deemed unsuitable for enrollment by the investigator.

Keywords: avatrombopag thrombocytopenia allogenic hematopoietic stem cell transplantation engraftment
a study in ckd patients with type 2 diabetes mellitus and albuminuria

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with chronic kidney disease with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * males or females aged 18 to 80 years, inclusive. * body mass index between 18 and 45 kg/m2, inclusive. * type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization * stage 3 ckd * mssbp ≥130 mmhg * urinary albumin: mean uacr ≥ 200 mg/g exclusion criteria: * urinary albumin: uacr \> 3500 mg/g * history of a renal transplant * mssbp \>180 mmhg or a msdbp of \>120 mmhg on two occasions during screening or run-in periods * history of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Keywords: albuminuria
the global cvad study

Conditions: Cardiovascular Diseases

Summary: the intent of the global cvad study is to utilize observational data of the abiomed, inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a tool to measure and improve the quality of patient care and to serve as a resource for future research and regulatory filings.

ongoing, observational, multicenter, records review of patients receiving the abiomed, inc. hemodynamic support device(s). to collect in-hospital data, a waiver of consent and authorization will be requested to avoid significant biases in data reporting due to the extremely high mortality. to collect the post-discharge data on subjects who survive the index hospitalization, an informed consent will be obtained from those subjects or a waiver of informed consent will be used to collect data if the subject was implanted greater than a year from enrollment. data will be collected through the review of existing medical records and subject telephone interview. clinical follow-up as an office visit is not required for this study protocol. however, clinical follow-up and event-driven visits (e.g. re-hospitalizations) may occur as clinically warranted. at each follow-up time point, a telephone call to the subject will be attempted to obtain updated medical history and self-assessed cardiac function. in addition to the telephone call, the subject's medical records at the study site will be reviewed for cardiac-related clinic visits and/or cardiac-related re-hospitalization, including echocardiographic imaging. all data collected for this study will be reported on study specific electronic case report forms (ecrfs) and entered into a controlled 21cfrpart11 compliant electronic data capture (edc) system by the designee at the participating site. monitoring of the study data will be performed according to the study monitoring plan. monitoring may be performed on-site or remotely and will not be conducted by anyone involved in data collection. a clinical events committee (cec) may be formed by the sponsor. if convened, the cec, an independent adjudication body composed of cardiologists and cardiac surgeons will adjudicate whether the site-reported adverse events and/or macce meet the study definitions for these events, and the relatedness of the events to the procedure and the device. a steering committee composed of internationally recognized investigators and experts in the field of interventional cardiology, cardiovascular surgery, cardiac electrophysiology, heart failure and mechanical circulatory support was established to provide technical and scientific oversight of the study.

Eligibility criteria:
inclusion criteria: 1. all subjects in the study population are eligible for enrollment at the time of receiving support from an abiomed, inc. hemodynamic support device, or at the time of attempt to implant an abiomed, inc. hemodynamic support device. exclusion criteria: 1. patients in whom an attempt to implant an abiomed, inc. hemodynamic support device did not occur.
persistent pain after cs delivery

Conditions: Persistent Pain After Delivery

Summary: many factors influence the development of persistent pain after cs (chronic pain) as well as post-partum depression. we are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. physical activity is monitored by subject's wearing a fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..

subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. preoperatively subjects complete a psycho-social/depressive screening questionnaire. pain treatments/satisfaction assessments are captured for the first 24 hours. mother/baby outcomes are also captured. physical activity and pain scores are also correlated with the subject's wearing of a fitbit physical activity bracelet with eligible subjects for 60 days post-delivery.

Eligibility criteria:
inclusion criteria: * \>/= 18 years of age english speaking exclusion criteria: non-english speaking

Keywords: chronic pain cesarean section pain
psychometric study of outcomes instruments

Conditions: Burns; Trauma

Summary: the purpose of this study is to develop a standardized, practical self-administered questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn management treatments with regard to improved function, physical appearance and other relevant outcomes.

identifying young adult burned patients at risk for poor outcomes remains an underpublished field of study. the first step to identifying these patients is to review their responses to this burn specific young adult measure, that attempts to quantify aspects of quality of life. we are validating this questionnaire by now collecting information from non burned community based subjects and by having burned patients complete the questionnaire at 4 timepoints. once we have recruited sufficient subjects we will finalize our testing of this questionnaire and publish the validity and reliability of the instrument. our questionnaires will help us answer the question of how burn people differ from non burned person's reported quality of life. this will complete our array of burn specific outcomes questionnaires from infancy through young adulthood.

Eligibility criteria:
inclusion criteria: * all burn injured young adults with or without grafting * all burned on or after their 17th birthday * between the ages of 19-30 * english speaking * present for inpatient or outpatient treatment exclusion criteria: non-burned skin conditions * non-english speaking * patients less than 19 years of age * patients over 30 years of age

Keywords: burns trauma outcomes quality of life