Kornimate/medical-research-clean huggingface dataset:
acupuncture reduces relapse in patients with crohn's disease: a superiority trial

Conditions: Crohn's Disease Relapse; Inflammatory Bowel Diseases

Summary: the aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of cd and to explore the efficacy mechanism of acupuncture efficacy enhancement.

acupuncture has been proven to be an effective and safe treatment for cd. in this trial, based on previous studies, which mainly treated cd from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating cd from the perspective of tonifying the shaoyang pivot mechanism to enhance the therapeutic effect.brain-gut axis dysfunction is one of the important pathogenic mechanisms of cd. this trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance cd by analysing brain-gut axis multi-pathway indicators.

Eligibility criteria:
inclusion criteria: 1. patients with clinical diagnosis consistent with cd; 2. aged 16-75; 3. patients in remission (cdai \< 150 and crp \< 5mg/l, or faecal calprotectin \< 50μg/g, or no ulcer under endoscopy); 4. patients with frequent disease recurrences (≥2) in the past years; 5. patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-tnf-α, il-12p40, α4β7); 6. those who have never experienced acupuncture; 7. patients signing informed consent. exclusion criteria: 1. patients who are recently pregnant or in pregnancy or lactation; 2. patients with serious organic diseases; 3. patients diagnosed as psychosis; 4. patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; 5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; 6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; 7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; 8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
accidentology and traumatology associated with foiling in brittany

Conditions: Sport Injuries

Summary: in the 2010s, the practice of water sports was turned upside down by the arrival of a new discipline: foiling. the number of sailors, particularly amateurs, is increasing every every year. the foil offers greater speed and height, and has therefore the accidents and injuries that result. injuries. but there are very few studies on the subject. the traumaf study proposes to compare the distribution of the number of patients injured during water sports with and without the use of foils. the study also looks at patient management and the type of injury. the aim is to anticipate the management of these patients during periods of practice of these sports. translated with deepl.com (free version)


Eligibility criteria:
inclusion criteria: * patient of legal age * patient not expressing refusal to participate in the study * patient consulting an emergency room following a boating accident that occurred no more than 7 days previously * patient able to complete a questionnaire exclusion criteria: * minor patient * patients who are illiterate and/or do not understand french * patient under legal protection
effects of a 9-months treatment of spiriva on health related quality of life in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (spiriva®) 18 mcg once daily on health related quality of life and lung function in patients with a chronic obstructive pulmonary disease.

this was a multicentre, randomised, double blind, parallel group, placebo-controlled, 9 month study. it was designed to determine the effect of inhaled tiotropium treatment on quality of life in patients with copd. following an initial 2-week screening period, patients were randomized to either tiotropium or placebo at visit 2. patients returned to the clinic at month 3 (visit 3), 6 (visit 4), and 9 (visit 5) for the conclusion of the trial. the patients received treatment daily for 9 months. quality of life was measured on each visit by using the saint george's respiratory questionnaire. additionally a short form questionnaire was developped for that study (visual simplified respiratory questionnaire). lung function was also measured at each visit by spirometry. study hypothesis: the primary objective of this study is to compare the efficacy of tiotropium and placebo on improving hrqol evaluated by the percentage of sgrq responders. the null hypothesis is that there is no difference in the effect on hrqol assessed by the percentage of sgrq responders between the two treatment groups. the alternative hypothesis is that there is a difference in effect on hrqol assessed by the percentage of sgrq responders between tiotropium and placebo. the test will be performed at the alpha = 0.05 level of significance. comparison(s): tiotropium 18 mcg once daily vs placebo

Eligibility criteria:
diagnosis of copd and matching the following criteria: * baseline 20 % \< fev1 \< 70 % of european community of coal and steel (eccs) predicted values . * baseline fev1/svc\ 10 pack-years (p.y.). a p.y. was defined as the equivalent of smoking one pack of cigarettes per day for one year.
ex-vivo lung perfusion to increase the number of organs for transplantation

Conditions: Disorder Related to Lung Transplantation; Brain Death; Graft Failure; Primary Graft Dysfunction

Summary: the recent introduction of ex-vivo lung perfusion (evlp) as a tool to evaluate and recondition lungs from marginal donors has opened a new era in the field of lung transplantation.

aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving marginal lungs procured from brain death donors and reconditioned by evlp, with that of subjects receiving lungs procured from standard donors.

Eligibility criteria:
inclusion criteria for donor lung: 1. recipient to undergo single or bilateral lung transplantation 2. donor arterial partial pressure of oxygen to fraction of inspired oxygen ratio (pao2/fio2) below 300 mmhg, or doubtful donor lung function exclusion criteria for donor lung: 1. massive lung contusion 2. aspiration 3. pneumonia 4. sepsis 5. malignancy
hrqol keratinocyte carcinomas

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma; Actinic Keratoses

Summary: rationale: keratinocyte skin cancer is known to influence the hrqol in a specific way. derived utility values are required for cost-effectiveness analyses of new interventions. however there is no sensitive tool to capture hrqol that translates into utilities available. objective: to document the exact hrqol in patients with in kc using the generic eq-5d-5l questionnaire, as well as the tto, 15d and the basqol questionnaire, and to develop health utilities based on these tools. study design: longitudinal observational study (at time 0 and time 0 +12 months). study population: patients aged ≥18 years consulting a dermatologist or their gp for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).

see protocol

Eligibility criteria:
inclusion criteria 1. patients with one or more premalignant lesion or kc diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion. exclusion criteria 1. patient is younger than 18 years old or unable to provide consent. 2. patient is unable to remember the diagnosis or symptoms of their kc or premalignant lesion upon request by the doctor. 3. patient was diagnosed with a melanoma or another nmsc. 4. patient is unable to understand the task and questionnaires.
stepped care for binge eating disorder: predicting response to minimal intervention in a randomized controlled trial

Conditions: Binge Eating Disorder

Summary: binge eating disorder (bed) affects as many as 3% of women and men in ontario, 8% of obese individuals, and 30% to 50% of those participating in weight loss programs. bed, the most common eating disorder, is characterized by over-eating with loss of control (i.e., binge eating), but with no purging (e.g., vomiting).our previous research indicates that the total health care costs for women with bed is 36% higher than the canadian average for women of a similar age, and that health care costs significantly decreased following intensive treatment at our centre. the main goal of our study is to inform the development of a stepped care approach to the treatment of bed. stepped care involves providing easily accessible low intensity treatment first, and then providing more expensive intensive treatment second, if necessary. the second goal is to assess if a second more intensive step of treatment provides added value. although stepped care for bed is suggested by a number of clinicians and researchers, no study adequately tests predictors of who might benefit from minimal treatment alone and who would require the more intensive second step. the results of this study will guide decision making regarding who benefits from stepped care, and will help to increase the accessibility, availability, and cost effectiveness of psychological treatments for bed.


Eligibility criteria:
inclusion criteria: * participants will be included if they: 1. are comfortable speaking or reading english; 2. do not have a history of an eating disorder other than bed, or a history of significant purging behaviour; 3. do not have a concurrent dsm-iv diagnosis of bipolar disorder, psychosis, drug or alcohol dependence; 4. are not currently or planning to be enrolled in a weight-loss program within the next year; 5. are women who are not pregnant or planning to be pregnant within the next year; and 6. are not currently or planning to be enrolled in other psychotherapies within the next year exclusion criteria: * participants will be excluded if they: 1. are not comfortable speaking or reading english; 2. have a history of an eating disorder other than bed, or a history of significant purging behaviour; 3. have a concurrent dsm-iv diagnosis of bipolar disorder, psychosis, drug or alcohol dependence; 4. are currently or plan to be enrolled in a weight-loss program within the next year; 5. are women who are pregnant or planning to be pregnant within the next year; and 6. are currently or plan to be enrolled in other psychotherapies within the next year
sustainable efficacy of vardenafil od versus vardenafil prn in erectile dysfunction

Conditions: Erectile Dysfunction

Summary: compare once daily vs on demand treatment in men with erectile dysfunction. treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out: a: once daily at bedtime for 12 weeks followed by 12 weeks of placebo b: once daily at bedtime for 24 weeksc: prn for 24 weeks


Eligibility criteria:
inclusion criteria: * males 18-64 years of age * mild or mild to moderate ed (defined as \>15 and \<21 score points according to the erectile function domain score from iief as assessed at the randomisation visit) * history of at least one of the following conditions: diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease * stable, heterosexual relationship for more than six months exclusion criteria: * primary hypoactive sexual desire * history of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * nitrate therapy.

Keywords: erectile dysfunction vardenafil
evaluation of short antibiotic combination courses followed by aerosols in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (iv) and iv (nebcin®) tobramycin for 5 days followed by solution for nebuliser inhalation (tobi®) for 9 days and antibiotic cures using 14 days of tobramycin iv. in the case of positive results, the reduction of the duration of iv treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.


Eligibility criteria:
inclusion criteria: * patient with cystic fibrosis confirmed by sweat or genetic test * patient with clinical signs of exacerbation (increased cough, sputum (abundance, purulence), fever, anorexia, weight loss and fev1) or acute exacerbations (defined at the clinician's discretion ) * fev1 ≥ 25% * pseudomonas aeruginosa chronic carriers (defined by at least two antipyocyanic precipitation arcs or at least 3 successive positive ecbcs over a period of 18 months) * patient who received at least 1 iv course of antibiotics in the 18 months prior to inclusion. exclusion criteria: * severe exacerbation (requiring hospitalization due to severe amputation of fev 1, oxygen deficiency, or severe impairment of general health). * patient with 3rd antibiotic therapy (triple therapy) * patient colonized in burkholderia cepacia * patient colonized by an atypical mycobacterium * patient with pulmonary transplant or transplant * chronic tinnitus * patient using hearing aid * hypersensitivity to tobramycin and other antibiotics of the aminoglycoside family * cirrhosis of grades b and c according to the child-pugh classification * myasthenia gravis * simultaneous administration of another aminoglycoside * renal failure * recent history of severe hemoptysis (within 2 months before inclusion) * patient participating simultaneously in another clinical study conducted on a drug for the duration of its participation in this research

Keywords: cystic fibrosis, tobramycin, antibiotic courses, fev1
association between pseudoexfoliation syndrome and diabetes mellitus

Conditions: Lens Diseases

Summary: pseudoexfoliation syndrome (pex) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by lindberg. it is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. despite extensive research, the exactchemical nature of the fibrillar material is unknown. it is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.


Eligibility criteria:
inclusion criteria: * phakic patients presenting to ophthalmology outpatient clinic of assiut university hospital. exclusion criteria: * patients with previous intraocular surgery.
vitamin d for the treatment of women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine if vitamin d will improve insulin resistance, inflammation, and overall well-being in women with pcos.

as many cells throughout the body possess the vitamin d receptor, adequate vitamin d levels may be essential for multiple physiologic functions. in recent years, vitamin d insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with polycystic ovary syndrome (pcos). we believe that vitamin d insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with pcos. these adverse effects may ultimately increase the risk for serious long-term complications in pcos, including type 2 diabetes and cardiovascular disease. the key objectives of this research study are to determine the effects of vitamin d supplementation on insulin resistance, inflammation, mood and overall well-being in women with pcos. the protocol has been modified by adding the following specific aim: to compare vascular function in healthy age and bmi similar matched women to pcos women pre-treatment. our hypothesis is that pcos women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. we are currently recruiting healthy women who are age and bmi similar to the pcos women and measure their retinal vascular reactivity for comparisons to the pcos women's pre-treatment vascular reactivity. these healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. they will not be enrolled in the placebo or vitamin d randomization process as described above.

Eligibility criteria:
inclusion criteria: * diagnosis of pcos based on: * eight or fewer menstrual periods per year or spontaneous intermenstrual periods of greater than or equal to 45 days, and * elevated testosterone levels exclusion criteria: * current pregnancy or nursing * elevated calcium * kidney stones or kidney disease * current use of vitamin d (other than a multivitamin) * use of metformin or other insulin sensitizing drugs in the last 3 months * elevated prolactin or untreated thyroid disease * diabetes, liver disease, heart disease, or other serious medical condition

Keywords: polycystic ovary syndrome vitamin d insulin resistance inflammation
sequential treatment with belkyra® then juvéderm® voluma™ with lidocaine for overall improvement in jawline contour

Conditions: Contour

Summary: this study has been designed to evaluate the safety and effectiveness of sequential treatment with belkyra® (for the treatment of convexity and fullness associated with submental fat) and voluma™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.

participants may be treated with up to 6 treatments with belkyra, followed by treatment with voluma. participants will have opportunity to participation in a skin biopsy sub-study.

Eligibility criteria:
inclusion criteria: * grade 2 or above on allergan loss of jawline definition scale (aljds) * grade 2 or 3 on reported clinician-rated submental fat rating scale (cr-smfrs) * stable body weight for at least 26 weeks * accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area exclusion criteria: * grade 4 on submental skin laxity grade (smslg) * grade 4 on allergan jowl fat rating scale (ajfrs) * body mass index (bmi) \>35 kg/m\^2 * history of, or current symptoms of dysphagia * history of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before screening for treatment above the medial canthi * history of facial and/or neck plastic surgery, tissue grafting or permanent facial implants anywhere in the face or neck * history of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat submental fat (smf) * evidence of any cause of enlargement in the submental area other than localized smf * history of mesotherapy or ablative procedures to the face and/or neck 52 weeks before screening * history of skin resurfacing in the neck or submental area within 26 weeks before screening * treatment with botulinum toxin injections in the neck or submental area within 26 weeks before screening * participants on prescription topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 26 weeks before screening and who are unable to maintain regimen for the study * systemic retinoid therapy within 52 weeks before screening * current use of oral corticosteroids * is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel) * has current injection site inflammatory or infectious processes, abscess, an unhealed wound, or a known cancerous or precancerous lesion in chin, masseter, or submental region * planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 2 weeks prior to and after voluma™ treatment

Keywords: lower face contouring
a 12-week, randomized, double-masked, parallel group comparison of evening dosing with xalacom in subjects with glaucoma

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: to demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 am, 10 am, 4 pm at weeks 2, 6 and 12.


Eligibility criteria:
inclusion criteria: * uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening exclusion criteria: * closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. * history of alt (argon laser trabeculoplasty) or slt(selective laser) within 3 months prior to screening
a research study looking at how the medicine nnc0194-0499 behaves in japanese and non-asian men

Conditions: Non-alcoholic Steatohepatitis

Summary: this study looks at how a new medicine called nnc0194-0499 works in the body of japanese men and non-asian men. japanese participants will either get nnc0194-0499 or placebo - which treatment participants get is decided by chance. non-asian participants will get nnc0194-0499. participants will get 1 or 2 injections of the study medicine. it will be injected with a needle into a skin fold on the stomach. the study will last for a maximum of 66 days. participants will have 8 scheduled visits with the study doctor. for 1 of the visits participants will stay at the clinic for 6 days (5 nights). the study includes blood sampling. participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.


Eligibility criteria:
inclusion criteria: * male, aged 20-55 years (both inclusive) at the time of signing informed consent * for japanese subjects only, both parents of japanese descent. for non-asian subjects only, both parents of non-asian descent * body mass index (bmi) between 23.0 and 34.9 kg/m\^2 (both inclusive) * body weight greater than or equal to 60 kg exclusion criteria: * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the american college of cardiology and the american heart association prevention guideline) greater than or equal to 5 percentage