Kornimate/medical-research-clean huggingface dataset:
comparison of insulin degludec with insulin glargine in subjects with type 1 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial was conducted in europe. the aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months * subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator * body mass index (bmi) between 18.0 and 28.0 kg/m\^2 (both inclusive) * glycosylated haemoglobin (hba1c) below or equal to 10.0 % based on central laboratory results * subject with a daily basal insulin requirement of between 0.2 iu/kg/day and 0.6 iu/kg/day will be allowed to participate in the trial. current total daily treatment with insulin must be less than 1.2 u/kg/day exclusion criteria: * known or suspected allergy to trial product(s) or related products * subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing * subject who has donated any blood or plasma in the past month or in excess of 500 ml within the 12 weeks preceding screening
reaching a caloric goal using a gastric sonar versus aspiration of gastric contents in critically ill patients receiving nasogastric enteral nutrition

Conditions: Enteral Nutrition Intolerance in Critically Ill Patients

Summary: enteral nutrition intolerance, manifested in delayed gastric emptying and high gastric residual, is a common problem in critically ill patients in intensive care, with adverse consequences on patients' outcomes. a decrease in the levels of the ghrelin hormone in these patients may contribute to this problem. the gastric residual test (grv) is used to assess enteral absorption and gastric motility, but the traditional methods can lead to inaccuracy and waste of resources. in recent years, the use of ultrasound (pocus) to assess grv has developed, but its effect on the rate of reaching the caloric goal has not yet been evaluated.


Eligibility criteria:
inclusion criteria: adult intensive care patients who recieve enteral nutrition via nasogastric tube - exclusion criteria: 1. pregnant patient 2. history of bariatric or other gastric surgery 3. post-operative patients with sub-costal incision 4. diaphragmatic hernia 5. patients who recieve parenteral nutrition 6. technically difficult us exam -
effects of tdcs and tus on pain perception in oa of the knee

Conditions: Chronic Pain; Osteoarthritis

Summary: the purpose of this study is to investigate the effects of transcranial direct current stimulation (tdcs) in conjunction with transcranial ultrasound (tus) on pain perception and functional limitations in people with osteoarthritis of the knee. the investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.


Eligibility criteria:
inclusion criteria: 1. able to provide informed consent to participate in the study. 2. subjects between 18-85 years old. 3. diagnosis of chronic osteoarthritis with pain of either knee as self-reported. 4. existing knee pain of at least 3 on a 0-10 vas scale on average over the past 6 months. 5. pain of at least 3 on a 0-10 vas scale on average over the week prior to the first stimulation session. 6. pain resistant to common analgesics and medications for chronic pain used as initial pain management such as tylenol, aspirin, ibuprofen, soma, parafon forte dcs, zanaflex, and codeine. 7. having the ability to feel pain as self-reported. exclusion criteria: 1. pregnancy or trying to become pregnant in the next 6 months. 2. history of alcohol or drug abuse within the past 6 months as self-reported 3. contraindications to transcranial brain stimulation or tus, i.e. implanted brain medical devices or implanted brain metallic devices. 4. unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). 5. epilepsy. 6. use of carbamazepine within the past 6 months as self-reported. 7. suffering from severe depression (with a score of \>30 in the beck depression inventory) 8. history of unexplained fainting spells as self-reported. 9. head injury resulting in more than a momentary loss of consciousness 10. history of neurosurgery as self-reported.

Keywords: transcranial direct current stimulation transcranial ultrasound non-invasive brain stimulation
effects of repetitive electric sensory stimulation (rss) as intervention in complex-regional-pain-syndrome type i (crps)

Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb

Summary: the purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with crps (complex regional pain syndrome) of the upper extremity.

a specific high frequency electric stimulation is conveyed at 5 days to the affected hand. each stimulation session lasts 45 minutes.

Eligibility criteria:
inclusion criteria: * patients diagnosed with crps type i exclusion criteria: * intolerable hyperalgesia * lesions at the fingertips * high grade digit contracture * central neurologic disorders * psychiatric disorders

Keywords: crps repetitive sensory stimulation cortical reorganization 2-point-discrimination
selective lung recruitment in moderate to severe ards : a pilot study

Conditions: Acute Respiratory Distress Syndrom

Summary: acute respiratory distress syndrome (ards) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). this condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. invasive mechanical ventilation is frequently required to grant sufficient oxygenation to the body. unfortunately, while it allows oxygenation, mechanical ventilation can cause arms to the lung because of the mechanical power it delivers to the lung and create ventilation induced lung injuries (vili). to reduce this risk, ventilator settings have been protocolized aiming to reduce the lung volume administered to the lung. it is effective to control the vili but oxygenation may be insufficient under those protective parameters. to correct this lack of oxygenation practicians use recruiting maneuvers when a transient increase of lung volume administered to the lung to open collapse parts of the lung. those maneuvers can cause barotrauma and provoke pneumothorax or decrease the heart flow. this study aim to assess the feasibility of selective recruitment maneuvers to increase oxygenation while reducing the risk of recruitment maneuvers. briefly, a dedicated bronchial blocker is introduce in a lower part of the lung, a balloon attached to the catheter is expended isolating a part of the lung and a recruiting pressure is administered through the lumen of the catheter to selectively expend the isolated part of the lung. after the selected recruitment maneuver, the investigators will assess the expansion of the lung with a ct-scanner.


Eligibility criteria:
inclusion criteria: * acute ards according berlin definition and a pao2/fio2 ratio inferior to 200 * patient under sedation and muscular blockade * postero-basal consolidation on ct or pulmonary ultrasound * affiliated to the french social insurance system exclusion criteria: * hemodynamic instability * pregnancy * patient under guardianship

Keywords: ards recruitment maneuvers selective recruitment maneuvers
lung and systemic inflammation in the critically ill patient

Conditions: Acute Respiratory Distress Syndrome (ARDS); Systemic Inflammatory Response Syndrome (SIRS); Sepsis

Summary: acute respiratory distress syndrome (ards) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ards and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. it has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ards, triggering systemic inflammation. conversely, it is possible that severe systemic inflammation may lead to ards by an influx of inflammatory mediators from the bloodstream to the lungs. however, the time course and the possible pathways for this transmission of disease have yet to be established. investigators hypothesize that: 1. primary systemic inflammation is followed by a secondary pulmonary inflammatory response 2. primary pulmonary inflammation is followed by a secondary systemic inflammatory response 3. both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins') 4. the inflammatory response is most pronounced in the primary afflicted compartment.


Eligibility criteria:
inclusion criteria: general: * age \>18 years * mechanically ventilated * \< 48 hours after admission to the intensive care unit specific: -ards: acute (\< 1 week) respiratory failure, characterized by hypoxemia (pao2/fio2 \< 300 mmhg/40kpa), and bilateral infiltrates on x-ray or ct of thorax, that can not be explained by heart failure og overhydration. or - sirs (two of the following): temperature \> 38°c or \ 90/min, respiratory frequency \> 20 or paco2 \ 12x10\^9/l) or leukopenia (\< 4x10\^9/l) or ards + sirs exclusion criteria: one lung ventilation; tube size \ 1.5 or thrombocytes \< 40x10\^9/l; intracranial hypertension; malignant arrythmias
evaluating the diagnostic performance of acs using nirs in traumatized lower extremities

Conditions: Compartment Syndrome of Leg

Summary: this is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.

this is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. the name of this technology is nirs (near-infrared spectroscopy). we have shown nirs can be helpful in diagnosing acs. we think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. we have studied the capabilities of nirs for many years. the last step in the process of proving nirs and its use in acs will be to test our recommendations and guidelines. the goal of this study is to test and prove our clinical guidelines we developed through previous work. this is an interventional study, which means the data we collect will be used to manage the patient and their care.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 65 years 2. ability to be enrolled within 12 hours of qualifying injury 3. must have at least one uninjured upper or lower extremity 4. must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury. anatomic location: 1. tibia/fibula shaft fracture 2. tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension) 3. gunshot wound to leg without tibia fracture high energy mechanism of injury (moi): 1. fall from more than 5-foot height 2. motor vehicle collision (more than 15mph) 3. motor vehicle versus pedestrian accident 4. high velocity gunshot wound (with or without tibia fracture) 5. crush injury 6. sport/recreation exclusion criteria: 1. application of nirs monitoring would be an impediment to care 2. known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease) 3. admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis) 4. consent cannot be obtained from the patient or their lar within 12 hours of injury 5. has already undergone fasciotomy of the injured leg prior to enrollment 6. has spinal injuries that result in complete loss of function (complete spinal cord injuries) 7. has bilateral upper and lower extremity injuries greater than simple soft tissue injuries 8. is in police custody at presentation to the hospital 9. is a woman who is pregnant 10. has open injury on the injured leg that is large enough that at least two nirs sensor cannot be safely placed. at a minimum two sensors must be placed on the injured leg(s).

Keywords: acs
a study to evaluate nivolumab in patients with unresectable advanced/metastatic gastric cancer and gastroesophageal junction cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Cancer

Summary: the purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (gc/gejc) in china


Eligibility criteria:
inclusion criteria: * participants aged ≥ 18 years at date of first administration of nivolumab * confirmed diagnosis of unresectable advanced or metastatic gastric cancer (gc) or gastroesophageal junction cancer (gejc) (histologically or cytologically) * participants newly received nivolumab as first-line (1l) treatment between 15 june 2018 and 30 june 2023 * participants with at least one tumor assessment after index date except for death or discontinuation due to adverse events exclusion criteria: * participants with primary malignancies other than unresectable advanced or metastatic gc/gejc * participants who participate in an interventional clinical trial in or before 1l nivolumab treatment for advanced/metastatic gc/gejc * participants with known her2 status positive * participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete
transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache

Conditions: SAH (Subarachnoid Hemorrhage); Headache

Summary: the study titled \&#34;transnasal sphenopalatine ganglion block for treatment of acute subarachnoid hemorrhage associated headache\&#34; is a randomized controlled pilot study aimed at evaluating the efficacy of a transnasal sphenopalatine ganglion (spg) block in addition to standard pain medication for reducing headache severity in patients with acute subarachnoid hemorrhage (asah). the study also examines whether this intervention can reduce opioid requirements during hospitalization and upon discharge.

the study is designed to test the hypothesis that the addition of a transnasal spg block to standard pain medication is more effective than medication alone in reducing headache associated with acute subarachnoid hemorrhage. it involves 40 participants who meet specific inclusion criteria, such as being over 18 years old, having a secured aneurysm, and the ability to verbalize pain scores. those with conditions like recent nasal or facial trauma, allergies to specific anesthetics, or pregnancy are excluded. participants are randomized into two groups: one receiving the standard care medication for headache and the other receiving both the standard care and a transnasal spg block. the spg block is administered using a needleless device called the tx360, which allows for the medication to be instilled directly to the the sphenopalatine ganglion via the nasal passageways. data on pain scores and opioid usage are collected and analyzed using statistical methods to assess the effectiveness of the spg block. the study also includes safety monitoring to track any adverse effects from the intervention. the entire study spans approximately 24 months, with individual participation lasting up to four weeks.

Eligibility criteria:
inclusion criteria: * acute subarachnoid hemorrhage * age greater than 18 years * secured aneurysm * patient can verbalize pain score to clinician, nurse, medical translator, or surrogate decision * maker * patient or surrogate decision maker is available to consent exclusion criteria: * less than 18 years old * unsecured aneurysm * pregnant or lactating * prisoner * unable to verbalize pain score to clinician, nurse, medical translator, or surrogate decision maker * nasal or facial trauma or surgery within the last three months * allergy to lidocaine, bupivacaine, or dexamethasone * patient is unable to consent and no available surrogate decision maker

Keywords: asah peripheral nerve block sphenopalatine ganglion subarachnoid hemorrhage headache
weight management intervention for obese women and the live birth outcome of in vitro fertilization (ivf)

Conditions: Infertility; Obesity

Summary: the primary aim of the study is to evaluate if weight management intervention for obese women (bmi≥30\<35 kg/m2) prior to ivf improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.

1. there will be two groups of patients. 1. the first group (n=167) will receive weight management intervention during up to four months prior to ivf treatment.the group randomized to intervention will start an intensive weight reduction plan. the aim of the weight reduction is to reach as close to normal bmi (\<25.0 kg/m2) as possible during a time of approximately 4 months. the purpose of the dietary intervention is to create a negative energy balance to induce weight loss. the intervention starts with 12 weeks of a low calorie liquid formula diet (lcd) and thereafter, diet re-introduction and weight control stabilization until ivf treatment begins. should the patient for some reason be unable to fulfil the lcd-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her ivf-treatment. 2. the second group (n=167) will start their ivf-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. the group randomized directly to ivf-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle. 2. tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. a special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. for the women having achieved a live birth in the index-cycle of ivf the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.

Eligibility criteria:
inclusion criteria * indication for ivf/icsi for the couple * woman's age \>18\< 38 years at randomization * first, second or third ivf/icsi treatment * bmi \> or = 30.0 \<35.0 kg/m2 * willing to participate and to sign informed consent exclusion criteria: * diabetes mellitus treated with insulin * oocyte or sperm donation planned * preimplantation genetic diagnosis (pgd) treatment planned * azoospermia known at randomization * patient not having adequate knowledge of swedish (to understand patient information and questionnaires) * qewp-r questionnaire indicating binge eating disorder for the woman * previous participation in the study

Keywords: obesity in vitro fertilization low calorie diet (lcd) obstetric outcome weight reduction
clinical performance evaluation of the qiastat-dx® cuti plus amr

Conditions: Complicated Urinary Tract Infection

Summary: performance evaluation of qiastat-dx cuti plus amr panel using the qiastat-dx® analyzer to demonstrate that the qiastat-dx cuti plus amr panel achieves its intended performance during normal conditions of use by the intended user in the intended environment

the objective of the study is to demonstrate that the qiastat-dx cuti plus amr panel achieves its intended performance during normal conditions of use by the intended user in the intended environment. the primary objective is to evaluate the performance of qiastat-dx cuti plus amr panel in comparison with the results obtained from the reference method. the secondary objective of the study is to evaluate the safety ofqiastat-dx cuti plus amr panel with respect to users/operators. the primary study endpoint will be the results for each analyte obtained from testing prospective specimens with qiastat-dx cuti plus amr panel and reference method. positive percent agreement (ppa) and negative percent agreement (npa) will be determined

Eligibility criteria:
inclusion criteria: * specimens from subjects of all ages and demographic characteristics can be enrolled. * specimen must come from patients with suspected cuti by their healthcare provider: * urine specimen with evidence of pyuria confirmed by positive urine analysis (dipstick analysis positive for leukocyte esterase or at least 10 white blood cells percubic millimeter) and * a sign or symptom of a cuti (for example: chills or rigors or warmth associated with fever, malaise, flank pain or pelvic pain and/or costo-vertebral angle pain or tenderness on physical examination, nausea or vomiting, dysuria, urinary frequency or urinary urgency) * specimen must be residual leftover and de-identified * specimen obtained preserved (containing boric acid, sodium formate or sodium borate) or unpreserved as midstream urine or fresh urine catheter * for preserved only: fresh prospectively collected preserved specimens stored to up 48 hours at 15°c-25°c or 24 hours at 2°c-8°c. * for unpreserved only: fresh prospectively collected unpreserved specimens stored up to 24 hours at 2°c-8°c. * specimen must have a minimum of 3 ml of urine available. * specimen date of collection and standard of care testing results should be available. * specimen must be unique (only one sample enrolled per patient). exclusion criteria: * specimens enrolled in the study may be excluded for the following reasons: * lack of clear subject identification or label on urine specimen. * specimen has been centrifuged. * obvious physical damage of residual specimen.

Keywords: qiastat-dx clinical performance study complicated urinary infection