Kornimate/medical-research-clean huggingface dataset:
scanadu urine device validation study protocol

Conditions: Urinary Tract Infections; Proteinuria; Ketone Urine; Hematuria; Glucose Intolerance

Summary: this study will test scanadu urine device for clinical performance and usability.

the objectives of this study are to: * evaluate and validate the clinical performance of the scanadu urine device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the siemens multistix® 10sg technology (k905396). * evaluate and validate the user-interface of the scanadu urine device by the intended users for human factors and user interface of the scanadu urine device. * evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Eligibility criteria:
inclusion criteria: * female and male * 18 years old or older * pregnant or not pregnant * must have experience using an apple iphone * have no visual impairments * able to hold smart phone horizontally in raised dominant hand * must be able to read and understand english * must provide informed consent exclusion criteria: * has a known history of a visual impairment that may affect reading and navigating the scanadu urine app * unable to void and collect urine specimen for testing * unable to hold phone steady (horizontally) or has history of tremors or conditions such as parkinson's disease
safety of apollo micro catheter in pediatric patients

Conditions: Brain Arteriovenous Malformation; Brain Vascular Malformations; Vein of Galen Malformation

Summary: this is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (avm). an avm is an abnormal connection between the arteries and veins of the brain. patients considered for this trial are 21 years and younger with avm suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with onyx liquid embolic system (onyx les) or trufill n-butyl cyanoacrylate (n-bca) liquid embolic system (both are liquid substances used in the embolization procedure to block the abnormal connection).

-why is this study being done? the purpose of this study is to evaluate the safety of the apollo embolization delivery micro catheter device (device that looks like a long thin hallow tube) when used in pediatric patients with vascular malformations. the apollo onyx delivery micro catheter device is manufactured by micro therapeutics, inc. d/b/a ev3 neurovascular. apollo onyx™ delivery micro catheter device is not approved for use in the u.s, although it is widely used and approved for use in europe (ce0297). this clinical study is sponsored by dr. alejandro berenstein of st.luke's-roosevelt hospital, new york who is also the principal investigator of the study. total duration of study is up to 30 months with approximately an 18 months enrollment period. patients follow up period is up to 12 months upon enrollment.

Eligibility criteria:
inclusion criteria: * the subject or subject's legally authorized representative has signed and dated an informed consent form. * subject's age is ≤ 21 years. * the subject has a confirmed diagnosis of brain arteriovenous malformation in the cerebral cortex, cerebellum or dura mater that is indicated for endovascular embolization with onyx™ les or trufill n-butyl cyanoacrylate (n-bca) liquid embolic systems and where the use of apollo embolization delivery micro catheter may or may not be indicated for surgical resection. * the subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization. * the subject has a life expectancy of at least 1 year with the exception of new born babies with vein of galen malformation with cardiopulmonary failure where no other treatment option remains. * the subject agrees to and is capable of completing all study required procedures exclusion criteria: * female who is pregnant or lactating. * current participation in another investigational drug or device study. * subject has a brain tumor or other malignancy

Keywords: arteriovenous malformation brain avm onyx micro catheter catheter entrapment, embolization vein of galen
tolerability and efficacy of cd+a compared to aq+sp for the treatment of p.falciparum malaria in rwandan children

Conditions: Malaria

Summary: in 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (cd+a): 800 children aged 12-59 months with uncomplicated p. falciparum malaria randomly allocated to aq+sp or cd+a were followed up until day 28 after treatment. adverse events, clinical and parasitological outcomes were recorded.

between 2001 and 2006, as an interim strategy, rwanda chose amodiaquine+ sulfadoxine-pyrimethamine (aq+sp) as the first line anti-malaria treatment. although the clinical response to this combination was relatively good in 2001, since then its efficacy has steadily declined: in 2002 the proportion of successful treatment (recorded at 28 days and pcr-unadjusted) was 83 % (rwagacondo et al., 2003) and in 2003 it was 74% (karema et al., 2006). different artemisinin-based combination treatments (acts) such as amodiaquine+artesunate (aq+as), dihydroartemisinin-piperaquine (dhappq) and artemether-lumefantrine (aln) have been tested in the past few years as possible alternatives to aq+sp (fanello et al., 2006; karema et al., 2006). chlorproguanil-dapsone (also known aslapdap) is an antifolate combination similar to sulfadoxine/pyrimethamine (sp) but for two important features: (1) it is rapidly eliminated and therefore exerts less selective pressure for resistance-conferring parasite mutations than does sp (winstanley et al., 1997; nzila et al., 2000b) and (2) it is active against the sp-resistant forms of the parasite that are found in africa (mutabingwa et al., 2001a,b; kublin et al., 2002). moreover, a pediatric course of treatment of lapdap is estimated to cost $0.15 (mutabingwa et al., 2001b), making it orders of magnitude less expensive than any marketed antimalarial drug other than chloroquine and sp. in 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (cd+a): 800 children aged 12-59 months with uncomplicated p. falciparum malaria randomly allocated to aq+sp or cd+a were followed up until day 28 after treatment. adverse events, clinical and parasitological outcomes were recorded. based on the results of all trials carried out by the nmcp, the rwandan ministry of health has now changed the first line to artemether-lumefantrine (aln), coartem®. the drug arrived in the country in october 2006.

Eligibility criteria:
inclusion criteria: * age 12-59 months; * weight ≥5 kg; * monoinfection with p. falciparum; * parasite density between 2,000-200,000/µl; * fever (axillary body temperature =\>37.5c) or history of fever in the preceding 24 hours; * packed cell volume (pcv) \>21%. exclusion criteria: * severe malaria; * mixed malaria infection; * any other concomitant illness or underlying disease; * known allergy to the study drugs being used in this trial; * clear history of adequate antimalarial treatment in the previous 72 hours.

Keywords: p.falciparum malaria lapdap+artesunate safety efficay
whole body mri to identify atypical neurofibromas in patients with nf1

Conditions: Neurofibromatosis 1; Neurofibroma; Atypical Neurofibroma; Atypical Neurofibromatosis; Plexiform Neurofibroma; Von Recklinghausen Disease

Summary: this study is being conducted to determine if whole body mri (wbmri) can be used to identify atypical neurofibromas (anf) in neurofibromatosis type 1 (nf1) patients with high tumor burden. each enrolled participant will have two (2) wbmris without sedation during the study period. eligible participants must be male or female between the ages of 8-30 with diagnosed nf1; with one or more pn greater than 3cm in diameter and willing to comply with study procedures.

this is a study to determine the feasibility of using whole body mri (wbmri) to detect atypical plexiform neurofibromas (anf) among neurofibromatosis type 1 (nf1) patients who are at highest risk for developing these tumors. in order to do this, the investigators will prospectively obtain wbmri scans on patients with high plexiform tumor burden (which investigators will define as \>=1 plexiform neurofibroma (pn) that is \>3cm in diameter on mri) at the same time as their regularly scheduled mri to allow for radiographic comparison of the identified pns. in this study, the investigators will plan to establish a method that effectively characterizes pns in terms of their volume, radiographic appearance on wbmri and association with clinical characteristics. as an exploratory aim, the investigators plan to collect blood samples from each patient at the same time as the mri to determine the feasibility of isolating cfdna (circulating free dna) from plasma of patients with high plexiform tumor burden.

Eligibility criteria:
inclusion criteria: 1. males or females between 8-30 years of age 2. confirmed diagnosis of nf1 3. stated willingness to comply with all study procedures and availability for the duration of the study 4. prior mri documentation confirming \>=1 pn that is \>3cm in diameter exclusion criteria: 1. unable to undergo mri without sedation 2. presence of metal or other devices that are contraindicated for mri
a study in reversing hepatic fibrosis or cirrhosis related to hepatitis b virus and finding biomarkers

Conditions: Hepatitis B; Liver Fibrosis

Summary: the aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis b virus in mainland china and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.

450 patients who are infected with hepatitis b virus for at least 6 months will be included in the study. they will be divided into two groups. one group will be treated with entecavir while another treated with entecavir and anluohuaxian pill. liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. furthermore, the samples will be used to evaluate if anluohuaxian pill could reverse liver fibrosis and cirrhosis.

Eligibility criteria:
inclusion criteria: 1. hbsag positive for at least 6 months 2. agree to have liver biopsy 3. male or female aged 18 to 70 years old - exclusion criteria: 1. patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease 2. platelet count \< 80 × 10\^9/l 3. prothrombin activity ≤ 60% 4. decompensated liver cirrhosis 5. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -

Keywords: fibrosis liver cirrhosis non-invasive biopsy hepatitis b virus
denosumab versus bisphosphonates (alendronate) in giop

Conditions: Osteoporosis

Summary: a randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

study design: an open-label randomized controlled trial duration of study: 12 months treatment arms: 1. denosumab: a total of 2 doses in a period of 12 months 2. oral alendronate: weekly dose in a period of 12 months target sample size: 220 patients (110 patients in each arm)

Eligibility criteria:
inclusion criteria: 1. adults (women or men) \>18 years of age 2. receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months). 3. informed consent from patients. 4. willing to comply with all study procedures exclusion criteria: 1. patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents. 2. premenopausal women who plan for pregnancy within 18 months of study entry. 3. patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism. 4. patients with unexplained hypocalcemia. 5. patients with serum creatinine level of \>=200umol/l.

Keywords: glucocorticoids, steroids, osteoporosis
breast cancer: axillary conservation after neoadjuvant chemotherapy in micro metastatic sentinel lymph nodes.

Conditions: Breast Cancer

Summary: italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with sln (sentinel lymph nodes) ypn1mi after nac (neo adiuvant chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative sln (sln ypn0) after nac ,where the omission of axillary treatment is currently the standard treatment.

the study includes patients with cn+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after nac. based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (group 1 experimental or group 2 standard) or in group 3 internal control group. group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases. referring to bio-pathologic characteristics after surgery patients will receive: * no further treatment * complementary radiotherapy * adjuvant medical therapy (hormonal therapy and/or biological therapy) irradiation: group 1 (experimental) and group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to guidelines. duration: patients enrollment in the study protocol will last for 3 years. patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines: * clinical examination every six months for the first 5 years * mammography and breast ultrasound yearly * axillary ultrasound yearly

Eligibility criteria:
inclusion criteria: 1. age: 18 ≤75 years 2. breast carcinoma with infiltrating histotype 3. tumor size: ct1 - ct2 - ct3 4. positive axillary lymph nodes (cn +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation 5. neoadjuvant chemotherapy performed 6. negative axillary lymph nodes (cn-) from the nac by clinical and ultrasound assessment 7. absence of distant metastases (m0) 8. negative medical history for previous infiltrating breast cancer exclusion criteria: 1. current pregnancy or lactation status 2. inflammatory breast cancer 3. in situ breast cancer 4. synchronous contralateral breast cancer 5. co-morbidity and/or medical disorder precluding any adjuvant therapy 6. co-morbidity and/or medical/mental disorder making impossible making a regular follow-up 7. other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)
safety and efficacy of valsartan plus hydrochlorothiazide and amlodipine in hypertensive patients

Conditions: Hypertension

Summary: a double-blind, active-controlled, randomized trial to compare valsartan plus hydrochlorothiazide 80mg/12.5mg and amlodipine 5 mg. study design: 2 weeks washout, 8 weeks treatment period.


Eligibility criteria:
inclusion criteria: * female or male patient with age ≧ 18 years old. * patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment. * patient with sitting systolic blood pressure (ssbp)/ sitting diastolic blood pressure (sdbp) ≦ 180/110 mmhg at screening visit. * for non-diabetic patient, sitting systolic blood pressure (ssbp) ≧ 140 mmhg or sitting diastolic blood pressure (sdbp) ≧ 90 mmhg at baseline visit; for diabetic patient, sitting systolic blood pressure (ssbp) ≧ 130 mmhg or sitting diastolic blood pressure (sdbp) ≧ 80 mmhg at baseline visit. * patient or his/her legally acceptable representative has signed and dated the informed consent form. exclusion criteria: * known or suspected secondary hypertension. * ssbp \> 180 mmhg or sdbp \> 110 mmhg at baseline visit. * patients taking more than two anti-hypertensive medications at the screening visit. (fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.) * known nyha functional class chronic heart failure (chf) iii and iv. * with a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters * sgpt (alt) or sgot (ast) \> two times upper the limit of normal range * serum creatinine \> 2.3 mg/dl or creatinine clearance \< 30 ml/min other protocol-defined inclusion/exclusion criteria may apply

Keywords: ampm, sbp, dbp, valsartan plus hydrochlorothiazide, amlodipine, high blood pressure
complexity & distraction in lbp

Conditions: Chronic Low Back Pain; Gait; Motor Activity

Summary: motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (clbp) patients. the aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in clbp patients.


Eligibility criteria:
inclusion criteria: * the patient must have his informed consent and signed the consent form. * the patient must be affiliated or beneficiary of a health insurance plan * the patient is at least 18 years old and under 75 years old * patients with common chronic low back pain for more than 6 months exclusion criteria: * the subject participates in another interventional study * the subject is in an exclusion period determined by a previous study * the subject is under the protection of justice, guardianship or curatorship * the subject refuses to sign the consent * it is impossible to inform the subject * chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory) * unable to walk for more than 10 minutes (during interrogation) * lower limb pain (eva lower limb (s) ≥ lumbar eva)
epicardial ablation in brugada syndrome to prevent sudden death

Conditions: Ventricular Arrhythmias and Cardiac Arrest

Summary: a total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with brugada-related symptoms (ablation+icd arm 105 patients vs icd only 45 patients).

the main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with brugada syndrome. as recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm). survival from any ventricular arrhythmia (va) recurrence will be considered as primary endpoint. a projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (ablation+icd arm 105 patients vs icd only 45 patients).

Eligibility criteria:
inclusion criteria: * patients affected by brugada syndrome diagnosed according to 2013 hrs/ehra/aphrs * consensus document criteria * the patient received at least 1 appropriate icd shock. * documentation of any previous ventricular arrhythmia (va) in the form of vt, non-sustained vt, non-sustained vf, rvot pvc with a daily burden \>10000; * age ≥ 18; * willingness to attend follow-up examinations; * written informed consent for participation in the trial. exclusion criteria: * a patient who does not meet inclusion criteria; * pregnancy or breast-feeding (which would exclude an ablation procedure); * contraindications to general anesthesia or epicardial ablation; * life expectancy \< 12 months
assessment of implantation potential of embryos by time-lapse technology

Conditions: Embryo/Fetus Death; Blastocyst Disintegration; Aneuploidy; Complication of Implant; Chemical Pregnancy

Summary: 1. culture conditions of developing embryos are highly controlled in the embryoscope and are monitored by time-lapse videography to produce 3d images at different stages.this cannot be done under conventional culture conditions. 2. the 3d images thus produced,are analysed with the help of embryoviewer, a part of the embryoscope,through latest software. 3. embryoviewer also identifies embryos for transfer, freezing and to be discarded.

1. there will be two arms of the study. the study arm in which embryos of patients will be cultured in the embryoscope. the control arm in which the embryos of patients will be cultured under conventional conditions. 2. embryos to be transferred will be identified by the embryoviewer in the study arm and the ones in the control arm will be identified by established subjective morphological criteria. 3. embryos with definite implantation potential will be transferred in both arms. 4. embryos not transferred will be frozen and/or discarded in both arms.

Eligibility criteria:
inclusion criteria: 1. women of age 21-39 yrs. 2. basal fsh \< 12miu/ml 3. anterior mullerian hormone(amh) \> 1.0 ng/ml 4. antral follicle count (afc) \> 8 5. body mass index (bmi) \< 35 mt2/kg 6. estradiol (e2) \< 50pg/ml exclusion criteria: 1. women with one ovary. 2. women in whom both ovaries are not seen on ultrasonography. 3. women with too small uterine cavity. 4. women with history of recurrent pregnancy loss 5. women with systemic lupus erythematosus (sle), nephrotic syndrome, meyer rocky tansky kustner hammer(mrkh) syndrome,etc. 6. human immunodeficiency virus (hiv) i and ii positive women.

Keywords: time-lapse monitoring of embryos. embryoscope ivf-et/icsi cetrorelix gonal-f