Kornimate/medical-research-clean huggingface dataset:
study of positive airway pressure in preeclampsia to reduce blood pressure

Conditions: Preeclampsia; Hypertension

Summary: the purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. part way through the study, irb granted approval to expand recruitment to include other hypertensive diagnoses. so, in effect, a more accurate post hoc title would be study of positive airway pressure to reduce blood pressure in hypertensive pregnancies.

Eligibility criteria:
inclusion criteria: * women with preeclampsia who receive care at the university of michigan hospitals * no current use of pap therapy. * willing and able to provide informed consent. exclusion criteria: * current pap therapy * any medical reason why pap therapy may not be suitable (e.g., in patients with recent head trauma). * cognitively impaired and unable to understand informed consent.

Keywords: sleep disordered breathing preeclampsia positive airway pressure
vitamin d3 combined with strengthening exercise for lateral epicondylitis of elbow

Conditions: Lateral Epicondylitis of Elbow

Summary: the goal of this study is to verify the effect of vitamin d3 combined with extensor muscle strengthening exercise in lateral epicondylitis of elbow are there significant differences in the improvement of functional scores between the study and control groups? are there significant differences in the improvement of sonographic findings and blood d3 levels between the study and control groups? participant will underwent d3 injection or saline injection and extensor muscle strengthening exercise with counter force brace. all the participant will undergo functional scoring, sonographic examination and blood d3 level testings until 6 months after initial visit.


Eligibility criteria:
inclusion criteria: * lateral epicondylitis(le) of elbow symptoms that persisted of increased for more than 3 months in which le was defined as pain on the lateral side of the elbow and pain at the lateral epicondyle upon direct palpation and during resisted dorsiflexion of the wrist exclusion criteria: * younger than 20 years * history of ipsilateral elbow surgery * common extensor tendon tears more than 30% in depth * inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, etc) * osteoarthritis with a limitation of range of motion (flexion contracture \>30 degree and further flexion \< 100 degree) * neurological deficits in the ipsilateral upper limb,and follow-ups less than 24 weeks

Keywords: vitamin d3 injection extensor strengthening exercise with counterforce brace plasma vitamin d3 level visual analog scale of pain (vas) mayo elbow performance score (meps) sonographic evaluation
a long-term safety study of fluticasone furoate (ff)/gw642444 in japanese subjects with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/gw642444 inhalation powder when administered once-daily for 52 weeks in japanese patients with copd.


Eligibility criteria:
inclusion criteria: * out patient at least 40 years of age * both genders; females childbearing potencial must be willing to use birth control method * a diagnosis of copd at screening * subjects with a current or prior history of at least 10 pack-years of cigarett smoking at screening * post-bronchodilator fev1/fvc ratio of less than 70% * post-bronchodilator fev1 of less than 80% exclusion criteria: * current diagnosis of sthma * respiratory disorders other than copd * upper or lower respiratory infection, or exacerbation of copd within 4 weeka prior to screening * concurrent other disease that would confound study participation or affect subject safety * allergies to study drugs, study drugs' excipients, medications related to study drugs * taking another investigational medication or medication prohibited for use during this study

Keywords: gw642444 copd fluticasone furoate
alterations in subgingival microbiota and hypoxia in occlusal trauma

Conditions: Chronic Periodontitis; Occlusal Trauma

Summary: present study suggests that excessive occlusal forces did not cause a significant change in hypoxia and vascular markers, however a slight alteration in subgingival microbiota was observed.

occlusal trauma is defined as tissue destruction and/or injury resulting in tissue changes in the periodontium as a consequence of excessive occlusal forces or hyper-occlusion. previous studies suggested accelerated periodontal destruction around teeth with occlusal trauma and increased mobility, however, the evidence is lacking. recent animal studies found that occlusal trauma increased osteoclastic activity and alveolar bone loss. one possible mechanism suggested for the progression of periodontal destruction with occlusal trauma is that tooth mobility creates a subgingival environment conducive to overgrowth by periodontal pathogens. however, the association of occlusal trauma and subgingival microbiota was not evaluated in previous studies. therefore, present study aimed to evaluate subgingival dental plaque components and compare with healthy individuals and periodontitis patients without occlusal trauma.

Eligibility criteria:
inclusion criteria: * systemical health * no drug use * no pregnancy or lactation for group 3 and 4; * bruxism at least for 2 years * occlusal trauma * existence of at least 20 functioning teeth exclusion criteria: * smoking * pregnancy/lactation * systemical disease * drug use * absence of at least 20 functioning teeth

Keywords: hyper-occlusion hypoxia occlusal trauma periodontitis subgingival microbiota
a study to assess the efficacy and safety of axs-05 in subjects with treatment resistant major depressive disorder

Conditions: Treatment Resistant Major Depressive Disorder

Summary: to evaluate the efficacy and safety of axs-05 relative to bupropion in subjects with treatment resistant major depressive disorder (mdd). this is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. the trial is being conducted in subjects with treatment resistant mdd. subjects will be considered to have treatment resistant mdd if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.


Eligibility criteria:
key inclusion criteria: * currently meets dsm-v criteria for mdd * history of inadequate response to 1 or 2 adequate antidepressant treatments * body mass index (bmi) between 18 and 40 kg/m2, inclusive * agree to use adequate method of contraception for the duration of the study * additional criteria may apply key exclusion criteria: * suicide risk * treatment with any investigational drug within 6 months * history of electroconvulsive therapy (ect), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months * pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study * additional criteria may apply

Keywords: axs-05 major depressive disorder treatment resistant depression trd mdd axsome nmda receptor refractory depression resistant depression depression
clinical features and airways inflammation in never smokers and smokers with copd

Conditions: COPD; Airway Obstruction; Inflammation

Summary: the aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (copd) in never smokers compared to smokers with copd.

40 copd patients (21 smokers and 19 never smokers) and 28 healthy never smokers were included in the present study. information about respiratory symptoms and comorbidities were collected. subjects underwent pulmonary function tests and copd was defined according to global initiative for chronic obstructive lung disease spirometric criteria. induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (interleukin-8 (il-8) and tumor necrosis factor-alpha (tnf-α)). the mann-whitney u and the χ2 tests were used for results comparisons. correlations between symptoms, spirometric parameters, cytokines levels, inflammatory cells and risk factors of copd were examined with spearman's rank correlation test.

Eligibility criteria:
inclusion criteria: * subjects with copd, according to gold criteria (smokers and never smokers). moreover, inhaled short-acting β2-agonists were stopped at least 8h before the test and inhaled long-acting β2-agonist were stopped at least 48h before the test. * healthy control subjects : never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms. exclusion criteria: * copd patients were excluded from the study if they had an exacerbation, a respiratory tract infection or if they used a systemic form of corticosteroid preparation (oral or intravenous injection therapy) or antibiotics within the two months prior to the study entry. patients with other respiratory disorder like pneumonia, pulmonary emboli, congestive heart failure, lung cancer or tuberculosis were also excluded.

Keywords: copd smoking induced sputum clinical features
comparison of two periarticular injection medications for adjunctive pain management following total knee arthroplasty (tka)

Conditions: Total Knee Arthroplasty

Summary: the investigators aim to study the efficacy of exparel as compared to marcaine, taking into account pain control, narcotic consumption, narcotic-related side effects, outcomes measures, and patient satisfaction. moreover, the investigators plan to perform cost-benefit analysis to evaluate whether use of exparel decreases analgesic consumption, duration of hospital stay and the need for physical therapy postoperatively, therefore, offsetting its higher price in comparison with marcaine.


Eligibility criteria:
inclusion criteria: all patients at least 18 years old who have primary unilateral tka for osteoarthritis performed at thomas jefferson university hospital. exclusion criteria: * american society of anesthesiologist (asa) score of 4 or higher * hepatic disease (contraindication for acetaminophen) * renal disease (contraindication for nsaids) * any contraindication for oxycodone, ketorolac, epinephrine, pregabalin, gabapentin, hydromorphone, tramadol, morphine or other narcotics that are considered as part of routine postoperative pain control protocol * fibromyalgia * any contraindication for intrathecal opioid injection * history of substance abuse during the last 2 years * history of allergy to amide compounds * current consumption of monoaminoxidase (mao) inhibitors and tricyclic antidepressant (tca) medications * allergy to metabisulfite compounds * chronic use of opioid medications in the month prior to surgery (leads to opioid tolerance and/or opioid-induced hyperalgesia) * body weight\ 40 kg/m2 * history of hypotension * patients with any surgery related complication in the first 4-6 weeks following tka, such as infection or mechanical failure
efficacy of erector spinae plane block for postoperative analgesia in adult patients undergoing thoracoscopy

Conditions: Pain, Postoperative

Summary: the erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. it consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. however, the analgesic efficacy has never been demonstrated in a randomized controlled trial. therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.


Eligibility criteria:
inclusion criteria: * patients scheduled for thoracoscopy * physical status i-iii exclusion criteria: * allergy to local anaesthetics * other contraindications to peripheral nerve blocks * patients suffering from chronic pain condition
quality of life and drug use in patients with car-t cells

Conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells

Summary: car-t cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) in 3rd line or more. kymriah® and yescarta® are the first car-t with marketing authorization and coverage by the french health insurance. their clinical interest has been demonstrated in non-comparative phase 1-2 trials. the non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of car-t (about € 320,000 for one treatment) warrant further studies. this prospective non-comparative study aims to describe in real life the quality of life of patients treated with car-t cells, real world drug use and patients' experience feedback.


Eligibility criteria:
inclusion criteria: * over 18 years old * eligible for treatment with car-t cells (outside any clinical trial) in an indication of dlbcl and for which treatment is scheduled * follow-up in the hematology department of the hospices civils de lyon * without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator * having given his non-opposition to participate in the study. exclusion criteria: * in an institution * under legal protection

Keywords: car-t cells quality of life drug use
pd-1 inhibitor based induction chemotherapy followed by de-escalation protocols in opscc

Conditions: Oropharyngeal Cancer

Summary: more and more studies have shown that the efficacy and prognosis of hpv （human papillomavirus）-positive oropharyngeal cancer (opc) patients are better than those of others. however, in the nccn (national comprehensive cancer network) oncology clinical guidelines for opc treatment, each group of p16+ is consistent with the corresponding group of p16-, which indicates that the treatment of opc is basically the same regardless of whether it is related to hpv. several studies attempted to reduce the toxicities of treatment of hpv related opc through reduced-dose radiation and showed promising results, and all of the studies have shown that induction chemotherapy is a good way to screen followed treatment. those who are effective in induction chemotherapy are usually more sensitive to radiation therapy, and reducing the intensity of subsequent treatment will not affect the survival outcome of patients. immune checkpoint inhibitors (icis) have proved to improve outcomes of head and neck cancers. however, in keymat-048, a phase iii controlled trial of relapsed/metastatic head and neck squamous cell carcinoma, icis showed an overall survival advantage, but the survival advantage was independent of hpv status. therefore, patients with hpv-negative opc still have a good response to icis. so we added anti-pd-1 antibody toripalimab to induction chemotherapy in order to achieve better response rates to receive de-escalation chemoradiotherapy followed regardless of whether it is related to hpv.


Eligibility criteria:
inclusion criteria: histological diagnosis of squamous cell carcinoma of oropharynx; ihc p16 positive or pcr hpv16 positive; ihc p16 negative or pcr hpv16 negative; t3-4n0-3m0 or t1-2n2-3m0 according to uicc/ajcc 8th staging system; age ≥18; no prior anti-tumor treatment; informed consent obtained; eastern cooperative oncology group (ecog) performance status of 0 or 1; normal complete blood count; normal hepatic function; normal renal function (creatinine ≤ 1.5 times the upper limit of normal). - exclusion criteria: previous radiotherapy; a history of any other type of malignancy; pregnancy or lactation; obvious disfunction of liver, renal, cardiac or lung function; un controlled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases; patients with mental disorders affecting patient participation in trial judgement. -

Keywords: oropharyngeal cancer immune checkpoint inhibitor induction chemotherapy de-escalation hpv-related hpv-unrelated
evaluation of a probiotic (bifidobacterium in the treatment of infantile colic (ic)

Conditions: Infantile Colic

Summary: infantile colic (ic) criteria includes all of the following in subjects aged ≤ 4 months: paroxysms of irritability, fussing, or crying that start and stop without obvious cause; episodes lasting 3 or more hours per day and occurring at least 3 days per week for at least 1 week; and no failure to thrive. the condition is very common in the first 4 months of life (10-30 % of infants) with a peak prevalence at 6-8 weeks and is characterized by excessive and inconsolable crying without an identifiable cause. infantile colic cause considerable stress for the baby and the family, huge medical expenses (the ic cause 10-20 % of all pediatric visits in the first 4 months of life) and frequent formula changes. the pathophysiology of ic is still poorly defined, but differences in gut microbiota composition seem to be involved. in particular, differences in the number and species of lactobacilli spp, klebsiella spp and escherichia coli spp have been demonstrated in subjects with ic, and it has been postulated that these alterations could be responsible for an abnormal gas production within gut lumen resulting in distension and abdominal pain. these findings suggest the potential role of probiotics as preventive and therapeutic strategy for the ic.


Eligibility criteria:
inclusion criteria: * exclusively breastfed healthy infants of both sex, aged ≤ 7 weeks; * diagnosis of ic according to rome iii criteria * written informed consent of the parent/tutor exclusion criteria: * birth weight\<2500 g * gestational age\<37 weeks * apgar 5 minutes \<7 * formula feeding * abnormal body growth/loss of weight (\<100 g/weeks from birth to the last reported weight) * neurological diseases * known or suspected food allergy * gastroesophageal reflux disease * use of substances that alter gut microbiota (pre/pro/synbiotic, antibiotics, gastric acidity inhibitors) or any anti-colic drug in the last 2 weeks prior the enrollment * history of fever and/or infectious diseases in the last 2 weeks prior the enrollment * ongoing systemic infections * history of congenital infections * chronic intestinal diseases (cystic fibrosis or other forms of pancreatic insufficiency primitive) * malformation of the gastrointestinal (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation), urinary or respiratory tract * metabolic diseases * genetic diseases and chromosomal abnormalities * primary or secondary immunodeficiencies * not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the protocol * previous participation in this study
overture metabolomics non-selection study

Conditions: Infertility

Summary: in this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (ivf) culture, prior to vitrification and embryo transfer for testing via metabolomic screening. metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. these analytes can be used to determine the implantation potential, and ploidy, of the embryo. this study will take place at multiple locations in the united states and spain.

patients will undergo ovarian stimulation, egg retrieval and fertilization of oocytes through intracytoplasmic sperm injection (icsi). all fertilized oocytes will be cultured up to blastocyst for five to six days. spent media will be collected on day 5-6 for all embryos reaching blastocyst on day 5, and on day 6 for those reaching blastocyst on day 6. the spent culture media will be sent to a lab for metabolomic analysis. details of sample collection and analysis are provided in sections 6.3.1 \& 6.3.2. single embryo transfer will be performed with the best morphology blastocyst being selected for transfer by the new hope embryologist. approximately 8-11 days after the embryo transfer, the patient will return to the clinic for a serum pregnancy test. should the test be negative, they will be closed out of the study. should the test be positive, they will continue to be monitored. the patient will return to the clinic at approximately 8 weeks after embryo transfer for a serum pregnancy test, and an ultrasound to detect fetal heartbeat. the outcome will be documented, and the patient monitored until 12 weeks of gestation at which time they will be closed from the study. the embryo transfer outcome will be compared to mpi and mei result to determine the npv and ppv of metabolomics vs implantation.

Eligibility criteria:
inclusion criteria: * women of any age, including egg donors. 50% will be \<35 and the rest 35 and older. * signed subject consent form. no inferior limit on number of eggs exclusion criteria: at the time of initial visit: * require or request pgt of any kind * low ovarian reserve defined as follicle stimulating hormone (fsh) \>10 iu/l on day 2-4 of a prior menstrual cycle and anti-mullerian hormone (amh) \<15 pmol/l (or \<2 ng/ml) within prior 12 months of cycle start at the time of embryo selection: -patients without at least one embryo to transfer.

Keywords: ivf genetic screening preimplantation genetic testing