Kornimate/medical-research-clean huggingface dataset:
defibrotide in the human endotoxemia model --- an exploratory trial investigating the effects and the mechanisms of defibrotide

Conditions: Healthy Volunteers; Endotoxemia

Summary: defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of veno-occlusive disease. although it has been in clinical use for almost 30 years, the exact mechanism of action has never been fully elucidated. thus, the effects of defibrotide will be investigated in the human endotoxemia model in order to gather further information on its actions.

defibrotide (df) is a highly complex polydisperse mixture of single-stranded phosphodiester oligodeoxyribonucleotides derived from the controlled depolymerization of porcine intestinal mucosal dna. the entire mode of action remains unknown. its actions may be summarized to pro-fibrinolytic, anti-inflammatory and anti-coagulatory actions. to better define the mechanisms of defibrotide the effects of the substance will be investigated in the well-established endotoxemia model. sixteen healthy volunteers will be randomized to receive lps±defibrotide/placebo and four subjects will be randomized to receive placebo± defibrotide/placebo in a single center, randomized, double blind, placebo controlled, two-way crossover trial. immediately after a 2h infusion of 6,25mg/kg bodyweight defibrotide or placebo a lps bolus of 2ng/kg bodyweight will be infused. analyses will be performed by blood sampling at pre-defined time-points.

Eligibility criteria:
inclusion criteria: * \>18 years of age * \<90kg body weight * normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant * ability to understand the purpose and nature of the study, as well as the associated risks exclusion criteria: * intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. platelet inhibitors, anticoagulants, etc.) * positive results of hiv or hepatitis virology * acute illness with systemic inflammatory reactions * known allergies, hypersensitivities or intolerances to any of the used substances * acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator * participation in an lps trial within 6 weeks of the first study day * pregnancy or breastfeeding

Keywords: coagulation inflammation defibrotide fibrinolysis
a study to assess the efficacy and safety of salix probiotic blend in participants with functional gastrointestinal disturbances

Conditions: Functional Gastrointestinal Disorders

Summary: the primary objective of this study is to assess the safety and efficacy of salix probiotic blend, administered orally for 30 days, in participants with functional gastrointestinal (gi) disturbances.


Eligibility criteria:
inclusion criteria: * participants who have symptoms of gi disturbances. * participant has recurrent abdominal pain, discomfort, bloating, and/or abdominal distention associated with a change in the frequency of stool and/or a change in the form (appearance) of stool. * participant is able to understand the nature and purpose of the study and provide informed consent. * sexually active males and sexually active females of child-bearing potential, defined as neither surgically sterile nor post-menopausal (that is, females age \>45 years and no menstrual periods for at least 1 year), must agree to use a highly effective method of contraception from screening to 30 days post last dose of study product. acceptable forms of contraception include the following: * abstinence * oral, injected, or implanted hormonal methods of contraception * intrauterine device or intrauterine contraceptive system * condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository * female whose last sexual intercourse with males was ≥6 months post-vasectomy exclusion criteria: * participant has active or a history of inflammatory bowel disease. * participant has other significant systemic diseases such as active cancer therapy, active/ongoing infection, uncontrolled diabetes, chronic renal failure, cirrhosis, congestive heart failure, and severe chronic obstructive pulmonary disease (copd). * participant has used antipsychotic medications within 3 months prior to screening. * participant has used systemic steroids within the month prior to screening. * participant has suffered from a major psychiatric disorder within the past 2 years. * participant is pregnant or breastfeeding. * participant has a known lactose intolerance. * participant is immunocompromised or has an immunodeficiency syndrome of any kind. * participant has undergone any abdominal surgery, except for hernia repair or appendectomy. * participant has had active treatment with prescription medication for irritable bowel syndrome (ibs) within 6 weeks prior to screening. * participant has been diagnosed with infectious gastroenteritis within 1 month prior to screening. * participant has undergone treatment with probiotics within 6 weeks prior to screening. * participant is on active treatment with antibiotics. * participant has a known fructose intolerance. * participant is currently on a low fermentable oligo-, di-, mono-saccharides and polyols (fodmap) diet. * participant has a known diagnosis of gastroparesis.

Keywords: gastrointestinal disorders, functional
safety of daily dose esomeprazole for gerd for pediatric and adolescent patients

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: this study is a phase iii, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed gerd. the treatment period will be up to 8 weeks.


Eligibility criteria:
inclusion criteria: * provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures. * patients must be male or female between the age of 12 and 17 years, inclusive. * patients must have a clinical diagnosis of gerd made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing. exclusion criteria: * patients who have used a ppi within 14 days prior to randomization, including over-the-counter prilosec®. * patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (gerd), such as histamine 2 receptor antagonists (h2ra) or prokinetics, within 3 days prior to randomization. antacids may be used, except for those containing bismuth. * patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
a phase 1 study of is-002 injection in patients undergoing robotic prostatectomy

Conditions: Prostate Cancer

Summary: this is a phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of is-002 intravenous (iv) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da vinci® x/xi surgical system with firefly® fluorescent imaging.


Eligibility criteria:
inclusion criteria: * subject is between the ages of 18 and 75. * subject has a confirmed adenocarcinoma by histology of the prostate. * subject has capra \> 6, or t3 a or b disease on imaging (trus and/or mri), or regional lymphadenopathy suspicious for nodal metastases * subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (eplnd) using an da vinci® x/xi surgical system with firefly® fluorescent imaging. * subject is willing and able to provide informed consent * subject is considered capable of complying with study procedures and of understanding a written informed consent document. * subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding finasteride, dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques) exclusion criteria: * subject has known active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months * subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile * subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy * subject has a known history of acute or chronic liver or kidney disease
the physical and psychologic effects of aromatherapy in cancer patients during chemotherapy

Conditions: Pain; Heart Rate Variability; Anxiety

Summary: background: stress is the critical method for survive of reacting to a condition including a threat, challenge or physical and psychological challenge. stress either physiological or biological is an organism's response to a stressor such as an environmental condition. stimuli that alter an organism's environment are responded to by multiple systems in the body. the hypothalamic-pituitary-adrenal (hpa) axis and autonomic nervous system are major systems which the body reacts to the stress. it has been reported that cancer patients receiving chemotherapy perceived a lot of stress. it has been believed and well known that stress-related illness is one of the reasons contributing to the increase in long-term sick leave during the last decade in many countries. purpose: the aims of this study are to evaluate the effects of aromatherapy on cancer patient receiving chemotherapy: 1) for physical effects by meridian electrical conductance, heart rate variability (hrv), vital sign, visual analogue scale (vas) for pain; 2) for psychologic effects by state-trait anxiety inventory (stai). materials and methods: this is a prospective, pre post comparison study. a total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. the characteristics data will be collected in all participants. blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. essential oils will be applied to all participants by inhalation for 30 minutes. meridian electrical conductance, hrv, vital sign, vas for pain, and stai were evaluated and compared before and after aromatherapy. expected outcomes: it is expected to understand more about the effects of aromatherapy on the meridian system, hrv and emotional status by undertaking 30 minutes session aromatherapy intervention for cancer patients receiving chemotherapy. the results may suggest aromatherapy as one of the affiliated programs of chemotherapy.


Eligibility criteria:
inclusion criteria: * cancer patients in chemotherapy * subjects who are aged from 20 to 70 years-old exclusion criteria: * subjects who are unable to read and sign the consent form * diagnosed with a major illness (such as acute myocardial infarction, stroke, paralysis, and major organ transplantation) * being pregnant
cesarean scar defect formation after first cesarean section.

Conditions: Cesarean Section Complications; Cesarean Wound Disruption; Cesarean Wound; Dehiscence

Summary: this study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.

cesarean scar defects, which may develop after cesarean deliveries, are associated with menstrual bleeding problems, infertility, and poor obstetric outcomes. no matter how excellent and standard surgical technique is applied, scar defects may develop after cesarean section. however, when cesarean operation decision is taken, the existing operational conditions can affect the formation of cesarean scar defect in the future. although the surgical technique is the same, a planned cesarean operation and an emergency cesarean section may differ for a future cesarean scar defect that may develop in the future.

Eligibility criteria:
inclusion criteria: * 18-45-year-old patients * patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week. exclusion criteria: * spontaneous vaginal birth * preterm birth * pregnant women with an obstetrical or gynecological complication.

Keywords: cesarean scar pregnancy isthmocele uterine niche cesarean scar defect
internal monitoring of eye movement in schizophrenia

Conditions: Schizophrenia

Summary: background: * researchers are studying how humans are able to move our eyes to a remembered region even when the target has disappeared. the ability to do this suggests that the brain can keep track of where the eyes have looked, without an external target for continued reference. this is called corollary discharge. * other research has indicated that patients with schizophrenia might have difficulty monitoring their eye movements. the corollary discharge process may be defective in patients with schizophrenia, and perhaps delayed in time. researchers have developed a test to examine this possibility in the hope of learning more about schizophrenia and eye movement. objectives: - to assess whether there is a defect in internal monitoring of eye movements in patients with schizophrenia. eligibility: * individuals over 18 years of age who are able to give informed consent and are able to concentrate on a 20-minute task that involves following projected targets and moving their eyes to remembered locations. * individuals with schizophrenia will be recruited from an ongoing nih protocol studying schizophrenia. * in addition healthy will be recruited for this protocol. design: * researchers will check participants' vision in each eye, and ask them to sit at a machine that measures eye movement in order to complete research tasks. researchers will monitor participants ability to complete these tasks. * the first task involves simply following a target that jumps to different parts of the screen. * the second is a 2-step task, in which a participant is asked to look at two separate light targets and then look at the remembered target positions when the lights are off. * this protocol does not provide treatment. participants will remain under the care of their own physicians during participation in this protocol.

objective: to study if there is a defect in internal monitoring of eye movements in patients with schizophrenia. study population: patients with schizophrenia and normal controls. design: patients and controls will be asked to follow targets to remembered locations and their eye movements will be monitored. outcome measures: eye movements will be examined for evidence of internal monitoring (corollary discharge) defects which would result in mislocalizing remembered targets.

Eligibility criteria:
* inclusion criteria: 1. adult subjects over 18 years of age who are able to give informed consent and are able to concentrate on a task for 20 minutes which involves following projected targets and moving their eyes to remembered locations. exclusion criteria:\ 1. large refractive error requiring strong glasses. glasses may interfere with the video eye movement recording system. however, participants may wear contact lenses. subjects with a history of eye disease affecting vision or eye movements will also be excluded. 2. participants with guardians will be excluded.

Keywords: saccadic eye movements schizophrenia healthy volunteer hv
circadian thermal sensing to detect breast disease

Conditions: Early-Stage Breast Carcinoma

Summary: the purpose of this study is to determine if cyrcadia's circadian biometric recorder (cbr™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.

the cyrcadia cbr™ (circadian biometric recorder) includes wearable biometric patches and a detachable data recording device. the cbr™ records chronobiologic data while the patient is totally ambulatory and going about her normal daily routine. following removal of the detachable data recording device from the wearable biometric patches, the data is transferred to a computer for analysis. the cyrcadia cbr™ will be placed on the patient for the duration of 2 to 24 hours. there is no restriction of daily activity. the study subject is requested to sponge bathe rather than shower while wearing the device, keeping the device dry during the testing procedure. after this period, the cbr™ will be removed and the data will be transferred to a computer for analysis. the primary endpoint of this 173 patient study is to determine the accuracy of cyrcadia cbr™ as a supplemental screening device to mammography and ultrasound in predicting a diagnosis of breast cancer. specific emphasis will be on the utilization of the cbr as a secondary screening device to reduce the number of biopsies currently performed on non-cancerous tissue. a secondary emphasis will be on the cbr to act as an improved screening solution over mammography specifically in those patients with dense breast parenchymal tissue. other endpoints of the study are: * to determine the accuracy of cyrcadia cbr™, including the positive predictive value, negative predictive value, false negative rate and false positive rate. * to determine the optimal wear time for the cyrcadia cbr™. * to demonstrate substantial equivalent or improved results when applied to cyrcadia original patient case study with identical advanced neural network analysis computational results. study subjects will be followed at 6, 12, 18, and 24 months to update their clinical status.

Eligibility criteria:
inclusion criteria: * women with a bi-rads category 4 or 5 designation on mammogram * women with a bi-rads category 4 or 5 designation on breast ultrasound * women with a bi-rads category 4 or 5 designation on breast mri * women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician exclusion criteria: * less than 21 years of age * unable to sign the consent form * pregnant or lactating * physically unable to wear the cyrcadia cbr™ for 6 hours * previous mastectomy * any breast surgery or biopsy within the last 90 days * any trauma to the breast within the last 90 days * any biopsy or treatment for the bi-rads category 4 or 5 abnormality * refusal to undergo recommended diagnostic evaluation of the bi-rads category 4 or 5 abnormality
cycloplegic refraction among children

Conditions: Cycloplegia

Summary: the primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations. this will be a prospective double-blinded randomized clinical trial (rct), multi center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.

refractive errors assessment especially in pediatric populations is usually affected by the accommodative spasm and possibly a myopic shift in the results. spasm of accommodation become evident as pesudomyopia or latent hyperopia. therefore, cycloplegic refraction using cycloplegic drugs is an effective way to reduce fluctuation in accommodation or spasm of ciliary muscle. the drug of choice should have a rapid onset, appropriate cyclopegic effect and minimum side effects. cyclopentolate and tropicamide are well known drugs used for accommodation relaxation. cyclopentolate is widely accepted drug of first choice for patients of all ages. its cycloplegic effects begins at 25-75 min after administration of the drop and recovery appears through 6-24 h later.6 ocular side effects may include irritation, lacrimation, allergic blepharoconjunctivitis, conjunctival hyperemia, and increase in intraocular pressure. some of its systemic side effects are drowsiness, ataxia, disorientation, incoherent speech, restlessness, and visual hallucinations. tropicamide, as an alternative, is a synthetic analog of tropic acid and is known as a safe agent for cycloplegic refraction. it characterized by a rapid onset and the cycloplegia effect appears 20-30 min after administration. its recovery appears 6 h later with safer profile compared to cyclopentolate. several studies have been conducted to compare the cycloplegic effect of these two agents and different results have been reported. because of inconsistencies in the previous reported results, this randomized clinical trial was conducted to compare the cycloplegic effect between cyclopentolate and tropicamide among pediatric populations (aged between 3 and 16).

Eligibility criteria:
inclusion criteria: * age: 3-16 years * brown irides; grade 4 and 5 using iris color classification system developed by seddon et al (16) * duration: 2 different visits ≥ 1 weeks apart within 3 months exclusion criteria: * abnormal red reflex (e.g., media opacity) * history of heart or neurological diseases * history of developmental delay * history of a previous allergy to cycloplegic agents * presence of syndromes (e.g., down's syndrome) * history of intraocular surgery

Keywords: vision cycloplegia cycloplegic refraction cyclopentolate cyclogyl tropicamide mydriacil refractive errors latent hyperopia
brief influenza vaccine education to pregnant women

Conditions: Influenza; Infectious Disease; Pregnancy

Summary: the investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * 18 years of age or older * in at least the second trimester of pregnancy * cantonese speaking * hong kong resident * no serious medical or obstetrical complications * have not yet received the influenza vaccine in this pregnancy * staying in hong kong for at least two weeks after delivery. exclusion criteria: * not entitled to health benefits in hong kong (nep)

Keywords: influenza influenza vaccines infectious disease pregnancy