Kornimate/medical-research-clean huggingface dataset:
assessment of an endotracheal tube securement device

Conditions: Respiratory Insufficiency

Summary: endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. hollister incorporated is assessing the functionality and performance of an endotracheal tube securement device.

this was a multiple site assessment of the anchor fast with enhanced tube protection. subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.the study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.

Eligibility criteria:
inclusion criteria: * is 18 years of age or older; male or female and requiring oral tracheal intubation. * has intact skin on application site. * willingly signs or their authorized representative willingly signs the informed consent. * is qualified to participate in the opinion of the investigator. exclusion criteria: * has an existing neck injury. * has protruding upper teeth, without teeth or is unable to wear upper dentures. * has facial hair. * has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer. * has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site. * has a known or stated allergy to adhesive bandages, or any of the product types being tested. * uses of topical drugs on the application site. * uses lotions, creams or oils on the application site. * currently is participating in any clinical testing which may affect performance of this device. * has been previously intubated with skin irritation or pressure sores surrounding the mouth.
oit effect on faqlq

Conditions: Food Allergy

Summary: patients with food allergy and their parents will answer a food allergy quality of life questionnaire that will be translated to hebrew and validated. questionnaires will be filled also by patients undergoing oral immunotherapy (oit).

the food allergy quality of life questionnaires (faqlq) for children 8-12 y/o, teenagers 13-17 y/o and adults \> 18 y/o and parents to children 0-12 y/o and to teenagers will be translated to hebrew. questionnaires will be given to patients with food allergy followed at asaf harofeh medical center. questionnaires will be examined for internal consistency. the food allergy independent measure (faim) questionnaire for the same age groups will also be translated to hebrew. the faqlq will be validated by correlation with the faim. the questionnaires will then be administered to patients and families undergoing food oral immunotherpy, before during and following treatment.

Eligibility criteria:
inclusion criteria: * patients with suspected food allergy exclusion criteria: * none
effects of transcranial magnetic stimulation after endovascular treatment for acute ischemic stroke

Conditions: Ischemic Stroke, Acute; Endovascular Thrombectomy

Summary: this is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of ctbs in treating patients with acute ischemic stroke after endovascular treatment.


Eligibility criteria:
inclusion criteria: 1. patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old. 2. imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the m1 segment of the middle cerebral artery. 3. dwi shows an infarct volume less than one-third of the mca territory, with onset of symptoms ≤6 hours, or a head ct within 24 hours of onset indicating an aspect score ≥6. 4. symptom onset time is ≤6 hours or between 6-24 hours with multimodal imaging (assessment) confirming eligibility for thrombectomy. 5. pre-stroke mrs score is ≤1. 6. nihss score before thrombectomy is between 6 and 25. 7. with vascular recanalization of mtici \> 2b/3. 6. informed consent form signed. exclusion criteria: 1. patients with contraindications to tms treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.; 2. patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys; 3. head ct/mri indicates midline shift or significant mass effect, or patients planned for surgical intervention; 4. head ct/mri suggests acute cerebral infarction in both sides; 5. patients with a history of congenital or acquired bleeding disorders, coagulation factor deficiencies, or thrombocytopenia; 6. patients with blood pressure more than 180/110 mmhg after antihypertensive treatment; 7. patients who are pregnant or breastfeeding; 8. patients with severe mental disorders or dementia who cannot cooperate with follow-up; 6. patients with other severe diseases resulting in an expected survival of less than 90 days; 7. patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition; 8. patients who cannot cooperate with informed consent.
post-marketing safety surveillance of breviscapine powder-injection : a registry study

Conditions: Adverse Drug Event; Adverse Drug Reaction; Chinese Medicine; Anaphylactic Reaction

Summary: this registry aims to monitor the safety of breviscapine powder-injection and to identify the potential risk factors for the adverse drug reactions.

breviscapine powder-injection is a kind of natural compound injection with high purity of scutellarin-na (over 98%). it's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. however, more and more case reports about the adverse drug events of chinese medicine injections extracted from dengzhanhua (herba erigernotis) (breviscapine is one of the most common compounds in it) have been reported in recent 10 years. therefore, this registry of breviscapine powder-injection aims to monitor the safety of breviscapine powder-injection and to identify the potential risk factors for the adverse drug reactions.

Eligibility criteria:
inclusion criteria: * patients who use breviscapine powder-injection in the monitoring departments of centain hospitals exclusion criteria: * none
youth metacognitive therapy feasibility trial

Conditions: Child Mental Disorder; Anxiety Disorders; Depression

Summary: one in eight children and young people (cyp) suffer mental health problems needing support or treatment and 5% have more than one such problem. the effects can be major, affecting cyp emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. parents, schools, policy makers and the nhs often struggle to find the best way to help, especially within their limited budgets. the uk government and the nhs have highlighted the need to improve mental health in cyp. the most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. one way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. this new treatment is called metacognitive therapy (mct). the aim of the study is to see if participating in a randomized trial of group mct is a feasible and acceptable treatment for cyp suffering with anxiety, stress, depression, or a combination in comparison to usual care. this allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about mct including training and supervision needs of clinicians and the experience of patients receiving it.


Eligibility criteria:
inclusion criteria: * seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression). * native fluency in english language * medication permitted but must be stabilised for 6 weeks. exclusion criteria: * presence of significant risk or safeguarding concerns * head injury/organic impairment * formal diagnosis or under assessment for autism spectrum disorder or attention deficit-hyperactivity disorder * eating disorder

Keywords: metacognitive therapy feasibility anxiety depression mental health
diagnosis of functional defecation disorders in childhood

Conditions: Constipation; Fecal Incontinence

Summary: purpose to compare different kinds of diagnostic investigations in order to identify the most sensitive and least invasive when diagnosing constipation.

defecation disorders in children are extremely common especially constipation and fecal incontinence. international studies show that constipation make up approximately 3% of pediatric outpatient clinic11 (192) and 25% of pediatric gastroenterology consultations. between 1,5-3% of all 4-12 year olds experience fecal incontinence. constipation and fecal incontinence can be extremely physical unpleasant and can have significant ramifications for a child's emotional and social functioning eg. low self esteem. though most agree that constipation and faecal incontinence are a considerable problem worldwide there is disagreement when it comes to a definition and diagnostic tools. several definitions have been used. this has led to great difficulties when trying to estimate prevalence, understand and compare in order to improve different treatments. hypothesis: * it is possible to diagnose constipation accurately by using a combination of anamnesis, stool diary, physical examination and transabdominal ultrasonography * transabdominal ultrasonography is a safe and sensitive diagnostic tool and can be used as an alternative or substitute to rectal examination. purpose to compare different kinds of diagnostic (tools) investigations in order to identify the most sensitive and least invasive when diagnosing constipation. material and methods 60 children referred to the paediatric outpatient clinic with fecal incontinence or suspicion of constipation. the investigations include anamnesis and physical examination with rectal examination and transabdominal ultrasonography. home registration of a stool diary based on the bristol scale for 3 weeks thereafter a colonic transit time is performed. data is compared to data from 30 healthy children that have gone through the same investigations except the ctt that is based on x-rays.

Eligibility criteria:
inclusion criteria: referred children * functional constipation and/or fecal incontinence healthy children * no sign of functional constipation and/or fecal incontinence exclusion criteria: referred children * organic constipation/ fecal incontinence healthy children * constipation/ fecal incontinence

Keywords: constipation fecal incontinence diagnosis children
the effects of weighted waist-hooping

Conditions: Healthy

Summary: purposes: 1) to determine the effects of weighted waist-hooping on balance in healthy individuals and 2) to observe whether these effects are attributed to neuromuscular conditioning or core strength gains. methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the control. the intervention consisted of six weeks of weighted waist-hooping four times a week for 10 minutes each session. balance was assessed pre and post intervention using the bess, sebt, and neurocom sot. core strength was assessed using hold duration of a bilateral and unilateral plank.


Eligibility criteria:
inclusion criteria: * healthy women age 18-45. exclusion criteria: * pregnancy and vertigo

Keywords: weighted waist-hooping balance proprioception neurocom
investigation to evaluate papilocare® gel effect on normalization of cervix cytological alterations caused by hpv.

Conditions: HPV Infection; Lesion Cervix

Summary: observational clinical study, national, multicentric, prospective, non-comparative, with medical device, under application consistent with ce marking, for the evaluation of papilocare® effectivness in the normalization of cervix cytological abnormalities caused by hpv.

300 patients will be included in approximately 50 spanish sites. the study comprehend a maximum of 3 visits. at visit 1, patient's writted informed consent will be collected, patient's selection critera will be checked, and patient's medial history data will be collected. at visit 2, 6 months after the first visit, the primary and secondary objectives will be evaluated. for those patients who finish treatment after 6 months, this will be the final visit. only in that cases where, by usual clinical practice, the doctor indicates patient should continue under treatment, visit 3, wich will take place 12 months after streatment stars, will be the last visit for the patient under study.

Eligibility criteria:
inclusion criteria: 1. woman over 25 years, whether or not they have been vaccinated against hpv. 2. able to read and understand the patient information sheet and the informed consent form and accept the participation in the study by signing the informed consent form. 3. patient who comes to a visit with a routine cytological result of ascus or lsil and hpv-positive test, of at most 3 months prior to the start of treatment with papilocare®. 4. patient who, under that situation, undergoes a colposcopy and has a concordant result with cytology. 5. patient who has been prescribed treatment with papilocare® by medical decision prior to their participation in the study. exclusion criteria: 1. any situation / alteration / pathology, gynecological or not, which, in medical judgment, does not advise or contraindicate the use of papilocare®. 2. women of childbearing age who do not use effective contraceptive methods, pregnant women, suspected pregnancy, desire for the same within the next 6 months or during breastfeeding. 3. participation in any one clinical trial at present or in the 4 weeks prior to inclusion in the study. 4. any planned surgery that precludes correct compliance with the guideline. 5. known allergies to any of the components of papilocare®.
standardization of prostatic resection by virtual computational reconstruction and computational flow dynamics

Conditions: Prostate Hyperplasia; Prostatic Diseases; Voiding Disorders

Summary: the enlargement of the prostate is responsible for voiding dysfunction in men, and especially elderly men. the primary surgical treatment for symptomatic benign prostatic hypertrophy (bph) was transurethral resection of the prostate (turp). however, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be respected. so, the investigators plan through the study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

benign prostatic hyperplasia (bph) is an enlargement of the prostate gland that develops in men and is a common cause of voiding dysfunction in elderly patients. it is a major public health concern, causing high morbidity and substantial worsening of men's quality of life. (qol) transurethral resection of the prostate (turp) is the standard surgical therapy for obstructive prostatic hypertrophy. various techniques have been suggested for the systematic removal of the adenomatous tissue, all based on the principle that the resection should be done stepwise as bleeding is the surgeon's major problem, leading to loss of visual field and disorientation, it is imperative that resection and hemostasis should both be completed in one area of the prostatic fossa before the next area is tackled. with the development of new techniques for prostate resection that decreases perioperative morbidity, larger sizes of the prostate are being resected, and a new category of patients is considered eligible for such an intervention with a large prostate size of more than 80 gm. however, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be resected to give us the best voiding outcome postoperative. so, the investigators plan through this study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Eligibility criteria:
inclusion criteria: * age: above 50 years old, undergoing an elective endo-urological procedure exclusion criteria: 1. neurogenic bladder 2. previous prostate or urethral surgery 3. associated urethral stricture
managing recurrent abdominal pain

Conditions: Abdominal Pain

Summary: the purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with recurrent abdominal pain (rap).

recurrent abdominal pain (rap) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. although 10-15% of children have rap, there is at present no accepted medical or behavioral treatment for it. we have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. the goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with rap. the study is a randomized clinical trial. children with rap are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (slcbt) or 2) an education and support condition (es). the slcbt protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing rap pain and stress. patients and parents in the es condition receive educational information regarding nutrition and the gastrointestinal system. both treatment arms consist of three sessions with a mental health professional, each one week apart. study families are recruited from physicians in the community and through community flyers and newsletters. outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. measures are designed to assess: rap symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress). primary hypothesis: children in the slcbt condition will exhibit a greater decrease in symptoms of rap and related maladaptive behaviors and cognitions than children in a comparison condition.

Eligibility criteria:
inclusion criteria: * child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities * primary caregiver willing and able to complete questionnaires * child aged 7-17 * child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime exclusion criteria: * positive physical or laboratory findings which would explain the child's abdominal pain * chronic disease * major surgery in past year * developmental disabilities that require full-time special education or impair ability to respond * inability to comprehend english

Keywords: recurrent abdominal pain illness behavior social learning cognitive behavioral therapy
clinical effects of locally-delivered gel containing camella sinensis extracts as an adjunct in peridontitis treatment

Conditions: Periodontitis

Summary: the purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing camella sinensis extracts as an adjunctive treatment in periodontal therapy


Eligibility criteria:
inclusion criteria: * subjects have sound tooth with pocket depth = or \> 5 mm. without caries, restoration, mobility and furcation involvement * no systemic complicated factors * no allergy to green tea or product of green tea * signing in informed consent form exclusion criteria: * smoking * pregnancy or lactation * antibiotic premedication or antibiotic intake in previous 3 month
sustained virological response (svr) to antiviral treatment of liver transplant recipients with recurrent hepatitis c

Conditions: Hepatitis C; Liver Transplantation

Summary: this study will assess the rates of sustained virological response following anti-viral therapy with peg-interferon plus ribavirin in patients that have been liver transplanted with recurrent hepatitis c and treated with neoral or tacrolimus.


Eligibility criteria:
inclusion criteria: * liver transplantation performed at least 6 months and up to 5 years prior randomization and due to hcv cirrhosis, with or without pre-transplant hepatocellular carcinoma (hcc) within milan or ucsf criteria * immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization * diagnosis of hcv genotypes 1 or 4 infection prior to transplantationconfirmed at screening * indication of treatment with peg-ifn and ribavirin due to histological evidence of chronic hcv infection defined as a fibrosis stage equal or greater than 1 using the ishak-knodell scoring system (ik ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization. exclusion criteria: * serum creatinine \>150 μmol/l (1.6 7 mg/dl) or egfr \< 50 ml/min (4-variable modification of diet in renal disease \[mdrd cockcroft-gault formula\]) * multi-organ transplant recipients * recent episode of steroid-treated acute rejection (ar) within 3 months prior to randomization, or \>1 episode of steroid-treated ar in the last 6 months, or any number of steroid-resistant ar episodes in the last 6 months including evidence of chronic rejection or ductopenia * evidence of conditions that could cause graft dysfunction other than hcv infection * patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \ 1.5mg/dl or, inr \>1.5) * co-infection with hiv or hepatitis b (defined as hbsag-positive) at screening * use of mtor inhibitors (everolimus or sirolimus) in the 6 months prior to screening * antiviral treatment for hcv administered at any time after liver transplantation * patients on daily doses of corticosteroids higher than 5 mg/day * patients with fibrosing cholestatic hepatitis * patients with current diagnosis of malignancies, including lymphoproliferative disorders * patients with platelet count \<70,000/mm3 or neutrophiles \<1,500/mm3 * history of hcc outside milan criteria based on radiology or ucsf criteria based on analysis of the explant

Keywords: hepatitis c liver transplantation anti-viral therapy