Kornimate/medical-research-clean huggingface dataset:
meal timing study: effect of time-restricted feeding on 24-hour glycemic control, blood pressure, and cardiovascular disease risk factors in adults with prediabetes

Conditions: PreDiabetes

Summary: one in three american adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. with the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. one new strategy may be to change when people eat. studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; tre) improves blood sugar control and cardiovascular health. preliminary studies suggest that tre also improves blood sugar, weight loss, and cardiovascular health in humans. this study will be the first full-scale, controlled feeding trial to determine whether tre can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. this clinical trial will also determine whether the benefits of tre depend on the time of day that people eat. participants will be assigned to one of three groups: (1) 'early tre' (eat between \~8 am-3 pm), (2) 'mid-day tre' (eat between \~1 pm - 8 pm), or (3) control schedule (\~8 am - 8 pm) for 8 weeks. all food will be provided and matched between groups.


Eligibility criteria:
inclusion criteria: * aged 30-70 years old * prediabetic as determined by hba1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with hba1c \>= 5.1% * fasting insulin less than 100.0 mu/l and, if hba1c \ = 8.0 mu/l * bmi between 30-60 kg/m\^2 * wake up at a regular time between 5-8 am exclusion criteria: * been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure * on weight loss medication * change in the dosage of a chronic medication within the past 2 months * have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels) * significant gastrointestinal disease, major gastrointestinal surgery, or gallstones * significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity * evidence of cancer (other than non-melanoma skin cancer) within the last 5 years * pregnant or breastfeeding * diagnosed psychiatric conditions * sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night * major change in health or medical history in the past 3 months * currently perform overnight shift work * regularly eat within a \<10.5-hour period each day * lost or gained more than 4% of weight in the past 2 months * traveled more than 2 time zones away in the 2 months prior to enrolling in this study * will travel outside the central time zone in the 2 weeks prior to testing * will travel more than 1 time zone away during this study * behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
clinical study to evaluate the lensgen® juvene® intraocular lens

Conditions: Cataract; Presbyopia

Summary: to assess the safety and effectiveness of the juvene® iol for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.


Eligibility criteria:
key inclusion criteria: * subjects must be 22 years of age or older * able to comprehend and provide written informed consent * willing and able to comply with schedule for follow-up visits * demonstrate sufficient cognitive awareness to comply with examination procedures * other inclusion criteria specified in the protocol may apply. key exclusion criteria: * subjects with clinically significant dry eye syndrome (des) expected to impact postoperative visual acuity * subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents) * prior intraocular or corneal surgery (including corneal refractive correction i.e., lasik, prk, etc.) * any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.) * other exclusion criteria specified in the protocol may apply.
ex vivo stimulation of whole blood as a means to determine glucocorticoid sensitivity to mild-to-moderate and refractory asthmatics

Conditions: Asthma

Summary: gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. the purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (gr) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.


Eligibility criteria:
inclusion criteria: to be eligible for the study, subjects must meet all of the following criteria: * age ≥ 18 years old * physician diagnosis of asthma confirmed through medical record documentation. * documented history of 12% fev1 reversibility post-bronchodilator and/or methacholine pc 20 score of 16mg/ml or less. * non-smoker for \> 6 months before enrollment into the trial * less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking. * willing and able to adhere to the study visit schedule and other protocol-specified procedures. exclusion criteria: subjects meeting any of the following criteria may not be enrolled in the study: * existence of lung disease (other than asthma) * recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks. * non-english speaking. * participation in another interventional research trial * self-reported pregnancy * inability or unwillingness to provide consent * febrile illness (\>38.0˚ c or 100.4˚ f) within 24 hours of visit.
multicenter retrospective analysis about the clinical characteristics of korean paroxysmal nocturnal hemoglobinuria (pnh) patients

Conditions: Hemoglobinuria, Paroxysmal

Summary: paroxysmal nocturnal hemoglobinuria (pnh) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. life-threatening thromboembolism (te) is the most feared complication of pnh, accounting for up to 45% of patient deaths. it is estimated that 40% of pnh patients experience a clinically evident te and 60% of patients without clinically diagnosed te demonstrate te by high-sensitivity mri, indicating the ongoing thrombotic risk in most patients with pnh. much of these data come from pnh patients from european descent. to understand the impact of te in patients with pnh from non-european regions, we performed this study to evaluate the clinical characteristics of korean patients with pnh.

to evaluate the clinical characteristics in korean pnh patients

Eligibility criteria:
inclusion criteria: * diagnosis confirmed by ham's test or flow cytometry patients have any flow cytometry data exclusion criteria: * patients have no flow cytometry data
a pilot study of quantitative tumor oxygen measurements in cervical cancer

Conditions: Gynecologic Cancer; Cervical Cancer

Summary: this research is studying the level of oxygen in tumors during the brachytherapy procedure.

tumors with low levels of oxygen have been found to be more resistant to standard radiation and chemotherapy treatments. for patients with tumors with low oxygen levels, it is not well known if higher radiation doses can overcome treatment resistance to radiation. currently, there are limited ways of measuring tumor oxygen levels. the investigators believe that measuring tumor oxygen levels during the brachytherapy procedure will allow the investigators to develop better and improved oxygen measurement techniques, and ultimately improve clinical outcomes for patients, such as better local tumor control. this research study is a pilot study, meaning that this is the first time investigators are examining the oxygen sensor being used. this study is designed to test the oxygen sensor's ability to measure the oxygen levels within the participant's cervical tumor with the aid of magnetic resonance imaging (mri) scans. mri scans use magnets to make detailed images of the participant's tumor and the surrounding normal tissues during the brachytherapy procedure.

Eligibility criteria:
inclusion criteria: * participants must have a biopsy-proven diagnosis of cervical cancer for which interstitial brachytherapy is planned as standard treatment * age 18 years or older * ecog performance status of 2 or less (see appendix a) * patients who have received prior radiation or chemotherapy may be enrolled on this study * participant is deemed to be an appropriate candidate for mr-guided brachytherapy by the radiation oncologist and the patient elects to be treated with mr-guided brachytherapy * participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques * ability to understand and the willingness to sign a written informed consent document. participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow- up exclusion criteria: * participants who have a contraindication to mri identified by the mr procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-mr-compatible device or implant * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: gynecologic cancer cervical cancer
risk stratification and mrd-driven maintenance for mm after asct

Conditions: Multiple Myeloma

Summary: this study evaluates the maintenance strategy based on risk stratification and mrd status after stem cell transplantation. this is a single-arm, multicenter, prospective study. participants who are r2-iss 1,2 and mrd negative receive the single drug lenalidomide maintenance. in other circumstances, for example, patients who are r2-iss 3 or 4 will receive daratumumab combined with lenalidomide regardless of mrd status, while patients with mrd positivity will also receive daratumumab plus lenalidomide maintenance.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (hdt) and autologous stem cell transplantation (asct) within 12 months of the start of induction therapy, and be within 6 months of asct. 2. must have a partial response (pr) or better response before maintenance. 3. must have an eastern cooperative oncology group performance status score of 0, 1, or 2. 4. this study allows for post-asct consolidation therapy. 5. anc ≥ 1.0 x 10\^9/l, hb ≥ 85 g/l plt ≥ 75 x 10\^9/l (if bmpc \< 50%) or plt ≥ 50 x 10\^9/l (if bmpc ≥ 50%). 6. no active infection. 7. a).tbil\<1.5 x upper limit of normal (uln) (\<3 x uln in patients with gilbert's syndrome); b).ast and alt \<3 x uln.; c. creatinine clearance ≥ 45ml/min. exclusion criteria: 1. must not refractory or non-tolerate to lenalidomide in arm a. 2. must not refractory or non-tolerate to lenalidomide and daratumumab in arm b. 3. must not have progressed on multiple myeloma (mm) therapy before screening 4. chronic obstructive pulmonary disease (copd) with fev1 less than 50 % of predicted normal； 5. have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification 6. history of stroke or serious thrombotic event within 12 months prior to screening.

Keywords: r2-iss stage minimal residual disease lenalidomide daratumumab
humectant activity of a new formulation of gynomunal® vaginalgel

Conditions: Vaginal Dryness; Menopause

Summary: aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness

randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit. both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. to investigate the activity of the products under study, 4 visits will be performed: a baseline visit (t0), a visit at the end of the first week-treatment (t1), a visit at the end of the wash out period (t2) and a final visit at the end of the second week-treatment (t3). volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.

Eligibility criteria:
inclusion criteria: * caucasian healthy female subjects, * complaining vaginal dryness, * women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place, * women who agree not to start a replacement therapy during the whole duration of the study, * women who do not present any active cutaneous pathology of external and internal genitalia, * women who did not receive any drug or cosmetic treatment on their genitalia during the 2 months preceding the trial, * women who did not apply vaginal products within at least 1 month before the inclusion in the study, * women who accept to use only the products authorised by the protocol, * women who accept not to undertake any treatment for internal and external genitalia during the trial, * women who did not use, phytoestrogenes based products on treated areas less than 4 weeks before inclusion time, * women accepting to sign the informed consent form, * women able to read the material dedicated to volunteers, to abide by the rules of the protocol and ready to accept its constraints exclusion criteria: * volunteers not fulfilling inclusion criteria, * severe symptoms of vaginal dryness, associated with mucosal signs * history of intolerance to a vaginal product, * concomitant participation to another trial, * refusal to sign the informed consent form, * known allergy to one or several ingredients of the product on trial, * change in the normal habits in the last 3 months, * participation in a similar study during the previous 3 months, * whose insufficient adhesion to the study protocol is foreseeable * women who start a replacement therapy during the trial * women who experience during the study the occurrence of any foreseeable risk to use daily the product on trial.

Keywords: vaginal dryness hyaluronic acid menopause
dose-escalation study of alxn1210 iv in participants with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: PNH

Summary: this study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (iv) doses of alxn1210 administered to participants with pnh who have not previously been treated with complement inhibitor.

the data presented is up to the primary completion date of the study and is for the 24-week primary evaluation period. the study also includes an extension period of up to 5 years.

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age 2. pnh diagnosis confirmed by documented high-sensitivity flow cytometry 3. documented meningococcal vaccination not more than 3 years prior to dosing 4. female participants of childbearing potential used highly effective contraception starting at screening and continuing until at least 24-weeks after the last dose of alxn1210 5. willing and able to give written informed consent and comply with the study visit schedule exclusion criteria: 1. treatment with a complement inhibitor at any time 2. females who were pregnant, breastfeeding or who had a positive pregnancy test at screening or day 1 3. participation in an interventional clinical study within 30 days before initiation of dosing on day 1, or use of any experimental therapy within 30 days prior to dosing on day 1, or within 5 half-lives of the product, whichever is greater 4. history of allergy to excipients of alxn1210 or known allergy to chinese hamster ovary cell proteins 5. inability to comply with study requirements 6. history of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the investigator's judgment, would preclude participation 7. other unspecified reasons that, in the opinion of the investigator or sponsor, made the participant unsuitable for enrollment

Keywords: paroxysmal nocturnal hemoglobinuria pnh complement inhibitor
apicoectomy longterm results

Conditions: Periapical Diseases

Summary: the purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.

all 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017. the patients will have a clinical and radiologic examination. the investigators will examine if new periapical lesions, bone loss, fracture of teeth or loss of teeth exist.

Eligibility criteria:
inclusion criteria: * all 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017. exclusion criteria: * pregnancy * patients who do not want to participate in clinical and radiological follow up.
open-label, single arm trial of bi 695502 in patients with previously untreated metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the objective of this trial is to evaluate the safety and tolerability of bi 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mfolfox6) and as maintenance therapy (when applicable). as well as to evaluate the following efficacy parameters: progression-free survival (pfs), objective response rate (proportion of patients with complete response \[cr\] plus partial response \[pr\]), overall survival (os), duration of response (dor), time to progression (ttp).


Eligibility criteria:
inclusion criteria: * males and females aged \>=18 years (for japan only: age \>=20 years at time of signing informed consent form) with histologically confirmed metastatic colorectal cancer (mcrc). * metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mfolfox6 (leucovorin/5-fluorouracil/oxaliplatin) + bevacizumab. * at least one measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. * adequate hepatic, renal and bone marrow function. * further inclusion criteria apply. exclusion criteria: * prior systemic therapy for metastatic disease * prior therapy with monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (vegf) or vegf receptors, including avastin® or avastin® biosimilar * previous malignancy other than colorectal cancer (crc) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix * spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment * any unresolved toxicity \> common toxicity criteria grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy) * history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding * a thrombotic or hemorrhagic event \<=6 months prior to screening (includes hemoptysis, gastrointestinal (gi) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease) * further exclusion criteria apply
motionpodtm validation in free-living conditio

Conditions: Obese; Healthy Volunteers

Summary: in this study, the investigators propose to assess the validity in measuring physical activity (pa) of a new pa monitor system the motionpodtm, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. the motionpodtm performances in predicting mean daily pa energy expenditure (paee) will be calculated against the reference paee gold standard measure, using the doubly labeled water method (dlw). the motionpodtm performances in predicting paee and pa patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer actigraphgt3x+tm and a device combining cardiofrequencemetry with accelerometry, the actihearttm. this latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/ee relationship that limits its use in large population samples. briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. the subjects will carry a motionpodtm, an actigraphgt3x+tm, an actihearttm and a gps for a total of 14 days in everyday life conditions and complete a physical activity diary. in half of the subjects, pa will be evaluated on a period of 14 days, with standard paee measured by dlw. the other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.


Eligibility criteria:
inclusion criteria: * male and female subjects * age : 18 to 75 years * patients or healthy volunteers * 40 obese subjects (bmi ≥ 30 kg/m2), 40 non-obese (bmi \<30 kg/m2) and active (pa level evaluated by the rpaq questionnaire) subjects, 40 non-obese and sedentary subjects * absence of cardiac rate disorders exclusion criteria: * subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3 previous months * subjects with a pathology restricting the walking distance (confinement, distance \<200 meters) * subjects with implants (pacemaker, cardiac implant or another active implant) * claustrophobic subjects (for subjects participating to "doubly labelled water" protocol) * drug use that could affect energy expenditure

Keywords: energy expenditure physical activity accelerometer magnetometer monitoring free-living conditions doubly labelled water