Kornimate/medical-research-clean huggingface dataset:
prospective study evaluating the medullary thyroid cancer management's care using pet f-dopa in patients with a high level of postoperative residual thyrocalcitonin

Conditions: Medullary Thyroid Cancer

Summary: the aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease. this is an inter-regional multicentric, prospective study evaluating the benefit of pet f-dopa imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer. the purpose of the study is to evaluate the impact and performance of a new pet / ct (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging. obtained data will be compared to the "gold standard" based on : * nodes cytology when they could be punctured * histology when a new surgery will be recommended * surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)


Eligibility criteria:
inclusion criteria: 1. age \> or = 18 years. 2. patient with medullary thyroid cancer (sporadic or hereditary form). 3. patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment). 4. patient with elevated thyrocalcitonin rate \> or = 150 pg/ml assessed within 6 weeks or more after surgery. 5. patient with standard imaging assessment performed during 3 months before pet 18-fdopa. 6. standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic ct-scan and/or a cervico-thoraco-abdomino-pelvic ct-scan and a liver mri. 7. patient able to be followed at least 6 months after pet 18-fdopa. 8. if women are breastfeeding, nursing should be discontinued during 24 hours after pet 18-fdopa. 9. patient must provide written informed consent prior to any specific procedure or assessment. 10. patient must be affiliated to the french social security system. exclusion criteria: 1. pregnant patient. 2. post-operative radiotherapy initiated before pet 18-fdopa. 3. patient with pet 18-fdg performed within 24 hours before pet 18-fdopa. 4. participation in any other clinical trial for therapeutic use. 5. patient with pet / ct-scan exam contra-indication. 6. any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures. 7. patient protected by law.

Keywords: medullary thyroid cancer pet f-dopa 18-fdopa
correlation among sperm dna fragmentation, genitourinary infection by mycoplasma in male and the pregnancy outcomes after iui in their partner

Conditions: Mycoplasma

Summary: genital ureaplasmas (ureaplasma urealyticum and ureaplasma parvum) and genital mycoplasmas (mycoplasma hominis and mycoplasma genitalium) are natural inhabitants of the male urethra contaminating the semen during ejaculation. however, these microorganisms, especially ureaplasma urealyticum (uu) and mycoplasma hominis (mh), are potentially pathogenic species playing an etiologic role in both genital infections and male infertility. despite there are many consentaneous opinions about its relationship with infertility, its correlation with sperm regular parameters is still controversially. sperm dna damage can negatively influence fertilization rate, embryo cleavage rate, implantation rate, pregnancy and live birth rate, and is a novel indicator for intrauterine insemination (iui) pregnancy rate and ivf or icsi pregnancy loss rate. until now, there were fewer clinical researches about the relationship among uu and/or mh infection, sperm dna damage, and the iui pregnancy rate. thus, the investigators conduct this prospective study to investigate the relationship among them.


Eligibility criteria:
inclusion criteria: * male with primary sterility with or without mycoplasma infection exclusion criteria: 1. combination with chlamydial infection 2. history of using hormone or cytotoxic drugs. 3. having some other surgical diseases, such as genital tract infection or varicocele 4. having some congenital diseases, such as klinefelter and y chromosome deficiency 5. having some endocrine diseases, such as kallmann, abnormality in pituitary gland, hyperthyroidism, hypercorticoidism, and so on 6. patients' spouse had some diseases that could not carry out spontaneous pregnancy, such as tubal obstruction or ovulatory failure.
multi-center clinical trial of limiting resident work hours on icu patient safety

Conditions: Physician Fatigue

Summary: in this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between pgy2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. through the clinical and translational science award (ctsa)-funded sleep research network, the largest and only federally-funded sleep science network in the u.s., we propose conducting a multi-center randomized crossover trial in six pediatric icus staffed by pgy2 and pgy3 residents. we will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (scs) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. our specific aims will be: 1. to test the hypothesis that pgy2\&3 residents working on an scs intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for icu patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses) 2. to test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the icu (i.e., those involving and those not involving residents) will be lower in icus when pgy2\&3 residents work on an scs intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: icu-wide preventable adverse events and near misses) 3. to test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks \[johns drowsiness score (jds) and psychomotor vigilance task (pvt) lapses\] - will be lower on the scs intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)


Eligibility criteria:
inclusion criteria: * must be a second or third year resident of pediatrics or a combined pediatrics program exclusion criteria: -

Keywords: resident fatigue sleep deprivation medical errors
screening evaluation for studies of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this research is being done to study mechanisms of progression of copd and to develop treatments for it. the investigators are doing the present study to identify people age 40 and older with mild to moderate copd who will qualify for such studies to include in a database. the study will include establishing a screening evaluation or characterization of the following two studies: * emphysema progression in copd- losartan's effects on airway parameters - na_00009980 * sleep-related physiology and inflammation in chronic obstructive pulmonary disease - na_00001771

this is a program to recruit and screen participants for clinical trials or more detailed observational studies of copd. there are no interventions or comparative results to be published from this study.

Eligibility criteria:
inclusion criteria: * age 40 years and older, either sex * mild to moderate copd (fev1/forced vital capacity (fvc) ratio ≤ 0.70, fev1 30-70% predicted, diffusing capacity of the lungs for carbon monoxide (dlco) ≥35% predicted) * on stable maintenance therapy for 2 months * current or former smoker (patient report of at least a 10 pack-year history) * ability to understand and willingness to sign consent documents exclusion criteria: * copd exacerbation requiring treatment within past 6 weeks * untreated arterial hypertension (systolic blood pressure \> 140 mm hg, diastolic blood pressure \> 90 mm hg) * decompensated heart failure * myocardial infarction within past 3 months or ever * evidence of interstitial, occupational or chronic infectious lung disease * renal dysfunction * supplemental oxygen \> 2 liters/m at rest * failure to keep screening appointments

Keywords: chronic obstructive pulmonary disease (copd)
high vitamin k intake diet intervention effect on cardiovascular risk percentage in young adults

Conditions: Overweight and Obesity

Summary: the goal of this clinical trial is to compare the effect of a high vitamin k diet intervention on vitamin k, insulin, osteocalcin serum levels and the cardiovascular risk percentage in normal weight and overweight or obese young adults. the main questions it aims to answer are: • does a diet intervention containing 500mcg of vitamin k increases serum vitamin k levels? • are vitamin k serum levels after the 500mcg of vitamin k diet intervention associated with insulin and osteocalcin serum levels or the cardiovascular risk percentage in normal weight and overweight or obese young adults? participants will have to follow a diet intervention that contains 500mcg of vitamin k, given as a cyclic menu for 6 weeks. also, participants will have to assist weekly to nutritional monitoring and to report any situation they observed regarding the intervention during this study. researchers will compare normal weight and overweight or obese groups with diet intervention with normal weight and overweight or obese groups without diet intervention and only dietetic recommendations to see if vitamin k serum levels, insulin, osteocalcin and the cardiovascular risk percentage improve after the 6 weeks diet intervention.


Eligibility criteria:
inclusion criteria: * young adults * acceptation for participate * acceptation to asist to monitoring sessions * sign information consent exclusion criteria: * under other dietetic intervention * under medications that interfere with vitamin k or diminish its absorbtion * vitamin e or a intake supplements * previous diagnose of metabolic syndrome, diabetes mellitus, hypertension, cancer or dyslipidemia. * chronic alcohol intake * some medical or health situation that impedes the following of the program

Keywords: vitamin k diet intervention cardiovascular disease overweight and obesity young adults
microbial diversity of pancreatic diseases

Conditions: Pancreatic Cancer; Pancreatic Disease

Summary: this study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer. the investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. finally，the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

first, all the participants provided written informed consent for participating in the study. and the collecting procedures have no intervention or impact on treatment measures. second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. if the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected. third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers. finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

Eligibility criteria:
inclusion criteria: * age ≥ 3 years old, ≤ 85 years old; * after mdt discussion, routine surgery or ercp can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases; * there is no serious damage to heart, liver and kidney function; exclusion criteria: * women who are breast-feeding during pregnancy and after pregnancy; * patients with evidence of sensory or motor neuropathy; * those who have a clear cardiovascular disease, severe associated disease or active infection, including known hiv infection; * those who have a history of other cancers; * those who are allergic to drugs or their excipients

Keywords: pancreatic cancer pancreatic disease
an approved drug to study a new indication for allergic rhinitis (0476-327)

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.


Eligibility criteria:
inclusion criteria: * japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress) exclusion criteria: * patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period
safety and pharmacokinetic study of alo-02 in children ages 7-17 with pain

Conditions: Moderate-severe Pain

Summary: safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

this is a multicenter, open-label, single-arm study designed to characterize the pk and to evaluate the safety of alo-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain. the study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks. the study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the pk endpoint. a safety follow-up visit is required at 1 week post-last dose.

Eligibility criteria:
inclusion criteria: * children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic. * be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \> 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing. exclusion criteria: * columbia-suicide severity rating scale (c-ssrs) for suicidal ideation and behavior in past year. * hypersensitivity to morphine, naltrexone. * a life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally. * undergone surgery within 3 days prior to the first day of dosing.

Keywords: pediatric pain indication controlled release oxycodone
tac-pf, avastin® in combination with photodynamic therapy to treat age related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: vertacl will investigate whether a triple therapy, avastin®, half fluence verteporfin photodynamic therapy (pdt), and triamcinolone acetonide-preservative free (tac- pf), results in improved 12-month vision outcome compared to avastin® alone in participants with neovascular amd.

the vertacl study is a multi-center, randomized, phase ii trial to investigate whether a triple therapy, avastin®, half fluence verteporfin pdt, and tac- pf, results in improved 12-month vision outcome compared to avastin® alone in participants with neovascular amd. participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (avastin®), or triple therapy (avastin®, half fluence verteporfin pdt, and tac- pf). participants in the avastin® alone arm will receive 1.25 mg intravitreal avastin®, at every study visit. participants in the triple-therapy arm will receive all treatments (avastin®, half fluence verteporfin pdt, and tac- pf) at baseline. following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (prn) basis if protocol-specific re-treatment criteria are met. after randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment. participants will return to the clinic at month 24 for a final study assessment. study assessments include: visual acuity, optical coherence tomography, and fundus photography.

Eligibility criteria:
inclusion criteria includes: * drusen \> 63 mm * choroidal neovascularization under the fovea (predominantly classic, minimally classic, and occult lesions acceptable) * greatest linear dimension (gld) of entire lesion \< 5400 µm (no reading center confirmation required) * etdrs best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score) * total area of lesion must \< 9 mps da * 0-3 intravitreal injections of anti-vegf monotherapy within 6 months of randomization with continuing evidence of exudative activity confirmed by fa or oct within 4-8 weeks after the last injection exclusion criteria includes: * oral steroid use within 6 months * prior complications from steroid therapy * prior stroke, myocardial infarction, or end-stage malignancy study eye exclusion criteria * geographic atrophy or fibrosis under the fovea * fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion * prior treatment with verteporfin within 12 months * iop is \>25 mmhg and the participant is on cosopt * intraocular surgery within 6 weeks * prior vitrectomy * peribulbar steroid injection within 6 months * poor reactions to topical or periocular steroid treatment including elevated iop

Keywords: amd wet amd verteporfin pdt avastin tac-pf
interval versus continuous training in heart failure

Conditions: Heart Failure

Summary: background: the physiopathology of the heart failure involves compensatory mechanisms as exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle disability and exercise intolerance. the interval exercise training has been proposed as one efficient method to heart failure patients. it seems that the main mechanism involved in the benefit of the interval exercise training is "shear stress". aim: to study the interval exercise training versus the continuous exercise training in the sympathetic activity and in the peripheral muscle perfusion in heart failure patients. moreover, we will evaluate the muscle apoptosis, microrna in plasma and muscle biopsy, biomarkers levels of inflammation, quality of life and exercise capacity. metodology: will be selected 40 patients (male and female) with age between 30 and 60 years, left ventricular ejection fraction less than 40% and functional class i, ii and iii. these patients will be randomized into three groups: interval (ait), continuous (mct) and control (cg). all patients will be evaluated with microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer, cardiopulmonary exercise test and quality of life before and after end of the period of 03 (three) months.


Eligibility criteria:
inclusion criteria: * stable chronic heart failure without changing in treatment for at least 6 weeks * ejection fraction less then 40%, as measured by transthoracic echocardiography * optimal clinical treatment for chronic heart failure according to current guidelines. exclusion criteria: * asthma or chronic obstructive pulmonary disease using inhaled corticosteroids * functional class iv (new york heart association - nyha) * atrial fibrillation * complex ventricular arrhythmia * pacemaker or implantable cardioversor/defibrillators * chronic renal insufficiency, defined as serum creatinine above 2,5 mg/dl * intermittent claudication * morbid obesity * cirrhosis * alcoholism * using illicit drugs * performing regular physical activity * participating in another study * invasive procedure planned * persistent nonadherence to therapeutic regimen * peak respiratory exchange ratio (rer) lower than 1.00

Keywords: heart failure exercise biomarkers sympathetic nervous system microrna
safety and efficacy study of altabax ointment in the treatment of secondarily infected atopic dermatitis

Conditions: Atopic Dermatitis; Secondary Infection

Summary: skin infections may complicate the treatment of atopic dermatitis.the use of topical ointments has become very important to avoid the use of oral antibiotics. there is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis. this study will investigate the safety and effectiveness of altabax ointment use in treating secondarily infected atopic dermatitis caused by staphylococcus aureus and streptococcus pyogenes.

atopic dermatitis patients are commonly secondarily infected with staphylococcus aureus and/or streptococcus pyogenes, more recently with methicillin-resistant staphylococcus aureus (mrsa), due to impaired barrier function. as cutaneous infections such as mrsa and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population. the current study will investigate the safety and efficacy of altabax ointment use for treatment of secondarily infected lesions caused by staphylococcus aureus and streptococcus pyogenes in both the pediatric and adult populations.

Eligibility criteria:
inclusion criteria: * female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice a reliable method of contraception. * secondary infection of atopic dermatitis with s.aureus or s.pyogenes as the probable causative agent. * an infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age. * skin infection rating scale score greater than or equal to 8. * able to understand and comply with the requirements of the study and sign informed consent/health insurance portability and accountability authorization forms. subjects under the legal age of consent must also have the written informed consent of parent or legal guardian. exclusion criteria: * female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control. * allergic to any component of the test medication. * clinical diagnosis of impetigo, folliculitis or minor soft tissue infection. * use of topical antibacterial medication to the study treatment area within 1 day of visit 1. * signs of systemic infection or evidence of abcess or cellulitis at the site to be treated. * medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study. * recent alcohol or drug abuse is evident. * history of poor cooperation, non-compliance with medical treatment or unreliability. * participation in an investigational drug study within 30 days of baseline visit.