Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of several replagal dosing regimens on cardiac function in adults with fabry disease

Conditions: Fabry Disease

Summary: the purpose of this study is to compare the safety and effectiveness of various doses of replagal in patients with cardiomyopathy due to fabry disease.

fabry disease is an inherited, metabolic disease caused by mutations in the gala gene. patients with fabry disease accumulate a complex glycosphingolipid named globotriaosylceramide (gb3) in various tissues and organs. all organs are affected in fabry disease but the majority of the morbidity and mortality are caused by cardiac, renal and neurological dysfunction. accumulation of gb3 in the heart causes hypertrophic cardiomyopathy, valvular abnormalities, arrhythmias and infarctions. replagal has been shown to reduce gb3 from key tissues and organs, and stabilize renal function in patients with fabry disease. evidence suggests that replagal reduces left ventricular mass (lvm) and improves midwall fractional shortening (mfs) of the heart. left ventricular hypertrophy is a major cause of morbidity and mortality in patients with fabry disease. this is a study of the safety and effectiveness of 3 dosing regimens of replagal in adult patients with left ventricular hypertrophy due to fabry disease. the primary objective of the study is to compare the effects of 2 dosing regimens of replagal (0.2 mg/kg iv every other week and 0.2 mg/kg iv weekly) on the reduction of left ventricular mass as measured by echocardiography. the secondary objectives of this study are to compare the effects of 2 dosing regimens of replagal (0.2 mg/kg iv every other week and 0.2 mg/kg iv weekly) on each of the following: exercise tolerance; improvement in disease-specific quality of life in heart failure patients; improvement of heart failure symptoms; magnitude of reduction in gb3; rate of decline in renal function and improvement in the severity of proteinuria/albuminuria; and safety. an alternative treatment regimen of 0.4 mg/kg replagal iv weekly will also be explored but without formal comparison to the 0.2 mg/kg regimens. the investigation of the safety and efficacy of the 0.4 mg/kg iv weekly regimen is a secondary objective of this study.

Eligibility criteria:
inclusion criteria: * \>18 years-old; * male:fabry disease confirmed by deficiency of alfa galactosidase a activity or female:fabry disease confirmed by a mutation of the alfa galactosidase a gene; * ert-naïve; * lvm/h \> 50g/m2.7 for males and \>47 g/m2.7 for females; * negative pregnancy test at enrollment and contraception use required throughout study for female patients; * signed informed consent; exclusion criteria: * class iv heart failure; * clinically significant hypertension; * hemodynamically significant valvular stenosis or regurgitation; * morbid obesity; * known autosomal dominant sarcoplasmic contractile protein gene mutation; * treatment with any investigational drug or device within the 30 days; * unable to comply with the protocol as determined by the investigator; * positive for hepatitis b, hepatitis c or hiv
brentuximab vedotin combined with avd chemotherapy in patients with newly diagnosed early stage, unfavorable risk hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this study is to compare the outcomes across the 4 different treatment groups. the investigators hope that this treatment will improve the ability to cure more patients with hl and also limit the long-term side effects from the treatment. although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with bv+avd chemotherapy alone there may be an increased risk of the hodgkin lymphoma coming back after initial treatment.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of classical, cd30 positive hodgkin lymphoma confirmed at enrolling institution * fdg-avid disease by fdg-pet/ct and measurable disease of at least 1.5 cm by ct * ann arbor stage i or ii disease * disease bulk defined as any lymph node mass with transverse maximal diameter \> 7.0 cm or coronal maximal diameter \> 7.0 cm on ct imaging * females of childbearing age must be on an acceptable form of birth control per institutional standards * ages 18 and over exclusion criteria: * cardiac ejection fraction ≤ 50% * hemoglobin-adjusted diffusing capacity for carbon monoxide \< 40% * anc≤1000/μl and platelets≤75,000/μl * total bilirubin ≥ 2.0 mg/dl in the absence of a history of gilbert's disease * serum creatinine clearance of \<30 ml/min as estimated by the cockcroft-gault method * known pregnancy or breast-feeding * known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * medical illness unrelated to hodgkin lymphoma, which, in the opinion of the attending physician and/or mskcc principal investigator, makes participation in this study inappropriate. * peripheral neuropathy \> grade 1 * patients receiving chronic treatment with systemic steroids. however, patients can receive up to 10 days of steroid therapy prior to starting treatment with bv+avd.

Keywords: dacarbazine doxorubicin/adriamycin sgn-35 (brentuximab vedotin) vinblastine involved-site radiation therapy (isrt) early stage 13-034
management of women with superficial dyspareunia

Conditions: Superficial Dyspareunia

Summary: superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration. they affect between 3 to 18% of women and are a source of physical and psychological suffering. some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints. the approach of sexuality remains a complex subject even within the medical field. as a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.

the main objective is to describe the management of superficial dyspareunia by health professionals.

Eligibility criteria:
inclusion criteria: * aged 18 or over * superficial dyspareunia, i.e.: * having already had several painful vaginal penetrative sex * having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys) * having persistent and/or recurrent pain (appearing in a manner regular) * agreeing to participate in the study exclusion criteria: * minors * protected by law (guardianship, curatorship, safeguarding of justice) * refusing to participate in the study

Keywords: superficial dyspareunia management
application of phototherapeutic keratectomy mode to mark the axis of astigmatism

Conditions: Astigmatism

Summary: corneal refractive surgery is an effective way to correct refractive error. modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. the key point in the correction of astigmatism is that as a vector parameter, astigmatism has both magnitude and direction. the angle error may be caused by the rotation of the patient's head position and the involuntary rotation of eyes. phototherapeutic keratectomy can precisely cut the corneal tissue, and is often used in clinic to remove corneal scars or repair corneal surface morphology. in this study, the excimer laser therapeutic keratectomy mode was used to achieve accurate marking of the axis of astigmatism by setting the treatment laser parameters. with the help of the static cyclotorsion of the eye, the precise treatment of astigmatism could realize.


Eligibility criteria:
inclusion criteria: * at least 18 years old exclusion criteria: * ocular disease
trial of posture correction girdle for adolescents with early scoliosis

Conditions: Scoliosis

Summary: adolescent idiopathic scoliosis (ais) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. spine curvature increases in youths as puberty progresses. generally, only observation is suggested for adolescents with early scoliosis (cobb's angle ≤ 20°). rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. flexible brace treatment is an alternative option; however, its efficacy is still controversial. posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. a scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.

the design of posture correction girdle will incorporate different mechanisms, such as 1. compression and pulling forces through a close fit of the intimate apparel 2. lumbar flexion by using a supporting belt 3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system 4. axial rotation or coupled motion by using a system with uneven straps, and 5. an active mechanism that aims to shift the trunk away from areas of pressure.

Eligibility criteria:
inclusion criteria: * diagnosis of ais * cobb's angle 10˚-20˚ * risser grade ≤ 2 * no prior treatment * pre-menarche or post- menarche by no more than 1 year * ability to read and understand english or chinese * physical and mental ability to adhere to anisotropic textile braces protocol exclusion criteria: * diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * history of previous surgical or orthotic treatment for ais * contraindications for pulmonary and/ or exercise tests * psychiatric disorders * recent trauma * recent traumatic (emotional) event

Keywords: posture correction girdle
local meht + tcm versus intraperitoneal chemoinfusion in treatment of malignant ascites: phase ii rct

Conditions: Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency

Summary: this trial studies efficacy and safety of combination of modulated electro-hyperthermia (meht) with traditional chinese medicine (tcm) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (cddp+5fu).

conservative treatment of peritoneal carcinomatosis with malignant ascites (pcma) is based on chemoinfusion with its inherent toxicity. there is a strong demand for a safe and non-toxic method of treatment of pcma. the new technology of modulated electro-hyperthermia (meht) has proven efficacy in many advanced cancers with minimal side effects and synergy with traditional chinese medicine (tcm). tcm has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. shi pi decoction is supposed to be the optimum co-treatment of pcma according to principles of tcm. intraperitoneal chemoinfusion (ipci) with cisplatin and fluorouracil is a widespread standard treatment of pcma in china. this randomized ii phase trial studies efficacy and safety of combination of meht with tcm in treatment of pcma versus standard ipci (cddp+5fu).

Eligibility criteria:
inclusion criteria: * pathologically confirmed pc with malignant ascites. * karnofsky performance status (kps) score ≥60%. * normal function of bone marrow. * predicted survival time \>1 month. * written informed consent. exclusion criteria: * surgery within 3 weeks or not full recovery of postoperative suture. * active bleeding or vascular occlusion in the meht treatment area. * emotional instability. * impossibility to place the patient into the meht machine. * metallic implants or replacements in the treatment area. * electronic implanted devices anywhere. * missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area. * very low white blood cell count (\<1.5×10(9)/l), agranulocytosis (\<0.5×10(9)/l) or severe anemia.

Keywords: peritoneal carcinomatosis malignant ascites modulated electro-hyperthermia traditional chinese medicine
testing the effect of ends flavors on neurotransmission

Conditions: Tobacco Dependence

Summary: the overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ends) by altering brain function and behavior.

for this randomized double-blind controlled trial, tobacco users will be randomized to use ends with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. laboratory measures of ends reinforcement, subjective ends ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fmri) will be collected at baseline and after ten days of ends use.

Eligibility criteria:
inclusion criteria: 1. 21 to 60 years old 2. regular users of inhaled tobacco products (≥5 days out of the last 28) 3. not planning to quit tobacco use within next month 4. able to read and write in english exclusion criteria: 1. major neurological conditions or brain trauma 2. current substance use impairing participation 3. unstable or significant medical conditions (e.g., copd, coronary heart disease) 4. current use of smoking cessation medication (e.g., varenicline, patch) 5. uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months 6. known allergic reaction to ends liquids ingredients propylene glycol or vegetable glycerin 7. unable to use study provided ends ad-libitum for at least 3 hours per day 8. pregnant or breastfeeding as indicated by self-report or urine pregnancy screen mri-specific exclusion criteria: 1. mri safety contraindications (e.g., metal implants, claustrophobia) 2. major neurological conditions or brain trauma

Keywords: tobacco nicotine smoking addiction
clinical database and biobank of patients with gynecologic neoplasms

Conditions: Cervical Cancer; Ovarian Cancer; Endometrial Cancer; Choriocarcinoma; Uterine Myoma; Endometriosis

Summary: the database and biobank establishment started in 1997 in our institute. however, the sample size was too small with respect to our clinical and fundamental scientific research's requirement. thus the chinese gynecological oncology study (gos) group was established to create a large multicentre database and biobank of patients with gynecologic diseases.

the database contains clinical and epidemiologic information about patients with gynecologic neoplasms, such as cervical carcinoma, ovarian carcinoma, etc. with the data gathered from this database, the investigators could further demonstrate the etiology, risk factor, clinical treatment, and other aspects of the complicated gynecologic diseases. the cervical cancer database v1.10 including more than 10,000 cases and more than 200 variables has been established. the biobank collects blood, fluids, tissue samples, and related clinical data from consenting patients with gynecologic neoplasms, such as cervical cancer, ovarian cancer, endometrial cancer, choriocarcinoma, uterine myoma, endometriosis. besides, blood samples of population-based healthy people with informed consent are also collected.

Eligibility criteria:
inclusion criteria: * patients with informed consent; * patients with gynecologic diseases; * patients with intact clinical and pathological information exclusion criteria: * not included in the inclusion criteria

Keywords: gynecologic disease
high dose chemotherapy followed by pbsc rescue for hd

Conditions: Hodgkin Disease

Summary: to evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation in the treatment of hodgkin's disease.

use of high dose chemotherapy followed by peripheral blood stem cell rescue for relapsed or resistant hodgkin's disease

Eligibility criteria:
inclusion criteria:- adequate organ function * recurrent hd exclusion criteria:- cns disease * no prior malignancy
acute kidney injury as a risk factor for myocardial injury and ventricular dysfunction

Conditions: Acute Kidney Injury; Ventricular Dysfunction; Myocardium; Injury

Summary: acute kidney injury (aki) is classically described as an abrupt or rapidly reversible reduction in the excretion of nitrogenous waste products, including urea, nitrogen and creatinine. acute kidney injury definition emphasizes on the filtration function of the kidney, a measure that is unique and easily and routinely measured . acute kidney injury is associated with significantly increased resource utilization and health care costs. major adverse cardiac events (mace) after non cardiac surgery are a leading cause of morbidity and mortality. the reported incidence of postoperative myocardial infarction (pomi) among patients undergoing non cardiac surgery is between 3% and 6%.


Eligibility criteria:
inclusion criteria: * patients with normal kidney functions and free normal heart functions, were enrolled to this study exclusion criteria: * patients with chronic kidney disease, cardiac disease, who with minor operations, or emergency, were excluded from the study.
glucovip - diabetes treatment by glucobay® with a special therapeutic view to chosen patient groups

Conditions: Diabetes Mellitus

Summary: evaluation of safety and effectiveness of glucobay® under daily-life treatment conditions in a large sample of patients.


Eligibility criteria:
inclusion criteria: * patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. the decision for treatment type and duration is taken by the investigator and is made before inclusion into the study. exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: diabetes mellitus
using open contest and neuro-influence experiment to develop and evaluate prep promotion messages for high risk men

Conditions: HIV/AIDS

Summary: the aim of this study is to examine the utility of neuroimaging technique to evaluate pre-exposure prophylaxis (prep) promotion messages for men who have sex with men (msm) at risk of hiv in baltimore.

this study will examine the utility of neuroimaging technique to evaluate prep promotion messages for msm at risk of hiv in baltimore. the investigators hypothesize that participants viewing top messages developed via open contests will show higher brain activation in the medial prefrontal cortex (mpfc) regions than those viewing messages developed by a social marketing approach. the investigators further hypothesize brain activation in the mpfc regions is significantly more correlated with prep behavioral intention, initiation, and action than self-reported message effectiveness.

Eligibility criteria:
inclusion criteria: * 18 years and older * biological male sex at birth * sexually active with men in the past 6 months * never taken prep * hiv negative * reside in baltimore city or surrounding counties * meet one of the criteria for being an appropriate prep candidate (i.e. in a relationship with a partner not known to be hiv-negative; are in a nonmonogamous relationship; have had any condomless anal sex with a casual male partner regardless of status in the prior 6 months; or had a positive sexual transmitted infection (sti) diagnosis within the prior 6 months). exclusion criteria: - participated in open contest

Keywords: pre-exposure prophylaxis health promotion hiv/aids primary prevention men who have sex with men neuroimaging
vagal tone and neonatal abstinence syndrome

Conditions: Neonatal Abstinence Syndrome; Vagal Tone

Summary: symptoms of neonatal abstinence syndrome (nas) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. vagal tone is a readily available measure of autonomic nervous system functioning. nas is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of nas, only approximately ½ have severe enough symptoms to require pharmacologic therapy. this research seeks to determine the relationship between infant vagal tone and nas severity. the determination of a link between newborn vagal tone and nas severity could result in the prediction of infants at risk for severe nas and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of nas in the infant.

consecutively born methadone exposed infants had hert period and cardiac vagal tone measurements extracted via standard ekgs on days 1 and 3 of life. the infant's nas course was assessed serially.

Eligibility criteria:
inclusion criteria: * term infant (\>= 37 weeks by 1st or second trimester sonogram), * in utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth * delivery to a client active in drug abuse treatment exclusion criteria: * significant medical complications in the infant * circumcision within 24 hours of the proposed ekg/vagal tone measurement (circumcision has been found to affect vagal tone) * infant hospitalization in the neonatal intensive care unit (nicu) * psychiatric impairment of the mother such that informed consent is not possible

Keywords: neonatal abstinence syndrome methadone vagal tone
augmented reality assisted lung nodule localization: a multicentered, prospective, randomly controlled, non-inferiority trial

Conditions: Lung Cancer

Summary: with the popularization of ct screening, the detection rate of small lung nodules has greatly increased. therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. accurate resection of lung nodule depends on precise localization of pulmonary nodules. however, preoperative ct-guided hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. augmented reality (ar) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. it can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. this project intends to use ar technology to localize the solitary pulmonary nodule (spn) before surgery, compared with ct-guided hook-wire localization. compared with the localization of spns under ct guidance, ar-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years inclusive; 2. no distant metastasis in preoperative clinical assessment; 3. the attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection; 4. target lung nodule diameter is no more than 2 cm; 5. the inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein; 6. non-pleural surface nodules; 7. preoperative ecog performance status score of 0/1; 8. voluntarily participating in this study and signing an informed consent form. exclusion criteria: 1. more than two lung nodules need to be removed at the same time. 2. the target node is located in the scapular region. because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients. 3. patients with chronic pain issues or those who have been taking pain medications for an extended period. 4. patients have uncontrollable mental illness and cannot make subjective assessment.

Keywords: augmented reality localization sublobectomy