Kornimate/medical-research-clean huggingface dataset:
dynamic internal fixation of femoral neck fractures

Conditions: Femoral Neck Fracture

Summary: evaluation of dynamic plate-screw-systems for internal fixation after femoral neck fractures. open registry for comparison of 1-screw-systems (dhs) with multi-screw-system targon fn.

two implant systems are mainly used for internal fixation: canulated screws and plate-screw-systems. regarding the latter, the dynamic hip screw systems (dhs)represent the most frequently used devices. targon fn (aesculap) is a new plate-screw system and available on the market since 2007. in contrast to the dhs, which uses only one telescrew, the targon fn provides up to four telescrews. with this registry, we want to evaluate the results of targon fn compared with dhs systems.

Eligibility criteria:
inclusion criteria: * men \>= 60 years, women \>= 55 years * femoral neck fractures needing surgical therapy * femoral head preserving indication * living in a 100 km radius from hospital exclusion criteria: * patient not able to walk * previous fracture or surgery on ipsilateral hip * pathological fracture * open fracture

Keywords: femoral neck fracture internal fixation dynamic hip screw
investigating the impact of tamoxifen therapy on ovarian aging

Conditions: Breast Cancer; Fertility

Summary: ovarian toxicity is a well-described side effect of traditional chemotherapy in premenopausal women receiving treatment for early stage breast cancer. however, the impact of long-term endocrine therapy on ovarian function is not established, and to our knowledge, has never been directly studied. understanding the effects of hormone therapy on ovarian aging will help breast cancer patients of reproductive age make more informed and empowered decisions regarding their treatment. the purpose of this study is to explore the relationship between tamoxifen therapy and ovarian aging. patients will be identified through the ucsf cancer registry and california pacific medical center cancer registry and will be evaluated based on age and menopausal status. women who read about the study from clinicaltrials.gov and contact the study coordinator will also be considered for enrollment. the age of menopause onset will be assessed through surveys and will be compared to the accepted national average age of natural menopause. biomarkers of ovarian reserve will be assessed in premenopausal women between ages 25-45 and will be compared to those of healthy age- and ethnicity-matched premenopausal controls from an ongoing ro1- funded prospective longitudinal ovarian aging (ova) study.


Eligibility criteria:
inclusion criteria 1. female 2. ≥25 years of age at the time of study enrollment 3. diagnosed with stage i-iii invasive breast cancer or ductal carcinoma in situ, or determined to be high risk for primary breast cancer 4. if endocrine therapy was used, women must have completed at least 2 years of endocrine therapy as defined by either 1. tamoxifen alone 2. ovarian suppression plus tamoxifen or aromatase inhibitor 3. ovarian suppression alone 5. women must have been premenopausal at the time of endocrine therapy initiation. premenopausal is defined as having had a menstrual cycle within 12 months before starting treatment. 6. for the biomarker assessments, patients must be off all endocrine therapy (tamoxifen, ovarian suppression with goserelin or leuprolide, or aromatase inhibitor) for at least 6 months prior to study enrollment. 7. for the biomarker assessments, patient must be off hormone contraceptives, fertility treatments, or other hormone therapies for at least 3 months prior to study enrollment 8. for the biomarker assessments, patient must have had regular periods the last 3 months. exclusion criteria 1. evidence for either local recurrence following use of adjuvant systemic therapy or evidence for distant recurrence of breast cancer. 2. prior history of ovarian surgery or manipulation 3. mother with premature ovarian failure as defined by onset of menopause at age \<40 4. prior chemotherapy exposure 5. prior history of endometriosis, anovulation or documented infertility 6. pregnant at the time of study enrollment

Keywords: hormone therapy ovarian aging ovarian reserve fertility breast cancer
a study of ro5045337 in combination with doxorubicin in patients with soft tissue sarcoma

Conditions: Sarcoma

Summary: this multicenter, open-label, phase 1b study will evaluate the safety, pharmacokinetics and efficacy of ro5045337 in combination with doxorubicin in patients with soft tissue sarcoma. cohorts of patients will receive escalating doses of ro5045337 orally on days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on day 1 of each cycle for up to 6 cycles.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * histologically or cytologically confirmed soft tissue sarcoma * evaluable disease according to recist version 1.1 criteria * eastern cooperative oncology group (ecog) performance status 0 to 1 * eligible for doxorubicin therapy * acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to nci-ctcae grade \</= 1 prior to start of study * adequate bone marrow, hepatic and renal function * patients with stable cns metastases are eligible exclusion criteria: * previous treatment with limiting doses of doxorubicin * patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment \</= 28 days from day 1 dosing on study treatment * history of seizure disorders or unstable cns metastases * severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study * pregnant or breastfeeding women * hiv positive patients who are currently receiving combination anti-retroviral therapy * patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia * patients receiving oral or parenteral anti-coagulants/anti-platelet agents
a trial of doxycycline in renal disease

Conditions: Chronic Kidney Disease; Cardiorenal Syndrome

Summary: the goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgbid) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.

this is a phase i, placebo-controlled, randomized crossover trial to determine the effects of 4-week treatment with subantimicrobial-dose doxycycline on serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease (egfr\<30ml/min/1.73m2). doxycycline is a matrix metalloproteinase inhibitor and is approved for use as an anti-fibrotic in the setting of gum and skin disease at low doses (20mgbid). at such a dose, serum levels are too low for antimicrobial effect and chronic usage is not thought to lead to tetracycline resistance. investigators hypothesize that doxycycline will ameliorate cardiac and renal fibrosis and thus investigators will detect a decrease in fibrotic markers during treatment with doxycycline.

Eligibility criteria:
inclusion criteria: * ckd pre-dialysis (egfr\< 30 ml/min/1.73m2 not on dialysis); * local 415/650/510 area codes; * primary language english or spanish exclusion criteria: * egfr worsening by greater than 5ml/min/1.73 m2 during the last 6 months; * systolic blood pressure less than 100mmhg or greater than 170 mmhg; * pregnancy; * ejection fraction less than 45%; * nyha class iii or iv hf; * myocardial infarction or hospitalization for hf within 4 months; * liver disease; * moderate or severe chronic obstructive pulmonary disease or pulmonary fibrosis; * current infection; * chemotherapy; * major surgery within last month; * bilateral dialysis access precluding lab draw; * self-reported use of iv drugs or cocaine within the last 6 months.
s.i.f.a. ii: prevention of thromboembolic events in patients with nonrheumatic atrial fibrillation

Conditions: Atrial Fibrillation

Summary: evaluate efficacy and safety of indobufen v. aspirin in preventing thromboembolic events in patients at high risk of cv events such as patients suffering from nonrheumatic atrial fibrillation.


Eligibility criteria:
inclusion criteria: * chronic or paroxysmal non rheumatic atrial fibrillation with cardioembolic risk factors: hypertension, ischemic cardiopathy, congestive heart failure, diabetes mellitus exclusion criteria: * clinically relevant organ disease * creatinine clearance \< 30 ml/min * gastric or duodenal ulcer * severe anaemia or poliglobulia

Keywords: prevention of thromboembolic events in patients with non valvular atrial fibrillation
lifestyle modification and potato consumption

Conditions: Obesity

Summary: the investigators hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. we will evaluate the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and ( the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

our primary objective is to compare the effects of potato consumption to those of commonly consumed carbohydrate sources on glucose tolerance and other cardiometabolic risk factors in overweight and obese, glucose intolerant men and women participating in a lifestyle intervention program. we hypothesize that consumption of potatoes is a healthy adjunct to lifestyle intervention in overweight and obese glucose intolerant adults. our specific aims include: (1) to evaluate of the effects of the consumption of potatoes (high or low resistant starch) vs. commonly consumed carbohydrate sources on glucose tolerance; and (2) to determine the extent to which potato consumption alters markers of lipid metabolism and inflammation in the context of a lifestyle intervention program.

Eligibility criteria:
inclusion criteria: * men and women between 20-65 years of age. * overweight or obese (bmi 25 - 39.9 kg/m2) * impaired glucose tolerance: fasting glucose between 100-125 mg/dl * willingness to comply with the demands of the experimental protocol * sedentary lifestyle exclusion criteria * major medical condition * smokers * unable to perform moderate exercise * use of medications that alter glucose or lipid metabolism * pregnant or lactating

Keywords: resistant starch lifestyle intervention
prospective multicenter nationwide registry of children with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: 1. registry of demographic, clinical, endoscopic and histological data at baseline. 2. registry of patients treated with ppi: * clinical, endoscopic and histological response at 8-12 weeks of induction treatment * clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment 3. registry of patients treated with two foods elimination diet: * clinical, endoscopic and histological response at 8-12 weeks of induction treatment * identification of food trigger: milk, gluten or milk and gluten * clinical, endoscopic and histological response at one year elimination of food trigger * registry of adverse events 4. registry of patients treated with swallowed steroids (budesonide or fluticasone): * clinical, endoscopic and histological response at 8-12 weeks of induction treatment * clinical, endoscopic and histological response at 6 months of maintenance steroid treatment * registry of adverse events


Eligibility criteria:
inclusion criteria: * children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (eoe) according to the recent european guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / cga) * and that they need to start treatment with any of the following options: ppi, diet excluding cow's milk and gluten, or swallowed corticosteroids . exclusion criteria: * presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis) * simultaneous treatment with more than one treatment modality (ppi, empirical elimination diet, swallowed corticosteroids).

Keywords: eosinophilic esophagitis; ppis, children, elimination diet, topical steroids
reducing disparities in medication adherence in sle

Conditions: Systemic Lupus Erythematosus

Summary: this is a pilot study to assess the feasibility of using surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus


Eligibility criteria:
inclusion criteria - all followup patients seen at the duke lupus clinic exclusion criteria * patients not seen at the duke lupus clinic * new patients seen for the first time at the duke lupus clinic * patients who are not prescribed any lupus medications

Keywords: medication adherence
safety and efficacy of endotracheal intubation using glidescope video-laryngoscope

Conditions: Respiratory Failure

Summary: the safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. this study will answer whether using a vl will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.


Eligibility criteria:
inclusion criteria: * all patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician exclusion criteria: * difficult airway * oxygen saturation \< 92% despite adequate mask ventilation

Keywords: urgent endotrachel intubation direct laryngoscopy video laryngoscopy glidescope critical care
a study of the safety and efficacy of pegylated inferferon alfa-2b (peg-intron™) versus pegylated interferon alfa-2a (pegasys™) in participants with chronic hepatitis b (p08450)

Conditions: Hepatitis B, Chronic

Summary: this study is being done to compare the safety and efficacy of peg-intron™ to that of pegasys™ in participants with chronic hepatitis b (hepatitis b envelope antigen \[hbeag\] positive or negative) who have not previously been treated with interferon.


Eligibility criteria:
inclusion criteria: * must be able to adhere to dose and visit schedules * ≥ 40 kg * hepatitis b surface antigen (hbsag) positive for at least 6 months * anti-hbs negative * female participants of childbearing potential must agree to use an acceptable method of contraception from at least 2 weeks prior to day 1 and continue until at least 1 month after last dose of study drug inclusion criteria for hbeag(+) participants: * hbeag(+) * anti-hbe(-) inclusion criteria for hbeag(-) participants: * hbeag(-) * anti-hbe(+) exclusion criteria: * co-infection with the human immunodeficiency virus (hiv) or hepatitis c or hepatitis d virus * prior treatment with interferon for hepatitis b * use of nucleoside/nucleotide analogues within 6 months of the screening visit or at any time during the study * use of any investigational drug within 30 days of the screening visit * prior treatment with herbal remedies with known hepatotoxicity. all herbal remedies used for hepatitis b treatment must be discontinued before day 1 * evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy * diabetic and/or hypertensive with clinically significant ocular examination findings * history of stroke or transient ischemic attack * immunologically mediated disease (e.g., inflammatory bowel disease \[crohn's disease, ulcerative colitis\], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder) * chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis) * current or history of any clinically significant cardiac abnormalities/dysfunction * any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial * myelodysplastic syndromes * organ transplants (including hematopoietic stem cell transplants) other than cornea and hair * pregnant or nursing, or intending to become pregnant during the trial period
follow-up-study of copd patients and healthy controls for evaluation of predictive non-coding rna biomarkers

Conditions: Chronic Obstructive Pulmonary Disease

Summary: between 2012 and 2014, a cohort of 90 copd subjects of disease severity grades gold i-iv as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. this observation study will follow-up/re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncrna/ transcriptome biomarkers for their potential to indicate disease progression. in addition, biobanking of respective biosamples for potential future copd biomarker research will be conducted.


Eligibility criteria:
inclusion criteria: * participants in study "11-03 ribolution" * able and willing to give written informed consent * not pregnant, as confirmed by pregnancy test exclusion criteria: * past or present disease occurred since participation in "11-03 ribolution", which as judged by the investigator, may affect the outcome of the study. * serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety * has experienced a significant upper or lower respiratory tract infection incl. moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. all courses of oral corticosteroids and antibiotics must be completed at least 4 weeks before study start * clinically significant pathological findings in safety laboratory tests having an impact on study participation. * actual drug or alcohol abuse. * suspected inability to understand and follow protocol requirements, instructions, study-related restrictions, and to understand nature, scope, and possible consequences of the study. * being a vulnerable subject (dependent, in detention, or without mental capacity)
therapeutic effectiveness of different machines in intense pulsed light treatment of meibomian gland dysfunction

Conditions: MGD-Meibomian Gland Dysfunction

Summary: this study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (ipl) treatment of meibomian gland dysfunction (mgd). subjects diagnosed with mgd underwent three sessions of ipl treatment in a control (m22) treatment group or experimental (opl-i) treatment group and were followed up three to four weeks after each session. tear breakup time (tbut), meibomian gland secretion scores (mgss), meibomian gland meibum scores (mgms), corneal fluorescein staining (cfs) scores, and the standard patient evaluation of eye dryness (speed) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.


Eligibility criteria:
inclusion criteria: 1. fitzpatrick skin type i-iv according to sun sensitivity and skin appearance 2. a standard patient evaluation of eye dryness (speed) score of ≥6 3. tear breakup time (tbut) of ≤10 s in the studied eye 4. corneal fluorescein staining (cfs) score of ≥1 (it is not necessary to consider this criterion if the tbut is ≤5 s) 5. meibomian gland secretion score (mgss) of ≥6 in the studied eye. exclusion criteria: 1. use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment 2. facial ipl treatment within the prior 12 months 3. any surgery of the eye or eyelids within the prior six months 4. ocular surface and eyelid abnormalities 5. any systemic condition that might cause eye dryness 6. use of photosensitive drugs within the prior three months 7. precancerous lesions 8. skin cancer or pigmented lesions in the treatment area 9. overexposure to the sun within the previous month 10. ocular infections within the previous six months 11. uncontrolled infections or immunosuppressive diseases

Keywords: mgd ipl non-inferiority analysis
treatment of failing blebs with ranibizumab

Conditions: Glaucoma, Open-Angle; Failing Bleb Following Trabeculectomy

Summary: this study was designed to evaluate the efficacy and safety in the use of ranibizumab, an effective vascular endothelial growth factor (vgef) inhibitor, in treating patients with a failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva, following trabeculectomy. six subjects from one site will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 40 years * patients with open-angle glaucoma who have had trabeculectomy * patients determined to have failing bleb with presence of superficial bleb vascularity and iop increase on 3 successive visits without topical medication * patients whose intraocular pressure (iop) is above goal iop after suture lysis and digital compression have been attempted exclusion criteria: * pregnancy (positive pregnancy test) or lactation. * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch. * current infection or inflammation in either eye * any abnormality preventing reliable applanation tonometry in either eye * other non-glaucomatous disease affecting visual field, (pituitary lesions, demyelinating disease, congenital optic nerve anomaly, prior retinal and optic nerve vascular occlusive disease, retinal dystrophy and degeneration, diabetes and hiv and aids infection) * strabismus, nystagmus, monocular patient * prior enrollment in the study * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial