Kornimate/medical-research-clean huggingface dataset:
dosing of intra-articular triamcinolone hexacetonide for knee synovitis in chronic polyarthritis

Conditions: Arthritis of the Knee

Summary: this prospective randomised controlled single blind trial comparing the relapse rate in 6 months for 20 mg versus 40 mg intraarticular triamcinolone hexacetonide (lederspan®) for knee synovitis in patients with rheumatoid arthritis (ra) and psoriatic artritis (psoa) is performed to find the optimal dose to use.

background: triamcinolone hecacetonide (tha) has been used for local intraarticular injecton treatment for knee synovitis in decades, but no dose finding studies have been performed. in the literature the doses for knee injections vary between 20 mg and 80 mg, depending on local traditions. the aim of the present study is to find the optimal tha dosing, comparing the relapse rate during a 6 month observation period for the two most used dosages . methods: adult patients with ra or psoa with treatment demands for ongoing knee synovitis are recruited at the rheumatology departments in gävle and falun. after informed consent patient characteristics,(age, sex, medical treatment), clinical and laboratory parameters of disease activity (das28, crp), as well as degree of functional impairment (haq) are collected. a radiographic examination of the knee is performed and assessed (using larsen dale index) by an independent radiologist. the patients are allocated to either 20 mg or 40 mg tha using the randomisation dose which is hidden in prepared closed envelopes. after complete synovial fluid aspiration the tha dose is injected . the patients are told to contact the rheumatology department if no treatment response or if symtoms from the treated knee recurr. if so, the knee is examined again and if synovitis is confirmed a relapse is registered. time from injection to relapse is calculated. patients without relapse are called after 6 months to confirm they still are well and that no unknown relapse have occurred. when the observation period for the last included patient is finished the relapse rate between the 20 mg tha group is compared with the 40 mg tha group.

Eligibility criteria:
inclusion criteria: synovitis of the knee, rheumatoid arthritis or psoriatic arthrthritis, written informed consent - exclusion criteria: * inability to understand study information, function class 4 according to steinbrocker, planning knee surgery, , joint infection, intraarticular glucocorticoid injection in this joint the past 3 months, oral glucocortoid treatment corresponding to \>10 mg prednisolone

Keywords: knee synovitis triamcinolone hexacetonide treatment response
urine alkalinisation in covid-19

Conditions: Covid19; Acute Kidney Injury

Summary: since the outbreak of coronavirus disease 2019 (covid-19), more than 100,000 patients have died in the united kingdom. acute kidney injury is common in critically ill patients with covid-19. it is associated with a high risk of dying. at present, it is not clear how to prevent or treat kidney failure in these patients. recent research has shown that the coronavirus can directly infect kidney issue. it uses a particular protein on the cell surface (the ace2 receptor) for entry into cells. entry into cells is easier if the blood is more acidic. the aim of this project is to find out whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with covid-19.

acute kidney injury (aki) is common in patients with coronavirus disease 2019 (covid-19). research has shown that the sars-cov-2 virus can directly infect kidney issue via the angiotensin-converting-enzyme 2 receptor which is ph dependent. the aim of this randomised controlled feasibility study is to explore whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with covid-19. critically ill patients with covid-19 and no aki will be randomised to intravenous nahco3 8.4% versus standard care for up to 10 days.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 positive * admission to critical care unit * bladder catheter in situ * central line in place * age ≥18y * written informed consent to participate in the study exclusion criteria: * stage 3 aki (as defined by kidney disease improving global outcome criteria) * chronic kidney disease stage 4 or 5 * contraindications to nahco3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure) * urine ph \> 7.5 * serum sodium \>150mmol/l * blood pressure \>180/100mghg * severe hypokalaemia (k\<3.0mmol/l) * severe hypocalcaemia (cai \<0.8 mmol/l) * pregnant or lactating and breast-feeding women * patient is on a medication that may interact with sodium bicarbonate
treatment of androgenetic alopecia in females, 9 beam

Conditions: Androgenetic Alopecia; Hair Loss; Female Pattern Baldness

Summary: the purpose of this study is to evaluate the efficacy of the hairmax lasercomb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.

this is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). the trial with 60 female subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have fitzpatrick skin types i-iv, with classifications of ludwig i-4, ii-1, ii-2, or frontal, have active hair loss within the last 12 months. subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration. initial efficacy endpoint for each subject will be assess at visit 4 (week 16). safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria:
inclusion criteria: * diagnosis of androgenetic alopecia * fitzpatrick skin types i-iv * ludwig i-4, ii-1, ii-2, or frontal * active hair loss within last 12 months exclusion criteria: * photosensitivity to laser light * malignancy in the target area * pregnancy * lactating females

Keywords: andregenetic alopecia hair loss female pattern baldness
efficacy of air cleaners in asthmatics allergic to cat in alyatec environmental exposure chamber

Conditions: Asthma; Allergy

Summary: the aim of this study is to determine the efficacy of rowenta® "intense pure air xl" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in alyatec environmental chamber (eec)

a monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. the study lasts 3 months for each patient, which includes a screening period, two exposure visits in the alyatec environmental exposure chamber (eec) with active or placebo air cleaners, and a follow-up visit. patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. randomization is balanced (1:1) between the two sequences. there is a 3-week wash-out period between the two exposures.

Eligibility criteria:
inclusion criteria: * controlled intermittent asthma (step 1 treatment, according to gina guideline 2016) with or without association with cat allergy related rhino-conjunctivitis; * sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (alk, hørsholm, denmark) and specific ige anti fel d 1 ≥ 0.7 ku/l ( immunocap, thermofisher, uppsala, sweden); * fev1 ≥ 70% of the predicted value; * no cat exposure at home or outside of the home during the study; * positive methacholine challenge test performed using an aerodoseur dtf-atomisor ato-ad 12 (saint-etienne, france); * early asthmatic response during baseline cat allergen exposure. exclusion criteria: * uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study. * uncontrolled asthma 2 weeks after stopping laba treatment. * laba treatment within the 2 weeks preceding the study. * severe asthma (\> gina 2) * subject lives with a cat * cat desensibilisation within the 6 previous months. * active smoker

Keywords: asthma cat allergy environmental exposure chamber air cleaner
stelara and tremfya pregnancy exposure registry otis autoimmune diseases in pregnancy project

Conditions: Psoriasis; Pregnancy; Psoriatic Arthritis; Crohn Disease

Summary: the purpose of the otis autoimmune diseases in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. with respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

the purpose of the stelara and tremfya pregnancy exposure registry otis autoimmune diseases in pregnancy project is to follow pregnant women or women who have delivered a baby, who have been treated with stelara or tremfya within 3 months of their last menstrual period (lmp) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

Eligibility criteria:
inclusion criteria: * documentation of an exposure to stelara (ustekinumab) or tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (lmp) for any number of days, at any time, at any dose, and at any time until completion of pregnancy. * documentation of gestational timing of the exposure to stelara (ustekinumab) or tremfya (guselkumab) exclusion criteria: * women who have not have an exposure to stelara (ustekinumab) or tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.

Keywords: autoimmune disease pregnancy psoriasis stelara ustekinumab birth outcome malformation birth defect psoriatic arthritis crohn's disease tremfya guselkumab
long-term outcomes after resection of primary duodenal adenocarcinoma

Conditions: Duodenal Cancer

Summary: the aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.


Eligibility criteria:
inclusion criteria: * patients subjected to resection of primary duodenal adenocarcinoma exclusion criteria: * none.
latinos cares (colorectal cancer awareness, research, education and screening)

Conditions: Colorectal Cancer; Colorectal Carcinoma

Summary: the purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (crcs) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.


Eligibility criteria:
inclusion criteria: * men and women, age 50-75 years * self-identify as hispanic/latino * able to understand, read, and speak spanish * prefer to receive health information in spanish * previously screened or not screened

Keywords: cancer screening colon
enteral nutrition in liver cirrhosis

Conditions: Liver Cirrhosis

Summary: malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality. long term prognosis after liver transplantation also depends on the nutritional status. therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. however, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion. specific aims: to investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.


Eligibility criteria:
inclusion criteria: * liver cirrhosis (child b or child c) exclusion criteria: * malignant comorbidity * encephalopathy

Keywords: liver cirrhosis child b or c
prospective multicenter randomized controlled trial on two-stage turnbull-cutait coloanal anastomosis for rectal

Conditions: Rectal Neoplasm

Summary: the aim of this study is to decrease the morbidity by 30% using the turnbull-cutait procedure in comparison to the standard surgery for low rectal cancer. the investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged turnbull-cutait colo-anal anastomosis after low anterior resection for rectal cancer.

anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. this prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged turnbull-cutait colo-anal anastomosis.

Eligibility criteria:
inclusion criteria: * patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis; * patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment; * patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention * any extension of the primary tumor (t 1-2-3-4) according to the tnm classification; * patients with or without lymph node metastasis (n - / +) and with or without resectable distant metastases; * patients clinically without fecal incontinence prior to the current illness and with a wexner incontinence score less than or equal to 5; * patients asa i, ii or iii and adequate hematological, renal and hepatic function; * patients who signed informed consent. exclusion criteria: * altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write * fecal incontinence (wexner equal to or greater than 6); * previous surgery or proctological, colonic and anorectal functional disease * diagnosis of synchronous colorectal or any other active neoplasm; * patients asa iv, v; * pregnancy and lactation; * rejection of the patient to sign the consent form.
macrophage activation markers during sofosbuvir-based treatment regimes of chronic hepatitis c

Conditions: Hepatitis C

Summary: the purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during sofosbuvir based treatment regimes of chronic hepatitis c. in order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (cd163 and cd206). to assess to which extent fibrosis disappear during treatment, we want to examine the liver with fibroscan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. we want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.


Eligibility criteria:
inclusion criteria: * hepatitis c and initiation of sofosbuvir-based direct-acting antiviral treatment exclusion criteria: * hiv or hepatitis b virus

Keywords: sofosbuvir direct acting anti-viral treatment liver cirrhosis
tobacco cessation in postmenopausal women (part i) - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to evaluate the effects of ert on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

female subjects were screened and randomized. following two weeks of medication monitoring, all participants continued smoking as usual for one week, at which time baseline measurements were taken. for the remaining two weeks (the experimental period), participants were randomized to a continued smoking or smoking abstinence condition. the abstinent group was provided with cessation counseling and monitored for abstinence. for all participants, data were collected during five clinic visits on all dependent measures: mnws, qsu, beck depression inventory (bdi), profile of mood states, motor speed tasks and reaction time tests. question of interest was whether hormone replacement therapy would improve these dependent measures as manifested during short-term smoking cessation.

Eligibility criteria:
inclusion criteria: female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal tsh. exclusion criteria: women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, bmi greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.

Keywords: tobacco cessation postmenopausal women
effects of alcohol history on effects of sevoflurane and nitrous oxide - 13

Conditions: Alcohol-Related Disorders; Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. all subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide sevoflurane ethanol subjective effects healthy volunteer
does thiazolidinedione therapy improve endothelial function and preserve renal function

Conditions: Chronic Kidney Disease

Summary: the hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with ckd but without diabetes.

despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (ckd). ckd constitutes one of the highest risk populations for cardiovascular disease. when the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. however, few studies have focused on the prevention or treatment of coronary artery disease (cad) in ckd patients. the development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. the broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with ckd. thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes. to address this hypothesis the following specific aims are proposed: 1. to determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with ckd (creatinine clearance ≤ 60 ml/ min, but not on dialysis) 2. to determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with ckd 3. to determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with ckd

Eligibility criteria:
inclusion criteria: * age over 18 years. * creatinine clearance ≤ 60 ml/min by the cockcroft-gault equation * patients not anticipated to go on dialysis or have renal transplantation in the next 6 months * ability to provide informed consent * life expectancy greater than 12 months exclusion criteria: * diabetes mellitus or a fasting blood glucose ≥ 110 mg/dl * acute renal failure * class 3 or 4 heart failure * liver failure, ascites, or an aspartate aminotransferase (ast) or alanine aminotransferase (alt) two times the upper limit of normal * hemoglobin less than 9 mg/dl * multiple myeloma * premenopausal women not using at least 1 form of birth control * pregnant or nursing women * prisoners * known allergy to pioglitazone

Keywords: kidney failure, chronic renal insufficiency, chronic proteinuria albuminuria
hematopoietic stem cell transplantation for the treatment of limb ischemia and diabetic neuropathy

Conditions: Limb Ischemia; Diabetic Neuropathy

Summary: several pathophysiological theories have been proposed for the development of diabetic chronic complications. in recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. we performed this study to evaluate the effect of autologous hematopoietic cd34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded iii or iv in the leriche-fontaine functional classification. exclusion criteria: * patients older than 75 years * hypercoagulable states * cardiac ejection fraction \< 30% * active vasculopathy in brain, kidneys or heart * neoplastic disease * active infection * diabetic ketoacidosis or hyperosmolar hyperglycemic state * gangrene of the extremity requiring immediate surgery.

Keywords: nerve conduction velocity hematopoietic stem cell transplantation