Kornimate/medical-research-clean huggingface dataset:
confocal reflectance microscopy of shave-biopsy sites on skin in vivo.

Conditions: Basal Cell Carcinoma; Melanoma; Squamous Cell Carcinoma; Non-Malignant Skin Disorders

Summary: the purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. the goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.


Eligibility criteria:
inclusion criteria: * patients undergoing shave-biopsy on an anatomical site that is readily accessible to the vivascope 1500 (for example, chest, back, legs, arms, cheek, forehead). * the additional 110 patients for this amendment will be imaged with the newly developed vivascope 3000 handheld confocal microscope. * ability to sign informed consent. * age ≥ 18 years. exclusion criteria: * shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes). * inability to give informed consent. * known hypersensitivity to adhesive rings. * inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).

Keywords: 06-009 confocal reflectance microscopy shave-biopsy
pilot study of a novel type of ct scan to assess treatment response during chemoradiotherapy for stage iii non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Stage III

Summary: dual-energy ct (dect) provides information on the blood volume in tumors and lymph nodes. as tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. investigators are therefore using dect to test whether it can be used on radiation treatment to rapidly assess response to treatment.


Eligibility criteria:
inclusion criteria: * patients aged greater than 18 years with a diagnosis of stage iii non-small cell lung cancer. * planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection. * pet-ct study within 4 weeks of next available dect study. * patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm. * kidney function sufficient to tolerate iodine-based ct contrast. * no allergy to iodine-based contrast. * ability to understand and the willingness to sign informed consent. exclusion criteria: * participants with a prior history of thoracic radiotherapy. * participants may not be receiving any other study agents. * inability to tolerate ct contrast * pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. these potential risks may also apply to other agents used in this study.
biomarkers to measure treatment response for alcohol dependence

Conditions: Alcohol Dependence

Summary: the purpose of the research study of the k23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. we will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. both men and women between ages 21 and 65 years can join the study. all participants must be of european decent.


Eligibility criteria:
inclusion criteria: * experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to niaaa definition) in the past 30 days exclusion criteria: * dsm-iv diagnosed alcohol dependence, other drug dependencies including nicotine dependence

Keywords: healthy volunteers social drinkers alcohol
progesterone to prevent preterm delivery

Conditions: Preterm Birth

Summary: preterm birth (ptb) is a major challenge to perinatal health. it is defined as delivery before 37 completed gestational weeks. it accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. it is estimated that the societal cost of ptb is $26 billion annually in the usa alone. until now, prevention or reduction of ptb is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. history of ptb and asymptomatic short cervix at the second trimester are both strong predictors for ptb. in women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce ptb. universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing ptb. these findings were confirmed in meta-analysis. nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. there is still a large proportion of ptb, which is currently not preventable, and the current approach to prevent ptb is far from ideal. one possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. therefore, we decide to use oral progesterone in the current study. the objective of the study is to determine whether early use of progesterone can prevent ptb better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.


Eligibility criteria:
inclusion criteria: * all women age ≥ 18 years old * confirmed intrauterine singleton pregnancy * gestational age less than 14 completed weeks as defined by pelvic ultrasound exclusion criteria: * silent miscarriage: mean gestational sac diameter ≥25 mm without fetal pole, or embryo with crown rump length ≥7 mm and no heartbeat, or no interval growth * suspected ectopic pregnancy * multiple pregnancy with silent miscarriage of one twin * heavy vaginal bleeding requiring surgical intervention * severe abdominal pain requiring surgical intervention * presence of fever * history of adverse reaction to progesterone * history of breast or genital tract malignancy * history of suspected thromboembolic disease * congenital uterine anomaly * unwillingness or inability to comply with study procedures * known paternal or maternal abnormal karyotype
statin therapy to improve atherosclerosis in hiv patients

Conditions: Cardiovascular Disease; HIV; Atherosclerosis; Inflammation; Statins, HMG-CoA; HIV Infections

Summary: in hiv patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. in addition to known cholesterol-lowering and c-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and t cell subsets to less atherogenic subpopulations.


Eligibility criteria:
inclusion criteria: 1. men and women age 18-60 with previously diagnosed hiv disease 2. subclinical coronary artery disease as defined by presence of one or more plaque on coronary cta without history of cardiac events or cardiac symptoms and no evidence of critical coronary stenosis. target to background ratio (tbr) as determined by pet of \> 1.6. 3. stable anti-retroviral (arv) therapy as defined by no changes in arv regimen for \>6 months 4. ldl-cholesterol \>70 mg/dl and \<130 mg/dl exclusion criteria: 1. history of acute coronary syndrome 2. contraindication to statin therapy 3. current statin use 4. ast or alt two times greater than the upper limit of normal or receiving treatment for active liver disease 5. renal disease or creatinine \>1.5 mg/dl (given the risk of contrast nephropathy during ct angiography of the heart) 6. infectious illness within past 3 months 7. contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac ct protocol. previous allergic reaction to beta blocker or nitroglycerin. 8. body weight greater than 300 lbs due to ct scanner table limitations 9. patients with previous allergic reactions to iodine-containing contrast media 10. active illicit drug use 11. patients who report any significant radiation exposure over the course of the year prior to randomization. significant exposure is defined as: 1. more than 2 percutaneous coronary interventions (pci) within 12 months of randomization 2. more than 2 myocardial perfusion studies within the past 12 months 3. more than 2 ct angiograms within the past 12 months 4. any subjects with history of radiation therapy. 12. patients already scheduled or being considered for a procedure or treatment requiring significant radiation exposure (e.g., radiation therapy, pci, or catheter ablation of arrhythmia) within 12 months of randomization 13. pregnancy or breastfeeding 14. coronary artery luminal narrowing \>70% seen on coronary cta

Keywords: cardiovascular disease hiv atherosclerosis inflammation statins treatment experienced
safety and efficacy study of dsp-visulex for the treatment of anterior uveitis

Conditions: Non-Infectious Anterior Uveitis

Summary: the purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate visulex (dsp-visulex) after repeated-dose administration in patients with acute anterior uveitis.

this is a multicenter, randomized, parallel group, double-masked, active- controlled study. subjects will be enrolled and randomized to either 8 % or 15% dsp-visulex with placebo drops or vehicle-visulex (v-visulex) with prednisolone acetate 1% eye drops. all subjects will receive concomitant treatment with cyclopentolate.

Eligibility criteria:
inclusion criteria: * non-infectious anterior uveitis exclusion criteria: * lntraocular pressure \> 25mm hg ou. * previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to visit 1. * historical or active intermediate or posterior uveitis in affected eye(s). * clear systemic causes of uveitis that may require or have required systemic treatment * uveitis suspected to have resulted from recent surgery or trauma. * use of ocular medication of any kind in affected eye(s) more than 2 days prior to visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs. * current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). current stable use is allowed.

Keywords: uveitis acute uveitis anterior uveitis dexamethasone sodium phosphate non-infectious uveitis dsp-visulex aciont
mri characterization of troponin elevation after cardiac surgery

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Summary: cardiac surgery under cardiopulmonary bypass (cpb) induces myocardial ischemia-reperfusion injury. this myocardial attack is a well-identified independent prognostic factor of postoperative morbidity and mortality. the quantification of these myocardial lesions by the postoperative plasma release of troponin has proven its diagnostic and prognostic value. cardiac magnetic resonance imaging (mri) can accurately measure and characterize the size of myocardial lesions. these lesions are associated with a poor prognosis. mri can also characterize myocardial edema secondary to ischemia-reperfusion which has not yet been studied in the context of cpb. it is therefore necessary, in a mechanistic approach, to quantify the respective share of necrosis, edema and reperfusion lesions during cardiac surgery under cpb in order to better understand these phenomena and to propose effective strategies for the prevention of these myocardial lesions.the relationship between the postoperative release of troponin and the amount of myocardial necrosis and edema measured by cardiac mri will be assessed.the hypothesis is to demonstrate a positive correlation between imaging and biology in order to better understand the perioperative myocardial lesion processes. this is an interventional study prospective, exploratory, in cardiac imaging, non-comparative and single-center, including 30 patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * aortic valve surgery with cec: aortic valve replacement, bentall, tirone-david, wheat with foreseeable clamping time of at least 40 minutes. * informed consent signed exclusion criteria: * emergency surgery * other unconventional heart surgery * aorto-coronary bypass associated with surgery * history of myocardial infarction or severe coronary artery disease, non-valvular hypertrophic cardiomyopathy (mhc) (primary mhc type, amyloidosis) and myocarditis * preoperative alteration of systolic function of the left ventricle (lvef \<40%) * presence of a contraindication to cardiac mri (claustrophobia, pacemaker or cardiac defibrillator, metallic body, hypersensitivity to gadolinium) * patients with a glomerular filtration rate (gfr) \<30 ml / min * patients with permanent atrial fibrillation (acfa) cardiac arrhythmia * patients treated with anthracyclines * pregnant and / or lactating woman * patient under legal protection * patient not benefiting from a social security system * patient participating in another clinical study that may interfere with the results of this study.

Keywords: cardiac surgery cardiopulmonary bypass ischemia reperfusion cardiac magnetic resonance imaging
study of dn101 and taxotere in patients with advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this phase 1/2 clinical trial is a multi-center, open-label study with three main objectives. the first (phase 1a) is to determine the maximum-tolerated dose of dn-101 when administered in combination with taxotere (docetaxel) every three weeks (closed). the second is to determine the maximum-tolerated dose of dn-101 when administered weekly in combination with taxotere(docetaxel)devery three weeks (open). the third is to evaluate the safety and objective tumor response rate of the combination in nsclc. dn-101 doses will be escalated at three dosing levels. patients will receive oral dn-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity.

dn-101 is an oral anti-cancer therapy for solid tumors and various hematologic malignancies. dn-101 is a unique formulation of calcitriol specifically designed for use in cancer. calcitriol is a naturally occurring hormone and the most potent biologically active form of vitamin d. in high doses, calcitriol is active in many laboratory and animal models of cancer and synergistic with many commonly used chemotherapeutic agents. until recently, the clinical use of calcitriol as an anti-cancer therapy was limited by hypercalcemia at doses required for anti-tumor activity. based upon clinical results to date, novacea believes it has successfully developed a solution to this problem through development of dn-101. chemotherapy for nsclc, while not curative, has been shown to prolong survival in patients with unresectable disease. a number of different chemotherapy agents have been shown to have single-agent activity in nsclc. these include cisplatin, carboplatin, vinorelbine, gemcitabine, paclitaxel and docetaxel. for first-line therapy of stage iiib or stage iv nsclc, these agents are generally used in combination. in most cases, first-line chemotherapy consists of a platinum-based agent, either cisplatin or carboplatin, and another chemotherapeutic. only one agent, taxotere®, has been approved in the united states by the food and drug administration for use as second-line chemotherapy in nsclc.

Eligibility criteria:
inclusion criteria: * histopathologically or cytologically proven non-small cell carcinoma of the lung (nsclc), either stage iiib or stage iv, that has progressed on or after first or second-line chemotherapy * measurable disease by recist criteria * eastern cooperative oncology group (ecog) performance status \< 1 * life expectancy \> 3 months * age \> 18 years * agrees to use adequate contraception throughout the treatment period and for at least 6 months following treatment * able to give informed patient consent

Keywords: dn101 calcitriol lung cancer nsclc taxotere
the effect of virtual reality on motor functioning and participation abilities among children with dcd

Conditions: Developmental Coordination Disorder

Summary: the subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using timocco) on the motor and participation abilities of children with dcd (developmental coordination disorder). the study will examine the efficacy of using virtual reality gaming environment (timocco) for treating children with dcd and the use of remote therapy, by shifting the focus of therapy from the clinic to the home environment, using the remote control system of timocco for home practice.

the efficacy of using vr (virtual reality) as a therapeutic tool as an integral part of occupational therapy intervention will be examined in this study. the study will be conducted in two stages: the first will be conducted at the child development center of the clalit hmo (health maintenance organization), and the second will take place in the child's home. the first intervention will take approximately 8 to 10 weeks, during which eight data collection sessions will be conducted, each of 45 minutes duration. the study group will integrate the use of timocco in occupational therapy sessions while the control group will be given conventional occupational therapy without using timocco. in the second intervention, the study group will be given access to the virtual-reality environment of timocco to be used at home, and will not include therapy sessions at the child development center. an assessment before and after intervention will be held for both groups for comparison.

Eligibility criteria:
inclusion criteria: * children, * native hebrew speakers, between the ages of 4 and 6 diagnosed with dcd. exclusion criteria: * children with complicated special needs (e.g., limited cognitive abilities, cp, asd), * children who received occupational or physical therapy interventions in the last 12 months.
registry study on patient characteristics, biological disease profile and clinical outcome in acute myeloid leukemia and related neoplasms - the biology and outcome (bio)-project

Conditions: Acute Myeloid Leukemia (AML); MDS/AML

Summary: this is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms investigator's sites: 80-90 sites in germany and austria estimated duration of observation of an individual patient: 10 years maximum objectives * to register all patients with aml and related neoplasms, newly diagnosed or relapsed/refractory in all amlsg participating centers (completeness) * to perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations) * to assess patient and family history, as well as patient characteristics * to evaluate treatment response (cr, crh, cri) and outcome data (event-free survival \[efs\], relapse-free survival \[rfs\], cumulative incidence of relapse \[cir\], cumulative incidence of death \[cid\], overall survival \[os\]) * to evaluate the impact of measurable residual disease (mrd) by different methods * to assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers) * to store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)


Eligibility criteria:
inclusion criteria: * patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the international consensus classification * age ≥ 18 years. there is no upper age limit. * signed written informed consent exclusion criteria: * severe neurological or psychiatric disorder interfering with ability to give an informed consent * no consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation * no consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Keywords: aml registry study biology and outcome mds/aml
intervention to improve self-care of symptoms in breast cancer survivors on adjuvant endocrine therapy

Conditions: Breast Cancer Female

Summary: hormone responsive breast cancer is common and costly. long-term adjuvant endocrine therapy (aet) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. i propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on aet. therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.


Eligibility criteria:
inclusion criteria: * age ≥ 50. * nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with aet (for \> 0 months and \< 6 months). * possess a household or cell telephone. * ability to provide informed consent. exclusion criteria: * clinically significant cognitive impairment. * communication barrier limiting ability to participate in telephone assessments.

Keywords: breast cancer. adjuvant endocrine therapy.
weighted blankets and chronic pain

Conditions: Chronic Pain; Chronic Pain Syndrome

Summary: the purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. multiple blanket weights will be tested.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. fluent in english 3. diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org) 4. willing to sleep with a weighted blanket and fitness watch for 1 week 5. able to safely lift up to 15lb 6. willing and able to use their personal smartphone for fitness tracker app and ema app to submit ratings using personal data plan exclusion criteria: 1. pregnancy 2. major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) 3. current or previous use of a weighted blanket 4. claustrophobia