Kornimate/medical-research-clean huggingface dataset:
intervention facilitates oral feeding in premature infants

Conditions: Premature

Summary: skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants

this study is conducted at the level 3 nicu of the children's hospital of fudan university, shanghai, people's republic of china, a tertiary medical center. infants admitted to the nicu are all outborn infants. the study is approved by the ethics committee of the children's hospital of fudan university. signed parental consent is obtained before participants'entry into the study. the rct is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding. the recruited infants are assigned to intervention group and control group. data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. one-way analysis of variance and fisher exact test is used to compare infants' baseline characteristics among the two groups. all statistical analyses are conducted using spss. a p value of less than 0.05 is regarded as statistically significant.

Eligibility criteria:
inclusion criteria: * gestational age ≤30 weeks * birth weight \< 1500g * age of admission \<72 hours * no congenital malformation exclusion criteria: * oi \> 40 * mother has trouble in communicating

Keywords: skin contact bresatfeeding premature oral feeding
creation of a shared medical decision-making tool for atopic dermatitis

Conditions: Atopic Dermatitis

Summary: hypothesis/objective : patient-centered health care and shared decision making are key components of increasing importance which are recommended by the french haute autorite de sante (has) and world health organization (who). in the context of dermatology and atopic dermatitis, european guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the task force on atopic dermatitis (etfad) has promoted the setting of treatment goals in a shared decision with the patient. the main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations. the second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision. method : we aim to develop a sdmt in ad following the recommendations of the international patient decision aid standards (ipdas) collaboration. development will use a multistep approach: 1) identification of priority domains for patients; 2) selection of domains to be included in the sdmt for ad; and 3) creation and testing of the sdmt. participants will be consecutive adult (\>18 years old) patients attending consultation for a ad in medical centres in france (toulouse, nantes and créteil). all participants will provide written consent to participate. the study will be submitted for approbation to the local ethics committees of the university hospital centres of paris and will be conducted according to the declaration of helsinki. step 1: identification of priority domains for patients step 2: selection of domains to be included in the sdmt for ad step 3: creation and testing of the sdmt


Eligibility criteria:
inclusion criteria: * age ≥18 years, male or female. * patient with atopic dermatitis * written information given to the patient and no objection from the patient to participate to the study exclusion criteria: * patient under guardianship or curatorship * patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire * patient under ame

Keywords: atopic dermatitis shared medical decision-making tool e-delphi
development of non-invasive mri applications for liver fibrosis and inflammation

Conditions: Liver Fibrosis

Summary: chronic liver disease is a major healthcare problem in hong kong and worldwide. the diagnosis of liver fibrosis and inflammation in patients with chronic liver disease has important prognostic and therapeutic implications. the current gold standard to evaluate and stage the severity of liver fibrosis and inflammation is based on liver biopsies, which are invasive and impractical for screening and monitoring the disease. the existing non-invasive methods still have significant limitations to meet the challenge. magnetic resonance effect can be used to obtain the molecular-level information on the biochemical properties of human tissues. the investigators will develop non-invasive quantitative mri technologies to evaluate and stage liver fibrosis and inflammation. our approaches are based on the endogenous contrast mechanism and thus do not need to inject an mri contrast agent. our approaches can be implemented on a regular mri scanner and do not need any extra hardware. to enable the technology for routine clinical use, the investigators will develop fully automated post-processing techniques for the proposed mri acquisition approaches. the investigators will perform multi-center clinical studies in hong kong and mainland china to validate our imaging measurements by histopathologic results from liver biopsies on patient cohorts.


Eligibility criteria:
inclusion criteria: * between the age of 18 and 65. * chronic liver disease (cld) patients at different stages of liver inflammation (a0-3) and liver fibrosis (f0-4). * cld patients who have indications and are scheduled to undergo liver biopsy. exclusion criteria: * patients diagnosed with hcc or other types of cancers. * patients who had undergone liver transplantation before enrollment. * any contraindications to either liver biopsy or mri scan.

Keywords: mri, liver fibrosis, liver inflammation
organ preservation with tislelizumab and total neoadjuvant therapy in patients with low rectal cancer: relieve -01 study

Conditions: RECTAL NEOPLASMS; Rectal Cancer

Summary: this is an open-label, multi-center, single-arm clinical study. all patients received concurrent chemoradiation therapy (crt) followed by 4 cycles of tislelizumab combined with capox, then underwent clinical response assessment. patients who achieved cr (ccr+ pcr confirmed by local resection of nccr) continue tislelizumab combined with capox for another 4 cycles and tislelizumab for 9 cycles, then watch and wait. patients who did not achieved cr underwent total mesorectal excision (tme).


Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent, understand and comply with the requirements and evaluation schedule 2. ≥18, ≤75 years old 3. histologically confirmed rectal adenocarcinoma 4. immunohistochemistry confirmed pmmr (positive for mlh1, msh2, msh6 and pms2), or pcr /ngs confirmed msi-l or mss 5. the distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or mri 6. clinical stage ct1-3n1m0 or ct2-3n0m0 (the 8th uicc/ajcc; t and n is evaluated by mri) 7. resectable primary tumor assessed by the investigator 8. have not received any anti-tumor treatment for rectal cancer 9. ecog ps ≤ 1 10. adequate organ function 11. female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose. exclusion criteria: 1. histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma 2. have received any treatments for rectal cancer, or evidence of distant metastasis 3. presence of following high risk factors assessed by mri: mrf +, emvi+, cn2, positive lateral lymph nodes, t3d 4. presence or in high risk of obstruction, perforation or bleeding; 5. not suitable for long-course radiotherapy 6. cannot tolerate surgery 7. ≥2 colorectal cancer lesions at the same time 8. contraindications for mri examination 9. other malignant tumors in the past or at the same time 10. have an active autoimmune disease requiring systemic therapy within the past 2 years 11. hiv infection 12. untreated chronic hepatitis b or chronic hepatitis b virus (hbv) carriers (hbv dna \&gt; 500 iu/ml) or active hcv carriers with detectable hcv rna; 13. hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container 14. other conditions judged by the researcher that do not meet the enrollment requirements

Keywords: tislelizumab low rectal cancer organ preservation watch and wait tnt
dual site-dual channel non-invasive brain stimulation for language and cognitive function in stroke patients

Conditions: Stroke; Aphasia; Cognitive Impairment

Summary: the aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in post stroke patients. simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. all subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. four conditions are 1) dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.


Eligibility criteria:
inclusion criteria: * left hemisphere involved stroke patients * patients diagnoses as post stroke aphasia exclusion criteria: * history of psychiatric disease * patients with metal implants * history of epilepsy * pregnancy * skin defect at the site of electrode attachment

Keywords: transcranial direct current stimulation dual stimulation
atazanavir and lamivudine for treatment simplification

Conditions: HIV Infections

Summary: objectives of the study: 1. to verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir. 2. to collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.

combined antiretroviral therapy has greatly improved the natural history of hiv infection/aids. yet, it is associated with important short- and long- term side effects. in particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density. our study aims to verify the safety and efficacy of a simplification of a dual therapy (lamivudine plus atazanavir with ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.

Eligibility criteria:
inclusion criteria: * patients treated with the same regimen including 2nrtis + atv/r from at least 6 months * aged 18 years or older * who gave informed consent to the participation to the study * with at least two viral load \< 50 copies/ml in two consecutive determinations at least 3 months apart * with cd4 cell count \> 200 cells/μl and absence of any opportunistic infection or aids-related disease by one year at least exclusion criteria: * pregnancy or breast feeding, desire of pregnancy in the short term * previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues * patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/ml at 12th hour or 0.15 μg/ml at 24th hour) at screening and/or at baseline * patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin) * concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications

Keywords: hiv/aids haart simplification atazanavir lamivudine treatment experienced
spiriva® 18µg once daily in chinese copd patients of different disease severities

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of the present post marketing surveillance study (pms) study is to evaluate safety and effectiveness of tiotropium bromide (spiriva®) 18 µg once daily in 5,000 patients with copd of varying severities over 8 weeks.

study design:

Eligibility criteria:
inclusion criteria: incl. criteria patients with clinical diagnosis of stable chronic obstructive pulmonary disease (copd) according to definition of china copd guideline. patients over 40 years old exclusion criteria: patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of spiriva® patient with known narrow-angle glaucoma * patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction * patient with known moderate to severe renal impairment (i.e.,creatinin clearance\<=50ml/min) * pregnant or nursing women * patient with any significant disease other than copd which would exclude him/her from participating in the study * patients with any conditions listed in \[special precautions\], \[drug interactions\], and \[contraindication\] of spiriva® china package insert * patients with signed informed consent of any other study
surveillance markers of utility for recurrence after neoadjuvant chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: this is a nested multicenter, prospective cohort study within the i-spy 2 trial for women undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing definitive surgical resection and have clinical or radiographic evidence of residual tumor at the completion of chemotherapy.


Eligibility criteria:
inclusion criteria: * enrollment on the treatment phase of the i-spy 2 trial * completed a standard neoadjuvant chemotherapy regimen or assigned treatment on i-spy 2 and planning definitive surgical resection. participants who have discontinued assigned treatment on i-spy 2, switched to standard of care, and have completed a standard neoadjuvant chemotherapy regimen are still considered eligible. * pre-surgical imaging or clinical examination demonstrating residual disease in the breast. participants with any extent of enhancement attributable to tumor on the pre-surgical mri are eligible. no minimum extent of palpable tumor pre-surgery is required. * willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications * no clinical evidence of distant metastatic disease. pre-chemotherapy staging scans are sufficient in the absence of any symptoms or subsequent clinical evidence suggesting distant metastases * age 18 or over and are able to give informed consent exclusion criteria: * individuals under the age of 18 * individuals who cannot understand and give informed consent. we will not be assessing decisional capacity; determination of ability to give informed consent will be at the discretion of the treating physician. * pregnancy. participants in the parent i-spy 2 trial are screened for pregnancy at enrollment and pregnancy is an exclusion criteria. no additional screening for pregnancy is required for participants enrolling on surmount. however if a study participant does become pregnant while on study or during the course of the 10 year follow-up, the study participant will remain on the study protocol and will not be withdrawn. because this is an observational study and does not have a therapeutic component, there will be no increased risk to following a study participant through annual blood draws and medical information abstraction from the medical chart who may or may not become pregnant during the course of the follow-up period.
far infrared radiation for sickle cell pain management

Conditions: Anemia, Sickle Cell

Summary: most patients with sickle-cell disease have periodic intensely painful episodes. to manage this pain, we are proposing the drinking of at least 500 ml of water followed by far infrared radiation.

painful sickle cell crises are treated with hydration and analgesics. ischemia is an absolute or relative shortage of the blood supply to an organ. relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue. it is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. in addition, the analgesic properties of far infrared will alleviate pain due to the crisis.

Eligibility criteria:
inclusion criteria: * people with sickle cell disease exclusion criteria: * none

Keywords: hemoglobin sc disease hemoglobin c disease sickle cell trait thalassemia
a study to evaluate the safety and efficacy of adalimumab in subjects with chronic plaque psoriasis and nail psoriasis

Conditions: Nail Psoriasis; Plaque Psoriasis

Summary: this study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.


Eligibility criteria:
inclusion criteria: * subject must have body surface area (bsa) ≥ 10% and a target fingernail modified nail psoriasis severity index (mnapsi) ≥ 8 at week 0, or bsa ≥ 5%, a target fingernail mnapsi ≥ 8 and a total mnapsi score of ≥ 20 at week 0. * subject must have a nail psoriasis physical functioning severity score of \> 3, or a nail psoriasis pain numeric rating scale (nrs) score of \>3. * subjects must have a physician's global assessment (pga) of fingernail psoriasis and a pga of skin psoriasis of at least moderate. * subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to week 0, ustekinumab must have been discontinued at least 12 weeks prior to week 0. * target fingernail must have mnapsi score of ≥ 8. * adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months). exclusion criteria: * prior adalimumab therapy. * diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis. * recent infection requiring treatment. * significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse. * female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. * history of cancer, except successfully treated skin cancer.

Keywords: nail psoriasis plaque psoriasis
the effects of growth hormone (gh) on lipid depots

Conditions: Growth Hormone Deficiency

Summary: this study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity. in addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% vo2max. finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated. hypothesis: 1) lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability. 3)free fatty availability during exercise will be reduced in growth hormone deficient patients 4)physical exercise may be an alternative way to diagnose growth hormone deficiency

using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed. lipid depots (skeletal muscle and liver) are measured by mr-spectroscopy, visceral fat mass by mr-imaging. exercise capacity ist measured on a treadmill. counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 vo2max identical investigations are performed in adult growth hormone (gh) deficient patients before and after six months gh replacement therapy, in sedentary matched control subjects and in endurance trained athletes.

Eligibility criteria:
inclusion criteria: * male and female patients with proven gh-deficiency defined as a peak gh of less than 3mu/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed. * ability to perform an exercise test on a treadmill or a walking band. * willingness to participate in the study and to give written informed consent. exclusion criteria: active neoplasia * severe cardiovascular disease (unstable coronary heart disease, heart failure nyha iii-iv) * type 2 diabetes mellitus * haemophilia or other coagulation disorder * inability to exercise * contraindications to exposure to a 3-t magnetic field (pace-makers, osteosynthetic material) * pregnant women * women in childbearing age unless on a continuous contraceptive therapy or surgically sterilised. * abnormal liver or renal function (creatinine \>130mmol/l, normal reference 45-93mmol/l; asat and alat \> 3 times the upper reference limit). * major depression, psychosis and other severe personality disorders * excessive alcohol consumption (\>60g/d) or drug-abuse * refusal to give written consent * patients, who are not suitable for the study according to the study physician
a non-interventional follow up study for subjects who received sildenafil for persistent pulmonary hypertension of the newborn (pphn)

Conditions: Pulmonary Hypertension, Persistent, of the Newborn

Summary: this single center study will monitor the developmental progress of pphn patients who received iv sildenafil in study a1481276. two visits will be conducted, at 12 and 24 months following the end of study drug infusion.

this study will monitor developmental progress of pphn patients for 2 years following study treatment, using bayley iii and hammersmith tools. data will be explored with descriptive statistics.

Eligibility criteria:
inclusion criteria: * any subject who received sildenafil treatment in study a1481276. * signed and dated informed consent document by legal guardian. exclusion criteria: * any subject who did not receive sildenafil treatment during study a1481276.

Keywords: pphn; development progress after pphn; developmental progress after sildenafil.