Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of clevidipine butyrate injection in hypertensive emergencies

Conditions: Hypertensive Emergency

Summary: the purpose of this study was to determine the efficacy and safety of clevidipine for treating hypertensive emergencies（defined as systolic blood pressure \>180 mmhg and/or diastolic blood pressure \>120 mmhg, accompanied by acute organ damage）.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 75, regardless of gender. 2. blood pressure increased seriously in a short time, systolic blood pressure (sbp) \> 180 mmhg and (or) diastolic blood pressure (dbp) \> 120 mmhg (measured at an interval of 5 minutes, both blood pressure values should be \> 180 / 120 mmhg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed: * hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms; * acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms; * unstable angina pectoris: ischemic chest pain with st-t dynamic changes. patients with sbp ≥ 220mmhg and / or dbp ≥ 140mmhg should be considered as hypertensive emergency; 3. the legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form. exclusion criteria: 1. patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention; 2. patients with severe aortic stenosis or severe mitral stenosis; 3. patients with obstructive hypertrophic cardiomyopathy; 4. patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study; 5. patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products; 6. patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia; 7. combined with other serious organ injury or serious complications which may affect the life of the subjects; 8. patients with a history of mental illness; 9. patients with known history of alcohol / drug abuse; 10. those who have participated in other clinical trials and used test drugs 3 months before the trial; 11. pregnant and lactating women; 12. researchers do not consider it appropriate to participate in the clinical trial.
effect of kangaroo care on heart rate variability

Conditions: Immaturity; Oral Intolerance; Postnatal Adaptation

Summary: physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. the investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. the investigators will use heart rate variability to measure the maturation of autonomic nervous system.


Eligibility criteria:
inclusion criteria: * premature infants between 32 t0 35 weeks old * after 7 days of extra-uterine life exclusion criteria: * sepsis, infection * cardiac disease * intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis

Keywords: newborn prematures feeding difficulty kangaroo care heart rate variability
immediate implant outcomes with and without bone augmentation

Conditions: Tooth Loss; Bone Loss, Alveolar; Dental Diseases; Dental Trauma

Summary: to evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

the present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. a secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Eligibility criteria:
inclusion criteria: * individuals 20 years and older * patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. * asa1 or asa2 (american society of anesthesiologists) * healthy individuals with good oral hygiene and motivation * no systemic uncontrolled diseases * not taking drugs known to modify bone metabolism exclusion criteria: * individuals with untreated \& generalized severe periodontitis * smokers (\>5 cigarettes/day) * poor oral hygiene * diabetes (hba1c \>6.5% as cutoff value) * uncontrolled cardiovascular disease * poor overall health (asa iv)

Keywords: immediate dental implant dental implant bone regeneration peri-implantitis
validation of a semi-automatized method to detect cyclic hyperinflation on ct-scan in ards

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: this study aims to validate a semi-automatized method to quantify cyclic hyperinflation on ct-scan of ards patients. the gold standard will be cyclic hyperinflation assessed on the same ct scan, using manual segmentation of the lung.


Eligibility criteria:
inclusion criteria: * ards patients defined by the berlin definition * invasive mechanical ventilation with an arterial oxygen pressure (pao2)/inspired fraction of oxygen (fio2) ratio ≤ 200 mm hg * indication of ct scan identified by the clinician in charge * oesophageal catheter already inserted exclusion criteria: * requirement of contrast agent for a chest ct-scan * ards criteria present for more than 72 hours * chronic obstructive pulmonary disease (copd) on a previous lung function test * pneumothorax or bronchopleural fistula * patient without both sedation and neuromuscular blocking agents * contra-indication to transport to the imaging facility * treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (co2) removal * latex or curare allergy * patient previously included in the study * pregnancy * patient under limitation of care * patient under an exclusion period following inclusion in another clinical trial * patient under a legal protective measure * patient unaffiliated with social security * inform consent not obtained by next of kin

Keywords: ards computed tomography cyclic hyperinflation mechanical ventilation
trial to reduce antimicrobial use in nursing home residents with alzheimer's disease and other dementias 2.0

Conditions: Dementia; Alzheimer Disease; Infections

Summary: the goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia the main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

this 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster epct of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (n=600; n=300/arm) living in nhs (n=50; n=25/arm). facilities are members of a provider managed care network, iowa health care quality network ('network'). the intervention will be similar to the original train-ad program, but adapted for moderate to advanced dementia and rolled out in the network. at each intervention nh, the intervention will be implemented for 24-months. control nhs will employ usual care. in all nhs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (figure 2). eligible residents with dementia will be identified using the ehr and minimum dataset (mds) and followed up to 12 months. outcome data will be ascertained from the ehr. randomization and program roll out will be at the facility level. analyses at the resident level. clinical outcomes compared between arms at 12 months will be: 1. antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (aim 1); and 2. number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (aim 2). a process evaluation of implementation will be conducted in the intervention arm based on the re-aim framework1 (aim 3) using quantitative and qualitative data (stakeholder interviews).

Eligibility criteria:
inclusion criteria: 1. age \> 60 2. a diagnosis of dementia (any type) 3. cognitive functional scale (cfs) \> 1 4. nh length of stay \>90 days the cfs score categorizes cognitive impairment status based on data in the electronic health record into: 1. none, 2. mild, 3. moderate, and 4. severe (advanced). for the primary outcome, the analysis will be restricted to residents with a cfs score of 3 or 4. exclusion criteria: 1. less than 60 years of age 2. living in nursing home for less than 90 days 3. does not have diagnosis of dementia 4. does not meet cfs \>1 score
mirror therapy in complex regional pain syndrome type i

Conditions: Complex Regional Pain Syndrome Type I

Summary: the aim is to evaluate the efficacy of mirror therapy on pain reduction and hand function in subjects with unilateral upper extremity complex regional pain syndrome type i.

subjects were randomly divided into two groups. group a carried out a ten-minute mirror therapy exercise daily, for a total duration of six weeks. group b acted as a control group for six weeks followed by six weeks of mirror therapy with the same characteristics as group a. upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. daily records on the visual analogue scale were used for pain evaluation. effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.

Eligibility criteria:
inclusion criteria: - diagnosis of crps i based on the budapest criteria exclusion criteria: * failure to meet the diagnostic budapest clinical criteria for crps i * previous use of mirror therapy prior to the commencement of this study * substantial difficulties in cooperation * a significant change to the subjects' treatment regimen, outside of the study design
immediate weight-bearing verses non-weight-bearing after foot & ankle surgery

Conditions: Foot and Ankle Surgery

Summary: the primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. this will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of aofas and sf-36 surveys.

the study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. the patients will be randomly placed into the study group and control group if they meet all eligibility criteria. this study will be conducted at 5 investigative clinic sites; west penn hospital, forbes regional hospital, jefferson regional hospital, bethel park surgery center, and monroeville surgery. recruitment will stop when a minimum of 230 subjects are consented. the study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. the entire follow up period will occur over 2 years.

Eligibility criteria:
inclusion criteria: 1. males or females age 18 to 89 years 2. undergoing foot and ankle surgery 3. must be able to read and understand english and consent for themselves exclusion criteria: 1. diagnosed peripheral neuropathy 2. diagnosed peripheral vascular disease 3. documented infection to the surgical extremity 4. previous surgery to the surgical limb 5. laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union 6. subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: ankle surgery foot surgery
screening nutritional status of hospitalized patients

Conditions: Malnourishment

Summary: this study investigated the results of the nutritional status of hospitalized patients with nutritional risk screening 2002 (nrs-2002) and subjective global assessment (sga) screening and compared the effects of two screening method in predicting malnutrition.

in the cross-sectional study demographic data, body mass index (bmi), length of hospital stay (los), and cause of hospitalization of hospitalized patients were recorded. for the nutritional assessment all patients were screened with nrs 2002 and sga within the first days of admission to the patients. the primary predictors of interest in our study were the nrs 2002 and sga results of patients.

Eligibility criteria:
inclusion criteria: * ≥18 years old * non-bed-dependent * non-criti̇cal service patients exclusion criteria: * \< 18 years old, * hospitalized due to surgical operation, * pregnant women, * breastfeeding women, * bed-dependent, * suffered an advanced disease that required palliative care.

Keywords: nutritional assessment nutritional risk screening 2002 subjective global assessment.
pharmacogenomics of paclitaxel in ovarian cancer

Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms

Summary: this study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). specifically we will study this retrospectively in patients who participated in clinical trials that are now closed. all patients had ovarian cancer and received paclitaxel/carboplatin chemotherapy after primary surgery.

paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. the effect and toxicity is unpredictable in the individual patient. paclitaxel is removed (eliminated) from the organism by oxidation. cyp2c8 is the enzyme mainly responsible. p-glycoprotein (pgp) is an efflux transport protein natural to the human organism. pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. paclitaxel is substrate for pgp. single nucleotide polymorphisms are possible causes for variation in both cyp2c8 and pgp expression/function. we will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future. we will use tissue from patients who participated in one of two clinical trials that are both closed for inclusion. genotypic data from this tissue will be correlated with toxicity and survival data drawn from a research database. we expect to be able to find \>300 available cases to study.

Eligibility criteria:
inclusion criteria: * patients enrolled in "tc/tec" in denmark, sweden or norway * patients enrolled in "ovar-9" in denmark, sweden or norway

Keywords: cyp2c8 mdr1 pharmacogenetics paclitaxel
a study of lenvima (lenvatinib) in korean unresectable hepatocellular carcinoma (uhcc) participants

Conditions: Liver Neoplasms; Carcinoma, Hepatocellular

Summary: the purpose of this study is to describe the following safety and the efficacy of lenvima for the first-line treatment indication of participants with uhhc in the post marketing setting: (1) serious adverse events and serious adverse drug reactions (2) unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) known adverse drug reactions (4) non-serious adverse drug reactions (5) other safety and efficacy related information.


Eligibility criteria:
inclusion criteria: 1. participants over 18 years 2. participants who are treated with lenvatinib according to the approved indication of uhcc as first-line therapy in korea 3. participants who have given their consent to study participation about the use of the personal data and medical data exclusion criteria: 1. participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib) 2. participants who are pregnant or breastfeeding.

Keywords: lenvatinib lenvima
improving asthma care for very low birth weight infants

Conditions: Asthma

Summary: children born less than 1500 grams are being enrolled into a study to test the effectiveness of a parental educational intervention in reducing the risk of future breathing problems. the intervention teaches parents of these children how to reduce the risk of / and recognize breathing problems.


Eligibility criteria:
inclusion criteria: * premature babies weighing less than 1500 grams at birth receiving care at strong memorial hospital neonatal intensive care unit exclusion criteria: * non-english speaking parents
a prospective study comparing the incidence of infantile hemangiomas following normal pregnancies versus pregnancies complicated by placental abnormalities

Conditions: Hemangioma

Summary: the purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as they relate to normal pregnancies and those pregnancies complicated by placenta abnormalities. women of all gestational ages will be enrolled in the study. maternal serum, placental, and cord blood samples will be obtained for each subject. a medical history will be obtained for each subject. post-delivery a member of the study team will perform a cutaneous exam of the infant to establish what birthmarks are present at birth. mother will receive four phone call follow ups to determine if the infant has had any skin changes. if yes, mother will be asked to bring the child in for evaluation. if a hemangioma is diagnosed, a blood draw will be performed.


Eligibility criteria:
inclusion criteria: * pregnant women delivering at sharp mary birch hospital for women in san diego, ca

Keywords: hemagiomas of infancy
the efficacy of acupuncture and laser acupuncture in treating chemotherapy or target therapy-induced hand-foot syndrome

Conditions: Hand-Foot Syndrome

Summary: chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. at present, there is no better treatment for this side effect of chemotherapy or target therapy. in severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. in recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. there have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.

the investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. outcome measures include common adverse events evaluation standard version 5.0 (ctcae) and visual analogue scale (vas), dermatology life quality index (dlqi) and assessment of cancer patients' quality of life questionnaire (eortc qlq-c30). answatch and thermal image camera are also used to assess those subjects. those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.

Eligibility criteria:
inclusion criteria: 1. cancer patients receiving chemotherapy or targeted therapy 2. age over 20 years old 3. western medicine diagnoses hand-foot syndrome 4. sign the consent form exclusion criteria: 1. pregnant or planning to become pregnant 2. serious arrhythmia (or cardiac pacemaker installed) 3. epilepsy 4. severe organ failure, such as heart and lung failure, liver and kidney failure 5. psychiatric history, unable to cooperate with acupuncture and assessors 6. those who received traditional chinese medicine treatment for hand-foot skin reaction

Keywords: acupuncture laser acupuncture chemotherapy target therapy hand-foot syndrome
study evaluating the efficacy of loco-regional anaesthesia pecs on chronic pain of a mastectomy

Conditions: Breastcancer; Mastectomy

Summary: a non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia pecs on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

the aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. it is done by evaluating the technique of anesthesia pecs used during this procedure so that the rate of chronic pain can be measured 6 month after the operation. as well as total mastectomy, patients are also eligible for an axillary lymph node dissection (alnd) and a reconstruction of the breast by prosthesis as options. other objectives of the study include: * evaluating the effectiveness of the pecs anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery * evaluating the type and intensity of the pain * evaluating the quality of life * study the link between chronic pain and the trajectory of acute pain.

Eligibility criteria:
inclusion criteria: * patients with unilateral breast cancer * surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain * age ≥ 18 ans * non-opposition of patients exclusion criteria: * reconstruction by other than prosthesis * previous breast surgery in the last year * hypersensitivity or allergy of anaesthetics * coagulopathy and local infections * pregnant or breastfeeding * patients under guardianship