Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of drm02 in subjects with rosacea

Conditions: Rosacea

Summary: the purpose of this study is to determine whether drm02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.

this is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of drm02. safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs. preliminary efficacy will be assessed through inflammatory lesion counts, the investigator's global evaluation (ige) and the rosacea signs and symptoms (rss) scale.

Eligibility criteria:
inclusion criteria: * male or female 18 to 70 years of age. * clinical diagnosis of rosacea with a score of 2 or 3 on the investigator's global evaluation (ige) of rosacea scale and at least 15 and not more than 40 papules. * subjects willing to minimize external factors that might trigger rosacea flare-ups. * male or non-pregnant, non-lactating females. * signed informed consent. exclusion criteria: * severe self-reported facial sensitivity. * severe sun sensitivity. * ocular-only, phymatous rosacea or steroid rosacea. * use of topical rosacea treatments in the 4 weeks prior to baseline. * use of systemic corticosteroids within the 4 weeks prior to baseline. * use of systemic antibiotics in the 4 weeks prior to baseline. * use of systemic retinoids for in the 6 months prior to baseline. * use of topical retinoids in the 3 months prior to baseline. * use of light- or laser-based rosacea treatments in the past 2 months prior to baseline. * cosmetic procedures within the 2 months prior to baseline. * use of topical anti-aging medications in the 2 weeks prior to baseline. * subjects who have poor skin condition within 5 cm of the treatment area. * subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections. * subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy. * subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days. * subjects who have a clinically significant laboratory value at screening.
evaluating the human papillomavirus self-collection experience in individuals who have experienced sexual trauma

Conditions: Cervical Carcinoma; Human Papillomavirus Infection

Summary: this study explores the human papillomavirus (hpv) self-collection experience among individuals with a history of sexual trauma. cervical cancer is the fourth most common cancer in women worldwide and is the second leading cause of cancer-related death in women ages 29-39. despite programs to improve accessibility of cervical cancer screening and overall high screening rates, disparities in routine surveillance have been demonstrated in certain populations, such as victims of intimate partner violence and sexual trauma. one barrier to participating in cervical cancer screening for this population is the office-based visit which necessitates the individual to undress, sit with their legs in stirrups, and undergo speculum examination for specimen collection. this type of visit may cause distress for participants who have experienced sexual violence. hpv self-collection has been studied with favorable outcomes in effectiveness and ease of use. this study evaluates the experience of hpv self-collection among individuals who have experienced sexual trauma.

primary objective: i. to explore the hpv self-collection experience among individuals with a history of sexual trauma. outline: participants complete a survey, use an hpv self-collection kit, and attend an interview over 30 minutes.

Eligibility criteria:
inclusion criteria: * individuals with a cervix who are eligible for primary hpv testing (age 25 and older) according to national cervical cancer screening guidelines * identify themselves as having a history of ipv, sexual abuse, or sexual trauma * participants will also need to have access to a smartphone, tablet, or computer with video capability * english speaking * reside in the state of oregon * patients who have participated in prior hpv self-collection study (reference institutional review board \[irb\] number- irb# 23478) will also be eligible to participate in the interview if they meet the remaining eligibility requirements (i.e. history of ipv, sexual abuse, sexual trauma) exclusion criteria: * individuals who are not english speaking * individuals \< 25 years old or no longer eligible/recommended to undergo cervical cancer screening * resides outside the state of oregon * adults who are unable to consent or are decisionally impaired * individuals without a cervix (i.e. prior hysterectomy)
ulinastatin's anti-inflammatory reaction in cardiac surgery

Conditions: Cardiovascular Disease

Summary: the purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (cpb)-activated systemic inflammatory response in cardiac surgery with cpb. serial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.

applying aortic cross-clamp (acc) and cardiopulmonary bypass (cpb) for cardiac surgery produces variable systemic inflammatory reactions. as a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing cpb and has been used as a major predictor of morbidity and mortality. circulating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. so far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions. ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production. the purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating cpb-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with cpb. serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (bpi), interleukin (il)-6, tumor necrosis factor (tnf)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-mb (ck-mb), troponin i (tni), c-reactive protein (crp), arterial o2 tension /inspired o2 fraction (pao2/fio2 ratio), will be performed to this purpose.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery employing cpb exclusion criteria: * urgent/emergency surgery, * previous heart surgery, * combined cabg and valve surgery, * age \> 75 yrs, * left ventricular ejection fraction \< 0.45, * diabetes treated with insulin, * active gastropathic disorder, * treatment for chronic obstructive pulmonary disease, * preoperative use of steroids * postoperative re-operation due to bleeding control * pre and postoperative renal replacement therapy * left ventricular assist device implantation

Keywords: ulinastatin systemic inflammation cardiac surgery cardiopulmonary bypass
boutonniere deformity effectiveness of thermoplastic and fabricated orthoses

Conditions: Orthotic Devices

Summary: the goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. it is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses) the main questions it aims to answer are: 1. how much improvement in dexterity will the patient wearing the orthosis get? 2. by how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. how will wearing the orthosis affect the pain associated with the disease? participants will 1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times. 2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times. 4. completion of the dash questionnaire 6. assessment of the nrs pain scale in relation to the period of 6 months before the start of the study 7. likert scale - evaluation of satisfaction with the use of the orthosis 8. the kapandji scale researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional.


Eligibility criteria:
inclusion criteria: * diagnosed with ra * diagnosed thumb deformity: butonier finger, type i or ii * female * age 18 - 65 years * patient's consent to the study exclusion criteria: * other deformity of the thumb * less than 1 year since surgical intervention in the hand * less than 6 months since delivery injections within the thumb * change in treatment during the study and 3 months before the study

Keywords: boutonniere deformity thermoplastic orthosis
assessment of efficacy and safety of insuman comb 25 versus novolin® 30r twice daily over 24 weeks in type 2 diabetes patients with insulin therapy

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare the efficacy of insuman comb 25 versus novolin® 30r on hba1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. secondary objectives: * to assess the effects of insuman comb 25 versus novolin® 30r in patients with type 2 diabetes mellitus on fasting plasma glucose (fpg) * to assess the safety and tolerability of insuman comb 25 versus novolin® 30r in patients with type 2 diabetes mellitus

the study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks open-label treatment + 1 week follow-up).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients, as defined by world health organization (who), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (oad) * signed written informed consent exclusion criteria: * hba1c \ 10% at screening * no self-monitoring of blood glucose within 3 months prior to screening visit * premix insulin treatment for less than 3 months. insulins other than premix insulin treatment within 3 months prior to screening visit * in case of treatment with oad, treatment with a stable oad dose and regimen for less than 3 months prior to screening visit the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
low-dose taxotere® (docetaxel) with concurrent radiotherapy for localized, inoperable carcinoma of the uterine cervix

Conditions: Cervix Neoplasm

Summary: the purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (taxotere) . the use of low-dose taxotere, once per week, with radiation is a new treatment for cervical cancer. this study will also see how well this treatment regimen can be tolerated.


Eligibility criteria:
inclusion criteria: * histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including figo (international federation of gynecologists and obstetricians) stage ib to iva with or without pelvic adenopathy. * no evidence of para-aortic or distant metastases. must have evaluable disease. * zubrod performance status 0-2 or karnofsky performance status \> 60 * laboratory values must be as follows: white blood cell count: \> 3,000/mm3,absolute granulocyte count: \> 1,500/mm3, hemoglobin \> 8.0 g/dl, platelets: \> 100,000/mm3, serum creatinine: \< 2.5 mg/dl, serum calcium: \< 1.3 x institutional upper normal limit,hepatic criteria as follows: total bilirubin \< uln for the institution, * signed study-specific informed consent p * age \> 18 years. * peripheral neuropathy must be \< grade 1. exclusion criteria: * prior or simultaneous malignancies (other than skin cancer) unless disease-free * medical illness preventing the use of taxane-based chemotherapy. * carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic. * previous or current medical or psychiatric illness that would prevent informed consent * patients known to be infected with hiv or a history of aids are excluded. * prior surgery for carcinoma of the cervix other than a biopsy. * patients with para-aortic disease. * previous pelvic radiation therapy or systemic chemotherapy is not permitted. * women who are pregnant or breast-feeding are excluded from this study. * previous history of hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80 must be excluded.
whole-body diffusion-weighted magnetic resonance imaging for staging and treatment prediction of lymphoma

Conditions: Lymphoma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma (Follicular, Diffuse B-cel Lymphoma, PTLD and Mantle Cel Lymphoma)

Summary: whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. these changes in water diffusion result in differences in signal intensity on diffusion-weighted-images that are quantified with the apparent diffusion coefficient (adc). in malignant lesions, the extravascular extracellular space (ees) will be diminished, due to the increased number of cells. this will restrict water diffusion, identified by increased signal intensity (si) on native dwi images and low adc. several studies indicate the value of dwi for differentiation of benign and malignant lymph nodes, detection of tumor recurrence and for adc-based prediction of treatment outcome in various solid tumours (koh dm et al, am j roentgenol 2007). patients with a new diagnosis of hodgkin or non-hodgkin lymphoma (only diffuse large b-cell lymphoma, follicular lymphoma, mantle cell lymphoma and ptld) will be included in the study. these patients will receive a wb-dwi scan before treatment, once or twice during treatment (depending on the type of lymphoma) and after the completion of the treatment. the mri scan will be performed on a 3 tesla-mri system without contrast administration and without exposing the patient to radiation. whole body diffusion-weighted images will be prospectively interpreted by two experienced radiologists, blinded to all clinical and imaging data. findings will be correlated to fdg-18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose , biopsies performed in clinical routine (bone marrow always - soft tissue lesions if indicated) and imaging follow-up. the purpose of this study is: * to evaluate whole body diffusion-weighted imaging for staging of lymphoma * to evaluate whole body diffusion-weighted imaging as an early predictive biomarker for treatment outcome * to evaluate whole body diffusion-weighted imaging for differentiating residual tumor from post therapy changes


Eligibility criteria:
inclusion criteria: * every patient with a new diagnosis of hodgkin or non-hodgkin lymphoma (only diffuse large b-cel lymphoma, mantle cell lymphoma, follicular lymphoma and ptld) exclusion criteria: * patient with general contraindications for mri (pacemaker, claustrophobia, etc.) * patients with a type of lymphoma other than those described in the inclusion criteria
interest of instantaneous fluctuations of pupillary diameter for pain evaluation in intensive care sedated patients.

Conditions: Intubation Complication

Summary: new pain assessment parameter, called the variation coefficient of pupillary diameter (vcpd) described. this parameter allows evaluating the pain of patients during uterine contractions in obstetrical labor, and postoperatively in recovery room. this parameter also allows evaluating the level of pain in intensive care unit (icu), in intubated or tracheotomized patients moderately sedated (riker score 3 or 4).

this study propose to recalculate the variation coefficient of pupillary diameter (vcpd) from pupil recordings performed in the intensive care unit (icu) in 2015-2016 and kept in the patients' records. from there, the variation coefficient of pupillary diameter (vcpd) will compare to the behavioral pain scale (bps), considered the gold standard pain assessment

Eligibility criteria:
inclusion criteria: * hospitalized in the surgical intensive care unit (icu) of the university hospital of saint-etienne between september 2015 and august 2016 for medical-surgical pathologies * requiring orotracheal intubation or tracheostomy * and presenting a riker sedation score of 3 or 4. exclusion criteria: * cerebral palsy * curarization * paraplegia or tetraplegia * intensive care neuromyopathy * ocular pathology * history of severe dysautonomic disease that could influence the evaluation of the behavioral pain scale (bps) or variation coefficient of pupillary diameter (vcpd) score * receiving antiarrhythmic treatment that could make the interpretation of the results difficult * on metoclopramide, droperidol, clonidine, or dexmedetomidine, which are known to alter the pupil dilation reflex.

Keywords: fluctuation of pupillary diameter variation coefficient of pupillary diameter pain monitoring behavioral pain scale videopupillometer intensive care unit
lorazepam for the treatment of status epilepticus in children

Conditions: Status Epilepticus

Summary: the purpose of this study is to gather the data to: 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. part 1 is a pharmacokinetic study (study of how much drug is found in the body after it is given through a vein and how fast the body gets rid of the drug).

lorazepam is in a class of drugs called benzodiazepines that is used to treat seizures. lorazepam has been widely used to treat children who have repeated or long seizures, a condition known as status epilepticus (se). however, lorazepam is not currently approved by the fda for use in children under 18 years of age. therefore, the purpose of this study is to gather the data needed for fda approval. specifically, we will 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. part 1 is a pharmacokinetic study. these are studies designed to identify and describe one or more of the following basic pharmacological concepts in humans: absorption (i.e. how much gets into the body); distribution (i.e. where it goes in the body); and metabolism and elimination (i.e. how the body gets rid of the medication and how long it takes). the study procedures involve taking blood samples from children, taking their vital signs, and conducting physical examinations. informed consent will be obtained from all participants as required by federal guidelines. patients will be divided into two groups. the first group will be patients who present to one of the 10 participating emergency rooms (ers) in status epilepticus (repeated or continuous seizures). we will either ask for consent in the er, or if we know they have a seizure disorder and have frequent visits to the er, consent them beforehand for future visits to the er. the second group will include patients who have a known seizure disorder and agree to be electively admitted to the hospital for a dose of lorazepam when they are not having seizures. we will draw blood samples from patients for up to 48 hours and then follow up via telephone for 30 days from the day the medication was given to assess for side effects.

Eligibility criteria:
inclusion criteria: * generalized tonic clonic seizures within 1 hour or 2 or more generalized tonic clonic seizures in rapid succession with no recovery of consciousness between seizures or a single ongoing generalized tonic clonic seizure which has lasted at least 5 minutes exclusion criteria: * inability to obtain informed consent or assent * sustained hypotension * significant arrhythmia * known hypersensitivity to or contraindication to use of benzodiazepines * use of lorazepam within 4 days of study drug dosing * american association of anesthesiology (asa) class \> 1

Keywords: children status epilepticus lorazepam safety pharmacokinetics status epilepticus in children
the relationship between arterial stiffness and pulmonary and extrapulmonary features in ankylosing spondylitis

Conditions: Ankylosing Spondylitis (AS)

Summary: the aim of this study was to investigate the relationship between arterial stiffness and pulmonary and extrapulmonary features in patients with ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: * diagnosis of ankylosing spondylitis according to asas diagnostic criteria * being aged 18-65 * stable medication use for at least 3 months * voluntary participation in the study exclusion criteria: * having uncontrolled cardiopulmonary disease * being pregnant * having undergone recent surgery * presence of malignancy * failure to perform to assessments