Kornimate/medical-research-clean huggingface dataset:
intra-articular injection of etanercept in patient suffering from rheumatoid arthritis : a double-blind randomized study

Conditions: Rheumatoid Arthritis

Summary: intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)


Eligibility criteria:
inclusion criteria: * must be able to understand the information about the study * diagnosis of rheumatoid arthritis for 6 month at least * suffering for 2 weeks at least * with evaluation of pain over 4/10 * with stable dmards treatment for three month at least exclusion criteria: * infection or surgery on the target joint * treated with infliximab,adalimumab or anakinra

Keywords: intra-articular injection acute synovitis etanercept
brain - home intervention trial

Conditions: Asphyxia

Summary: we plan to test a home-based parent-provided early developmental intervention (ei) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. the trial will evaluate the effect of a resource-intensive early intervention (ei) program on the outcomes in infants born in rural communities in zambia, india, and pakistan. it will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. the control group will receive enhanced health counseling (hc). the overall goal will be to implement and evaluate an ei program for infants following birth asphyxia, which is sustainable in developing countries. the challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. because there are limited data on normative development and ei programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. a final aim will be to address individual variation in ei effects that could be due to child and/or family characteristics. a randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either ei or enhanced health education counseling (hc). the trial will randomize infants to a home-based parent-provided early developmental intervention (ei) with frequent home interaction between parents and parent trainers vs. hc. a group of infants without birth asphyxia or other major perinatal complications also will be randomized. children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).


Eligibility criteria:
inclusion criteria: * birth asphyxia * birth weight of at least 1,500g * neurological examination consistent with normal, stage i or ii on the ellis scale (ellis, et al. 2000) * willing to participate in an intervention program for 36 months. exclusion criteria: -

Keywords: asphyxia neurodevelopmental outcome home counseling
percutaneous tibial nerve stimulation in the treatment of anterior resection syndrome after rectal cancer surgery

Conditions: Rectal Cancer; Low Anterior Resection Syndrome

Summary: the study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (ptns) associated with conservative therapy (arm a) for the treatment of low anterior resection syndrome (lars) compared with only conservative therapy (arm b). the secondary aims are the evaluation of the following parameters: * effect of ptns on manometric parameters * effect of ptns on quality of life * effect of ptns on the severity of fecal incontinence and / or obstructed defecation * safety of ptns

the study is a prospective randomized clinical trial that compares two treatments in patients with lars: arm a: ptns + conservative treatment (based on predominant symptom) arm b: only conservative treatment the study is divided into two phases: 1. pretreatment phase the patients with lars score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to : * collection of personal data * collection of medical records * collection of data relating to the intervention of anterior resection of the rectum * verification of the criteria for inclusion / exclusion * collection of informed consent * administration of the questionnaires european organisation for research and treatment of cancer - quality of life questionnaire cancer 30 (eortc qlq-c30), european organisation for research and treatment of cancer - quality of life questionnaire colorectal 38 (eortc qlq-cr38), faecal incontinence severity index (fisi); fecal incontinence quality of life questionnaire (fiql), obstructed defaecation syndrome (ods) score questionnaire and constipation-related quality of life questionnaire (crqol) * endoanal ultrasound * anorectal manometry 2. phase of treatment during the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. even anorectal manometry will be repeated at the end of treatment. it is expected to enroll approximately 12 patients.

Eligibility criteria:
inclusion criteria: * patients with lars score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer; * age\> 18 years; * obtaining informed consent. exclusion criteria: * patients carrying ostomy; * patients with clinical or radiological evidence of local or distant tumor recurrence; * patients suffering from neurological disorders; * patients with inflammatory bowel disease (ibd); * patients who have a pacemaker or defibrillator; * patients taking antiplatelet agents or anticoagulants; * patients unable to follow the procedures of the protocol or to provide informed consent.

Keywords: ptns rectal cancer low anterior resection syndrome
pharmacokinetic study of cvt-301 (levodopa inhalation powder)

Conditions: Parkinson's Disease

Summary: this study will be an open-label, randomized, multi-center, 2-way crossover pharmacokinetic pk evaluation of a single inhaled dose of cvt-301 84 mg and a single oral dose of carbidopa/levodopa cd/ld 25 mg/100 mg (sinemet®) under fed conditions in parkinson's disease (pd) patients who regularly take cd/ld.

the study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center. on each of two treatment days, subjects will consume a standard high fat meal and then receive either (a) a single inhaled dose of cvt-301 or (b) a single dose of oral cd/ld followed by pharmacokinetic (pk) sampling for 4 hours. a crossover design will be used such that each subject receives both treatment a and treatment b over the 2 treatment days, randomized 1:1 to the treatment sequence ab or ba.

Eligibility criteria:
inclusion criteria: * men and women between the ages of 30 and 85 years, inclusive. * have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years. * classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity. * stable on other non levodopa pd medications for at least 4 weeks prior to the screening visit. * subjects must have normal cognition as confirmed by a score of ≥ 25 on the mini mental state examination (mmse), performed in the on state. * forced expiratory volume in one second (fev1) ≥60% of predicted for race, age, sex, and height and fev1/fvc (forced vital capacity) ratio ≥70%. * body mass index (bmi) between 18 - 32 kg/m2, inclusive. exclusion criteria: * any flu-like syndrome or other respiratory infections within 2 weeks prior to the screening visit. * chronic obstructive pulmonary disease (copd), asthma, or other chronic respiratory disease within the last 5 years. * history of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma. * narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening. * previous surgery for pd (including but not limited to deep brain stimulation or cell transplantation). * current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the screening visit, or expected use during the study. * marijuana smoking within 4 weeks prior to the screening visit, or expected smoking/inhalation during the study.
impact of case-management on therapeutic alliance with first episode psychosis patients (camat)

Conditions: Psychotic Disorders

Summary: the first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. the second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. the third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.


Eligibility criteria:
inclusion criteria: * age between 16 and 30 years * first episode psychosis diagnosis according to dsm-5 criteria exclusion criteria: * lees of 16 years or more than 30 years * not fulfilling dsm-5 criteria for first episode psychosis * any treatment with the psychologist or the psychiatrist of the team
levalbuterol compared to albuterol regarding cardiac side effects and potassium lowering effects.

Conditions: Hyperkalemia

Summary: hyperkalemia is a common life-threatening electrolyte disturbance which may impair cardiac and many other organs' functions. unfortunately, a well-established guideline for the treatment of hyperkalemia in the emergency setting is still missing. however, the last "kidney disease: improving global outcomes (kdigo)" conference proposed a treatment protocol for hyperkalemia and addressed controversies in this matter. beta2-agonists were one of the main lines in the approach towards managing a patient with hyperkalemia. however, this evidence was only available for racemic albuterol. levalbuterol is the isolated r-enantiomer of racemic albuterol which is comprised of s- and r-enantiomers. several lab and clinical studies have assessed the effect, affinity, and selectivity of each of the enantiomers. few studies in medical literature have compared the difference between these two drugs regarding cardiac effects with inconclusive results, and even fewer studies have compared the efficacies of these two drugs regarding potassium lowering effect. to the investigators' knowledge, no study to date has compared the efficacy and safety of albuterol compared to levalbuterol in hyperkalemic patients with the properly adjusted dosing. so, in clinical practice, the investigators wanted to know based on evidence if levalbuterol can be an effective substitute for albuterol in lowering potassium levels in hyperkalemia patients while yielding fewer cardiac side effects. to answer this question, the investigators designed a single-centered controlled clinical trial that includes adult hyperkalemia patients in aleppo university hospital.


Eligibility criteria:
inclusion criteria: * adult patients * serum potassium level \>5.9 meq/l exclusion criteria: * pseudohyperkalemia: * hemolysis of blood sample * thrombocytosis \> 10\*6 /mm3 * hyperleukocytosis \> 10\*5/mm3 * mechanical trauma during venipuncture * fist clenching during blood drawing * tourniquet time \> 1 minute * diabetes acute complications * dka * hyperosmolar hyperglycemic syndrome * insulin-dependent diabetes mellitus ( if insulin is taken recently) * pregnant women * hyperthyroidism * hemodynamic instability * pacemakers if providing impulses (demand pacemakers that are not firing right now are included) * atrial fibrillation or any other arrhythmia * baseline tachycardia \>120 bpm * acute exacerbations of hf * patients expected to require emergency intubation and ventilation * patients expected to require dialysis within the first 60 minutes * patients with hypersensitivity to the medication * patients with acute coronary syndrome * patients on beta-blockers / beta-agonists or anti-arrhythmic drugs * patients with severe dyspnea or hypoxia spo2 \<90%

Keywords: hyperkalemia albuterol levalbuterol heart rate
diagnostic laparoscopy in the preoperative staging of pancreatobiliary cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer.

to evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer. all analyses are performed using sas version 9.1.3 for windows (sas institute, cary, nc). clinical and pathological variables will be analyzed using the χ2 test (or fisher's exact test) and the student's t test, depending on the normality of the distribution. p-values of \< 0.05 are considering statistically significant.

Eligibility criteria:
inclusion criteria: 1. resectable pancreatobiliary cancer confirmed by radiologic studies (ct scan, mri, pet-ct) 2. no evidence of distant metastasis 3. aged 15-80 year old 4. performance status (ps) of 0 or 1 on eastern cooperative oncology group (ecog) scale 5. adequate organ functions defined as indicated below 1. wbc 3000 \~ 12 000/mm3 2. \> hb 8.0 g/dl 3. \> plt 100 000/mm3 4. \< cr 1.2 mg/dl 5. \> ccr 60 ml/min/body exclusion criteria: 1. cystic neoplasm, neuroendocrine tumors 2. pregnant or breast-feeding women 3. previous upper abdominal surgery except laparoscopic cholecystectomy 4.serious illness in medical condition 1. unstable angina or myocardial infarction within 6 months of the trial 2. unstable hypertension 3. congestive heart failure 4. severe respiratory disease requiring continuous oxygen therapy 5. liver failure 6. systemic administration of corticosteroids 7. severe mental disorder

Keywords: staging laparoscopy pancreatic cancer biliary cancer
evaluation of cortisol and bile acids metabolism in obese patients

Conditions: Obesity

Summary: bariatric surgery is currently the most efficient treatment for obesity. the sustained weight loss and metabolic improvement seen following roux-en-y gastric bypass (rygb), is explained partly by modifications in hormones including bile acids (ba). after rygb, an increased total ba pool and a reduction in hepatic cortisol exposure is observed. hydroxysteroid 11-β dehydrogenase 1 (hsd11b1), steroid 5α-reductases (srd5a), and steroid 5β-reductases, akr1d1 (also a ba metabolizing enzyme), are three enzymes involved in the metabolism of cortisol in the liver and are known to participate in metabolic syndrome. their activity has been shown to be decreased after rygb. interestingly, the mechanisms explaining the modification of hepatic cortisol exposure and the activity of theses enzymes after rygb are unknown. in view of the few data suggesting a link between cortisol metabolism and bile acids, this work aim to study and characterize this link in a context of rybp


Eligibility criteria:
inclusion criteria: * non-menopausal women * bmi between 35 and 50 kg/m² included * social insured * ability to give consent exclusion criteria: * moderate and severe kidney insufficiency * hepatic insufficiency * known gallbladder lithiasis * history of cholecystectomy or cholecystectomy planned during the gastric bypass * history of bariatric surgery except gastric band and gastric balloon * history of type 1 * treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months * treatment by ba as ursodeoxycholic acid, bile acids sequester, statin, fibrate stopped less than 4 weeks ago

Keywords: cortisol bile acids obesity bariatric surgery insulin resistance
management of postoperative pain following total knee arthroplasty by using acupuncture-moxibustion therapy

Conditions: Osteoarthritis, Knee

Summary: orthopedic surgery is reportedly among the most painful surgical procedures. surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs. we design a prospective randomized study for postoperative pain control following total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * diagnosed for surgery of osteoarthritis of knee * ability to tolerate surgery under general anesthesia. exclusion criteria: * refusal or the lack of mental ability to provide informed consent * neuropathic pain or sensory disorders in the leg requiring surgery * previous surgery of the knee joint * coagulation abnormalities * chronic opioid users * known history of intolerance to acupuncture-moxibustion therapy
local tolerability of chitosan-n-acetylcysteine eye drops in healthy young volunteers

Conditions: Dry Eye Syndromes

Summary: the "dry eye syndrome" des is a highly prevalent ocular disease, in particular in the elderly population. one mainstay of therapy for patients suffering from des is the use of topically administered lubricants. however, despite many efforts, no "ideal" formulation has yet been found. recently, croma pharma has introduced chitosan-n-acetylcysteine eye drops, designed for treatment of symptoms related to des. chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. additionally, the new formulation comprises n-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with des. we have recently shown in a phase i trial that single instillation of chitosan-n-acetylcysteine eye drops is well tolerated in young healthy subjects. however, due to the fact that intraocular pressure has been measured as one of the main safety variables, topical anesthesia was necessary. thus, the data about local ocular discomfort after administration are limited. this trial seeks to investigate whether single instillation of chitosan-n-acetylcystein leads to ocular discomfort such as burning and stinging.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 45 years * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 6 dpt exclusion criteria: * participation in a clinical trial in the 3 weeks preceding the study * abuse of alcoholic beverages * symptoms of a clinically relevant illness in the 3 weeks before the first study day * ametropia less than 6 dpt * pregnancy

Keywords: dry eye syndromes chitosan-n-acetylcysteine
ambulatory blood pressure monitoring for antihypertensive treatment guidance

Conditions: Hypertension

Summary: the purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.

blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. however, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure. aim: to test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

Eligibility criteria:
inclusion criteria: * uncontrolled hypertension (office bp \>139/89mmhg and 24h bp \>129/79mmhg) exclusion criteria: * severe concomitant illness including heart failure, significant valvular heart disease or malignancy

Keywords: hypertension ambulatory blood pressure monitoring blood pressure risk assessment
a multiple dose, dose escalation trial of aeb1102 in patients with aml or mds

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this is the first study of the safety of increasing dose levels of aeb1102 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. the study will also evaluate the amounts of aeb1102 in blood, the effects of aeb1102 on blood amino acid levels and the antitumor effects of aeb1102.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * age 18 and older * diagnosis of aml or mds according to the who criteria * aml relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens * mds refractory to treatment with hma therapy or with recurrence or progression of mds following a response to an hma * has adequate organ function: ast and alt \ 50 ml/minute * ecog performance score of 0 -2 * recovered from the effects of any prior systemic therapy, radiotherapy or surgery * willing to use physician approved birth control method exclusion criteria: * current cns leukemia * acute promyelocytic leukemia or aml with a t(15;17) (q22;q12) cytogenetic abnormality or bcr/abl positive leukemia * \< 60 days from asct; has chronic graft-versus host disease (gvhd) or requires continued treatment with systemic immunosuppressive agents * uncontrolled infection * known hiv, hepatitis b or hepatitis c. * other active malignancy that requires therapy * if female, is lactating or breast feeding * hypersensitivity to peg or other component of aeb1102 (co-argi-peg)

Keywords: aml mds