Kornimate/medical-research-clean huggingface dataset:
pilot study of the effect of hyperbaric oxygen treatment on behavioral and biomarker measures in children with autism

Conditions: Autism

Summary: the purpose of this study is to increase the understanding of the effect of hyperbaric oxygen treatment (hbot) on the behavior and functioning of children with autism. the main goal of this study is to demonstrate that hbot is safe and tolerable in autistic children, and to measure the effect of hbot on specific chemicals in their blood that may play a role in the child's behavior.

during the study's 20-week duration, all children will receive hyperbaric oxygen treatment (hbot) for two eight-week sessions, with a four week session between. therefore, all children will participate in the study for 20 weeks, and will receive hbot for 16 weeks. this is an open label study. this means that there will not be a placebo group in the study. all study participants will receive the same treatment of hbot in a hard shell chamber. normal air contains about 24% oxygen at a pressure of about 1 atmosphere absolute (ata). the chamber will contain 100 percent oxygen at a pressure of 1.5 ata, which is equivalent to the pressure at a depth of 15 feet in sea water. each subject will complete the first 40 treatments during one hour sessions on 5 separate days in each of the first 8 weeks. they will then take a 4-week break before they begin their next 40 treatments, which will also occur during one hour sessions on 5 separate days in each of the last 8 weeks. the entire study will last 20 weeks. the child's behavior will be measured and evaluated at the mind institute at the beginning of the study, at week 8, and at week 20.

Eligibility criteria:
inclusion criteria: 1. diagnosis of dsm-iv defined autism and meets cut off for autism on the autism diagnostic inventory-revised (adi-r) or social communication questionnaire (scq) and the autism diagnostic observation scale (ados). 2. age 3 to 8 years. 3. nonverbal iq of 50 or above. 4. parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention. exclusion criteria: 1. clinical evidence of seizure disorder 2. active infection with fever 3. fragile x or other known genetic cause of autism 4. perinatal brain injury (e.g. cerebral palsy) 5. previous adequate trial (at least 20 session) of hbot 6. inability to clear ears in the hbot chambers
a culturally specific end-of-life communication skills training

Conditions: End-Of-Life

Summary: the goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (cst) among chinese oncology nurses. the main question it aims to answer is: what is the effectiveness of culturally specific end-of-life cst among chinese oncology nurses? participants will receive an 8-week communication skills training. researchers will compare the intervention group and the wait-list group to see if skills, self-efficacy, and outcome expectancy beliefs will be improved.

objectives: the study aims to evaluate the effectiveness of culturally specific end-of-life cst among chinese oncology nurses. design and participants: it is designed as a single-blind, pre-post randomized controlled trial (rct). registered nurses who work with advanced cancer patients in hospital settings will be recruited. the participants will be randomly assigned to either the intervention group (ig) or the control group (cg). the ig will receive the end-of-life cst between the two measurement points, and the cg will be a waitlist group and receive the training after the end of data collection. data analysis: demographic information about the participants will be summarised in descriptive statistics. independent t-tests and chi-square tests are used to investigate the comparability of groups in terms of the demographics generated by randomization. the primary and secondary outcome variables will be examined using covariate-adjusted linear mixed models. this approach enables the consideration of missing data. for non-repeated continuous measurements, ordinary linear regression and logistic models will be adopted. the intention-to-treat (itt) analysis and post hoc analyses of contaminated data will be performed. expected results: nurses' skills, self-efficacy, and outcome expectancy beliefs will improve after the cst.

Eligibility criteria:
inclusion criteria: * registered nurses who work with advanced cancer patients in hospital settings * consent to participate in the study exclusion criteria: * nurses working temporarily in the two hospitals as scholars or trainees from other hospitals * specialized nurses in palliative care

Keywords: communication nurse terminally ill
prognostic implications of pre-stent pullback pressure gradient and post-stent quantitative flow ratio in patients undergoing percutaneous coronary intervention

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (pci) focal or diffuse disease patterns combined with post-pci quantitative flow ratio (qfr).

coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after pci, especially in those with good post-pci physiologic results. qfr can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (ppg) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now. the chart-origin study aims to investigate the independent and additive prognostic implications of pre-pci functional disease patterns assessed by ppg with post-pci qfr in vessels with stent implantation.

Eligibility criteria:
inclusion criteria: * patients with at least one vessel with measurable qfr * ppg index can be calculated from virtual qfr pullback curve; * the patient is willing to comply with specified follow-up evaluations; * patients who agree to accept the follow-up visits. exclusion criteria: * culprit vessels for acs myocardial infarction; * pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure; * patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year); * patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (pla) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated; * any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study; * currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
low-dose neuroleptanalgesia for postoperative delirium in elderly patients

Conditions: Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Sigmoid Neoplasms; Liver Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Osteoarthropathy; Fractures, Bone; Gynecologic Cancer

Summary: postoperative delirium（pod）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. in order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. the efficiency and safety of neuroleptanalgesia on the incidence of pod would be evaluated in elderly patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 65 years old and ≤ 85 years old; 2. selective non-cardiac major surgery; 3. informed consent and voluntary participation in the trial; 4. asa class i-ii; 5. anticipated operation duration ≥ 2 hours; 6. no plan to icu after operation. exclusion criteria: 1. neurosurgery; 2. patients with neurological and mental diseases: such as basal ganglia disease, parkinson's syndrome, severe central nervous depression, alzheimer's disease , etc; 3. patients with prolonged q-t interval, cardiac repolarization disorder and other severe arrhythmia; 4. patients with severe cardiopulmonary disease, liver and kidney dysfunction; 5. allergic or contraindications to droperidol or fentanyl citrate; 6. admitted to icu after operation. 7. operation duration \< 2 hours;

Keywords: postoperative delirium neuroleptanalgesia aged noncardiac major surgery
pressure levels on lung expansion

Conditions: Pleural Effusion

Summary: question: what level of noninvasive positive airway pressure is able to expand the lungs of people with pleural drainage? design: cross-sectional, experimental and randomized study. participants: four consecutive people with pleural effusion drained within 24 hours, with controlled pain and without contraindications to use of noninvasive positive pressure. intervention: each person will be randomly subjected to three levels of noninvasive positive airway pressure: 0 (zero), 4 and 15 cmh2o for evaluation via chest computed tomography. outcome measures: lung area.


Eligibility criteria:
inclusion criteria: * age over 18 years * presence of pleural drainage after traumatic hemothorax * thoracic drainage within 24 hours * controlled pain (below 3 points in the visual numeric scale, varying from zero to ten) exclusion criteria: * contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding * previous application of any sort of lung expansion technique after thoracic drainage.
addressing gender based violence in hiv testing and counseling

Conditions: Intimate Partner Violence

Summary: the overarching goal of this study is to pilot an approach to hiv testing and counseling (htc) that addresses intimate partner violence. the results of the study will fill an important gap in the literature and contribute to efforts by kenyatta national hospital in nairobi, kenya-and the hiv and sexual and reproductive health field globally-to better address intimate partner violence in our work.


Eligibility criteria:
inclusion criteria: * lived in the community for at least one year * aged 15-49 years * satisfy gender requirement exclusion criteria: * lack of informed consent
multi-point intra-mucosal injections of cross-linked hyaluronic acid (desirial®) in the vaginal vestibule

Conditions: Menopause; Dyspareunia

Summary: the main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

the secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection: a. vaginal flora and nugent score. b. vaginal ph. c. functional evolution via the vhi index by gloria bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the pgi-i questionnaire (patient global impression and improvement). d. procollagen i and iii gene expression (by pcr) and mitotic activity of the mucosa (ki67 proliferation marker) based on biopsies.

Eligibility criteria:
inclusion criteria: * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 8 weeks of follow-up * the patient is menopausal (amenorrhea) for over 2 years and less than 10 years * the patient has a body mass index \<35 * the patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness. exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant or breastfeeding * the patient is not menopausal (both clinically and biologically) * the patient has a body mass index \> 35 * the patient has a genital prolapse higher than stage 2 with a surgical indication * the patient has stress incontinence with a surgical indication * the patient suffers from vaginismus * presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection * hemorrhagic or neoplastic genital pathologies * existence of a hormone-dependent tumor, genital bleeding of unknown origin * current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin * known hypersensitivity to hyaluronic acid or mannitol * known hypersensitivity to betadine * known hypersensitivity to lidocaine * hypersensitivity to emla® * previous urogynaecological vulvovaginal surgery

Keywords: vaginal discomfort vaginal dryness
incidence, risk factors and consequences of acute kidney injury in patients undergoing esophageal cancer surgery

Conditions: Acute Kidney Injury; Postoperative Complications

Summary: esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. there is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence. the investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. the investigators will also identify risk factors associated with acute kidney injury occurrence.


Eligibility criteria:
inclusion criteria: * elective esophagectomy exclusion criteria: * end-stage renal disease * missing data for acute kidney injury definition * second surgery (for patients having multiple surgeries performed during a 30-day period, only the first in each period will be included)
does premature luteinization matter?

Conditions: Premature Progesterone Rise

Summary: elevation of serum progesterone on the day of ovulation triggering in ivf/icsi cycles is suggested to be associated with compromized outcomes. others found that this rise didnot affect the ivf/icsi outcomes. it is still controversal if premature luteinization would affect the ivf/icsi outcomes.


Eligibility criteria:
inclusion criteria: * planned fresh embryo transfer exclusion criteria: * cancelation of the embryo transfer for any reason
the reproductive microbiome & perinatal health outcomes

Conditions: Human Microbiota; PreTerm Birth; Human Gastrointestinal Microbiota; Metabolomics

Summary: pregnant african american women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. a urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. the biological specimens will then be analyzed for their microbiomial profile. this will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.


Eligibility criteria:
inclusion criteria: * able to read and understand english, full decision making capabilities, african american (self-identified), pregnant, at 20 weeks or less of gestation, singleton pregnancy, 18-45 years of age exclusion criteria: * race other than african american, advanced gestational age (\>20 weeks), multiple gestations, less than 18 years or greater than 45 years of age.

Keywords: preterm delivery preterm birth vaginal microbiome microbiome gut microbiome african american metabolomics pregnancy
rethink reflux registry

Conditions: Gastroesophageal Reflux

Summary: the rethink reflux registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the linx device. the primary objective of the study is to confirm the long-term safety profile of the linx device and procedure (implant/explant) up to 10 years post-implant.

the rethink reflux registry or research to further inform thinking about the role of linx for reflux disease is sponsored by ethicon endo-surgery, inc. this is a post-market prospective, multi-center, observational, single arm, long-term safety surveillance registry of subjects implanted with the linx device. up to 500 subjects will be enrolled and implanted at up to 50 centers in both the us and selected countries outside the us with regulatory approval for the linx reflux management system. the study will collect data from patients 10 years post implant. the primary objective of the study is to confirm the long-term safety profile of the linx device and procedure (implant/explant). secondary objectives include effectiveness, health economics and health utilization.

Eligibility criteria:
inclusion criteria: 1. subject is \>or=21 years old 2. subject with prospective plans for a linx procedure 3. subject provides written informed consent 4. subject must be willing and able to complete questionnaires/ surveys electronically (epros) exclusion criteria: 1. subject who was previously implanted with linx device 2. any reason which the principal investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years) note: physicians should refer to the linx reflux management system ifu for a complete list of contraindications, warnings, and precautions.

Keywords: gastroesophageal reflux disease gerd reflux regurgitation esophageal disease lower esophageal sphincter les magnetic sphincter augmentation msa
long-term study of cariprazine in patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients and corresponding caregivers who have provided informed consents prior to any study specific procedures. * patients currently meeting the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the structured clinical interview for diagnostic and statistical manual of mental disorders, fourth edition (scid). * patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ecg). exclusion criteria: * patients with a dsm-iv-tr diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar i or bipolar ii disorder, or psychotic disorders other than schizophrenia.

Keywords: schizophrenia acute schizophrenia psychotropic drugs antipsychotic agents mental disorders dopamine agents central nervous system agents
open, non comparative study of voriconazole in slovak patients with very high risk of developing an invasive fungal infection

Conditions: Invasive Fungal Infections

Summary: assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. the study is conducted in slovakia only.


Eligibility criteria:
inclusion criteria: * male or female patient of age 2 years or older. * high-risk patients with proven, probable or possible invasive fungal infection (ifi) according to the eortc/msg criteria. * patients indicated for secondary prophylaxis of invasive aspergillosis. exclusion criteria: * patients with known hypersensitivity to voriconazole or to any of the excipients. * patients with contraindicated concomitant medications according to the smpc. * children less than 2 years of age. * pregnancy and lactation.

Keywords: observational study voriconazole high-risk patients
catastrophism in chronic inflammatory rheumatism

Conditions: Chronic Inflammatory Rheumatism

Summary: catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. it has three components: rumination, amplification and vulnerability. the assessment of catastrophism is carried out using a validated questionnaire called the "pain catatrophizing scale" (pcs). recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. in these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic. in chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.


Eligibility criteria:
inclusion criteria: * major patients, hospital follow-up, with ra according to acr 2010 criteria, or spondyloarthritis according to asas 2009 criteria or according to amor or psoriatic arthritis according to caspar 2006 criteria. * patient who has given free and informed consent. * patient who has signed the consent form. * patient affiliated or benefiting from a health insurance plan. * adult patient (≥18 years old). exclusion criteria: * patient under the protection of justice, under guardianship or curatorship. * patient unable to express consent. * patient for whom it is impossible to provide informed information. * poor command and understanding of the french language making it impossible to complete self-questionnaires

Keywords: catastrophism
omega-3 fatty acid supplementation in older adults

Conditions: Inflammation

Summary: the purpose of this study to determine whether fish oil (omega-3 fatty acid) supplementation has an impact on inflammation and lean body mass in older adults. the investigators expect that fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.


Eligibility criteria:
inclusion criteria: * 60 years of age or over exclusion criteria: * fish, seafood allergies, nut allergies, soy allergies * habitual (\>1/week) fish or seafood consumption * current omega-3 supplement use * gastrointestinal problems * current anti-inflammatory medication use * current anticoagulant medication use

Keywords: omega-3 fatty acid fish oil muscle mass muscle strength older adults circulating inflammatory cytokines skeletal muscle mass upper body strength lower body strength