Kornimate/medical-research-clean huggingface dataset:
intralymphatic immunotherapy enhanced by vitamin-d, a randomized placebo-controlled trial and comparison with slit

Conditions: Allergic Rhinitis Due to Grass Pollen

Summary: a national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years grazax sublingual immunotherapy or 3 intralymphatic injections with alk alutard timothy. in a second step, the ilit group will be double blind randomised 1:1 to an intramuscular injection of vitamin d vicotrat or placebo, 4 week before the start of the intralymphatic treatment. the primary outcome measure is daily combined symptoms and medication scores during grass pollen season.


Eligibility criteria:
inclusion criteria: * moderate to severe allergic rhinitis due to grass pollen, with rhinitis total symptom score \>/= 8. * informed consent exclusion criteria: * chronic rhinosinusitis with or without nose polyps * previous immunotherapy (slit or scit) * bmi \> 35 * house dust mite allergy with symptoms * allergy towards furry animals if exposition cannot be avoided * 25(oh)vitamin d levels \ 75 nmol/l * use of vitamin d supplementation or excessive use of sun tanning booths * mental incapacity to follow study protocol * other significant disease * allergy towards study medication * uncontrolled asthma * severe atopic dermatitis * pregnancy or nursing * autoimmune disease * hyper ige-syndrome * cardiovascular disease * lung disease * liver or kidney disease * hematologic disorder * metabolic disease * chronic infectious disese * medications interacting with the immune system * cancer * previous cytostatic therapy * medication with beta-blockers or ace-inhibiters, if medication cannot be paused at the day for treatment * drug or alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent exclusion criteria only for ilit group (due to vitamin d treatment) * medication witch can interacts with vitd: (ace-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics) * tendency for formation of kidney stones * hyperparathyroidism or other disease conferring risk of hypercalcemia * hereditary pseudohypoparathyroidism with decreased phosphorous secretion * malabsorption or bowel disease with diarrhea * mb paget, osteoporosis or sarcoidosis * skin disease at the groin (where the treatment will be injected)
exhaled nitric oxide : biomarker of acute respiratory distress syndrome

Conditions: ARDS, Human; Nitric Oxyde

Summary: the aim of the study is to see if endogenous exhaled nitric oxyde (eno) concentrations measured are significantly higher in ards patients admitted in icu ; compared to control subjects in good health with no lung disease or global inflammation, operated under general anesthesia (i.e. intubated and ventilated) for thyroid or parathyroid.

the measurement of endogenous exhaled no is monitored using a laser spectrometer machine connected to the expiratory circuit of the respirator. the measure is non-invasive and made by sampling expiratory gaz like for capnography. in control subjects, the measurement period corresponds to the first ten minutes after induction of anesthesia (with intubation) before surgical incision. in ards patients in intensive care, the measurement of eno is made in the first twenty-four hours after intubation and ventilation of the patient with mechanical respirator. the primary endpoint is a significantly higher eno concentration in patients suffering from acute respiratory distress syndrome (ards). secondary endpoints will assess correlations between eno concentrations and usual ards severity criteria: pao2/fio2; ventilator-free days; length of stay in intensive care and all-cause hospital mortality at 30 days.

Eligibility criteria:
inclusion criteria: * for ards patients : * patients with ards (according to the berlin criteria) admitted in intensive care unit and intubated for less than 24 hours. * for control patients : * patients with no major disease (classified 1 or 2 in the classification of the american society of anaesthesiology) * patients undergoing general anaesthesia for a thyroïd or parathyroïd surgery exclusion criteria: * minors under the age of 18 years old * pregnant women * prisoners * patients who have withdrawn their consent.

Keywords: ards lung oedema capillary-alveolar permeability nitric oxyde laser spectroscopy
a study to investigate efficacy and safety of kbl697 in patients with mild to moderate active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the study is designed to investigate efficacy and safety of kbl697 in patients with mild to moderate active ulcerative colitis. kbl697 has been developed as a potential new treatment for ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patient has an established diagnosis of ulcerative colitis for at least 3 months prior to screening * patient has active mild to moderate ulcerative colitis at visit 2 * patient is taking at least one of the following oral medication: 5-asa, corticosteroids, immunomodulators exclusion criteria: * patient has a possible or confirmed diagnosis of crohn's disease or other forms of inflammatory bowel disorders * patient has a persistent fever of ≥ 38.3°c * patient has current signs or symptoms of infection * patient has any immunosuppressant condition * patient has a known malignancy within 5 years prior to screening * patient who has a medical history of drug abuse or alcohol abuse * patient who, in the opinion of the investigator, has a clinically significant co-morbid disease * patient has hepatic failure * patient is pregnant or plans a pregnancy within the study period * patient has no previous history of treatment for ulcerative colitis (treatment-naïve patient) * patient has ongoing or failed treatment for ulcerative colitis with calcineurin inhibitor * patient has received biologic medication * patient has received antibiotics within 4 weeks prior to visit 2 * patient is unable to stop previous antibiotics treatment during study period * patient has received probiotics within 2 weeks prior to visit 2 * patient with history of major surgery in any region of the gastrointestinal tract * patient has received any investigational product or participated in another clinical trial * patient has a stool culture or other examination positive for an enteric pathogen * patient tests positive for cmv by pcr test at screening * patient tests positive for hiv at screening * exclusion criteria based on results of hepatitis b at screening * exclusion criteria based on results of hepatitis c at screening

Keywords: microbiome kbl697 inflammatory bowel disease
preimplantation genetic testing in women of advanced maternal age

Conditions: Infertility, Female

Summary: the getset trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (pgt-a) in elective single embryo transfer in women between 35 and 40 years of age.

in this randomized controlled trial, a total of 240 patients divided evenly across the two participating ivf centers will be recruited. patients will be randomized to a control and to a treatment group, each containing 120 participants. only patients with at least one evaluable blastocyst will be randomized. patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by ivf center. in the control arm, patients will undergo a single frozen embryo transfer with an untested blastocyst with the best morphology. all other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. pgt-a results of the untransferred embryos will be revealed to the patient after the outcome of the initial et is known. if the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected. in the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and pgt-a. pgt-a will be performed regardless of the number of blastocysts available. patients will undergo frozen transfer of the single, best quality euploid blastocyst. if the initial transfer results in a non-conception cycle and additional embryos are available for transfer, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.

Eligibility criteria:
inclusion criteria: * women undergoing ivf of between 35 and 40 years of age at ivf cycle start * utilization of intracytoplasmic sperm injection icsi * utilization of ejaculated or testicular sperm * utilization of autologous or donor sperm * all controlled ovarian hyperstimulation (coh) protocols exclusion criteria: * patients with anovulatory polycystic ovarian syndrome (pcos) * utilization of donor oocytes * utilization of gestational carrier * recurrent pregnancy loss (rpl) defined as ≥ 3 consecutive miscarriages * recurrent implantation failure (rif) defined as ≥ 3 more failed embryo transfers
integrated exercise program in opioid agonist therapy clinics

Conditions: Substance-Related Disorders

Summary: background: drug use is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. particular people with opioid dependence have high morbidity and reduced quality of life. a reduction in fitness level for people with substance use disorder reduces the general health and quality of life. physical activity is recommended as an adjunctive treatment for people with substance use disorder. due to its positive effects on health, quality of life and substance use. there is minimal evidence from well-controlled randomised trials among people receiving opioid agonist therapy. however, studies indicate that exercise could be promising in opioid agonist therapy. study design: bareaktiv is a multicentre randomised controlled trial. the study aims to recruit approximately 225 patients receiving opioid agonist therapy. intervention: a 16-week group-based exercise intervention with workouts twice a week. the exercise program will consist of endurance and strength training. the intervention will be integrated into outpatient's clinics in bergen and stavanger, norway. study population: the target group will be patients over 18 years of age with severe opioid use disorder receiving oat in outpatient clinics. expected outcome: this study will inform the relative advantages and disadvantages of an integrated exercise program as an adjunctive treatment. both physical and mental health outcomes are of interest. further scale-up will be considered if the provided exercise program is safe and effective.

see below each section

Eligibility criteria:
inclusion criteria: * receiving oat from an included outpatient clinic with follow-up weekly * low level of physical activity measured using ipaq (assessed at screening) * confirming interest in participating in physical activity intervention and providing informed consent (criteria specified) * giving informed consent exclusion criteria: * not able to participate in the intervention due to physical disabilities or severe mental disorders * being imprisoned or in inpatient treatment settings

Keywords: opiate substitution treatment exercise therapy exercise substance-related disorders
controlled clinical trial of traditional chinese medicine mouthrinse

Conditions: Gingivitis

Summary: traditional chinese medicine (tcm) has been seen as the predominant way of treating disease in china over three thousand years. certain tcm have scientifically proved to have anti-bacterial property. patients having orthodontic treatment have higher risks of caries and gum diseases. the purpose of this study was to determine whether the use of tcm mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic patients in maintaining proper oral health.

the aim of this study was to investigate the effects of a traditional chinese medicine (tcm) mouthrinse on gingival health and microbial profiles in orthodontic patients. this six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. the subjects were allocated to (1) negative-control group: oral hygiene instruction (ohi) alone; (2) positive-control group: ohi plus an eo mouthrinse (listerine®)(3) test group: ohi plus the tcm mouthrinse (5% fructus mume extract). clinical examinations included plaque index (pi), bleeding index (bi) and modified gingival index (mgi). salivary microbial quantifications included total aerobic and anaerobic bacteria, streptococci and lactobacilli counts. clinical and microbiological examinations were conducted at baseline, 3 and 6 months (t1, t2 and t3).

Eligibility criteria:
inclusion criteria: * subjects who have at less 20 permanent teeth * subjects who have a healthy systemic condition * subjects with age range 13-35. * subjects who are no-smoker; * subjects who haven't taken antibiotic medicine within a 2 week period prior * subjects who do not currently undergo any medication or will undergo any medication in next six months * subjects who have not dental diseases that required ongoing treatment, which would confound the evaluation of result * subjects who are competent in giving consents * subjects who are not pregnant or lactating women * subjects who do not report teeth sensitivity * subjects who are not allergic to ethanol * subjects presented a minimum level of pre-existing gingivitis (mgi\>1) but without peridontitis.(probing depth\>4mm)

Keywords: chinese medicine gingivitis cytokine microbial
decreasing alzheimer's risk through online choreographed exercise - down syndrome

Conditions: Down Syndrome; Physical Inactivity

Summary: the investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with down syndrome. participants will take part in a 12-week exercise program with two 35-minute session per week delivered in a group setting. the aims of the project are to: * assess the feasibility of a 12 week remotely delivered group dance intervention. * assess changes in aerobic fitness and cognitive function in response to a 12 week remotely delivered group dance intervention. * assess the intensity and total energy expenditure of remotely delivered group dance sessions.

the incidence of alzheimer's disease for persons with down syndrome exceeds 90%, and physical activity engagement has demonstrated potential to delay onset of alzheimer's disease for this population. adults with down syndrome participate in less physical activity than their counterparts without disability, partially due to unique barriers preventing engagement in typical modalities of physical activity for this population. dance, which is characterized by rhythmic physical movements offers the potential for social engagement, and stimulation of brain functions may offer a reasonable alternative to traditional physical activity modalities. however, empirical evidence to support the feasibility of a remotely delivered group dance intervention and evaluation of the intensity and energy expenditure achieved by a dance intervention for adults with down syndrome are currently unavailable and will be the focus of the proposed pilot trial. adults with down will be asked to attend 35 minute remotely delivered (zoom®) group dance sessions twice weekly across 12 weeks to assess the acceptability, appropriateness, and feasibility of the intervention, energy expenditure achieved during the exercise sessions, and evaluate change in aerobic fitness and cognitive function after 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of down syndrome * sufficient functional ability to communicate through spoken language * no plans to relocate outside the study area over the next 12 weeks * possession of a personal device that allows for connectivity to the internet and participate in 2x weekly group video calls * ability to participate in moderate to vigorous physical activity exclusion criteria: * serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty as determined by the research staff * unwilling to participate in outcomes assessments * uninterested
study comparing etanercept 50 mg once weekly to 25 mg twice weekly in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (as).


Eligibility criteria:
inclusion criteria: * diagnosis of as, as defined by modified new york criteria for ankylosing spondylitis. * active as, defined by average of visual analog scale (vas) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: vas for patient global assessment ≥ 30; average of vas for nocturnal and total pain ≥ 30; basfi ≥ 30 (all scores on a scale of 0 to 100). exclusion criteria: * complete ankylosis (fusion) of spine. * previous treatment with etanercept, antibody to tumor necrosis factor α (tnfα), or other tnfα inhibitors or other biologic agents. * use of disease modifying antirheumatic drugs (dmards) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study. * receipt of multiple nonsteroidal anti-inflammatory drugs (nsaids) at baseline. * dose of nsaid changed within 2 weeks of baseline evaluation. * dose of prednisone \>10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
prognostic values of coronary microvascular dysfunction patients treated with rotational atherectomy during percutaneous coronary intervention

Conditions: Coronary Arterial Disease (CAD); Coronary Microvascular Dysfunction (CMD)

Summary: the goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in patients treated with rotational atherectomy during percutaneous coronary intervention. the main question it aims to answer is: does the coronary microvascular dysfunction impact the outcomes in patients treated with rotational atherectomy during percutaneous coronary intervention. participants will answer survey questions about their clinical outcomes for 2 years by telephone.

this study was a retrospective, multicenter observational investigation and approved by the local human research ethics committee and conducted in accordance with the principles outlined in the helsinki declaration.patients aged 18 years or older who had severe coronary calcification and underwent successful ra during pci were eligible for inclusion in the study. exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed ra and ra not used for severe coronary calcification. angiography-derived index of microcirculatory resistance was measured in the target vessel treated with ra pre-pci and post-pci and blinded and performed by an independent core laboratory.the follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who had severe coronary calcification and underwent successful ra during pci exclusion criteria: * target vessel was chronic total occlusion, poor angiographic image quality, failed ra and ra not used for severe coronary calcification

Keywords: coronary microvascular dysfunction index of microcirculatory resistance coronary artery disease rotational atherectomy
microneedling and latanoprost in acrofacial vitiligo

Conditions: Vitiligo

Summary: to compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.

patients meeting inclusion and exclusion criteria presented to dermatology outpatient clinic, sohag university hospital will be enrolled in the study after obtaining a written consent from them. full history will be obtained and meticulous examination will be carried out. patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.

Eligibility criteria:
inclusion criteria: - acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions). exclusion criteria: * history of scar formation. * patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension). * patients who are receiving chemotherapy or radiotherapy. * pregnant and lactating females.

Keywords: acrofacal vitiligo, latanoprost, microneedling
early detection of advanced fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease; Liver Fibrosis

Summary: non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects. the investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.

the investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease. nafld score and elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications. the detection of participants with nafld score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma. if the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey. moreover, the investigators will check whether there is a correlation between nafld score and elastography in participants without know liver disease with nafld score more than 0.675.

Eligibility criteria:
inclusion criteria: 1. subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily. 2. subjects without known liver disease. 3. subjects agree to sign a consent form. - exclusion criteria: 1. history of right-sided heart failure 2. history of liver disease including positive infectious serology for hepatitis b or c 3. pregnant women 4. people incapable of judgment -

Keywords: nafld score elastography