Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety of an early mobilization protocol in a pediatric intensive care unit

Conditions: Critical Illness

Summary: this study evaluates the safety and effectiveness of an early rehabilitation program in a pediatric intensive care unit (picu). half of the participants will receive intensive and frequent an early mobilization program and others will receive conservative mobilization program.

the 14 early rehabilitation sessions(10=physical therapy, 4=occupational therapy) occurred per week over a 2-week period (excluding weekends) in the early rehabilitation group for 15 minutes each. the control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Eligibility criteria:
inclusion criteria: * children admitted to the picu due to critical illness * children aged 1-18 years exclusion criteria: * increased intracranial pressure(icp) * history of brain surgery * children with fracture * admitted to the participating picu ≤ 3 days * children with suspected brain death

Keywords: picu acute rehabilitation early mobilization
rexmedical- option* vena cava filter ide study

Conditions: Pulmonary Embolism

Summary: this study is designed to evaluate the safety and efficacy of the rexmedical option\* vena cava filter in the treatment of patients who are at increased risk for pulmonary embolism and require caval interruption.


Eligibility criteria:
key inclusion criteria: * patient is at least 18 years of age * patient requires temporary or permanent caval interruption key exclusion criteria: * patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant * patient is currently enrolled in another investigational device or drug trial

Keywords: increased risk for pe require caval interruption
post market clinical foiiow up (pmcf) medical device (md) of z-systems monotype zirconia dental product: z5m dental implants registry

Conditions: Missing Teeth

Summary: commercially pure (cp) titanium is the gold standard to produce dental implants because it has a huge volume of scientific publications over a period of more than 50 years, it is cheap and simple to produce (i.e., making dental implants economically "affordable") and comes in numerous specitic designs of screws tor various indications. that is why more than 95% of the implant market 5 dominated by titanlum. however, there is an innovation trend to manufacture implants from more inert and biocompatible materials. ceramic implants represent a valuable alternative for expanding the patient base of clinicians, especially in cases with challenging aesthetic demand. furthermore, there has been a significant increase in the number of patients requesting metal-free dentistry or bio-holistic implant treatments. in the past, ceramics were often branded as "inferior" quality due to its reputation as being brittle but the growing volume of scientific publications specifically an zirconia are demonstrating that lt is comparable in fracture-strength with titanium implants. there is a clear market niche for zirconia implants, especially in cases of: * aesthetic reconstructions in the anterior region, especially in patients with a thin gingival biotype * gingival recessions where a white colored implant is a great advantage * for patients with a titanium intolerance/sensitivity * for patients who prefer a bio-holistic/metal-free dental approach. today, clinicians are asking tor long-term clinical results of zirconia as a dental implant material. therefore, z-systems ag is conducting this zirconia dental implant registry. a registry design was chosen because it will capture long-term benefits/risks from clinical routine without patient selection.


Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the z-systems z5m product group * patient has signed informed consent. exclusion criteria: • inability to give consent
benign migratory glossitis associated with antiangiogenic drugs

Conditions: Cancer; Geographic Tongue

Summary: oral clinical descriptions related to adverse events in patients treated with those elective multi-targeted receptor tyrosine kinase inhibitors and a recombinant humanised monoclonal antibody

electronical medical and dental records, high-resolution digital photograph were reviewed. demographic data, medical background, clinical and laboratory information were recorded for each individual case.

Eligibility criteria:
inclusion criteria: * patient's charts which underwent antiangiogenic targeted drugs exclusion criteria: * chemoterapy without angiogenesis inhibitors

Keywords: antiangiogenic drugs glossitis benign migratory
a real world study of the efficacy and safety of flumatinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase

Conditions: CML, Chronic Phase

Summary: flumatinib is an orally available tki with high selectivity and potency against bcr-abl1 kinase. it's a multi-center, open-label, real world study to explore the efficacy and safety of flumatinib versus imatinib as the first line therapy in patients with chronic myleiod leukemia(cml) in chronic phase(cp).

the purpose of this study is to investigate the long-term efficacy and safety of flumatinib versus imatinib in newly diagnosed cml-cp patients to the provide the real world evidence for the clinical treatment of cml-cp in china. the overall design is a multicenter, prospective, observational study. the study plans to enroll 2,400 newly diagnosed cml-cp subjects.the primary efficacy endpoint is the rate of major molecular response (mmr) , as measured by rq-pcr at 12 months. hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (a month is defined as 28 days)

Eligibility criteria:
inclusion criteria: 1. men or women aged more than or equal to (≥) 18 years. 2. patients with philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (ph+ cml-cp) within 6 months of diagnosis.. 3. eastern cooperative oncology group (ecog) performance status: 0\~2. 4. signed and dated informed consent form. exclusion criteria: 1. patients with previously documented t315i mutation. 2. received bcr-abl tki(s) treatment before enrollment. 3. any treatment with anti-cml therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment 4. participated in other clinical trials that might affect the efficacy and safety of cml during this study. 5. pregnant or lactating female.

Keywords: chronic myeloid leukemia flumatinib bcr-abl tki real world prospective
impact of neuropsychological disorders in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study involves ms patients with and without neuropsychological disorders. the patient will benefit from: * a routine neuropsychological assessment, including a cognitive and emotional assessment * a clinical examination * a three-dimensional analysis of movement


Eligibility criteria:
inclusion criteria: * understanding and able to speak french * carriers of ms with relapsing remitting form (rrms-rr) with an edss \<4 * no significant motor, cerebellar or somesthesia disorders of the upper limbs or visual disturbances (side to a visual edss \<2) * absence of corticosteroid intake in the last four weeks * benefiting from health insurance coverage * not showing any flare-ups or worsening of the disease in the last 6 weeks * no botulinum toxin injection for more than 4 months exclusion criteria: * people with previous neurological pathologies, head trauma with loss of consciousness, psychiatric pathologies, serious general ailments, perceptual or dysarthric disorders preventing verbal communication or reading, * treatment with psychotropic drugs (except benzodiazepines and hypnotics). * refusal to participate after clear and fair information about the study. * adults under tutorship, curatorship or safeguard of justice * with orthopedic treatment influencing walking * pregnant woman
a 2-week trial of pf-04991532 in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this will be a 2-week oral dose study of pf 04991532, performed in patients with type 2 diabetes. safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (oad) that can be temporarily discontinued for approximately 8-10 weeks. for those taking a single oad, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to screening. oad medications that are acceptable to be discontinued include: a sulfonylurea (su), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (dpp-4i), or an alpha glucosidase inhibitor. * body mass index (bmi) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs). * hba1c \>/=7% and \ /=6.5% and \</=9% if the patient requires to be washed off an oad. exclusion criteria: * evidence or history of diabetic complications with significant end organ damage. * history of stroke or transient ischemic attack. * history of myocardial infarction. * history of coronary artery bypass graft or stent implantation. * clinically significant peripheral vascular disease. * any history or clinical evidence of congestive heart failure, nyha classes ii iv. * current history of angina/unstable angina. * one or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months. * a positive urine drug screen. * use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day. * blood pressure \>/=160 mm hg (systolic) or \>/=100 mm hg (diastolic), following at least 5 minutes of rest. * pregnant or nursing females; females of childbearing potential.

Keywords: inpatient diabetes phase 1
neuroinflammation and cognitive dysfunction after orthopedic surgery

Conditions: Surgery; Acute Phase Reaction

Summary: the primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated cns inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.

patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial csf and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.

Eligibility criteria:
inclusion criteria: * asa physical health class 1-4 * age 50-85 years * fluent in swedish language * scheduled for primary hip replacement surgery due to arthrosis * mmse (minimental state test score \>= 25. exclusion criteria: * patient refusal to participate in the trial * current autoimmune disease, including arthritis * ongoing smoking, snuff or other nicotine compound treatment * significant neurologic or psychiatric disorder (such as alzheimer's disease, parkinson's disease, multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative mmse score ≤ 24 * history of stroke with neurological sequelae. * current severe cardiac (nyha\>iv) or renal (plasma creatinine\> 0.250 mmol/l) coagulopathy making spinal anesthesia and intrathecal catheter placement impossible * terminal phase of a chronic disease. * patient on chronic steroidal therapy * poorly controlled diabetes mellitus. * presumed uncooperativeness or legal incapacity.
determining baseline respiratory duty cycles in subjects with and without airway hyperresponsiveness

Conditions: Airway Hyper Responsiveness

Summary: the study investigates the inspiratory duty cycle in subjects with and without airway hyper-responsiveness both at rest and during a bronchoprovocation challenge. the primary goal is to determine an average inspiratory duty cycle for standard use in the calculation of bronchoprovocation test results.

at least fifteen subjects with airway hyper-responsiveness and fifteen without airway hyper-responsiveness will be recruited to participate in this randomized, crossover study. subjects will complete 2 methacholine challenges at least 24 hours apart. one methacholine challenge will entail the volumetric method using a vibrating mesh nebulizer. the second methacholine challenge will be performed identically except that the nebulizer will be fitted onto an ultrasonic nebulizer so as to measure the inspiratory duty cycle throughout the bronchoprovocation challenge.

Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * participants with airway hyper-responsiveness must have a positive methacholine challenge * forced expiratory volume (fev1) of at least 65% of predicted (based on age, height, and gender) * participants without airway hyper-responsiveness must have a negative methacholine challenge * all participants must avoid strenuous exercise on test days * no short-acting beta-2 agonist use within 6 hours of study visit exclusion criteria: * participants without known airway hyper-responsiveness cannot have a current or historical respiratory condition (e.g. asthma, allergic rhinitis) * participants cannot be taking long-acting bronchodilators * participants cannot be pregnant or lactating * participants cannot have cardiovascular problems
patient perception of physician's compassion, communication skills, and professionalism during an outpatient palliative care visit

Conditions: Malignant Neoplasms of Independent (Primary) Multiple Sites; Advanced Cancer

Summary: the goal of this research study is to learn how patients feel about their doctors' attitudes toward supportive care and treatment options for advanced cancer patients.

if you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. these questionnaires should take about 17 minutes to complete. study groups: after you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups. each group will watch 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. each video is about 4 minutes long and will discuss the same content, but setting of each video will be different. after watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. these questionnaires should take about 5 minutes to complete. after you watch the second video, you will complete the same 3 questionnaires. you will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. it should take about 8 minutes to complete these questionnaires. length of study: it should take about 38 minutes to watch both videos and to complete all questionnaires. your participation on this study will be over after you have completed the last questionnaire. other information: you must attend the study visit alone. your family members should not be in the room with you while you are participating in the study. you may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions. this is an investigational study. up to 120 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease. 2. outpatients (either new referrals or follow ups) seen in the supportive care clinic. 3. age \>/= 18 years old 4. english speaking 5. patients with normal cognitive status (memorial delirium assessment scale (mdas) \</=6/30) who are able to understand the nature and purpose of the study and have the ability to complete the consent process. exclusion criteria: 1) patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. this will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit.

Keywords: malignant neoplasms of independent (primary) multiple sites questionnaires surveys videos advanced cancer
the belgian endothelial surgical transplant of the cornea

Conditions: Corneal Edema; Corneal Endothelial Disorder; Fuchs' Endothelial Dystrophy; Bullous Keratopathy; Pseudophakic Bullous Keratopathy

Summary: this study is designed as a randomised multicentric parallel group pragmatic trial of descemet stripping automated endothelial keratoplasty (dsaek) versus descemet membrane endothelial keratoplasty (dmek) in corneal endothelial decompensation. the purpose is to compare the clinical and patient reported outcomes of both therapies across a broad range of indications.

the current problem concerns variability in the provision of corneal endothelial keratoplasties available to patients in belgium. some patients receive dsaek and some (albeit fewer) receive dmek. currently the type of corneal graft that a patient receives depends on the treating surgeon opinions. in this study 220 patients in 11 surgical centres will be recruited and allocated to one of the two surgical options. both the ultrathin dsaek and dmek grafts will be prepared by corneal banks in the university hospital of liege and university hospital of antwerp respectively. patients will be examined preoperatively and postoperatively at 3, 6 and 12 months. clinical information such as best-corrected visual acuity and refraction will be collected as well as quality of life information based on the eq-5d-5l and the vfq 25 assessment tools. these data be used to compare the interventions both on the clinical level as well as from the patient perspective.

Eligibility criteria:
inclusion criteria: * fuchs endothelial dystrophy (fed); * bullous keratopathy (bk); * other miscellaneous causes of endothelial dysfunction including decompensation of a previous corneal graft; * pseudophakic (post cataract surgery); * patients over 18 with the capacity to read and to understand the study information and to give informed consent, as well as study quality of life questionnaires; * patients willing and capable to attend the 3, 6, and 12-month follow-up appointments. exclusion criteria: * inability to provide informed consent; * patients unable to attend the proposed follow up; * inclusion of the fellow eye in the study; * complex surgery combined with multiple pathologies (i.e., glaucoma surgery); * other contraindications to lamellar corneas surgery; * patients who elect not to participate; * patients under 18 years of age; * patients that are currently pregnant or breastfeeding; * phakic patients with no direct plan to perform cataract surgery.

Keywords: dmek dsaek ut-dsaek
assessment of cognitive function in patients undergoing carotid artery stent placement

Conditions: Cognitive Function in Carotid Stenting

Summary: to determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

single center, case controlled design using pre and post stent cognitive function testin. patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

Eligibility criteria:
inclusion criteria: * 40-80 years of age * right hand dominate * asymptomatic:defined as: no symptoms of tia/stroke in the previous 6 months * baseline doppler study with a peak systolic velocity of 400cm/sec * patient is deemed candidate for carotid artery stenting * timi flow of 1,2 or 3 * 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in acas * subjects are able to give informed consent * subjects are willing/able to complete follow-up visits exclusion criteria: * history of major stroke: within the past 6 months * history of alzheimers disease or dementia * unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months * planned intervention opposite carotid artery within 2 months * ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy * any individual identified with cognitive impairment which would affect their performance during cognitive testing.

Keywords: carotid stenting cognitive function pre and post stent severe carotid artery stenosis
a study of prn1008 in patients with pemphigus

Conditions: Pemphigus

Summary: this was a phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment \[bt\] period) followed by an open-label extension \[ole\] period intended to evaluate the efficacy and safety of oral prn1008 in moderate to severe pemphigus. after completing the open-label extension period, eligible participants might continue in a long term extension (lte) period of 48 weeks.

a total of 131 male or female participants with newly diagnosed or relapsing moderate to severe pemphigus (pemphigus vulgaris \[pv\] or pemphigus foliaceus \[pf\]) were enrolled in the trial worldwide. the trial would last 68 weeks (approximately 17 months) for each participant. for participants eligible to enroll in the lte, the trial might last up to 116 weeks. participants were randomized at day 1, using a 1:1 ratio to receive prn1008 or placebo twice per day, by relapsing/newly diagnosed disease history (newly diagnosed defined as within 6 months of screening).

Eligibility criteria:
inclusion criteria: * male or female participants, aged 18 to 80 years old with moderate to severe, newly diagnosed or relapsing pv or pf, with a clinical presentation and histopathology consistent with pv or pf. * positive circulating anti-desmoglein 1 (anti-dsg1) or 3 autoantibody titer. * at screening, pemphigus disease area index score of at least 9 points for relapsing participants or at least 15 points for newly diagnosed participants. * adequate hematologic, hepatic, and renal function. * effective means of contraception. exclusion criteria: * suspected paraneoplastic pemphigus and other forms of pemphigus that were not pv or pf. * previous use of a bruton tyrosine kinase inhibitor. * pregnant or lactating women. * electrocardiogram clinically significant abnormalities. * a history of malignancy of any type within 5 years before day 1, other than surgically excised non-melanoma skin cancers or in situ cervical cancer. * use of immunologic response modifiers as concomitant medication and with the washout period. * use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of day 1. * concomitant use of known strong-to-moderate inducers or inhibitors of cytochrome p450 3a (cyp3a) within 3 days or 5 half-lives (whichever is longer) of day 1 * use of cyp3a-sensitive substrate drugs. * had received any investigational drug within the 30 days before day 1. * history of drug abuse within the previous 12 months. * alcoholism or excessive alcohol use. * any other clinically significant disease, condition or medical history that, in the opinion of the investigator, would interfere with participant safety, trial evaluations, and/or trial procedures.

Keywords: pemphigus vulgaris (pv) pemphigus foliaceus (pf)