Kornimate/medical-research-clean huggingface dataset:
study of ts-022 in adult patients with atopic dermatitis with pruritus (poc)

Conditions: Atopic Dermatitis

Summary: the purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of ts-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.

(none provided)

Eligibility criteria:
inclusion criteria: 1. adults, males or females, 18 - 65 years of age at the time of obtaining the written informed consent 2. generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition 3. a score of 2 (mild disease), 3 (moderate disease) or 4 (severe disease) on the investigator's global assessment of atopic dermatitis (iga) scale 4. a score of 2 (moderate pruritus), 3 (severe pruritus) or 4 (very severe pruritus) on the five-point pruritus scale 5. patient satisfies the diagnostic criteria for ad as determined by the criteria of hanifin and rajka 6. patient understands the study procedures and agrees to participate in the study by giving written informed consent 7. ability to read and understand english and to provide written informed consent and authorization for protected health information disclosure exclusion criteria: 1. concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than ad 2. use of phototherapy, including exposure to tanning beds, within 28 days of study drug application 3. taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of study drug application 4. females who are planning a pregnancy, who are pregnant, or who are breastfeeding 5. inability or unwillingness to discontinue current ad treatment(s) 6. inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol

Keywords: atopic dermatitis pruritus
topical coconut oil application and incidence of sepsis in neonates

Conditions: Late-Onset Neonatal Sepsis

Summary: the randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

purpose and specific aims the purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the neonatal intensive care units of indira gandhi institute of child health, cloudnine hospital at old airport road, and cloudnine hospital at jayanagar in bangalore, india. the aim is to determine the effect of topical coconut oil application on: * the incidence of neonatal late onset culture positive sepsis * neonatal skin integrity versus a no treatment control using standard skin evaluation methods * biomarkers of neonatal innate immune function * temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality. the investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (los) in premature and full-term infants versus the current standard of care, i.e., no treatment. the oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.

Eligibility criteria:
inclusion criteria: * premature infants 24-36 weeks gestational age * full-term infants 37-42 weeks gestational age * less than 48 hours of age at enrollment * admitted to the neonatal intensive care unit of indira gandhi institute for child health, cloudnine hospital at old airport road and cloudnine hospital at jayangar, bangalore * expected to be in the neonatal intensive care unit for at least 4 days after enrollment * able to tolerate study procedures as described * parent/guardian willing to provide written informed consent exclusion criteria: * medically unstable * parent/guardian unable to provide written informed consent * presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa * presence of major congenital anomalies * infants undergoing surgery

Keywords: late-onset neonatal sepsis premature infant full-term infant skin skin barrier biomarker stratum corneum skin surface acidity (ph) transepidermal water loss imaging d'squame tape microbiome coconut oil
evaluation of the prophylactic use of letermovir in kidney transplant recipients at risk of cytomegalovirus infection

Conditions: CMV Infection

Summary: the two main cytomegalovirus (cmv) prevention strategies are prophylaxis and preemptive therapy. prophylaxis effectively prevents cmv infection after solid organ transplantation (sot), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. in contrast, preemptive therapy has the advantage of leading to lower rates of cmv disease and robust humoral and t-cell responses. it is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations.

oral letermovir for 84 days is effective in the prophylaxis of cmv infection in high-risk kidney transplant recipients. oral letermovir for 84 days, is associated with a lower incidence of cmv infection in high-risk high-risk kidney transplant recipients. in addition, the use of letermovir is safe and associated with a low incidence of cmv syndrome or disease up to 6 months after after kidney transplantation. finally, prophylaxis with letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection

Eligibility criteria:
inclusion criteria: * kidney transplant or re-transplant recipients, aged ≥18 years; * undergoing induction therapy with anti-thymocyte globulin; * receiving maintenance treatment with tacrolimus, mycophenolate and prednisone; * positive cmv serology for donor and recipient. exclusion criteria: * cmv serology positive for donor and negative for recipient; * multiple organ recipients, or other organs

Keywords: cytomegalovirus letermovir kidney transplant
effects of nefazodone on treatment of female cocaine abusers - 3

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.

this study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.

Eligibility criteria:
inclusion criteria: females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence exclusion criteria: unstable medical illness, dx of mr, obs, bipolar

Keywords: cocaine dependence
trial of either surgery or stereotactic radiotherapy for early stage (ia) lung cancer

Conditions: Lung Cancer

Summary: the standard treatment for an early stage i lung cancer is surgery. however, surgery can be associated with complications and long-term impairment of the quality of life of patients. stereotactic radiotherapy (srt) is a outpatient technique which allows for local control rates that are comparable to those achieved using surgery. in this study, patients with stage ia non-small cell lung cancer will be randomized to either surgery or srt in order to study the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.


Eligibility criteria:
inclusion criteria: * patients with a cytological or histological diagnosis of stage ia non-cell lung cancer diagnosed in accordance with dutch cbo guidelines \[2004\]. when no pathological diagnosis is available, a patient with a new or growing pulmonary lesion with radiological features consistent with malignancy and a lesion showing uptake on a fdg-pet scan will be eligible \[herder 2005\]. * no evidence of regional or distant metastases on a standardized fdg-pet scan within 6 weeks of any protocol treatment . * the medial extension of tumors should be least 2 cm away from main and lobar bronchi, and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and main pulmonary artery. lesions of at least 2 cm from the mediastinal pleura will be eligible if the responsible radiation oncologist judges that the specified normal tissue tolerance doses specified in the protocol will not be exceeded. * patients who are judged by a multi-disciplinary team to have 2 primary lung tumors (on the basis of clinical, radiological, fdg-pet and/or cyto-pathology findings) are eligible for randomization provided that both surgery and srt can be performed in accordance with protocol requirements. * patient should be fit to undergo a complete surgical resection of the lesion in accordance with dutch cbo guidelines \[2004\] * performance score of ecog ≤ 2 before any treatment. * able to comply with post-treatment follow-up * patients must sign and date a written independent ethics committee approved informed consent form. exclusion criteria: * prior chemotherapy or radiotherapy for the present diagnosis of nsclc. * history of any active malignancy (other than nsclc) unless treated more than 3 years with curative intent and no recurrence, with the exception of non-melanoma skin cancers or in-situ cervical cancers. * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease). * concomitant treatment with any other experimental drug under investigation. * pregnancy * men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.

Keywords: surgery stereotactic radiotherapy tumor control quality of life
systemic screening for hereditary colorectal cancer in china

Conditions: Hereditary Colorectal Cancer

Summary: the purpose of the this study is to determine the prevalence of germline cancer susceptibility gene mutation among chinese population, and to find best ways to screen patients with colorectal cancer in china. to accomplish this objective, the investigators will establish a large sample database of hereditary colorectal cancer related information using multigene panel testing based on next-generation sequencing.

hereditary factors play a very important role in colorectal cancer risk. identification of the germline cancer gene mutation at the time of colorectal cancer presentation has significant implications for the patients and families, as it directs follow up and clinical options. professional guidelines recommend patients with colorectal cancer receive a phenotype-driven genetic testing strategies. for example，lynch syndrome was identified in 2%-4% of patients with crc using micro-satellite instability (msi) or dna mismatch repair (mmr) protein immunohistochemistry (ihc) tumor testing in preselected patients for germline mmr gene testing. however, there is few of clinical characteristics or germline gene mutation data from chinese population. with the advent of next-generation sequencing (ngs), genetic testing for hereditary crc has shifted from phenotype-specific single gene assessment to broad panels providing simultaneous assessment of multiple genes implicated in various hereditary cancer syndromes. this study plans to screen and establish a database of 500 consecutive newly diagnosed patients with crc using multigene panel testing based on next-generation sequencing. the purpose of this study is to: 1. determine the prevalence of hereditary colorectal cancer and spectrum of germline cancer gene mutation among chinese population. 2. evaluate the cost-effectiveness and optimize the design of multigene panel testing. 3. establish a statewide screening model for hereditary colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed with colorectal adenocarcinoma (all stages) patients. for individuals who are old than 70 years old should meet the revised bethesda guidelines or polyposis syndromes testing criteria. 2. agree to provide related information. exclusion criteria: 1. individuals who are under the age of 18. 2. individuals who refuse to test.

Keywords: hereditary colorectal cancer screening
triple antiemetic regimen for chemoradiotherapy in cervical cancer or nasopharyngeal cancer

Conditions: Cervical Cancer; Nasopharyngeal Cancer; Chemotherapy-induced Nausea and Vomiting; Radiation-Induced Nausea and Vomiting; Antiemetic

Summary: the study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south chinese cohort.

the study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed nasopharyngeal carcinoma (ajcc 8th stage ii-iva) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical figo stage ib2-iva;), planning to receive concurrent chemoradiotherapy),18 years or older, with an eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: * took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.
can right toe perfusion index or pleth variability index predict spinal anesthesia induced hypotension?

Conditions: Cesarean Section Complications; Hypotension; Spinal Anesthesia; Perfusion Index; Pleth Variability Index

Summary: spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. hypotension during delivery may cause maternal and fetal complications. if parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. perfusion index (pi) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. this is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. a lower pi indicates greater peripheral vasomotor tone. pleth variability index (pvi) is calculated using maximum and minimum values of perfusion index during respiratory cycles. pvi is one of the dynamic indices that can predict fluid responsiveness. there are several studies investigating the predictive value of finger pi and pvi on hypotension after spinal anesthesia. however the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. so, in this study we aimed to investigate whether the right toe pi and pvi values at supine and left lateral positions can predict hypotension during caesarean section.


Eligibility criteria:
inclusion criteria: * singleton parturient * planned for elective lscs under spinal anesthesia exclusion criteria: * gestational age \< 36 weeks * emergency cases * placenta previa, pre-eclampsia * bmi\>40 * reynauld disease * patient refusal * cardiovascular disease
impact of hemiplegia due to stroke on the microarchitecture of the bone

Conditions: Stroke; Hemiplegia

Summary: in hemiplegic, there is very little data on the impact of neurological deficit on the microarchitecture independent of bone mineral density and composition of the bone marrow. rare studies have shown the relationship between some micro-architectural parameters and severity of neurological deficit. there is no study in humans on the evolution of the parameters of the microarchitecture assessed by 3d micro-tomography in the early phase of the installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a non-load bearing bones, radius.

each patient must answer several questionnaires about their calcium intake and its ability to perform everyday tasks. they will also have 3 blood samples (15 ml each time), 3 measure of bone by 3d micro-tomography and 2 mri examination. these examinations and sampling will take place after 30 days after stroke onset (except for mri) and again after three months and six months after the stroke (the same day as the medical follow-up visit).

Eligibility criteria:
inclusion criteria * at least 30 years * vascular hemiplegia * national institute of health stroke score equal 4 or greater with a motor of upper limb score greater than or equal 2 and a motor score of greater than or equal legs 2 exclusion criteria * concomitant bone disease * endocrinopathies * phasic disorders understanding * contra-indication to mri

Keywords: bone microarchitecture hemiplegia
genetic basis of rosacea study (control)

Conditions: Rosacea

Summary: rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. it it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. the exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. the purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. the investigator hopes to better understand the abnormal gene functions that might contribute to this condition. this understanding may lead to the development of additional and better treatments for rosacea.


Eligibility criteria:
inclusion criteria include: 1. fitzpatrick skin type ii or iii 2. age greater than or equal to 18 years 3. individuals without a history of rosacea exclusion criteria include: 1. women who are pregnant or lactating 2. use of topical prescription medications or procedures to the face within one month of enrollment 3. skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)
anti-bk virus immune response and kidney transplantation

Conditions: Kidney Transplantation

Summary: bk virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. this reactivation leads to a viremia for 10 to 15% of patient during this same period. the most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in nantes). an intensive et persisting viral replication, assessed by detection of high blood viral load, could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft. biological follow-up of these infections lay on the measures of viral load. their positivity must alert the physician and lead him to modulate immunosuppressive treatment. actually, there is no real consensus about the modalities of pharmacological immunosuppression decrease (decrease dose or change of molecule). specific lymphocytic anti-bkv evaluated on several cohorts of patients permit to prove: * weakness of immune cellular response for patient with high viremia * increase of this response when viral load decrease these studies laid on detection of infg synthesis by elispot after stimulation with viral antigens and in vitro cellular expansion. new prospective and longitudinal data comparing the immune cellular response (systematic and early) after graft between patients controlling or not bkv infection are necessary to improve the comprehension of illness natural history. the investigators propose to enlarge the investigation of anti-bkv immune cellular response to other functions than ifng synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control. furthermore, the investigators propose to identify better diagnostic and prognostic makers.


Eligibility criteria:
inclusion criteria: * kidney-transplanted patient, since less than 30 days * older than 18 years old * treatment with tacrolimus and mycophénolate mofetil exclusion criteria: * no informed consent * pregnant women * patient under legal guardianship * treated by ciclosporin or mtor-inhibitor

Keywords: patient with a kidney transplantation since less than 30 days
multiparametric diagnostic model of thick-section clinical-quality mri data in detecting migraine without aura

Conditions: Migraine Without Aura

Summary: recently, radiomics combined with machine learning method has been widely used in clinical practice. compared with traditional imaging studies that explore the underlying mechanisms, the machine learning method focuses on classification and prediction to propose personalized diagnosis and treatment strategies. however, these studies were based on thin-section research-quality brain mr imaging with section thickness of \< 2 mm. clinical, the usage of thick-section clinical setting instead of thin-section research setting is especially important to shorten the acquisition time to reduce the patient's suffering. here investigators want to build multiparametric diagnostic model of migraineurs without aura using radiomics features extracted from thick-section clinical-quality brain mr images.


Eligibility criteria:
inclusion criteria: * right-handed * international headache society criteria for episodic migraine without aura exclusion criteria: * addition (including alcohol, nicotine, or drug) * physical illness
observatory of patients with metastatic prostate adenocarcinoma that is resistant to castration and multi-line strategies

Conditions: Metastatic Prostate Adenocarcinoma

Summary: evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration


Eligibility criteria:
inclusion criteria: * patient monitored for castration-resistant metastatic prostate * patients starting a first or second line treatment as part of castration resistance * patient not objecting to the study after reading the information letter * patient aged over 18 years exclusion criteria: * patient monitored for non-metastatic prostate cancer * patient monitored for castration-nonresistant prostate cancer * patient not able to understand the information letter