Kornimate/medical-research-clean huggingface dataset:
influence of unrestricted introduction of pacifiers on breastfeeding duration

Conditions: Lactation

Summary: we will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .

given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation a research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups: unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.

Eligibility criteria:
inclusion criteria * understands the benefits and risk for offer liberally the pacifier during their stay at the maternity. * expressed an intention to breast feed exclusively their infant for at least 3 -months * possibility of contact by telephone * has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier * primiparous single birth * mother´s age 18 years or more exclusion criteria: * maternal risk factors for lactation * lack of noticeable breast enlargement during pregnancy * flat or inverted nipples * variation in breast appearance (marked asymmetry, hypoplastic, tubular) * any previous breast surgery, including plastics procedure * psychosocial problems (eg, depression, poor or negative support of breastfeeding * mother with a chronic condition that could influence development , including feeding ability * mother with eating or mental disorder. * mothers who smoke during pregnancy

Keywords: pacifier breastfeeding sudden unexpected infant death
a prospective study to evaluate the wp in comparison to psg in patients suspected of sleep disorders

Conditions: Sleep Disorder

Summary: the current study is a prospective blinded study to collect data regarding the performance of the wp device in detecting sleep disorders. for that purpose, the wp with finger probe and chest sensor will be worn by the subject simultaneous to psg in a sleep study at the clinical sleep lab. a psg system will be recording the psg data.

subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. recruited patients will be asked to sign an informed consent form. subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms. the subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night psg recording with the standard psg channels. the wp with finger probe and chest sensor will be worn by the subject simultaneous to psg. a psg system will be recording the signals and manual scoring will be performed blinded - without access to wp data. the wp analysis will be done automatically.

Eligibility criteria:
inclusion criteria: * age between 12-99 * subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory * subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea. exclusion criteria: * permanent pacemaker: atrial pacing or vvi without sinus rhythm. * finger deformity that precludes adequate sensor appliance.

Keywords: watchpat polysomnography ambulatory device sleep apnea apnea-hypopnea index
efficacy and safety of algrx 4975 in the treatment of postoperative pain after gall bladder removal

Conditions: Postoperative Pain

Summary: postoperative pain after gall bladder removal can be significant, mobility limiting and extend hospital stay. algrx 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. this study will determine whether algrx 4975 can provide pain relief following gall bladder removal.

postoperative pain after open cholecystectomy can be significant and mobility limiting, causing increased risk of deep venous thrombosis, pulmonary complications, and extended hospital stay. with increasing emphasis on early postoperative mobilization, adequate postoperative pain control is essential. acute postoperative pain is currently managed largely with opioids and co-administration of nonsteroidal anti-inflammatory drugs (nsaids). opioids are highly effective in managing acute postoperative pain, however dosing is often limited by side effects such as respiratory depression, nausea and vomiting, and sedation. nsaids are administered to reduce opioid use, but may also have limiting side effects, such as gastrointestinal toxicity and platelet dysfunction. new strategies to manage acute postoperative pain would provide clinical benefit. algrx 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. this study will determine whether algrx 4975 can provide pain relief following open cholecystectomy.

Eligibility criteria:
inclusion criteria: * subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis * american society of anesthesiologists (asa) class i or ii exclusion criteria: * active pancreatitis, any obstruction of the biliary tree, or hyperbilirubinemia (total bilirubin \> 2.5 mg/dl) * previous abdominal surgical procedure with the exception of inguinal hernia repair or appendectomy by the lateral approach or cesarean section or hysterectomy if the surgery was performed more than 1 year prior to study participation and the subject experienced no postoperative complications * diabetes mellitus with hba1c \> 9.5 or a history of prolonged uncontrolled diabetes mellitus * systolic blood pressure greater than 150 mmhg or diastolic greater than 95 mmhg

Keywords: postoperative pain open cholecystectomy capsaicin
use misoprostol to optimize prevention of cervical cancer

Conditions: Cervical Cancers

Summary: this is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (via) who have type 3 transformation zone (tz) and randomized to receive either misoprostol or placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of type 3 tz confirmed on exam prior to randomization * age 25 years or older exclusion criteria: * with type 1 or 2 tz prior to randomization * currently pregnant * history of hysterectomy * any cancerous lesions * active cervicitis

Keywords: cervical cancers
clinical trial of h2-bp electronic sphygmomanometer

Conditions: Low Blood Pressure; Normal Blood Pressure; Prehypertension; Hypertension

Summary: the study compares h2-bp, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. both devices are used on the same arm. after confirming wrist and upper arm circumference, h2-bp is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. each subject undergoes alternating measurements of h2-bp on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. the two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. validity assessment variables are derived from the recorded values to evaluate the accuracy of h2-bp.


Eligibility criteria:
inclusion criteria: * outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension * individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants. * those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions. exclusion criteria: * patients who do not consent to participate in the study. * individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions. * those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications. * individuals with arrhythmia. * those who have eaten within 30 minutes before blood pressure measurement. * individuals who have consumed caffeine-containing beverages within 1 hour or smoked within 15 minutes before measurement. * participants who have exercised immediately before blood pressure measurement. * other patients deemed unsuitable for the study at the discretion of the researchers.
quantification of micrornas in diagnosis of pulmonary nodules

Conditions: Pulmonary Cancer

Summary: one of the main challenges of thoracic oncology lies in earlier diagnosis of lung cancer to improve survival rate, wich is about 15% at 5 years. this poor prognosis is often linked to late diagnosis. efforts are being made worldwide to offer testing in patients at risk or earlier diagnosis of lung cancer in order to offer the patient curative treatments. indeed, supported at the stage of nodule (less than 3 cm lesion), lung cancer is curable by surgery in 80% of patients. nevertheless, there are many differential diagnoses and access to these lesions is often difficult and risky. in this context, the management of pulmonary nodules, which can be either benign lesions or beginners cancers, is a real challenge for pulmonologists and thoracic oncologists every day: it is important not to disregard a potentially operable nodule and avoiding offer patients invasive procedures for benign nodules. indeed, many procedures (endoscopy, puncture under scanner, thoracotomy) are made to determine if suspicious nodules are benign or not. in the large national lung screening trial, 28% of the procedures were associated with complications (including 11% classified severe and 16 deaths). it is therefore essential to develop non-invasive tools to refine treatment decisions.


Eligibility criteria:
inclusion criteria: * patients with suspected abnormal chest x-ray image of malignancy defined by one solitary pulmonary nodule (nps) nps or 2 if operable, higher than 5 mm and less to 30 mm, without histological evidence. * affiliation to social security. * signature of informed consent. exclusion criteria: * nodule not accessible to curative local therapy (surgery, thermoablation, radiotherapy). * patients in whom resection for diagnostic purposes this emergency such as one of these characters can not be delayed (these patients are not likely to belong to the people that can take a dosage of clinical interest mirnas because the characteristics radiographic their nodule only tell them a high probability of lung cancer) * history of an unhealed cancer * patients benefiting from a system of legal protection
inhaled nitric oxide for ards-related pulmonary hypertension

Conditions: Acute Respiratory Distress Syndrome; Pulmonary Hypertension

Summary: open-label pilot study of early inhaled nitric oxide (ino) for patients developing de novo pulmonary hypertension during acute respiratory distress syndrome (ards.) the study aims to determine whether ino has possible hemodynamic and clinical benefits when given early in the course of ards to patients with evidence of elevated pulmonary artery pressure.


Eligibility criteria:
inclusion criteria: * diagnosis of ards based on the berlin criteria * mechanically ventilated * age ≥ 18 years exclusion criteria: * primary cardiogenic shock * history of more than mild pulmonary hypertension preceding ards diagnosis * presence of pre-existing significant valvular disease * presence of pre-existing left ventricular dysfunction or significant hypertrophy * consent cannot be obtained from the patient or his/her surrogates * refusal of consent * opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome
psychological intervention for parent-child relationship and couple relationship under covid-19 in china

Conditions: Parent-child Relationship and Couple Relationship Under COVID-19 in China

Summary: under the covid-19, individuals who were home quarantine experienced new challenges on their parent-child relationship and couple relationship. the current project aimed to provide psychological interventions for both parents and couples in order to improving their relationship. the online intervention of group intervention and individual intervention are going to be conducted. the relationship between parent-child, couples and emotion regulation will be tested.


Eligibility criteria:
inclusion criteria: 1. parents of students in primary and secondary school. 2. parents must had primary school education or above. exclusion criteria: 1. parents cannot speak or read chinese. 2. parents have severe mental or physical illness.

Keywords: covid-19 parent-child relationship couple relationship
the evaluation of the safety of a new drug for benign prostatic hyperplasia used for 9 months

Conditions: Benign Prostatic Hyperplasia

Summary: a new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

this will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the international prostate symptom score, maximum urine flow rate, adverse events, concomitant medications, and compliance. all subjects had previously participated in a 12-week double-blind placebo controlled trial (nct000224107 or nct000224120)

Eligibility criteria:
inclusion criteria: * males in good general health and at least 50 years of age, who have completed si04009 or si04010. exclusion criteria: * medical conditions that would confound the efficacy evaluation. * medical conditions in which it would be unsafe to use an alpha-blocker. * the use of concomitant drugs that would confound the efficacy evaluation. * the use of concomitant drugs that would be unsafe with this alpha-blocker.

Keywords: benign prostatic hyperplasia, alpha blocker
aspires (activating cancer survivors and their primary care providers to increase colorectal cancer screening) study

Conditions: Colorectal Cancer; Early Detection of Cancer

Summary: the primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

this is a 12-month, 3-arm randomized controlled trial of 315 childhood cancer survivor study (ccss) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. participants will be randomly assigned to one of three groups: control, patient activation (pa) using a text message/video intervention, or patient activation + primary care provider activation (pa + pcp) which will include providing primary care providers with resources about colorectal cancer risk in this population. all participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations. the primary outcome is the proportion of patients who complete the colonoscopy or cologuard test (cologuard test plus colonoscopy if the cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. the study will test the hypothesis that, compared to controls, survivors randomized to the pa and pa + pcp activation groups will have significantly higher rates of completion of colorectal cancer screening.

Eligibility criteria:
inclusion criteria: eligible participants will include people who: * enrolled on the childhood cancer survivor study * were treated with radiation to the abdomen, pelvis, spine, or total body irradiation * have no history of colorectal cancer * have not had a colonoscopy in the last 5 years or cologuard in the last 3 years * have a smartphone exclusion criteria: * do not reside in the united states * do not speak english

Keywords: colorectal cancer cancer survivor
ultra-high-frequency ecg for prediction of left ventricular remodeling

Conditions: RV Pacing; Negative Remodeling; Dyssynchrony; UHF-ECG; Physiological Pacing

Summary: the main goal of the project is to prove that ultra-high-frequency ecg (uhf-ecg) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. the prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. if proved to be valid in left ventricular negative remodeling prediction, uhf-ecg-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. this information can help the operator to identify patients with the urgent need for physiological pacing (hb or lbbp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.


Eligibility criteria:
inclusion criteria: 1. expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up, 2. a good quality of images during echocardiography, 3. willingness to attend clinical check-ups in the implanting center for at least two years. 4. life expectancy of at least 2 years exclusion criteria: 1. planned cardiac surgery or transcatheter aortic valve implantation 2. hypertrophic cardiomyopathy 3. an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker 4. active myocarditis 5. cardiac surgery or coronary revascularization in the last ten days 6. persistent/permanent atrial fibrillation during randomization 7. severe aortic stenosis 8. mitral valvular disease with an indication to intervention.

Keywords: myocardial pacing physiological pacing negative remodeling dyssynchrony ultra-high-frequency ecg
icsi versus conventional ivf in couples with non-severe male infertility

Conditions: Male Infertility

Summary: a multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between icsi and conventional ivf among couples with no-severe male-factor infertility in china.

a multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of ivf or icsi. the study will recruit participants from 6 reproductive medical centers across mainland china.the participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. on the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- icsi protocol, and conventional ivf protocol. all participants will be randomized through stratified block randomization according to the study sites.

Eligibility criteria:
inclusion criteria: * infertile couples scheduled for their first or second ivf/icsi cycle. * men with non-severe male infertility: sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type a+b) 10-32%. * women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment. * informed consent obtained. exclusion criteria: * couple with contraindication for ivf or icsi. * couples receiving donor sperm or donor eggs. * couples undergoing pgd and pgs. * sperm concentration with progressive motility used for insemination \<100,000/ml on the day of oocyte retrieval. * women with 0 oocytes after oocyte retrieval. * using frozen semen. * poor fertilization in previous cycle (≤ 25%).

Keywords: male infertility in vitro fertilization intracytoplasmic sperm injection
change in mapse during treatment of sepsis

Conditions: Sepsis

Summary: patients with bloodstream infections (sepsis) have been found in prior studies to have infection-related heart dysfunction, even if they did not have preexisting heart problems. factors related to the infection may cause the heart to not pump as well as it should, causing critical illness in the form of low blood pressure (shock) and heart failure. ultrasound is frequently used in the emergency department to evaluate why a patient might have low blood pressure. part of that evaluation may include obtaining ultrasound images and making measurements about how well or poorly the heart is pumping. the investigators will evaluate a certain measurement that relates to cardiac function, determine how it changes in patients before and after they are treated for septic shock. this will involve placing an ultrasound probe on the patient's chest, measuring the upward and downward movement of the mitral valve, the mitral annulus systolic plane excursion (mapse), and comparing the measurements before and after treatment is started. the investigators are attempting to determine if this measurement improves before and after treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of sepsis or septic shock exclusion criteria: * age equal to or less than 17 * patient in the emergency department * unable to perform pocus exam due to medical necessity * patients without sepsis * unable to obtain consent or have a legal representative consent

Keywords: pocus emergency department echocardiography