Kornimate/medical-research-clean huggingface dataset:
comparative performance of molecular breast imaging (mbi) to magnetic resonance imaging (mri) of the breast in identifying and excluding breast carcinoma in women at high risk for breast cancer

Conditions: Breast Cancer

Summary: to evaluate the diagnostic performance of tc99m sestamibi (mbi) compared to breast mri in women who are at high risk for developing breast cancer. to assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in mbi detected cancers.

primary objective: -to compare the diagnostic performance of molecular breast imaging (mbi) to breast magnetic resonance imaging (mri) in women who are at high risk of developing breast cancer. secondary objectives: * to evaluate the sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv) of mbi compared to breast mri in women who are at high risk of developing breast cancer. * to assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire (see addendum). * to assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to mbi lexicon \[1\].

Eligibility criteria:
inclusion criteria: * the subjects to be studied will include female patients ages 18 and older of any race, identified as carrying an elevated risk for breast cancer referred to mdacc. * high risk may be defined as having a calculated lifetime risk \>20%, histopathology of lobular neoplasia or atypical ductal hyperplasia, atypia nos or a genetic mutation known to predispose the patient to breast cancer. * subject who are scheduled for a breast mri who are willing to participate fully in all aspects of the study including completing both a breast mri \& mbi screening exam within a two-week time window, a biopsy of any positive findings and complete a post examination survey. consent for the enrollment may be obtained upon scheduling the mri examination. for non-english speakers, a language interpreter will assist in translation. * written consent will be obtained from all participants to obtain mbi of the breasts and biopsy as indicated, based on findings. all participants will be asked to provide a post examination survey of their experience with both tests. exclusion criteria: * subjects who are pregnant will be excluded as mbi exam involves injection of radioactive tracer * contrast enhanced mri involves gadolinium injection, both of which are contraindicated during pregnancy.
a phase 2a study of biib074 in the treatment of erythromelalgia

Conditions: Primary Inherited Erythromelalgia

Summary: the primary objective of the study is to investigate the efficacy of repeat oral dosing of biib074 on paroxysmal pain in participants with primary inherited erythromelalgia (em). the secondary objective of the study is to investigate the efficacy of repeat oral dosing of biib074 on varying additional aspects of pain in participants with em; and to investigate the safety and tolerability of repeat oral dosing of biib074 in participants with em.

this study was previously posted by convergence pharmaceuticals, ltd., which has been acquired by biogen.

Eligibility criteria:
key inclusion criteria: * a diagnosis of primary inherited em with family history of em made at least 3 months from initial diagnosis. * failed at least one prior treatment for em (defined as an inadequate response or intolerance to treatment). * approved concomitant medications must have been stable for at least 4 weeks prior to day 1. key exclusion criteria: * positive screening hepatitis b surface antigen or positive hepatitis c antibody result. * received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to day 1. * males whose partner is pregnant. * failed at least one prior treatment for em (defined as an inadequate response or intolerance to treatment). note: other protocol defined inclusion/ exclusion criteria may apply.
treatment of adult attention deficit hyperactivity disorder (adhd) in methadone patients - 1

Conditions: ADHD; Opioid-Related Disorders; Cocaine Dependence

Summary: the purpose of this study is to treat adult attention deficit hyperactivity disorder (adhd) in methadone patients.

this project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of mph and bpr, relative to each other and to placebo, for treating persistent adhd in methadone-maintained patients. one hundred and twenty subjects, will be randomized to receive either mph, bpr, or placebo with equal probability. randomization will be stratified by site, and whether or not cocaine is also being used. efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of adhd symptoms and overall functional status.

Eligibility criteria:
inclusion criteria: * individuals who meet dsm-iv criteria for opiate dependence and are currently maintained on methadone * patients must meet dsm-iv criteria for persistent adult adhd * must be on stable methadone dose for at least 3 weeks * individuals positive for hiv will not be excluded. exclusion criteria: * patients meeting dsm-iv criteria for current psychiatric disorders (other than adhd or substance abuse) which requires psychiatric intervention * patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use * individuals diagnosed with other forms of adult adhd other than persistent, particularly substance-induced adhd * those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (sbp \>160, dbp\>100, pulse \>110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ecg, glaucoma, or history of urinary retention or seizures, or advanced aids will not be included * patients who are taking prescription psychotropic medications other than methadone * patients who have exhibited suicidal or homicidal behavior within the past two years * patients with known sensitivity to mph or bpr * patients with cognitive impairment or who cannot read or understand the self-report assessment forms unaided or are so severely disabled they cannot comply with the requirements of the study. * patients unable to give full and informed consent * patients with a history of an eating disorder * patients recently convicted of a violent crime. (last two years) * nursing mothers and pregnant women

Keywords: adhd cocaine treatment methadone
fractional co2 laser assisted photodynamic therapy

Conditions: Actinic Keratosis; Basal Cell Carcinoma

Summary: nodular basal cell carcinomas: compare the efficacy and safety of conventional versus fractional laser assisted pdt for difficult to treat nodular cell carcinomas in the face. actinic keratosis: compare the efficacy and safety of conventional versus fractional laser assisted pdt for moderate to severe actinic keratoses located in the face and on the hands.


Eligibility criteria:
inclusion criteria: * age 18 or older * skin type i-iii * fertile women using secure birth control * moderate to severe actinic keratoses in the face or on the hands, * difficult to treat nodular basal cell carcinomas in the face exclusion criteria: * pregnancy or breast feeding patients * patients with porphyria * patients with gorlins syndrome * patients with a tendency to produce hypertrophic scars or keloids * patients with known allergy to metvix * patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.) * patients with pigmented or morphea basal cell carcinomas * know herpes simplex virus infection in treatment areas

Keywords: moderate to severe actinic keratoses difficult to treat nodular basal cell carcinomas
an observational study evaluating patient satisfaction and quality of life associated with switching insulin

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch. the additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.


Eligibility criteria:
inclusion criteria: * are at least 18 years of age * according to the clinical judgement of the investigator have been diagnosed with type ii diabetes * have presented within the normal course of care * at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other * are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study * have been fully informed and have given their written consent for the use of their data * have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires exclusion criteria: * no specific exclusion criteria exist for this study
use of desmopressin prior to graft kidney biopsy in patients with high risk of bleeding

Conditions: Bleeding; Transplant, Kidney; Desmopressin; Kidney Biopsy

Summary: the goal of this study is to evaluate the efficacy and safety of desmopressin to prevent bleeding after percutaneous renal graft biopsy in patients at high risk of bleeding. researchers will compare desmopressin (ddavp) to placebo to see if the drug reduces the risk of bleeding events related to kidney biopsy. participants will receive intravenous desmopressin medication (100ml) or placebo (100ml of saline solution) before the kidney biopsy.


Eligibility criteria:
inclusion criteria: * kidney transplant patients with gfr \&lt;60ml/min/1,73m² * need for graft biopsy as indicated by the kidney transplant medical team * platelets \&gt;80.000 cells/mm³ * blood pressure levels controlled before the procedure * normal coagulogram levels exclusion criteria: * pregnant women * prior history of allergic reaction to ddavp * use of prohibitive medications in screening: warfarin, direct oral anticoagulants, unfractionated and low molecular weight heparin in full anticoagulation doses * history of previous blood dyscrasias
severe complications triplicate the costs of major surgical procedures

Conditions: Major Surgical Procedures

Summary: the purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.

to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality

Eligibility criteria:
inclusion criteria: * undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) exclusion criteria: * missing data of in-hospital costs * mortality

Keywords: clinical outcome (complications), in-hospital costs the influence and impact of postoperative complications on in-hospital costs
bitter tastants and reflux

Conditions: Gastro Esophageal Reflux

Summary: recently the relationship between intragastric pressure (igp) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (gerd) patients and in healthy volunteers. ingestion of a meal was accompanied by a drop in igp. however, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (tlesrs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in igp was associated with a higher rate of reflux events and vice versa. this finding suggests that a smaller meal-induced drop may act as a trigger for reflux. it has been demonstrated that bitter administration leads to a smaller meal-induced drop. therefore, bitter can be a dietary trigger for tlesrs facilitating the occurrence of symptoms of gerd. to evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of tlesrs and reflux events in healthy volunteers. additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of tlesrs, via a change in gastric tone.


Eligibility criteria:
inclusion criteria: * healthy female volunteers * age between 18 and 65 * written informed consent exclusion criteria: * a history of any upper gi symptoms or gi surgery; * psychological disorders; * concomitant use of other medication or treatments except for oral contraceptives; * use of medication altering esophageal or gi motility; * pregnant or nursing women.

Keywords: bitter tlesrs gastric tone
effects of ofatumumab treatment on immune cells and meningeal lymphatic drainage in patients with demyelinating diseases

Conditions: Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder; Demyelinating Diseases of the Central Nervous System

Summary: this is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (rms) or neuromyelitis optica spectrum disorder (nmosd) after receiving ofatumumab treatment over an observational period of 12 months.

this is an uncontrolled, prospective, observational cohort study in patients with rms or nmosd who will receive ofatumumab treatment over an observational period of 12 month. ofatumumab was administrated 20mg by subcutaneous injection on days 1, 7 and 14 for initial loading, followed by monthly infusion up to 12 months. dynamic contrast-enhanced magnetic resonance imaging (dce-mri) will be performed to assess meningeal lymphatic flow in participants before and after ofatumumab treatment.the change of immune cell landscape in rms or nmosd patients after receiving ofatumumab treatment will be monitored by mass cytometry (cytof). assessments also include clinical assessments( clinical relapse rate and edss score) and mri assessments (t2 lesion load, t1 gadolinium enhancing lesion number).

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. rrms subtype according to 2017 mcdonald diagnostic criteria 3. diagnosis of nmosd according to the 2015 international panel diagnostic criteria for nmosd with aqp4-igg 4. newly diagnosed with ms/nmosd and initiating ofatumumab treatment within the next 3 months exclusion criteria: 1. hypersensitivity to trial medications 2. history of life-threatening reaction to ofatumumab 3. acute or uncontrolled chronic medical condition 4. have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, claridbine, etc.) 5. impaired hearing 6. claustrophobia 7. 300 lbs of greater (weight limit of mri table) 8. pregnancy or breastfeeding 9. sensitivity to imaging agents 10. contraindications to mri 11. use of benzodiazepines, topiramate, doxycycline, mynocicline

Keywords: multiple sclerosis neuromyelitis optica spectrum disorder demyelinating diseases ofatumumab meningeal lymphatic drainage
study of seroprevalence of anti-sars-cov2 among children of hospital workers in ap-hp

Conditions: SARS-CoV2

Summary: the purpose of this study is to define seroprevalence of anti-sars-cov2 among children of hospital workers in aphp, particularly exposed population, according to parents' sars-cov2 serological status.


Eligibility criteria:
inclusion criteria: hospital workers : 1. individuals aged over 18, having a professional activity at the aphp (employees, interns, volunteers) 2. affiliated to a social security regimen 3. have at least one child under the age of 18 living in the same house. 4. have signed consent child (ren), spouse and other member (s) residing at household: child (ren), spouse and any other member residing in the household of a professional of the paris center hospitals meeting the inclusion criteria above. exclusion criteria: refuse to participate in research

Keywords: sars-cov2 covid-19 serology hospital workers children
snp-based prediction of oral mucositis risk in patients receiving hematopoietic stem cell transplants (hsct)

Conditions: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Multiple Myeloma

Summary: the goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following hsct. the study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.

subjects will be provided with a saliva collection kit which can be used at home. subjects will return the collection kit in a paid, pre-addressed mailer to the laboratory at biomodels. the laboratory will isolate and store the dna located in the cells of the saliva. a portion of this dna will be used to analyze the different forms of genes. the remainder of the dna will be destroyed when this study is completed. biomodels will not be provided with patient identifiers. the investigators will also collect information from medical records, including information about diagnosis, treatment, stem cell transplantation and post-transplantation outcomes. this information will be de-identified.

Eligibility criteria:
inclusion criteria: * have given informed consent to submit a sample of saliva for dna isolation and snp analysis * have undergone autologous hsct for treatment of hodgkin's or non-hodgkin's lymphoma or multiple myeloma at the dana-farber cancer institute from 1/1/2006 through 6/30/2010 * have medical records identifying whether the participants did or did not develop severe mucositis exclusion criteria: * received palifermin (kepivance) prior to their conditioning regimen

Keywords: stem cell transplant mucositis
subclinical cardio-toxicities evaluation with strain rate echocardiography after chemotherapy and/or mediastinal radiotherapy in patient with lymphoma

Conditions: Lymphoma, Non-Hodgkin; Hodgkin Lymphoma; Toxicity, Cardiac

Summary: treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. complete echocardiographic assessment including 2-dimension global longitudinal strain (2d-gls), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. the aim of cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2d-gls.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of hodgkin disease (hd) or primary mediastinal b-cell lymphoma (pmbcl) or diffuse large b-cell lymphoma (dlbcl) * disease requiring treatment with anthracycline containing regimen only (cohort a) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort b) * written informed consent exclusion criteria: * age \> 70 years * unable to perform anthracyline containing regimen * previous treatment with mediastinal radiotherapy * kidney failure (defined as creatinine x2 unl) or liver failure (defined as ast and alt x2 unl) * ecog ps \> 2 * echocardiographic acoustic windows not suitable for strain evaluation * any other conditions or situations preventing patients to sign informed consent

Keywords: strain-rate echocardiography chemotherapy radiotherapy, mediastinal lymphoma hodgkin
cervical preparation before dilation and evacuation

Conditions: Abortion, Induced

Summary: the purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion. * osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix * osmotic dilators plus mifepristone, a medicine that is swallowed * osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum hypotheses: * adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer. * adding oral mifepristone at the time of laminaria placement will confer a similar benefit. * the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents. * significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences. * patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.


Eligibility criteria:
inclusion criteria: * 18 years and older * able to give informed consent * medically eligible for outpatient second trimester pregnancy termination at the clinical site * english-speaking or spanish-speaking at sites with ability to obtain informed consent in spanish exclusion criteria: * active bleeding (\>1 pad/hour) or hemodynamically unstable at enrollment * signs of chorioamnionitis or clinical infection at enrollment * signs of spontaneous labor or cervical insufficiency at enrollment * spontaneous intrauterine fetal demise * patient incarcerated * allergy to mifepristone or misoprostol * chronic steroid use or adrenal insufficiency * porphyria * inflammatory bowel disease requiring treatment

Keywords: abortion, induced