Kornimate/medical-research-clean huggingface dataset:
efficacy of freshkote and systane for the treatment of dry eye and improvement of osmolarity

Conditions: Dry Eye

Summary: the purpose of this study is to compare the efficacy of freshkote and systane for the reduction of dry eye signs and symptoms.


Eligibility criteria:
inclusion criteria: * dry eye patients with level 2 disease or greater as defined by the delpi panel * tear osmolarity of at least 308 mosm * at least 18 years of age, male or female * willing to provide written informed consent * likely to complete all study visits * if currently using ocular lubricants, must complete a 10-14 day washout exclusion criteria: * presence of any active ocular disease other than dry eye * use of topical ophthalmic medications * use of contact lenses during the trial * pregnant or nursing, or planning a pregnancy. patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative. * any known sensitivity to any ingredients of either study drop * oral anti-inflammatory medications, omega 3 supplements, or doxycycline * punctal plugs inserted within the last 6 months or less * uncontrolled systemic disease * subjects with known sensitivity or inappropriate responsiveness to any of the medications used. * acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.) * corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium) * concurrent participation or participation in the last 30 days in any other clinical trial
kinetic tremor in parkinsons disease: its course under pramipexole (mirapexin®) treatment and impact on quality of life

Conditions: Parkinson Disease

Summary: the study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.


Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease with or without fluctuations 2. indication for treatment with pramipexole (mirapexin®) 3. presence of at least mild tremor symptoms (as judged by the treating physician) exclusion criteria: 1. any contraindications according to the summary of product characteristics (spc): hypersensitivity to pramipexole or to any of the excipients. 2. ongoing treatment with pramipexole (mirapexin®)
a biomarker identification trial of tarceva (erlotinib) in patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. it will also assess the efficacy and safety of tarceva in this patient population. patients will be randomized to receive either tarceva 150mg/day po, or placebo po daily. tumor tissue will be used for biomarker analysis. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer; * measurable disease according to recist; * failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy; * ecog performance status of 0-2. exclusion criteria: * local or locally advanced-resectable pancreatic cancer; * any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer; * major surgery within 2 weeks prior to randomization.
a research study of how a new medicine nnc0365-3769 (mim8) works in the body of healthy people

Conditions: Healthy Volunteers - Haemophilia A

Summary: nn0365-3769 (mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia a (an inherited disorder in which blood does not coagulate properly). this study will investigate if different doses of mim8 are safe, and also check how mim8 behaves in the body. twelve different doses will be tested. participants will only get one of the doses. which dose participants get is decided by chance. participants will get a single injection under the skin of the belly by means of a syringe and a needle. the study will last for about 17 - 21 weeks.


Eligibility criteria:
inclusion criteria: * male, aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index between 18.5 and 29.9 kg/m\^2 (both inclusive) * body weight between 60.0 to 100.0 kg (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis * any clinical signs or established diagnosis of venous or arterial thromboembolic disease * factor viii activity greater than or equal to150% at screening * any of the thrombophilia markers listed below: * protein c, protein s or antithrombin below the lower normal laboratory range * factor ii activity, activated protein c resistance, lupus anticoagulant, anti-cardiolipin antibody (igg and igm) or anti-β2 glycoprotein i antibody (igg and igm) outside the normal laboratory range at screening
cardiomems hf system real-world evidence post-approval study

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III

Summary: the purpose of this post-approval study (pas) is to evaluate the long-term safety and effectiveness of the cardiomems™ hf system using real-world evidence (rwe) methods.

subjects will be identified in abbott's merlin.net remote monitoring database. merlin.net data will be linked to medicare fee-for-service (ffs) claims data to longitudinally track outcomes. each subject will be followed for a minimum of 36 months.

Eligibility criteria:
inclusion criteria: * subject implanted with a cardiomems pa sensor and enrolled in merlin.net * subject resides in the united states as documented in merlin.net * nyha class ii or class iii as documented in merlin.net at the time of cardiomems implant (only nyha class ii subjects contribute to the primary cohort) * subject identified in merlin.net data can be linked to medicare ffs claims * subject is enrolled in medicare part a and b, and not enrolled in medicare part c, at implant and for 12 months prior to implant, to establish qualification for cardiomems * subject ≥18 years of age at time of cardiomems implant exclusion criteria: * subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to cardiomems implant

Keywords: cardiomems hf system
evaluation of the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation

Conditions: Coagulopathy; Endstage Liver Disease

Summary: post-marketing requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (olt). the primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (olt) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other fda and aabb approved plasma products).


Eligibility criteria:
inclusion criteria: * male or female age ≥18 years * patient is scheduled to undego orthotopic liver transplantation (olt) * patient has a natural mayo end-stage liver disease (meld) score of 15-40 * patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care exclusion criteria: * patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product * patient is known to be iga deficient with documented antibodies against iga * patient is a planned recipient for a living donor olt * patient has a severe deficiency of protein s * patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their olt

Keywords: intra and post-op coagulopathy in patients undergoing olt
medtrum a7+ touchcare insulin patch pump (medinps)

Conditions: Diabetes Mellitus

Summary: demonstration study of the interest of the medtrum a7+ touchcare insulin patch pump versus insulet omnipod® patch pump

compare the daily use of two single usage patch pumps and demonstrate the interest of use of the a7+touchcare® (medtrum) patch pump for type 1 \& 2 diabetes management. main objective is an estimation of patients a1c (glycated haemoglobin) based on the average blood glucose (obtained from a flash glucose monitoring) and to compare it in both groups. secondary objectives: * comparison of mean a1c (laboratory values) between the two groups at baseline and study end. comparison to be established in a non-inferiority * observe skin \& overall tolerance, technical incidents with the device (failure, disconnection, catheter obstruction...) * collection of glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)

Eligibility criteria:
inclusion criteria: * patient with type 1 or 2 diabetes, 18 years of age and over * patients already equipped with omnipod® ® (insulet) insulin patch pump and abbott freestylelibre sensor®. * a1c ranking from : \>= 6,5% to \<= 9.5% * any type of rapid insulin except fiasp (which can be substituted if necessary) with 60 iu max per day (unauthorized use of insulin supplements by pen injector) * patient able to receive and understand study information, give written informed consent, and easily participate to the trial * patient affiliated to the french social security system exclusion criteria: * - patient already participating in another study * patient under the protection of justice or under guardianship or curatorship * type 2 diabetic patient requiring a daily insulin dose \> 60 iu * patients not suitable for suing insulin pump such as: severe psychiatric disorders, rapidly progressing ischemic or proliferative retinopathy before laser treatment, and exposure to high magnetic ﬁelds * patients allergic to nickel and adhesive * pregnant women, breastfeeding women * or any other criteria as appreciated by the study investigator.

Keywords: diabetes management insulin pump
evaluation of a patient navigation system to reduce time to waitlisting for potential kidney transplant recipients

Conditions: End-Stage Renal Disease

Summary: the purpose of this study is to measure the effect of introducing a patient navigator to guide high and moderate risk patients through the pre-waitlisting phases of the kidney transplant process. patients identified as being at high and moderate risk of delay to waitlisting will be linked with a patient navigator, who will facilitate their completion of pre-waitlisting requirements. we believe that patients who are randomized to a patient navigator will be more likely to complete the pre-waitlisting process and will complete the process more quickly than high and moderate risk patients who do not receive additional assistance from a patient navigator.

the investigators plan to implement a newly developed risk assessment tool that uses medical and demographic indicators to estimate the probability of waitlisting for all patients beginning the transplant process at the emory transplant center. medical secretaries will collect information about patients' medical and demographic characteristics during the appointment scheduling phone call. this information will be entered into the redcap risk assessment tool, which will be used to calculate the probability of waitlisting. a previously defined cut-off will be used to categorize the risk of delay to waitlisting. a random subset of patients identified as being at high and moderate risk of delay to waitlisting will be connected with a patient navigator, who will be available not only to answer questions, but also to manage clinical information prior to, during, and following transplantation. the navigator will work to identify potential barriers and to ensure that the most up-to-date clinical information has garnered responses at the nurse and physician levels. the effect of connecting high and moderate risk patients with a patient navigator on time to waitlisting and rate of waitlisting will be analyzed to determine whether such a program is an effective means of increasing access to transplant for patients who are likely to face financial, racial, and demographic barriers.

Eligibility criteria:
inclusion criteria: * kidney transplant candidates older than 18 years of age at emory transplant center exclusion criteria: * there are no exclusion criteria that would limit subject participation

Keywords: transplantation healthcare disparities quality assurance
phone call in type 2 diabetes patient

Conditions: Behavior Change

Summary: to assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. the investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. casuistic and methods: a randomized "quasi-experimental" enrolling 48 t2dm patients using a pedometer for 6 weeks. the intervention group received phone calls stimulating them to increase their walking activity. the control group received only one telephone call to explain pedometer use. the investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.


Eligibility criteria:
inclusion criteria: * to assign written informed consent * to have a phone call number * to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day exclusion criteria: * don´t agree to assign written informed consent * don´t have phone number * don´t have conditions to answer all the questionnaire * don´t agree to use pedometer for 6 weeks

Keywords: type 2 diabetes physical activity behavior change profile personality phone call support
dc vaccine combined with cik cells in patients with sclc

Conditions: Small- Cell Lung Cancer

Summary: the aim of this study is to evaluate the safety and efficacy of dendritic cells (dc) combined with cytokine-induced killer (cik) cells treatment patients with extensive-stage small-cell lung cancer. experimental adopted recombinant adenovirus-code muc1 and survivin transfected dc, which are used for dc-based immunotherapy. based on the results of our previously preclinical research with dc combined with cik cells, the investigators plan to perform the clinical trial.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of small- cell lung cancer * age \>18 years at time of consent * received standardized treatment of small-cell lung cancer * interval between the last standardized treatment and dc/cik treatment ≥ 4weeks * kps (karnofsky performance scale) \>60 * patient's written informed consent * no severe viral or bacterial infections * predicted survival \>3 months exclusion criteria: * clinically relevant diseases or infections (hbv, hcv, hiv) * females who are pregnant or nursing * immunosuppressant treatment * currently participating in another clinical trial * unfit for participating in this clinical trial in investigators' opinions
evaluate the effectiveness of brain network activation (bna™) technology in the management of sport related concussion

Conditions: Minor Traumatic Brain Injury (TBI)

Summary: currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. event related potentials (erps), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. the erps provide excellent temporal information, but spatial resolution for erps has traditionally been limited. however, by using high-density electroencephalograph (eeg) recording spatial resolution for erps is improved significantly. the paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (bna™) to temporally and spatially map brain function, connectivity and synchronization. the proposed study will provide additional evidence for the utility and contribution of the bna™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.


Eligibility criteria:
inclusion criteria: * age 17-24, both genders, enrolled in a recognized college and members of a sport team of their school. exclusion criteria: current or history of any of the following: * tbi (i.e., glasgow coma scale \<13) or brain surgery * any psychiatric disorder * any neurological disorder * substance abuse * special education * any medication affecting cns * significant sensory deficits such as deafness or blindness * residual symptoms or deficits related to a previous concussion

Keywords: minor traumatic brain injury (tbi) concussion
interaction between smoking, gcf periostin, il17a, il17e and non-surgical periodontal therapy

Conditions: Periodontitis; Smoking

Summary: it was aimed to evaluate the changes in the levels of periostin, il-17a and il-17e cytokines in the gingival crevicular fluid (gcf) of periodontitis patients which non-surgical (phase i) periodontal treatment applied to and their interactions with smoking. the study included systemic healthy smokers(sp)(n:11) and non-smokers(p)(n:11) with periodontitis, smokers (ss)(n:11) and non-smokers(s)(n:11) with periodontal healthy individuals phase i periodontal treatment was applied to the groups with periodontitis. before treatment (day 0), clinical measurements evaluating periodontal status were recorded and gcf samples were collected. gcf samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. gcf periostin, il-17a and il-17e levels were determined by elisa method. all data were evaluated statistically.

the sh and h groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. however, after the gcf sampling, patients in the sp and p groups received non-surgical periodontal treatment(nspt) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session they were instructed to refrain from using any chemicals, including mouthwash, to remove plaque. the periodontitis patients received a follow-up call on the 15th and 30th days following treatment. the gcf sampling procedure was first repeated on the teeth from which a previous gcf sample had been taken. then, values for the clinical examination parameters (pi, gi, bop, pd, and cal) were once again measured and recorded. daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. all these procedures were performed by a single investigator.

Eligibility criteria:
inclusion criteria: * generalized stage 3 periodontitis or periodontally healthy; * smoker ((≥10 cigarettes/day for \>5 years) or nonsmoker (never smoked in their lifetime); * not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause. exclusion criteria: * under 18 years of age * those with a systemic disease * cancer patients, those with a history of chemotherapy and radiotherapy * pregnant and breastfeeding women * those who smoke less than 10 cigarettes a day and those who quit smoking * having received orthodontic treatment in the last 6 months * using antibiotics, anti-inflammatory or any medication in the last 6 months * those who do not consent voluntarily

Keywords: non surgical periodontal therapy smoking periostin il-17 gingival crevicular fluid
pain in patients with cystic fibrosis in rouen university hospital

Conditions: Pain; Cystic Fibrosis

Summary: objectif principal - to evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of rouen university hospital, normandy, france. objectifs secondaires * to assess the relationship between pain and disease severity. * to assess the relationship between pain and the age of the patient. * to describe the pain locations. * to describe the use of pharmacological or nonpharmacological treatment. * to evaluate the procedural pain.

patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit. primary evaluation criteria : intensity and frequency of pain are evaluated with the prospective diary. * the pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : faces pain scale revised. children 6 years and older, adolescents and adults: numerical rating scale self-reported * the pain frequency is completed twice a day (morning and evening) on the prospective pain diary. secondary evaluation criteria * the disease severity, estimated using recent forced expiratory volume in one second (fev1) (best measurement of the year before bronchodilator, collected in the patient's medical record) * pain locations, pharmacological or nonpharmacological treatment and procedural pain are evaluated using the diary and the questionnaire. * demographic data and characteristics of cystic fibrosis are collected using the medical file.

Eligibility criteria:
inclusion criteria: * children and adults followed at the cystic fibrosis center of rouen university hospital, normandy, france. * seen for routine planned visits. * having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors exclusion criteria: * patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized. * major patient under legal protection. * major patient having problems understanding the oral and written french language or child whose parents or legal representatives have problems understanding the oral and written french language.

Keywords: pain cystic fibrosis epidemiology adults children