Kornimate/medical-research-clean huggingface dataset:
assessment of body, liver and labile plasma iron and their association with outcome and immunological recovery in myelodysplastic syndrome (mds) or acute myeloid leukemia (aml) patients undergoing allogeneic stem cell transplantation - allive (allogeneic iron investigators) observational trial

Conditions: MDS and AML Prior to Allogeneic SCT

Summary: the allive (allogeneic iron investigators) trial aims at quantifying the extent and dynamic change of lpi occurrence during conditioning and at identifying lpi-predictive peri-transplant parameters. further points of interest are the improvement of systemic iron overload (sio) diagnostics and the correlation of different sio parameters with outcome after transplantation. the results of this trial will help to design prospective interventional studies addressing therapeutic options in patients at risk for sio-associated toxicity during allogeneic stem-cell transplantation (allo-sct).


Eligibility criteria:
inclusion criteria: * age \>= 18 years at the time of signing the informed consent form * signed informed consent * diagnosis of aml or mds according to who classification * planned allogeneic stem cell transplantation after reduced intensity or myeloablative conditioning from related or unrelated donors * at risk for iron toxicity as defined by ferritin \>500 ng/ml and/or history of more than 10 rbc transfusions prior to allo-sct exclusion criteria: * claustrophobia or other mental disorders making mri imaging unbearable for the patient * cardiac pacemakers, metal implants splinters or other contraindications for mri * more than 1 human leukocyte antigen (hla) allele or antigen mismatch between donor and recipient * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study * patients who are not likely to follow the trial protocol (lack of willingness to cooperate)

Keywords: mds aml allogeneic sct
hifu in patients with non-malignant thyroid nodules

Conditions: Non-malignant Thyroid Nodules

Summary: use of a high intensity focused ultrasound (hifu) in patients with non-malignant thyroid nodules.


Eligibility criteria:
inclusion criteria: * male or female patient 18 years or older. * patient presenting with at least one thyroid nodule with no signs of malignancy: 1. non suspect clinically and at ultrasonography imaging 2. benign cytological diagnosis at fine-needle aspiration biopsy (fnab) from the last 6 months 3. normal serum calcitonin 4. no history of neck irradiation * normal thyroid-stimulating hormone (tsh). * targeted nodule accessible and eligible to hifu * absence of abnormal vocal cord mobility at laryngoscopy. * nodule diameter ≥ 10mm measured by ultrasound. * nodule volume inferior to 10 cc * composition of the targeted nodule(s) : no more than 30% cystic exclusion criteria: * head and/or neck disease that prevents hyperextension of neck. * known history of thyroid cancer or other neoplasias in the neck region. * history of neck irradiation. * macrocalcification inducing a shadow in the thyroid significant enough to preclude the hifu treatment * posterior position of the nodule if the thickness of the nodule is \<15mm * pregnant or lactating woman * any contraindication to the assigned analgesia/anaesthesia.
screening program for type 1 diabetes in a high-risk population

Conditions: Type 1 Diabetes

Summary: type 1 diabetes mellitus (t1d) is a growing public health concern in saudi arabia, ranking ninth globally in t1d incidence and tenth in t1d prevalence in children, and the rates are expected to rise and incur greater healthcare costs. genetic and immunological factors are believed to play a significant role in disease development, and recent clinical trials have shown promise in delaying or preventing t1d onset in high-risk individuals. early screening for immunological or genetic markers in children is crucial to identify high-risk individuals and provide early intervention. last year, the american diabetes association's recommended clinicians to screen first degree relatives of individual with t1d. unfortunately, saudi arabia and other arab countries lack established t1d screening programs, making early identification and intervention challenging. the benefits of screening include education for symptom awareness, monitoring to track progression to clinical t1d, a five-fold reduction in diabetic ketoacidosis (dka) at onset, and improved glucose control for the first years following diagnosis. to address this issue, exploring effective and efficient screening methods in identifying high-risk children and the cultural acceptability, feasibility, and barriers to a broader implementation of such screening programs among saudi families is crucial. therefore, the investigators aim to conduct a prospective cohort study among young children and adolescents with a family history of t1d (i.e., t1d first-degree relatives). children 2-18 years old will be screened using a 5 spots filter-dried blood sample for the following: 1. islet autoantibodies: iaa, gada, ia-2a, zn-transporter autoantibodies using the antibody detection by agglutination pcr (adap) assay. 2. hla phenotyping 3. genetic risk score after the cross-sectional assessment those who are determined to be in stage i, or ii of t1d will be offered prospective follow-up for 5 years.


Eligibility criteria:
inclusion criteria: * t1d diagnosis in a first-degree relative: diabetes is defined based on the american diabetes association (ada) definition: classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/l (200 mg/dl), or fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl). fasting is defined as no caloric intake for at least 8 h, or two-hour post load glucose ≥11.1 mmol/l (≥200 mg/dl) during an ogtt, or hba1c \>6.5%. exclusion criteria: * first-degree relative case with maturity-onset diabetes of the young (mody) or type 2 diabetes mellitus (t2dm). * non-saudi children. * first-degree relative not following at our centre.

Keywords: screening early detection adap
investigation of efficacy and tolerability of a lactic acid containing vaginal suppository in post-menopausal women with vva

Conditions: Vulvovaginal Atrophy

Summary: the aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with vva.


Eligibility criteria:
inclusion criteria: * post-menopausal women with subjective symptomatology of vulvovaginal atrophy * signed written informed consent before participation in the trial exclusion criteria: * known hypersensitivity against any of the ingredients of the investigational product * systemic hormonal replacement therapy, or phytohormonal therapy or use of serms within 3 months before and / or during the conduct of the trial * local hormonal therapy (vagina/vulva) within 3 months before the trial * if in the opinion of the investigator the patient should not participate in the study for any reason
part-time versus full-time spectacles for myopia control (parma study)

Conditions: Myopia

Summary: the purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.

a prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50d and -6.00d, were recruited. a random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. part-time use was for 4-6 hours a day, 7 days a week for a year. clinical assessment included follow-up at 6 months and at 12 months upon allocation. the primary outcomes were a) change in spherical equivalent refraction (ser) measured by cycloplegic autorefraction, and b) change in axial eye length (al). the secondary outcomes were a) change in choroidal thickness (cht), and b) assessment of the subjective tolerance.

Eligibility criteria:
inclusion criteria: * age 4 to 16 years old at the time of enrollment. * best-corrected visual acuity (bcva) logmar 0.1 or better, in each eye. * cycloplegic autorefraction: myopia, ser between -0.50d and -6.00d, in each eye. astigmatism less than or equal to 1.50d, in each eye. anisometropia less than or equal to 1.50d between the two eyes. * absence of any ocular or systemic condition that could influence refractive development, other than myopia. * eagerness to participate in this study and receive myopia treatment in a randomized fashion. availability for at least 1-year follow-up. subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject. exclusion criteria: * presence of strabismus. * presence of amblyopia. * prematurity (gestational age less than 37 weeks). * presence of an ocular condition affecting refraction (ie. cataract, dislocated lens). * presence of a systemic condition affecting refraction (ie. down syndrome, marfan syndrome). * allergy to cyclopentolate. severe ocular or systemic allergies.

Keywords: myopia spectacles full-time correction part-time correction childhood
genicular radiofrequency ablation versus pulsed radiofrequency

Conditions: Osteoarthritis of Knee

Summary: this study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. these techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. despite both being found effective, no clear consensus exists on which method is superior. the study seeks to compare these techniques and contribute new insights to the existing literature.

chronic knee pain, especially in osteoarthritis patients, is a common condition that significantly affects mobility and quality of life. in individuals over the age of 60, the incidence is 9.6% in men and 18% in women. in patients with osteoarthritis, weight loss and appropriate exercises are recommended as the primary treatments. this is followed by medical therapy, injection treatments, and, if necessary, total knee arthroplasty. however, for patients with a body mass index (bmi) of 40 or higher, total knee arthroplasty is avoided due to the high surgical risk. in recent years, genicular nerve diagnostic block and radiofrequency ablation have been shown to reduce pain and improve function in these patients . radiofrequency ablation works by blocking the transmission of sensory nerves, thereby improving function. the innervation of the knee joint originates from the femoral nerve's articular branches, the common peroneal, saphenous, tibial, and obturator nerves. these articular branches are known as the genicular nerves, which are superficial and can be easily accessed using both fluoroscopy and ultrasound. in osteoarthritis patients, superior medial, superior lateral, and inferior medial genicular nerve blocks are applied. after the diagnostic block, some clinics apply radiofrequency thermocoagulation to the genicular nerve branches for a lasting effect, while others use pulsed radiofrequency. both techniques have been found to be effective, but there is no data in the literature regarding which technique is superior. the aim of this study is to determine which of the two techniques is more effective and share the findings with the literature.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 * osteoarthritis * grade 2-4 gonarthrosis according to the kellgren-lawrence (kl) classification * pain 6-10 on the numeric rating scale (nrs) exclusion criteria: * patients with chronic knee pain due to another pathology (e.g., meniscopathy, trauma, rheumatoid arthritis) history of previous knee surgery history of intra-articular injection in the last 3 months coagulopathy, use of antiplatelet or anticoagulant medications infection severe psychiatric disorders patients with a cardiac pacemaker or defibrillator renal or hepatic failure

Keywords: osteoarthritis of knee pulsed radio frequency treatment radiofrequency ablation
educational intervention among informal caregivers of person with dementia

Conditions: Caregiver Burden

Summary: the goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. the main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver. participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.

caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. the caregiver will be approached by the primary researcher and explained about the details of the study. the caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained. the researcher will then check the eligibility of the caregiver to participate. if the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. the caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. this study will use equal allocation with a ratio of one to one for each two groups. the caregiver will be randomly allocated by using permuted block randomization technique. this study will be conducted as single blind study. only the respondents would be blinded and concealed from the group allocation. the intervention group will be given the educational intervention which are educational module and short videos related to dementia care. after the baseline data collection, the soft copy of the educational module will be shared to the participants via whatsapp messenger so that they can review the module before the virtual educational session. one short educational video will be then shared to all the participants through individual whatsapp in each wednesday of the week for 12 weeks. each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. after the video shared to the participants, they are encouraged to ask any questions related to the content of the video.

Eligibility criteria:
inclusion criteria: 1. informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents). 2. age 18 years old and above. 3. able to understand, read and speak bahasa malaysia language exclusion criteria: 1. caregiver with previous history of mental illness. 2. caregiver with physical disabilities that cause limitation in providing care for person with dementia. 3. paid informal caregiver (maid).

Keywords: informal caregiver of person with dementia educational intervention
pneumococcal post-vaccination titers

Conditions: Smokers, Elderly, Asthma, COPD, Recurrent Infections

Summary: the study is looking at the pneumonia vaccine and the immune system response to this vaccine. the information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, chronic obstructive pulmonary disease (copd), or elderly patients. it is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.

one hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the ppv-23 vaccine. they will then receive the vaccine. all subjects will be given the vaccination as standard of care. approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.

Eligibility criteria:
inclusion criteria: informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. the cohorts will be: 1. smokers between the ages of 19-80. 2. elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, copd or asthma. 3. copd subjects between the age of 19 and 80, without a history of recurrent bacterial infections. 4. asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections. 5. individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency. exclusion criteria: the following groups will be excluded: 1. subjects who are currently receiving or have ever received immunoglobulin replacement therapy. 2. subjects who are on immune suppressive agents. 3. subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year. 4. subjects on antiepileptic agents. 5. subjects who have received the pneumococcal polysaccharide vaccine, ppv-23 6) pregnant women
infection surveillance in intensive care patients

Conditions: Infection; Pneumonia; Sepsis; Cross Infection

Summary: purpose of the study is to investigate and quantify known and possible new riskfactors for nosocomiel infection and death in the intensive care setting. as new riskfactors mannose binding lechtin and procalcitonin are chosen and compared to established riskfactors.


Eligibility criteria:
inclusion criteria:admission to icu - exclusion criteria:absence of informed consent and age less than 18 years -
study to evaluate the safety and immunogenicity of pandemic monovalent (h5n1) influenza vaccines (whole virus formulation) in adults 18 and 60 years of age

Conditions: Influenza

Summary: today, the leading contender for the next pandemic of influenza is h5n1, a strain of avian virus. prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.this study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic h5n1 vaccine formulated from whole virus. the vaccines contain different antigen doses. for each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the h5n1 influenza strain.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * healthy subjects as established by medical history and clinical examination before entering into the study. * if the subject is female, she must be of non-childbearing potential. exclusion criteria: * administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one. * administration of an influenza vaccine other than the study vaccines during the entire study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * history of hypersensitivity to vaccines. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study. * lactating women * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

Keywords: prophylaxis of pandemic influenza
extension study of patients successfully treated by ziprasidone in study a1281031

Conditions: Schizophrenia

Summary: open label extension study of ziprasidone, evaluation of safety of long term use of ziprasidone


Eligibility criteria:
inclusion criteria: * patients who successfully completed study a1281031 (cgi score of 1 or 2 at final visit) or zip-ny-98035 and with qtc \<= 500 msec. exclusion criteria: * all other patients who do not fit the inclusion criteria as stated above.
pharmacokinetics of small spectrum beta-lactam antibiotics (amoxicillin/clavulanic acid and cefuroxime) in patients on intensive care units

Conditions: Infection

Summary: adequate antibiotic therapy is very important in the treatment of infections. spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. this is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure... the investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics. in this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. all the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. by measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.


Eligibility criteria:
inclusion criteria: * patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection exclusion criteria: * informed consent lacking * haematocrit \< 21 % * arterial catheter lacking

Keywords: amoxicillin clavulanic acid cefuroxime patients in the intensive care unit, with an infection which requires amoxicillin/clavulanic acid or cefuroxime