Kornimate/medical-research-clean huggingface dataset:
s9810: gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery

Conditions: Malignant Mesothelioma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery.

objectives: i. estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin. ii. evaluate the qualitative and quantitative toxicities of this regimen in this patient population. outline: patients receive gemcitabine iv over 30 minutes, immediately followed by cisplatin iv over 30 minutes on days 1, 8, and 15. courses are repeated every 28 days. treatment continues in the absence of unacceptable toxicity or disease progression. patients with a complete response receive 2 additional courses of therapy. patients are followed every 6 months until death. projected accrual: a total of 50 patients will be accrued for this study within 25 months.

Eligibility criteria:
disease characteristics: histologically confirmed diagnosis of unresectable malignant mesothelioma of the pleura epithelial, fibrosarcomatous, or mixed type bidimensionally measurable disease no cns metastases patient characteristics: age: over 18 performance status: swog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least lower limit of normal hepatic: bilirubin no greater than 2.0 mg/dl sgot or sgpt no greater than 2.5 times upper limit of normal (uln) renal: creatinine no greater than 2 times uln and creatinine clearance at least 60 ml/min other: not pregnant or nursing fertile patients must use effective contraception no other prior malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer currently in complete remission must have chest x-ray within the past 28 days prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy no other concurrent chemotherapy endocrine therapy: concurrent hormones for non-disease-related conditions allowed concurrent steroids for antiemesis, adrenal failure, or septic shock allowed radiotherapy: no prior radiotherapy no concurrent radiotherapy surgery: at least 4 weeks since prior major surgery and recovered

Keywords: advanced malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma
sequential ascending dose study to assess the safety and tolerability of regn668 (sar231893) in patients with atopic dermatitis

Conditions: Dermatitis

Summary: the purpose of this study is to assess the safety and tolerability of regn668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic atopic dermatitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit * investigator's global assessment (iga) score of \>/= 3 at the screening and baseline visits * \>/= 15% body surface area (bsa) of ad involvement at the screening and baseline visits * history of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for ad within 3 months before the screening visit * willing and able to comply with clinic visits and study-related procedures * patient able to read and understand, and willing to sign the informed consent form exclusion criteria: * a positive quantiferon® - tb (tuberculosis) gold test at the screening visit * known history of human immunodeficiency virus (hiv), hepatitis b or hepatitis c and/or positive hepatitis b surface antigen (hbsag), positive hepatitis c antibody (hcv) * treatment with an investigational drug within 8 weeks before the baseline visit * treatment with leukotriene inhibitors within 4 weeks before the baseline visit * treatment with systemic corticosteroids within 4 weeks before the baseline visit * treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit * systemic treatment for ad with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit * chronic or acute infection requiring treatment * history of clinical parasite infection, other than treated trichomoniasis * history of malignancy within 5 years before the baseline visit * any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results * pregnant or breast-feeding women * unwilling to use adequate birth control, if of reproductive potential and sexually active
early prevention of atheroma progression

Conditions: Coronary Arteriosclerosis

Summary: the purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild cad (nonobstructive coronary atherosclerotic plaques) and normal ldl (low-density lipoprotein) cholesterol levels(\<130mg/dl).


Eligibility criteria:
inclusion criteria: * men or women at least 35 years of age * mild cad (nonobstructive coronary atherosclerotic plaques, lumen narrowing \<50%) and cac score \<300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries * ldl cholesterol \<130mg/dl exclusion criteria: * history of stable angina, or acute coronary syndrome * history of transient ischemic attack, or stroke * chronic kidney disease (egfr\< 60ml/min) * diabetes mellitus with microvascular complications or insulin therapy * hypertriglyceridemia (triglyceride \>500mg/dl) * any statin therapy in the past 4 weeks * planned cardiac surgery or planned major non-cardiac surgery within 6 months. * chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). * a diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. * any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study. * hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast \> 3 times upper limit of normal). * history of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). * unwillingness or inability to comply with the procedures described in this protocol. * positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hcg) pregnancy test performed at screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating. * hypersensitivity to crestor * skeletal muscle disease * combination use with cyclosporine * galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption * combination use of protease inhibitor

Keywords: coronary arteriosclerosis rosuvastatin
muse study to evaluate the pharmacokinetics, safety and tolerability of s6g5t-3

Conditions: Acne Vulgaris

Summary: to assess the degree of systemic exposure of s6g5t-3 compared to the reference listed drug (rld) retin-a® 0.1% cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 9 years of age or older. 2. subject must consent to participate, verified by signing an approved written informed consent form (icf). 3. subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations 4. all females of child-bearing potential and premenarchal, excluding women who are surgically sterile exclusion criteria: 1. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment. 2. underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.; 3. subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function). 4. any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
transcranial brain stimulation in vegetative state patients

Conditions: Vegetative State; Minimally Conscious State

Summary: the aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rtms) and transcranial direct current stimulation (tdcs), are effective in terms of eeg coherence and clinical changes in patients in vegetative and minimally conscious state.


Eligibility criteria:
inclusion criteria: * diagnosis of vegetative state od minimally conscious state defined by the disability rating scale with a score between 17 and 29. * age between 18 and 65 years. * time from the lesion: more than 4 months. * stable clinical condition. * written consent fron the legal administrator of the patient. exclusion criteria: * presence of epileptiform activity on eeg. * previous history of epilepsy. * extensive hemorrhage or ischemia. * metallic clips or intracranial implants. * pacemaker e baclofen infusion. * presence of drugs influencing arousal or awareness.
better patient selection to transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis; Left Ventricular Dysfunction; Myocardial Fibrosis

Summary: this study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue doppler imaging and myocardial fibrosis by cardiac magnetic resonance imaging (mri) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

in this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after tavi. we intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (mri) methods and new echocardiographic methods. these measures will be primarily related to long term (12 months) mortality.

Eligibility criteria:
inclusion criteria: * patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation. exclusion criteria: * aortic valve endocarditis * aortic annulus \>31mm * preoperative pacemaker * severe aortic insufficiency (\>grad 3) * rapid atrial fibrillation * unprotected left main coronary stenosis not suitable for percutaneous intervention. * unstable angina * life expectancy less than 12 months * mental disorder including dementia and condition which interferes with protocol compliance. * renal failure (glomerular filtration rate \< 45 ml/min/m2), only have t1 mapping by cmri. * patients with metal not suitable for mri.

Keywords: myocardial fibrosis aortic valve stenosis tavi outcome
the roam research study therapy (ltot) version

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this research is to test a device being developed that can see how patients use oxygen therapy over a long period of time. this study will focus on developing a new display part called roam module which will be attached to your oxygen source. the display will provide easily-accessible information that can show how you interact with your supplies and the oxygen machine automatically without connecting the oxygen source to the internet or other devices.

the respiratory oxygen adherence monitor (roam) system objectively determines the duration and pattern of adherence to oxygen therapy on a minute-by-minute basis and provides feedback of usage metrics to patients and their clinicians. the purpose of the roam monitor is, ultimately, to improve the clinical management of patients with chronic obstructive pulmonary disease (copd) and patients requiring long-term oxygen therapy (ltot), to improve health outcomes in these patients, and to reduce costs that arise from the expensive and preventable exacerbations associated with patient non-adherence. the prevalence of copd poses an enormous burden to the u.s. healthcare system. ltot is a well-established treatment for patients with oxygen desaturation due to copd and other cardiopulmonary diseases. the benefits of adequate adherence to ltot are substantial both to copd patients (in terms of reduced morbidity and mortality) and to society (in terms of healthcare cost savings). despite these benefits, patient adherence to ltot remains poor. the lack of a method to objectively and reliably quantify ltot usage complicates the challenge of managing these patients. furthermore, current adherence metrics (e.g., power-on time) fail to provide information regarding the timing of oxygen use within each 24-hour interval. the roam system combines several unobtrusive sensing modalities with adaptive algorithms that detect breathing. in this study, the team will develop a patient-ready product prototype targeted at improving patient ltot adherence.

Eligibility criteria:
inclusion criteria: post-bronchodilator fev1/fvc \<.80 * race demographics of the recruitment area reflect the population of the charlottesville metropolitan statistical area (msa). * due to underrepresentation in local demographics, special effort (via targeted advertising) will be made to recruit hispanic participants to better match national percentages. * participants with medical history of copd * subjects has to have a prescription for oxygen use via nasal cannula or mask at home * at baseline of health with no hospitalization/exacerbation within the past 6 weeks * use of continuous oxygen at baseline exclusion criteria: post -bronchodilator fev1 \< 25% * intermittent oxygen use at home * inability to understand simple instructions * no respiratory infections and exacerbation within 6 weeks of study
clinical effectiveness of bonded versus vacuum-formed retainers

Conditions: Relapse

Summary: the purpose of the study was to compare the clinical effectiveness of bonded versus vacuum-formed retainers regarding their retention capacity; periodontal health; survival rates; and patients' perception after 12 months of removal of fixed appliances. the null hypotheses considered that there was no differences between the retainers in relation to the aspects evaluated.

this single-center randomized controlled trial was performed at the department of orthodontics, bauru dental school, university of são paulo, brazil. a total of 50 patients completing orthodontic treatment were recruited. the patients were prospectively and randomly allocated into two groups. the first group consisted of 25 patients with canine-to-canine v-bend bonded retainers; while the second group comprised 25 patients with vacuum-formed retainers. in both groups, the same retainers were installed in the maxillary and mandibular arches. patients were evaluated at deboning (t0), after 3 months (t1), 6 months (t2), and 12 months (t3). in each appointment, digital models were obtained and the other clinical variables were evaluated. the primary and secondary outcomes were compared between retainers in the time-points evaluated.

Eligibility criteria:
inclusion criteria: * patients with the proper completion of orthodontic treatment and correction of the initial malocclusion. * acceptable oral hygiene (assessed through clinical examination). * presence of all teeth up to the second molars. * clinically acceptable teeth alignment. exclusion criteria: * patients with any systemic condition that may have an influence on periodontal health. * patients with facial deformities. * initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery. * history of periodontal diseases.

Keywords: orthodontic retainers orthodontic appliances, removable orthodontics
conventional bronchoscope with bal vs. thin bronchoscope with bw to diagnose pulmonary tb

Conditions: Tuberculosis, Pulmonary

Summary: this study aims to compare the diagnostic yield of bronchoalveolar lavage (bal) using a thick conventional bronchoscope and bronchial washing (bw) using a thin bronchoscope in the diagnosis of pulmonary tuberculosis.

in patients with suspected pulmonary tuberculosis (tb), confirm the presence of tb bacilli through sputum testing is essential for diagnosis. however, the sensitivity of sputum specimens is suboptimal, and some patients may be unable to produce sputum. in such situations, it is traditionally known that obtaining samples through bronchoscopy increases the diagnostic yield of pulmonary tb. typically, the method of using a thick, conventional bronchoscope to perform bronchial washing (bw) or bronchoalveolar lavage (bal) is commonly employed. however, a drawback of the conventional bronchoscope is its inability to reach close to peripheral pulmonary tb lesions due to its larger diameter. recent studies have reported an increased diagnostic yield for pulmonary tb when using a thin bronchoscope for bw compared to using a thick, conventional bronchoscope for bw. however, a direct comparison with the method of performing bal (bal may have a higher diagnostic yield compared to bw) using a conventional bronchoscope has not been conducted. this study aims to prospectively compare the diagnostic yield for pulmonary tb between bal using a conventional bronchoscope and bw using a thin bronchoscope.

Eligibility criteria:
inclusion criteria: * participants age \> 17 years with suspected pulmonary tb * possible active pulmonary tb evident on chest radiography or ct scan * negative afb smear results (using two consecutive self-expectorated sputum) * negative tb-pcr results (using one self-expectorated sputum) * inability to produce self-expectorated sputum exclusion criteria: * a request for empirical tb treatment rather than bronchoscopy * suspect pulmonary tb lesions that are difficult to target for bal or bw (e.g., multiple discrete tiny nodules) * contra-indication of bronchoscopy (e.g., bleeding tendency, hypoxemia requiring oxygen, or uncontrolled cardio/cerebrovascular disease)
cognitive behavioral therapy for trauma-related insomnia in veterans

Conditions: Sleep Initiation and Maintenance Disorders

Summary: understanding the effectiveness of cognitive behavioral therapy for trauma-related insomnia (cbt-i) is important because sleep difficulties often persist after traditional post-trauma treatments are completed and other trauma-related symptoms have resolved. the objective of this study is to examine whether cbt-i will equivocally reduce problems falling and staying asleep (insomnia) related to military-related ptsd when administered in person versus through telephone therapy to veterans living in rural areas. rural populations are at a disadvantage in receiving treatment because of lack of access to healthcare services. telemedicine uses technology (e.g., telephones) to provide distance counseling to the populations who lack access to health care. thus, telephone-counseling strategies could provide broad access to interventions for management of trauma-related insomnia. veterans who live more than 30 miles from veterans affairs (va) ptsd specialty services will be offered participation in this study. all veterans receive 6 weeks of individual cbt-i for trauma-related insomnia. participants will be randomized to one of two treatment conditions: (1) cbt-i in person or (2) cbt-i via telemedicine (defined as receiving treatment by telephone). no changes will be made to the cbt-i, other than mode of delivery, for the telemedicine group. through this study the investigators hope to demonstrate the effectiveness of cbt-i for trauma-related insomnia can be delivered effectively to rural veterans in person and via telemedicine.


Eligibility criteria:
inclusion criteria: * veterans living 30 or more miles from va ptsd specialty services * diagnosis of ptsd or subthreshold ptsd symptoms * trauma-related insomnia exclusion criteria: * primary sleep disorder other than insomnia(e.g., restless leg syndrome) * psychosis * active alcohol dependence * active drug dependence

Keywords: cognitive behavioral therapy insomnia traumatic stress
safety and tolerability qat370 compared to tiotropium in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will assess the safety and tolerability of qat370 compared to tiotropium in patients with copd.


Eligibility criteria:
inclusion criteria: * patients between 40 and 80 years of age with controlled copd. * women must be surgically sterilized or postmenopausal. additional birth control and post-menopausal information will be available at time of enrollment. * body mass index (bmi) must be within the range of 18 to 32 kg/m2 exclusion criteria: * participation in any interventional clinical investigation with 4 weeks of study start * blood loss or donation of 400 ml or more within 2 months of study start significant illness (other than respiratory) within 2 weeks of study start * past medical personal or close family history of clinically significant ecg abnormalities * any medical condition that may interfere with exercise testing or that may make spirometry unsafe * a known hypersensitivity to the drug. * history of immunocompromise, including a positive hiv test result. * history of drug or alcohol abuse within 12 months of study start * any condition that may compromise patient safety

Keywords: copd pharmacokinetics plethysmography cycle ergometry exercise testing spirometry
safety and performance of the sinusys dilation system for dilation of the maxillary sinus ostium

Conditions: Sinusitis

Summary: the purpose of this study is to assess safety and performance of the sinusys dilation system for dilation of the maxillary sinus ostium.

a multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (crs) chronic rhinosinusitis

Eligibility criteria:
inclusion criteria: -diagnosis of chronic maxillary sinusitis exclusion criteria: * previous antrostomy * sinonasal tumours * cystic fibrosis * history of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus * pregnant or breastfeeding females * currently participating in another drug or device study