Kornimate/medical-research-clean huggingface dataset:
iron absorption from encapsulated iron sulphate in microspheres

Conditions: Iron-deficiency

Summary: food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. water-soluble iron compounds, such as ferrous sulphate (feso4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes. encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. in the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (ha) and a polymer from the eudragit family.


Eligibility criteria:
inclusion criteria: * female, 18 to 40 years old * marginal iron status (pf \<25 ng/ml) * body weight \< 65 kg * normal body mass index (18.5 - 25 kg/m2) * signed informed consent exclusion criteria: * pregnancy (assessed by a pregnancy test) / intention to become pregnant * lactating up to 6 weeks before study initiation * moderate or severe anaemia (hb \< 9.0 g/dl) * elevated c reactive protein (crp) (\> 5.0 mg/l) * any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * continuous/long-term use of medication during the whole study (except for contraceptives) * consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration * blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * earlier participation in a study using fe stable isotopes or participation in any clinical study within the last 30 days * participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)

Keywords: iron deficiency iron fortification iron encapsulation
comparison of diaphragmatic breathing and muscle relaxation for rumination

Conditions: Rumination

Summary: rumination is an upper gastrointestinal (gi) disorder characterized by the frequent regurgitation of recently ingested food. very little is understood about the nature and treatment of this disorder. the act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. however, an effective behavioral mechanism may be relaxation of the muscles. from a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination. to date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for gi rumination. in the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for gi rumination through a treatment as usual paradigm (proposed n = 20). our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age. 2. diagnosis of rumination by romeiii criteria exclusion criteria: 1. active alcohol or substance abuse 2. presence of a depressive disorder as measured by phq-9 score of 10 or above 3. presence of clinical significant anxiety disorder as measured by gad-7 score of 10 or above. 4. severe levels of health focused anxiety as measured by shai score of 26 or above. 5. any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures. 6. any active psychosis or suicidality.

Keywords: rumination
high flow nasal oxygenation vs endotracheal intubation on recovery profiles in laryngeal microsurgery

Conditions: Cough

Summary: transnasal humidified rapid-insufflation ventilatory exchange(thrive), or also termed high flow nasal oxygenation (hfno) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. this study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

laryngeal microsurgery is mainly performed by a conventional method of general anesthesia with endotracheal intubation (et), which may have difficulty accessing the lesion behind the larynx, and may be limited in securing space for surgical manipulation. to compensate for these shortcomings, a method of maintaining general anesthesia without using an endotracheal tube has been introduced, and high-flow nasal oxygen(hfno) and transnasal humidified rapid insufflation ventilatory exchange(thrive) enable tubeless anesthesia due to apnea oxygenation and apnea ventilation effect during laryngeal microsurgery. coughing and straining can be accompanied by emergence after general anesthesia. forceful vocal cord adduction especially after upper respiratory surgery such as laryngeal microsurgery can cause damage and bleeding of surgical tissue, delaying wound healing. if a small amount of remifentanil is continuously injected during emergence after total intravenous anesthesia(tiva), airway complications such as coughing can be reduced during emergence without delay in recovery time, and hemodynamic stability can be promoted. in this study, the effect of endotracheal intubation and high-flow nasal oxygen on the emergence cough and postoperative sore throat is compared when total intravenous anesthesia(tiva) using propofol and remifentanil is performed in patients undergoing laryngeal microsurgery. this study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists classification 1 or 2 who receive general anesthesia for laryngeal microsurgery exclusion criteria: * patients with major cardiovascular, pulmonary, and cerebrovascular disease * laser laryngeal surgery * morbid obesity (bmi\>35 kg/m2)

Keywords: high flow nasal oxygenation laryngeal microsurgery emergence cough
proton therapy for chordomas and/or chondrosarcomas

Conditions: Chordomas; Chondrosarcomas

Summary: the purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility criteria:
inclusion criteria: * histologically proven chordoma or chondrosarcoma. * sites: base of skull and/or spine. * age 18 years or older. exclusion criteria: * previous radiation to the head and neck or brain. * evidence of metastatic disease.

Keywords: chordomas chondrosarcomas cancer outcomes proton radiation
a study of avastin (bevacizumab) in patients with non-squamous non-small cell lung cancer with asymptomatic untreated brain metastasis

Conditions: Non-Small Cell Lung Cancer

Summary: this study will assess the efficacy and safety of avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. two cohorts of patients will be studied; the first will receive av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin auc6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive avastin 15mg/kg iv every 3 weeks combined with second line t arceva 150mg/kg po.the anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * stage iv non-squamous non-small cell lung cancer; * asymptomatic, untreated brain metastasis; * ecog performance status 0-1. exclusion criteria: * previous treatment for brain metastasis; * history of migraine or epilepsy; * previous treatment with angiogenesis inhibitors; * for cohort 2, previous first line treatment with avastin or tarceva; * current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
hamburg aortic valve cohort

Conditions: Aortic Valve Stenosis

Summary: the primary aim of the study is to identify the optimal treatment modality for patients with aortic valve disease, incorporating the individual patient's risk profile and anticipated clinical outcomes. this includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

patients with severe aortic valve disease have a poor prognosis under medical therapy, making replacement of the failing valve the preferred option. in addition to surgical aortic valve replacement (savr), transcatheter aortic valve implantation (tavi) has evolved as an alternative treatment option for patients at intermediate and high operative risk. before expansion of tavi to low-risk and younger patients can be recommended, several questions remain to be investigated, e.g. optimal patient selection, periprocedural complications and long-term durability. therefore every patient with a relevant aortic valve disease (aortic stenosis, aortic regurgitation or degenerative aortic valve prosthesis) who meets the inclusion/exclusion criterias is planned to be involved in the study. predictors of outcome are yet to be defined in patients with aortic valve disease in order to improve risk prediction for the different treatment modalities (medical, savr, tavi). the primary aim of the study is to identify the optimal treatment modality for the individual patient, incorporating the individual patient's risk profile and anticipated clinical outcomes. this includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.

Eligibility criteria:
inclusion criteria: * patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis) * written informed consent exclusion criteria: * insufficient knowledge of the german language (able to understand and write the german language) * physical or psychological incapability to take part in the investigation
self-monitoring shopping intervention

Conditions: Intellectual Disability; Down Syndrome

Summary: the purpose of this study is to examine the effectiveness of a self-monitoring intervention to improve shopping performance in adults with intellectual disability (id) secondary to down syndrome (ds). the research question asks, can an 8-week self-monitoring intervention, provided in a community-based setting, increase observable shopping skills in adults with id secondary to ds?

adults with intellectual disability secondary to down syndrome often have difficulty performing complex activities of daily living, such as shopping. these difficulties may, in part, be influenced by deficits in metacognitive abilities, which include self-monitoring of one's performance. there is evidence that interventions which target self-monitoring skills can improve functional performance in adults and adolescents with traumatic brain injury. functional magnetic resonance imaging (fmri) studies on adults with down syndrome have demonstrated impairments in metacognitive abilities, resulting from significant volume reduction in the frontal lobes and anterior cingulate cortex. these deficits likely contribute to the difficulties experienced by this population when performing instrumental activities of daily living (iadl), such as shopping. although metacognitive-focused interventions that address self-monitoring skills have been used to improve functional performance in adults and adolescents with traumatic brain injury, these techniques have not yet been used to improve iadl performance in adults with intellectual disability secondary to down syndrome. this 16-week study is a single-subject aba design across ten participants to determine the effectiveness of a self-monitoring intervention on shopping performance in adults with intellectual disability secondary to down syndrome. the intervention will span 8 weeks and will include weekly sessions that are delivered in an alternating group-individual format. sessions will provide participants the opportunity to practice and apply self-monitoring techniques across a variety of shopping tasks and settings to promote generalization and transfer of learning. this study has the potential to provide preliminary information on the effectiveness of a self-monitoring intervention, provided in community-based settings, to increase observable shopping skills in adults with intellectual disability secondary to down syndrome.

Eligibility criteria:
inclusion criteria: * adults with intellectual disability secondary to down syndrome * members of a community center called gigi's playhouse hillsborough exclusion criteria: * severe behavioral disorder that would prevent cooperation with study protocol

Keywords: shopping activities of daily living
use of a mobile-based app for scd patients

Conditions: Sickle Cell Disease; Chronic Pain

Summary: the study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with internet access daily. the study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. the study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. this study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or ipad with an android or ios operating system.

the study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. the study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. this study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or ipad with an android or ios operating system. the study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with internet access daily. patients enrolled in this study will be ask to use a mobile device such as a smartphone or a tablet with android or ios operating system to record daily pain level and related information once daily or more frequently for a period of forty-two days. a 1:1 randomization assignment will be made to have patients receive automated "canned" provider feedback or not.

Eligibility criteria:
inclusion criteria: * scd, thalassemia, or history of experiencing pain exclusion criteria: * none

Keywords: sickle cell pain
effects of mega-dose vitamin d pulse and maintenance therapy on seizure frequency, fatigue, and quality of life: a prospective study

Conditions: Epilepsy

Summary: we inform consent overall process of this trial study through face-to-face use of the irb, clarify patient questions, and allow subjects to fully understand the trial study.


Eligibility criteria:
inclusion criteria: * aged 20 or above (inclusive) * diagnosed patients (refractory epilepsy refers to those who have used more than two drugs, and each drug has reached the when epileptic seizures cannot be well controlled at standard reasonable treatment doses, it is called refractory epilepsy) * there is no imaging evidence of persistence or expansion of brain damage in the past three years * subjects or family members (caregivers) can comply with the trial plan and take vitamin d patients exclusion criteria: -

Keywords: mega-vitamin d epilepsy fatigue quality of life
chronic aphasia - improved by intensive training and electrical brain stimulation (cats)

Conditions: Aphasia; Anomia (Word-Finding Impairment)

Summary: the purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.

stroke is the leading cause of death and disability worldwide. given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. one of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. high-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. however, despite its general effectiveness, treatment effect sizes are only low to moderate. thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. this is the prerequisite to improve existing and/or develop new treatment paradigms. thus, in the present project the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. they will be using anodal transcranial direct current stimulation (atdcs) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atdcs. treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. the investigators will also use functional and structural magnetic resonance imaging (mri) to elucidate language network changes in the two groups.

Eligibility criteria:
inclusion criteria: * chronic stroke (\> 1 year after event) * aphasia due to stroke with naming impairment * german as first language * first-ever stroke exclusion criteria: * more than 1 stroke * history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity * dementia * contraindications for magnetic resonance imaging or transcranial direct current stimulation
multi-centre study on the performance of the ponto bhx implant system (in adult patients)

Conditions: Hearing Loss

Summary: this multi-centre study funded by oticon medical ab will be conducted at seven hospitals across europe (uk, spain, denmark). patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. a total of 50 patients will be included in the study. the purpose of this study is to investigate the rate of successful bahs use after implantation of the ponto biohelix (bhx) implant system.

this multi-centre study funded by oticon medical ab will be conducted at seven hospitals across europe (uk, spain, denmark). patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. a total of 50 patients will be included in the study. the purpose of this study is to investigate the rate of successful bahs use after implantation of the ponto bhx implant system. the implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. the primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines * adequate bone quality to allow for a ponto bhx implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected exclusion criteria: * patients undergoing re-implantation * patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales. * diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus * known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator * any other known condition that the investigator determines could interfere with compliance or study assessments
patients with distal radius fracture

Conditions: Physical Disability

Summary: surgically and conservatively treated distal radius fractures followed for six month. in this period 12 weeks rehabilitation programme applied for each group. nine different evaluations were done in the initial, after physical therapy and 6th month. results were presented.

distal radius fracture (drf) affects overall health status. the international classification of function (icf) based approach is appropriate in the management of drf. the purpose of this study was to investigate functional status and activity participation levels of drf patients. the patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. the evaluation of the body function and structure were done with visual analogue scale, algometer, range of motion (rom) and grip strength. also, radiographic evaluations were done. activity participation assessments were done with push-off test (pot), michigan hand outcomes questionnaire (mhoq), short form of disabilities of arm-shoulder and hand questionnaire (q-dash) and jebsen-taylor hand function test (jthft). mann-whitney u and wilcoxon tests were used respectively for intergroup and intra-group comparisons. statistical significance level was p\<0,05.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 * diagnosed with distal radius fracture * primary fixation after injury. exclusion criteria: * bilateral distal radius fracture * concomitant ulna styloid fracture * another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb * patients who underwent surgery that involved ipsilateral upper extremity * associated injuries such as nerve or tendon injuries * secondary procedures at follow-up * un-cooperated patients.

Keywords: distal radius fracture functional status activity participation hand therapy