Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy and safety of xalost s in glaucoma patients.

Conditions: Glaucoma

Summary: in patients with glaucoma, xalost s or xalatan or taflotan-s are administered for 12 weeks. after 12 weeks, among them, xalatan administration group are switched to xalost s or taflotan-s. extension study period is 8 weeks. to compare effect (ocular surface damage) and safety of preservative-free latanoprost/tafluprost to benzalkonium chloride-preserved latanoprost in primary open angle glaucoma or normal tension glaucoma.


Eligibility criteria:
inclusion criteria: * male or female diagnosed with glaucoma, age 19 or over * written informed consent to participate in the trial exclusion criteria: * patients who have received or have plans lacrimal puntual occulsion * use of contact lenses * any other glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) closed anterior chamber angle/ angle-closure glaucoma) * any condition limiting patient's ability to participate in the trial
study of rivaroxaban use and potential adverse outcomes in routine clinical practice (germany)

Conditions: Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Acute Coronary Syndrome

Summary: this prospective cohort study will provide information about: characteristics of rivaroxaban use in patients who are prescribed rivaroxaban for the first time compared to patients who are prescribed phenprocoumon for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility criteria:
inclusion criteria: * all male and female patients who have been prescribed for the first time either rivaroxaban or standard of care from the date of market authorization of rivaroxaban to dec 31, 2017 exclusion criteria: * patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day

Keywords: rivaroxaban stroke prevention in atrial fibrillation anticoagulants hematologic agents therapeutic uses observational venous thromboembolism secondary prevention of acute coronary syndrome intracranial hemorrhages gastrointestinal hemorrhage
effect of dehydroepiandrosterone administration in patients with poor ovarian response according to the bologna criteria

Conditions: Infertility

Summary: women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during ivf treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. the ideal stimulation regimen for poor responders is currently unknown. dehydroepiandrosterone (dhea) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all ivf centers world-wide. however, the current clinical evidence for dhea on improvement of ovarian response and ivf outcome is insufficient. the validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. recently a uniform definition on poor ovarian response, the bologna criteria, has been proposed by the european society for human reproduction and embryology(eshre). however, no studies have been performed study to evaluate the potential effects of dhea supplementation according to these standards. the purpose of this study is to assess the impact of dhea supplementation on ivf outcome of poor ovarian responders that fulfill the bologna criteria.


Eligibility criteria:
inclusion criteria: patients with poor ovarian response according to the bologna criteria exclusion criteria: women aged \> 45 years or baseline follicle stimulating hormone(fsh)levels \>40 iu/l.
medicine acuity patching combined massage in the treatment of patients with acute poisoning

Conditions: Poisoning Patients

Summary: this topic in western medicine combined on the basis of gastric lavage therapy in patients with acute poisoning acupoint sticking of traditional chinese medicine and acupuncture point massage treatment, aims to smoothly accelerate cleaning and discharge poison, increase the poisoning patients rescue success rate, improve patient quality of life, for the clinical treatment of acute poisoning provides a new method of tcm nursing, to further exert tcm nursing characteristics.

with the rapid development of national economy, people's exposure to a variety of chemicals, drugs and other opportunities to increase, the types of substances causing poisoning tend to be diversified, acute poisoning frequently occur. data showed that in some regions of china, poisoning cases accounted for 2.7%\~ 3.6% of the patients admitted to the emergency department in the same period , and 8.3 % of the patients rescued in the emergency department in the same period , and its fatality rate was higher than the total fatality rate in the emergency department . the incidence of poisoning was 18/100,000 in urban residents and 69.22/100,000 in rural areas, accounting for 10.7% of all deaths. poisoning incident is an important part of national public health emergency management. according to the statistics of china's ministry of health in 2013, poisoning has entered the top five major causes of death in china, and the number of acute poisoning cases has been increasing year by year . the diagnosis and treatment of acute poisoning and the effective and rapid treatment have become an important task for emergency clinical workers.

Eligibility criteria:
inclusion criteria: 1. patients with oral acute poisoning who were first diagnosed in our hospital and completed gastric lavage; 2. the skin of umbilical cord and bilateral zusanli acupoints had no injury, scar, rash and other skin diseases. 3. the patient or the patient's family member signed the informed consent and expressed their willingness to receive treatment. exclusion criteria: 1. patients with severe conditions requiring cardiopulmonary resuscitation or with severe trauma or multiple injuries; 2. patients with heart, brain, liver, kidney and hematopoietic system diseases and other serious primary diseases; 3. patients with a history of gastrointestinal diseases (such as postoperative cancer, intestinal obstruction, and large intestinal polyps) that affect gastrointestinal emptying; 4. failing to receive treatment according to regulations or taking poison again during hospitalization and unable to judge the curative effect.

Keywords: acute oral intoxication acupoint application point massage
school-based support for pre-school aged children with developmental disabilities and delays

Conditions: Developmental Delay

Summary: this proposal aims to test whether a proposed community-clinical linkage (ccl), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. the investigators designed an educational-clinical linkage model, preschool and me (prem) which incorporates key components of a ccl. it also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based services.

participants (n=320) will be randomized to either: 1) 6 months of prem (intervention group) or 2) a waitlist control arm receiving the intervention after a 6-month delay. all participants will be followed for 12 months with data collection occurring at 4 timepoints (baseline, 3-, 6- and 12-months). there will also be a simultaneously conducted mixed-methods implementation evaluation focusing on implementation outcomes to serve as indicators for implementation success; measures of implementation quality; and intermediate outcomes to understand and address successes and failures in relation to clinical outcomes.

Eligibility criteria:
parent-child dyads who meet inclusion criteria will be enrolled. child inclusion criteria are: 1. meets age requirements for early childhood special education (ecse) services for illinois (i.e., 3-5 years old); 2. diagnosed with a developmental delay or disability (dd) or determined to be at risk for dd (clinical concerns raised by primary care provider/healthcare provider or by parents at the time of enrollment); 3. is not receiving any ecse services. exclusion criteria: if inclusion criteria is met, no other exclusion criteria will be applied. parent inclusion criteria are: 1. aged18 years or older; 2. lives in chicago; 3. speaks english or spanish; 4. a legal guardian of a child who meets inclusion criteria.

Keywords: primary care implementation linkage
a study of qlm2011 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this trial is an open-label, single-center, dose-escalation and cohort-expansion phase i clinical study in patients with advanced solid tumors. the purposeaim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of qlm2011 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * age ≥18, ≤80 years, no gender limitation； * histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable for the patient； * at least one measurable lesion as per recist version 1.1； * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1； * life expectancy ≥3 months； * all subjects of reproductive potential must agree to use an effective method of contraception during the study and for 3 months after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose. exclusion criteria: * chemotherapy, radiotherapy, targeted therapy， endocrine therapy, immunotherapy and other anti-tumor treatment within 28 days of the first dose of the study drug, 6 weeks for nitrosoureas or mitomycin c, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional chinese medicine with anti-tumor indications. * uncontrolled or clinically symptomatic serous cavity effusions (e.g., pericardial effusion, pleural effusion, ascites, etc.) requiring repeated puncture drainage or medical intervention. * toxicity from prior antitumor therapy has not recovered to ≤ grade 1 per the common terminology criteria for adverse events (ctcae v5.0) (exceptions include alopecia, peripheral neuropathy, isolated laboratory abnormalities, or other toxicities deemed by the investigator to pose no safety risk). * have a history of other malignant tumors within 3 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma or squamous cell carcinoma of the skin that has received radical treatment;
study of biological markers in children with sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease is associated with significant morbi-mortality hence the interest in an early and targeted care. at present, there is no plasmatic marker able to identify infants at higher risk of developping severe complications later in life. however, recent studies have demonstrated a correlation between certain complications of the disease and biomarkers of the endothelial dysfunction characterizing it. investigators prospectively followed a cohort of children diagnosed with scd through the universal neonatal screening using inflammatory and haemostatic plasmatic markers to study their annual evolution. investigators then will evaluate potential associations between these biological markers and the occurrence of scd related complications. a secondary objective of this study is to evaluate the repercussions of therapeutic intervention on these markers. .


Eligibility criteria:
inclusion criteria: * patient aged less than 6 months * sickle cell syndrome ss, sβthal or sc confirmed by hemoglobin electrophoresis * subjects legal representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to let participate their child in the study exclusion criteria: * congenital abnormality other than sickle cell disease except for a glucose-6-phosphate-deshydrogenase * prematurity * initiation of the following therapies before enrollment: chronic transfusion regimen or bone marrow transplantation

Keywords: sickle cell disease, children, thrombin generation, inflammation, cytokines, adhesion molecules, plasmatic markers, coagulation
a study to evaluate the safety and effectiveness of asoprisnil in the treatment of uterine fibroids

Conditions: Leiomyoma

Summary: this study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

no medical therapy is currently available for the long-term treatment of uterine fibroids. the objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Eligibility criteria:
inclusion criteria: * women between 18 and 49 years of age * diagnosis of either 1 or more uterine fibroids * history of regular menstrual cycles of 21 to 35 days in length. exclusion criteria: * any abnormal lab result the study-doctor considers significant * history of severe reaction to or current use of hormone therapy * history of osteoporosis or other bone disease * history of uterine artery embolization, cryomyolysis, or electrical myolysis * subject currently breast feeding * hemoglobin \< 8 g/dl at baseline

Keywords: fibroid uterus leiomyoma uterine fibroids asoprisnil
the use of magnesium to improve blood pressure, cholesterol, and glucose control

Conditions: Coronary Artery Disease; Hypertension; Dyslipidemia; Diabetes

Summary: the purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (icds).

magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. it has been determined that patients with cardiovascular disease have intracellular magnesium (mgi) deficiencies. among the icd registries in europe and the united states 64% and 77% of patients also carry the diagnosis of cad, respectively. patients with cad have risk factors that lead to the development and or propagation of atherosclerosis. paramount among these risk factors are hypertension, dyslipidemia, and diabetes. comparison: magnesium compared to placebo in patients with icds to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.

Eligibility criteria:
inclusion criteria: * newly implanted icd or recent icd shock (within 6 months) exclusion criteria: * inability to swallow * a non-cardiac disease with a survival prognosis of less than 12 months * hypermagnesemia * creatinine clearance less than 30ml/min * lactic acidosis or systemic acidosis syndrome * previous intolerance to magnesium l-lactate

Keywords: hemodynamics hypertension dyslipidemia diabetes implantable cardioverter defibrillator blood pressure
safety and efficacy study of renewal 4 avt

Conditions: Heart Failure; Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Fibrillation

Summary: the purpose of this study is to assess the safety and effectiveness of the contak renewal 4 avt device.

this is a prospective, two-arm, non-randomized, multi-center european field following, designed to demonstrate the safety and effectiveness of the contak renewal 4 avt device in humans.

Eligibility criteria:
inclusion criteria: * indications for the device * availability for follow-up at an approved field following center, at the protocol defined intervals * willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation * prescribed to stable optimal pharmacologic therapy for hf * age 18 or above, or of legal age to give informed consent specific to national law * able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion. exclusion criteria: * right bundle branch block morphology * life expectancy of less than six months due to other medical conditions * expectation of a heart transplant during the period of the study * patients with or who are likely to receive a mechanical tricuspid valve during the course of the study * have a preexisting unipolar pacemaker that will not be explanted/abandoned * have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment * have a known hypersensitivity to dexamethasone acetate * enrolled in any other study, including drug investigation * women that are pregnant or planning to become pregnant * a cerebral vascular event/ transient ischemic attack within 12 months of implantation * during the four weeks prior to implantation, a patient experiences an episode of af \>= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (inr \>= 2.0) for the 4 weeks prior to enrollment

Keywords: heart failure tachycardia atrial fibrillation atrial flutter ventricular fibrillation
pharmacokinetics and adhesion of lidocaine topical system 1.8% under conditions of heat and exercise

Conditions: Healthy

Summary: the objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ztlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.

in this open-label, three-period crossover study, 12 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. during each treatment period, subjects have three lidocaine topical systems applied to their back for 12 hours with 7-day washout between treatments. in each treatment period, the subject will either exercise (treatment a), apply a heating pad (treatment b), or refrain from these activities (treatment c) while wearing the topical system. blood samples for lidocaine pk will be collected pre-dose until 48 hours. adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.

Eligibility criteria:
key inclusion criteria: * must be healthy based on by medical history, laboratory work, and physical exam * be at least 18 years of age * if childbearing potential, use of acceptable form of birth control * in the case of females of childbearing potential, have a negative serum pregnancy test key exclusion criteria: * allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation * any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin * subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin) * history of addiction, abuse, and misuse of any drug * use of nicotine-containing products within 30 days
trial comparing bst-cargel and microfracture in repair of articular cartilage lesions in the knee

Conditions: Knee Injuries

Summary: this study will investigate whether the treatment of damaged cartilage in the knee with bst-cargel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone. furthermore, the effect of bst-cargel in decreasing cartilage related pain and improving cartilage-related function in the knee will be assessed.

cartilage repair currently remains a problematic orthopedic concern with no effective solution. the development of new surgical techniques or therapies is critical in meeting this medical need. this canadian trial will be a pivotal protocol study, conducted as a randomized, controlled trial. a total of 80 subjects, 40 subjects in each of the two groups (bst-cargel applied to a microfractured lesion or microfracture alone), will be enrolled in this study. the subjects and investigative medical staff will not be blinded to treatment due to the difference in surgical incision size. however, although the treatment will not be blinded, the primary effectiveness assessment will be blinded. the primary endpoint of this study will be cartilage repair at 12 months proved by demonstrating that bst-cargel treatment effectively fills cartilage lesions with high quality cartilaginous tissue. the secondary endpoints will be pain, stiffness and function while other tertiary endpoints will include safety, quality-of-life (qol), as well as macroscopic characterizations of tissue repair. the primary measure of this study will occur at 12 months, when imaging of repair tissue using magnetic resonance (mr) and associated analyses will compare tissue volume, quality and other anatomical variables. radiographic evaluations will be blinded. volunteer biopsies at 13 months may be obtained. pain, stiffness, function and qol will be assessed prior to treatment, and at 3, 6 and 12 months following treatment using self-administered validated scores (womac and sf-36). in addition, subject safety will be assessed through a record of adverse events.

Eligibility criteria:
inclusion criteria: * between 18 and 55 years of age * focal articular cartilage lesion on the medial femoral condyle * grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion * stable knee exclusion criteria: * multiple lesions or kissing lesions * clinically relevant compartment malalignment (\> 5 degrees) * undergone ligament treatments in the affected knee within 2 years prior to trial * inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout * previous surgical cartilage treatments in the affected knee in the last 12 months

Keywords: cartilage repair cartilage knee knee pain microfracture arthroscopy bone marrow stimulation chondrogenesis scaffold chitosan a02.165.165 a10.165.382.332 g07.574.500.325.377.625.180 a10.165.382.400 articular cartilage repair