Kornimate/medical-research-clean huggingface dataset:
a mediterranean diet in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the medra study is a 12-week randomised controlled trial that aims to assess effects of a mediterranean dietary telehealth intervention compared to the irish healthy eating guidelines on the physical function and quality of life of adults living with rheumatoid arthritis in ireland. investigators will be able to determine how closely people living in ireland can accept the mediterranean dietary practices and adhere to them with dietetic input and guidance.

rheumatoid arthritis (ra) is a long-term inflammatory disease which commonly occurs in the small joints of the hands, wrists and feet leading to swelling, pain and stiffness in the affected joints. the condition is two to three times more prevalent in women than in men. although it might occur at any age, the incidence of the disease is highest between the ages of 40 and 65 years. currently, there is no treatment that provides complete remission of the disease for people living with ra. treatment of ra aims to reduce the symptoms and improve the health of the patient. although diet is not part of the mainstream treatment, many studies have reported beneficial effects of certain diets on ra symptoms. the medra study will examine the habitual dietary intakes of people living with ra in ireland and will explore whether people with ra will benefit from either a mediterranean dietary pattern or the healthy eating guidelines in ireland. this small scale study will provide useful information on whether people with ra in ireland can adhere to a mediterranean dietary pattern and whether the intervention will have beneficial impact on the physical function and quality of life. this is important work prior to proceeding to larger intervention studies.

Eligibility criteria:
inclusion criteria: * age ≥ 18 year * definite diagnosis of rheumatoid arthritis according to acr or eular criteria * full access to internet/smartphone * english speaking exclusion criteria: * age \<18 years * breastfeeding, pregnant or trying to get pregnant. * patients who have commenced nutritional supplements or a new dietary regime in the month prior to study enrolment. * patients who do not have access to the internet/smartphone

Keywords: mediterranean diet randomised controlled trial ireland
micro-rnas of neutrophils in renal antineutrophil cytoplasmis antibody (anca) -associated vasculitis

Conditions: ANCA-associated Vasculitis

Summary: activation of neutrophils by anca ("anti-neutrophil cytoplasm antibodies") and subsequent microvascular endothelial cell damage is the main feature of anca-associated vasculitis (aav), a severe autoimmune disease that often targets the kidney. there is no specific treatment for aav to date and 25% of patients with renal damage evolve towards end-stage renal disease, requiring dialysis and kidney transplantation. in addition, there is no reliable biological marker of the disease activity available, which makes the diagnostic, follow-up and treatment of patients difficult. therefore, the identification of new therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to improve aav patients care and to ameliorate their renal outcome.


Eligibility criteria:
inclusion criteria for patients: * adult patients aged over 18 years * patients with granulomatosis with polyangiitis or microscopic polyangiitis meeting the criteria of chapel hill. * corticosteroid treatment \<20 mg / day. * informed consent: oral for participation in research and writing for biological collection. inclusion criteria for controls patients: - healthy-topics matched for age, recruited from the etablissement français du sang or in the department of internal medicine of nantes university hospital non inclusion criteria: * anca-associated vasculitis with eosinophilic granulomatosis with polyangiitis (aav-egpa). * infectious or progressive tumor pathology. * pregnancy, lactation * treatment with cyclophosphamide in the 6 months prior to inclusion. * terminal chronic renal failure, presence of organ allograft. * thrust patients receiving corticosteroids\> 20 mg / d in the previous 4 weeks. * inability to give informed about information (subject in emergencies, understanding of the subject of difficulty, ...) * minor subject, under judicial protection, guardianship
comparison of two titration programs of adding insulin detemir to oads in poorly controlled type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study compared the effectiveness and safety of two treatment algorithms for insulin detemir initiation and titration: active titration algorithm (performed by investigator weekly) versus usual titration algorithm (performed by study subjects weekly) in patients with type 2 diabetes poorly controlled by oads.

this is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the taiwan. the effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. the safety will be followed during the 24-week study period. inclusion criteria: patients must meet all of the following criteria: 1. men and women with type 2 diabetes. 2. 20 years of age. 3. patients who have received stable doses of any oads for at least 10 weeks prior to the screening visit. 4. patients with inadequate glycemic control (hba1c \>=7% and \< 11%). 5. patients who are willing and able to cooperate with study and give signed informed consent. after enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms: * active titration algorithm: contact with investigator by telephone weekly. * usual titration algorithm: contact with investigator only at routine study visit.

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria: 1. men and women with type 2 diabetes. 2. 20 years of age. 3. patients who have received stable doses of any oads for at least 10 weeks prior to the screening visit. 4. patients with inadequate glycemic control (hba1c \>=7% and \< 11%). 5. patients who are willing and able to cooperate with study and give signed informed consent. exclusion criteria: 1. patients with type 1 diabetes. 2. renal dialysis patients. 3. history of hypoglycemia unawareness. 4. patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit. 5. patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit. 6. patients hypersensitive with insulin detemir or its excipients. 7. patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.

Keywords: type 2 diabetes basal insulin insulin detemir insulin titration algorithm
study to evaluate the safety, tolerability and efficacy of folfox + ct-011 versus folfox alone

Conditions: Metastatic Colorectal Cancer

Summary: this clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. the study will evaluate the safety, tolerability and efficacy of the study drug, ct-011, in combination with folfox chemotherapy (folfox4 or mfolfox6) compared with treatment by folfox alone.

the proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, ct-011, administered at 3mg/kg in combination with folfox chemotherapy (folfox4 or mfolfox6) compared with treatment by folfox alone. approximately 168 patients are planned to be enrolled to this study.

Eligibility criteria:
inclusion criteria: 1. patient's age is 18 years or older, both genders. 2. patients with metastatic disease who are eligible for first line folfox chemotherapy. adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted. 3. ecog performance status ≤ 1 4. at least 4 weeks from prior major surgery or radiotherapy. 5. life expectancy \>3 months 6. hematology: anc ≥ 1.5x109/l; platelets \>100x109/l. 7. adequate renal function 8. adequate hepatic functions 9. normal cardiac function exclusion criteria: 1. patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months. 2. patients who had received oxaliplatin within 12 months prior to diagnosis of metastatic disease. 3. patients on concurrent anti cancer therapy other than that allowed in the study. 4. patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids 5. presence of clinically apparent or suspected brain metastasis. 6. patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months. 7. serious active infection at the time of pre-study screening. 8. active or history of autoimmune disorders/conditions. 9. women who are pregnant or lactating 10. concurrent active malignancy. 11. ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease. 12. other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years. 13. subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study. 14. patients with history of life threatening allergic reactions to food or drugs 15. patients with symptomatic peripheral neuropathy\> grade 1. 16. known positive hiv, hepatitis b surface antigen or hepatitis c antibody.

Keywords: metastatic colorectal cancer folfox chemotherapy
treatment of androgenetic alopecia in males

Conditions: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness

Summary: the purpose of this study is to evaluate the efficacy of the hairmax lasercomb 2009 7 beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.

this is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). the trial will involve 45 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have fitzpatrick skin types i-iv, with classifications of norwood-hamilton iia to v, have active hair loss within the last 12 months. subjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment duration. initial efficacy endpoint for each subject will be assessed at visit 4 (week 16). safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria:
inclusion criteria: * diagnosis of androgenetic alopecia * fitzpatrick skin types i-iv * norwood-hamilton iia to v * active hair loss within last 12 months exclusion criteria: * photosensitivity to laser light * malignancy in the target area

Keywords: androgenetic alopecia hair loss male pattern baldness
comparison of embryo transfer in egg donation recipients with transvaginal and transabdominal ultrasound

Conditions: Infertility

Summary: transabdominal ultrasound guidance is the golden standard for embryo transfers. transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. the purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.


Eligibility criteria:
inclusion criteria: * patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3 exclusion criteria: * submucous or \>3 cm intramural fibroids * turner syndrome * black recipients

Keywords: female infertility oocyte donation embryo transfer transvaginal ultrasonography transabdominal ultrasonography
atelectasis during delivery - comparing cesarian (c) -section and labor

Conditions: Delivery, Obstetric; Cesarean Section; Labor; Respiration Disorders; Atelectasis

Summary: pregnancy promotes respiratory system's restrictive component. this study observes the generation of atelectasis during labor.

pregnancy causes restriction of diaphragm movements as well as higher resistive component to the respiratory system. spirometry studies have shown that the supine position increases risks of hypoxemia. there seems to be only casual observation regarding the generation of atelectasis during labor.

Eligibility criteria:
inclusion criteria: * post-anesthesia recovery exclusion criteria: * hemodynamic disorder during labor

Keywords: delivery, obstetric atelectasis
automatic tube compensation vs. pressure support ventilation during spontaneous breathing trials in adults

Conditions: Spontaneous Breathing Trial in ICU

Summary: for patients requiring mechanical ventilation, spontaneous breathing trials (sbts) are conducted to determine if it is safe to remove the breathing tube. there are multiple methods for conducting sbts. the purpose of this study is to compare the effects of 2 methods, pressure support ventilation (psv) versus automatic tube compensation (atc), on successful extubation for critically ill adult patients who received mechanical ventilation for over 24 hours.

the delivery of pressure support through the ventilator can be fixed using the pressure support ventilation (psv) mode or variable using the automatic tube compensation (atc) mode. similar to psv, atc provides pressure support but dynamically adjusts it to compensate the resistive work of breathing and the mechanical load on respiratory muscles imposed by an artificial airway, such as an endotracheal or tracheostomy tube. although both atc and psv are licensed and used in clinical practice, the optimal method to deliver pressure support during a spontaneous breathing trial (sbt) remains unknown. at rush university medical center, atc has been used for sbts for over a decade. however, given the growing popularity of psv, the sbt protocol was updated and now approves the use of psv and atc as standard care for sbt without making a recommendation for a preferred mode. the choice between psv and atc during sbt is left to the discretion of the clinician, reflecting the ongoing equipoise in the conduct of the sbt. as patients will be exposed to the potential benefits and risks of psv or atc under this change in clinical practice, the investigators are conducting a cluster-randomized cluster-crossover trial to compare the mode's effect on successful extubation.

Eligibility criteria:
inclusion criteria: * admitted to intensive care unit (icu) * age 18 years or older * requiring invasive mechanical ventilation for at least 24 hours * pass spontaneous breathing trial screen criteria exclusion criteria: * clinical decision made not to proceed with extubation regardless of spontaneous breathing trial (sbt) results * do not intubate (dni) order * presence of tracheostomy * pregnancy * known prisoner * immediate need for extubation, self-extubation, or unplanned extubation that precludes safe performance of study procedures * enrolled in another clinical trial that impacts ventilator weaning or liberation

Keywords: ventilator liberation spontaneous breathing trial
effect of joint mobilization in the treatment of chronic ankle instability

Conditions: Ankle Sprain

Summary: the purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.

novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. preliminary evidence suggests ankle joint mobilization can improve contributions of spinal influences on ankle muscle activation in individuals with ankle joint pathology, but there is a considerable gap in understanding cortical contributions to muscle activation following joint injury. it is unknown how joint mobilization concurrently affects cortical and spinal neural motor pathways, as well as clinical measures of patient function. the overall aim of this grant is to determine the immediate effects of talocrural joint mobilization on cortical and spinal muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with chronic ankle instability (cai). the secondary aims of this study will examine changes in ankle dorsiflexion range of motion (rom) and dynamic balance. this innovate approach will provide the necessary scientific knowledge regarding the potential mechanism and efficacy of joint mobilization.

Eligibility criteria:
inclusion criteria: * age 16-45 years * history of one or more ankle sprains * scoring at least an 85% on the foot and ankle ability measure (faam) sport or at least 3 on the modified ankle instability instrument (aii). * at least 5° ankle dorsiflexion asymmetry compared to the contralateral limb or ankle dorsiflexion rom less than 21° exclusion criteria: * lower extremity injury or surgery within the past 6 months (including lateral ankle sprain) * diagnosed ankle osteoarthritis * history of ankle surgery that involves intra-articular fixation * medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures

Keywords: ankle sprain chronic ankle instability ankle mobilization talocrural joint mobilization cortical muscle activation spinal muscle activation
3d characteristics, functional appliances and sleep related breathing disorders

Conditions: Retrognathic Mandible

Summary: facial scans of the patients eligible for the functional appliance treatment (twin block appliance) will be taken prior to and after the end of treatment. also, a facial scan of the predicted final outcome will be taken, and compared to the actual final outcome. parents / caregivers will fill out the pediatric sleep questionnaire (psq) prior to and upon the end of treatment to asses perceived influence on sleep related breathing problems in their children.

the harmonious growth of the upper and lower jaw enables further favorable development of the orofacial region and the functions of breathing, chewing, swallowing and speaking, as well as the general growth and development of the child. translation into croatian and administration of the questionnaire for early detection of sleep disorders related to breathing in children (psq) will enable triage and early recognition of children with sleep disorders, which also affect general psycho-physical development. the impact of functional appliance therapy (fa) on changes in craniodentofacial characteristics, dimensions of the upper airway and sleep problems in children will be determined. the non-invasive three-dimensional representation of the face surface provides information about the surface and volume of the observed object, which is used for better diagnostics and therapy planning. class ii is a frequent malocclusion, characterized by a discrepancy of sagittal interjaw relationships. the diagnostic method, which helps in deciding on a therapeutic approach, is the so-called fränkel maneuver (fm). by comparing the observation of the soft tissue profile of the subjects at rest and after the application of fm, a decision is made on the therapeutic approach. previous research indicates the validity of using fm in making a decision about fn therapy, with high reliability and consistency. the analysis of latero-lateral (ll) x-ray cephalograms in numerous studies has provided a series of data, which is used, among other things, to assess the remaining growth in order to apply fn therapy in a timely manner, but also to expect a desirable response. the evaluation of the success of therapy based on fm don\&#39;t exist, because a reliable 2d analysis through ll cephalogram would require additional radiation of the subjects. research indicates that the analysis of scan surfaces is more appropriate than the analysis of anatomical points for detection of the area and amount of changes.

Eligibility criteria:
inclusion criteria: * retrognathic mandible, increased overjet exclusion criteria: * craniodentofacial deformities

Keywords: psq twin block 3d facial scan
neutrophil extracellular traps and neonatal (pv4991) & pediatric sepsis (pv5063)

Conditions: Sepsis

Summary: this study is designed to assess the role of neutrophil extracellular traps (nets) in neonatal and pediatric sepsis as well as to evaluate markers of nets formation as early predictors of neonatal and pediatric sepsis.

severe infection resulting in sepsis is recognized as a leading cause of morbidity and mortality worldwide (stehr and reinhart, 2013). the incidence of sepsis in developed nations has been increasing while overall mortality is decreasing, but still remains around 30% (mayr et al., 2014). moreover, morbidity in survivors is often functionally devastating, and may include neurological impairment, chronic organ dysfunction, increased days admitted to hospital, and high rates of mortality postdischarge (prescott et al., 2014). emotional, social, and financial costs to individuals and health care systems are immense (brun-buisson et al., 2003). neutrophils are the first line of innate immune defense against infectious agents. in addition, neutrophils' ability to eliminate pathogens by phagocytosis and/or degranulation, it has recently been demonstrated that neutrophils can bind to and kill a wide range of microorganisms by forming neutrophil extracellular traps (nets) (brinkmann et al., 2004). this novel mechanism consists of the release of web-like structures of dna decorated with histones and antimicrobial proteins, known as nets. microbes are immobilized in these traps, which contain a lethal concentration of antimicrobial agents killing a broad range of microorganisms, including gram-negative and gram-positive bacteria, fungi, viruses, and protozoa (brinkmann et al., 2004, fuchs et al., 2010, camicia et al., 2014). the role of nets in pediatric infection is not well understood. we hypnotize that children are capable of forming nets and that netosis plays an important role in pediatric sepsis. this study is designed to assess the role of neutrophil extracellular traps (nets) in neonatal and pediatric sepsis as well as to evaluate markers of nets formation as early predictors of neonatal and pediatric sepsis.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by the parent or guardian of the patient 2. chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch) 3. suspicion of sepsis infection