Kornimate/medical-research-clean huggingface dataset:
novel skin care product for the management of acute radiodermatitis

Conditions: Radiodermatitis; Acute; Radiation Dermatitis

Summary: notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (qol) - impairing complications. especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. the number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (rt) techniques. acute radiodermatitis (ard) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing rt. important organizations in the field of oncology and supportive care, such as the mascc, the asco, and the esmo, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. still, for some interventions, the evidence of recommendation is moderate to insufficient. therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. based on the previously mentioned supportive care guidelines for the rtskin project, a novel emollient to tackle ard has been developed. the rtskin project general aim is to evaluate the efficacy of a novel skincare product to manage ard in breast cancer patients.

primary objective evaluate the efficacy of a novel emollient for the management of ard in comparison with the current standard of care in breast cancer patients secondary objective 1 compare the ard-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care. secondary objective 2 compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care. secondary objective 3 correlate the severity of ard with the applied rt parameters and personal - medical characteristics

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer and underwent lumpectomy or mastectomy * scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the jessa hospital (hasselt, be) * age ≥ 18 years * able to comply to the study protocol * able to sign written informed consent * signed written informed consent exclusion criteria: * previous irradiation to the breast region * metastatic disease * patients with pre-existing skin rash, ulceration or open wound in the treatment area * substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Keywords: skin toxicity radiotherapy oncology skin care emollient
a study of intravenous sulopenem and oral pf-03709270 in community acquired pneumonia that requires hospitalization

Conditions: Pneumonia, Bacterial

Summary: the purpose of this study is to test if intravenous sulopenem and an oral drug, pf-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.


Eligibility criteria:
inclusion criteria: * hospitalized male or female patients 18 years of age or older. * female patients of childbearing potential must not be pregnant. * must exhibit at least two pre-specified clinical symptoms/signs of pneumonia. * must require hospitalization for the pneumonia. * chest xray must be suggestive of a pneumonia. exclusion criteria: * hospital or ventilator associated pneumonia. * patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis. * previous treatment for the current pneumonia episode received for more than 24 hours. * allergies to penems or beta lactams.
hemorrhagic myocardial infarction detection by biomarkers

Conditions: Acute Myocardial Infarction

Summary: pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. index stemi 3. coronary angiogram with pci to occur irrespective of the onset of the symptoms. 4. ability to provide informed consent for themselves exclusion criteria: 1. history of prior myocardial infarction, 2. cardiogenic shock, 3. patients who present with current cardiac arrest 4. any contraindication to cardiac cmr (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium), 5. presence of permanent atrial fibrillation, 6. unconscious patient, 7. severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy), 8. women who are pregnant or breastfeeding. women of reproductive potential must have a negative pregnancy test.

Keywords: stemi troponin intramyocardial hemorrhage cardiac mri
alcohol interaction study

Conditions: Alcoholism

Summary: the purpose of this study is understand the effects of gsk114814 and alcohol in healthy volunteers when taken together.

the primary objective of this study is to investigate the cns effects of co-administration of gsk1144814 with alcohol. healthy volunteers who meet the eligibility criteria will be randomized to receive gsk1144814 or placebo with alcohol.

Eligibility criteria:
inclusion criteria: * healthy male and female * body weight 50 kg or higher and bmi within the range 19 - 29.9 kg/m2 * willing to use appropriate contraception methods exclusion criteria: * positive hiv, hepatitis b surface antigen or hepatitis c antibody result * any serious medical disorder or condition * any history of an endocrine disorder. * any clinically significant laboratory abnormality. * history of psychiatric illness. * any history of suicidal attempts or behavior. * positive urine drug screen or positive blood alcohol * pregnant, nursing or potential to have a child * past history of alcohol dependence or abuse. * history of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated. * smokers

Keywords: alcohol drug interaction pharmacodynamic
adapalene-benzoy peroxide (bpo) gel in the treatment of acne vulgaris as a 6-month maintenance

Conditions: Acne

Summary: the purpose of this study is to demonstrate the efficacy of adapalene 0.1% /benzoyl peroxide 2.5% gel compared to its vehicle gel as an acne maintenance treatment in subjects previously treated with adapalene-bpo gel or adapalene-bpo vehicle gel both associated with doxycycline hyclate 100 mg. the safety of the two investigational treatments will also be assessed.

this study is a follow-up to rd.03.spr.29074 - access i / nct00688064 - "adapalene-bpo gel associated with doxycycline 100 mg in the treatment of severe acne vulgaris"

Eligibility criteria:
inclusion criteria: * subjects who completed the previous study (rd.03.spr29074 - nct00688064)and had obtained at least a good improvement (grade, 0, 1, 2 or 3) exclusion criteria: * female subjects who are pregnant, nursing or planning a pregnancy during the study * subjects who foresee intensive uv exposure during the study (mountain sports, uv radiation, sunbathing, etc).

Keywords: acne
safety and efficacy study of kai-1678 to treat pain in subjects with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to determine whether kai-1678 is effective in the treatment of pain associated with spinal cord injury.


Eligibility criteria:
inclusion criteria: * spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months * central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months * pain score at least 4 on 11-point numerical rating scale (0-10) * stable doses of analgesic medications for at least 1 month exclusion criteria: * history of chronic alcoholism or chronic substance abuse * tolerance to opioid analgesics * clinically significant abnormality on laboratory tests or ecg

Keywords: analgesics. non-narcotic / therapeutic use spinal cord injuries pain pain measurement / drug effect pain postoperative / drug therapy
impact of overfeeding and following exercise training in individuals with and without increased risk of type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Insulin Resistance; Dyslipidemia

Summary: low birth weight (lbw), a marker of impaired fetal growth is an independent and strong risk factor for type 2 diabetes (t2d). a western lifestyle characterized by a surplus of calories, and/or a low physical activity level, associated with increased fat storage and altered lipid metabolism plays a central role in the pathogenesis of insulin resistance and t2d. using state-of-the-art large-scale integrative physiology studies combined with basic studies of adipose and muscle tissue stem cell functions, the investigators aim to determine if lbw individuals exhibit decreased subcutaneous adipose tissue expandability, postprandial hyperlipidaemia and ectopic fat accumulation when exposed to 4 weeks of carbohydrate overfeeding. the investigators will subsequently examine if exercise training can revert and/or minimize the deleterious effects of carbohydrate overfeeding in a possibly birth weight differential manner.


Eligibility criteria:
inclusion criteria: * without known disease (approved health examination) * caucasian * born at term (weeks 39-41) in denmark * recruited from the national danish birth registry * born with either low or normal birthweight (see previous) exclusion criteria: * family history of diabetes in two generations (1st and 2nd degree relatives) * self-reported high physical activity level (\>10hrs /week). * weight loss/gain \>3 kg within the past 6 months * alcohol intake of more than general recommendations * substance abuser * intake of medication know to affect outcomes
comparing sensitivity and specificity of pacemaker id application and cardiac rhythm management device-finder application.

Conditions: Cardiac Arrhythmia

Summary: smart phone-based applications to identify cardiac implantable electronic devices (cied) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. few studies have provided insight regarding the utility of these applications. we have studied two widely available applications i.e., pacemaker id app (pmida) or cardiac rhythm management devices-finder (crmd-f) to identiy device manufacturers in cieds.

smart phone-based applications to identify cardiac implantable electronic devices (cied) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. few studies have provided insight regarding the utility of these applications. we have studied two widely available applications i.e., pacemaker id app (pmida) or cardiac rhythm management devices-finder (crmd-f) to identiy device manufacturers in cieds. 547 patients who underwent cied implantation from year 2016 - 2020 in our institute were enrolled. there were 438 medtronic and 109 st. jude's devices. all chest radiographs were de-identified and resized into 225\*225 pixels focusing on the cied. pmida and crmd-f applications were used to identify cied. accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.

Eligibility criteria:
inclusion criteria: * all patients undergoing cied implantation and having xray post-implant at any point and time. exclusion criteria: * patients with cied for whome xray was not available.
pd-l1-expressing regulatory t cells in localized prostate cancer patients undergoing iodine-125 permanent brachytherapy

Conditions: Prostate Cancer

Summary: immunotherapy is currently revolutionizing the field in oncology. however, prostate cancer is poorly responsive to immune checkpoint inhibition. the combination of immunotherapy and radiotherapy is an emerging clinical treatment aradigm. x-ray radiation treatment can activate both the adaptive and innate immune systems through directly killing tumor cells, causing mutations in tumor-derived peptides, and causing localized inflammation that increases immune cell trafficking to tumors. recently, preclinical study reported that immune checkpoint inhibition combined with radiotherapy treats cprc with significant increases in median survival compared to drug alone.

permanent brachytherapy is one of those standard treatments for localized prostate cancer patients. biopsy confirms prostate cancer. blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)

Eligibility criteria:
inclusion criteria: - biopsy confirms prostate cancer localized prostate cancer, ≤ct3 no chemotherapy or hormonal therapy before permanent brachytherapy exclusion criteria: - unacceptable operative risk poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (turp) defect, large median lobe, large gland size). pathologically positive lymph nodes significant obstructive uropathy distant metastases use steroids regularly the diagnosis was accompanied by immune-related diseases allergic constitution abnormal white blood cell and lymphocyte counts ever underwent other treatments for prostate cancer, such as chemotherapy or hormonal therapy accompanied by other malignancies splenectomy hiv positive receive an anti-infective vaccine for the last 6 months
remote ischemia precondition (ripc) for hepatic protection in patients undergoing hepatectomy

Conditions: Liver Neoplasms

Summary: remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.

remote ischemia precondition (ripc) had been proofed beneficial to ischemia reperfusion injury of heart, kidney, liver, brain and spinal cord in experimentation on animals. and the clinical studies of ripc were mainly focused on heart, ripc's protection effect on hepatic ischemia reperfusion injury in patients undergoing hepatectomy still remains unknown, so we designed this study to demonstrate the hypotheses.

Eligibility criteria:
inclusion criteria: * no other main organ diseases, american society of anesthesiologists (asa) classification ⅰ-ⅱ grade * selective hepatectomy, one time hepatic portal occlusion * child-pugh a exclusion criteria: * peripheral vessels diseases * not the same surgical procedure as expected * administered anti-inflammatory drugs as glucocorticoid etc * diagnosed of diabetes * history of liver surgery * history of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy * refuse to join the research * patients with psychopathy * acute infection need antibiotic therapy * hepatic artery or portal vein embolism

Keywords: hepatic ischemia reperfusion injury ischemia precondition remote ischemia precondition anti-inflammation
multicenter retrospective observatory of patients with acute myeloid leukemia to core binding factor

Conditions: Acute Myeloblastic Leukemia Core Binding Factor

Summary: acute core binding factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. their management now follows the reference pattern from the french trial cbf-2006 closed to inclusions since november 2010. this includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by rt qpcr . these leukemias have not been the subject of multicenter clinical trials since that date. the results of this treatment regimen need to be evaluated. known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (mrd) will be analyzed and updated in this recent cohort. the interaction between residual disease and mutational profile will be evaluated on the prognosis. treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. the course and early treatment of molecular relapses will be analyzed. the treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

not provided

Eligibility criteria:
inclusion criteria: * patients over 18 years old * diagnosis of acute myeloid leukemia with cbf confirmed by cytogenetics (karyotype and / or fish): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (runx1-runx1t1 fusions or cbfb-myh11) * initial management by intensive chemotherapy, hypomethylants or targeted therapies exclusion criteria: - opposition expressed to research
natural evolution of muscle structure and stiffness following brain lesion

Conditions: Stroke, Acute; Traumatic Brain Injury

Summary: we propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. patients will be assessed two weeks, one month, three months and six months after their brain lesion. secondary objectives: to compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity. to compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb. to compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb. to study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.


Eligibility criteria:
inclusion criteria: * female or male ≥ 18 years and ≤ 80 years at screening * hemiparesis secondary to a first stroke or traumatic brain injury * \< 1 month post-stroke/brain injury subjects must meet all of the inclusion criteria in order to be eligible to participate in the study. exclusion criteria: * bilateral limb paresis * major cognitive impairments limiting the functional evaluation * neurological or orthopedic affection interfering with the paretic limbs function * underlying neuromuscular disease (e.g. myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis) * contraindication to perform mri subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
the impact of tibial tubercle-trochlear groove distance and patellar height on the outcome of isolated medial patellofemoral ligament reconstruction

Conditions: Patellar Dislocation

Summary: the investigators plan to perform a prospective observational cohort study of patients undergoing mpfl reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. the investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.


Eligibility criteria:
inclusion criteria: * mpfl reconstruction exclusion criteria: * trochleoplasty required * prior ipsilateral knee surgery * iwano grade 2+ * chondral injury requiring surgical treatment beyond debridement * major ligamentous injury to the knee
study of sanguinate™ in the treatment of sickle cell disease patients with vaso-occlusive crisis

Conditions: Anemia, Sickle Cell

Summary: safety and effect of sanguinate on sickle cell disease patients experiencing a vaso-occlusive crisis

patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment and screening into the sgsc-005 study. patients who meet all inclusion/exclusion criteria will be randomized to receive either sanguinate 320 mg/kg or placebo (saline) over a 2 hour infusion period. assessments of vital signs, ecgs, safety labs, adverse events as well as patient and physician questionnaires will be completed up to 6 hours after the start of the infusion. patients will then be assessed for discharge either to home or admitted to the hospital for further treatment depending on their disease severity. follow-up phone calls will be completed 24 hours and 7 days after initiation of treatment . a follow-up visit will be completed in the clinic at 72 hours after initiation of treatment.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, 2. sickle cell disease (all genotypes), 3. diagnosis of a severe vaso-occlusive crisis (voc), based on the clinical judgement of the investigator, 4. participant needs to be admitted to the ambulatory site for treatment of voc requiring iv pain medication, 5. able to provide written consent, 6. able to receive iv infusion of study drug. exclusion criteria: 1. in the judgment of the investigator, the participant is not a good candidate for the study, 2. an acute severe complication of scd beyond voc, 3. pregnant or actively trying to become pregnant, or breastfeeding, 4. participant had \> 6 urgent visits for scd complications in the prior 3 months, 5. fewer than 30 days since any prior treatment with iv pain medication for voc, 6. onset of current acute painful crisis \> 3 days prior to dosing, 7. evidence of moderate to severe renal insufficiency (crcl \ 2 x uln) based on past medical history, 8. concurrent or prior treatment within 90 days with an investigational medication, 9. abnormal ecg due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the investigator.