Kornimate/medical-research-clean huggingface dataset:
early diagnosis of pulmonary fibrosis - diagnostic delay

Conditions: Idiopathic Pulmonary Fibrosis

Summary: patients with newly diagnosed ipf are investigated for the diagnostic delay before a diagnosis of ipf is made.

pulmonary fibrosis can be secondary to connective-tissue disease, environmental exposure, or drug toxicity, but it can also appear sporadically without any known cause, i.e. idiopathic interstitial pneumonitis (iip). idiopathic pulmonary fibrosis (ipf) is the commonest iip and usually follows a rapidly progressive course with a short median survival time. ipf is often diagnosed after a long diagnostic delay, which also affects the prognosis. as new anti-fibrotic treatments have been approved, and awareness of ipf is rising, the diagnostic delay and its implications can be expected to be changing. also, the new diagnostic guidelines of 2011 could change the diagnostic delay. in order to reduce the diagnostic delay, it is important to investigate the health care utilization and decisions made by healthcare professionals in the period before the final diagnosis is made. this study will prospectively include all patients at the two centres in denmark where patients are treated for ipf and has thus a good opportunity to include the majority of incident cases of ipf in denmark. patients are included immediately after the diagnosis which reduces recall bias. the database will include both patient reported data and objective data from national registries and patient records. a main focus is the distribution of the diagnostic delay between patient and different health care providers, and the health care utilization by the patients before a diagnosis of ipf is made. risk factors for a delayed diagnosis are investigated. the importance of the diagnostic delay for the prognosis and the course of the disease will also be investigated. the database created in this study will also be used for future research in ipf.

Eligibility criteria:
inclusion criteria: * diagnosis of ipf according to international guidelines exclusion criteria: * unable to provide written informed consent * age below 18 years

Keywords: diagnosis
an outpatient study investigating non-prescription treatments for covid-19

Conditions: COVID-19

Summary: this is a platform study to investigate the effectiveness of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently tested positive for covid-19.

this study will screen for the activity of a variety of non-prescription approaches for the treatment of non-hospitalized adults recently diagnosed with covid-19. this will be a randomized, blinded placebo-controlled study with respect to the active treatment (chlorine dioxide) vs placebo, and randomized open-label with respect to a non-prescription medication (famotidine) and supplements including zinc, egcg and lactoferrin. treatment will last for 7 days.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 20-70 4. confirmed diagnosis of covid-19 by positive covid-19 test. symptoms of a mild degree such that hospitalization is not required. within 7 days of symptom onset. 5. ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen exclusion criteria: 1. covid-19 symptoms of a severe enough nature that requires hospitalization 2. pregnancy or lactation 3. diagnosis of diabetes mellitus 4. currently taking paroxetine or digoxin 5. individuals with diabetes mellitus
test: registry for endoscopic head and neck surgery

Conditions: Head and Neck Cancer

Summary: the goal of this data review research study is to create a registry database using information (data) collected from patients who have had endoscopic head and neck surgery (ehns). researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have ehns. 1.1 primary objective: to develop a registry database of patients who have had ehns. 1.2 secondary objective: to evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing ehns performed at m.d. anderson cancer center (mdacc). 1.3 tertiary objective: to collect data on long-term oncologic outcomes including local and distant failure and survival following ehns.

information from medical records will be collected and entered into the registry database at m. d. anderson cancer center for future research related to cancer. the information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed. this is a registry study evaluating endoscopic head and neck surgery. the data from the surgical resection will be descriptive. comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who, in the opinion of the treating mdacc physician, are candidates for ehns will be included 2. medically fit for an endoscopic surgical resection by consensus of mdacc surgical oncology and anesthesia faculty (common best practice criteria). 3. date of records anticipated to be reviewed would be from march 1, 2011 to june 30, 2013 4. approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review. exclusion criteria: none.

Keywords: registry database ehns endoscopic head and neck surgery transoral endoscopic surgery trial test melanoma head and neck surgery
plerixafor in treating patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant

Conditions: Multiple Myeloma; Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Summary: rationale: giving colony-stimulating factors, such as g-csf and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. purpose: this phase ii trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.

primary objective: i. to determine the proportion of patients reaching a stem cell yield of 3 million cd34 cells/kg by second day of apheresis with intravenously administered amd3100 among patients receiving primary therapy for myeloma with lenalidomide. secondary objectives: i. safety and tolerability of intravenously administered amd3100. ii. rate of failure to mobilize. outline: patients receive plerixafor iv on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed at 30 days.

Eligibility criteria:
inclusion - absolute neutrophil count \>= 1000/ul - platelet \>= 75000/ul - hemoglobin \>= 8.0 g/dl - serum aspartate aminotransferase (ast)/serum glutamic oxaloacetic transaminase (sgot), serum alanine aminotransferase (alt)/serum glutamic pyruvic transaminase (sgpt) and total bilirubin \ 2 weeks prior to registration - eligible to undergo autologous transplantation - ecog performance status (ps) 0 or 1 - willingness to return for follow-up - provide informed written consent - adequate cardiopulmonary function: ejection fraction \>= 45%, corrected pulmonary diffusion capacity of \>= 50%, fev1 \>= 50%, fvc \>= 50% - negative serum or urine pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only exclusion - a co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications - active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer - other co-morbidity which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated heart or lung disease - other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational - use of cyclophosphamide as part of stem cell mobilization - use of more than one regimen for treatment of symptomatic myeloma - dialysis dependent renal failure - pregnant women or women of reproductive ability who are unwilling to use effective contraception - nursing women - men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment - acute infection, active hiv infection
proof of mechanism study to determine efficacy of pf-04455242 in blocking spiradoline (pf-00345768) stimulated prolactin release

Conditions: Bipolar Depression

Summary: this study will be a proof of mechanism (pom) study to establish evidence of central pharmacodynamic activity for pf 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male subjects. once subjects achieve steady state of pf 04455242, they will undergo pf 00345768 (spiradoline) challenge. data will be analyzed to determine whether pf-04455242 blocks spiradoline induced prolactin release.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 21 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Keywords: proof of mechanism study
the cost effectiveness and evaluation of disease management of chronic kidney disease and high risk population

Conditions: Chronic Kidney Diseases; Chronic Kidney Insufficiency

Summary: this study is being implemented for 3 aims. the first has been to conduct a systematic literatures review on ckd intervention models and their effectiveness. findings have been adopted in our intervention program. the second purpose is to establish a practical management model or an intervention model for ckd patients and high risk population with the 18-month of follow-up.in the third year, we will use social perspective point to evaluate the costs and the benefits of intervention.

the object of the study is by screening for adults (20 years) with chronic kidney disease (ckd stage 1-3a) and high-risk groups. they were randomly assigned into experimental groups (self management and peer-assisted management) and control group (general management). all participants received a general education with the knowledge on care for early chronic kidney disease recently establishes by the national health insurance system. we then used the cross-theoretical model to assess the intervention among the three groups. we collected information on baseline and follow-up data on biochemical and physiological check-ups, health promotion behavior, dietary intake status, self-efficacy and cost etc. information on behavior changes, including smoking, chewing betel nut, medication, exercise and diet, was also collected and assessed. participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with digital video disc (dvd) courses. we negotiated their behavior change set goals for them etc. the peer-assisted management group received similar program for 3 months, the peer oriented group activities followed, including group discussions to share experience and sports map etc. the effectiveness assessments have been set for the baseline, 3rd, 6th, 12th and 18th months. with one year of intervention period, the 3 groups will be assessed at the 18th months of follow-up next year. in the third year, we will use social perspective point to evaluate the costs and benefits of intervention. we suppose that a 100,000 people to screen out cases of chronic kidney disease (ckd stage 1-3a) and high-risk groups, and we will compare the cost-effectiveness analysis between the experimental group with accept the intervention for 12 months to the control groups without receiving extra intervention.

Eligibility criteria:
inclusion criteria: * age greater than 20 with chronic kidney disease (ckd) stage 1-3a patients and high-risk groups. exclusion criteria: * inability to communicate in chinese. * lack of capacity to write in chinese. * ongoing treatment in dialysis. * suffering from major diseases. * treatment in cancer or suffering from cancer less than two years. * have received organ transplants or bone marrow transplantation.

Keywords: chronic kidney disease high risk intervention hypertension hyperglycemia hyperlipidemia
inter-rater reliability of the reflux finding score among gastroenterologists

Conditions: Laryngitis; Reflux

Summary: title: inter-rater reliability of the reflux finding score based on endoscopic laryngeal findings in the diagnosis of laryngopharyngeal reflux disease participants: voluntary participants after invitation among members (a total of about 40 gastroenterologists) of gangwon branch of korean society of gastrointestinal endoscopy and an otorhinolaryngologist primary endpoint: interrater reliability (kappa coefficient) on the sum of reflux finding score more than 7 points between an otorhinolaryngologist and gastroenterologists (7 points means the cut-off value for the diagnosis of laryngopharyngeal reflux disease) secondary endpoint: agreement (%) on 8 items of reflux finding score for laryngopharygeal reflux among gastroenterologists

study design 1. recruitment of doctor participants: introduction by e-mail 2. education on reflux finding score - standardized materials (instructional video) 3. pretest (15 pictures) / feedback (at-a-glance assessment format) 4. test 1 (50 pictures) - acess format including 8 items at each pictures 5. feedback education (individualized intruction of an otorhinolaryngologist) 6. test 2 (50 pictures) - acess format including 8 items at each pictures 7. test-retest reliability - repeat test 2 with 1 week interval (participants should take retest of test 2 with the concealment of the answer) 8. analysis

Eligibility criteria:
inclusion criteria: * participants: gastroenterologists (gi specialists) or trainees / * pictures: endoscopic laryngeal pictures with good quality exclusion criteria: * participants: major other than gastroenterology / * pictures: endoscopic laryngeal pictures without good quality

Keywords: reflux finding score, interrater reliability
assessing csf flow dynamics in pediatric hemorrhagic hydrocephalus

Conditions: Post-hemorrhagic Hydrocephalus (PHH)

Summary: the purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (icg) in order to assess cerebrospinal fluid (csf) ventricular dynamics and extracranial csf outflow using fluorescent cap-based transcranial optical tomography (fctot) and near-infrared fluorescent (nirf) imaging and to evaluate inflammation markers of the csf and to correlate with csf ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.


Eligibility criteria:
inclusion criteria: * children born premature currently in the nicu with a diagnosis of phh who have undergone ventricular reservoir placement. * for the first four study subjects, we will attempt for the child to undergo ct cisternography when clinically stable 3-4 weeks after reservoir placement. exclusion criteria: * parents who do not consent for procedure on their child * children who are deemed clinically unstable or unsuitable for imaging by clinical staff as defined by the subject's level of intensive care (e.g. can the subject be repositioned without compromise to the level of care needed or condition) * children known or suspected to have allergy to iodine or icg * children who do not have a subcutaneous reservoir for csf diversion from the lateral ventricle

Keywords: cerebrospinal fluid (csf) premature infants indocyanine green (icg)
effects of the v1a agonist fe 202158 in patients with septic shock

Conditions: Septic Shock

Summary: the purpose of this trial was to examine the safety and tolerability, pharmacokinetics of fe 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. fe 202158 had previously been tested in healthy volunteers.

this was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of fe 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up to 7 days. the trial comprised of three treatment arms where fe 202158 was administered in 1.25 ng, 2.5 ng and 3.75 ng dose, respectively. a placebo arm was also included in the trial where patients received isotonic saline. efficacy of fe 202158 was determined by evaluating its ability to maintain mean arterial pressure (map) \>60 mmhg and its modulating effect on inflammatory markers. effects of fe 202158 on other variables like vital signs, morbidity, mortality and pulmonary function were also determined.

Eligibility criteria:
inclusion criteria: * signed informed consent form by the patient or a legal representative according to local regulations * man or woman 18 years of age or older * proven or suspected infection * low blood pressure * signs of decreased circulation in the tissues * willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication. exclusion criteria: * present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). patients who have been asymptomatic for 6 months after coronary revascularisation are eligible. * hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test. * known or suspected cardiac failure * pregnancy or breastfeeding * any cause of hypotension other than early septic shock * use of vasopressin or terlipressin for blood pressure support during the current hospital admission * proven or suspected acute mesenteric ischemia, as judged by the investigator * known episode of septic shock within 1 month prior to randomisation * underlying chronic heart disease * traumatic brain injury * present hospitalisation with burn injury * symptomatic peripheral vascular disease including raynaud's syndrome * previously randomized in this trial * intake of an investigational drug within the last 3 months (or longer if judged by the investigator to possibly influence the outcome of the current study) * known participation in another clinical trial * considered by the investigator to be unsuitable to participate in the trial for any other reason

Keywords: v1a agonist
haemochromatosis and periodontitis

Conditions: to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic

Summary: periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. it is strongly associated with the major pathogenic "red complex", including porphyromonas gingivalis, tannerella forsythia and treponema denticola1 and thus is considered an infection. recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.


Eligibility criteria:
inclusion criteria: * patients aged 35 to 64 years with homozygosity hemochromatosis c282y * patients regularly enrolled in a health insurance plan * patients with at least 10 natural teeth * patients who have given informed written, dated and signed consent exclusion criteria: * diabetic patients * simultaneous participation in another study * pregnant or lactating women * the incapacitated persons and persons deprived of their liberty * patients who do not speak french, both written and spoken * patients previously included in this trial * patients with heart valves or endovascular equipment (risk of infective endocarditis ...) * patients with a history of maxillofacial surgery * patients whose oral status is considered incompatible with entry into the study, at the discretion of the investigator * patients on drugs that can cause gingival hypertrophy, such as hydantoins (phenytoin), dihydropyridines, diltiazem or ciclosporin * patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin).
the effectiveness of pasteurized goat milk in the treatment of childhood oral ulcer diseases

Conditions: Oral Ulcer

Summary: children with acute diseases with oral ulcers (not included presentations of sle, ibd or immunocomprmized states)will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. children will than be followed for length of the disease - signs and symptoms.

a prospective randomized controlled study that will include 110 previously health 6months - 5 years children (55 in each group) with acute oral ulcer disease (\< 48 hours). children will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. children will than be followed for length of the disease - sings and symptoms by questioner to parents, and physical examination by there physicians. .

Eligibility criteria:
inclusion criteria: * age \> 6 months or \< 5 years. * acute (\< 48 hours) oral ulcer disease. * \> 5 ulcers. * cooperative parents . * signing inform consent. exclusion criteria: * all types of immunosuppression, ibd, sle, recurrent oral ulcer, disease \> 48 hours, age , 6 \ 5 years.

Keywords: children
a study of avastin (bevacizumab) in combination with chemotherapy in patients with primary breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the effect of avastin (15mg/kg iv) in combination with docetaxel and xeloda, given as pre-operative therapy to patients with primary breast cancer. avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * female patients, 18-70years of age; * histologically-proven invasive breast cancer; * no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix; * no distant disease/secondary cancer. exclusion criteria: * pregnant or lactating women; * pre-operative local treatment for breast cancer; * prior or concurrent systemic antitumor therapy; * clinically significant cardiac disease.