Kornimate/medical-research-clean huggingface dataset:
clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia

Conditions: Acetaminophen,Mechanical Ventilation,Critically Ill Children

Summary: patients were randomized to receive either paracetamol during mechanical ventilation. when patients were randomized to receive paracetamol (40 mg/kg per day in 4 doses), a placebo infusion of normal saline was administered continuously at the same rate as an equivalent infusion. placebos could not be distinguished from the active study drug in color, odor, or viscosity. in both study groups, imv was maintained with sufentanil (0-0.2 mcg/kg/h), propofol (0-4 mg/kg/h), and dexmedetomidine (0-1 mcg/kg/h). assessment of sedation levels by the bedside nurse using the flacc pain scale to determine if the child is adequately comfortable or in need of more or less medication to maintain adequate ventilation. assessment of sedation levels by the bedside nurse using the flacc pain scale (every 6 hours as a minimum time interval).


Eligibility criteria:
inclusion criteria: * inclusion criteria were body weight greater than 1500 g; and mechanically ventilated patients with confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. exclusion criteria: * exclusion criteria were admitted with a tracheostomy in situ; extracorporeal membrane oxygenation treatment; neurologic dysfunction, hepatic dysfunction, or renal insufficiency; known allergy to or intolerance for paracetamol; and administration of paracetamol in the 24 hours prior to mechanical ventilation.
clinical impact of lung ultrasound monitoring for diagnosis of vap

Conditions: Ventilator Associated Pneumonia

Summary: the study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. half of the participants will be diagnosed with vap using a combination of lung ultrasound and clinical features and half will be diagnosed using the johanson criteria, which is a combination of clinical features and chest x-ray.

the current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of vap. however many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure. emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. when combined with clinical and microbiological features it has shown to be helpful in early diagnosis of vap, but a study to show whether such early detection improves outcome is lacking.

Eligibility criteria:
inclusion criteria: * mechanical ventilation for more than 48 hours * absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis) exclusion criteria: * recent trauma or surgery to the thorax (including chest tube insertion) * presence of dressings or skin conditions restricting access to the thorax * confirmed pregnancy * if already enrolled in the study * denial of consent

Keywords: ventilator associated pneumonia lung ultrasound
the effects of high energy acoustic shock wave therapy on local skin perfusion and dfus

Conditions: Diabetic Foot Ulcer

Summary: this is an observational, single-arm, on-label study. this clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. all subjects will receive standard of care treatment which includes dfu treatments with the dermapace device.

the dermapace system will be used according to label along with standard of care. perfusion will be measured using tcpo2 methods and also using cleared hyperspectral imaging equipment. the intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermapace treatment, during the treatment period, and two weeks post treatment period

Eligibility criteria:
inclusion criteria: 1. is male or female ≥22 years of age at visit 1; 2. wagnergrade 1 or 2 dfu; 3. in the leg with the target ulcer has an abi \> 0.70 and \ 1.20 has a toe pressure \>50 mmhg at visit 1 4. has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit. 5. has type i or type ii diabetes mellitus; 6. hba1c \< 12% at visit 1; 7. patient is willing to comply with all study requirements and treatment visits. 8. patient is willing to comply with off-loading directions. 9. patient is willing to comply with offloading instructions exclusion criteria: * potential subjects who meet any of the following criteria will be excluded from participating in the study. a subject who: 1. is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating; 2. known or suspected systemic infection; 3. enrolled in another investigational study; 4. has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment; 5. subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment; 6. unable to tolerate offloading footwear or total contact casting (tcc); 7. has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at visit 1 or 2; 8. has active charcot foot at visit 1 or 2; 9. has osteomyelitis in the foot or ankle on which the target ulcer is located at visit 1 or 2
a comparison of gastric ph control with high dose intravenous or oral esomeprazole

Conditions: Gastrointestinal Hemorrhage

Summary: the investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric ph near neutral and that ph control with esomeprazole given in such a high dose either intravenous or orally is identical.

bleeding peptic ulcer is a common and life threatening condition. endoscopic therapy has become the mainstay of controlling bleeding. recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. we previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome \[lau jy n engl j med 2000\]. the newer ppi, esomeprazole, is an s-isomer of omeprazole. esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. the gastric ph with a high dose esomeprazole when given either orally or intravenously has not been measured among hong kong chinese. if a high dose oral esomeprazole achieves a similar ph control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. this represents significant convenience in dosing and cost savings.

Eligibility criteria:
inclusion criteria: * patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80 * endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained * absence of h. pylori infection * informed written consent exclusion criteria: * known incompatibility to the study drugs; * known incompatibility and hypersensitivity to proton pump inhibitor * h. pylori infection * recent h2ra or ppi use (within last 4 weeks) * concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone) * pregnancy or lactation; * non-compliance e.g. mental subordination * nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter * significant liver disease as ppi is metabolized by the cytochrome p-450 system * previous gastric surgery * chronic aspirin user * presence of esophageal/ gastric varices * moribund patients, terminal malignancy \& patients with severe renal disease * patient unable to give written consent

Keywords: 24 hours ph monitoring
multidisciplinary prehabilitation management pathway and network platform construction

Conditions: Lung Cancer; Prehabilitation

Summary: the goal of this clinical trial is to learn if "prehabilitation model for internet+ devices"improve patients' preoperative status and reduce the postoperative recovery time, postoperative complications，comparing to trditional prehabilitation model. the main questions it aims to answer are: 1. does the prehabilitation model for internet+ devices works out? 2. does"prehabilitation model for internet+ devices" better increase the patient's six-minute walk test distance? participants will: take internet+devices model or traditional model to prehabilitation for 2-4weeks. test 6mwt before operation.


Eligibility criteria:
inclusion criteria: 1. age: 18-75 years; 2. adults with suspected lung cancer proposed for vats lobectomy/sublobar resection. exclusion criteria: 1. patient refusal; 2. asa classification iv or higher; 3. pre-neoadjuvant chemotherapy; 4. inability to cooperate (psychiatric abnormalities, impaired consciousness, mental retardation); 5. comorbidities cannot tolerate home rehabilitation or functional motor examination; 6. inability to use a smartphone or read chinese; 7. average weekly moderate-intensity/high-intensity exercise of \>90min/\>60min.
moderate whole body hyperthermia for patients undergoing re-irradiation for head and neck cancer -influence on the tumor microenvironment

Conditions: Head and Neck Neoplasms; Recurrence Tumor

Summary: the aim of the study is to determine the feasibility and efficacy of moderate weekly whole body hyperthermia treatment during radiochemotherapy for pre-irradiated locally or regionally recurrent head and neck squamous cell carcinomas. the primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia. secondary endpoints include an increase of tumor perfusion by the use of hyperthermia, measured by magnetic resonance imaging during week two of treatment and reduction of tumor hypoxia, measured by hypoxia specific positron emission tomography.

previously irradiated patients with loco/ loco-regional recurrent head and neck squamous cell carcinomas usually undergo re-irradiation. however prognosis of these patients is unfavourable, especially for non-human papilloma virus associated cancers. moderate whole body hyperthermia will be performed by water-filtered ir-a-radiation using a heckel-ht3000 device. preclinical data have indicated that moderate whole body hyperthermia decreases intratumoral interstitial fluid pressure and leads to increased perfusion of the tumor. the study investigates if this holds also true in patients and leads to a marked decrease of tumor hypoxia, measured by 18f-fluoromisonidazole pet. the primary aim of the study is feasibility, defined as 80% of patients completing at least four applications of hyperthermia. secondary endpoints include an increase of tumor perfusion by the use of hyperthermia, measured by magnetic resonance imaging during week two of treatment and reduction of tumor hypoxia, measured by hypoxia specific positron emission tomography.

Eligibility criteria:
inclusion criteria: * patients with unresectable local, regional or loco-regional recurrent non hpv-associated squamous cell head and neck cancer with prior high-dose radiotherapy of the head and neck region * time interval of 6 months to 5 years after completion of last radiotherapy of the head and neck region * completed staging examinations, preferentially 18f-fluorodeoxyglucose (fdg) pet of the whole body * general health condition according to ecog status of 0,1 or 2 * age between 18 and 75 years * written informed consent exclusion criteria: * hpv associated primary tumor or recurrent tumor * recurrence more than 5 years after end of previous radiotherapy * any medical circumstances impeding the application of radiotherapy, concomitant chemotherapy or whole body hyperthermia

Keywords: head and neck squamous cell carcinoma hyperthermia hypoxia 18f-fluoromisonidazole positron emission tomography fmiso pet whole body hyperthermia local recurrence lymph node recurrence radiochemotherapy
millet products study - investigation of glycemic index and satiety

Conditions: Hyperglycemia; Lack of Satiety

Summary: the purpose of this study is to investigate how millet incorporation into different baked product types influences glycemic response and satiety.

the purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety. this project will examine the effect of millet, on glycemic response and satiety. to determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit. all product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.

Eligibility criteria:
inclusion criteria: * men, age 19-40, non-smoking * normal fasting plasma glucose (\<5.6 mmol/l but not below 3.6 mmol/l) * normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. \<7.8 mmol/l but not below 3.6 mmol/l) * bmi ranging from 18.5 to 29.9 kg/m2 exclusion criteria: * insulin resistance (ir) will be calculated from fasting glucose and insulin values using the homeostasis assessment model 2 (homa2). a homa2-ir value of greater than 1.0 will be considered indicative of insulin resistance (levy j.c. et al. 1998). * regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week * smoking or use of recreational drugs * heavy alcohol use (defined as typically \>14 drinks per week or \>4 drinks on one occasion) * very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings. * restrained eater as defined by the questionnaire at screening (three factor eating questionnaire, stunkard et al.,1985) * food neophobic defined by food neophobia scale questionnaire * unusual sleep patterns or irregular breakfast consumption * recent (i.e. \>4 kg in previous 3 months) or intended weight loss or gain * food allergies or any life-threatening allergy (food or otherwise) * inflammatory bowel disease or other gastrointestinal disorders * use of drugs which influence carbohydrate metabolism * training or elite athletes * inability to adhere to study protocols
phase ii study in patients with recurrent non-small-cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: determine tumor response rate and time to disease progression, survival and safety in total populations.

to determine the tumor response rate and time to disease progression, survival and safety in the egfr-positive, egfr-negative and total populations.

Eligibility criteria:
inclusion criteria 1. subjects with recurrent or progressive nsclc with either present or prior histologic confirmation or pathologic confirmation of nsclc 2. subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination 3. unidimensionally measurable nsclc 4. subjects with tumor tissue available for egfr assessment 5. ecog performance status of 0 or 1 6. subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids exclusion criteria 1. women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. male subjects must also have agreed to use effective contraception 2. women of childbearing potential using a prohibited contraceptive method 3. women who were pregnant or breastfeeding 4. women with a positive pregnancy test on enrollment or prior to study drug administration.

Keywords: non small cell lung cancer
psma-rlt in biochemically recurrent pca

Conditions: Prostate Cancer Recurrent

Summary: prospective single-center one-arm phase ii study in patients with prostate cancer and confirmed biochemical recurrence (bcr) with psa of ≥ 0.2 ng/ml after radical prostatectomy (rp) or psa \> nadir + 2ng/ml after radiotherapy (rt) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 gbq in first cycle and 6 gbq in the second cycle) psma-rlt at 6-week intervals.


Eligibility criteria:
inclusion criteria: * patients with biochemical recurrence after radical prostatectomy and radiotherapy with a psa doubling-time (dt) of ≤ 12 months. * no hormonal therapy within the last 12 months or recovered testosterone levels. * psma pet negative result for local recurrence; presence of distant metastases is allowed: (cn0, cm0/cm1). * eastern cooperative oncology group (ecog) performance status: 0-1 * patients must have adequate bone marrow reserve: wbc ≥1.5 x 109 /l, platelets ≥100 x 109 /l and haemoglobin ≥9 g/dl. * patients must have adequate renal function with egfr ≥ 50ml/min/1.73m2 using the modification of diet renal disease (mdrd) equation and an albumin level of ≥2.5 g/dl. * patients must be able to sign informed consent form. exclusion criteria: * concomitant participation in any other interventional trial. * concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year. * presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study. * complete urinary out-flow obstruction or severe unmanageable urinary incontinence.

Keywords: [177lu]lu-psma i&t psma-radioligand therapy biochemical recurrence prostate cancer psa value
levofloxacin ocular implant for ocular surgery

Conditions: Cataract

Summary: this is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single levofloxacin ocular implant in the posterior sulcus of the surgical eye at the end of cataract surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of cataract in the intent to treat eye * endothelial cell density in the study eye of at least 2000 cells per mm2 exclusion criteria: * history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema * recent surgery in the study eye * subjects receiving a glaucoma device in conjunction with cataract surgery * subjects with a compromised posterior capsule during surgery * corneal disease that prevents effective imaging of endothelium including fuch's dystrophy. * sensitivity to fluoroquinolones
effectiveness of levonorgestrel-intrauterine system (lng-ius) versus depot medroxyprogesterone acetate (dmpa) in treatment of pelvic pain in clinically diagnosed endometriotic patients

Conditions: Endometriosis

Summary: randomized controlled trial eligiblility criteria provisional diagnosis clinical presentation progressive dysmenorrhea chronic pelvic pain deep dyspareunia evidences of endometriosis endometriotic nodule cul-de-sac nodularity endometrioma detected by ultrasonography size \< 4 cm inclusion criteria female age 18-45 yr moderate to severe pelvic pain categorized by vas \>50 previous sexual intercourse exclusion criteria co-existing other genital tract disease associated pain previous hormonal use within 3 months history of dmpa treatment failure who eligibility criteria 2009 for dmpa and lng-ius category 3,4 fertility desire in upcoming 1 year primary objective to compare efficacy of pain control in endometriosis associated pelvic pain between lng-ius and dmpa secondary objective to compare side effect, continuation rate, satisfaction and quality of life between lng-ius and dmpa in treatment of endometriosis associated pelvic pain primary outcome severity of pelvic pain measured by vas score 0 mean no pain 100 mean most pain secondary outcomes vaginal bleeding pattern side effects of systemic progestogen lipid profiles weight gain quality of life measured by quesionaire sf36 satisfaction measrured by linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3 satisfied 4 very satisfied continuation rate endometrioma size reduction


Eligibility criteria:
inclusion criteria: * female age 18-45 yr * moderate to severe pelvic pain categorized by vas \>50 * previous sexual intercourse exclusion criteria: * co-existing other genital tract disease associated pain * previous hormonal use within 3 months * history of dmpa treatment failure * who eligibility criteria 2009 for dmpa and lng-ius category 3,4 * fertility desire in upcoming 1 year
pharmacokinetic, safety and tolerability study of aclidinium/formoterol fixed dose combination and formoterol in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this phase ii study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (fdc 400/12 μg via the almirall inhaler and formoterol 12 μg via the foradil® aerolizer®, both administered twice daily for five days to patients with moderate to severe copd.


Eligibility criteria:
inclusion criteria: * current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years * a diagnosis of stable moderate to severe copd and stable airway obstruction as defined by the global initiative for chronic obstructive lung disease guidelines and stable airway obstruction. exclusion criteria: * patients who have been hospitalized for an acute copd exacerbation within three months prior to screening * any respiratory tract infection (including the upper respiratory tract) or copd exacerbation in the six weeks before screening * patients with any clinically significant respiratory conditions other than copd * clinical history that suggests that the patient has asthma as opposed to copd * chronic use of oxygen therapy ≥ 15 hours/day * patients with clinically significant cardiovascular conditions * patients with a history of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medications

Keywords: copd chronic obstructive pulmonary disease chronic bronchitis emphysema airflow obstruction, chronic chronic airflow obstruction chronic obstructive airway disease chronic obstructive lung disease