Kornimate/medical-research-clean huggingface dataset:
screening for albuminuria at the first line for early identification of ckd

Conditions: Chronic Kidney Diseases; Albuminuria

Summary: early detection of kidney disease

early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. there is a well-established relationship between albuminuria and renal- and cardiovascular disease. elevated albuminuria has a relatively high prevalence in the general population (5-9%). the prevalence of albuminuria is even higher in high-risk patients with diabetes mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. however, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. the current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.

Eligibility criteria:
inclusion criteria: * diabetes mellitus (diagnosis or prescription for the disease based on the nhg guidelines) * adipositas (diagnosis) * hypertension (diagnosis or prescription for the disease based on the nhg guidelines) * cardiovascular disease (diagnosis, specified in protocol section 5.2.2) * lipid disorder (diagnosis or prescription for the disease based on the nhg guidelines) exclusion criteria: * inability to understand and sign the informed consent form * pregnancy
cardiomyopathy in dmd: lisinopril vs. losartan

Conditions: Duchenne Muscular Dystrophy (DMD); Cardiomyopathy

Summary: this trial is a double-blind randomized clinical trial of lisinopril versus losartan for the treatment of cardiomyopathy in duchenne muscular dystrophy (dmd). both drugs are known to be effective for the treatment of dilated cardiomyopathy. acei have been reported to delay the onset and progression of left ventricle dysfunction in children with dmd. multiple studies show therapeutic efficacy of losartan in animals with cardiomyopathy related to muscular dystrophy and in patients with cardiomyopathy from diverse causes. arbs are often reserved for patients in whom heart failure is not adequately treated or where side effects preclude the use of an acei. however, in dmd, losartan might be a better choice as a first line drug because of studies demonstrating a potential benefit for skeletal muscle in the mdx mouse. considering that both skeletal and cardiac muscles are major contributors of the disability of dmd, a drug that could improve both heart and skeletal muscles simultaneously would need consideration as the drug of choice for the cardiomyopathic dmd patient.


Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy patients of all ages * null mutation of the dystrophin gene or muscle with \<5% dystrophin * doppler echocardiogram with ejection fraction (ef) \<55% within 30 days of enrollment * ability to cooperate for testing * glucocorticoid treatment acceptable including daily or weekend administration of prednisone or deflazacort exclusion criteria: * patients with ef 55% or greater * patients with ef \<40% after washout * patients taking \>5 mg lisinopril, or \>25 mg losartan or \>5 mg enalapril * skeletal deformities or pulmonary anatomical variants that preclude consistent measures of doppler echocardiography

Keywords: duchenne muscular dystrophy (dmd) cardiomyopathy losartan lisinopril
niche development with closure of cesarean uterotomy by modified or conventional two-layer technique

Conditions: Cesarean Scar Niche

Summary: the aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.


Eligibility criteria:
inclusion criteria: * singleton pregnant * intended elective cesarean section exclusion criteria: * cervical dilatation of more than 4 cm * previous cesarean section
pregnancy and neonatal follow-up of ongoing pregnancies established during phase ii clinical trials of org 36286 (study 38817)(p06054)(completed)

Conditions: Pregnancy

Summary: the objective of this trial was to evaluate whether org 36286 treatment in any phase iia clinical development trial of org 36286 for oi or coh in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. data from subjects who participated in trials 38805 and 38807 and became pregnant were evaluated.

this was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any phase iia clinical trial of org 36286 for oi or coh for ivf. for this trial, no study specific assessments were required, but information obtained in standard practice was used.

Eligibility criteria:
inclusion criteria: * subjects taking part in any clinical development trial of org 36286 for oi or coh for ivf in phase iia; * ongoing pregnancy confirmed by ultrasonography (uss) at or beyond 12 weeks of gestation; * able and willing to give written informed consent. exclusion criteria: * none

Keywords: neonatal outcome congenital malformations in-vitro fertilization controlled ovarian stimulation follow-up ovulation induction neonates
phase iii: assess conventional rt w/ conventional plus accelerated boost rt in the treatment of nasopharyngeal ca

Conditions: Nasopharyngeal Carcinoma

Summary: phase iii: assess conventional rt w/ conventional plus accelerated boost rt in the treatment of nasopharyngeal ca

it's a phase iii study to assess conventional rad therapy with conventional plus accelerated boost rad therapy in the treatment of nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * patients with nasopharyngeal carcinoma exclusion criteria: * patients with carcinoma other than histo-pathologically confirmed nasopharyngeal ca
effects of lignan-rich diet on cardiometabolic risk factors

Conditions: Metabolic Syndrome; Overweight; Central Obesity; Impaired Glucose Tolerance

Summary: diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular disease and certain cancers. studies have shown that diets with high whole-grain content could decrease the risk of these lifestyle related diseases and in sweden the national dietary guidelines recommends whole-grain based instead of refined cereal products. it is, however, not clear whether whole-grain from wheat and rye share similar protective effects since there are large differences in amount and quality of dietary fibre and associated bioactive compounds. the aim of this study is to evaluate the impact of a wholegrain diet with low- or high lignan content on different cardiometabolic risk factors with the primary endpoint being blood glucose levels after 2h oral glucose tolerance test in men with metabolic syndrome or sign thereof.

the study will be conducted in a randomized, cross-over design (8 wk intervention periods). the lignan-rich diet will be based on whole-grain rye products whereas the control diet will be based on whole-grain wheat products with some added wheat bran. both diets will provide similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre quality will be different). although rye has high lignan content, the aim is to further increase the lignan intake half-way through the whole grain rye intervention period. this will allow us to distinguish the effect of lignans from the effect of whole grain rye as well as evaluating potential differences in effects on cardiometabolic risk factors between whole grain wheat and whole grain rye intake after 4-week consumption. the study design will also allow us to investigate the effects of a putative interaction between microbiome x lignan rich diet and its implication of metabolic risk factors. blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8 weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks of the second intervention period. at each examination day participants will arrive to the test laboratory for blood samples and an oral glucose tolerance test (ogtt) where participants will be given a drink with 75 g of glucose to consume within 10 minutes. blood samples will be taken after 30, 60 and 120 minutes. furthermore, participants will be instructed to complete one 3-day weighted food record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.

Eligibility criteria:
inclusion criteria: * bmi \> 25 kg/m2 * waist circumference \> 102 cm * at least one of the following: blood pressure \>130/85 mmhg, serum triglycerides ≥1.69 mmol/l; hdl cholesterol \<1.04 mmol/l; or serum glucose ≥6.1 mmol/l exclusion criteria: * smokers * antibiotic use past 6 months * cancer diagnose (past 5 years) or other chronic disease diagnosis * excessive alcohol consumption (\>21 units/week)

Keywords: intervention lignans whole-grain
the clinical investigation of toothpaste as compared to toothpaste and mouthwash in reducing plaque and gingivitis: a six-week clinical study in the us

Conditions: Dental Plaque; Gingivitis

Summary: the objective of this clinical research study is to evaluate clinical efficacy of colgate total toothpaste as compared to crest pro-health toothpaste and crest pro-health mouthwash, and crest cavity protection toothpaste and crest fluoride mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.


Eligibility criteria:
inclusion criteria: 1. subjects, ages 18-70, inclusive. 2. availability for the six-week duration of the clinical research study. 3. good general health. 4. minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. 6. initial plaque index of at least 1.5 as determined by the use of the quigley and hein plaque index (turesky modification). 7. signed informed consent form exclusion criteria: 1. presence of orthodontic bands. 2. presence of partial removable dentures. 3. tumor(s) of the soft or hard tissues of the oral cavity. 4. advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. five or more carious lesions requiring immediate restorative treatment. 6. antibiotic use any time during the one month prior to entry into the study. 7. participation in any other clinical study or test panel within the one month prior to entry into the study. 8. dental prophylaxis during the past two weeks prior to baseline examinations. 9. history of allergies to oral care/personal care consumer products or their ingredients. 10. on any prescription medicines that might interfere with the study outcome. 11. an existing medical condition which prohibits eating or drinking for periods up to 4 hours. 12. history of alcohol or drug abuse. 13. pregnant or lactating subjects.
validation of the zigzag tracking task test for the evaluation of handwriting difficulties in writer's cramp

Conditions: Dystonic Disorder

Summary: writer's cramp (wc) is a task specific dystonia that occurs from the moment patient starts writing. it leads to partial or complete inability to use the hand only during the handwriting gesture. it is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm. clinical scales currently use for the assessment of wc fail to accurately reflect changes in the characteristics of handwriting in response to treatments (botulinum neurotoxin injections and / or retraining therapy). the zigzag tracking task (zztt), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. this timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. it permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). the investigators propose to validate the zztt for the assessment of the handwriting gesture of wc.


Eligibility criteria:
inclusion criteria: * scholarship in french language, at least until 16 years old * writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders) * prescription of botulinum neurotoxin injection * prescription de novo or absence of injection in the last 3 months * informed consent * medical insurance coverage exclusion criteria: * writing tremor * -other neurological disease with effect on handwriting * pain or traumatism of the upper limb, with effect on handwriting * non-corrected visual disturbances * patient living outside the region where the study will be held (ile-de-france) * participation in another research with a potential impact on evaluation criteria * pregnant or breast feeding patient * patient under judiciary protection
a study to investigate ans014004 in participants with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this is a phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, pk, and preliminary anti-tumor activity of ans014004 as a single agent in participants with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status: 0-1 * life expectancy ≥ 12 weeks * measurable disease per recist v1.1 * adequate organ and marrow function as defined in the protocol * with a pathogenetic met alteration (including met mutation, met amplification, met overexpression, met fusion) exclusion criteria: * active infection including tuberculosis and hbv, hcv or hiv * known active or untreated cns metastases * participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression * participants with serious cardiovascular or cerebrovascular diseases
medication adherence in patients with sarcoidosis

Conditions: Medication Adherence; Sarcoidosis

Summary: the goal of the study is to look at the relationship between how individuals with sarcoidosis take the sarcoidosis medicines and how it affects the disease, to evaluate any factors that may make individuals not want to take the medicines, and to develop and refine ways to help support individuals with sarcoidosis especially when it comes to the medicines. the overall hypothesis is higher medication adherence will be associated with better clinical outcomes in sarcoidosis. the investigators will enroll 150 patients with biopsy proven pulmonary sarcoidosis for at least one year who are on any oral treatment regimen for at least six months into a 12-month longitudinal study.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * physician diagnosis of sarcoidosis. * biopsy proven pulmonary involvement of sarcoidosis. * on oral sarcoidosis medications for at least 6 months. * permanently reside in maryland or d.c. * fully vaccinated against covid-19. exclusion criteria: * non-english speaking. * unable to provide consent. * unable to participate in orally administered questionnaires.

Keywords: sarcoidosis adherence
prospective study of the impact of systemic corticosteroid use on measures of sleep disordered breathing

Conditions: Sleep Apnea

Summary: weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect of long-term systemic steroids therapy. this study aimed to investigate the impact of long-term systemic steroid treatment on sleep apnea.


Eligibility criteria:
inclusion criteria: * for inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required exclusion criteria: * patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded

Keywords: steroids patients treated with systemic steroids
study on amino acid uptake in brain tumors

Conditions: Brain Neoplasms

Summary: the purpose of this study is to determine the uptake of the amino acid o-(2-\[f-18\]fluorethyl)-l-tyrosin (fet) in human brain tumors using positron emission tomography. a comparison to mri and histopathological samples is used.

radioactively labelled amino acids have been used for years to delineate primary brain tumors and for the early detection of tumor recurrence. positron emission tomography studies indicate that the extent of amino acid uptake correlates to the true histological extent of gliomas. recently a fluorine-18 labelled amino acid has been introduced (o-(2-\[f-18\]fluorethyl)-l-tyrosin (fet)), which is suitable for routine use in brain tumor patients. there is evidence that this amino acid is transported into brain and brain tumors by the amino acid transport of the l-type. the cdna of this l-transporter has recently been cloned and has been shown to be identical to the light chain of the 4f2-antigen (cd98), which has previously been described as marker of cell growth and proliferation. the heavy chain of this heterodimer is known to modulate integrins which are thought to play a fundamental role in glioma invasion. besides the evaluation of the diagnostic capability of fet in brain tumors, a comparison of fet uptake in vivo and cd98 expression ex-vivo is performed with tissue slices as available after routine surgery in glioma patients.

Eligibility criteria:
inclusion criteria: * patients with suspected primary brain tumors * ct or mri showing lesion of \>= 2,5 cm * any age; parents informed consent in children available * karnofsky-index \>= 20 % * referral by depts. of neurology, neuro-oncology, neurosurgery, or pediatric neurology at the ukm * biopsy and/or surgery planned * patient is able to lie during the pet scan for 50 minutes without moving • patient must be able to give informed consent; signature must be present before the pet scan exclusion criteria: * pregnancy or breast feeing * patients, who by psychiatric disease are not able to give informed consent * complete renal failure * inclusion to other studies according to § 23 of the german radiation protection law

Keywords: brain neoplasms positron-emission tomography amino acids magnetic resonance imaging
effectiveness of cognitive behavioral therapy (cbt) for child anxiety disorders in community clinics in norway

Conditions: Separation Anxiety Disorder; Social Phobia; Generalized Anxiety Disorder

Summary: the purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. the treatment will be conducted as individual therapy or group therapy.


Eligibility criteria:
inclusion criteria: * primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the adis interview schedule, dsm-iv criteria exclusion criteria: * pervasive developmental disorder * psychotic symptoms * intelligence score \< 70 * use of medications with anxiety reducing effects during treatment * neither parent competent in norwegian language
efficacy of manual therapy in the treatment of somatic tinnitus

Conditions: Tinnitus, Subjective

Summary: somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. the hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. this study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.

somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. it results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. the temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (scm) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus. despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. the hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. this study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.

Eligibility criteria:
inclusion criteria: patients aged ≥ 18 and ≤ 65 years patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus 1. neck pain 2. cervical joint range of motion limitation (especially rotation) 3. modulation of tinnitus in relation to head and neck movements and posture 4. tenderness in the cervico-occipital muscles patients reporting cervical pain between \>2 and \<7 on a visual analogue scale (vas) on most days of the last month patients with stable medical and psychological status patients willing to participate in the study exclusion criteria: objective tinnitus subjective tinnitus with hearing loss meniere's disease history of vertigo middle ear pathologies history of intracranial pathology history of whiplash injury history of cervical spinal surgery history of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia pregnancy patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months
post market registry of the cbso

Conditions: Atrial Septal Defect; Patent Foramen Ovale

Summary: multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (asd) or patent foramen ovale (pfo) in routine clinical use


Eligibility criteria:
inclusion criteria: * patient suffers from asd (including ostium secundum asd or a fenestration from a fontan procedure) or pfo and is planned to receive the cbso. * patient (or legal guardian) has been informed and agreed to and signed the informed consent form. * a cbso is implanted into the patient. exclusion criteria: * patient is known to have one or more of the contraindications listed in the instructions for use. * patient is currently participating in one or more interventional studies, with exception of a study investigating the cbso. * patient is implanted with another product in the atrial septum.