Kornimate/medical-research-clean huggingface dataset:
s086 tablets in the treatment of mild to moderate essential hypertension

Conditions: Essential Hypertension

Summary: efficacy and safety of s086 tablets in the treatment of mild to moderate essential hypertension:a randomized,double-blind,placebo-controlled,multicenter phase ii clinical trial


Eligibility criteria:
inclusion criteria: * for mild to moderate essential hypertension * not receiving treatment or being treated with antihypertensive drugs (single drug or combination therapy of two drugs, including compound preparations containing 2 drug components) * not receiving treatment (newly diagnosed essential hypertension or a history of hypertension but not taking any antihypertensive drugs at least 4 weeks before screening), during the screening period (v1) and before randomization (v4), the mean sitting systolic blood pressure (mssbp) ≥ 150mmhg and \<180mmhg; * patients who are receiving antihypertensive drugs (treated with antihypertensive drugs within 4 weeks before screening), at the end of the wash period (v2), must meet the average sitting systolic blood pressure ≥140mmhg and \<180mmhg; before randomization (v4), the average sitting systolic blood pressure must be ≥150mmhg and \<180mmhg; * the patient's average sitting systolic blood pressure before randomization (v4) must be the difference between the previous average sitting systolic pressure (at the end of the washing period (v2)) ≤15mmhg; voluntarily participate in the trial and sign an informed consent form. exclusion criteria: * have a history of allergies to relevant components of the test drug, known or suspected to be allergic to s086, sacubatril, valsartan sodium or olmesartan medoxomil and related drugs (arb, acei, and renin inhibitors); * currently in pregnancy, breastfeeding female subjects whose pregnancy or pregnancy tests are positive; or those whose subjects or their partners cannot guarantee effective contraception during the trial period (acceptable methods of contraception: true abstinence; intrauterine contraceptive devices; barrier contraceptives; or partners accepted sterilization surgery. unacceptable contraceptive methods: periodic abstinence, such as contraception based on calendar, ovulation, symptomatic body temperature); * or those who have a childbirth plan within 6 months after the end of the trial; * have a history of drug abuse or alcohol abuse within 6 months before screening history: participated in any drug or medical device or other clinical trial within 3 months before screening, or participated in any drug or medical device or other clinical trial during the planned trial or within 3 months after the end of the trial.
study to determine and evaluate a safe and tolerated dose of hdm201 in patients with selected advanced tumors that are tp53wt

Conditions: Advanced Solid and Hematological TP53wt Tumors

Summary: to determine and evaluate a safe and tolerated dose of hdm201 in adult patients with selected advanced tumors characterized by wild-type tp53.


Eligibility criteria:
inclusion criteria: * patient with a tp53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by recist 1.1 criteria. * patients with the tp53wt hematological tumors (aml, all, hr-mds) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy. other protocol-defined inclusion criteria may apply exclusion criteria: * prior treatment with compounds with the same mode of action * subjects with significant or uncontrolled cardiovascular disease * history of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism * previous and concomitant therapy that precludes enrollment, as defined in the protocol * known human immunodeficiency virus (hiv) infection and/or active hepatitis b or hepatitis c infection * patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery * women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply

Keywords: hdm201,tp53wt, p53, mdm2, hdm2, advanced tumors, blrm (bayesian logistic regression model)
effectiveness of synagis (palivizumab) immunoprophylaxis in preterm infants with high risk of severe respiratory syncytial virus (rsv) infection

Conditions: Respiratory Syncytial Virus Infection

Summary: published data by the organización panamericana de la salud shows that peru's mortality rate from acute respiratory infections (ari) in infants less than one year of life is second only to haiti (14,150/100,000). government data reports shows a marked increase of rsv infections in peru. "instituto nacional de salud" (peru's national institute of health) reports between january 1st to february 26th 2006, 62% of their positive samples corresponded to rsv. epidemiological data from lima-peru, demonstrates that there is no specific season for rsv infection although some data suggest an increase in rsv activity during cold months (may to september; ins data). clinical studies show that giving five doses of synagis (palivizumab) resulted in serum concentrations \> 30 ug/ml for \>20 weeks. the aim of this post-marketing observational study is to determine the rsv hospitalization rate in high-risk infants who received synagis (palivizumab) through the social security hospitals in the context of routine clinical practice.


Eligibility criteria:
inclusion criteria: * receiving synagis (palivizumab) immunoprophylaxis during respiratory syncytial virus season, according to the usual clinical practice: * infants born \< or = 32 weeks of gestation and are younger than 6 months of age at the beginning of the respiratory syncytial virus season. * children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months, until the first year of life. * children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment). exclusion criteria: * major congenital malformation aside from congenital heart disease * chronic pulmonary disease other than bronchopulmonary dysplasia * active infections * contraindication to synagis * receipt of another immunoglobulin preparation including but not restricted to polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin (cytogam), or respiratory syncytial virus hyperimmunoglobulin (respigam). * any other condition that according deemed an obstacle for study conduction or representing an unacceptable risk by the participating investigator.

Keywords: synagis (palivizumab) immunoprophylaxis respiratory syncytial virus infection preterm infants
ivus guidance to reduce contrast in coronary angioplasty

Conditions: Contrast Media Reaction; Acute Renal Failure

Summary: this study tests the hypothesis that ultrasound-guided pci reduces contrast volume during the procedure.

contrast-induced acute kidney injury (ci-aki) is an important adverse effect of percutaneous coronary interventions. despite various efforts, very few preventive measures have been shown effective in reducing its incidence. the final volume of contrast media utilized during the procedure is a well-known independent factor affecting the occurrence of ci-aki. intravascular ultrasound (ivus) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (pci). when fully explored, ivus provides precise information for guiding the pci strategy. ivus allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). therefore, ivus has the potential to reduce the utilization of contrast media during pci. in the present study, we hypothesize that ivus guidance is associated with a significant reduction in the volume of contrast media during pci, in comparison to standard angiography-guided intervention.

Eligibility criteria:
inclusion criteria: * written informed consent * age \>=18 years * coronary artery disease scheduled for percutaneous intervention * technical feasibility for intravascular ultrasound to guide coronary angioplasty * increased risk for contrast-induced acute renal failure (e.g. age \> 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney) exclusion criteria: * anticipated technical impossibility for intravascular ultrasound * unknown baseline renal function * baseline end-stage renal failure needing dialysis * acute renal failure with dynamic change in renal function at the time of index procedure * iodine contrast administration \<= 72 prior to index procedure * known allergy to iodine contrast

Keywords: coronary angioplasty percutaneous coronary intervention stent contrast acute renal failure intravascular ultrasound prevention
effects of medical and surgical weight loss on metabolism

Conditions: Type 2 Diabetes; Obesity

Summary: this study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.


Eligibility criteria:
inclusion criteria: * morbidly obese subjects with type 2 diabetes or metabolic syndrome * age \<70 exclusion criteria: * contra-indications to bariatric surgery
implemental flutter mucus clearance devices on geriatric lung function

Conditions: Pulmonary Disease

Summary: the purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.

respiratory diseases are still increasing in the elderly population. the fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.

Eligibility criteria:
inclusion criteria: * available to perform the device, the elders in geracomium * male and female * aging 85 years or more exclusion criteria: * not available to perform the procedure * untreated pneumothorax * diffusion interstitial lung disease * acute coronary syndrome * third stage hypertension * advanced cancer * severe heart, liver, renal, blood system and endocrine system dysfunction * noninvasive mechanical ventilation * active hemoptysis

Keywords: geriatric pulmonary disease flutter sputum physical therapy techniques
multimorbidity management supported by a digital platform

Conditions: Chronic Disease

Summary: this study aims to assess whether the use of the methis digital platform using a patient-centered approach contributes to an improvement in the quality of life, mental health and physical activity of patients with multimorbidity followed up in primary health care. practices will be randomly allocated between: providing access to consultations through the methis platform (intervention) or following patients by the traditional method (control). they will complete questionnaires on quality of life, mental health and report the number of steps taken, at the beginning and end of the study.

a superiority, cluster randomised trial will be conducted at primary health care practices (1:1 allocation ratio). all public practices in the lisbon and tagus valley region, portugal, not involved in a previous pilot trial, will be eligible. the intervention combines a training programme and a customised information system (methis). both are designed to help clinicians to adopt a goal-oriented care model approach and to encourage patients and carers to play a more active role in autonomous healthcare.

Eligibility criteria:
inclusion criteria: * community-dwelling people * aged 50 or older * with complex multimorbidity (co-occurrence of three or more chronic conditions affecting three or more different body systems) * with access to an internet connection and a communication technology device exclusion criteria: * inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver

Keywords: primary health care information management research design telemedicine digital health patient-centered care goal-oriented care
once or twice daily administration of biib021 to subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of the study is to see if daily and twice daily administration of biib021 is tolerated in patients with advanced solid tumors.

heat shock protein 90 (hsp90) inhibitors are anticipated to have clinical activity in solid tumors because hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. the maximum tolerated dose (mtx) for biib021 administered twice weekly in a phase i study in subjects with advanced solid tumors have been defined at 600mg. it is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of hsp90.

Eligibility criteria:
inclusion criteria: subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available. age greater than or equal to 18 years at the time of informed consent. ecog performance status of less than or equal to 2. lab values consistent with adequate renal, hepatic, and bone marrow functions. exclusion criteria: prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels. subjects with known brain metastases. concurrent severe or uncontrolled medical disease. must utilize effective contraception.
desolve® x-pand global post market registry

Conditions: Coronary Artery Stenosis

Summary: the x-pand registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with desolve in patients with cad.

the xpand registry is a single-arm, multi-center, clinical follow up study of patients with significant coronary stenosis who are treated with a commercially available desolve scaffold. the registry is an observational study. the patients should be treated according to the current desolve ifu, professional societies guidelines \& internal hospital guidelines.

Eligibility criteria:
inclusion criteria: 1. minimal age 18 years 2. patient is willing/able to cooperate with study procedures and required follow up visits. patient or legal representative has been informed \& agrees by signing ec approved written consent. consent can occur before implantation of the desolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure). 3. planned or unplanned desolve scaffold implantation exclusion criteria: none

Keywords: bioresorbable scaffold cad
fetal alcohol spectrum disorder : clinical description and search for epigenetic biomarker (epi-tsaf)

Conditions: Fetal Alcohol Spectrum Disorders

Summary: the goal of this clinical trial is to carry out a clinical description of a reunionese series of patients (aged 0 to 18 inclusive) with fetal alcohol spectrum disorders followed up in the genetics department of the university hospital in reunion island the aim is also to identify a specific "epigenetic signature" for fetal alcohol spectrum disorder, in order to provide early diagnostic markers, determine the origin of the micrornas identified and study the phenotypic-epigenetic relationship (micrornas). this research is descriptive and monocentric. * retrospective on the clinical description of 182 fetal alcohol spectrum disorderpatients * prospective on the micrornas part, with 18 patients in the fetal alcohol spectrum disorder group and 18 in the control group (participants without fetal alcohol spectrum disorder). for the 18 patients in the fetal alcohol spectrum disorder group, the doctor will take a blood sample (for genetic testing) during a scheduled consultation. a remaining 4 ml of blood will be collected for research purposes (fetal alcohol spectrum disorder group only). a buccal smear will also be taken for research. for the 18 participants in the control group (healthy participants of the same age and sex as the fetal alcohol spectrum disorder group), only a buccal smear will be taken for research purposes during a consultation.


Eligibility criteria:
inclusion criteria: fetal alcohol spectrum disorder group : * born in reunion * aged between 0 and 18 years old * having been exposed to alcohol during the prenatal period * have a diagnosis of fetal alcohol spectrum disorder by a referring physician control group : * born in réunion * aged between 0 and 18 years old * be matched on the age and sex of the fetal alcohol spectrum disorder children sampled (n=18) * not having been exposed to alcohol during the prenatal period * not having been diagnosed with fasd * not have congenital malformations * not have neurodevelopmental disorders exclusion criteria: fetal alcohol spectrum disorder group : * patients with fetal alcohol spectrum disorder who also present another genetic syndrome. control group : - people who are not matched on the age and sex of the fetal alcohol spectrum disorder patients sampled

Keywords: fetal alcohol spectrum disorders epigenetic microrna
early diagnosis of pulmonary hypertension in patients with inflammatory rheumatic connective tissue diseases

Conditions: Connective Tissue Disease; Pulmonary Hypertension

Summary: the purposes of this study are (i), to evaluate various screening methods for their ability to predict and to confirm pulmonary hypertension (ph) in scleroderma patients, and (ii) to evaluate the incidence of ph (i.e. the number of new cases per year) in scleroderma patients.


Eligibility criteria:
inclusion criteria: * consent form * men and women\> 18 years * fulfill the current definition of a collagen vascular disease according to the actual guidelines of the american college of rheumatology (acr) exclusion criteria: * all contraindications for exercise testing * significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months * patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity * pregnancy
efficacy and safety of gonioscopy assisted transluminal trabeculotomy in patients with primary open-angle glaucoma and cataract.

Conditions: Open Angle Glaucoma (OAG)

Summary: prospective, randomized, , double-blind, clinical trial, comparing the variation of intraocular pressure (iop) of patients with mild or moderate primary open-angle glaucoma (oag) and cataract divided into three groups. all study participants should be treated for the pathology with one or more hypotensive medications or, regardless of the number of drugs, when iop is greater than 20 mmhg and less than 26 mmhg. the two-year follow-up should also compare the reduction in the number of medications used, reoperation rate, adverse effects, visual acuity, endothelial loss, induction of astigmatism, variation in iop according to axial diameter of the eye, anterior chamber and age, in addition to the existence of change in the quality of life of patients in the postoperative period


Eligibility criteria:
inclusion criteria: * patients aged 40 years or older, * previously included in the glaucoma departments of the participating institutions, * indication for cataract surgery, diagnosed by clinical examination with visual acuity (va) equal to or worse than 20/40, * primary open angle glaucoma (poag), determined by the presence of typical visual field (vf) defects and/or by the aspect of the optic nerve observed at fundoscopy or retinography (increased vertical optical excavation with thinning of the neural rhyme, asymmetry of the cup/disc ratio greater than 0.2, localized loss ("notch") or defect in the retinal nerve fiber layer ("hoyt")). * apic classification with amplitude greater/equal to 2 and pigmentation less than 4 on gonioscopy. * intraocular pressure (iop) less than or equal to 25 mmhg before washout of hypotensive eye drops. * iop between 22 and 30 mmhg after washout of hypotensive eye drops or with a history of iop greater than or equal to 21 mmhg in more than one previous care described in the medical record. exclusion criteria: patients who have any of the following situations: * severe glaucoma, determined according to the hoddap-parrish-anderson criteria; * axial diameter greater than 26 mm or less than 21.00 mm; * endothelial count less than 1500 cc; * pachymetry less than 480 or greater than 600 microns; * patients undergoing some type of intraocular surgery or laser procedure in the preoperative period and/or after these procedures in the postoperative period; * those who present some important per-operative complication during the study. * with high risk of progression, the so-called rapid progressors, who are patients with high iops even with the use of many medications, regardless of the severity of the nerve injury.

Keywords: open angle glaucoma cataract oag goniotomy assisted transluminal trabeculotomy gatt trabeculotomy goniotomy hemi-gatt
using icdas ii and kavo diagnodent pen detecting tooth pit and fissure level incipent caries progression

Conditions: Dental Caries on Pit and Fissure Surface

Summary: the study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in icdas, and to evaluat the correlation between icdas and diagnodent over 24 months. over 200 8-year-old children with at least 2 permanent molar with the international caries detection and assessment system (icdas) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with icdas and diagnodent before sealents placement and 6, 12 and 24 months after.


Eligibility criteria:
inclusion criteria: * subjects provided written informed consent; * they were 7 to 9 years old; * they have at least 2 permanent molar with the international caries detection and assessment system (icdas) scores 0-4; * they were generally heallthy exclusion criteria: * they were allergic to the constituents in pit and fissure sealants

Keywords: icdas diagnodent glass ionomer sealant resin-based sealant pit and fissure sealants effectiveness of preventing caries