Kornimate/medical-research-clean huggingface dataset:
individualized treatment of acute achilles tendon rupture

Conditions: Achilles Tendon Rupture

Summary: to asses the functional outcome after individualized treatment of acute achilles tendon rupture. the treatment is individualizes on the basis of ultrasonographic status of tendon overlap and barfod's ultrasonographic length measure. patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon. the study includes two control groups of non-operative and operative treatment.


Eligibility criteria:
inclusion criteria: * appointment in the outpatients department within 4 days of injury. * total achilles tendon rupture. * initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury. * the patient must be expected to be able to attend rehabilitation and post-examinations. * the patient must be able to speak and understand danish. * the patient must be able to give informed consent. exclusion criteria: * rupture of the achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae. * previous rupture of the achilles tendon in any of the two legs. * treated with fluoroquinolones or corticosteroids within the last 6 months. * in medical treatment of diabetes. * suffers from rheumatic disease. * other conditions prior to the injury resulting in reduced function of any of the two legs. * contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the achilles region of the injured leg. * inability to lie in prone position on the operating table. * terminal illness or severe medical illness: asa (american society of anesthesiologists) score higher than or equal to 3.

Keywords: individualized treatment functional outcome
recurrent nerve monitoring during aortic arch repair

Conditions: Recurrent Laryngeal Nerve Injuries; Aortic Arch Hypoplasia

Summary: almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. this causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. as these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery. in other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. to date, this type of monitoring has not been possible in newborns. this study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.


Eligibility criteria:
inclusion criteria: * only patients with parents/ carers able to give informed consent to participation in the trial will be included. • male and female patients will be included * only neonates (babies less than 28 days of age) will be included in the study. * only patients undergoing repair of the aortic arch via median sternotomy will be included in the study exclusion criteria: * patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients. * patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from participation.
multicentre randomised controlled trial of help (heat loss prevention) in the delivery room

Conditions: Hypothermia in Premature Infants

Summary: does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the neonatal resuscitation program guidelines (i.e. drying under radiant heat)?

thermoregulation is a major problem for low birth weight infants. the epicure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees celsius. hypothermia is associated with increased risk of morbidity and mortality. the help trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. forty-five centers are currently involved in this study. infant enrollments began in december 2004. primary outcome: to determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate pilot study and centers may choose if they wish to participate in this group or not. secondary outcome: the key secondary outcome will be axillary temperature taken on introduction into a warm environment in the nicu. we will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. length of stay and cause of death at discharge will also be recorded. long-term follow-up is critical to our understanding of the implications of any new intervention. as such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth. preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.

Eligibility criteria:
inclusion criteria:infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support. - exclusion criteria:1. infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele) 2. infants born with blistering skin conditions that preclude the use of occlusive wrap -

Keywords: hypothermia, premature infants, polyethylene occlusive wrap
clinical effects of temperature controlled laminar airflow (tla)

Conditions: Asthma; Perennial Allergy

Summary: the purpose of this study is to determine whether clean air administered to the breathing zone with temperature controlled laminar airflow (tla) during night is effective in the treatment of perennial allergic asthma.

background: exposure to inhaled allergens is a pathogenetic factor in allergic asthma. however, most studies that previously looked at air cleaning devices have shown little or no effect on patients with perennial allergic asthma. aims and objectives: this study aims to investigate a novel treatment, tla, using temperature controlled laminar airflow with a very low particle concentration directed to the breathing zone of teenagers and adults with allergic asthma during night sleep. the hypothesis is that the decreased allergen exposure during the night will have an effect on bronchial inflammation and quality of life. method: patients are randomized to start with active or placebo treatment for 10 weeks. all patients receive both active and placebo treatment with unfiltered air, with a 2-week wash-out period in between treatments. maintenance treatment with inhaled corticosteroids is unaltered during the trial period. health related quality of life (miniaqlq)is the primary effectiveness measure. exhaled nitric oxide (feno) and spirometry are also investigated.

Eligibility criteria:
inclusion criteria: * diagnosed for asthma for more than 1 year. * more than 12% reactivity in fev1 on bronchodilating medication or less than 90% of the fev1 reference value according to hedenström. * perennial allergy * at least 3-mm wheal reaction in a skin prick test to at least one of following: house dust, mold spores, dust mites, animal hair and dander. * little or no reactivity to other inhalant allergens. * no known allergy to another inhalant allergen or chemical to which there is exposure in winter time. * no allergen injection treatment in the preceding 2 years. * a history of a requirement for daily medication for asthma including; * 400µg steroid medication (pulmicort or equal) for children and 800µg for adults. * beta agonist treatment on less than 4 days per week. * willingness to follow the clinical trial protocol, including medications, baseline and follow-up visits and procedures. exclusion criteria: * inclusion in another allergen avoidance program. * smoking in the family * participation in a drug trial

Keywords: protexo asthma temperature controlled laminar airflow perennial allergy quality of life miniaqlq feno fev1 pef
a study assessing the efficacy and safety of adalimumab in active ulcer(s) of pyoderma gangrenosum in participants in japan

Conditions: Pyoderma Gangrenosum

Summary: this study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in japan with active ulcer(s) due to pyoderma gangrenosum (pg).


Eligibility criteria:
inclusion criteria: * participant must be able and willing to provide written informed consent. if the participant is \< 20 years old, a parent or legal guardian must be willing to give written informed consent * participants must have a diagnosis of ulcerative (classic) pg made by the investigator * participants must have demonstrated an inadequate response to conventional pg therapy or in the opinion of the investigator they are not a suitable candidate for conventional pg treatment. exclusion criteria: * participants with pustular, bullous/atypical, or vegetative variants of pg * participants with clinical evidence of ulceration that is non-pg related, vasculitis, thrombosisprone conditions, or monoclonal gammopathy * participants with a histopathological finding that is consistent with a diagnosis other than pg * participants receiving a therapeutic dose of prednisolone * participants with prior exposure to adalimumab or previous participation in an adalimumab clinical study.

Keywords: pyoderma gangrenosum ulcer efficacy safety adalimumab humira® japan
analysis of cerebral correlates of pedophilia with neuroimaging techniques

Conditions: Pedophilia

Summary: the main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.


Eligibility criteria:
inclusion criteria (for patients): * diagnosis of pedophilia * male * age between 18 and 65 * informed consent signed inclusion criteria (for healthy patients): * male * age between 18 and 65 * informed consent signed exclusion criteria (for patients): * iq \<70 * ongoing treatment with cyprostrerone acetate or gnrh agonist or antidepressant treatment (5ht reuptake inhibitor) * ongoing detention exclusion criteria (for healthy patients): * psychiatric disorders * iq\<70 * sexual disorders

Keywords: brain, pedophilia, neuroimaging
development of a clinical screening, diagnostic and evaluation tool for patients with lower limb lymphedema: aim 4

Conditions: Lower Limb Lymphedema

Summary: research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. to assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. first of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. therefore, the research questions in this study are: which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? when can a clinician speak of a clinically relevant change?


Eligibility criteria:
inclusion criteria: * intensive treatment group * unilateral or bilateral, primary or secondary lll * no active metastases * if cancer-related lymphedema, time interval since surgery/ radiotherapy/ chemotherapy is ≥3 months * objective diagnosis of lymphedema: ≥ 5% volume difference or ≥ 2 minor/ 1 major criteria on lymphoscintigraphy or presence of icg dermal backflow * age ≥ 18 years * able to read, understand and speak dutch * planned to start with intensive decongestive lymphatic therapy at one or both legs * maintenance treatment group * see inclusion criteria 'intensive treatment group' * but: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy) exclusion criteria: * pregnant participants * presence of chronic venous insufficiency c4, c5, c6; deep venous thrombosis; post-thrombotic syndrome * presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion

Keywords: lymphedema measurement clinical evaluation
use of glidesheath slender to reduce radial artery occlusion and vascular access site complications following transradial coronary angiography

Conditions: Embolism and Thrombosis of the Radial Artery; Coronary Heart Disease

Summary: the objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new terumo (tokyo, japan) glidesheath slender, in comparison with the currently used 6 french (6 fr.) radial sheath.

based on previously reported studies the rates of radial artery occlusion using a standard 6 fr. sheath is around 5-10%, compared to the single feasibility study of the glidesheath slender by aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%. this study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the glidesheath slender (terumo, tokyo, japan) and the standard 6 fr. radial sheath in patients undergoing transradial coronary catheterization. * the study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (pci) via transradial approach at the university of ottawa heart institute. * a baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery. * patients will be randomized in 1:1 fashion to either receive the terumo glidesheath slender versus the currently used 6 fr. sheath. * the standard angiogram/ pci will be performed as per usual practice. * following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge. * at 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.

Eligibility criteria:
inclusion criteria: * patients undergoing coronary angiography and/or pci via transradial approach * informed consent * documented normal allen's test exclusion criteria: * patient who had a previous angiogram using the same radial artery * abnormal allen's test * previous failed radial access. * known bleeding disorder or hypercoagulable condition * cardiogenic shock

Keywords: transradial coronary angiography radial artery occlusion coronary heart disease glidesheath slender
psycho-educational cognition intervention in patients with blood and lymph cancer

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this pilot trial studies how well a psycho-educational program called emerging from the haze works in helping patients with blood and lymph cancer. sometimes, patients who have undergone treatment for cancer experience thinking or memory problems that make work, school, or everyday life activities, such as grocery shopping, difficult. the emerging from the haze program may provide resources to help deal with these types of challenges in patients with blood and lymph cancer.

primary objectives: i. demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing emerging from the haze program. secondary objectives: i. describe, summarize study population. ii. characterize, compare the measure scores at pre-intervention assessment to the measure scores at post-intervention assessment. outline: patients participate in the emerging from the haze psycho-educational program weekly over 2 hours for 6 weeks.

Eligibility criteria:
inclusion criteria: * a diagnosis of a hematological malignancy. * having received chemotherapy with or without radiation therapy. * physician approval. * functional assessment of cancer therapy-cognition (fact-cog) score \< 59 on the perceived cognitive impairments (pci) subscale. * eligible after 2 months (60 +/- 5 days) of completing all their active cancer treatment with the exception of patients that are post-transplant. * subjective complaint of cognitive concerns at time of enrollment. * must be able to understand and communicate proficiently in english. * ability to understand and the willingness to sign a written informed consent. * agree to complete study surveys. exclusion criteria: * patients who have significant personality disorders or unstable psychiatric disorders as assessed by the interviewing clinician. * patients with known brain metastases, history of brain metastases or radiation to the brain. * patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction. * non-english speaking patients.
oral endocannabinoids in people with prediabetes and diabetes

Conditions: PreDiabetes; Diabetes Mellitus, Type 2; Obesity; Oral Dysbiosis; Mouth Disease

Summary: this study evaluates the relationship of endocannabinoids in saliva with inflammation and oral dysbacteriosis present in people with periodontal disease and prediabetes/type 2 diabetes

diabetes is a disease that affects millions of people worldwide, and the number of cases is expected to continue to increase in the coming years. type 2 diabetes (t2d) is the most common form of diabetes and is closely related to prediabetes, a condition in which blood glucose levels are high but not high enough to be diagnosed as diabetes. both prediabetes and t2d increase the risk of cardiovascular disease and are also associated with diseases of the oral cavity, such as dental caries and periodontal disease. the presence of pathogenic bacteria in the mouth has been linked to these diseases. the endocannabinoid system, a signaling system in the body that regulates various biological processes, has been found to play an important role in energy homeostasis and is implicated in obesity, prediabetes, and t2d. this study seeks to investigate the role of endocannabinoids and related lipids in diseases of the oral cavity in the context of prediabetes and t2d. a bidirectional relationship has been observed between periodontitis and t2d, with inflammation playing a central role in both diseases. although subtle differences in the microbial composition of the mouth have been identified in people with diabetes, the exact mechanisms remain unclear. our findings could open up a promising line of research on the therapeutic potential of cannabinoid drugs for the treatment of this type of complications in people with prediabetes/t2d.

Eligibility criteria:
inclusion criteria: * adults, both sexes (40-65 years) * with obesity and prediabetes: bmi 30-40 and hba1c 5.7-6.4 * with obesity and diabetes: bmi 30-40 and previous diagnosis of diabetes exclusion criteria: * pregnant women * diagnosis of some type of neoplasia or treated with radiotherapy and/or chemotherapy in the last year. * ongoing inflammatory diseases (crohn's disease, ulcerative colitis, arthritis, etc.) and/or anti-inflammatory treatments * presence of systemic diseases of vital organs * participants in treatment with drugs that could alter salivary flow * smokers * participants who have not followed the specifications prior to sampling * participants who did not sign the informed consent

Keywords: endocannabinoids prediabetes diabetes mellitus type 2 obesity oral dysbiosis oral disease cannabinoids
ritual training program in hnc patients

Conditions: Education; Cognitive Change

Summary: to evaluate the effects of a ritual training program in head and neck cancer (hnc) patients.

the purpose of this study will to evaluate the effects of a ritual training program on disfigurement, self-esteem, social interaction, and body image in head and neck cancer (hnc) patients. a prospective, repeated measures, randomized controlled therapeutic intervention design was employed. the experimental group will receive a ritual training program, and the control group will receive routine care. patients will be assessed at three time points: baseline assessment (t0), and then at 1, 2, and 3-months (t1, t2, and t3) after participating in the ritual training program or routine care.

Eligibility criteria:
inclusion criteria: * \> 20 years old, * newly diagnosed first occurrence of hnc, * completion of treatment and more than 3 months post-treatment exclusion criteria: * recurrence

Keywords: head and neck cancer ritual training disfigurement body image