Kornimate/medical-research-clean huggingface dataset:
omega 3 fatty acids in patients with chronic renal disease

Conditions: Renal Insufficiency, Chronic

Summary: to study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and vascular function and inflammatory parameters in patients with chronic renal disease

in a double blind trial in patients with chronic renal disease, the effects of a 3.7 g supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of corn oil during 12 weeks, will be assessed on the following parameters: 1. urine albumin excretion 2. renal function measured with serum creatinine, cystatin c and beta-2 microglobulin 3. carotid intima media thickness and pulse wave velocity 4. inflammation status assessed measuring serum levels of c reactive protein and interleukin 6 5. metabolic control of diabetes 6. serum lipid levels

Eligibility criteria:
inclusion criteria: * urinary albumin excretion over 30 mg/g creatinin * chronic renal failure stage 2 to 4 * absence of serious conditions such as cáncer, decompensated heart failure, chronic infections and severe arterial lesions exclusion criteria: * blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8% * presence of cognitive impairment that does not allow to sigin a written informed consent * alcohol or illicit drug abuse

Keywords: albuminuria carotid intima-media thickness pulse wave velocity inflammation
effects of increased, egg-based protein intake on muscle composition,

Conditions: Muscle Composition; Sarcopenia; Hypertrophy; Inflammation

Summary: this study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 55-80 * body mass index between 27-35 * non diabetic * normal liver, kidney and heart functions within 10% of clinical normalcy * not currently following a weight loss or other special /non balanced diets * weight stable exclusion criteria: * fasting glucose \> 110 mg/dl * blood pressure \> 160/110 mm hg * plasma total cholesterol \> 260 mg/dl * ldl-cholesterol \>160mg/dl * triacylglycerol\>400 mg/dl * \>than 1 hour/week of habitual aerobic and /or resistance exercise * currently taking prescribed blood thinners

Keywords: skeletal muscle lipid content whole muscle volume fasting glucose insulin blood urea nitrogen
ultrasound guided supracondylar nerve block & hematoma block for closed reduction of distal end radius fractures

Conditions: Adults >18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department

Summary: comparison of analgesia between ultrasound guided supracondylar radial nerve block and hematoma block for closed reduction of distal end radius fractures- an observational study

a patient who presents to the emergency department with a suspected distal end radius fracture will be assessed with a baseline nrs score1 and given analgesics if needed. further they will be sent for an x-ray. if the x ray-shows a distal end radius fracture a decision to give hematoma block or supracondylar radial nerve block will be taken as per the choice of the treating physician. patients who do not meet the exclusion criteria are excluded from the study at this phase. nrs score 2 is assessed once again prior to block and a hematoma block/ supracondylar radial nerve block is given. needle in and out time will be noted and the pain during needling is evaluated using the nrs score 3. pain score will further be evaluated for every 10 mins after needle out time for a maximum of 30 mins or when the patient gets adequate analgesia ( nrs score 4a, 4b, 4c, 4d). if the block is successful, the treating physician will proceed to fracture reduction. if the block is a failure the physician will go for a rescue analgesia. nrs score5 will be evaluated at this stage. further a nrs score 6 will be assessed 15 minutes post reduction. an x-ray will be checked for the evaluation of the reduction procedure performed and the patient will be discharged or admitted as necessary. the patient will be further followed after 1 week for delayed complications.

Eligibility criteria:
inclusion criteria: 1. adults \> 18 years with distal end radius fracture requiring closed reduction in emergency department 2. patient who legally consent for study exclusion criteria: 1. history of allergy to local anesthetics 2. pregnant or lactating women 3. infection or burn with local anaesthetic at injection site 4. patients having other fractures or significant injuries that are causing pain 5. patients with hemodynamic instability which includes patients with gcs score less than 15 under influence of alcohol/ inebriated state. 6. patients on anticoagulants 7. patients with compromised neurovascular system

Keywords: distal end radius fracture
preoperative gabapentine for carpal tunnel

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study was to evaluate the postoperative analgesic effect of preoperative gabapentine for carpal tunnel syndrome surgery.

there was studied 40 patients. group 1 patients received 600 mg of gabapentin 1 hour before surgery; g2 received placebo 1 hour before surgery. anesthesia was regional intravenous block. postoperative analgesia when needed was with acetaminophen. if needed was administered codeine. the evaluation of neuropathic pain was made by dn4 questionnaire. pain intensity was assessed by numeric scale at block and after 30min, 1h, 2h, 2wk, 4wk, 6m. it was noted the duration of analgesia, and the amount of acetaminophen and codeine. the statistical program used for analysis of the results was the instat graph

Eligibility criteria:
inclusion criteria: * carpal tunnel syndrome exclusion criteria: * disorientation, psychiatric disease, myocardial ischemia, hypertension, arrhythmia, another pain syndrome, drug user, and pregnant

Keywords: gabapentine postoperative pain
everolimus in combination with cyclosporine a and prednisolone for the treatment of graft versus host disease

Conditions: Graft Versus Host Disease

Summary: the present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment csa/prednisolone with the new combination csa/prednisolone/everolimus.

the primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with csa/prednisolone in patients with agvhd after allogeneic hsct. this evaluation takes into account the following parameters: * feasibility of oral application everolimus * daily dose needed to reach the targeted plasma level everolimus * time to reach the targeted plasma level of everolimussecondary objectivesthe study will evaluate the toxicity and safety of the treatment with ever-olimus/csa/prednisolone with regard to * incidence and severity of treatment induced toxic events * incidence, severity and seriousness of adverse events * treatment induced morbidity * treatment induced 1-year-mortality furthermore the study will collect data about * efficacy of everolimus/csa/prednisolone on agvhd * drug interactions between everolimus and csa

Eligibility criteria:
inclusion criteria: * written informed consent prior to inclusion into the study * allogeneic hsct from hla-identical related or unrelated donors * clinically confirmed acute gvhd ≥ grade ii * age \ 18 years, male or female * karnofsky performance status \> 60 % exclusion criteria: * oral treatment is not feasible * severe hepatic impairment child-pugh c * active cerebral epilepsy * renal failure (creatinine clearance \< 50 ml/min) * life expectancy \< 3 months * known hypersensitivity to everolimus, sirolimus or to any of the excipients * confirmed pregnancy (serum β-hcg) * non-effective contraception for both, male and female patients, if the risk of conception exists * patients with limited legal capacity * patients unwilling and unable to undergo study procedures

Keywords: acute gvhd immunosuppression
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 the knee as self-reported. prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. this document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. after consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail. 4. existing knee pain in the past 6 months of at least 3 on a 0-10 vas scale on average. 5. 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. 6. 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
sarc037: a phase i/ii study to evaluate the safety of trabectedin in combination with irinotecan in ewing sarcoma patients

Conditions: Ewing Sarcoma

Summary: this study evaluates the trabectedin and irinotecan in the treatment of ewings sarcoma, with a ews-fli1 mutation. patients will also receive an infusion of 18f-flt in combination with a positron emission tomography (pet) scan to help evaluate the effect of treatment. phase i was completed on 11/16/2022. phase ii is actively recruiting.

trabectedin and irinotecan may inhibit the activity of this ewing sarcoma mutation. trabectedin may suppress the proliferation of the gene involved in dna damage response. it blocks ews-fli1 by inactivating the fusion protein and silences the target genes. irinotecan also suppresses the genes regulating the tumor cells, generating dna damage. together, these drugs work in combination to suppress the gene regulating the tumor cells. this combination may suppress the activity of the tumor regulating genes, disrupting the activity of the genes. the infusion of 18f-flt in combination with a positron emission tomography (pet) scan will demonstrate whether the target cells have been suppressed.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed and refractory ewing sarcoma with ews-fli1 fusion type for which there is no known therapy proving to prolong survival * measurable disease * ecog performance status of 0-2 or lansky of 50 * adequate organ function * written, voluntary consent * willing to undergo tumor biopsy * negative hepatitis infection exclusion criteria: * prior therapy with trabectedin or lurbinectedin * known history of hypersensitivity to irinotecan or topotecan or their excipients. * known brain metastases * known bleeding diathesis * pregnant or breastfeeding * currently receiving other investigational drugs or anticancer agents * clinically significant unrelated illness or uncontrolled infection * unable to comply with the safety monitoring requirements
post-exercise appetite responses in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of type 1 diabetes individuals


Eligibility criteria:
inclusion criteria: * aged between 18-50 years old (male or female). * free from any diabetes related complications (apart from mild background diabetic retinopathy). * hba1c \<8.5%. * not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study. * demonstrate normal cardiac function in response to exercise. exclusion criteria: * aged younger than 18, or older than 50 years. * suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy). * hba1c \>8.5%. * currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or detemir, and lispro or aspart for at least 6 months before the start of the study. * failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Keywords: type 1 diabetes mellitus exercise appetite
utility of point-of-care device for rapid determination of cogulopathy in trauma patients

Conditions: Severe Trauma

Summary: traumatic coagulopathy is frequent and is an independent risk factor of mortality. its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (inr). these tests are not available at the bedside. point of care (poc) device for inr measurement are now available like the coaguchek, roche, france. the aim of the present study is to test the correlation between the poc inr and the laboratory inr.


Eligibility criteria:
inclusion criteria: * age \> 15 y-o * admission for severe trauma exclusion criteria: * patients under oral anticoagulant

Keywords: point of care device; post traumatic coagulopathy
gastric retentive carbidopa/ levodopa in parkinson's patients; a one year, open label, safety extension study

Conditions: Parkinson's Disease

Summary: an extension of study in 09 004 testing the long term safety of the accordion pill carbidopa/levodopa (ap-cd/ld)


Eligibility criteria:
inclusion criteria: * subject satisfactorily completed study in 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study * subject with parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours off a day at the discretion of the pi (does not include early morning akinesia or nocturnal akinesia) * subject that has been treated for at least 3 months prior to the study with 500-1000 mg levodopa + ddci, in 4 or more divided doses per day * hoehn and yahr stages i-iii * subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study * prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study. exclusion criteria * subject has undergone deep brain stimulation (dbs) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem) * subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation * subjects with a recent history of clinically defined gerd, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation
sub-study to spinal cord stimulation to restore cough

Conditions: Spinal Cord Injuries; Spinal Cord Diseases; Paralysis; Central Nervous System Diseases; Cough

Summary: evaluation of wire electrodes to activate the expiratory muscles to restore cough

patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. in fact, pneumonia is a major cause of death in this patient population. in a recent clinical trial, we have shown that the expiratory muscles can be electrically activated by spinal cord stimulation (scs), a technique which involves the surgical placement of disc electrodes on the surface of the spinal cord. this method is successful in achieving an effective means of expiratory muscle activation, as demonstrated by the generation of large airway pressures and peak airflow rates. importantly, scs facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. this method therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects. the purpose of this trial is to directly compare activation of the expiratory muscles using wire electrodes, which can be inserted percutaneously through a needle, with the previously employed disc electrodes. in this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (t5 level or higher), at least 12 months following the date of injury. after an evaluation including medical history, a brief physical examination, and initial testing, each participant will undergo a surgical procedure to implant small electrodes (metal discs) over the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. prior to permanent implantation of this system, wire and disc electrodes will be compared by assessing the degree of expiratory muscle activation with each electrode type. the disc electrodes will then be permanently implanted, allowing the participant to have use of a fully functioning stimulation system to restore an effective cough.

Eligibility criteria:
inclusion criteria: * stable spinal cord injury t5 level or higher * expiratory muscle weakness exclusion criteria: * significant cardiovascular disease * active lung disease * brain disease * scoliosis, chest wall deformity, or marked obesity

Keywords: spinal cord injury paralysis cough cervical spinal cord injury thoracic spinal cord injury
inflammatory responses in solitary and multiple erythema migrans

Conditions: Erythema Migrans

Summary: the investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, th1, and th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.


Eligibility criteria:
inclusion criteria: * erythema migrans in patients \> 18 years * borrelia afzelii isolated from skin exclusion criteria: * pregnancy or immunocompromising conditions * taking antibiotic with antiborrelial activity within 10 days
study to investigate the effect of aprotinin of transfusion requirements in patients undergoing surgical procedures for lung or esophageal cancer

Conditions: Blood Loss, Surgical

Summary: study to investigate the effect of aprotinin of transfusion requirements in patients undergoing surgical procedures for lung or esophageal cancer.


Eligibility criteria:
inclusion criteria: * men or women 18 years of age and older * subjects requiring protocol specified oncological surgery. subjects must have histological confirmation of malignancy in lung or esophagus * documented, signed and dated informed consent obtained prior to any study specific procedures being performed exclusion criteria: * subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin * subjects undergoing laparoscopic surgery * subjects with sepsis or mesothelioma * subjects with impaired renal function (serum creatinine \>2.5 mg/dl or 221 micromoles/liter) * subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. based on the investigator's opinion of any active significant medical illness the subject may have. * subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of \<24% or hemoglobin of \<8 g/dl) * subjects who have participated in an investigational drug study within the past 30 days * subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception * planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid * subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)
a phase 1 study of imgn289 in adult patients with egfr-positive solid tumors

Conditions: EGFR Positive Solid Tumors

Summary: this is a phase 1, first-in-human study to determine the recommended dose of imgn289 in adult patients with advanced egfr-positive tumors.


Eligibility criteria:
inclusion criteria: * 18 years old at time of consent * diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable * egfr-positive tumor expression * adequate blood and organ function * must agree to use contraception while on study and for 12 weeks after the last dose of imgn289 as applicable * must be willing and able to sign informed consent and follow the study schedule and other protocol requirements exclusion criteria: * other anti-cancer treatment during the study * symptomatic brain metastases * other clinically significant disease as defined by the protocol * chronic skin condition that requires prescribed oral or intravenous treatment * history of severe rash that required discontinuation of prior egfr targeted therapy * receiving therapeutic doses of warfarin or heparin for anti-coagulation * known diagnosis of hiv or active viral hepatitis * women who are pregnant or breast feeding

Keywords: imgn289 antibody drug conjugate antibody egfr nsclc scchn head and neck squamous cell carcinoma solid tumor immunogen lung phase 1