Kornimate/medical-research-clean huggingface dataset:
epidemiological study of iron deficiency and iron deficiency anemia in chinese pregnant women

Conditions: Anemia, Iron-Deficiency

Summary: the purpose of this study is to know the prevalence of iron deficiency (id) and iron deficiency anemia (ida) among pregnant women in chinese urban district at present, and to analyze the epidemiological characteristics of id/ida and influencing factors.

this is a national large-scale multi-center cross-sectional survey aimed at investigating the epidemiology of iron deficiency (id) and iron deficiency anemia (ida) among chinese pregnant women in the real world at present, which is anticipated to complete enrollment in two months. a total of 24 hospitals are selected from 6 regions (north, northeast, east, south, southwest, and northwest) of china by the method of multi-stage stratified sampling, each region with one tertiary teaching hospital and three general hospital or health care hospital for women and children. according to the sample size calculation formula combined with the feasibility and flexibility of study, 12000 eligible outpatient pregnant women are expected to be enrolled. structured questionnaires, which are needed filled in both by patients and doctors, are used to collect participants' data, including basic demographic characteristics (age, occupation, educational level, family income, etc.), reproductive factors (menstrual history, times of pregnancy or parity, history of cesarean section, etc.), pre-pregnancy weight, pregnancy comorbidities and complications, laboratory test of blood routine and serum iron protein, use of iron supplements, diet and living habits during pregnancy, and others. the outcomes are defined by the recommendations on the guidelines for the diagnosis and treatment of chinese iron deficiency and iron deficiency anemia during gestation period in 2014. all these data are requested to input the electronic data collecting (edc) system in time and managed level-to-level, with chinese evidence-based medicine centre finally monitoring the quality of data. during the whole course, no intervention is given to the participants and thus will not have a negative effect on the health and rights of the participants.

Eligibility criteria:
inclusion criteria: * receive outpatient service at selected hospitals for the first time during the survey period; * sign an informed consent form; * at selected hospitals, establish registry of personal file for obstetric examination, or ensure regular follow-up. exclusion criteria: * participate in any clinical trial of medicine or nutrition from 3 months before pregnancy till survey time.

Keywords: iron deficiency iron deficiency anemia pregnant women gestation china epidemiology
an upgrading of the resuscitative patterns by utilization of the balanced crystalloids and synthetic colloids and the non-invasive hemodynamic monitoring during burn shock

Conditions: Burns; Shock

Summary: fluid therapy lithium dilution cardiac output (lidco) controlled trial in burns (fact in burns) is a prospective randomized multicentric study. introduction: the goal of this trial is the verification, optional upgrading and optimizing of the resuscitative patterns in light of the new generation of balanced crystalloids and colloids and, by utilization the non-invasive hemodynamic monitoring lidco.

methods: the extensively burnt patients (age range 18-75 years) with second and the third degree burns, with tbsa above 15%, with or without inhalation injury will be included to the study within 2009-2010. the patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of the hospitalization, with surgically insoluble extent of burns or the dialyzed patients will be excluded.the patients will be routinely monitored. we will use the continuous real-time hemodynamic monitoring through transpulmonal lithium dilution additionally. the monitor lithium dilution cardiac output (lidco) plus permits through analysis of the arterial blood pressure trace to acquire items about co, svr and do2 . in fluid resuscitation, we will use a combination of the balanced crystalloids and synthetic colloids (of the middle molecular weight) in the ratio 2 ml/kg/% tbsa : 1 ml/kg/% tbsa. the control group will be composed of the patients supervised in a standard way, volume resuscitated according to the brooke or parkland formulas. map \> 65 torr, urine output 0,5 ml/kg/h, ci 2,5 - 4,0 l/min/m2, do2i 500 - 600 ml/min/m2 are the goals.we will measure the levels of proanp (pro natriuretic peptide) and angiotensin converting enzyme (ace) at artificial ventilated patients. the plasma ace and proanp concentrations were measured by commercially available elisa immunoassays. conclusions: we will evaluate the total fluid balance at day 1, 2 and cumulative fluid balance at day 7, reversal of organ dysfunction according to sofa score at day 3 and 7 in both group. the days of invasive ventilatory support, length of icu stay, icu survival, total length of hospital stay and hospital survival are the additional endpoints.

Eligibility criteria:
inclusion criteria: * extensively burnt patients (age range 18-75 years) with second and third degree burns * with tbsa above 15% * with or without inhalation injury exclusion criteria: * patients meeting inclusion criteria but with an adverse critical prognosis from the beginning of hospitalization * with surgically insoluble extent of burns * dialyzed patients will be excluded

Keywords: burned shock volume resuscitative patterns non-invasive hemodynamic monitoring
efficacy and safety of valsartan in combination with amlodipine compared to losartan plus hydrochlorothiazide in patients with hypertension and left ventricular hypertrophy

Conditions: Hypertension; Hypertrophy, Left Ventricular

Summary: this study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy


Eligibility criteria:
inclusion criteria: * caucasian; male or female outpatients and age between 18-80 years of age, inclusive. * patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure \>=90 and \ =90 and \<= 100mmhg. * patients with left ventricular hypertrophy exclusion criteria: * severe hypertension * symptomatic heart failure * history of stroke, heart attack, coronary bypass surgery etc. * insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus. other protocol-defined inclusion/exclusion criteria may apply

Keywords: left ventricular hypertrophy, hypertension, valsartan, amlodipine
minimally invasive cardiac output monitoring device

Conditions: Cardiac Event

Summary: the overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. the specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (co) in units of liters-per-minute. to achieve this objective, the waveforms for analysis and reference pulmonary artery catheter co measurements will be recorded from critically ill patients and then analyzed off-line at retia medical. successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.


Eligibility criteria:
inclusion criteria: * all adult patients admitted to the university of michigan icu following cardiac surgery with both a pulmonary and radial artery catheter. exclusion criteria: * adult patients with mechanical cardiac support including intra-aortic balloon pumps, lvad, or ecmo, and persistent ventricular arrhythmias.
phase 1/2 study of agn-241622 in healthy participants and participants with presbyopia

Conditions: Presbyopia

Summary: the objective of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of agn-241622 ophthalmic solution for the first time in human participants


Eligibility criteria:
inclusion criteria: * age 40 to 65 at the time of study participation. * be a nonsmoker and nonuser of nicotine-containing products within the previous 1 year. * be able and willing to follow study instructions and complete all required study visits in the opinion of the study doctor. exclusion criteria: * history of alcohol or substance abuse within the 5 years prior to study participation. * enrollment in another investigational drug or device study within 30 days of study participation. * women who are pregnant, nursing, or planning a pregnancy during the study.

Keywords: presbyopia,healthy subject,subjects with presbyopia
post-occlusive reactive hyperemia and basal-cell carcinoma

Conditions: Carcinoma, Basal Cell

Summary: the investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (porh) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature. this new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy. this clinical trial will use skin flap model for trunk and facial basal cell carcinoma (bcc), with respect the classical excision margin of bcc surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the bcc, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released. in case of limb bcc, limb tourniquet will be used, and occluded during 3 minutes upstream to the bcc location. during all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * histologically proved cutaneous bcc * patient being informed and having signed the consent to participate to the study exclusion criteria: * counter-indication to surgery * patient being unable to attend future follow-up visits * patient with severe cognitive impairment * patient not affiliated to a social security regimen * patient with limb bcc and history of peripheral vascular artery surgery like bypass and/or vascular prothesis on the same limb (tourniquet counter-indication) * local bone invasion of bcc detected with imagery
telehealth group-based emotional awareness and expression therapy for patients with persistent physical symptoms: a pilot study

Conditions: Somatic Symptom and Related Disorders; Somatic Symptom Disorder; Functional Somatic Disorder; Functional Somatic Syndrome

Summary: delivering emotional awareness and expression therapy (eaet) through digital or telehealth platforms in a group format offers several key advantages. first, it significantly improves access to care, allowing individuals with persistent physical symptoms (pps) to receive effective, emotion-focused therapy regardless of their geographic location. telehealth can also benefit those who face mobility issues or have limited access to specialized care in rural or underserved areas. group-based telehealth eaet promotes social connection among participants, fostering a supportive environment where individuals can share experiences, which may enhance therapeutic outcomes. additionally, the convenience of remote therapy can reduce barriers to participation, such as time constraints and travel costs, making it easier for patients to commit to treatment. finally, the digital format allows for flexible, scalable interventions that can be easily integrated into routine psychiatric care, potentially increasing treatment uptake for individuals who might otherwise avoid in-person therapy due to stigma or logistical challenges.


Eligibility criteria:
inclusion criteria: * the participant certifies that he or she has undergone a medical evaluation for their physical symptoms (see separate certificate). * the participant rates either moderate distress from physical symptoms on the phq-15 form (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom). * the participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile. * any prescribed medications must have been stable for at least 1 month. exclusion criteria: * participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.). * participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines). * participants are involved in other psychological treatments focused on physical symptoms. however, other psychological treatments are allowed as long as the supportive therapy does not occur more than once a month. * participants do not have sufficient proficiency in the swedish language.
a pilot clinical trial to evaluate the biological activity of fulvestrant in breast ductal carcinoma in situ (dcis)

Conditions: Breast Carcinoma

Summary: the subjects in this trial have been diagnosed as having a pre-cancerous disease of the breast called ductal carcinoma in situ (dcis). this condition is associated with the development of breast cancer in up to 50% of cases. the subjects are being asked to participate in this research study. they are being offered voluntary admission to this study to test the effects of a new investigational drug called fulvestrant (faslodex). this drug is approved by the united states food and drug administration (fda) for the treatment of advanced breast cancer but has not been approved for the treatment of dcis. however, the fda has given permission for the drug to be tested in this study. the purpose of this study is to find out if fulvestrant has any effect on the subject's precancerous changes by comparing samples taken before and after receiving fulvestrant.


Eligibility criteria:
inclusion criteria: * postmenopausal women with newly diagnosed dcis. women will be considered to be in menopause if they fall into one of the following groups: * age \> 60 * age \> 45 with amenorrhea \> 1 year with intact uterus * status post bilateral oophorectomies * fsh/estradiol levels in postmenopausal range for the institution * dcis must have been diagnosed with a minimally invasive biopsy technique, such as a vacuum-assisted large core tool (mammotome) or an equivalent method. * there must be available tissue from the diagnostic biopsy to perform molecular markers. * baseline mammogram within 8 weeks of study entry. * serum creatinine less than or equal to 2.0 mg/dl. * total bilirubin less than or equal to 2.0 upper limit of normal (uln), transaminases (sgot and/or sgpt) and alkaline phosphatase may be up to 2.5 x institutional upper limit of normal (uln), agc greater than or equal to 1500, platelets greater than or equal to 100,000, hemoglobin greater than or equal to 8.0 g/dl * peripheral neuropathy grade 0-1. * no prior therapy for dcis. * swog performance status of less than or equal to 1 * all patients must provide informed written consent exclusion criteria: * prior hormonal therapy (antiestrogens, estrogen, serm's, progestins, or aromatase inhibitors) within 6 months of study entry. * underlying medical, psychiatric or social conditions that would preclude patient from receiving treatment. * history of dvt or pulmonary embolism
oral antibiotics after 2-stage revision for infected total hip arthroplasty and total knee arthroplasty

Conditions: Prosthesis-Related Infections

Summary: the primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.


Eligibility criteria:
inclusion criteria: adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. patients must be able to tolerate oral antibiotics and agree to participate in the study. exclusion criteria: patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.

Keywords: revision knee hip arthroplasty oral antibiotics infection
low energy therapy to convert ventricular tachycardias

Conditions: Ventricular Tachycardia

Summary: the lever study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (mvts).

the lever study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (mvts). subjects must be already indicated for standard of care vt procedure during which vt is likely to be induced (such as vt testing, vt ablation, vt mapping, or vt risk stratification testing.) the study patches will be applied to the subject's torso, and the patches will be connected to the lever acute study system. pacing capture threshold capture may be assessed. if monomorphic vt is induced and reaches at least 170bpm (350ms/cycle), one or more of the low energy therapies will be applied under oversight of the investigator, in an attempt to treat and convert the vt.

Eligibility criteria:
inclusion criteria: * subjects with a history of ventricular tachycardia indicated for ventricular testing procedures that may include vt induction, such as vt testing, vt ablation, vt mapping, or vt risk stratification testing. * subjects age 18 or above, or of legal age to give written informed consent specific to local laws and requirements * subjects who, in the opinion of the investigator, are suitable to be enrolled in a clinical study exclusion criteria: * subjects with any comorbidities that, in the opinion of the investigator, would exclude them from standard of care vt testing * subjects with vt that is known to be focal in nature * subjects whom the investigator believes are not hemodynamically stable enough to tolerate testing * subjects of childbearing age who may be pregnant. * subjects who are unwilling or unable to provide written informed consent. * subjects with any implanted device that emits electrical energy where either therapy cannot be temporarily disabled, or the subject cannot tolerate temporary disabling of therapy.

Keywords: implantable cardioverter-defibrillator
fnirs-based neurofeedback training in children with adhd: the effects of vr

Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)

Summary: the study aims to explore whether the treatment using fnirs-based neurofeedback training for children with attention-deficit/hyperactivity disorder (adhd) is useful. furthermore, the study hopes to evaluate whether the use of virtual reality (vr) technology will have an impact on the treatment's effectiveness. the program includes the following components: participants will be randomly assigned to one of three intervention groups: the neurofeedback with virtual reality (vr) group, the 2d neurofeedback group (with no vr technology applied), and the vr without neurofeedback group. all participants will complete academic-related tasks in simulated lessons. participants in the vr neurofeedback group will wear vr goggles and a neurofeedback device that measures blood oxy-hemoglobin levels in brain cortical tissue and provides feedback via visual images or auditory sounds to the participants. those in the 2d neurofeedback group will use a computer to complete the tasks, with all other settings (e.g., neurofeedback settings) remaining the same. the vr without neurofeedback group will wear vr goggles to complete tasks, but without the neurofeedback component. all participants will complete a total of 16 training sessions over 8 weeks (twice a week), with each session lasting approximately 35 to 60 minutes. to investigate the intervention's effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory before the intervention (i.e., time 1), immediately after the 8-week training (i.e., time 2), and 2 months after the training (i.e., time 3, a 2-month follow-up). the assessment will take around 1 hour and will be conducted at the laboratory at the university of hong kong. additionally, parents and teachers will be asked to complete a questionnaire assessing children's behavior at home and at school at three time points.


Eligibility criteria:
inclusion criteria: * children aged 7- 12 * clinical diagnosis of adhd * significant teacher- or parent-reported attention problems during screening exclusion criteria: * inability to answer the first five questions in raven's progressive matrices * hearing, visual, or physical impairments that might hinder participation in the training and assessment activities * clinical diagnosis and suspected cases of autism spectrum disorder (asd) * prior or current participation in nft * current participation in a psychotherapeutic treatment

Keywords: neurofeedback fnirs adhd children virtual reality
impact of aminoglycosides in hypotensive septic oncology patients

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Septicemia

Summary: this study evaluates the impact of aminoglycosides in hypotensive septic oncologic patients. in the oncologic patient population, sepsis is a major health concern due to high mortality rates and healthcare costs. prior research shows aminoglycosides antibiotics are frequently used to treat sepsis, but their clinical impact in hypotensive oncology patients upon the progression of sepsis is not known.

primary objective: i. to assess the impact of beta-lactam (bl) + aminoglycoside (ag) combination therapy in hypotensive septic oncology patients. outline: patients' medical charts are reviewed retrospectively.

Eligibility criteria:
inclusion criteria: * adult patients (age \>= 18 years) with a diagnosis of sepsis during the index hospital admission identified by international classification of diseases (icd)-10 codes (as specified below) receiving bl antibiotics within 6 hours prior to or following the onset of hypotension * to be included in the ag group, patients must have received at least 1 dose of intravenous (iv) tobramycin or amikacin in addition to the bl therapy within the above time period exclusion criteria: * age \< 18 years * receipt of iv ag outside of the above time frame in the ag group or receipt of iv ag within 48 hours prior to or following the onset of hypotension in the bl backbone group * pregnancy * patients not receiving therapy with bl antibiotics