Kornimate/medical-research-clean huggingface dataset:
oxygenation methods and non-invasive ventilation in patients with acute respiratory failure and a do not intubate order

Conditions: Acute Respiratory Failure; Cancer; Hematologic Malignancy; Cardiac Insufficiency; Chronic Respiratory Insufficiency

Summary: icu care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. the benefits of non invasive ventilation (niv) in this population are debated especially in cancer patients. the more recently used nasal humidified high flux canula oxygenation (hfnc) therapy may have benefits over niv in these patients. it is supposed to have better tolerance and could allow better compliance and thus higher efficiency. these potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

observational prospective multicenter study primary outcome: to analyze the efficacy and tolerance of niv and hfnc in patients admitted to intensive care unit, or intermediate catre unit for acute respiratory insufficiency for whom a a do-not intubate order decision was taken upon admission or after extubation if the patient initially received mechanical ventilation. secondary outcomes: to analyze the efficacy and tolerance of niv and hfnc according to the following reason for icu admission: chronic obstructive pneumopathy decompensated copd, severe heart failure, evolutive cancer or hematologic malignancy; to analyze tolerance and acceptability of different techniques; to analyze the duration of the oxygenation methods use; to analyze the modalities of eventual withdrawing life support therapies and the associated sedative and opioid treatments; to analyze the satisfaction for the use of the non invasive technique by the relatives and the caregivers; to analyze mortality at d28 and d90 and quality of life at 3 and 6 months in surviving patients

Eligibility criteria:
inclusion criteria: * acute respiratory failure defined by respiratory rate\>25/min and or hypoxemia (spo2 \ 3l/min) * admission in icu or intermediate care unit * decision to not intubate the patient or to not re-intubate the patient * indication to niv or hfnc-o2 * french social security affiliation exclusion criteria: * refusal to participate * legal protection * pregnancy * prophylactic treatment by vni or hfnc-o2 after extubation

Keywords: non-invasive ventilation nasal high flow humidified canula oxygenation palliative acute respiratory failure withholding therapies withdrawing therapies
co-bedding as a comfort measure for twins undergoing painful procedures

Conditions: Neonatal Procedural Pain Response

Summary: a rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to neonatal intensive care units. skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. the main question of this study is whether the contact of a twin could provide a similar form of comfort. sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. primary outcome will be physiologic and behavioral pain response. if found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Eligibility criteria:
inclusion criteria: * all medically stable twin infants admitted to the nicu who are: 1. free from infection; and 2. breathing room air or receiving oxygen via nasal prongs. * twins may be receiving feeds via gavage tubes, iv therapy via peripheral or central line, and may be experiencing periods of apnea. exclusion criteria: * weigh less than 1000 grams; * receiving ventilator support; * have chest tubes or umbilical catheter in situ; * have major congenital anomalies or chromosomal aberrations; or * if only one of the twins require overhead phototherapy.

Keywords: co-bedding procedural pain twin comfort rct
relationship between musculoskeletal, sensorimotor and functional factors and nonspecific chronic neck pain

Conditions: Neck Pain

Summary: several factors have been associated with neck pain. controversy exists regarding the degree of association between some of these factors and neck pain. information regarding the degree of association of each factor to neck pain is needed for effective prevention and appropriate treatment strategies. the aim of this study is to investigate the association among musculoskeletal, sensorimotor factors and functional disability and occurrence of chronic nonspecific neck pain.


Eligibility criteria:
inclusion criteria: * for subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale. * for healthy subjects: no history of neck pain exclusion criteria: * history of cervical discopathy * any surgery on neck * traumatic neck injury * any congenital disorders
obtain additional information on use of cormatrix ecm (extracellular matrix)

Conditions: Coronary Disease

Summary: the objective of the study is to actively gather additional information on the use of cormatrix ecm for pericardial reconstruction.

up to 100 clinical sites will enroll subjects who have received cormatrix ecm for pericardial reconstruction. the following clinical data will be collected at a single post-operative visit: * demographic information * pre-operative risk factors * surgical procedure * blood transfusion information, if applicable * chest tube placement information * surgical complications * use of anticoagulation medication * cardiac related procedures since surgical procedure * device related adverse events

Eligibility criteria:
inclusion criteria: * subjects who have received cormatrix ecm for pericardial reconstruction * sign an informed consent exclusion criteria: * none

Keywords: open heart surgery, cardiac repair
inhalation slit cisplatin (liposomal) for the treatment of osteosarcoma metastatic to the lung

Conditions: Osteosarcoma Metastatic

Summary: phase ib/iia open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (slit cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.


Eligibility criteria:
inclusion criteria: * histologically proven, progressive or recurrent high grade osteosarcoma metastatic to the lung * patients with histologically proven, fully malignant high-grade osteosarcoma of bone * measureable pulmonary metastases * less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function * ecog performance status of 0, 1 or 2 * fev1 of 50% or greater of predicted value * fev1/fvc ratio of 65% or greater * serum creatinine of ≤ 1.5 mg/dl * total bilirubin ≤ 1.5mg/dl and sgot or sgpt \< 2.5 times upper normal limit * anc of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3 exclusion criteria: * grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen * patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy * concurrent systemic chemotherapy * greater than grade 2 pulmonary toxicity * pulmonary atelectasis * reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy * concurrent serious infections * unstable or serious concurrent medical condition * recent major surgery or thoracic radiation therapy or chemotherapy * significant pulmonary fibrosis secondary to prior radiation * major ventilatory distribution abnormalities * osteosarcoma secondary to radiation or premalignant conditions * history of prior malignancy * low grade osteosarcoma, parosteal or periosteal sarcoma

Keywords: osteosarcoma relapsed progressive metastatic lung
immune profiling of covid19-patients admitted to icu

Conditions: COVID-19

Summary: sars-cov-2 is the novel coronavirus responsible for covid-19, coronavirus disease 2019. this new coronavirus was first detected in wuhan, china in late december 2019. according to who, the incidence rate of covid-19 is prominent among adults and elderly people, reaching so far \>2 million cases globally. meanwhile, confirmed death cases reached \>126 thousands of reported cases in 185 countries and still increasing. we anticipate that immunological differences among covid19-infected patients might be a reason behind the variation of patient outcomes. therefore, we intend to investigate cellular and humoral immune responses of covid19-positive patients, and we claim to discover new indicators of patients' prognosis. our target population includes three categories of patients staying at icu, hmc (covid19-positive vs. covid19-negative vs. healthy control). throughout their icu stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. such parameters can provide the more comprehensive status of covid19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. following analysis, the main prospective outcome of this study is to identify the most reflective markers of covid19-positive patients' outcomes.


Eligibility criteria:
inclusion criteria: * admitted to icu for suspicious covid-19 * signed consent form exclusion criteria: * immuno-compromised or immuno-deficient patients * diagnosed with any immunological disorders, cancer, and onco-hematological diseases at the inclusion date * patients under treatment or treated within 5 years before inclusion or at the end of chemotherapy within the 6 months prior to inclusion date * patients under any immune-suppressive medications, antibody therapy, corticosteroids, bone marrow transplant under the last 6 months of inclusion * unsigned consent form

Keywords: covid-19 sars-cov-2 icu immune profiling humoral immunity cellular immunity
placebo controlled, randomized safety and efficacy study of rc-1291 in cancer anorexia/cachexia

Conditions: Cancer Cachexia

Summary: activation of ghrelin receptors have been demonstrated to stimulate appetite. rc-1291 hcl, by virtue of its ghrelin like activity and growth hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. this placebo controlled study will evaluate the safety and efficacy of rc-1291 hcl in cancer patients with cachexia.

anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. activation of ghrelin receptors have been demonstrated to stimulate appetite. rc-1291 hcl, by virtue of its ghrelin like activity and growth hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. this placebo controlled study will evaluate the safety and efficacy of rc-1291 hcl in cancer patients with anorexia and cachexia.

Eligibility criteria:
inclusion criteria: * community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer. * involuntary loss of body weight greater than 5% within the past 6 months exclusion criteria: * presently hospitalized or in a nursing care facility. * inability to increase food intake from secondary causes. * liver disease * if female-pregnant, breast-feeding or of childbearing potential.
efficacy of pons in reducing symptoms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this pilot study is to determine whether a program involving both in-lab and at-home training using cranial nerve stimulation (cn-ninm) delivered via the tongue can reduce symptoms of multiple sclerosis (ms) and improve movement control and therefore provide ground work for a controlled clinical trial. the effects of the stimulation will be measured using a variety of standardized tests of movement control and cognitive function, functional brain imaging, and ms-specific surveys of your quality of life.

fourteen ms patients, seven each in an active and a sham stimulation group are expected to participate. participants will receive intensive physical therapy and working memory training for 14 weeks. functional magnetic resonance imaging (fmri) using motor imagery and working-memory tasks will be completed prior to and following therapy, as will be sensory organization tests (sot), motor performance measures, and neuropsychological assessment. prior to the start of cn-ninm training, each participant will undergo baseline evaluations including structural and fmri, balance tests (sot), dynamic gait index (dgi), neuropsychological assessment (handedness; wechsler abbreviated scale of intelligence (wasi) vocabulary and matrix reasoning; california verbal learning test (cvlt)-11; d-kefs trails, color/word and verbal fluency; tower of london second edition; ruff 2 and 7; wechsler adult intelligence scale fourth edition (wais-iv) letter-number sequencing, coding and symbol search; paced auditory serial addition test (pasat); leonard tapping; and grooved pegboard). in addition, the ms impairment scale, fatigue impact scale, cognitive function inventory for ms, and beck depression and anxiety questionnaires will be completed.

Eligibility criteria:
inclusion criteria: * relapsing/remitting or secondary progressive ms with balance and gait problems; * recent edss score of 3.0 - 6.0; * provided informed consent and willing to participate exclusion criteria: * use of tobacco products; * oral health problems including abrasions, cuts, cold sores, piercings, or tissue inflammation in the oral cavity; * baseline edss \>6.
effects of i-prf on non-surgical periodontal treatment

Conditions: Platelet-Rich Fibrin

Summary: injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. the low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. it also contributes to the wound-healing process by increasing vascularization. it is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. for this reason, in this study it was aimed to investigate the early effects of injectable prf applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid

the study was planned as a randomized controlled split-mouth clinical trial. a split-mouth design was used to better assess how the same host responded to two different treatment modalities. two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups. test group: injectable platelet-rich fibrin application into the selected deep periodontal pocket after scaling and root planning (srp) procedure. control group: no agent was applied to the periodontal pocket after scaling and root planning. on the first visit, clinical periodontal measurements were taken before the srp procedure. plague index (pi), gingival index (gi), probing depth (pd), clinical attachment level (cal), and bleeding on probing (bop) were used as clinical periodontal parameters. after 1 week, the patients were called again for the srp procedure. injectable prf obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the srp procedure in the test group. clinical periodontal measurements at 1 month and 3 months after srp were repeated. gingival crevicular fluid (gcf) samples were taken from selected teeth before the srp procedure. on the 3rd and 7th day after the srp, gcf samples were taken again from the same region. gcf vascular endothelial growth factor (vegf), tumor necrosis factor-alpha (tnf-α), and interleukin (il)-10 levels were evaluated by using the elisa method and compared between groups.

Eligibility criteria:
inclusion criteria: * patients with stage 3 grade b periodontitis exclusion criteria: * patients with systemic disease * pregnant and breastfeeding * acute or chronic infection in the past 6 months * use of systemic antibiotic therapy in the past 6 months * use of drugs that can affect periodontal health * receiving hormone therapy * smokers * teeth with endodontic lesions * teeth with class 2 and 3 mobility

Keywords: platelet-rich fibrin non-surgical periodontal treatment wound healing growth factor cytokine
efficacy and tolerability of treatment with lanthanum carbonate in patients with end stage renal disease receiving dialysis

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to assess phosphate reduction and control in patients with end stage renal disease treated with lanthanum carbonate


Eligibility criteria:
inclusion criteria: * males and females of childbearing potential agree to take adequate precautions to prevent contraception * patients diagnosed with esrd must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study * patient requires treatment for hyperphosphataemia exclusion criteria: * pregnant or lactating women * patients who continue to require treatment with compounds containing calcium, aluminum or magnesium * patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma * patients who are hiv+ * patients with any significant gastrointestinal surgery or disorders
cognitive fusion prostate biopsy with biparametric magnetic resonance in the detection of prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Diagnosis

Summary: the goal of this prospective observational study is to evaluate the diagnostic precision of the biparametric magnetic resonance imaging (bpmri) in the detection of clinically significant prostate cancer (pca) in patients with biochemical suspicion of prostate cancer with psa (prostate specific antigen) \> 4 ng/ml and a normal digital rectal examination and without a biopsy previous to the mri. secondary aims are: * determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpmri. * develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpmri.

in spain, pca is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern. pca generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated prostate specific antigen (psa) in blood test and/or a pathologic digital rectal examination. multiparametric magnetic resonance imaging (mrimp) plays an important role in the diagnosis. it allows the visualization of the tumor, it values its agresitivity with a scale named "prostate imaging-reporting and data system" (pi-rads v2 scale), and permits a directed biopsy to the suspicious lesion. this tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with pca suspicion. biparametric mri emerges as an alternative with a new protocol, performed with less image sequences (t2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. thus, this technique is more assumable by a public sanitary system.

Eligibility criteria:
inclusion criteria: * male patients between 18 and 80 years * bpmri performed in a 3 months period before the prostatic biopsy * first transrectal prostatic biopsy * psa \> 4 ng/ml and \< 20 ng/ml * patients acceptance to participate in the study signing a written specific informed consent exclusion criteria: * not having all the inclusion criteria described * suspicious digital rectal examination of prostate cancer * previous urinary tract infection in the last six months, acute urinary retention or being a chronic carrier of bladder catheter * previous prostatic surgery in any of its variants * concomitant treatment with luteinizing hormone-releasing hormone (lhrh) analogue, antiandrogens or 5-alfa-reductase inhibitors
a study to learn how different amounts of the study medicine danuglipron are taken up into the blood in otherwise healthy adults with overweight or obesity

Conditions: Obesity

Summary: the purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: * how the study medicine, danuglipron, is taken up into the blood * about the safety and tolerability of danuglipron the total number of weeks of the study is about 15 (about 4 months).


Eligibility criteria:
key inclusion criteria: * 18 years of age or older * body mass index (bmi) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb) key exclusion criteria: * evidence or history of any clinically significant medical conditions or laboratory abnormality * any condition possibly affecting drug absorption * known intolerance/hypersensitivity to a glp-1r agonist

Keywords: overweight obesity danuglipron glp-1 overtly healthy