Kornimate/medical-research-clean huggingface dataset:
broccoli sprout extract in preventing lung cancer in smokers

Conditions: Lung Cancer

Summary: rationale: chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. the use of broccoli sprout extract may prevent lung cancer. purpose: this clinical trial is studying how well broccoli sprout extract works in preventing lung cancer in smokers.

objectives: primary * evaluate the effect of broccoli sprout extract on levels of dna adducts in participants who smoke. * determine the effectiveness of broccoli sprout extract in reducing tobacco-carcinogen induced dna adducts in these participants. secondary * determine the effects of broccoli sprout extract on markers of the nrf2 pathway in these participants. * determine the effectiveness of broccoli sprout extract, in increasing the activity of the nrf2 pathway, in these participants. * evaluate the feasibility of using lymphocytes and buccal cells to monitor dna adducts and changes in the nrf2 pathway in these participants. outline: participants are stratified according to gst genotypic polymorphism (m1 vs t1). participants receive oral broccoli sprout extract daily for 3 weeks. participants keep a daily diary of their eating and smoking habits for 3 weeks before, during, and for 3 weeks after study treatment. they must continue to smoke during the study, but are encouraged to quit after completing the study treatment. projected accrual: a total of 70 participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * current smoker with ≥ 30 pack-year history of smoking patient characteristics: performance status * ecog 0-2 life expectancy * not specified hematopoietic * wbc \> 4,000/mm\^3 * platelet count \> 100,000/mm\^3 hepatic * bilirubin ≤ 1.5 mg/dl renal * creatinine ≤ 1.5 mg/dl other * not pregnant or nursing * negative pregnancy test * fertile participants must use effective contraception * no other medical condition that would preclude study treatment or compliance * no gastrointestinal condition that would affect absorption, preclude taking oral medication, or necessitate iv alimentation prior concurrent therapy: surgery * no prior surgery affecting absorption other * more than 6 weeks since prior vitamins, herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics * no concurrent dietary intake of cruciferous vegetables

Keywords: non-small cell lung cancer small cell lung cancer
improving sleep in gynecologic cancer survivors

Conditions: Sleep Disturbance; Gynecologic Cancer

Summary: this purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

this study has two parts. in part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. results of part 1 will inform the design and delivery of the candidate components in part 2. in part 2, a 2\^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.

Eligibility criteria:
inclusion criteria: * history of stage i, ii, or iii gynecologic cancer * age 18+ years * english language proficiency * current sleep disturbance demonstrated by a pittsburgh sleep quality index (psqi) score \> 5 * usual sleep onset time between 9:00pm and 3:00am * reliable telephone and internet access exclusion criteria: * stage iv disease * diagnosed or suspected psychiatric or medical condition that may interfere with participation (e.g., psychosis, dementia, bipolar disorder, abuse of alcohol or illicit substances within the past 6 months, narrow angle glaucoma, retinal disorders, epilepsy or a similar condition) * diagnosed sleep apnea, narcolepsy, periodic limb movement disorder, or restless legs syndrome unless well controlled * use of medications that may be contraindications for study procedures due to safety concerns or due to potential impact on intervention efficacy or assessment validity (e.g., sedatives/hypnotics), to be identified on a case-by-case basis * shift worker * severe physical or cognitive impairment (≥ 2 errors on a brief six-item version of the mini mental state exam \[mmse\] or patient reported functional status \[prfs\] score \> 2, which is based on the eastern cooperative oncology group \[ecog\]but has been modified to be in lay language) * plans to travel across 3 or more meridians/time zones during the 6 intervention weeks or plans to cross any meridians/time zones during the 2 weeks leading up to wearing an actiwatch. * history of a primary diagnosis of a distinct non-gynecologic or non-skin cancer other than a non-melanoma skin cancer within the 5 years prior to enrollment * for participants with stage iii ovarian cancer: less than 2 years post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgery. for patients with any other gynecologic cancer/stage: less than 30 days post-completion of primary gynecologic cancer treatment and/or less than 60 days post-surgical intervention (e.g., hysterectomy) * male * have received cbt-i or systematic bright light therapy within the past 6 months
testing the efficacy of two behavioral interventions at recalibrating physician heuristics in trauma triage

Conditions: Wounds and Injuries

Summary: the objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics.

treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. most of this under-triage occurs because of physician decisions (rather than first-responder decisions). existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. these strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. the investigators have developed two separate behavioral interventions to recalibrate physician heuristics in trauma triage, and will compare the effect of these interventions, an educational program, and no intervention on physician performance on a virtual simulation.

Eligibility criteria:
inclusion criteria: * emergency medicine physicians who work at a non-trauma center. * emergency medicine physicians who work at a level iii/iv trauma center. exclusion criteria: * emergency medicine physicians who work only at a level i/ii trauma center. * emergency medicine physicians who do not practice in the us.
chronic graft-versus-host disease (cgvhd) prophylaxis with or without atg prior to stem cell transplantation (sct) from hla-identical siblings in patients with acute leukemia

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Summary: this multicenter, prospective phase iii-study is to compare the administration of atg fresenius to the non-administration of atg fresenius in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an hla-identical sibling in patients with acute leukemia. this clinical trial is to show that the administration of atg fresenius reduces the risk of chronic graft-versus-host disease after allogeneic stem cell transplantation from hla-identical siblings.


Eligibility criteria:
inclusion criteria: * acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary aml) * acute lymphoblastic leukemia in first or subsequent complete remission * patient's age: 18 - 65 years * myeloablative standard conditioning * hla-identical sibling (hla-a, hla-b, hla-drb1 and hla-dqb1) * no major organ dysfunctions * patient's written consent exclusion criteria: * no complete remission at time of randomization * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, sgpt or sgot 5 times upper the normal level * left ventricular ejection fraction \<30% * creatinine clearance \<30 ml/min * dlco \<35% and/or receiving supplementary continuous oxygen * positive serology for hiv * pregnant or lactating women * serious psychiatric or psychological disorders * progressive invasive fungal infection at time of registration

Keywords: hematopoietic stem cell transplantation
coping skills training in individuals with migraine

Conditions: Migraine

Summary: this study was planned to investigate the effects of coping skills training on pain, quality of life, disability level, and coping skills in individuals with migraine.

migraine is a type of headache that lasts 4-72 hours, and it is characterized by throbbing pain on one side of the head, and recurrent attacks, making routine daily activities and movements difficult. also, nausea and vomiting may accompany migraine, and sensitivity to both light and sound may increase. the world health organization (who) lists migraine as the disease that causes the most disability. approaches to the treatment of migraine consist of pharmacological and non-pharmacological treatments. within the scope of non-pharmacological approaches, it is aimed to increase the coping skills of the individual by using methods such as exercise, stress management, and cognitive behavioral therapy, which include physical, mental, and cognitive interventions. although these approaches are effective respectively, since migraine affects the whole life of the individual, there is a need for applications in which the approaches are applied with a combined and individual perspective. it has been shown that coping skills training improves both the physical and mental health and well-being of individuals with chronic headaches. it is known to cause a decrease in pain intensity, migraine attacks, and drug use. at the same time, it is aimed to adapt the individual to live efficiently. despite these positive effects, there is a limited number of studies examining the effect of migraine coping skills training on individuals' disabilities and coping skills. therefore, within the scope of this study, the effects of client-centered coping skills training on pain, disability, coping skills, and quality of life were examined.

Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine meeting the international headache society diagnostic criteria (ichd-3 beta international classification of headache disorders), * to be between the ages of 18-65, * to have a migraine onset age younger than 50 (migraine onset age shouldn't be 50 years or more because being above is usually a secondary reason) * to be literate. exclusion criteria: * have psychotic disorders, organic brain damage, other types of headaches, a history of traumatic head injuries, neck pain, any pathology causing headaches in the head and neck, * alcohol or substance use, * pregnancy

Keywords: migraine pain coping skills quality of life
clinical performance of the new plasma filter px2 in tpe treatments

Conditions: Autoimmune Diseases

Summary: the plasma filter is applied for a single use in extracorporeal blood purification therapy. the intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process. the investigation involves the collection of treatment data of the new plasma filter px2 in combination with the multifiltrate and multifiltratepro in therapeutic plasma exchange (tpe) treatments. the multifiltrate and multifiltratepro are devices for extracorporeal blood purification treatments. no further control treatments will be investigated in this one arm design. the design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new plasma filter px2. no specific treatment schedule is defined by the study protocol. the tpe treatment is performed with the plasma filter px2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. the participation in the study will have no influence on the treatment plan. the documentation of the treatment includes the therapy up to the tenth (10th) treatment.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/authorized physician * minimum age of 18 years * patients with an indication for a therapeutical plasma exchange * patients to be treated with the plasma filter px2 in combination with the multifiltrate or multifiltratepro * no contraindication against systemic anticoagulation * ability to understand the nature and requirements of the study exclusion criteria: * patients with known or suspected hypersensitivity to any of the materials of the px2 plasma filter (polysulfone, polyvinylpyrrolidone, polypropylene, polyurethane, silicone) and trial related products * patients suffering from a heparin allergy * patients with a prescription for tpe treatment with the completion of \ 2.0 pv * any conditions which could interfere with the patient's ability to comply with the study * women of childbearing age (\< 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period * participation in a different interventional clinical study during the preceding 30 days * previous participation in this investigation

Keywords: therapeutical plasma exchange
extension study of etelcalcetide in the treatment of secondary hyperparathyroidism (shpt) in patients with chronic kidney disease (ckd) on hemodialysis

Conditions: Hyperparathyroidism, Secondary

Summary: this study is designed to describe the long-term safety and efficacy of etelcalcetide (amg 416) for the treatment of shpt in adults with ckd on hemodialysis.


Eligibility criteria:
inclusion criteria: * subject understands the study procedures and agrees to participate in the study by giving written informed consent. * subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (ipth), from an amg 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (nct01785849), 20120230 (nct01788046), or 20120359 (nct01932970). * subject agrees to not participate in another study of an investigational agent during the study. * other inclusion criteria may apply exclusion criteria: * currently receiving treatment in another investigational device or drug study. * currently receiving other investigational procedures while participating in this study. * subject has known sensitivity to any of the products or components to be administered during dosing. * subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the investigator. other exclusion criteria may apply

Keywords: secondary hyperparathyroidism (shpt), chronic kidney disease (ckd), hemodialysis, parathyroid hormone (pth), hypocalcemia, bone and mineral metabolism
a study of improved efficacy, safety and compliance to administer insulin in pen vs. vial and syringe

Conditions: Diabetes

Summary: this research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.

this research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. patients will have no prior experience using insulin or other self-administered injectable medicine. the study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.

Eligibility criteria:
inclusion criteria: * adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. they must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses. exclusion criteria: * previously treated with injectable medicine

Keywords: diabetes - insulin administration
in-house produced pmma- versus peek-cages

Conditions: Cervical Disc Degeneration; Cervical Stenosis

Summary: subsidence of cervical cages is a common problem. for the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. as control, a commercially available peek-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. the investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the peek-cage, but at a much more favourable cost-performance ratio.


Eligibility criteria:
inclusion criteria: * virgin spines * no emergency operation * age above 18 * sufficient knowledge of the german language * indication for anterior cervical discectomy and fusion * absence of concomitant spinal disease exclusion criteria: * prior cervical surgery * indications other than acdf * concomitant neoplastic, metabolic, severe general or infectious disease
a study to assess the concentration of budesonide in breast milk from asthmatic women

Conditions: Asthma

Summary: the purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (pulmicort turbuhaler), and to estimate the exposure of budesonide to infants.


Eligibility criteria:
inclusion criteria: * be willing and able to comply with study procedures and provide informed consent. * be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months. * be asthmatics that have been on maintenance treatment with pulmicort turbuhaler 200 or 400 µg bid for at least 3 months prior to visit exclusion criteria: * clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator. * clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study. * a suspected/manifested infection of hiv, hepatitis b or c or other infection according to who risk classification 2-4
flutiform® compared with seretide® in the treatment of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (copd).

a multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of copd. subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.

Eligibility criteria:
inclusion: 1. male or female subjects aged ≥ 40 years at screening visit. 2. diagnosis of copd 3. willing and able to replace current copd therapy with study medication. 4. able to demonstrate correct use of a pmdi with or without a spacer and accuhaler. 5. willing and able to attend all study visits and complete study assessments. 6. able to provide signed informed consent. exclusion: 1. ongoing moderate or severe exacerbation of copd in the 2 weeks before screening. 2. current diagnosis of asthma. 3. documented evidence of α1-antitrypsin deficiency as the underlying cause of copd. 4. other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans. 5. previous lung resection. 6. use of long-term oxygen therapy (ltot) or mechanical ventilation. note: ltot is defined as \>15 hours use per day 7. chest x-ray or ct scan that reveals evidence of clinically significant abnormalities not believed to be due to copd. 8. evidence of uncontrolled cardiovascular disease. 9. evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease. 10. current malignancy or a previous history of cancer which has been in remission for \< 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded). 11. clinically significant sleep apnoea requiring use of continuous positive airway pressure (cpap) device or non-invasive positive pressure ventilation (nippv) device. 12. participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study. 13. known or suspected history of drug or alcohol abuse in the last 2 years. 14. requiring treatment with any of the prohibited concomitant medications. 15. known or suspected hypersensitivity to study drug or excipients. 16. received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Keywords: chronic obstructive pulmonary disease fev1 ≤ 50%
study to evaluate efficacy, safety and tolerability of jte-051 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the efficacy, safety, tolerability and pharmacokinetics (pk) of jte-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.


Eligibility criteria:
inclusion criteria: * a diagnosis of ra prior to the screening visit. * active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the screening and baseline visits. * screening hs-crp ≥1.2 x upper limit of normal (uln). exclusion criteria: * prior/current exposure to biologic and/or kinase inhibitor therapy. * known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the screening visit. * positive test results for human immunodeficiency (hiv) virus, hepatitis b virus or hepatitis c (hcv) virus at the screening visit. * positive drug of abuse and alcohol test results. * history of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to day 1.

Keywords: jte-051 active rheumatoid arthritis efficacy safety tolerability rheumatoid arthritis