Kornimate/medical-research-clean huggingface dataset:
continuation of tki with or without chemotherapy beyond gradual progression

Conditions: Non Small Cell Lung Cancer

Summary: there have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (egfr-tkis) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from egfr-tkis. however, whether egfr tki with or without chemotherapy provides more survival benefit has not been formally evaluated.

we design this clinical trial to compare the efficacy of continuation of egfr tki with or without chemotherapy in patients beyond gradual progression.

Eligibility criteria:
inclusion criteria: patient who was confirmed stage iv nsclc by pathologic histology or cytology. males or females aged ≥18 years, \< 75 years. eastern cooperative oncology group (ecog) performance status 0-2. life expectancy ≥12 weeks. males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. definition of gradual progression: 1. slow pd (6 months of partial response/stable disease), 2. asymptomatic minimal pd, 3. new brain metastasis controlled locally. patients with asymptomatic, treated brain metastases are eligible for trial participation. adequate bone marrow, renal, and liver function are required. able to comply with the required protocol and follow-up procedures, and able to receive oral medications. institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment. exclusion criteria： any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. female subjects should not be pregnant or breast-feeding. adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function :total bilirubin £ 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt )and aspartate aminotransferase (ast )\< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) in treating women undergoing surgery for stage ii or stage iii breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase ii/iii trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage ii or stage iii breast cancer.

objectives: primary * determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage ii-iiib breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (abraxane\^®). secondary * evaluate the safety of this regimen in these patients. * determine overall clinical response rate in patients treated with this regimen. outline: patients receive up to 4 courses of capecitabine and paclitaxel (nanoparticle albumin-stabilized formulation) (abraxane\^®) in the absence of disease progression. patients then undergo definitive surgical resection of the tumor off study. projected accrual: a total of 33 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer * stage ii-iiib disease (t1-4, n1-2, m0) * previously untreated disease * previously unresected disease * high-risk disease that is not resectable by lumpectomy alone * any her2/neu status (positive, negative, or unknown) allowed * hormone receptor status: * any estrogen/progesterone status (positive, negative, or unknown) allowed patient characteristics: * female * menopausal status not specified * ecog performance status 0-2 * life expectancy \> 3 months * absolute neutrophil count \> 1,500/mm³ * platelet count \> 100,000/mm³ * hemoglobin \> 9.0 g/dl * creatinine \< 1.5 mg/dl * bilirubin \< 1.5 times upper limit of normal (uln) * alt and ast \< 2.5 times uln (5 times uln if due to gilbert's disease) * alkaline phosphatase \< 2.5 times uln (5 times uln if due to gilbert's disease) prior concurrent therapy: * see disease characteristics

Keywords: inflammatory breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer
efficacy and safety of increased dose of ta-650(infliximab) in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of ta-650 in combination with methotrexate (mtx) after three infusions (weeks-0, 2, 6) of 3mg/kg in rheumatoid arthritis (ra) showing an insufficient response to mtx.


Eligibility criteria:
inclusion criteria: * patients with active ra in spite of stable dose of mtx exclusion criteria: * having received infliximab in the past * having a history of serious infection which caused hospitalization within 6 months before the registration * having an active tuberculosis * having a complication or a history of malignancy within 5 years before the registration

Keywords: rheumatoid arthritis ra infliximab ta-650 remicade
laparoscopically assisted anorectal pull-through versus posterior sagittal anorectoplasty

Conditions: Anorectal Malformation

Summary: anorectal malformations are congenital malformations, in which the terminal part of the hindgut is abnormally placed and lies outside (partially or completely) the sphincter mechanism.

the incidence of anorectal malformation \~1 in 5,000 more common in down's syndrome and cat-eye syndrome. male \>female (60:40).it is classified into many types according to the degree of descent of the rectal pouch in the pelvis, the fistula between the rectum and the urinary system in males and genital system in females. the most common type in males is high anorectal malformation with rectourethral fistula there are many historical operations for the management of the high type, but the most popular operation now is the posterior sagittal anorectoplasty which was published for the first time in 1982. children undergoing posterior sagittal anorectoplasty may have lifelong bowel management problems of constipation, incontinence, and encopresis. after the introduction of laparoscopy in pediatric surgery, many surgeons hope that the use of laparoscopy instead of posterior sagittal anorectoplasty may reduce the complications of the complications of the big incision and disturbance of sphincter mechanism which occur in posterior sagittal anorectoplasty operation. in addition to its role in diagnosis in complex anomalies like cloaca which is well established now. so the question is to what extent can the laparoscopy replace usual surgery for anorectal malformation.

Eligibility criteria:
inclusion criteria: -all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done exclusion criteria: * all cases with low anomalies will be excluded. * female child with vestibular anus * case with short distal pouch
tumor-induced osteomalacia disease monitoring program

Conditions: Tumor-induced Osteomalacia (TIO)

Summary: the objectives of this observational study are to assess the long-term safety and long-term effectiveness of burosumab in patients with tio who are being treated with burosumab as prescribed by their physician and to monitor the course of the underlying phosphaturic mesenchymal tumor (pmt) overtime in patients with tio irrespective of their treatment status.

enrolled patients may or may not be treated with commercially available burosumab during the tio dmp at the discretion of their treating physician. given the observational nature of the tio dmp, specific treatments or supportive management will not be provided as part of the study.

Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of tio based on the presence of an underlying pmt (confirmed by imaging) and/or historical documentation. note: for adult patients with tio in whom the causative pmt has never been located, and all pediatric patients, documented evidence of negative genetic testing for other hereditary hypophosphatemic disorders is necessary * for patient safety, all participating female patients of child-bearing potential must be willing to have pregnancy tests prior to certain assessments performed as part of the dmp * be willing to provide access to prior medical records including tumor pathology reports and biopsy slides, imaging, biochemical, and diagnostic, medical, and surgical history data, if available * be willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related procedures * be willing and able to comply with the study visit schedule and study procedures exclusion criteria: * have a clinical diagnosis of tio deemed to be caused by a tumor other than a pmt * serious medical or psychiatric comorbidity that, in the opinion of the investigator, would present a concern for patient safety or compromise the ability to provide consent or comply with the study visit schedule and study procedures * less than 1 year of life expectancy (for any cause) in the opinion of the investigator * concurrent enrollment in a clinical trial without prior approval from the tio dmp sponsor * undergoing treatment with burosumab for an unapproved indication
methylphenidate in adhd - addiction(s) comorbidity: value of adding a cognitive remediation program to improve short- and medium-term therapeutic response

Conditions: ADHD-add

Summary: methylphenidate in adhd - addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response

it seems essential to optimize the therapeutic management of patients suffering from adhd/addiction(s) comorbidity by specifically targeting their neuropsychological deficits, in addition to the pharmacological and psychosocial approaches currently recommended. by intensively training deficient functions on the one hand, and promoting the development of compensatory strategies on the other, cognitive remediation could thus be a therapeutic tool of choice, producing beneficial effects that persist over time and translate into objectifiable changes in daily life. cognitive training programs have been successfully proposed to patients with adhd, but these were mainly programs designed for children, and very few studies have been carried out in adults, a fortiori in adults with adhd-addiction(s) comorbidity. the main aim of the study was to evaluate the effectiveness of cognitive remediation compared with the control program in addition to mph treatment in reducing the functional impact of adhd in patients with other addictive comorbidities, at the end of treatment.

Eligibility criteria:
inclusion criteria: * age over 15 (patients treated in the "adult" stream); * diagnosis of adhd confirmed by diva-5 interview (for patients over 18) or young diva-5 (for patients between 15 and 17) following a specialized adhd-addiction(s) consultation; * indication for mph treatment according to european recommendations (j. j. s. kooij et al., 2019) and absence of contraindications (particularly cardiological); * presence of at least one comorbid addictive disorder (tus and/or ac); * having given their consent to take part in the study; * being affiliated to the french social security system or benefiting from such a system. exclusion criteria: * presence of disorders of the higher functions or difficulties in reading or writing the french language making it impossible to collect data; * pregnant or breast-feeding woman; * person deprived of liberty; * person under compulsory psychiatric care; * participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome; * guardianship or safeguard of justice.

Keywords: methylphenidate cognitive remediation functional improvement
the association between diabetes mellitus, oral lichen planus and insulin-like growth factors 1 and 2 (igf1 and igf2)

Conditions: Oral Lichen Planus; Diabetes Mellitus

Summary: diabetes mellitus is among the most common chronic diseases, with significant and well documented impact on oral cavity health. among the most common diseases of the oral cavity mucosa and complications in patients with impaired glucose metabolism and diabetes mellitus is oral lichen ruber (olr), which according to world health organisation (who) is considered potentially malignant disorder. it was found that lichen ruber in diabetes mellitus has a much more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. although olr etiology is unknown, evidence suggests cell-mediated autoimmune pathogenesis. olr epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (igf-1 and igf-2) metabolism. the hypothesis of our research is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.

oral lichen ruber (olr) in the diabetes mellitus patients has more aggressive clinical course in the form of atrophic-erosive and ulcerative lesions showing an increased tendency to malignant transformation. olr epithelial cells show anomalies in both enzymatic activity and carbohydrate metabolism, which may be related to hormones regulating carbohydrate, insulin and insulin-like growth factors 1 and 2 (igf-1 and igf-2) metabolism. the role of insulin-like growth factors (igfs) is of great importance in normal growth and cell development (cell proliferation, differentiation and apoptosis), and is involved in different aspects of cell transformation in malignant phenotype. a change in the expression of igf1, igf2 and igf2r proteins is described in several types of malignant tumors including oral cancer. however, data on their role in the development of malignant lesions of the oral cavity are scarce, and the results are inconsistent. our hypothesis is that patients with diabetes mellitus and oral lichen ruber lesions will have a disturbance of insulin-like growth factors 1 and 2 and hence a greater risk of malignant transformation, compared to patients with oral lichen ruber without diabetes and healthy patients without alterations in the oral mucosa.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed oral lichen ruber patients, with and without diabetes mellitus * healthy volunteers referred for alveolotomy exclusion criteria: * non-consent patients
to evaluate drug-drug interactions between dwn12088 and nebivolol or paroxetine in healthy volunteers

Conditions: Idiopathic Pulmonary Fibrosis

Summary: an open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between dwn12088 and nebivolol or paroxetine in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male adults aged ≥ 20 and ≤ 55 years at screening * subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information exclusion criteria: * subjects unable to have the standard meal provided at the study site * subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose
healing ointment usage post-surgical procedure

Conditions: Surgical Wound

Summary: to evaluate benefits of a healing ointment in skin improvement after dermatologic procedures

this is an open-label, multi-center study to evaluate the safety and efficacy of a healing ointment in skin improvement after dermatologic procedures such as mohs surgery, skin biopsy, excision on the head/neck or body. the study is designed to enroll approximately 20 subjects, in which 10 subjects undergo dermatologic procedure on the head/neck and 10 subjects on the body. eligible subjects apply the test product twice daily after the procedure, followed by efficacy and tolerability assessments, standard photography, and self-assessment questionnaire at each follow-up visit.

Eligibility criteria:
inclusion criteria: * subject who undergo mohs surgery, skin biopsy, excision on the head/neck or body * ability of giving consent for participation in the study * agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments exclusion criteria: * history of allergy or hypersensitivity to cosmetic ingredients * pregnant, planning pregnancy during the course of the study or breastfeeding * subject with a history of keloids or hypertrophic scars * presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments * subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator * subjects with inability to comply with all study protocol restrictions and visits
a multicenter open-label clinical study on the prevention of premature ovarian failure after hsct

Conditions: Hematopoietic Stem Cell Transplantation; Premature Ovarian Failure

Summary: hsct is an effective method to cure hematologic malignancies. however, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (pof), which seriously affect the long-term quality of life of patients. this clinical trial aimed to observe the effect of gonadotropin-releasing hormone analogues (gnrha) on ovarian function in women of reproductive age after hsct, so as to provide clinical evidence for whether gnrha should be used for the prevention of pof.

hematopoietic stem cell transplantation (hsct) is an effective method for the treatment of hematologic malignancies. however, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (pof), seriously affecting the long-term quality of life of patients. exogenous injection of gonadotropin-releasing hormone analogue (gnrha) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. however, there is a lack of large-scale clinical studies on pof in hsct. therefore, this clinical trial aimed to observe the effect of gnrha application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether gnrha application for fertility function protection.

Eligibility criteria:
inclusion criteria: * diagnosed with acute leukemia, mds, lymphoma, multiple myeloma, saa and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation. * female, aged 18-45 years. * ovarian function was normal before treatment. * volunteer to participate in clinical research and sign the informed consent form. exclusion criteria: * no menstruation before treatment, undergone hysterectomy or ovarian surgery. * abnormal sexual development. * received radiotherapy. * combined with tumors affecting gonadal function. * deep vein thrombosis. * hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.
sickle-cell disease registry of the gpoh

Conditions: Sickle Cell Disease

Summary: sickle cell disease is one of the most common hereditary diseases. most severe complications can be avoided if the disease is detected early and treated appropriately. the sickle cell disease registry of the society for paediatric oncology/haematology aims at describing the epidemiology of sickle cell disease in german-speaking central europe. patients with sickle cell disease will be characterized clinically and genetically and treatment will be documented with the aim to find predictors of the course of disease. in addition, the registry results should provide a solid evidence base to incorporate sickle cell disease into routine newborn screening and to update the national guidelines for the management of patients suffering from sickle cell disease in germany. a consortium of five university hospitals (berlin, frankfurt, hamburg, heidelberg, ulm) has been mandated by the society for paediatric oncology/haematology to implement this registry. the number of participating centers is constantly increasing and new centers that take care of either pediatric or adult patients with sickle cell disease are encouraged to support the registry. for further information please refer to: http://www.sichelzellkrankheit.info/


Eligibility criteria:
inclusion criteria: * signed informed consent * current residency in either germany, austria or switzerland * sickle cell disease confirmed by hemoglobin analysis or molecular genetic analysis * homozygous sickle cell disease (hbss) * hbsc disease * sickle cell disease hbs / bthal * other, rare sickle cell syndromes such as hbs/oarab, hbs/hpfh, hbs/e, hbs/d punjab, hbs/c harlem, hbc/s antilles, hbs/quebec-chori, hba/s oman, hba/jamaica plain exclusion criteria: - isolated heterozygous trait for hbs

Keywords: anemia, sickle cell sickle cell disease