Kornimate/medical-research-clean huggingface dataset:
chronic obstructive pulmonary disease (copd) monitoring

Conditions: COPD; COPD Exacerbation

Summary: the present feasibility study aims at assessing whether the emg of respiratory muscles can serve as an objective marker of dyspnea in copd patients. the study aims also at evaluating the changes in physiological parameters (i.e., emg, respiration rate, heart rate, temperature, and spo2) occurring when simulating daily activities before, during and after acute exacerbations. all this information can be useful to detect the exacerbations earlier or to provide better treatment during the exacerbations.


Eligibility criteria:
inclusion criteria: * subject must have a clinical diagnosis of copd * mmrc (modified medical research council) dyspnea scale score \> 1 * subject must be indicated for regular inpatient pulmonary rehabilitation * subject must be hyperinflated, defined as residual volume (rv)\>120% of the predicted value, measured by whole body plethysmography * subject must be willing to provide informed consent for their participation in the study * subject must be ≥18 years of age exclusion criteria: * subjects who are unable/unwilling to voluntarily participate in the study * subjects who cannot read/write * subjects who are dependent on oxygen and/or unfit to wear a mask during sub- maximal constant work rate test (cwrt) * subject has congenital heart disease * subject has unstable coronary artery disease * subject has an active implanted cardiac device (i.e. ipg, icd) * subject has heart failure nyha 4 * subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study * subject is legally incompetent * subject is pregnant or has suspect to be pregnant * subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from medtronic study manager * borg scale assessment is evaluated as unreliable due to patient's cognitive condition
basil extract (ocimum basilicum) in the management of recurrent aphthous stomatitis

Conditions: Oral Ulcer

Summary: a randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control 10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. the other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w pva (mw = 31-50 kda, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)

a randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control. inclusion criteria will be: (i) age \> 18 years; (ii) a clear history of ras(recurrent apthous stomatitis)occurring no less than four times a year; (iii) presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment; (iv) ulcers that took \> 5 days to resolve without treatment. individuals will excluded if they: (i) had underlying systemic disease(s) or a history of immunologic disorder(s); (ii) were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; (iii) are smokers; (iv) are pregnant; (v) had a history of abusing drugs or alcohol; (vi) could not provide written informed consent. 10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. the other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w pva (mw = 31-50 kda, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)

Eligibility criteria:
inclusion criteria: * age \> 18 years; * a clear history of ras (recurrent apthous stomatitis) occurring no less than four times a year; * presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment; * ulcers that took \> 5 days to resolve without treatment. exclusion criteria: * had underlying systemic disease(s) or a history of immunologic disorder(s); * were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; * are smokers; * are pregnant; * had a history of abusing drugs or alcohol; * could not provide written informed consent

Keywords: aphthous stomatitis basil extract endocan marker
a study to evaluate the benefits and risks of conversion of existing adolescent kidney transplant recipients aged 12 to <18 years to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen, and their adherence to immunosuppressive medications

Conditions: Renal Allograft Recipients

Summary: the purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.


Eligibility criteria:
inclusion criteria: * male and female adolescents 12 to less than 18 years of age * recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment * receiving a stable regimen of a calcineurin inhibitor (cni), with mycophenolate mofetil (mmf) or enteric-coated mycophenolate sodium/mycophenolate mofetil (ec-mps/mpa), with or without daily corticosteroids for ≥ 30 days prior to randomization * clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined criteria for proteinuria and estimated glomerular filtration rate (egfr) * serologic evidence of past exposure to epstein-barr virus (ebv) and current absence of ebv dna replication at or prior to renal transplantation and during the screening period * completion of an initial course of sars-cov-2 vaccination per local standard of care, a minimum of 6 weeks prior to enrollment exclusion criteria: * recipients with ebv serostatus negative or unknown at screening or at transplant * treatment for biopsy-proven acute rejection (bpar) of any degree of severity within 6 calendar months prior to enrollment * biopsy-confirmed antibody-mediated acute rejection at any time with the current allograft * banff 97 grade iia or higher acute cellular rejection (or equivalent), or treatment with plasmapheresis or rituximab for any acute rejection at any time with the current allograft * current evidence or past history of active or inadequately treated latent tuberculosis (tb) infection * previously treated with belatacept or previously enrolled in a belatacept trial with their present allograft other inclusion/exclusion criteria apply

Keywords: acute rejection belatacept calcineurin inhibitors (cyclosporine, tacrolimus) conversion donor-specific antibodies egfr immunosuppressive regimen adolescent kidney transplant recipients
ultrasound appearance of the endometrium post radio-frequency ablation

Conditions: Menorrhagia

Summary: * the study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a novasure ablation. investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings. * secondary aims include correlation of ultrasonographic findings to demographic patient data.

heavy and irregular menses affects 9-14% of gynecologic patients. surgical can be employed intervention is sought when medical management fails. endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. the current mainstay intervention is non-resectoscopic radio frequency ablation. these procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. post operative complications, both short and long term, and failure rates have been well studied. a limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.

Eligibility criteria:
inclusion criteria: * women of premenopausal age * 18 years and older * intended ablative management of menorrhagia exclusion criteria: * uterine cavity anatomic abnormality * previous uterine ablation procedure * previous cervical procedure * presence of submucosal fibroids * tissue diagnosis of endometrial hyperplasia/endometrial carcinoma * pregnancy and delivery less than 1 year before ablation.

Keywords: novasure ablation menorrhagia endometrium
assessment of the safety and performance of a compression ankle support in the prevention of injuries during sports practice

Conditions: Chronic Pain; Chronic Instability of Ankle Joint

Summary: decathlon has developed anklesoft100 product which is medical device designed to reduce pain and joint instability during sport practice. the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon anklesoft100 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility criteria:
inclusion criteria: * subject is aged ≥18 years old * subject has chronic pain and / or chronic ankle instability * the current condition of his/her ankle allows the subject to pursue a usual physical activity * subject has been informed and is willing to sign an informed consent form * subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks) * subject is affiliated to the french social security regime non-inclusion criteria: * subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * subject has worn a support (ankle brace or articulated orthosis) during sports sessions during the last month * subject has any medical condition that could impact the study at investigator's discretion * subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, elastane, polyester, synthetic rubber) * adult subject to a legal protection measure
evaluation of efficacy of anthelios sunscreen on face versus usual routine on signs of aging

Conditions: Aging

Summary: this experimental, randomized study aims at evaluating the preventative effect of a sun protection factor (spf) 50+ sunscreen (anthelios uvmune 400 fluid spf 50+) with high ultraviolet a (uva) protection on clinical signs of skin aging.

the study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the international council on harmonisation (ich) topic e6(r2)5 ref: ema/chmp/ich/135/1995, ich good clinical practice (gcp) addendum nov 2016 and applicable regulatory requirement. statistical plan: tx represents the values observed at time x, for each parameter and by subgroup. quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (sd). qualitative variables will be summarized in the form of counts and percentages. for each parameter, a graphical representation of the means ±95% confidence interval (ci) will be produced to visually assess the evolution across time, by treatment group.

Eligibility criteria:
inclusion criteria: * subjects with signs of photo aging (global score of at least 14) * all skin types exclusion criteria: * any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site * pregnant or breastfeeding women * subject with known allergy to cosmetic products or to any ingredient of the sunscreen product

Keywords: skin aging anthelios uvmune 400 oil control fluid spf 50+ preventive effect
predictive equations for resting energy expenditure

Conditions: Polycystic Ovary Syndrome

Summary: predictive equations are the main clinical tool for determining resting energy expenditure (ree). thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. the purpose of this study is to investigate the accuracy and agreement of predictive equations of ree in overweight women with polycystic ovary syndrome (pcos). the ree of all participants was measured (mree) by means of indirect calorimetry and predicted (pree) through ten equations basing on the anthropometric parameters (harris \& benedict, who/fao/unu including weight, who/fao/unu including weight and height, owen, mifflin-st. jeor, institute of medicine, ireton-jones, müeller, de luis and lazzer).


Eligibility criteria:
inclusion criteria: * women treated in an endocrinology centre specialising in hyperandrogenism at the university hospital of university federal of minas gerais (belo horizonte, minas gerais, brazil) * the patients were of reproductive age (range: 18-45 years) * were overweight or obese (body mass index ≥ 25.0 kg/m2) and * signed an informed consent statement exclusion criteria: * women who were pregnant, * were lactating, * had a diagnosis of hypothyroidism or hyperthyroidism or * had high physical activity levels were excluded from the sample.

Keywords: resting energy expenditure predictive equations overweight
mesalazine therapy in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether mesalazine is effective in the treatment of the abdominal discomfort or pain of irritable bowel syndrome patients.

the present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of ibs. in a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. we expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of ibs patients, thus providing the rationale for the assessment of this treatment on symptoms of ibs.

Eligibility criteria:
inclusion criteria: * ibs patients with positive diagnosis inclosing rome iii criteria exclusion criteria: * any organic or metabolic disease

Keywords: mesalazine in irritable bowel syndrome
path clinical data research network (cdrn) atrial fibrillation (af) clinician-patient partnership cohort

Conditions: Atrial Fibrillation

Summary: the purpose of the path network af clinician-patient partnership cohort is to use clinical data from electronic health records (ehr) and patient reported outcomes (pro) to answer questions of clinical importance to patients, providers, and other stakeholders.

the primary objective is to create the path network af clinician-patient partnership cohort, which will allow the conduct of patient-centered observational studies on af across the multiple institutions of the path network. creating the af clinician-patient partnership cohort will involve: 1. recruiting patients with af to participate in the path network af clinician-patient partnership cohort 2. administering surveys to the af clinician-patient partnership cohort approximately every 6 months to collect patient reported outcomes (pros) 3. collecting individual patient health record data into the af clinician-patient partnership cohort database 4. tracking whether the patient participant has biospecimens in a path site biorepository and prepare for possible sharing of biospecimens in future studies. 5. identifying potential participants for future research studies. the secondary objectives are to use the path network af clinician-patient partnership cohort to answer patient-centered research questions including: 1. what is the incidence of complications requiring re-hospitalization after an ablation procedure for af? 2. what are the predictors of major bleeding and stroke among patients that receive each anticoagulant class (vit k antagonist, direct factor x inhibitor, direct thrombin inhibitor)? 3. is the longitudinal change in applied cognition-executive function score in af patients associated with the choice of rate versus rhythm control and anticoagulation strategy?

Eligibility criteria:
inclusion criteria: * age: 18 years or older at time of query * visits: 3 non-ed outpatient visits between 1/1/2011 and 12/31/2014 * af : af diagnosis documented between 1/1/2011 and 12/31/2014 * af diagnosis can be coded ehr (on billing or problem lists) and/or derived from ekg reports * af diagnoses associated with surgery, certain thyroid conditions, or certain medications cannot count as the qualifying af diagnosis for inclusion in this cohort. exclusion criteria: * deceased * not proficient in english * already enrolled in the path clinical data research network (cdrn) atrial fibrillation (af) clinician-patient partnership cohort at another path institution
18793 - human photoallergy test

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive * be lightly pigmented (fitzpatrick skin type i, ii, iii) * have read and signed the written informed consent form and have completed a hipaa authorization form (health insurance portability and accountability act) in conformance with 45cfr parts 160 and 164 * be in general good health as determined by the subject's medical history and in the discretion of the investigator exclusion criteria: * have a visible sunburn * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products * subjects who are employees of the cro (contract research organization) and/or bayer or is a household member of an employee
risk of uncomplicated peptic ulcer in the general population

Conditions: Peptic Ulcer [Iowa Type (107680.0010)]

Summary: the analyses are conducted in a previous population-based cohort study using the health improvement network database in the uk (cai et al 2009).the aims of the post hoc analyses are: to estimate the relative risk of uncomplicated symptomatic peptic ulcer (upu) associated with use of low dose aspirin (asa) and other anti-inflammatory drugs (nsaids, steroids) in the general population to estimate the dose-response and duration-response associated with use of these drugs to estimate the relative risk of upu associated with naive/non-naive use of low dose asa in the general population to evaluate the effect of proton pump inhibitors (ppi) (alone or in combination with anti-inflammatory drugs) on the occurrence of upu in the general population to investigate the management of low dose asa/oral antiplatelets after upu

risk of uncomplicated peptic ulcer in the general population

Eligibility criteria:
inclusion criteria: - patients aged 40-84 years in 1997-2005 ( see study population description) exclusion criteria: - patients aged below age 40 and 85 years and above ( see study population description)

Keywords: uncomplicated peptic ulcer low dose aspirin (asa) acid-suppressing drugs epidemiology
comparing the effect of melatonin, diazepam, and placebo on decreasing the level of anxiety preoperatively

Conditions: Anxiety; Preoperative Anxiety

Summary: the goal of this clinical trial is to compare the effect of melatonin, diazepam, and placebo on the level of anxiety in patients undergoing surgery. the main question it aims to answer is: • is melatonin effective in reducing the anxiety of patients undergoing surgery? participants will be asked to answer a questionnaire then they will receive either melatonin, diazepam, or placebo, and then after an hour, they will answer the same questionnaire again. researchers will compare melatonin, diazepam, and placebo to see if melatonin is as effective in reducing the level of anxiety as diazepam in patients undergoing surgery.

anxiety is a tense unpleasant sensation experienced by many individuals secondary to their concerns or due to the anticipation of an unpleasant experience like a surgery. even with the advancement of medical treatment, preoperative anxiety remains a widespread complaint that affects the patients psychologically and physically, and at the same time adversely affecting the outcome of the operation and the experience of the patient. in this triple-blind, randomized clinical study, we aim to compare melatonin to diazepam regarding its efficacy in reducing preoperative anxiety, as well as assessing multiple other effects such as sedation, orientation, and cognition, by applying validated tools to patients undergoing elective surgeries before and after administering the premedication.

Eligibility criteria:
inclusion criteria: * asa 1 or 2 * posted for general anesthesia * aging between 18 and 65 years exclusion criteria: * allergy to any of the drugs under study * pregnancy * illiteracy * any mental illness * taking antipsychotics, antidepressants, anxiolytics, or sedatives

Keywords: preoperative anxiety anxiolytic melatonin diazepam sedation premedication
halodine nasal antiseptic in patients with covid-19

Conditions: SARS-CoV-2 Infection

Summary: povidone iodine (pvp-i) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. halodine nasal antiseptic is formulated for topical application pvp-i to nasal passages, and has demonstrated effectiveness against sars-cov-2 in vitro - 99.99% inactivation within 15 seconds. this study will evaluate the ability of halodine nasal antiseptic to impact sars-cov-2 in vivo.

this is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with covid-19. baseline nasopharyngeal swabs will be performed on all individuals. halodine nasal antiseptic will then be applied to the anterior nares. serial nasopharyngeal samples will then be collected at specified time points after the application. all samples will be tested for sars-cov-2 by real-time reverse transcription (rrt)-pcr assay.

Eligibility criteria:
inclusion criteria: * hospitalized with covid-19 * positive sars-cov-2 (rrt)-pcr within 48 hours of enrollment exclusion criteria: * allergies to iodine-containing compounds

Keywords: nasopharyngeal sars-cov-2 viral load