Kornimate/medical-research-clean huggingface dataset:
phase i study of dalotuzumab (mk-0646) in combination with cetuximab and irinotecan in participants with colorectal cancer (mk-0646-016)

Conditions: Colorectal Cancer

Summary: the purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the human anti-human antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in japan.


Eligibility criteria:
inclusion criteria: * is 20 years of age or older * has a histologically or cytologically confirmed colorectal cancer * has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression as verified by previous radiologic scans * must have adequate organ function exclusion criteria: * has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to initial dosing on this study or whose toxicities from agents administrated 4 weeks earlier have not resolved to at least grade 1 or baseline * has experienced intolerable toxicity to irinotecan therapy * has prior exposure to insulin-like growth factor 1 receptor (igf-1r) inhibitors or epidermal growth factor receptor (egfr) inhibitors (e.g. cetuximab) * is concurrently using growth hormone (gh), or gh inhibitors
awake craniotomy for arteriovenous malformation

Conditions: Awareness, Anesthesia; Arteriovenous Malformations

Summary: the study aimed to retrospectively review cases of brain arteriovenous malformation that were surgical resected with the patient awake during the procedure.

four patients' charts were retrospectively reviewed and neurological status before and after awake craniotomy was assessed to look for any deterioration.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of arteriovenous malformation in brain * awake craniotomy for surgical resection of arteriovenous malformation exclusion criteria: * patients with incomplete records
micrornas role in pre-eclampsia diagnosis

Conditions: Preeclampsia

Summary: pre-eclampsia is one of the most threatening pregnancy complications. so far neither a secure, competent therapy for pe nor effective biomarkers for a premature discovery has been achieved.the aim of our study was to identify mirnas 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with pe, as valuable markers for pe early prediction.


Eligibility criteria:
inclusion criteria: to have an uncomplicated pregnancy: 1. gestational age at venipuncture between 20 - 42 weeks 2. no medical, obstetrical, or surgical complications 3. absence of labor at the time of venipuncture 4. delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age exclusion criteria: patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded

Keywords: micrornas exosomes preeclampsia mesenchymal stem cells
diet and physical activity intervention for the prevention of adt-induced metabolic changes in patients with prostate cancer, triple-a pilot study

Conditions: Localized Prostate Carcinoma; Prostate Adenocarcinoma

Summary: this clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (rt) and androgen deprivation therapy (adt). adt effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of rt. despite the clinical gains, adt leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. a diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving adt and rt.

outline: patients are randomized to 1 of 2 groups. group i (diet and physical activity): patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instructions on a modified dash diet. patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. patients may also complete up to 21 additional supervised exercise sessions. group ii (control): patients attend a single in-person or virtual session with a registered dietitian to receive standard lifestyle recommendations based on the united states (us) dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight maintenance.

Eligibility criteria:
inclusion criteria: * age \>= 40 years * histologically confirmed adenocarcinoma of the prostate, (d'amico risk category intermediate or high risk, localized or locoregional) * primary treatment is rt + adt \[zoladex, lupron, degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone \[lhrh\])-directed therapies\] with standard rt dose and fractionation (anti-androgen monotherapy will not be allowed * physically able to undertake an exercise program exclusion criteria: * advanced, metastatic disease * planning to join a commercial/structured diet change or fitness program * have significant pre-existing t2d (poor glycemic control while on medication, defined as hemoglobin a1c of \>= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (cvd) (myocardial infarction or stroke within prior six months) * physician confirmed cognitive impairment or alcohol/narcotic abuse
pharmacokinetics and pharmacodynamics of bct194 in psoriatic patients

Conditions: Psoriasis

Summary: this study will evaluate the pharmacokinetics and pharmacodynamics of bct194 in psoriatic patients to better understand the skin penetration of topically applied bct194.


Eligibility criteria:
inclusion criteria: * male patients and post menopausal or surgically sterile female patients aged 18 - 75 years. * diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening * psoriatic plaques accessible for microperfusion at body sites (e.g. trunk) convenient for the patients. exclusion criteria: * currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular. * currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). * recent previous treatment with anti-tnf-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus. * current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the patient unsuitable for the trial. * presence of major chronic inflammatory autoimmune diseases like rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: psoriasis stable plaque psoriasis lesions tnf-alpha bct194
plaque inhibitory effect of neutral electrolysed water in the form of a mouthwash in a 4-day non-brushing model

Conditions: Gingivitis

Summary: electrolysed water (eow) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. eow is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. its antimicrobial activity is generally attributed to its hypochloric acid content - a product of chlorine gas dissolved in water. due to its biocompatibility, known uses of eow include ocular disinfection, nasal irrigation and chronic cutaneous wound care. in the dental setting, it may be used as a mouthwash, disinfectant, irrigant, mouthwash or dental gel. the aim of this study is to investigate the effect of a mouthwash containing neutral electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an intraoral scanner), gingival inflammation, mmp-8 activity and the oral microbiome. in this double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate in all three arms of the study. each arm will last 4 days, during which the subjects will be asked to refrain from toothbrushing and the use of interdental cleaning devices. instead, they will be instructed to rinse their oral cavities twice daily with either eow, placebo or a positive control (chlorhexidine), according to a randomisation chart (each subject will receive a different mouthwash type in every arm of the study). the outcomes will be assessed at baseline and after 4 days. a washout period of at least 7 days will be implemented between each study arm.


Eligibility criteria:
inclusion criteria: * age 20 - 30 years, * non-smoker, * systemically healthy, * without regular systemic medication, * presence of at least 6 teeth in each jaw quadrant, * plaque index \< 10 % at baseline visit, * absence of periodontal pockets measuring \> 4 mm. exclusion criteria: * known allergy or suspected hypersensitivity to chlorhexidine digluconate, * gingivitis, * regularly use of mouthwash as part of oral hygiene routine, * antibiotic treatment in the last 6 months or during the observation period, * pregnancy or lactation, * fixed or removable prosthetic devices, dental implants.
lllt treatment of lung inflammation in covid-19

Conditions: Covid19

Summary: to determine if a reduction of pneumonic inflammation occurs after treatment with low-level laser therapy (lllt) applying red-light technology in the respiratory system of covid-19 patients suffering from acute viral pneumonia.

this clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light lllt therapy for acute lung inflammation as a result of covid-19 infection. patients are enrolled to undergo lllt therapy in addition to all standard ongoing therapies for covid-19. outcomes for patients receiving lllt in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for covid-19 (control group). effects of lllt treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.

Eligibility criteria:
inclusion criteria: * participant is diagnosed with covid-19. * study participant is 18 years of age or older. * patient exhibiting moderate-to-acute respiratory distress. exclusion criteria: * photosensitive condition or medication. * active chemotherapy treatment or other cancer treatment. * autoimmune disorder. * pregnant, possibly pregnant or planning pregnancy prior to the end of study participation. * developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
sr-registration study 1, row: efficacy and safety of seroquel® in the treatment of patients with schizophrenia

Conditions: Schizophrenic Disorder

Summary: the purpose of this 6-week study is to determine whether treatment with seroquel® sustained release (sr) is more effective than placebo in the treatment of acute schizophrenia. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * to be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate. exclusion criteria: * patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

Keywords: schizophrenic disorder
correlation between spirometry and functional independence in adult post-icu patients

Conditions: Intensive Care (ICU) Myopathy; Functional Independence

Summary: several complications and comorbidities are frequently found in patients admitted to an intensive care unit (icu), including acquired icu muscle weakness and physical and cognitive limitations. these issues lead to impaired quality of life and post-discharge functional independence. thus, it is important to evaluate these factors in order to verify the effects of long-term hospitalization. objective: to relate functional independence to the degree of pulmonary involvement in adult patients three months after discharge from the icu. methods: this will be a retrospective study with data collected from january 2012 to december 2013, that will include patients who underwent spirometry and answered the functional independence measure questionnaire. patients will be divided into groups according to the classification of functional independence and spirometry.


Eligibility criteria:
inclusion criteria: * patients who discharged alive evaluated three months after discharge from the icu * patients that underwent spirometry and answer the functional independence measure questionnaire. exclusion criteria: * patients unable to perform spirometry * patients unable to respond to the functional independence measure questionnaire
anomalies of dense platelet granules

Conditions: Spontaneous Induced Unexplained Haemorrhagic

Summary: the study aims to know the overall prevalence of granular deficits and their breakdown by type (anomaly of number, content or secretion) in a population of patients with hemorrhagic symptomatology after exclusion of other known causes. this study consists also to evaluate the association between the presence of a deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...) -evaluate the association between the type of deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...)

patients will be recruited during the exploration visit (v0) or the confirmation/typing visit (v1) according to their follow-up. * exploration visit (v0): inclusion of patients without prior platelet exploration, and study of their dense platelet granules. * confirmation/typing visit (v1): verification of the persistence of anomalies detected in patients with an abnormality identified during v0 (no later than 6 months after v0) and in patients for whom a dense granules anomaly has already been identified during their standard management prior to the start of the study. completion of complementary examinations to complement the typing of the granular anomaly and molecular analysis for family cases

Eligibility criteria:
inclusion criteria: * adult or child patient ≥ 2 years * having a hemorrhagic score isth \> 3 for men, \> 5 for women and \> 2 for children. * with no abnormal coagulation (defined by normal tp and tck or activity ≥ 50% of fii, fv, fvii, fx, fviii, fix, fxi) * no deficiency of willebrand factor (defined by a cofactor activity with ristoctin (vwf: rco \< 50%)) * no a known major thrombocytopenia/thrombopathy linked to a deficiency of one of the major platelet receptors * information of the patient and/or his legal representative present exclusion criteria: * inability or refusal of compliance with research requirements * thrombocytopenia \< 100 g/l * treatments interfering with platelet functions within 10 days prior to inclusion * malignant hemopathy

Keywords: dense platelet granules thrombopathy hemorrhagic symptomatology
bedside ultrasound in the diagnosis of ankle fractures in children

Conditions: Ankle Fracture

Summary: objectives: a lot of children who injure their ankles come to the emergency department for an evaluation, and often an x-ray of the ankle is obtained to determine if a bone fracture is present. in more than 85% of cases, however, the injury is a sprain and not a bone fracture and can be treated with rest, ice, elevation, and pain medications. x-rays obtained in the emergency departments are time consuming, often uncomfortable for the patient, and expose children to radiation, the long-term effects of which are not yet fully understand by doctors or scientists. bedside ultrasound is a non-invasive and a non-painful device that does not produce radiation. it was been shown to determine the presence of bone fracture in childrens' wrists and forearms just as well as x-rays do. in our study, the investigators would like to determine if a bedside ultrasound can also be used to evaluate ankle fractures in children. research procedures: in our study, the investigators will ask the parents and children, who are scheduled to get an x-ray of their ankle in the emergency department, to examine their ankles with an ultrasound machine as well. since the bedside ultrasound is not significantly time-consuming, does not require patients to remain still, and is readily available in the department, the procedure will be performed while kids are waiting to get an x-ray, getting registered, or awaiting further treatment. on the data collection form, the investigators will document the patients' names, birthdates, medical record numbers so that their x-ray results can be compared to the ultrasound results for the purpose of the study. the information will be stored in a secure cabinet in a locked office. the investigators will also document which side is injured, where the patient feels pain and what the ankle looks like to help perform the ultrasound. the results of both the ultrasound and x-ray will be documented for each patient.


Eligibility criteria:
inclusion criteria: * age 2-18 years old * ankle ray ordered in er exclusion criteria: * open fracture * multi-system trauma/other significant injuries * history of ankle fractures? (same ankle broken within past year)
vanguard knee anterior stabilized versus posterior stabilized bearing study

Conditions: Osteoarthritis; Degenerative Arthritis

Summary: the purpose of this study is to compare the performance of two fda-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.


Eligibility criteria:
inclusion criteria are identical to the indications stated in the fda approved labeling for the device 510(k) k023546, k033489, and k050222. these indications are stated below: * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus, or posttraumatic deformity. * correction or revision of unsuccessful osteotomy, or arthrodesis. patient selection factors to be considered include: * need to obtain pain relief and improve function * ability and willingness of the patient to follow instructions, including control of weight and activity level * a good nutritional state of the patient * the patient must have reached full skeletal maturity exclusion criteria will be identical to the contraindications stated in the fda approved labeling for the device 510(k) k023546, k033489, and k050222. these contraindications are stated below: -absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions * osteoporosis, * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site, * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * vascular insufficiency, muscular atrophy, neuromuscular disease, * incomplete or deficient soft tissue surrounding the knee

Keywords: knee osteoarthritis joint replacement knee surgery
a trial to investigate the safety, tolerability and pharmacokinetics of intravenous spm 927

Conditions: Epilepsy

Summary: the purpose of this trial was to evaluate the safety and tolerability of spm 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral spm 927 for partial seizures with or without secondary generalization. trial procedures will include medical history update, physical/ neurological exams, ecgs, blood /urine sample collections and seizure diary completion. subjects completing the trial will return to the ole trial to resume dosing with oral spm 927.


Eligibility criteria:
inclusion criteria: * subject with partial seizures with or without secondary generalization exclusion criteria: * subject had previously received iv spm 927 * subject met the withdrawal criteria for the open-label extension trial with spm 927 or was experiencing an ongoing serious adverse event.

Keywords: epilepsy
health outcomes after participating in exercise (hope)

Conditions: Weight Loss; Obesity; Aging

Summary: aging is associated with significant declines in muscle mass, strength, and physical performance, all of which lead to disability, loss of independence, and adverse clinical outcomes. obesity exacerbates these age-related declines in function and is associated with poorer clinical outcomes and quality of life. weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. the overall goals of this study are to determine if the short-term functional benefits of intentional weight loss are sustained long-term, and to examine the long-term benefits and risks of weight loss.

obesity exacerbates age-related declines in function and is associated with poorer clinical outcomes and quality of life. although clinical trials conducted study teams show that diet-induced weight loss interventions in obese older adults, when combined with exercise, improve body composition and physical and metabolic function in the short-term, the overall safety and long-term benefits of intentional weight loss in older adults remain controversial. weight loss can also worsen age-related loss of muscle mass and decrease bone mineral density. because of these concerns, health care providers are reluctant to recommend weight loss in obese older adults. the goal is to determine whether weight loss-induced improvements in body composition and physical and metabolic function observed in short-term clinical trials persist over time is critical to inform geriatric obesity treatment.

Eligibility criteria:
inclusion criteria: * all former participants from the five intervention trials who respond to our recruitment strategies will be scheduled for clinic/home visits or a phone interview. exclusion criteria: * none - all former participants from the five intervention trials are eligible

Keywords: obese exercise