Kornimate/medical-research-clean huggingface dataset:
radiofrequency ablation versus i-131 for solitary autonomous thyroid nodules

Conditions: Thyroid Nodule, Toxic or With Hyperthyroidism; Autonomous Thyroid Function; Thyroid Nodule; Hyperthyroidism; Radiofrequency Ablation; Iodine Hyperthyroidism; Iodine Adverse Reaction

Summary: the purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or i-131 for solitary autonomous thyroid nodules.


Eligibility criteria:
inclusion criteria: * age \> 18 years * hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (htn), either located in an otherwise normal thyroid gland, or in a multinodular goitre (mng), with a diagnosis based on the following characteristics: * blood tsh level below the lower limit of normal, and associated with either normal or elevated ft4 and ft3 levels * anti-tsh antibody negative * solitary htn confirmed by a diagnostic i-123 scintigraphy, corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration \< 75%, nodule size \<50 mm. * treatment with rai indicated, and eligible for rfa treatment * signed informed consent patients who are ineligible for randomization due to unsuitability for rfa, may be eligible for the rai cohort group. exclusion criteria: * multifocal htn * htn \> 50 mm * presence of a medical device susceptible to disturbances caused by rfa generated currents * patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe rfa procedure under local anesthesia * patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility * uncorrectable haemorrhagic diathesis * pregnant or breastfeeding women
pharmacokinetics and safety study of pt010 in healthy subjects

Conditions: COPD

Summary: this is a single-center, phase i, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.


Eligibility criteria:
inclusion criteria: * informed consent form (icf) prior to any study related procedures * male and female subjects 18 to 55 years, inclusive * good general health * medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential * clinical labs within normal ranges or determined to be not clinically significant by the investigator exclusion criteria: * pregnancy, nursing female subjects, or subjects trying to conceive * clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study * history of ecg abnormalities * cancer not in complete remission for at least 5 years * clinically significant, symptomatic prostatic hypertrophy * male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening * clinically significant bladder neck obstruction or urinary retention * inadequately treated glaucoma * history of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study * subjects with pre-existing anemia and/or iron deficiency

Keywords: healthy volunteers
chiropractic manual therapy in infantile colic

Conditions: Infantile Colic

Summary: efficacy of chiropractic manual therapy in infants with excessive crying behaviour. influence of parental bias in reporting crying behaviour.


Eligibility criteria:
inclusion criteria: * excessive crying, * infant less than 8weeks of age, * born at gestational age 37 weeks or later, otherwise healthy exclusion criteria: * not accepted for chiropractic care
effect of intralymphatic immunotherapy

Conditions: Allergy; Immune Tolerance; Injection Site Discomfort

Summary: the investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. the investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. the investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

patients are injected with 3 or 4 doses of alk 225 phleum pratense 1000 standard quantity units/ml in a lymph node in the groin. the investigators monitor clinical response and use of medication during the grass pollen season. sms (symptom and medication score) will be used. the investigators count the number of immunoglobulin e grass producing plasma cells in blood one week after each injection. the investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect. adverse events will be recorded.

Eligibility criteria:
inclusion criteria: * allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years. exclusion criteria: * uncontrolled asthma. * severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected. * severe co morbidity. allergy to fenol or aluminium hydroxid. * any autoimmune diseases. treatment with beta blocking medicine. * any heart diseases. * severe arterial hypertension. kidney failure. * known malignancy. known pregnancy.

Keywords: allergic rhinitis allergen immunotherapy
effectiveness of a pain management programme

Conditions: Chronic Pain

Summary: persistent pain (pp) affects many people worldwide. patient education is central to good management. pain neurophysiology education (pne) is a new form of education. it aims to help patients 'reconceptualise' their understanding of pain away from the perception that pp is an indicator of tissue damage, to pp is due to a sensitised nervous system. this perception is considered a less threatening and more conducive to rehabilitation. there is a growing body of evidence supporting its effectiveness. one unpublished australian study combined pne with a pain management program and found significant beneficial effects. however, there is a need to test this intervention rigorously under randomised controlled trial conditions to inform clinical practice. the medical research council state that during the development and evaluation of a complex intervention (in this case a pne informed pmp), it is important to undertake feasibility work, to investigate the components of randomised controlled trial (rct) methodology prior to a full scale trial. the overarching aim of this mixed-methods study is to develop a feasible research protocol for a rct investigating the efficacy of a pain neurophysiology education informed pain management programme. in this feasibility study, participants with pp will be assessed before and after a pne informed pain management program that they are due to receive as part of their usual care. in the week before the programme participants will attend teesside university (tu) where they will complete a battery of outcome measures. a subsample of participants will also undergo a semi-structured interview. in the week following completion of their usual care pmp participants will once again attend tu where they will complete the same outcome measures and the same subsample of participants will undergo a second semi-structured interview. at this point participants will have completed the study.


Eligibility criteria:
inclusion criteria: * have capacity to give informed consent * 18+ years of age * have had pain that has persisted for greater than six months * have been referred to the pain management programme at james cook university hospital. exclusion criteria: * pain arising from a non-musculoskeletal origin such as cancer pain, visceral pain or post stroke pain * have worsening neural signs * anyone being treated by or who has been treated by the researcher (jw)
the effects of scapular muscles training using a suspension system in patients with non spacific chronic neck pain and scapular dyskinesia

Conditions: Scapular Dyskinesis

Summary: the study aimed to investigate the effect of scapular muscle training using a suspension system in patients with non spacific chronic neck pain with scapular diskinesia


Eligibility criteria:
inclusion criteria: * patients age between 20-35 years. * patients with non spacific pain(pain \> 3 month). * pain must have been present for at least the previous 12 weeks. * patients with non spacific chronic neck pain with scapular dyskinesia. * patient bmi\<30. exclusion criteria: * history of previous neck surgery. * recent or old fractures. * cognitive impairment and inability to understand the scale. * systematic inflammatory disease e.g., rheumatoid arthritis and ankylosing spondylitis. * neck pain with radiculopathy or neuropathy. * scapular dyskinesia due to other pathology such as shoulder impingement

Keywords: scapular diskinesia non spacific chronic neck pain suspension system
gene-based personalised diet and physical activity advice on adiposity indices personalised diet and physical activity advice on adiposity indices in university students

Conditions: Adiposity; Behavior, Health

Summary: a longitudinal study to determine the effect of gene-based personalised diet and physical activity advice on adiposity indices in university students.

the study uses a randomised controlled design; data for all variables (participant characteristics, height, weight, body mass index (bmi), waist circumference (wc), body fat percentage (bf%), healthy eating motivation, dietary intake and physical activity) will be collected initially from participants at st mary's university during september and october 2019. participants will be genotyped, stratified randomisation (based on genotype and bmi) will be used to allocate participants to three different groups (1. control: no advice, 2. non genetic personalised advice: dietary and physical activity advice based on reported dietary intake and physical activity 3. genotype- based personalised advice: dietary and physical activity advice based on genotype, reported dietary intake and physical activity. following allocation to groups participants in groups 2 and 3 will receive appropriate dietary and physical activity advice via email (appendix a) and all participants will complete the healthy eating motivation questionnaire for a second time. in april/may 2020 follow up variables (smoking status, weight, bmi, wc, bf%, healthy eating motivation, dietary intake and physical activity) will be measured again. these follow up variables will be measured every september and april/may until september 2022. after each follow up participants in groups 2 and 3 will be resent their dietary and physical activity advice and updated information based on their reported dietary intake and physical activity.

Eligibility criteria:
inclusion criteria: • age 18-25 years exclusion criteria: * pregnancy and lactation * chronic disease * a history of disordered eating and following a restricted diet.
adipokines, inflammation, insulin resistance and endothelial dysfunction in preeclampsia

Conditions: Pre-Eclampsia

Summary: the aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications.

this observational parallel study will be conducted on pregnant women with normal pregnancy, pregnant women with preeclampsia, and on healthy non-pregnant women. all participants will be recruited from the outpatient clinic of obstetrics and gynecology department at menoufia university hospital (shebin el-kom, egypt). the study will be approved by the research ethics committee of menoufia university and all the involved subjects will give their written informed consent. this study will involve a total number of 60 women who will be further classified into: 20 non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. the pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. the gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.

Eligibility criteria:
inclusion criteria: * pregnant women with normal pregnancy (n=20) * pregnant women with preeclampsia (n=20) at their third trimesters of pregnancy will be included in the study. preeclampsia will be defined and diagnosed by constant elevation in blood pressure greater than 140/90 mmhg and by the presence of proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and previous history of hypertension. * apparently healthy non-pregnant females (n=20) will be included in this study also. exclusion criteria: * women with risk factors for oxidative stress such as smokers and * those with a medical history of diabetes mellitus (dm) and tuberculosis (t.b). * women with a history of hypertension, familial hyperlipidemia, liver diseases, inflammatory diseases, and renal impairment. * non-pregnant women on hormonal therapy or hormonal contraceptives.
allogeneic genoidentical stem cell transplantation in children with sickle-cell anemia and cerebral vasculopathy

Conditions: Sickle Cell Anemia; Cerebrovascular Accident

Summary: the aim of this study is to demonstrate that cerebral velocities assessed by transcranial doppler (tcd) are more significantly decreased by sct than by long-term transfusion program a multicenter, national, non-randomized, prospective study of paired cohort will be conducted, with 2 groups of exposed (sct) and non-exposed (tp) patients.

the aim of this study is to demonstrate that cerebral velocities assessed by transcranial doppler (tcd)are more significantly decreased by sct than by long-term transfusion program a multicenter, national, non-randomized, prospective study of paired cohort will be conducted, with 2 groups of exposed (sct) and non-exposed (tp) patients. sixty-three patients will be enrolled, namely 21 sickle-cell patients in the "sct" group and 42 in the "transfusion program (tp)" group

Eligibility criteria:
inclusion criteria: * sickle cell anemia patients (ss/sb0) * \< 15 years old * history of abnormal transcranial doppler (tcd) (≥ 200 cm/sec) * siblings from the same parental couple * parents amenable to human leucocyte antigen (hla) typing, sct if an hla-identical sibling is available or to long-term transfusion program exclusion criteria: * sickle cell patients older than 15 years * no history of abnormal transcranial doppler (tcd) (≥ 200 cm/sec) * no sibling from the same parental couple * parents averse to hla typing, sct if an hla-identical sibling is available or to long-term transfusion program
a randomized controlled trial to assess the impact of live and recorded music-based interventions on pre-operative stress, mood, pain and biomarkers, in neurosurgical patients (music-star trial)

Conditions: Stress; Pain

Summary: the study plans to enroll a total of 132 patients. the goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (stai-s, poms-sf, and vasp). we will collect demographic information on each participant. participants will also complete the brief musical experience questionnaire (bmeq) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

primary objectives: * to evaluate the effects of the two (live and recorded) prescribed preoperative containing cer on physiologic and perceived stress in patients undergoing neurosurgery. * to evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients. secondary objectives: • to measure correlative effects of demographic variables, prior musical training, experience, preference, and exposure to music.

Eligibility criteria:
inclusion criteria 1) patients undergoing neurosurgical procedures will be eligible to enroll in this study. exclusion criteria 1. patient is unable or unwilling to provide informed consent. 2. patient is deaf or hearing-disabled. 3. patient is less than 18 years in age. 4. patient was previously enrolled in the study. 5. non-english-speaking patients (patient must be fluent in english and not require translation services per mdacc institutional policy. 6. subjects on contact isolation precautions.
early administration of ivabradine in children with heart failure

Conditions: Acute Heart Failure; Dilated Cardiomyopathy

Summary: this is a monocentric, prospective, single arm, not for profit study. it is designed to study the early use of ivabradine in patients with dilated cardiomyopathy and ejection fraction (ef) \< 45%.

the study is divided into a screening and enrollment visit (v1) where eligibility for treatment will be confirmed. ivabradine will be administered to eligible patients with increasing dosage during the titration period (tp) which will last from a minimum of 3 days to a maximum of 15 days. this will be followed by a maintenance period (mp) of the drug for a further 14 days. the follow-up period (fu) will last 4 months. the dose of ace inhibitors will be introduced after 72 hours of clinical stability after the introduction of titrated ivabradine at maximum dose according to protocol. the anti-aldosterone will be introduced 24 hours after the introduction of ivabradine. the diuretic will not be modified during the titration phase of the drug, unless there is clinical necessity. during the fu ivabradine will be continued at stable dosage, in order to maintain the target heart rate (hr) reached during the maintenance phase (hr \> 80 bpm, in the group of patients older than 6-12 months, or hr \> 70 bpm in patients aged 1-3 years or hr \> 50 bpm between 3-18 years). in all patients, the drug dose will be decreased or discontinued in case of bradycardia (hr\< 80 bpm in patients 6-12 months, hr\< 70 bpm in patients 1-3 years of age or hr\< 60 bpm in patients 3-18 years of age) and/or symptoms related to bradycardia or for other safety reasons.

Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy defined according to the indications of the cardiomyopathy task force (dilation \> 2 standard deviations (sd) and hypokinesia); * class nyha/ross ≥ ii; * ejection fraction \< 40%; * patients with acute heart failure episodes (both new episode and relapse) in the last three months; * systolic blood pressure \> 50° age and height; * heart rate: 6-12 months: ≥105 bpm, \>1 year \ 70 bpm. exclusion criteria: * cardiogenic shock in the three months; * hypertrophic, restrictive or mixed cardiomyopathy; * acute lymphocytic myocarditis diagnosed with endomyocardial biopsy; * significant valvular pathology; * sinus block and congenital long qt syndrome; * atrial fibrillation; * aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels \> 2.5 times normal, bilirubin \> 3 and creatinine \> 2.5 mg/dl; * pregnancy and/or positive pregnancy test patients; * hypersensitivity to the active substance or any of the excipients; * participation in a clinical trial in which an experimental drug was administered within 30 days or 5 half-lives of the investigational drug; * chronic lung disease or other clinical condition that the investigating physician believes is incompatible with the study; * egfr \<15 ml/min/1.73 m2.

Keywords: ivabradine heart failure pediatric cardiomyopathy
polar body biopsy for preimplantation genetic screening

Conditions: Aneuploidy

Summary: people with infertility undergoing in vitro fertilization (ivf) can test the embryos using a method called preimplantation genetic screening (pgs) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. one or more cells are removed from the embryo. the chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s). the investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. this method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.

the polar body (pb) technique makes use of the 23 chromosomes contained in the first polar body, a part of the egg that is extruded at ovulation. normally the first polar body disintegrates. however, it can be salvaged by polar body biopsy prior to this so that the chromosomes within can be analyzed. pb has three distinct advantages over conventional fluorescent in-situ hybridization (fish) analysis. first, the polar body biopsy is performed on the day that the oocyte is retrieved (day 0) rather than day 3 so results are available earlier. secondly, this methodology does not remove cells from the growing embryo. the polar body biopsy removes genetic material that would otherwise degrade. finally, microarray analysis evaluates all 23 chromosomes while only 9-10 chromosomes can be studied with fish analysis. the investigators propose to perform microarray analysis in 50 ivf/icsi (intracytoplasmic sperm injection) patients undergoing pgs. day 0 icsi; pb\* day 1 day 2 day 3 embryo biopsy with fish or microarray analysis day 4 day 5 embryo transfer or embryo biopsy with microarray analysis followed by embryo cryopreservation polar body biopsies will be frozen and later analyzed, the pb results will remain undisclosed until the end of the study period. pb results will not be used to guide treatment or clinical management. embryos will be chosen or deselected for transfer solely based on the standard of care treatment aneuploidy screening analysis. the three specific aims of the project are as follows: * to determine the efficacy of pb biopsy and analysis by comparing the pb results to the fluorescent in-situ hybridization (fish)/microarray results * to evaluate the safety of pb by comparing the implantation , miscarriage, pregnancy, and delivery rates * to determine the error rate of fish analysis by analyzing the remaining cells in embryos determined to be abnormal by initial fish/microarray analysis

Eligibility criteria:
inclusion criteria: 1. are undergoing ivf/intracytoplasmic sperm injection(icsi) 2. are considering preimplantation genetic screening for aneuploidy 3. are between ages 18 and 42 inclusive (female partner) exclusion criteria: 1. using sperm from a testicular source 2. fewer than 10 oocytes retrieved 3. fewer than 6 oocytes fertilized normally 4. complete fertilization failure (no oocytes fertilize)

Keywords: pgs,pgd, ivf, polar body biopsy, fish, microarray analysis