Kornimate/medical-research-clean huggingface dataset:
pain and stress management for people with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: self-management of rheumatoid arthritis (ra) symptoms using written emotional disclosure (ed), coping skills training (cst), or a combination of both may benefit people with ra. the purpose of this study is to determine the benefits of ed, cst, or cst and ed together in adults with ra. this study will be conducted at wayne state university in detroit, michigan and duke university medical center in durham, north carolina.

two self-management strategies hold promise for improving the health of people with ra: ed (writing about stress, ra, and coping options) and cst (learning six pain and stress coping skills). a strategy integrating ed with cst may be more effective than either intervention alone. this study will compare the effectiveness of ed, cst, ed in combination with cst, and control groups in alleviating the symptoms of ra. this study will last until may 2009. participants with ra will be randomly assigned to 1 of 4 treatment groups. each participant will receive 3 writing sessions and 8 training sessions. group 1 will receive ed writing followed by cst; group 2 will receive ed writing followed by arthritis education; group 3 will receive health behavior writing followed by cst; and group 4 will receive health behavior writing followed by arthritis education. participants will be evaluated at baseline and at months 1, 4, and 12 for pain, physical disability, psychological impairment, and disease activity. in addition, participants will record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood prior to each of the evaluations. changes in health status over time will be compared among groups.

Eligibility criteria:
inclusion criteria: * meet american college of rheumatology (acr) 1987 criteria for ra exclusion criteria: * other disorders that would significantly affect function (e.g., lupus, chronic obstructive pulmonary disease \[copd\], congestive heart failure \[chf\], cancer) * judged by the physician to have cognitive impairment (dementia, retardation, psychosis) or illiteracy * has experienced recent (last 6 months) significant stressor resulting in substantial emotional instability * currently in psychotherapy or a formal behavioral pain management program * unable to walk. participants who use walking aids are not excluded. * physically unable to write

Keywords: stress coping expressive writing self-efficacy disclosure
an open-label, long-term extension study to evaluate the safety of cb-03-01 cream, 1% in participants with acne vulgaris

Conditions: Acne Vulgaris

Summary: the primary objective of this study is to determine the long-term safety of cb-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the phase 3 pivotal studies for a total treatment of up to 12 months.

this was a multicenter, open label, long-term extension study for cb-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the phase 3 pivotal studies \[cb-03-01/25 and cb-03-01/26\]. participants applies the active medication (cb-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator and desired by the participant, truncal acne for nine additional months of treatment. thus, overall participants were exposed to cb-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the phase 3 pivotal study and an additional nine months in this long-term safety study). participants treated facial acne per protocol for nine months. treatment of truncal acne was discussed by the investigator and participant. treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk). participants were rolled over from the phase 3 pivotal studies \[cb-03-01/25 and cb-03-01/26\] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Eligibility criteria:
inclusion criteria: * participant has successfully completed participation in one of the phase 3 pivotal studies \[cb-03-01/25 and cb-03-01/26\]. * participant agrees to use effective method of contraception throughout study, if applicable. * participant has provided written informed consent or assent. * participant is willing to comply with study instructions and return to the clinic for required visits. exclusion criteria: * participant is pregnant, lactating, or is planning to become pregnant during the study. * participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy. * participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study. * participant plans to use any other investigational drug or device during participation in this study. * participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients. * participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study

Keywords: acne clascoterone anti-androgen
sars-cov-2 otc at home test

Conditions: COVID-19 Pandemic

Summary: the objective of this study is to evaluate the 3eo health covid-19 test in individuals presenting at a medical facility. in eligible subjects, nasal samples will be collected for use with the 3eo health covid-19 test, which will be compared to the zymo® rrt-pcr test results obtained via samples specified by the manufacturer (e.g., an \[anterior nares\] swab) to determine accuracy of the 3eo health covid-19 test in detecting covid-19 in participants.

3eo health, inc. has developed the 3eo health covid-19 test, a unique rapid molecular test system, to detect sars-cov-2 virus in the otc setting using a dedicated test reader "3eo cube" to test nasal swab samples. early testing will help to determine limit of detection (lod) of the 3eo health covid-19 test and will be compared to a sensitive molecular test that has been authorized for emergency use by the fda. the 3eo health covid-19 test will leverage the processing and testing of the 3eo health swab device when inserted directly into the reaction tube (3eo key) where reverse transcription, loop-mediated isothermal dna amplifications (lamp) processing and sequence-specific probe technologies to detect segments of the sars-cov-2 genome are managed automatically by the 3eo health cube test reader.

Eligibility criteria:
inclusion criteria: 1. individuals suspected of covid-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive covid-19 test 2. individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian 3. individuals willing and able to provide informed consent or obtain consent from legal authorized representative (lar) exclusion criteria: 1. if symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite) 2. unable to provide consent or obtain consent from a lar 3. unwilling or unable to collect all sample types 4. enrolled in a study to evaluate an investigational drug 5. eating/drinking/smoking 30 minutes prior to specimen collection 6. prisoner or under incarceration 7. have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection
the effect of newspaper reporting on covid-19 vaccine hesitancy: a randomised controlled trial

Conditions: Vaccine Hesitancy

Summary: covid-19 vaccine hesitancy can be observed at different rates in different countries. 1,068 people were surveyed in france and italy to inquire about individual potential acceptance, focusing on time preferences, in a risk-return framework: having the vaccination today, in a month, and in 3 months; perceived risks of vaccination and covid-19; and expected benefit of the vaccine. a randomized controlled trial was conducted to understand how everyday stimuli, such as fact-based news about vaccines, impact on audience acceptance of vaccination. the main experiment involved two groups of participants and two different articles about vaccine-related thrombosis taken from two italian newspapers. one article used a more abstract description and language, and the other used a more anecdotical description and concrete language; each group read only one of these articles. two other groups were assigned categorization tasks; one was asked to complete a concrete categorization task and the other an abstract categorization task.

the goal of this rct is to learn how journalistic news can affect vaccine hesitancy. 2 cohorts of unvaccinated individual, one italian, one french. 5 arms design: 1. participants reading a fact-based newspaper article written in an abstract language 2. participants reading a fact-based newspaper article written in a more concrete language 3. participants performing abstract categorization task 4. participants performing concrete categorization task 5. control group answering questionnaire research questions: i) does a more abstract vs concrete language increase the willingness to receive the vaccine? ii) does a more abstract vs concrete mindset increase the willingness to receive the vaccine? iii) is a gender effect detectable?

Eligibility criteria:
inclusion criteria: unvaccinated individuals exclusion criteria: vaccinated individuals

Keywords: vaccine hesitancy
evaluation of the diagnostic value of pet (18f-fdg) in chronic graft versus host disease (cgvh)

Conditions: Chronic Graft Versus Host Disease

Summary: allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. it results in the development of graft versus host disease (gvhd) in 30-70% of cases. chronic gvhd diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. however, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression. pet-ct with 18f-fdg has already been evaluated in chronic inflammatory diseases such as crohns disease with good sensitivity and specificity. it interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment. among patients with chronic gvhd scleroderma form, pet with 18f-fdg enabled to view musculoskeletal uptakes localized to the affected areas identified with mri. the investigators propose a study evaluating the sensitivity and specificity of the examination by pet-ct with 18f-fdg in the diagnosis of chronic gvhd compared to conventional diagnostic tools.

patients will have pet/ct at day 150+/-15d post-hematopoietic stem cell transplantation (hsct)

Eligibility criteria:
inclusion criteria: * adult \>18 years * signed informed consent * subject covered by a social security system * absence of contraindication to pet (18f-fdg) * allogeneic stem cell transplantation exclusion criteria: * adult patient under tutelage. * pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception * age\<18 years * evolutive infectious disease * glycemia \>10mmol/l
esprit btk post-approval study

Conditions: Chronic Limb-Threatening Ischemia

Summary: the esprit btk pas is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the esprit™ btk everolimus eluting resorbable scaffold system under commercial use, in patients with diseased infrapopliteal lesions causing clti (chronic limb-threatening ischemia) in a real-world setting. the clinical investigation will be conducted at up to 50 sites in the united states (us) and additional sites may be added outside of the us (ous). approximately 200 patients with a minimum of 50% of patients in the us will be registered in the clinical investigation.


Eligibility criteria:
inclusion criteria: * general inclusion criteria 1. subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site. 1. informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first. 2. subject, or a legally acceptable representative must provide written informed consent per site irb/ec requirements. 2. subject must be at least 18 years of age. 3. subject has evidence of symptomatic chronic limb-threatening ischemia (clti) with infrapopliteal lesions. * anatomic inclusion criteria 1. subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm. 2. target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. if needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels. exclusion criteria: * general exclusion criteria 1. subjects who have contraindications to the esprit btk system per the instruction for use (ifu). 2. subject is currently participating in another clinical investigation. 3. subject is unable or unwilling to provide written consent prior to enrollment. 4. subject with life expectancy ≤ 1 year. 5. subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation. * anatomic exclusion criteria 1. subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure. 2. subject had been previously treated with esprit btk scaffold(s).

Keywords: abt-cip-10519 esprit btk system infrapopliteal lesions post-approval study
corticosteroids in acute urticaria in emergency department

Conditions: Urticaria; Angiœdema

Summary: to demonstrate the non-inferiority of the efficacy of a single antihistamine in comparison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

acute urticaria (hives) is a common skin disease. the prevalence of acute urticaria in life is about 15 to 20% in the general population. it is responsible for a frequent use of emergency departments (ed). the usual treatment is based on early administration of an association of antihistamines and corticosteroid. the therapeutic efficacy of corticosteroids has never been established by high evidence studies. however, corticosteroids are frequently used. when stopped, corticosteroids could promote the occurence of urticaria recurrences, and a transition to chronic urticaria. in addition, corticosteroids may be rarely responsible for gastrointestinal bleeding, hypertension and diabetes.

Eligibility criteria:
inclusion criteria: * age \> 18 years * isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria * acute urticaria with angioedema without laryngeal edema * obtain patient's consent * social security affiliation exclusion criteria: * pregnancy or breastfeeding * acute hives with anaphylaxis * bradykinin angioedema * angioedema without urticaria (hives) * laryngeal edema with urticaria (hives) * corticosteroid administration in the previous 5 days visiting the emergency department * antihistamines greater than 1 tablet per day in the previous 5 days visiting the ed * other treatment for urticaria : omalizumab, montelukast, ciclosporin a * chronic urticaria before acute urticaria diagnosis * atopic dermatitis * eczema * bullous pemphigoid * acute exanthematous pustulosis * diabetes mellitus * gastrointestinal ulcer * refusal to participate * known allergy to the study drugs or formulation ingredients * known renal failure defined by creatinine clearance \< 10 ml/min or cardiac failure defined by ejection fraction \< 40%. * corticoid use in 5 days prior to randomisation * contra-indication to corticotherapy: * any live vaccine * psychotic states still uncontrolled by treatment limiting the participant's compliance with the research

Keywords: acute urticaria
prospective study on quality of life in patients with intracranial germ cell tumors

Conditions: Quality of Life

Summary: the primary purpose of this study is to characterize the quality of life in patients with intracranial germ cell tumors. those findings can contribute towards a better understanding of the impact of the current treatment strategy on survivors.

the characteristics of the quality of life in patients with intracranial germ cell tumors are far from understood. the main reason is the rare occurrence of the disease. as a result, most findings came from retrospective studies in which only dozens of patients participated. generally, patients with intracranial germ cell tumors have a good prognosis, especially those with germinoma. over 90% of patients with germinoma will survival after ten years of follow-up. thus, the quality of life in long-term survivors is of concern. the investigators designed this prospective study to address this issue to understand better the characteristics of the quality of life in patients with intracranial germ cell tumors and provide information for optimizing the current treatment strategy.

Eligibility criteria:
inclusion criteria: * 3 years ≤ age ≤ 21 years * newly diagnosed primary intracranial germ cell tumors * written informed consent exclusion criteria: * relapsed disease * poor compliance

Keywords: intracranial germ cell tumors quality of life
phase 3 study of khk7580 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism

Conditions: Parathyroid Carcinoma; Primary Hyperparathyroidism

Summary: to evaluate the efficacy of khk7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.


Eligibility criteria:
inclusion criteria: * personally submitted written voluntary informed consent to participate in the study * patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. * corrected serum calcium level is \> 11.3 mg/dl at screening. exclusion criteria: * patients receiving cinacalcet hydrochloride within 2 weeks before screening * patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. * severe heart disease * severe hepatic dysfunction * uncontrolled hypertension and/or diabetes * treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
comparison of olanzapine and metoclopramide for treatment of breakthrough emesis

Conditions: Emesis

Summary: this trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-ht 3 receptor antagonists and aprepitant in patients receiving chemotherapy. efficacy will be assessed using a modified mascc questionaire with a visual analog scale.


Eligibility criteria:
inclusion criteria: * break through emesis after prophylaxis with dexamethasone, 5-ht 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea\>25mm on vas * signed ic exclusion criteria: * psychiatric disorders * drug abuse * pregnancy * high dose chemotherapy * treatment with other antiemetic drugs

Keywords: break-through emesis break through emesis after prophylaxis with dexamethasone, 5-ht 3ra and aprepitant
scripps polster breast care center investigational genebank

Conditions: Breast Cancer

Summary: breast cancer is a disease of complex origin with a strong genetic component. the incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. the investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. if the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. in contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer. by developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.

women the age of 30 or over who are undergoing screening or diagnostic breast imaging as an out patient at the scripps polster breast care center in la jolla, ca, with at least 5 years of historic breast imaging data available will be eligible to enroll. for this study, consecutive subjects who have completed screening or diagnostic breast imaging at the scripps polster breast care center will be enrolled for one day. it is estimated that up to 5000 subjects will be included in the cohort.

Eligibility criteria:
inclusion criteria: 1. age 30 years or older 2. be reliable, cooperative and willing to comply with all protocol-specified procedures 3. able to understand and grant informed consent 4. be undergoing screening or diagnostic breast imaging 5. have at least 5 years of breast imaging data available exclusion criteria: 1. have a significant chronic medical condition which, in the investigator's opinion, would interfere with the subject's participation in the study 2. have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study 3. have taken any cns sedation or depressants in past 12 hours
eus-cpn: a retrospective review

Conditions: Pancreatic Cancer

Summary: the purpose of this retrospective study is to measure the safety of eus-cpn in patients that have undergone this procedure in the last decade.


Eligibility criteria:
inclusion criteria: * any subject that has undergone eus-cpn will be considered for this study. exclusion criteria: * subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.