Kornimate/medical-research-clean huggingface dataset:
assessing intellectual and motor outcomes in high-risk infants

Conditions: Cerebral Palsy; Cerebral Palsy (CP); Cerebral Palsy Children; High-risk Infants; Intellectual and Developmental Disabilities; Motor Impairment; Cognitive Development

Summary: cerebral palsy (cp) is a condition when a baby has a brain injury that affects their movement and muscle tone. some people with cp can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. some newborns are at higher risk of developing cp, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. however, most babies with a higher risk of cp do not develop cp. the problem is that doctors can't tell early on who will and who will not develop cp, they can only say who has a risk of it. therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the early intervention team. if there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having cp. in this study the aim is to try and reduce the age of diagnosis of cp by assessing children in high-risk out-patient clinics using novel and specific examinations. this study is being conducted at several hospitals in ireland, including cork university maternity hospital (cumh), the rotunda hospital and the coombe women and infants hospital. it is being coordinated by the in4kids network and will be conducted in the infant centre/ university college cork (ucc). the study has been funded by science foundation ireland (sfi) and the cerebral palsy foundation, usa.


Eligibility criteria:
inclusion criteria: - (high risk group) legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol. all infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including: all preterm infants born ≤32 weeks post menstrual age or ≤1500 gm birth weight all encephalopathic infants neurological risk factors (e.g., cerebral birth defect, injury/malformation on neuroimaging, persistently abnormal neurological exam) (control group) all full term infants will be eligible if: term infants born \> 37 weeks gestational age not admitted to the nicu no neurological impairments at birth (no identified congenital or genetic abnormalities) exclusion criteria: - (high risk \& control groups) death prior to discharge from the neonatal unit (high-risk infants only) no parental consent (high-risk and control infants)

Keywords: cerebral palsy high-risk infant follow-up motor difficulty intellectual delay cognitive impairment
maintaining nonsmoking

Conditions: Nicotine Dependence

Summary: the research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. this treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. the current study will evaluate the treatment model when implemented in a medical outpatient setting.

this study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. all participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. participants will be randomly assigned to one of four treatment conditions. all participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). following this brief treatment, participants will be randomly assigned to one of four treatment protocols 1. monthly brief contact or 2. extended non-specific behavioral treatment or 3. extended relapse prevention treatment or 4. extended relapse prevention treatment + availability of varenicline treatment. each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment. all participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * must be smoking 5 or more cigarettes per day exclusion criteria: * previous history of bipolar/manic-depressive disorder * current diagnosis of schizophrenia * acute life threatening diseases * evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol * pregnancy or lactation * individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or coronary artery bypass grafting (cabg) within one year, and congestive heart failure (chf)

Keywords: smoking tobacco nicotine smoking cessation
growth hormone adding to controlled ovarian hyperstimulation for improving embryo quality

Conditions: Infertility,Female

Summary: gh plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.gh can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.in this study, a prospective randomized control was used to explore the effect of gh adjuvant therapy on embryo quality.


Eligibility criteria:
inclusion criteria: * 1)infertility women whose age ≥20 and ≤39 years old; 2)women has done ivf/icsi assisted treatment ≥1 times； 3)number of ivf/icsi assisted treatment cylces with ≥6 oocytes retrieved ≥1； 4)number of ivf/icsi assisted treatment cylces with ≥50% fertilization rate ≥1 ; 5)historical assisted reproduction cycles without ≥6c-ⅱ level embryos at the third day after oocytes retrieval or without blastocyst formation after blastocyst culturing. exclusion criteria: - 1) diseases related to ivf treatment outcome, such as untreated hydrosalpinx, uterine fibroids affecting uterine cavity, myometriosis, endometrial lesions, obvious uterine abnormalities,etc; 2)severe acute or chronic liver or kidney diseases, such as cirrhosis, acute or chronic renal failure, hepatitis b virus activity period,etc.;in patients with abnormal liver and kidney function, the ast or alt detection value was 2.5 times higher than the upper limit of normal, and the serum creatinine was 2 times higher than the upper limit of normal. 3)endocrine and metabolic diseases and adrenal diseases, such as diabetes, cushing's syndrome,etc.; 4)people has allergy history of growth hormone product; 5)participating in other clinical research; 6)other conditions that researchers determined not fit to be enrolled.

Keywords: infertility,female embryo development
heart rate variability to predict hypotension following spinal anesthesia in cesarean delivery

Conditions: Cesarean Section

Summary: based on the patient's heart rate variability, the analgesia nociception index (ani) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. the investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.


Eligibility criteria:
inclusion criteria: * adult pregnant women scheduled for cesarean section under spinal anesthesia exclusion criteria: * emergency cesarean section * when performing general anesthesia or epidural anesthesia * multiple pregnancies * surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa * cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies * cranial nervous system disease * autonomic nervous system-related underlying diseases not related to pregnancy * fetal malformations * those who have an allergic skin reaction to adhesive substances such as bandages
prevalence of endometriosis in a well defined group of infertile women

Conditions: Endometriosis; Infertility

Summary: at the leuven university fertility centre (lufc) of the department of obstetrics and gynecology of the university hospitals leuven, belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.

in this study, the electronic files of all patients who consulted the lufc since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to world health organization (who) criteria (n = 304). after exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.

Eligibility criteria:
inclusion criteria: * all patients who consulted the lufc since 2003 * with at least 1 year of infertility, * a regular cycle (variation 21 - 35 days), * whose partner had normal sperm according to world health organization (who) criteria. exclusion criteria: * a previous laparoscopic diagnosis of endometriosis before referral to our centre

Keywords: endometriosis prevalence fertility pain ultrasound
adherence to care for children with congenital zika virus infection in puerto rico

Conditions: Zika Virus Infection; Adherence, Patient

Summary: given the magnitude of the epidemic in puerto rico, congenital zika virus infection may have devastating complications to a significant population of children, also affecting families and society at large. this proposal takes a critical first step to ensuring that children with exposure to congenital zika virus infection receive the follow-up care they need for optimal clinical outcomes. we anticipate that lessons learned from this study may also positively impact models for adherence to early intervention services in puerto rico.

overview: participants will be the primary caregivers (age ≥18 years) of children with possible congenital zika virus infection. participants will be recruited from the pediatric services of the university of puerto rico medical sciences campus (upr-msc), as well as other clinics and community-based organizations in puerto rico. in the intervention, a community health worker (chw) will deliver personalized sessions framed around a multi-media health communication tool. the chw will deliver the intervention over a 6-month period. study procedures: participants will be the primary caregivers (age ≥18 years) of children with possible congenital zika virus infection. participants will be recruited via provider referral, peer referral, and flyers. once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline interview. after completion of the baseline interview, study staff will randomize participants into an enhanced control condition (ecc) or intervention condition that receives an individually-tailored community health worker intervention. at trial exit, all participants, including the ecc group, will complete an in-depth assessment to measure their barriers to follow-up zika-related pediatric services and provide feedback about their experience in the study.

Eligibility criteria:
inclusion criteria: * age 18 years or older and able to communicate in spanish * being the primary caregiver of a child with possible congenital zika virus infection exclusion criteria: * those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.

Keywords: zika virus puerto rico community health worker
tnt to increase the clinical complete response rate for distal larc

Conditions: Rectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III; Chemoradiation

Summary: this is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (tnt) in patients with locally advanced resectable rectal cancer.

standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision. a new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. the rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. as compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate. the objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. the investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.

Eligibility criteria:
inclusion criteria: * rectal adenocarcinoma * ct3-4anany or ctanyn+ * location ≤5 cm from the anal verge * no distant metastasis * no gastrointestinal obstruction or relieved obstruction * no previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy * ecog 0-1 * expected survival length ≥ 2 years * age 18-70 * sufficient bone marrow, kidney and liver function * effective contraception during the study * patient and doctor have signed informed consent exclusion criteria: * distant metastasis * chronic intestinal inflammation and/or bowel obstruction * contra indication for chemotherapy and/or radiotherapy * previous pelvic radiotherapy or chemotherapy * severe renal, hepatic insufficiency (serum creatinine\<30ml/min) * peripheral neuropathy \> grade 1 * pregnant or breast-feeding woman * certain or suspicious allergy to research drug * cachexia, organ dysfunction * active severe infection * multiple primary cancers * epileptic seizures * malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma * severe arrhythmia, cardiac dysfunction (nyha grade iii or iv ) * uncontollable severe hypertesion * persons deprived of liberty or under guardianship * impossibility for compliance to follow-up

Keywords: rectal cancer chemoradiation total neoadjuvant treatment
hf vs niv in acute cardiogenic pulmonary edema

Conditions: Pulmonary Edema Cardiac Cause

Summary: the study's primary aim is * to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (nppv) and high-flow nasal cannulae (hfnc), in the acute cardiogenic pulmonary edema (acpe) setting, in terms of echocardiographic parameters of rv systolic and rv strain. * to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed. * to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (map), heart rate (hr), respiratory rate (rr), oxygen saturation (spo2), and on arterial blood gases (abg) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort). enrolled patients will receive nppv and hfnc oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, t0 and time 1, t1), followed by clinical and echocardiographic evaluation


Eligibility criteria:
inclusion criteria: * age ≥ 18 y.o.; * clinical diagnosis of acpe in the setting of either ami, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic hf with rlvef diagnosed according to european society of cardiology (esc) guidelines \[4\]; * hypertensive crisis with systolic blood pressure \>200 mmhg; * other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous. * written informed consent. exclusion criteria: * age \<18 y.o.; * hypercapnia with respiratory acidosis (paco2 \> 45 mmhg with ph \< 7.35); * history of fever in the previous 4 days; * white blood cell count \> 12.000; * increased procalcitonin serum levels; * consolidative areas at chest radiograph; * hypotension (systolic blood pressure \< 85 mmhg); * cardiogenic shock; * right ventricular (rv) dysfunction; * previous cardiac surgery, * glasgow coma scale score ≤ 8 points; * impaired ability to protect the airway from aspiration; * orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers; * respiratory arrest; * severe hemodynamic instability; * facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the nppv interface to patient's face.
abuse potential of buprenorphine/naloxone

Conditions: Opioid-Related Disorders

Summary: buprenorphine is a treatment for opioid dependence. naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. the purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. however, there is concern that buprenorphine may be abused due to its high abuse potential. a sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. the purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone. participants will be maintained on both low and high doses of buprenorphine/naloxone. they will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. during study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

Eligibility criteria:
inclusion criteria: * actively abusing illegal opioids * qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry * meets dsm-iv criteria for opioid dependence exclusion criteria: * significant medical problems (e.g., insulin dependent diabetes mellitus) * non-substance use psychiatric disorders (e.g., schizophrenia) * seeking substance abuse treatment
surveillance of hfmd in pediatric outpatients

Conditions: Hand, Foot and Mouth Disease; Herpangina; Enterovirus Infections

Summary: the aims of this prospective multicentric study is to determine the types of enteroviruses (evs) responsible for hand, foot and mouth disease (hfmd) or herpangina in children seen within an ambulatory setting : * to detect an ev-a71 epidemic or another type associated with atypical forms of the disease at an early stage * to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of ev.

any child presenting signs suggestive of hfmd/herpangina can be included in the study by one of the investigating paediatricians. after giving the information note to the parents (and to children over 3 years of age) and asking them not to object, the paediatrician collects a throat or mouth swab to confirm the enterovirus infection. at the same time as the swab is taken, anonymised demographic and clinical data are collected by the doctor during the consultation. the sample and the information sheet are sent to the national reference laboratory for enteroviruses (clermont-ferrand university hospital).the diagnosis is performed by ev genome detection and if positive, genotyping is done to identify the type of the enteroviruses.

Eligibility criteria:
inclusion criteria: * children aged 0 to 10 years presenting with hfmd or herpangina exclusion criteria: * refusal to participate by holders of parental authority * refusal to participate for children over 3 years of age

Keywords: hand, foot and mouth disease enterovirus a71 coxsackievirus a6 herpangina primary care in paediatrics
multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: phase iii, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. gonarthrosis grade 2, 3 or 4 of kellgren and lawrence (kellgren \& lawrence, 1957) assessed by two observers. 2. chronic painful knee of mechanical characteristics. 3. absence of local or systemic septic process. 4. hemat imetric and biochemical analysis without significant alterations that contraindicate the treatment. 5. written informed consent of the patient. 6. the patient is able to understand the nature of the study. 7. body mass index 20-35 kg/m2. exclusion criteria: 1. patient \< 18 years old, or legally dependent. 2. patient \> 75 years old. 3. congenital or developmental diseases that translate malformation and / or significant deformations of the knee (varus\>10º; valgus\>20º) and condition difficulties of application and evaluation of the results. 4. pregnant or breastfeeding women. 5. neoplastic disease. 6. intra-articular infiltration of any drug in the 3 months prior to study inclusion. 7. concurrent participation in another clinical trial or treatment with another investigational product within 30 days prior to study enrollment. 8. allergy to gentamicin (antibiotic used in the cell culture process ). 9. other diseases or circumstances that compromise participation in the study according to medical criteria.