Kornimate/medical-research-clean huggingface dataset:
the role of complement factor h polymorphism in the regulation of choroidal vascular tone in young healthy subjects

Conditions: Age-Related Macular Degeneration

Summary: age related macular degeneration (amd) is a multifactorial disease with a strong genetic component. given that it is known that impaired regulation of choroidal vascular tone is present in patients with amd, the current study seeks to investigate whether genetic polymorphisms in risk alleles for amd are associated with altered choroidal blood flow regulation in healthy subjects. for this purpose a total of 220 healthy volunteers will be included. choroidal blood flow regulation will be evaluated by measuring choroidal blood flow during isometric exercise. in addition, flicker induced vasodilatation will be studied and retinal vessel calibers will assessed, as well as retinal thickness and macular pigment optical density.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 45 years, nonsmokers * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * systolic blood pressure \< 160 mmhg, diastolic blood pressure \< 90 mmhg * normal ophthalmic findings, ametropia less than 3 diopters exclusion criteria: * regular use of medication * abuse of alcoholic beverages * participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug (except hormonal contraceptives) * symptoms of a clinically relevant illness in the 3 weeks before the first study day * blood donation during the previous 3 weeks * history or family history of epilepsy * pregnancy, planned pregnancy or lactating

Keywords: genetic association studies
air fluidized therapy (aft) in patients with suspected deep tissue injury (sdti)

Conditions: Pressure Ulcers

Summary: patients with a suspected deep tissue injury (or a purple reddened area over a bony prominence of their body, which is expected to break down into a pressure ulcer) will be place on the clinitron® rite hitetm bed to see if the air fluidized mattress decreases the amount of tissue breakdown from their bruise.

up to 15 centers will participate in this case series in acute care and long term acute care facilities. patients who present with sdti and consent for study will have the clinitron® rite hitetm bed ordered and delivered within a 12 hour window to be able to participate. they will have their sdti photographed, and an assessment of expected breakdown will be noted by the clinical team. the patient will be followed during the course of hospitalization and additional photographs and documentation will be performed by the clinical team to demonstrate the actual breakdown that occurred. information including the pertinent history of current illness, co-morbid conditions, and demographic information will be shared with the sponsor in order to demonstrate each case.

Eligibility criteria:
inclusion criteria: 1. patients with sdti on the supine aspect of their body 2. patient does not require a pulmonary specialty bed for care 3. patient is expected to be in the hospital for at least 3 days 4. patient weighs between 30 and 350 lbs. 5. patient's height is less than 75 inches tall 6. patient, or patient's representative, is willing and able to sign written informed consent 7. patient is expected to survive hospitalization. exclusion criteria: 1. patient is less than 18 years of age 2. patient has already participated in this study

Keywords: sdti pressure ulcers therapy surfaces mattresses deep tissue injury pressure ulcer treatment
dara-bcd for rare mgrs

Conditions: Monoclonal Gammopathy of Renal Significance (MGRS)

Summary: this is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (pgnmids), or light chain proximal tubulopathy (lcpt), or thrombotic microangiopathy (tma), or cryoglobulinemic glomerulonephritis, (cggn), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

the current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed pgnmids, lcpt, tma, cggn. approximately 10 subjects will receive primary therapy with daratumumab-cybord. the primary endpoint is overall complete hematologic response (chr) rate at 6 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pgnmids, or lcpt, or tma, or cggn. 2. evidence of clonal plasma cell in bone marrow. 3. ecog 0,1,2 4. neu≥ 1.0\*10\^9/l, hgb ≥70g/l, plt ≥ 50\*10\^9/l. 5. total bilirubin (tbil) ≤3×upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3.0×uln; 6. informed consent explained to, understood by and signed by the patient. exclusion criteria: 1. prior therapy for mgrs, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid) 2. fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 3. presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 4. severe or persistent infection that cannot be effectively controlled; 5. presence of severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis b or hepatitis c (\[hbvdna+\] or \[hcvrna+\]); patients with hiv infection or syphilis infection; 7. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Keywords: pgnmids lcpt tma cggn daratumumab
neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis

Conditions: Detrusor Muscle Hyperactivity

Summary: the purpose of this study is to determine the efficacy and safety of a single dose of 750 u of dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.


Eligibility criteria:
inclusion criteria: * subject, family member or care giver was willing and able to perform clean intermittent catheterisation (cic) for the duration of the study * inadequate response or refractory to anticholinergic medication * botulinum toxin naive for intradetrusor injections and with no previous treatment with botulinum toxin of any type, within 3 months prior to study entry for any other condition * have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (ief) over the 3 days preceding the baseline visit exclusion criteria: * significant baseline renal and/or urinary tract pathology * previous treatment with any endovesical pharmacology agent including detrusor botulinum toxin injection

Keywords: detrusor muscle overactivity
efficacy and safety study of dx-88 to treat acute attacks of hereditary angioedema (hae)

Conditions: Hereditary Angioedema (HAE)

Summary: the purpose of this study is to determine if a subcutaneous dose of dx-88 (ecallantide; an investigational product) is safe and relieves symptoms of hae in patients suffering from moderate to severe acute attacks of hae.


Eligibility criteria:
inclusion criteria: * age 10 and older * documented diagnosis of hae, type i or ii * executed informed consent * presentation for treatment within 8 hours of patient recognition of moderate to severe hae attack exclusion criteria: * receipt of investigational drug or device, other than dx-88, within 30 days of treatment * receipt of non-investigational c1-inh (c1 esterase inhibitor) within 7 days of treatment * diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema * pregnancy or breastfeeding * patients who have received dx-88 within 7 days of presentation for dosing in the double-blind phase
the exogenous progesterone free luteal phase after gnrha trigger - a pilot study in normo-responder ivf patients

Conditions: Infertility

Summary: after hcg trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. instead we suggest the use of two small doses of hcg after the trigger during the early luteal phase after gnrha trigger, promoting the endogenous progesterone production from the corpora lutea (cl).


Eligibility criteria:
inclusion criteria: * age between 20 and 40 * normal menstrual cycles: 25-34 days * oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the rotterdam criteria 2004) * bmi \>18 and \<35 kg/m2 exclusion criteria: * patients with \>14 follicles on day of trigger * previous hyperresponse with ohss development * previous low response (less than 3 oocytes on a high dose of fsh stimulation) * endocrine disorders
a study of avastin (bevacizumab) in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer.

Conditions: Non-Small Cell Lung Cancer

Summary: this study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous non-small cell lung cancer. patients will be randomized to one of 2 groups, to receive either avastin 7.5mg/kg iv on day 1 of each 3 week cycle, or avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * locally advanced metastatic or recurrent non-squamous non-small cell lung cancer (nsclc); * \>=1 measurable tumor lesion; * ecog performance status 0-1. exclusion criteria: * prior chemotherapy or treatment with another systemic anti-cancer agent; * evidence of cns metastases; * history of grade 2 or higher hemoptysis; * evidence of tumor invading or abutting major blood vessels; * malignancies other than nsclc within 5 years prior to randomization, other than adequately treated cancer in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer or dcis; * clinically significant cardiovascular disease; * current or recent use of aspirin (\>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
iron absorption from tef-injera in women of reproductive age

Conditions: Iron Deficiency

Summary: anemia is one of the most common health problems all over the world with around half of preschool-aged children (\<5 years) and one third of women affected. nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. so in ethiopia, where injera is the major staple food. despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef. the aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. therefore, a 50/50 and a 25/75 blend of feso4 and nafeedta for iron fortification will be evaluated. further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. the phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. the studies will be conducted in healthy women using stable isotope techniques.


Eligibility criteria:
inclusion criteria: * reproductive age females 18-40 years * maximum body weight 65 kg * normal body mass index (18.5-25 kg/m2) * no intake of mineral/vitamin supplements 2 weeks before and during the study * no metabolic or gastrointestinal disorders or chronic diseases * not pregnant or lactating * no regular intake of medication (except oral contraceptives) * no blood donation or significant blood loss (accident, surgery) over the past 4 months * not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study * no former participation in a study involving administration of iron stable isotopes * no eating disorders or food allergy * subject who can be expected and are willing to comply with study protocol * having received oral and written information about the aims and procedures of the study * having provided oral and written informed consent

Keywords: nafeedta phytate injera iron absorption
trirec - trileaflet reconstruction of the aortic valve with autologous pericardium

Conditions: Alternative Surgical Treatment for Aortic Valve Disease

Summary: reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (eoa) to surgical aortic valve replacement (savr) with a biological prosthesis (st. jude trifecta gt) as gold- standard.


Eligibility criteria:
inclusion criteria: * age \>= 50 years * documented symptomatic moderate or greater aortic stenosis or severe insufficiency * aortic annulus \> 19 mm * written informed consent of the patient. exclusion criteria: * concomitant intervention of the aortic root * concomitant intervention of the aortic arch * concomitant valve surgery * emergency surgery for any reason * neurological events (i.e. stroke, tia) within 6 months preoperatively * coagulation disorders (including thrombocytopenia \< 100.000/ml) * porcelain aorta * active endocarditis or other active systemic infections * participating in another trial that may influence the outcome of this trial * pregnancy * dual antiplatelet therapy * previous cardiac surgery (excluding percutaneous procedures)

Keywords: aortic stenosis aortic regurgitation trileaflet reconstruction of the aortic valve biological aortic valve prosthesis effective orifice area
uterus transplantation from live donor

Conditions: Primary Uterine Infertility

Summary: uterus transplantation, as a possible future treatment for uterine factor infertility, has been developed in animal species during the last decade. the study protocol includes transplantation of the uterus from a live donor (mother, relative, friend) into women with absolute uterine factor infertility (lack of uterus from birth or due to life saving hysterectomy).the recipient will be treated by standard immunosuppression and transfer of embryos (acquired by ivf before surgery) will be attempted when at least 12 months have passed from transplantation. approval for a case series including up to 10 patients has been acquired.

the study is ongoing, with inclusion of 9 patients.

Eligibility criteria:
inclusion criteria: * less than 39 years * good general health exclusion criteria: * poor ovarian resaerve or older than 39 years * systemic or psychiatric disease

Keywords: uterus transplantation infertility
efficacy and safety of riociguat in patients with systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: to investigate if riociguat is effective in the treatment of systemic sclerosis


Eligibility criteria:
inclusion criteria: * men or women aged 18 years and older * systemic sclerosis, as defined by acr/eular (american college of rheumatology/european league against rheumatism) 2013 criteria * dcssc (diffuse cutaneous systemic sclerosis) according to the leroy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis * disease duration of ≤ 18 months (defined as time from the first non-raynaud's phenomenon manifestation) * ≥ 10 and ≤ 22 mrss (modified rodnan skin score) units at the screening visit * fvc (forced vital capacity) ≥ 45% of predicted at screening * dlco (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening * negative serum pregnancy test in a woman of childbearing potential at the screening visit * women of childbearing potential must agree to use adequate contraception when sexually active. "adequate contraception" is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). this applies since signing of the informed consent form until 30 (+5) days after the last study drug administration. exclusion criteria: * limited cutaneous ssc (systemic sclerosis) at screening * major surgery (including joint surgery) within 8 weeks prior to screening * hepatic insufficiency classified as child-pugh c * patients with isolated ast or alt \>3xuln or bilirubin \>2xuln can be included in the trial under the condition of additional monitoring during the trial * estimated glomerular filtration rate (egfr) \< 15 ml/min/1.73 m\^2 (modification of diet in renal disease formula) or on dialysis at the screening visit. patients entering the trial with egfr 15-29 ml/min/1.73 m\^2 will be undergo additional monitoring of renal function * any prior history of renal crisis * sitting sbp (systolic blood pressure) \< 95 mmhg at the screening visit * sitting heart rate \< 50 beats per minute (bpm) at the screening visit * left ventricular ejection fraction \< 40% prior to screening * any form of pulmonary hypertension as determined by right heart catheterization * pulmonary disease with fvc \< 45% of predicted or dlco (hemoglobin-corrected) \< 40% of predicted at screening * active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization * not permitted prior and concomitant medication * pregnant or breast feeding women * women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
wearable mci to reduce muscle co-activation in acute and chronic stroke

Conditions: Stroke; Stroke, Acute

Summary: the purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (mci), to improve arm movement in people who have had a stroke. impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. these abnormal co-activation patterns are thought to be due to abnormal movement planning.the mci aims to reduce abnormal co-activation by providing feedback about individual muscle activations. this randomized, controlled, blinded study will test the home use of an mci in chronic and acute stroke survivors.


Eligibility criteria:
inclusion criteria: chronic stroke participants * hemiparesis from first ever stroke at least 6 months prior to screening * severe motor impairment (fma of 7-30) * at least some voluntary shoulder and elbow muscle activation. acute stroke participants * hemiparesis from first ever stroke within the past 21 days * severe motor impairment (fma of 3-20), or total manual motor score of 1-8 combined in shoulder abduction and finger extensors exclusion criteria: * cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the mci task * visual impairment (such as hemianopia) preventing full view of the screen * anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the nih stroke scale extinction and inattention subtest). * participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study * inability to understand or follow commands in english due to aphasia or other reason * diffuse or multifocal infarcts * substantial arm pain preventing participation for 90 minutes a day * new spasticity treatment (pharmacological or botox)

Keywords: rehabilitation
relationship between computed tomography manifestation and histopathological classification of thymic epithelial tumors

Conditions: Thymoma

Summary: the world health organization (who) has proposed a classification of histopathological thymic tumor and it significance in prognosis. chest computed tomography (ct) is the most common method to evaluate thymic epithelial tumors before operation. therefore, the question is to predict the histopathological type of thymic epithelial tumors before surgery based on ct-scan images , to help determine treatment strategy and prognosis. in vietnam, there are no published literature on this issue.

1. introduction: the world health organization (who) has proposed a classification of histopathological thymic tumor and it significance in prognosis. chest computed tomography (ct) is the most common method to evaluate thymic epithelial tumors before operation. therefore, the question is to predict the histopathological type of thymic epithelial tumors before surgery based on ct-scan images , to help determine treatment strategy and prognosis. in vietnam, there are no published literature on this issue. 2. materials and methods: 2.1. cross-sectional descriptive study on 53 patients with diagnosed of thymoma by ct and had postoperative histopathology results as thymic epithelial tumors 2.2. time and place: in departement of ctvs, military hospital 103, vietnam from 10/2013 to 7/2017. 2.3. methods: * study in chest ct scan: * measure the maximun diameter of the tumor * the contour: smooth contour or irregular contour * the shape: round, oval and plaque base on the ratio between long axis and short axis of the tumor * some other characteristics: degree of enhancement, level of drug absorbed, calcification, invasion the local organs and capsular destruction. * histopathological study: based on the 2004 who classification: * thymoma: type a, ab, b1, b2, b3 * thymic carcinoma * data processing: use software epi info 2000. 3. expectation of results * relationship between the size and histopathological type of thymic epithelial tumors. * comparison of some characteristics of the tumor on preoperative chest ct scans and histopathological type of thymic epithelial tumors

Eligibility criteria:
inclusion criteria: * all of patient have a chest ct scan pre-operation and a result of thymic epithelial tumors postoperative histopathology exclusion criteria: * incomplete or loss the ct and postoperative histopathology

Keywords: computed tomography thymic epithelial tumors
detection of mycoplasma pneumoniae

Conditions: Mycoplasma Pneumoniae

Summary: the objective of this clinical trial is to define the methods to be used to document that illumigene® mycoplasma direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.


Eligibility criteria:
inclusion criteria: * the subject has willingly given written informed consent. * specimens provided from subjects with symptoms of upper respiratory infections which may be attributable to mycoplasma pneumoniae, or from patients suspected of having mycoplasma pneumoniae. * dual throat swab collected per subject. exclusion criteria: * subjects who are unwilling to sign the written informed consent. * multiple sets of specimens collected from the same subject. * subjects who are unwilling or unable to provide the required number of throat swabs.