Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of metal panel allergens: mercury, aluminum and palladium dose response study

Conditions: Contact Dermatitis

Summary: the purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.

this is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of mercury, aluminum and palladium in 20 adult subjects who have a clinical history of contact dermatitis and have had a past positive patch test to one of the allergens on this study. investigators and subjects will be blinded to the exact location of each dose within the allergen panel but will not be blinded to the allergen being tested, nor the range of allergen doses within each panel.

Eligibility criteria:
inclusion criteria: 1.15 years of age or older. 2. history of contact dermatitis. 3. positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate) or 3) palladium (sodium tetrachloropalladate and/or palladium chloride) within the past 10 years. 4. male or non-pregnant non-lactating female. female subjects must state, at visit one that they are not pregnant, not lactating nor are they intending to become pregnant for the course of the study. 5. has understood and signed the approved informed consent/assent form, which is consistent with all institutional, local and national regulations. assent form for all minor subjects (ages 15-17) must be signed by the guardian/parent. exclusion criteria: 1. breastfeeding or pregnant or intending to become pregnant for the course of the study. 2. topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study. 3. systemic treatment with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents during the 7 days prior to inclusion in this study. inhaled treatments are permitted. 4. treatment with ultraviolet (uv) light (including tanning) during the 3 weeks prior to inclusion in this study. 5. acute dermatitis outbreak or dermatitis on or near the test area on the back. 6. inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). 7. participation in a clinical trial of an investigational drug, treatment or device other than t.r.u.e. test during this study or 3 weeks prior to inclusion in this study. 8. an opinion of the investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.

Keywords: patch test allergy testing contact dermatitis mercury, aluminum or palladium skin allergy
effects of methylphenidate on cellular abnormalities in children with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with attention deficit hyperactivity disorder (adhd) treated for 3 months with either extended release methylphenidate or behavioral therapy.

this study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with attention deficit hyperactivity disorder (adhd) affects the frequency of chromosomal abnormalities.

Eligibility criteria:
inclusion criteria: * children of both genders, 6-12 years old * written informed consent by the parent and the patient (over 7) * diagnosis of adhd * age-appropriate cognitive functioning * all patients who had at least one post-baseline cytogenetic assessment in the core study can enter the observation phase. exclusion criteria: * history of malignant neoplasm * history of seizures (except childhood febrile seizures) * hyperthyroidism * concurrent medical condition which may interfere with study other protocol-defined inclusion/exclusion criteria may apply

Keywords: attention deficit hyperactivity disorder, adhd cytogenetic abnormalities, extended-release methylphenidate,
subcutaneous suppressive antibiotic therapy for bone and joint infections

Conditions: Bone Infection; Joint Infection

Summary: for patients having a bone or joint infections, with or without device, optimal surgical therapy could be sometimes non-feasible, especially in the elderly population. therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (psat) seems to be an option to prevent recurrence and prosthesis loosening. subcutaneous (sc) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care. the aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.


Eligibility criteria:
inclusion criteria: * patients having bone or joint infection, * patients with or without device treated by sub-cutaneous prolonged antibiotic therapy exclusion criteria: * diabetic foot osteomyelitis * pressure ulcer-associated osteomyelitis
a prospective study of a haptic device evaluation of the acute abdomen

Conditions: Acute Abdomen

Summary: the study hypothesis is a haptic sensor can aid in the evaluation of the acute abdomen. investigators from the msu department of surgery in collaboration with msu engineering are assessing the ability of a non invasive, optical device that is placed on a patients abdomen (much like an ultrasound transducer) to evaluate a patient with an acute abdominal presentation. conditions such as appendicitis, cholecystitis, diverticulitis or small bowel obstruction will be examined with the haptic device. data will be collected by the device and later compared to the abdominal findings recorded from an examination conducted by the principle investigator who is a surgeon. the surgeon will not have acess to data collected by the haptic sensor and therefore it will have no impact on the decision making process in the care of the patient. the impact on the individual patient will require obtaining a consent to participate in the study, a few minutes to place the device gently on the abdomen and collect the sensor data. there is no direct benefit to the patient by participating in the study. the potential for such a study may be to develop the technology to have a device that non-medical staff can use to collect patient data and transmit that data to a healthcare provider at another location.


Eligibility criteria:
inclusion criteria: * all patients referred to the msu acute care surgery service for the evaluation of abdominal pain. exclusion criteria: * under 18 years of age

Keywords: evaluation
outcomes of bariatric surgery/ummmc bariatric surgery registry

Conditions: Morbid Obesity

Summary: the purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at umass memorial medical center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

see brief summary

Eligibility criteria:
inclusion criteria: * must be scheduled for bariatric surgery @ ummmc exclusion criteria: * not scheduled for bariatric surgery @ ummmc

Keywords: morbid obesity obesity weight loss bariatric surgery
a post marketing surveillance study on pregabalin (lyrica) on efficacy, safety and tolerability of pregabalin

Conditions: Neuropathic Pain

Summary: this study is being conducted as a regulatory requirement post initial marketing authorization. this is primarily a safety study. this was an open label study and patients were enrolled once the decision to prescribe the medication was made by the investigator.


Eligibility criteria:
inclusion criteria: * male or female, 18 years old and above diagnosed with neuropathic pain. exclusion criteria: * patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Keywords: pregabalin neuropathic pain safety
caring connections: a program to alleviate social isolation and loneliness in individuals living with spinal cord injury

Conditions: Spinal Cord Injuries and Disorders (SCI/D)

Summary: this study will use a randomized controlled design with an active attention control group to evaluate an intervention intended to reduce social isolation and loneliness in persons with sci/d. the intervention, caring connections, is a peer-based intervention which is important because peers with sci/d play an important role in improving quality of life, mental health, and social health in persons with sci/d.

the overall study objective is to conduct and evaluate a fully powered randomized control trial (rct) to assess changes in loneliness and social isolation outcomes between the caring connections intervention and attention control condition in community-dwelling individuals with sci/d. the caring connections intervention (described in detail below) is a peer-based, facilitated, letter writing program designed to provide feelings of social connectedness and moments of positivity to reduce loneliness and social isolation in persons with sci/d.

Eligibility criteria:
inclusion criteria: * our target population will include adult veterans with chronic sci/d (duration of injury \> 1 year); this may include those with traumatic and non-traumatic sci/d, and may include sci, nonmalignant neoplasms resulting in neurologic deficit; vascular insults of a thromboembolic, hemorrhagic, or ischemic nature; cauda equina syndrome producing neurologic deficit; inflammatory disease of the spine, spinal cord, or cauda equina resulting in non-progressive neurologic deficit; and demyelinating disease of the spinal cord. exclusion criteria: * veterans with sci/d under the age of 18 will be excluded. individuals with new injuries (injury duration less than one year) will be excluded as it is plausible that social isolation and loneliness may more likely occur after the first year of injury when individuals have transitioned to the community and may no longer be surrounded by people consistently for help with their acute care needs (dickson 2011). there are no sci/d level or severity exclusions, as we wish to reach a diverse group of individuals.
efficacy of hydroxychloroquine prophylaxis for health care workers at high risk for covid-19

Conditions: COVID-19

Summary: the hcw prophylaxis (hcwp) study, single, open and off label intervention study. up to 350 participants will be assigned to group that takes hcq or group that opts to not take study medication. participants will be unm health system hcw at high risk for occupational exposure to sarscov- 2. study timepoints will include day 1 screening/enrollment, 30 day, 60 day, and 90 day assessments. questionnaires will be collected in all timepoints.

this is an open and off label use, interventional, single site study. the hcwp study eligibility are hcws at high risk for sars-cov-2 exposure (eg md/do, np, rn, and respiratory therapists in ed, pediatric ed, urgent care, pediatric urgent care and on covid-19 units) at unm health system meeting all inclusion criteria. total number of participants: 350 (group a and b) group a: up to 275 (hcw who choose to be provided hcq). will receive a 600 mg loading dose followed by 200 mg daily (tablets). group b: up to 75 (hcw who choose not to be provided hcq)

Eligibility criteria:
inclusion criteria: 1. men or women ≥18 years of age who are unm health system health care workers and are asymptomatic for known presenting symptoms of sars-cov-2: 2. unmhs hcws include: md/do, np, rn, and respiratory therapists working in ed, pediatric ed, urgent care, pediatric urgent care or on covid-19 units. study pi's will consider study enrollment of hcws from other settings, for example certain outpatient clinics or inpatient units. 3. are not positive for sars-cov-2 testing 4. willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures 5. willing and able to provide informed consent exclusion criteria: 1. known hypersensitivity to hcq or other 4-aminoquinoline compounds 2. currently hospitalized 3. symptomatic with subjective fever, cough, or sore throat 4. current medications exclude concomitant use of hcq, for example anti-arrhythmic agents, digoxin, cyclosporin, cimetidine, or tamoxifen. 5. concomitant use of other anti-malarial treatment or chemoprophylaxis 6. history of retinopathy of any etiology 7. psoriasis 8. porphyria 9. known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes \<1500) or thrombocytopenia (\<100k) 10. known liver disease 11. known long qt syndrome 12. use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period. there may be some exceptions to requiring a 30-day washout that will be evaluated by the co-investigators on a case by case basis.
swedish ibrance registries insights (siri)

Conditions: Malignant Neoplasm of Breast

Summary: the main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in swedish clinical practice.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. one or more (≥1) filled prescription of palbociclib (atc code: l01xe33) 2. age ≥18 years at index date exclusion criteria: there are no exclusion criteria

Keywords: metastatic breast cancer (mbc)
hong kong spinocerebellar ataxias registry

Conditions: Spinocerebellar Ataxia

Summary: spinocerebellar ataxias (sca) 1, 2, 3 and 6 are the most common, autosomal dominantly inherited cerebellar degenerations. and in the chinese population, the most common sca is sca3 and the frequency of sca 3 among sca patients is 72.5%, followed by sca 2 that the frequency is 12% among sca patients. for sca 1, the frequency among sca patients is 7%. even scas are rare diseases, a significant amount of chinese in hong kong still suffer from this disorders. sca association in hong kong has 88 members who are suffering from spinocerebellar degeneration, many of them have a genetic confirmation. as there are few treatments for scas; therefore, understanding scas clinical manifestation and disease mechanisms are the first step towards development of effective treatment. the objective of this study is to develop the first sca registry in hong kong with bio-repository bank for clinical and genetic information as well as serum and fibroblasts.

all the members from hong kong sca association will be invited and discuss the study with them. after obtaining the informed consent, their genotypes will be determined and collect clinical information. some of the participant will have clear genotyping via department of health. participants with a genetic confirmation of sca1, 2, 3, 6, 7, 8 and 12 genes will be included in the study. the relatives of genetically confirmed participants, who also had ataxic symptoms, might be included in the study without further determination of the genotypes. detailed clinical history including age of onset, clinical symptoms will be collected. a detailed neurological examination with an emphasis of eye movements (such as pursuit, saccadic, and convergence eye movements). we will also perform sara scale, a validated ataxia scale. timed 25 foot-walk test will be performed. two-year annual follow-up will be arranged for recruited subject for neurological physical examination, sara scale, in order to continue assessment for any progress change in disease stage.

Eligibility criteria:
inclusion criteria: 1. age 18 years and above 2. presence of symptoms and signs of ataxia 3. definite molecular diagnosis of sca1, 2, 3, 6, 7, 8 or 12 either in the participant or another affected family member 4. willingness to participate in the study and ability to give informed consent exclusion criteria: 1. known recessive. x-linked, and mitochondrial ataxias
efficacy and safety of elbasvir (mk-8742) + grazoprevir (mk-5172) in treatment-naïve/treatment-experienced (tn/te) french participants with hepatitis c virus (hcv) genotype 4 (gt4) infection (mk-5172-096)

Conditions: Hepatitis C Virus (HCV) Infection

Summary: the purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (fdc) of elbasvir (ebr) 50 mg + grazoprevir (gzr) 100 mg (i.e., mk-5172a) as assessed by the percentage of participants with hepatitis c virus (hcv) genotype (gt) 4 infection that achieve sustained virologic response (hcv ribonucleic acid \[rna\] \< lower limit of quantification \[lloq\]) 12 weeks after the end of study therapy (svr12). this study also evaluated the safety and tolerability of ebr/gzr.


Eligibility criteria:
inclusion criteria: * be a current resident of france * have hcv rna (≥ 10,000 iu/ml in peripheral blood) at the time of screening * have documented chronic hcv gt4 (with no evidence of non-typeable or mixed genotype) infection * have liver biopsy performed within 24 months of day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have fibroscan® performed within 12 months of day 1 of this study with interpretable result in kilopascals (kpa) as follows: fibrosis score of f0-f2, fibrosis score of f3, or cirrhosis (f4) * have a prior treatment history of either hcv tn or hcv te with interferon (ifn) +/- ribavirin (rbv) +/- sofosbuvir (sof) (on-treatment failure, relapser, or other/intolerant) * females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity or (2) use (or have her partner use) acceptable contraception during heterosexual activity * if human immunodeficiency virus (hiv) co-infected, then have hiv-1 infection documented prior to screening exclusion criteria: * had prior treatment (defined as 1 dose or more) with direct-acting antiviral (daa) therapy * has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease * classified as child-pugh b or c or has a child pugh-turcotte score (cpt) \> 6 * has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc * hepatitis b virus surface antigen (hbsag) positive at screening. participants who are hbsag negative and hepatitis b core antibody (anti-hbc) positive at screening may be included * under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
facilitating aftercare for alcohol detox patients

Conditions: Alcohol Abuse; Alcohol Dependence

Summary: the purpose of this study is to determine whether peer visits (known as "12th step calls") and professional counselors (using "motivational enhancement therapy") are effective helping alcoholics link to substance abuse treatment programs after being in the hospital for detox.

for those with an alcohol use disorder, the decision to seek detoxification treatment often represents a desire or willingness to change drinking behavior. this gives clinicians with the opportunity to intervene and improve the lives of these individuals. even patients admitted involuntarily or who have been coerced may be amenable to change. therefore, inpatient alcohol detoxification treatment offers an opportunity to prepare these patients for and link them with aftercare treatment. unfortunately, clinicians have little to guide them on how the current standard of care for alcohol detoxification might be improved. improvement in clinical practice is ideally driven by clinical research, but there is little recent published information to guide the development of evidence-based pharmacological or psychological practices or interventions in detoxification settings. as a result, alcohol detoxification treatment has changed little over the past 25 years. taken as a whole, the literature suggests that the outcomes of inpatient detoxification are less than optimal. a limited number of published studies suggest that a majority of these patients are not linked to any aftercare following inpatient detoxification treatment and return to drinking within a few weeks of hospital discharge. however, there is some evidence to suggest that interventions, performed while the patient is hospitalized, could encourage patients to initiate involvement in aftercare (i.e., professional treatment and/or mutual self-help following hospitalization) and to decrease drinking or initiate abstinence. motivational enhancement therapy and twelve-step facilitation are two interventions that show promise. the study proposed in this study addresses this issue by testing two brief interventions, motivation enhancement therapy (met) and peer-twelve step facilitation (p-tsf, also known as "12th step calls"), which have shown potential to enhance initiation of a period of abstinence and engagement in treatment and/or self-help programs among alcohol detoxification patients.

Eligibility criteria:
inclusion criteria: * male and female inpatients 18 years of age or older. * participants will have a current dsm-iv diagnosis of alcohol abuse or dependence. * able to understand/speak english * participants will have signed a witnessed informed consent. exclusion criteria: * cognitive impairment (e.g., mental retardation) * participants who meet current dsm-iv criteria for bipolar disorder, schizophrenia, or dementia * participants who are homeless, without contact person * participants enrolled in a methadone maintenance treatment program.

Keywords: detoxification treatment
role of regulatory t cells in pathogenesis of primary iga nephropathy

Conditions: Glomerulonephritis, IGA

Summary: along structural iga abnormalities, hyperproduction of iga is thought to play a role in the pathogenesis of primary iga nephropathy. cd4+cd25+fox3p regulatory t cells are instrumental in suppressing adaptative immune responses, including b cells production of immunoglobulins. we, the researchers at centre hospitalier universitaire de saine etienne, will test the hypothesis that iga production in patients with iga nephropathy is dysregulated because of a quantitative and/or qualitative defect of cd4+cd25+foxp3+ regulatory t cells.


Eligibility criteria:
inclusion criteria: * patients with pathogenesis of berger's disease confirmed by renal biopsy * glomerular filtration \> 60 ml/min/1,73m2 * written informed consent * patient affiliated to social insurance exclusion criteria: * immunosuppressor treatment within 6 months before the study inclusion * clinical infection within 2 months before the study inclusion * c-reactive protein (crp) \> 10 mgl-1

Keywords: iga kidney berger'disease regulatory t cells pathogenesis of berger's disease