Kornimate/medical-research-clean huggingface dataset:
validation of strasbourg environmental exposure chamber alyatec in cat allergic subjects with asthma

Conditions: Allergic Asthma; Allergy; Allergy to Cats

Summary: this is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the alyatec environmental exposure chamber (eec). the study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in alyatec eec.


Eligibility criteria:
inclusion criteria: * subjects having signed the informed consent * subjects affiliated to a social security scheme * non-specific bronchial hyperreactivity (hrbns) assessed by a positive methacholine test * fev1 value \> 70% of theoretical fev1 value * asthma control test (act) ≥ 20/25 in 4 weeks prior to eec exposure * women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception. group a: * cat allergic asthma (gina 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat. * positive skin prick-test to cat allergen extract (wheal diameter \>3 mm compared to the negative control) specific immunoglobulin e (ige) for cat allergen \> 0.7 ku/l group b: * mild allergic asthma (gina 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis. * negative skin prick-test and specific ige for cat allergen * positive skin prick-test and specific ige for another allergen. exclusion criteria: * uncontrolled asthma, act asthma control questionnaire less than 20, in the last 4 weeks * uncontrolled asthma 2 weeks after interruption of laba * long-term treatment by laba, within 2 weeks prior to inclusion * existence of a severe obstructive syndrome with fev1 \<70% of the theoretical value * obstruction triggered by spirometric evaluations * hospitalization for asthma or exacerbation in the last 4 weeks * subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study * history of severe acute asthma requiring hospitalization in intensive care or intubation * subjects treated with biotherapy in the 4 months prior to inclusion in the study * presence of a cat at home, or daily exposure to cat allergens * desensitization to cat allergens in the last 6 months * active tobacco: plus 10 cigarettes / day or tobacco history plus 10 pa

Keywords: cat allergy allergic rhinitis allergy
evaluation of post-dural puncture headache in female patients undergoing obstetric and non-obstetric surgery

Conditions: Post-Dural Puncture Headache

Summary: the goal of this observational study is to compare the incidence, severity, and potential risk factors for post-dural puncture headaches (pdph) in obstetric and non-obstetric female patients undergoing spinal anesthesia. the main questions it aims to answer are: are there differences between these two groups? are there contributing factors? researchers will compare obstetric and non-obstetric patients to see if pregnancy affects female patients in context of pdph. participants will be monitored periodically for pdph development. the frequency and severity of headaches will be assessed using the numerical rating scale (nrs) and wong-baker scale. additionally, the need for medical consultations and any complications arising from pdph will be recorded.

after obtaining informed consent, eligible patients will be included in the study. demographic data and headache history will be recorded, and preoperative anxiety levels will be assessed using the state-trait anxiety inventory (stai). in the operating room, patients will be monitored with electrocardiography, pulse oximetry, non-invasive blood pressure, and pleth variability index (pvi) sensors. baseline measurements, including peak heart rate (hr), peripheral oxygen saturation (spo2), systolic (sbp) and diastolic blood pressure (dbp), mean arterial pressure (map) and pvi will be recorded. measurements will be repeated at five-minute intervals for the first 30 minutes of the operation and at 15-minute intervals thereafter. following spinal anesthesia, procedural details such as the experience level of the practitioner, patient positioning, needle brand, type and size, number of attempts, puncture level, and anesthetic dose will be documented. patients will be monitored periodically for pdph development. the frequency and severity of headaches will be assessed using the numerical rating scale (nrs) and wong-baker scale. additionally, the need for medical consultations and any complications arising from pdph will be recorded.

Eligibility criteria:
inclusion criteria: * female patients aged 18-65 years undergoing surgery under spinal anesthesia * patients classified as asa i or ii according to the american society of anesthesiologists (asa) classification exclusion criteria: * asa iii and above patients * patients requiring intensive care unit (icu) admission * patients with mental retardation * patients with communication difficulties (e.g., hearing loss, speech impediments, language barriers) * conversion to general anesthesia due to pain after spinal anesthesia * emergency surgeries
chemotherapy and monoclonal antibody therapy in treating patients with b-cell non-hodgkin's lymphoma that has relapsed following peripheral stem cell transplantation

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. purpose: phase ii trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with b-cell non-hodgkin's lymphoma that has relapsed following autologous peripheral stem cell transplantation.

objectives: * determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-hodgkin's lymphoma following autologous peripheral blood stem cell transplantation. * assess the response rate and duration of response to this regimen in these patients. outline: patients receive rituximab iv weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine iv on weeks 2-4, 6-8, and 10-12. patients who achieve partial response may continue on vinorelbine from week 14 until disease progression. patients are followed until disease progression. projected accrual: a total of 18-25 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * patients with b-cell lymphoma, relapsing after high dose chemotherapy and autologous stem cell transplantation or allogeneneic stem cell or bone marrow transplant * age \> 18 years old * adequate hematologic function, as manifested by anc \> 1000/mm3 and platelet count \> 40,000/mm3 * ps who: \< 3 exclusion criteria: * patients with serum creatinine \> 2 mg%, transaminases (alt, ast) \> 3 times upper normal value, direct bilirubin \> 2 mg%, unless they result from tumor involvement * pregnant or lactating females * history of myelodysplastic syndrome * uncontrolled cns disease * active serious infection * history of refractoriness to vinorelbine. however, prior treatment with rituxan is not an exclusion (synergy may still occur)

Keywords: waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma splenic marginal zone lymphoma
mucormycosis in covid-19

Conditions: Covid19; Mucormycosis; Aspergillosis; Candida Infection

Summary: the purpose is to allow phsyician reporters to contribute to munco registry. mucormycosis in covid-19 is a rapidly escalating medical emergency reported in high numbers in india during the ongoing coronavirus surge. there is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (covid-19). in light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication


Eligibility criteria:
inclusion criteria: diagnosed case of mycotic infection in covid-19 exclusion criteria: * none
economic impact of switching from metoprolol to nebivolol for hypertension treatment

Conditions: Hypertension

Summary: this is a retrospective data analysis of patients with high blood pressure (hypertension) who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum of 6 month to treat hypertension. these patients will be identified from a large medical claims database. this study tests the hypothesis (alternative, higher or lower) that average patient monthly health care administrative cost changes after switching from metoprolol to nebivolol.


Eligibility criteria:
inclusion criteria: * be at least 18 years old at initiation of metoprolol (or first date on metoprolol treatment between 2007 and 2011) * had one or more inpatient or outpatient claims with a primary or non-primary diagnosis of hypertension (icd-9-cm 401.xx-405.xx) * received nebivolol treatment continuously (defined as supply gap \<30 days) for at least 6 months after initiation * received metoprolol treatment continuously for at least 6 months prior to switching to (initiation of) nebivolol (defined as metoprolol was discontinued whereas a prescription for nebivolol was filled) * had at least 12 months of continuous enrollment (as verified using enrollment file): 6 month prior to nebivolol initiation and 6 months following nebivolol initiation.

Keywords: hypertension health care cost monthly health care cost
adjunct vr pain management in acute brain injury

Conditions: Traumatic Brain Injury; Headaches Posttraumatic; Trauma; Pain, Acute

Summary: severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. in this study, the investigators will use virtual reality (vr) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. the investigators hypothesize that vr therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries, including tbi.

each participant will undergo one vr session and two control sessions. the vr session will take place in a commercially available vr environment, the blu, and last 20-30 minutes (vr blu). the control sessions will include a 2d-tablet based session that mimics the vr content (tablet blu) and a content-less placement of the vr headset (vr blank). the order of these sessions will be randomized across participants are intended to complete all sessions. each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. these scales will help us determine which patient-level factors predict response to vr. before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. pre- and post-vr opioid use will be recorded. basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. advanced measures of autonomic response will include heart rate variability,,and pupillometry metrics. at the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using vr (perceived effectiveness)

Eligibility criteria:
inclusion criteria: * diagnosis of traumatic injury (including but not limited to traumatic brain injury) * age greater than or equal to 18 years-old * endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours. * glasgow coma scale of 15 * expected to stay in the hospital for at least 12 hours after enrollment exclusion criteria: * seizure prior to enrollment * pregnancy * non-english speaking * known intolerance of virtual reality * patient unable to consent for themselves
evaluation of postoperative pain after endodontic retreatment using different working length determination methods: a randomized clinical trial

Conditions: This Study Compares the Effects of Two Working Length Methods on Postoperative Pain in Single-rooted, Single-canal Teeth During Root Canal Retreatment

Summary: the aim of this study is to compare the effects of two different working length determination methods on the incidence of postoperative pain in single-rooted, single-canal teeth undergoing root canal retreatment (rcr). sixty-four previously treated, single-rooted, single-canal teeth, which were determined to require rcr based on clinical symptoms and radiographic findings, were randomly and equally divided into two groups and included in the study. two distinct working mechanisms of an integrated endodontic motor with an apex locator were used in our study. one method involved simultaneous determination of the working length during canal shaping, while the other method determined the working length with a hand file after the canal filling was removed. after the session in which the methods were applied and the working length was determined, participants' pain levels were recorded using a visual analog scale (vas) at 6-12 hours and on days 1-2-3-4-5-6-7.


Eligibility criteria:
inclusion criteria: healthy volunteers aged between 18 and 65 with no systemic diseases. teeth without acute apical abscess. single-rooted and single-canal teeth that have previously undergone root canal treatment, failed, and require re-treatment (diagnosed based on clinical symptoms and radiographic findings). individuals with preoperative pain rated 50 or lower on the 100 mm vas scale exclusion criteria: individuals with systemic diseases or allergic reactions. pregnancy and breastfeeding. teeth with open apex. teeth with internal or external root resorption. patients who have taken analgesic, anti-inflammatory, or antibiotic medications within the last twelve hours. teeth with broken instruments in the canal. individuals with bruxism problems.
healthy volunteer study using 3 different formulations of firategrast

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study will investigate how 3 types of drug formulations are absorbed by the body. this study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. the study is split into 2 parts. part 1, involves volunteers receiving 2 new formulations, as a single dose. there is no placebo (dummy-drug; no active ingredient) in this study. volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. the new fomulations will be administered with food and the reference formulation will be given without food. in part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. each of these doses will be given with food.

the present study will be conducted in two parts in healthy male volunteers. part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. subjects will receive each formulation in a randomised 3-way single dose crossover fashion. part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.

Eligibility criteria:
inclusion criteria: * male aged 18 to 65 yrs inclusive * healthy, as determined by study physician * capable of giving iformed consent exclusion criteria: * positive drugs of abuse result * positive for hiv or hepatitis b and/or c viruses * history of alcohol consumption in excess of average recommended weekly intake (more than 12 units for males) * participation in a clinical trial within 30 days of scheduled first dose

Keywords: firategrast pharmacokinetics, modified release, firategrast, simulated gastro-retentive pharmacokinetics healthy volunteers, simulated gastro-retentive healthy volunteers modified release
system for determining ideal drug doses for adhd - stages 1 and 2

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the goal of this study is to create a formal, quantitative methodology to determine what is the most beneficial dose of central nervous system (cns) stimulant (ritalin, methylphenidate) to improve cognitive and behavioral function of children diagnosed with attention deficit hyperactivity disorder (adhd) individually. if successful, it will change the way in which the dose of cns stimulant for treating adhd is determined for children in need of therapeutic intervention. the project will be focused on developing the necessary methodology to analyze the children's data with the drift-decision model (ddm), and to develop the required technology, i.e., a computer game with which to measure cognitive/behavioral function and its validation with eye-tracking measurements.


Eligibility criteria:
inclusion criteria: * 8-12 years of age; * accompanied by caregiver (parent or legal guardian); * able to understand and speak english; * able to read basic english; * no counseling or current/past history of psychiatric illness, as confirmed by the child behavior checklist (cbcl) and conner's rating scale exclusion criteria: * active psychosis or suicidality * history of primary psychotic disorder (e.g., schizophrenia) or bipolar disorder * recent (past 2 weeks) substance abuse or dependence * history of brain damage or significant developmental delay * unstable medical condition such as newly diagnosed type i diabetes or rheumatoid arthritis * use of oral steroids * participation in the last 30 days in a clinical study involving an investigational drug * current use of a psychotropic medicine
pharmacologic impact on sedation assessments

Conditions: Pediatric Acute Lung Injury

Summary: pisa is an ancillary study to the nih funded clinical restore trial (u01 hl086622). this study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

pisa is an ancillary study to the nih funded clinical restore trial (u01 hl086622). this project will use sophisticated modeling and simulation techniques to evaluate the impact of genetics and other variables such as degree of illness, age, weight and organ dysfunction on the pharmacokinetics and pharmacodynamics of morphine and midazolam in children who are mechanically ventilated for respiratory failure, and require sedation. this proposed work will allow the design of a pharmacologic model that can be used to individualize therapy in children requiring mechanical ventilation with the goal of optimizing sedation while minimizing the duration of mechanical ventilation. this study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Eligibility criteria:
inclusion criteria:• enrolled in restore clinical trial * be greater than or equal to 7 kg * receiving morphine and/or midazolam continuous infusions * give informed consent/assent exclusion criteria: * intubated and mechanically ventilated for immediate post-operative care and stabilization * cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt * history of single ventricle at any stage of repair * congenital diaphragmatic hernia or paralysis * primary pulmonary hypertension * critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass) * ventilator dependent (including noninvasive) on pediatric intensive care unit (picu) admission (chronic assisted ventilation) * neuromuscular respiratory failure * spinal cord injury above the lumbar region * pain managed by patient controlled analgesia (pca) or epidural catheter * family/medical team has decided not to provide full support (patient treatment considered futile) * enrolled in any other sedation clinical trial concurrently or within the last 30 days * known allergy to any of the study medications.

Keywords: sedated intubated mechanically ventilated pediatric lung injury
lifezig personalized reminiscence video with slideshows and music for individuals with alzheimer's and dementia

Conditions: Alzheimer's Disease; Dementia

Summary: the lifezig project is a research study of a new reminiscence activity for individuals with alzheimer's disease (ad) and other types of dementia, based on the lifezig system, with personalized video channels containing old photographs and music on television. the goal of the lifezig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.

this program creates personalized tv channels with old photographs of ad patients, music, narration and relaxing sounds; as an activity to relax dementia patients.

Eligibility criteria:
inclusion criteria: * inclusion criteria for dementia patients: * documented diagnosis of probable alzheimer's or other type of dementia, medically stable, and visual/hearing capabilities to watch television. * inclusion criteria for family members/caregivers: * provide care or be a family member of dementia patient, have knowledge of the person, and be able to provide old photographs of dementia patient.