Kornimate/medical-research-clean huggingface dataset:
effect of secukinumab on radiographic progression in ankylosing spondylitis as compared to gp2017 (adalimumab biosimilar)

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified stoke ankylosing spondylitis spine score (msasss) in patients with ankylosing spondylitis (as).

this was a phase iiib, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with as. the study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (weeks 112 and 120). subjects in both secukinumab dose groups received study treatment at baseline, weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through week 100. subjects in the gp2017 group received study treatment at baseline and every two weeks through week 102. subjects could self-administer all secukinumab / placebo and gp2017 doses at the study site or at home. study treatment (secukinumab vs. gp2017) was provided in an open-label fashion. subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. subjects were treated for 104 weeks with two follow-up visits (weeks 112 and 120). a total of 859 subjects were randomized to treatment at 171 sites in 30 countries in europe, north america, south america, and asia. .

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-nursing female patients at least 18 years of age * diagnosis of moderate to severe ankylosing spondylitis with radiologic evidence (centrally read x-ray) fulfilling the modified new york criteria for as despite previous or current nsaid/ nonbiologic dmard therapy * active as assessed by total basdai ≥ 4 on a scale of 0-10 * spinal pain as measured by basdai question #2 ≥ 4 (0-10) * total back pain as measured by visual analog scale (vas) ≥ 40 mm (0-100 mm) * hscrp ≥ 5 mg/l or presence of at least 1 syndesmophyte on centrally read spinal x-ray exclusion criteria: * patients with total ankylosis of the spine * pregnant or nursing (lactating) women * evidence of ongoing infectious or malignant process * previous exposure to any biologic immunomodulating agent, including those targeting il-17, il-17 receptor or tnfα * subjects taking high potency opioid analgesics * previous treatment with any cell-depleting therapies including but not limited to anti-cd20, investigational agents other protocol-defined inclusion/exclusion criteria may apply

Keywords: ankylosing spondylitis as secukinumab gp2017 adalimumab biosimilar msasss asas20 asas40 adult r-axspa ain457 radiographic surpass
genetic polymorphisms and their association with temporomandibular disorders

Conditions: Temporomandibular Disorders; Orofacial Pain

Summary: temporomandibular disorders (tmd) are the most common orofacial pain disorders of non-dental origin with the prevalence of 6.1-10.2%, and incidence of 3.9%. observable pathology is mostly absent, and the etiology often remains unknown. since some other painful conditions of unknown origin (eg. fibromyalgia), also imply genetic factors, the aim of the study is to investigate genetic predisposition in relation to the risk for tmd onset. this will be achieved through analysis of polymorphisms in the selected genes in tmd patients (dc/tmd) and matched control subjects. the possibility of involvement of specific polymorphisms in modulation of therapy response will also be investigated. the hypotheses: (i) the single nucleotide polymorphism (snps) clustering will be dependent on presence or absence of tmd (comparison of patients with control subjects), and will possibly depend on source of pain, pain intensity, presence of bone changes, psychological features and previous orthodontic therapy, and (ii) snps will influence the treatment response. along with anamnestic and clinical examination and occlusal splint therapy, genomic dna will be analyzed from the buccal swabs. isolated dna will be used for the determination of 19 polymorphisms of selected genes using real-time pcr method. the analysis of salivary oxidative stress markers and opiorphin will be also performed, as their relationship with tmd has been shown previously. this time, their concentration will be associated with polymorphisms in the promoters of genes responsible for their synthesis. the investigators expect to show that particular gene profile or group of snps represent a risk factor for tmd development. innovative approach of the concept of determining the genetic predisposition for tmd has the potential for development of commercial genetic test with potential for risk estimation in relation to tmd onset. this could enable early interventions and active avoidance of environmental risk factors.


Eligibility criteria:
inclusion criteria: * diagnosis of myofascial pain / arthralgia / painful disc displacement according to diagnostic criteria for temporomandibular disorders (dc/tmd) * average pain in the last 10 days \>30 mm on a visual analogue scale * pain duration of at least 3 months * good oral hygiene * presence of own natural teeth * absence of any form of chronic pain in the orofacial region or in other regions of the body exclusion criteria: * other orofacial pain conditions including dental pain * poor oral hygiene, gingivitis or periodontitis * chronic medical conditions (diabetes, cardiovascular diseases, cancer, and autoimmune diseases) - - - * neurological and psychiatric disorders * pregnancy * causes of headache, unrelated to tmd, listed in the international classification of headache disorders
a safety study of dapivirine vaginal ring in africa

Conditions: HIV Infections

Summary: this is a double-blind, randomized, placebo-controlled phase i/ii study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.


Eligibility criteria:
inclusion criteria: * women between 18 and 40 years of age inclusive who can provide informed consent * available for all visits and consent to follow all procedures scheduled for the study * healthy and self-reported sexually active * hiv-negative * on a stable form of contraception and willing to continue or have undergone surgical sterilization at least 3 months prior to enrollment * in the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses * upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator * asymptomatic for genital infections at the time of enrolment * willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study * willing to answer to acceptability, adherence and behavioural assessments throughout the study * willing to refrain from participation in any other research study for the duration of their participation * willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures exclusion criteria: * currently pregnant or last pregnancy within 3 months prior to enrolment * currently breast-feeding * participated in any other research study within 60 days prior to screening * previously participated in any hiv vaccine study * untreated urogenital infections within 2 weeks prior to enrolment * presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy * history of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence * pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation * any grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the daids table for grading adverse events * any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment * any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer * any serious acute, chronic or progressive disease * any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives

Keywords: hiv infections anti-hiv agents hiv-1
0.9% nacl/dextrose 5% vs 0.45% nacl/dextrose 5% as maintenance intravenous fluids in critically ill children

Conditions: Hyponatremia

Summary: the primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% nacl/dextrose 5% or 0.9% nacl/dextrose 5%, in critically ill children requiring iv maintenance fluid administration.

in patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. since the original descriptions by holliday and segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 meq/l of sodium. however hyponatremia has become increasingly recognized in hospitalized children suggesting that holliday and segar's recommendations are frequently inappropriately applied. it has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions. more over, non-physiologic antidiuretic hormone (adh) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions. it has been suggested that isotonic 0.9% nacl/dextrose 5% should be the standard maintenance intravenous (iv) solution, to avoid the development of hyponatremia. there are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.

Eligibility criteria:
inclusion criteria: * age 1 month to 18 years * icu stay \>24 hours * normal seric sodium (135 - 145 meq/l). * requirement of iv maintenance solutions \>80% total fluids intake exclusion criteria: * patients with diagnoses of renal failure (serum creatinine \>1 g/dl in \ 1,5 in \>3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, kawasaki disease, sickle cell anemia, syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease. * diuretics use in the first 48 hours thereafter indicated iv solutions. * plasma glucose is \>200 mg%. * any patients requiring iv fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).

Keywords: hyponatremia maintenance solutions pediatrics
efficacy of zinc sulfate with probiotics for the treatment of acute diarrhea in children

Conditions: Acute Watery Diarrhoea

Summary: diarrheal disease is one of the major causes of morbidity and mortality in children under five. disease is treated symptomatically with oral rehydration (ors) as a basic measure. in children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. zinc supplementation may also helpful in diarrheal children without zinc deficiency. effectiveness of zinc was proven in developing countries but was not in europe. objective of our study is to assess whether zinc supplementation given with probiotics and ors is effective in acute diarrhea in children in poland.

a double-blind, placebo controlled trial - we are going to enroll 256 patients (aged \> 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days. exclusion criteria: severe dehydration (\> 10%) coexisting severe infection (e.g. sepsis, pneumonia, meningitis) immune deficiency chronic digestive tract disease (e.g. celiac diseases, food allergy) therapy with antibiotics patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days. randomization 1:1

Eligibility criteria:
inclusion criteria: * age 1-36 months * acute diarrhea defined as 3 or more watery stools per day * informed consent (parents) exclusion criteria: * severe dehydration (\> 10%) * coexisting severe infection (e.g. sepsis, pneumonia, meningitis) * immune deficiency * chronic digestive tract disease (e.g. celiac diseases, food allergy) * antibiotic therapy

Keywords: acute diarrhoea, children
endo-vac-therapy for post-sleeve gastrectomy leaks

Conditions: Anastomotic Leak

Summary: endoscopic negative pressure therapy (enpt) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. the purpose of this study is to determine the safety and efficacy of enpt in the management of proximal staple line leak after sleeve gastrectomy.

clinical data of 40 cases of post-sg proximal staple line leak treated with enpt are analysed. success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).

Eligibility criteria:
inclusion criteria: * staple line leak detected by endoscopy and/or ct within 30 days after surgery. * age 18 years or older. * written informed consent. exclusion criteria: * declined informed consent. * leaks detected later than 30 days after surgery.

Keywords: staple line leak endoscopic vacuum therapy endoscopic negative pressure therapy laparoscopic sleeve gastrectomy
a study to assess retention rate, persistence and adherence in population of spondylarthritis (ankylosing spondylitis and psoriatic arthritis) patients treated with adalimumab in routine clinical settings in russian federation

Conditions: Spondylarthritis; Psoriatic Arthritis; Ankylosing Spondylitis (AS)

Summary: the objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (spa) (ankylosing spondylitis (as) and psoriatic arthritis (psa)) participants treated with adalimumab in routine clinical settings in the russian federation.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of as or psa. * planned prescription or prescribed no more than 1 month before to enrolment therapy with adalimumab. treatment has to be prescribed according to the local product label and prescription guidelines. * at the moment of start of treatment with adalimumab moderate/severe as or psa (basdai \> 4 for as; das28 \>3,2 for psa). * negative result of tuberculosis (tb) screening test and tb specialist permission to start biologic therapy. * authorization (consent) for use/disclosure of data signed by the participant. exclusion criteria: * has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label). * participants who are unable to walk and perform basic self-care activities either due to spa or a comorbid condition. * any biologic drugs taken over before 3 months of enrolment to the study. * previous participation in this program.

Keywords: adalimumab ankylosing spondylitis psoriatic arthritis spondylarthritis humira®
hydration amongst nurses and doctors oncall

Conditions: Dehydration

Summary: the main purpose of this study is to assess and compare the hydration status of medical and nursing staff and to investigate the relationship between the hydration status, cognitive function and serum cortisol (marker of stress). we hypothesise that a significant proportion of doctors and nurses will be dehydrated at the end of their working day. some, as in other occupations, may be dehydrated at the start of their working day. this is likely to be associated with impairment in cognitive performance at the end of the working day compared to the beginning and expected to be more pronounced after a night shift. there may be less noticeable difference amongst nursing staff given the protected break time. dehydration and associated impairment in cognition is of important clinical value as it can impact patient care. participants will be involved in the study for two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15 medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day and 15 night shifts from each group). those that do not work both day and night shifts will participate for only one shift and a new participant will be recruited until target number of shifts is achieved.

end points 1. to assess the hydration status of hospital staff nurses and doctors oncall at work by measuring the following: 1. urine and serum osmolality 2. urine mass produced during the shift 3. kidney function (u \&es) 4. bioimpedance measures 2- to assess the effect of hydration on status of cognitive function and subjective feelings. 3- to assess the association between hydration status on stress hormone (cortisol) levels. inclusion criteria all medical and nursing staff working on acute medical and surgical admissions at the queens medical centre nottingham. exclusion criteria: pregnancy pre-existing kidney disease patients on diuretics unwell in the past 6 week with acute illness that warrants hospital admission or prescribed medication.

Eligibility criteria:
inclusion criteria: * all medical and nursing staff working on acute medical and surgical admissions at the queens medical centre nottingham exclusion criteria: * pregnancy pre-existing kidney disease patients on diuretics unwell in the past 6 week with acute illness that warrants hospital admission or prescribed medication.

Keywords: hydration cognitive function doctors nurses nurses and doctors oncall
use of gm-csf treatment in recurrent implantation failure

Conditions: Women With Recurrent Implantation Failure in IVF

Summary: the purpose of this study is to determine whether in assisted reproductive technologies the treatment with gm-csf, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in ivf cycles.

the gm-csf is a cytokine promoting leukocyte growth, but also trophoblast development. in this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after ivf, at leat three failed previous ivf attempts. the study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. the inclusion criteria will be, at least three previous failed egg donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. these women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous gm-csf 60 micrograms/day from the day of transfer to the day of β-hcg test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hcg levels at 14/21/28 and 35 days after embryo transfer.

Eligibility criteria:
inclusion criteria: * women 50 years old or less with three or more previous egg donation cycles failed, * with a total of at least 4 blastocysts replaced in uterus exclusion criteria: * chromosomal defects in the patients, * metabolic diseases (diabetes etc.) * genetic diseases (thalassemia, cystic fibrosis, etc.)

Keywords: gm-csf, ivf failure,pregnancy
a safety, efficacy and tolerability study of sep-225289

Conditions: Depressive Disorder, Major

Summary: to determine the safety, efficacy and tolerability of sep-225289 in subjects with major depressive disorder

this is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of sep-225289 in male and female subjects with mdd. subjects meeting dsm-iv criteria for melancholic or atypical features specifier are eligible for participation. the study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. total subject participation will be approximately 91 days (13 weeks). this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * the duration of the current episode must be at least 1 month but not longer than 12 months. * subjects must have a primary diagnosis of major depressive disorder. * subjects must have had at least one previous, diagnosed episode of mdd in the past 5 years. * mdd must be the condition that was chiefly responsible for motivating the subject to seek treatment. * subject is in general good health. exclusion criteria: * subject is participating in, has participated in, or plans to participate in any investigational drug study. * subject who has donated blood within the last 30 days or plans to donate blood during and 30 days following participation. * known failure to respond (in the past 5 years) to two adequate (dose and duration) antidepressant medications with distance mechanisms of action including tricyclics. * subjects who have undergone electroconvulsive therapy treatment. * treatment with fluoxetine, in the 6 weeks before baseline. * subject with psychotic disorders, anorexia nervosa, bulimia or post-traumatic stress disorder. * subject with a history or presence of bipolar disorder (i.e., current or past history of manic episode). * subjects with obsessive compulsive disorder. * subjects with a lifetime diagnosis of panic disorder. * subject received treatment with antidepressants within 2 weeks. * subject with lifetime history of suicidal attempts, alcohol dependence or abuse, drug(s) dependence or abuse (excluding nicotine and caffeine) or has a positive urine drug screen. * subject has a history of significant risk of suicide or homicide. * bereavement - defined as death of a loved one within 3 months. * subject has a documented history of hiv, hepatitis b or hepatitis c.

Keywords: depression mental disorders mood disorders depressive disorder, major dysthymic disorder