Kornimate/medical-research-clean huggingface dataset:
impact of parathyroidectomy on vascular calcification and clinical outcome in hemodialysis patients

Conditions: Hyperparathyroidism, Secondary

Summary: the aim of this study is to assess the clinical, laboratory and vascular calcification outcome within 6 months duration in patients undergoing surgical parathyroidectomy (total, subtotal, and total with autotransplantation)

all patients above the age of 18, with end stage renal disease maintained on regular hemodialysis and are indicated for surgical parathyroidectomy. the indications for parathyroidectomy included persistently elevated intact parathormone hormone levels of greater than 500 pg/ml, uncontrolled hypercalcaemia with hyperphosphataemia or clinical symptoms of secondary hyperparathyroidism refractory to medical treatment. these symptoms included bone pain, pruritus, fracture, fatigue and calciphylaxis these patients will be exposed to pre-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using ecg- gated non contrast ct in hemodialysis patients undergoing parathyroidectomy post-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using non contrast ct will be done 6 months post-operative assessment of the relation between preoperative and postoperative measures patients with the following criteria will be excluded: 1. chronic kidney disease patients not yet on regular hemodialysis 2. patients who had primary hyperparathyroidism 3. patients who had received kidney transplantation 4. patients who underwent repeated parathyroidectomy 5. patients who were lost to follow-up or with missing data.

Eligibility criteria:
inclusion criteria: * all patients above the age of 18 * patients with end stage renal disease maintained on regular hemodialysis * indicated for surgical parathyroidectomy exclusion criteria: * chronic kidney disease patients not yet on regular hemodialysis * patients who had primary hyperparathyroidism * patients who had received kidney transplantation * patients who underwent repeated parathyroidectomy * patients who were lost to follow-up or with missing data.
comparison between jacobson's progressive muscle relaxation technique and audio-visual distraction technique in reducing dental anxiety in children during dental visit

Conditions: Dental Anxiety

Summary: dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. it has been cited as the fifthmost common cause of anxiety by agras et al. dental anxiety may have major and long-lasting implications for the child and their family. cohen et al reported that dental anxiety affects an individual's life in multiple ways. the physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. this research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.


Eligibility criteria:
inclusion criteria: * children: 6 to 9 years old children. teeth: tooth requiring dental treatment exclusion criteria: * children having allergy to local anaesthesia or systemic problem. refusal of participation mentally ill or mentally retarded children
profiling children and youth with cerebral palsy in relation to feeding and nutrition

Conditions: Cerebral Palsy

Summary: hcps will complete questionnaires about their patients with cerebral palsy (cp) and invite parents/caregivers of these patients to fill in questionnaires as well. questionnaires include questions on individualized treatment, nutritional profile and management, and patient characteristics.

coordinating health care professionals (hcps; e.g. paediatric neurologists, physiotherapists) in different centres across different countries will be asked to participate in this cross-sectional study. a) for the hcp to fill out a questionnaire about their cp child, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status; and b) for parents (/legal representatives) to receive and fill out questionnaires about their cp child and themselves, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status, participation and (their own) quality of life. if parents (/legal representatives) agree to "a)", but not "b)" then a subject will still enter the study, but without the parental assessment.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of cerebral palsy 2. age\<18 years 3. have visited the hcp within the last year 4. written informed consent provided by parents/legal representatives according to local law exclusion criteria: 1. neurodegenerative diseases 2. acute infections: meningitis, encephalitis or poliomyelitis

Keywords: cerebral palsy
dynamic contrast enhancement computed tomography for evaluating tumor perfusion in patients with metastatic renal cell carcinoma receiving targeted therapies: renal cell carcinoma (rcc) scramble

Conditions: Renal Cell Carcinoma

Summary: this is a companion protocol to md anderson cancer center study 2010-0085 (sequential therapy in advanced renal cell carcinoma therapy: the "start" trial). the goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (dce-ct) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.

to perform a dce-ct scan, a small amount of a special dye (called "ct contrast medium") is injected by vein into the body. several ct images are then taken over a few minutes to learn how much dye spreads outside of the tumor. this can show how much blood flows to and from the tumor. by performing dce-ct scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working. study procedures: if you are found to be eligible to take part in this study, you will have a dce-ct scan to check the status of the disease at the following times: * within about 4 weeks before you begin treatment on study 2010-0085. * eight (8) weeks after starting treatment on study 2010-0085. before each of the dce-ct scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function. if your doctor thinks it is needed, you will also have a standard-of-care ct scan at these timepoints to check the status of the disease. length of study: your participation in this study will be over after the scan(s) 8 weeks after starting treatment on study 2010-0085. you will be taken off of this study if you leave the 2010-0085 study early. this is an investigational study. the dce-ct scan is commercially available. using dce-ct scans to check the status of kidney cancer is investigational. up to 120 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. patient must be enrolled or being considered for enrollment on protocol 2010-0085. 2. patients must have metastatic renal cell carcinoma (rcc). 3. age \>/= 18 years. 4. subjects must have adequate renal function as defined by serum creatinine \< 1.5x upper limit of normal. exclusion criteria: 1. radiotherapy: subjects may not have received prior radiotherapy to the index lesion within 4 weeks 2. female subjects who are pregnant or lactating. 3. female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment). 4. allergy to ct contrast media requiring the administration of steroid prophylaxis.

Keywords: rcc kidney cancer metastatic renal cell carcinoma mrcc dynamic contrast enhanced ct dce-ct tumor perfusion
meta-analysis - eltrombopag

Conditions: Thrombocytopaenia

Summary: the purpose of the meta-analysis was to explore the efficacy of eltrombopag versus placebo (standard of care)

meta-analysis of three studies: bussell 2007 \& bussell 2009 \& raise (tra102537).

Eligibility criteria:
inclusion criteria: * adults with itp * received a pre-specified treatment * prospective clinical studies with at least 10 patients exclusion criteria: * subjects with itp due to other causes
a survey of factors associated with the successful recognition of agonal breathing and cardiac arrest.

Conditions: Cardiac Arrest

Summary: the overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers in the province of ontario, canada to better understand the factors associated with the successful identification of cardiac arrest (including victims with agonal breathing) over the phone. specific objectives are: 1. to conduct iterative semi-structured interviews to identify behavioural factors influencing identification of cardiac arrest by 9-1-1 call takers; 2. to develop a survey instrument about behavioural factors influencing the ability of 9-1-1 call takers to identify cardiac arrest based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs from the theory of planned behaviour; and 3. to conduct a survey among ontario 9-1-1 call takers using the survey instrument, and to identify factors and strategies that might be targeted by knowledge translation interventions.


Eligibility criteria:
inclusion criteria: * 9-1-1 call-takers, male or female, full or part-time, employed in an eligible ambulance communication centre exclusion criteria: * ambulance communication centre managers, support staff or administrative staff

Keywords: agonal breathing cardiac arrest 9-1-1 call taker survey
extended-release of octreotide (lf-pb) for the treatment of seroma

Conditions: Seroma

Summary: this is a multicentre, double blind, randomized placebo controlled trial to assess the effect of lf-pb on seroma formation in women with breast cancer undergoing axillary lymph node dissection (alnd). recruited patients will be randomly assigned to receive lf-pb 30 mg or placebo.

the study will randomize between 24 and 72 subjects that received an alnd. a staged adaptive design is employed with two intermediate analyses and a final analysis. the first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).

Eligibility criteria:
inclusion criteria: * signed informed consent form; * undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial; * negative serum pregnancy test for women of childbearing potential; * aspartate aminotransferase and alanine aminotransferase \< 2 x the upper limit of normal; * ecog ps ≤ 1. exclusion criteria: * previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary); * previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study; * concomitant participation to other clinical trial; * uncontrolled diabetes; * cholelithiasis; * human immunodeficiency virus or hepatitis b or c by screening serology; * uncontrolled hypothyroidism: if patient is being administered eutirox/ levothyroxine (or analogues) and levels of t3, t4 and tsh are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study; * pregnant or lactating; * ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation; * corrected qt (using the bazett formula, qtc) interval at screening or baseline \> 450 msec (as the mean of 3 consecutive readings 5 minutes apart); * presence of any disease or use of concomitant medication known to increase the qt interval; * clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding; * corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days); * current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.
sentinel lymph node detection after neoadjuvant chemotherapy for large operable breast cancer

Conditions: Breast Cancer

Summary: neoadjuvant chemotherapy (nac) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. after nac, patients are operated with systematic axillary lymph node dissection (alnd), although more than half of these patients do not have lymph node involvement. these results lead us to consider the indication of the sentinel lymph node (sln) technique after nac in order to avoid unnecessary alnd in patients whose sln is free of involvement. we need to validate the sln technique after nac in patients who have proven lymph node involvement prior to nac. ganea2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before nac. this primary evaluation allow to determine two groups of patients : group 1 (pn+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cn0). patients of group 1, will undergo slnb and complete level i-ii axillary lymphadenectomy. patients of group 2 will undergo slnb and a complete axillary level i-ii lymphadenectomy only in the case of detection failure or involved sln and a slnb alone in the others cases. patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.


Eligibility criteria:
inclusion criteria: * t2-t3 operable infiltrating breast carcinoma * no allergy to patent blue * pre-operative diagnosis of unifocal infiltrating breast carcinoma. * patient planned to be treated by nac. * informed consent. * surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery) exclusion criteria: * pt4d (inflammatory breast cancer) * locally advanced or metastatic breast cancer * any previous chemotherapy of contra-lateral breast cancer. * breast cancer local relapse * previous surgical removal of breast cancer. * inadequate biopsy for pathological analysis. * dementia or altered mental disorder * pregnant woman or breast feeding or without efficacious contraceptive method. * contra-indication to nac nac interrupted due to progressive disease. * neoadjuvant radiotherapy.

Keywords: breast cancer neoadjuvant chemotherapy false negative rate axillary lymph node dissection sentinel lymph node
establishment of a biological biobank of subjects vaccinated against sars-cov-2 infection (covid-19)

Conditions: Coronavirus Infections

Summary: establishment of a biological bank of subjects vaccinated against sars-cov-2 infection (covid-biovac)

the purpose of the covid-biovac study is to establish a biobank of biological samples from subjects who have received the anti-sars-cov-2 vaccine, with the ultimate aim (following approval by the ec of specific substudies) to study and characterize the antiviral immune response generated following anti-sars-cov-2 vaccination. to this end, the covid-biovac biobank will be officially established for the collection and storage of human biological material, non-profit, to support research activities aimed at advancing scientific knowledge, including in the genetic field, on the immune response. vaccination-induced anti-sars-cov-2.

Eligibility criteria:
inclusion criteria: * age ≥18 years * who have vaccinated for sars-cov-2 with pfizer-biontech vaccine or others * signing of informed consent from january to march 2021 exclusion criteria: * none

Keywords: biobank sars-cov-2 covid-19
exercise promotion in primary care

Conditions: Physical Activity; PreDiabetes; Diabetes

Summary: the investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes. the investigators built on an existing innovation at kaiser permanente, in which physical activity is assessed at every outpatient visit. the primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.


Eligibility criteria:
inclusion criteria: * prediabetes or diabetes not prescribed insulin * less than 30 min of physical activity per week * cleared to increase physical activity by primary care provider exclusion criteria: * health condition that may limit unsupervised physical activity * height and weight that were combined and resulted in a bmi \> 40 kg/m2 * disabling rheumatoid or osteoarthritis * ongoing treatment for cancer * unstable coronary heart disease
evaluation of an iris dilatation ring in cataract surgery (adicc-id)

Conditions: Small Pupil

Summary: during cataract surgery, it is necessary to dilate the iris in order to remove the crystalline lens and position the implant. the diameter of the optical implant being 6 mm, in case of capsulorhexis crystalline access 5.5 mm, the expansion should be at least 6 mm. at pre-operative consultation, the iris is always dilated by instillation of eye drops and measured at the slitlamp. for patients with an inadequate dilation, the intervention requires the use of a mechanical dilatation device. this study aims to assess the value of an alternative dilatation ring to malyugin ring, which can be inserted and removed through an incision of less than 2 mm in diameter, due to its size smaller than that of the malyugin ring. our hypothesis is that this bhattacharjee ring ensures sufficient and stable iris dilation during surgery, enabling implant placement in good conditions.


Eligibility criteria:
inclusion criteria: * patient with programmed cataract surgery under topical or local anesthesia * need to use a dilatation ring during operation, highlighted by iris dilatation ≤ 6 mm on slitlamp, after mydriatic solution and 10% phenylephrine eye drops instillation exclusion criteria: * pregnant or breastfeeding woman * patient's refusal to participate in the study * patient non covered by health insurance * complete iridectomy * tearing of iris sphincter * important posterior synechiae (when the iris is attached to the anterior surface of the implant) * anterior chamber very deep (depth of the anterior chamber lower than 1mm after injection of the viscous product)
follow-up study to assess one boost immunization with affitope® pd01a with regard to safety and clinical activity

Conditions: Parkinson's Disease

Summary: this is a follow-up study to assess safety and clinical activity of continued affitope® pd01a vaccinations in patients with parkinson's disease. patients, who have already participated in aff008 will be involved and will be receive one boost immunization with affitope® pd01a. one study site in vienna (austria) will be involved. in addition, up to 8 patients will be offered participation within an untreated control group.


Eligibility criteria:
inclusion criteria: * prior participation in aff008 and aff008e * written informed consent signed and dated by the patient and the caregiver (caregiver is not mandatory) * in the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these * female patients of childbearing potential are eligible if they use a medically accepted contraceptive method * stable doses of pd medications for at least 3 months prior to visit 0 and during the entire trial period and of all other medications for at least 30 days prior to visit 1 if considered relevant by the investigator exclusion criteria: * women of childbearing potential without birth control or pregnant women * participation in another clinical trial (except aff008e) within 3 months before visit 0 * history of questionable compliance to visit schedule; patients not expected to complete the clinical trial * autoimmune disease or allergy to components of the vaccine * history of cancer (exceptions: basal cell carcinoma, intraepithelial cervical neoplasia) * active infectious disease * immunodeficiency * significant systemic illness or psychiatric illness * alcoholism or substance abuse * prior treatment with experimental immunotherapeutics for pd including ivig (with the exception of affitope ® pd01a), with immunosuppressive drugs or treatment with deep brain stimulation * venous status rendering it impossible to place an i.v. access
a study to evaluate pharmacokinetics, efficacy, safety, tolerability, and pharmacodynamics of satralizumab in pediatric patients with aquaporin-4 antibody positive neuromyelitis optica spectrum disorder (nmosd)

Conditions: Neuromyelitis Optica Spectrum Disorder; NMOSD

Summary: this study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (aqp4) antibody seropositive neuromyelitis optica spectrum disorder (nmosd). efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * age at screening 2-11 years, inclusive * body weight at screening \>=10 kg * for female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception * diagnosed as having nmosd with aqp4 antibody seropositive status as defined by the wingerchuk 2015 criteria clinical evidence of at least one documented attack (including first attack) in the last year prior to screening * neurological stability for \>=30 days prior to both screening and baseline * expanded disability status scale (edss) 0 to 6.5 * for patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline exclusion criteria: * pregnancy or lactation * evidence of other demyelinating disease mimicking nmosd * active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline * evidence of chronic active hepatitis b or c * evidence of untreated latent or active tuberculosis (tb) * receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline * history of severe allergic reaction to a biologic agent