Kornimate/medical-research-clean huggingface dataset:
neuron-qi: an intervention to promote preterm infants' neurodevelopment

Conditions: Neurodevelopmental Disorders

Summary: neuron-qi aims to evaluate the effects of an intervention consisting of periods of: 1) parents/preterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator/bed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.


Eligibility criteria:
inclusion criteria for preterm infants: * born between 24 and 33 6/7 weeks ga; * ready for ssc inclusion criteria for mothers and fathers: * agree to do at least one ssc session/week combined with 10 min of auditory stimulation until 36 weeks of ga of their preterm infant; * mothers express breast milk for their preterm infants for twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study. exclusion criteria for preterm infants: * congenital anomalies or genetic disorders * intraventricular hemorrhage \> grade ii * are small for ga defined as birth weight \<10th percentile * on postnatal day 19 (maximum days targeted for study start) * are still receiving analgesics, sedatives, paralyzing agents * are under mechanical ventilation exclusion criteria mothers and fathers: * are aged \<18 years; * have a physical condition that does not allow the ssc * abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions * feed their preterm infant exclusively with commercial infant formula * mothers had a breast surgery that could influence their breast milk production * do not speak, read or write in french or in english

Keywords: nicu skin to skin contact neurodevelopment preterm infants positive stimulation environmental control
6 fec 100 vs 4 fec 100 followed by 4 taxol in n+ breast cancer

Conditions: Breast Cancer

Summary: the main objective of this randomized trial is to compare 6 fec100 to 4 fec100 + 4 taxol in patients with resected node positive breast cancer. main endpoint is disease free survival. secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. a total of 840 patients have been included in the trial.


Eligibility criteria:
inclusion criteria: * histologically proven cancer of the breast, * mastectomy or complete tumorectomy, * histologically proven homolateral, axillary lymph node involvement (at least 1 n+) * period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy \< 2 months, * biological criteria (before the first fec cycle): * neutrophils \>1.5 109 /l * platelets \>100 109/l * hemoglobin \>10 g/dl * creatininemia \<120 mmol/1 * bilirubinemia \<1.5 upper normal value * female patients over 18 years old * written and signed informed consent * performance status less than or equal to 2 (who scale, see annex iv) exclusion criteria: * prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast, * bilateral breast cancer or history of contralateral breast cancer * cardiac history: cardiac insufficiency (lvef \<50%) or coronary decompensation * pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) * inflammatory breast cancer * distant metastasis or supraclavicular adenopathy * benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years * contra-indication to anthracyclines, cyclophosphamide, 5fu or taxol * psychiatric pathology * patient participating in another trial
a study to assess the impact of implementing modified early warning score in terms of competency and self-efficacy of nurses at ilbs, delhi

Conditions: Liver Diseases

Summary: in this study nurses will be taught regarding modified early warning score and how to mark the involved physiological parameters in the mews chart and then scoring will be given i.e mews score and according to the score intervention would be taken by nurses by communicating with other health team members. this scoring will allow nurses to assess early deterioration and early icu admission and at last nurses will be asked regarding the barriers or facilitators they faced while performing mews score.


Eligibility criteria:
inclusion criteria: * registered nurses working in general, semi-private and private ward nurses willing to participate exclusion criteria: * registered nurses who will not be present at the time of data collection. pull out staffs.
safety and efficacy study to determine anti-asthmatic effect of esomeprazole magnesium; nexium reflux asthma

Conditions: Asthma; GERD

Summary: the purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.


Eligibility criteria:
inclusion criteria: * adults with diagnosis of asthma since at least 6 months. * symptoms of asthma during run-in. * at least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth. exclusion criteria: * patients with clinically relevant abnormalities. * patients with a smoking history of ≥10 pack-year. * patients who have had previous surgery on the esophagus or the stomach.

Keywords: moderate to severe asthma gastroesophageal reflux disease esomeprazole gerd
assessment of corneal graft attachment in patients with fuchs endothelial corneal dystrophy following dmek using ultra-high resolution oct

Conditions: Fuchs' Endothelial Dystrophy

Summary: fuchs endothelial corneal dystrophy (fecd) is a progressive disease characterized by the loss of endothelial cells, thickening of descemet's membrane and deposition of extracellular matrix in the form of guttae. this result in failure of the endothelium to support corneal deturgescence leading to corneal edema. affected patients complain about blurred vision at early stages of the disease which can progress to blindness. the pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. additional risk factors that have been identified are female sex, smoking and older age. while for a long time penetrating keratoplasty (pkp) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (dmek) have been developed. in dmek, only the descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. for fecd, this brings the advantage that only the diseased part of the cornea is replaced. graft detachment has been identified as the main complication following dmek. in the investigators' study, an ultra high resolution oct system will be used to detect graft detachment in patients with fecd after dmek. with this technique, even small detachments can be visualized. the area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. a follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years scheduled for primary dmek because of fuchs' endothelial dystrophy exclusion criteria: * any disease inhibiting oct acquisition; such as blepharospasm, severe tremor or immobility * any previous intraocular surgery other than cataract extraction * previous clinically significant ocular trauma in the study eye, as judged by the investigator * pregnancy, planed pregnancy, or lactating * appointment of a custodian * progressive retinal disease * history or presence of glaucoma

Keywords: fuchs' endothelial dystrophy, dmek
study of micafungin in patients with invasive candidiasis or candidemia

Conditions: Candidiasis; Candidemia

Summary: the purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

the purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. the maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. a post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Eligibility criteria:
inclusion criteria: * patients must have candidemia or invasive candidiasis. exclusion criteria: * patients who have received an echinocandin within one month prior to study entry. * patients who have received more than two days of prior systemic antifungal therapy for the current infection.

Keywords: treatment effectiveness treatment efficacy investigational, therapies antifungal, systemic antibiotics, antifungal micafungin
resection versus microwave ablation for resectable colorectal cancer liver metastases

Conditions: Colorectal Neoplasms; Neoplasm Metastasis; Hepatic Neoplasms

Summary: this single-center, prospective, randomized clinical trial is designed to compare the clinical characteristics and outcomes of hepatic resection and microwave ablation (mwa) to determine the optimal operative intervention for the local treatment of resectable colorectal cancer liver metastases. the primary aim of this study is to test the following hypothesis: 2-year local disease control is equivalent between patients receiving the experimental therapy (mwa) and patients receiving the standard therapy (hepatic resection) as treatment for colorectal cancer liver metastases determined to be resectable by radiographic imaging. secondarily, the investigators expect that 2-year intrahepatic (regional) and metastatic disease recurrence rates are equivalent between the two treatment arms in this study.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma of the colon or rectum (diagnosed at the time of colon or rectal resection or on endoscopic biopsy) with liver metastases (by liver biopsy or by history of biopsy-proven colon/rectal cancer with characteristic imaging findings): * imaging showing typical features of colorectal cancer liver metastasis; * cytologic/histologic diagnosis of colorectal cancer or colorectal cancer liver metastasis. * no more than 3 hepatic metastatic lesions noted on preoperative imaging * no lesion greater than 5 cm in maximal dimension * adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic liver resection or microwave ablation as treatment for colorectal cancer liver metastases * willing and able to give informed consent exclusion criteria: * radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases * evidence of recurrent disease adjacent to a previous ablation or resection site * severe renal dysfunction (creatinine clearance of \<40 ml/min) * pregnant or nursing women

Keywords: microwave ablation ablation techniques operative surgical procedures hepatic resection surgery outcomes assessment
negative pressure wound therapy in obese gynecologic oncology patients

Conditions: Postoperative Complications; Obesity; Gynecologic Neoplasms

Summary: the purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. there has been a dramatic increase in obesity rates in the us with more than one third of us adults being obese (body mass index (bmi) of \> 30kg/m2). there is a direct link between obesity and wound complications following surgery with an increasing bmi leading to increasing rates of complications. negative pressure wound therapy (npwt) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. npwt has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. to date, there is no prospective study evaluating the application of prophylactic npwt in laparotomy patients. this study will be a randomized clinical trial. patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. participants will be randomized to one of two groups: 1) standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) npwt group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. the rate of wound complications for two groups will be compared.

Eligibility criteria:
inclusion criteria: * known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned * obese - defined as a body mass index (bmi) ≥ 35 kg/m2 as calculated in the epic computer record exclusion criteria: * known true tape allergy * sensitivity to silver * history of intolerance to negative pressure wound therapy

Keywords: wound healing obesity gynecologic surgery gynecologic neoplasms surgical complications
the real world study of autism spectrum disorder in china

Conditions: Autism Spectrum Disorder

Summary: the investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.

children with autism spectrum disorder registered in xinhua hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (mri), functional near - infrared spectroscopy(f-nirs), electroencephalography and eye movement. the investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.

Eligibility criteria:
inclusion criteria: * diagnosed with autism spectrum disorder * registered in xinhua hospital * written informed consent provided exclusion criteria: * na
blind child melatonin treatment study

Conditions: Blindness

Summary: the primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.

we intend to study as many as 26 blind children through up to three melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. the 3 treatment plans differ only in the start dose. successfully treated subjects (of one treatment plan) will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. the final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Eligibility criteria:
inclusion criteria: * children and adults 5 to 20 years old * blindness for at least one year, verified by an ophthalmologic exam * ability to comply with the requirements of the experimental protocol * and no clinically significant abnormalities (other than blindness) on a general physical examination. * subjects must be competent to sign informed consent if age 18 or older. parents and subjects will be interviewed together and, when appropriate (for example, subject is age 18 or older), separately as well. exclusion criteria: * abnormal heart, liver or kidney function; intractable seizure disorders * significant laboratory abnormalities on cbc, comprehensive metabolic set, or ua (dip stick method) * pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method * a current axis i psychiatric or substance abuse disorder according to the dsm-iv manual ; or * external demands that limit the ability to maintain a regular schedule, e.g. night shift work.

Keywords: melatonin circadian rhythms sleep
lower lugol's solution concentration on reducing the adverse symptoms of chromoendoscopy with iodine staining

Conditions: Mucosal Irritation; Image Quality

Summary: this study was to test an optimal concentration of lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.

it is widely accepted that chromoendoscopy using lugol's solution is effective for the detection of early esophageal squamous neoplasia. however, this modality may cause severe chest pain and discomfort owing to mucosal irritation. the conventional concentration of lugol's solution is in the range of 1.2% to 2.5% . image quality can be guaranteed with this range of lugol's solution. however, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. this study was to test whether a lower concentration of lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.

Eligibility criteria:
inclusion criteria: * patients in the high-risk population of escc; * or general risk population of escc between 40 to 74 years old. definition of high-risk population of escc is list in supporting information33. exclusion criteria included the following: * with obvious abnormalities in stomach, confirmed by either white-light endoscopy (wle) or pcle, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, h. pylori infection and severe bile reflux gastritis; * advanced esophageal carcinoma; * known esophageal surgery or endoscopic treatment; * known esophageal radiotherapy or chemotherapy; * esophageal stenosis; * food retention; * allergy to iodine or fluorescein sodium; * hyperthyroid; * coagulopathy; * acute bleeding; * severe organ failure; * pregnant or breastfeeding women.

Keywords: lugol's solution esophageal squamous cell cancer mucosal irritation image quality
the efficacy and safety of a single 70% glycolic acid peel with vitamin c for the treatment of photoaging

Conditions: Photoaging

Summary: our study involves the evaluation of a high potency peel in its efficacy for skin rejuvenation in the treatment of photoaging. this chemical peel regime is a high potency peel 70% glycolic acid combined with vitamin c that is purported to provide a good balance between yielding results and patient safety. aim we aim to qualitatively evaluate its efficacy and safety profile. our hypothesis is that a single peel of 70% glycolic acid combined with vitamin c will result in improvement of the features of photoaging with few side effects.

1. assessment of photoaging to compare using photography a and e - for static analysis. for each element from ii to xi, a rating of nil (0), mild (l), moderate (2), and severe (3) for each category was made by the same evaluating physician. i. physician vas scale - assessment of wrinkles prepeel, post peel (score 1 -10). ii.fine peri-orbital wrinkles (less than 1 mm in width or depth) (fpw); iii.course peri-orbital wrinkles (greater than 1 mm in width and depth) (cpw); iv.upper lip wrinkles (ulw); v.lower lip wrinkles (llw); vi.melasma defined as blotchy, brown, epidermal macules with indistinct margins; vii.solar lentigines defined as dark brown macules with distinct margins measuring from 3 to 10 mm; viii.solar keratoses defined as diffuse erythema with keratotic adherent scaling; ix.guttate hypomelanosis defined as localized macules of absent melanin measuring from 3 to 10 mm in diameter; x.poikiloderma defined as a symmetrical reddish-brown pigmentation of the neck, typically sparing the sub-mental area; the totaling of the scores of the above parameters will form a prepeel score. this will be compared against the patient's score post peel - we expect to find an improvement. 2. safety profile assessment * redness, swelling, oozing, hyperpigmentation, scarring * each of the 5 parameters will be scored from 0 -3, none, mild, moderate, severe * this will serve as a safety assessment.

Eligibility criteria:
inclusion criteria: photoaging grade 2-4 (face) skin type i - iv exclusion criteria: * pregnancy, breast feeding active dermatitis on the face, rosacea, allergic rhinitis, herpes known hypersensitivity previous keloids laser ablative procedures within the last one month chemical peels in the last 6 months used oral retinoids in the last 6 months used topical retinoids in the past one week used scrub, alpha hydroxy acid, skin irritant for the past 24h presence of facial warts, fungal infections photoallergies prior poor reaction to a chemical peel radiotherapy skin type v and vi

Keywords: photoaging 70% glycolic acid peel
clinical outcomes of bilateral clareon vivity in post-refractive patients

Conditions: Correction Vision Surgery; Cataract Surgery

Summary: millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. however, having a history of refractive surgery, poses challenges in the selection of the iols and can lead to visual outcomes that are unpredictable. data from an international registry and single prospective study show that vivity iol provided effective distance, intermediate and near vision in eyes with previous lasik with minimal effects on day vision associated with the surgery. the purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the clareon vivity/vivity toric lenses


Eligibility criteria:
inclusion criteria: * o bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential clareon vivity iols * prior history of uncomplicated post-refractive myopic surgery (lasik/prk) with up to 1 enhancement treatment * potential acuity measured post-operatively 20/25 or better in both eyes * patients with regular astigmatism that can be managed with t3 toric lens or arcuate incision exclusion criteria: * o ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc. * prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding rk * patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities * total hoa cutoff of ≤0.5, coma ≤0.3 * rle patients