Kornimate/medical-research-clean huggingface dataset:
cyclophosphamide, abatacept, and tacrolimus for gvhd prevention

Conditions: Graft-versus-host Disease

Summary: this is a single arm, open label, optimal 2-stage simon design phase ib-ii clinical trial. adult patients with hematological malignancies undergoing allogeneic hsct from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (sops), meet all inclusion criteria, and do not satisfy any exclusion criteria. patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. patients will receive cyclophosphamide, abatacept, and short-duration tacrolimus for gvhd prophylaxis.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. karnofsky score ≥ 70% 3. no evidence of progressive bacterial, viral, or fungal infection 4. creatinine clearance \> 50 ml/min/1.72m2 5. total bilirubin, alt and ast \< 2 x the upper limit of normal (except for diagnosed gilbert's syndrome) 6. alkaline phosphatase ≤ 250 iu/l 7. left ventricular ejection fraction (lvef) \> 45% 8. adjusted carbon monoxide diffusing capacity (dlco) \> 60% 9. negative hiv serology 10. negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hcg) for women of childbearing age and potential. exclusion criteria: 1. donors are excluded in case of donor-specific hla antibodies or positive cross-match. 2. pregnant or nursing females or women of child bearing age or potential, who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of conditioning regimen through day +180. a woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row. 3. male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. this must be done even if they are surgically sterilized (i.e., post-vasectomy). 4. inability to provide informed consent. 5. patient had myocardial infarction within 6 months prior to enrollment or has new york heart association (nyha) class iii or iv heart failure (see appendix e), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening must be documented by the investigator as not medically relevant. 6. known allergies to any of the components of the investigational treatment regimen. 7. serious medical or psychiatric illness likely to interfere with participation in this clinical study. 8. participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. 9. prisoners
t-dm1 with abraxane and lapatinib for metastatic her2 positive breast cancer

Conditions: Metastatic Breast Cancer

Summary: this open-label, single-center phase ib study will assess the safety and tolerability of combining trastuzumab emtansine (t-dm1) with lapatinib and abraxane in patients with metastatic her2-positive breast cancer.

this open-label, single-center phase ib study will assess the safety and tolerability of combining trastuzumab emtansine (t-dm1) with lapatinib and abraxane in patients with metastatic her2-positive breast cancer. patients will receive abraxane on day 1 of each 1-week cycle and t-dm1 on day 1 of each 3-week cycle. patients with take lapatinib orally daily. patients will receive the study treatment for 12 weeks.

Eligibility criteria:
inclusion criteria: * documented metastatic her2 over-expressed breast cancer. * age ≥ 18 years patients must have received at least two prior therapies for their malignant disease. * patients must have \< grade 2 pre-existing peripheral neuropathy (per ctcae) * adequate organ function (cardiac ejection fraction of ≥ 45%), * cbc not less than .75 of institutional lower limit. * patients must have adequate liver function: ast and alt \< 2.5 x upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, unless bone metastasis is present in the absence of liver metastasis bilirubin \< 1.5 mg/dl * patients must have adequate renal function: creatinine \<1.5 mg/dl is recommended; however, institutional norms are acceptable. * negative serum or urine β-hcg pregnancy test at screening for patients of childbearing potential * fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abstinence. oral, injectable, or implant hormonal contraceptives are not allowed). contraception method must be used during treatment and for three months after completing treatment signed informed consent form (icf) exclusion criteria: * any medical or psychiatric condition that would prevent informed consent or limit survival to less than 4 weeks. * absolute qt interval of \>460 msec in the presence of potassium \>4.0meq/l and magnesium \>1.8mg/dl. * patient with hiv and post- transplant associated lymphoproliferative disorders. * patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of trastuzumab emtansine, lapatinib or abraxane. * pregnant or lactating women. * concurrent treatment with an investigational agent or participation in another therapeutic clinical trial * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab emtansine, lapatinib, abraxane, or their components. * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. * subjects with ulcerative colitis are also excluded.

Keywords: breast cancer her2 positive breast cancer
gravitas-309: itacitinib and corticosteroids as initial treatment for chronic graft-versus-host disease

Conditions: Chronic Graft-versus-host Disease

Summary: the purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cgvhd).


Eligibility criteria:
inclusion criteria: * active, clinically diagnosed, moderate or severe cgvhd per nih consensus criteria * underwent allogeneic stem cell transplantation (allo-hct) * karnofsky performance status score ≥ 60%. * evidence of myeloid and platelet engraftment. * willingness to avoid pregnancy or fathering children based on protocol-defined criteria. exclusion criteria: * has received more than 3 days/72 hours of systemic corticosteroid treatment for cgvhd. * has received any other systemic treatment for cgvhd, including extracorporeal photopheresis (ecp). * prior treatment with a janus kinase (jak) inhibitor for acute gvhd, unless the participant achieved complete or partial response and has been off jak inhibitor treatment for at least 8 weeks before randomization. * cgvhd occurring after a nonscheduled donor lymphocyte infusion (dli) administered for pre-emptive treatment of malignancy recurrence. * evidence of relapsed primary malignancy.

Keywords: graft-versus-host-disease itacitinib janus kinase inhibitor corticosteroids
evaluation of hypothyroidism incidence after breast cancer supraclavicular irradiation

Conditions: Irradiation; Adverse Effect; Irradiation Hypothyroidism

Summary: prospective, multicentric, comparative, non randomised, in current care. primary objective: * to evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months). secondary objectives : * to calculate the dose of irradiation received by thyroid gland during the treatment. * to compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2). * to estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups. * to look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters. * to propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

prospective, multicentric, comparative, non randomised, in current care study 2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation: * group 1 : patients receiving a supra-clavicular irradiation * group 2 : patients not receiving a supra-clavicular irradiation. schedule projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients) intermediate study of the results in 30 months duration of follow-up of 60 months

Eligibility criteria:
inclusion criteria: * women older than 18 * non metastatic breast cancer, histologically proved, whatever t and n stages and receptors status. * breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies) * breast cancer requiring an adjuvant radiotherapy * treatment by radiotherapy made in participating centers * information of patient and signature of the informed consent. exclusion criteria: * pre-existent dysthyroidism revealed before radiotherapy or at inclusion checkup (ths lower or superior to the standard of the laboratory, whatever the rate of free t4) * history of thyroid surgery * bilateral breast cancer * history of cervical and/or supra-clavicular radiotherapy * lack of social security insurance * subjects deprived of free behavior or under administrative control
promoting mental health in young children - a dialogue based approach in kindergartens

Conditions: Child Behavior; Child Development

Summary: the goal of this clinical trial is to learn if the novel dialogue based early detection (dbed) method can prevent impaired mental health in kindergarten children. it will also learn about the screening properties of dbed to identify children with impaired mental health, if dbed facilitates early interventions, and if dbed is well accepted and sustainable in an ordinary kindergarten setting. the main questions it aims to answer are: * do children in kindergartens where dbed is implemented develop better mental health scores than children in kindergarten where dbed is not implemented? * how well identifies dbed kindergarten children with impaired mental health compared to a traditional screening instrument (the strengths and difficulties questionnaire)? * what is the impact of dbed on activation of interventions for mental health problems? * what is the social validity of dbed? researchers will compare outcomes in kindergartens where dbed is implemented with outcomes in kindergartens where it's not. * during the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual dbed parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings. * twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school). * participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting. * the kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.


Eligibility criteria:
inclusion criteria: * attendance in kindergarten * inclusion during the first half-year of the third last year in kindergarten exclusion criteria: * parents don't communicate in norwegian or english

Keywords: health promotion secondary prevention kindergarten child mental health parent involvement
effect of gastric bypass surgery on brain responses

Conditions: Obesity; Hormone Responses; Cognitive Health

Summary: after obesity surgery gastric bypass (gbp) patients usually lose more than 50% of its former preponderance in relative short time (\~ 2 years). but knowledge of the underlying biological mechanisms of decline in body weight is still inadequate. this project intends to examine patients' background activity in the brain (i.e. "the resting state activity") and brain volume using mri both before and one year after surgery.

we will also investigate whether hormonal changes in response to food intake after obesity surgery is associated with patients' impulsive control when exposed to pictures of food in the mri.

Eligibility criteria:
inclusion criteria: * female * right-handed * scheduled for bariatric surgery in the academic hospital of uppsala, sweden exclusion criteria: * undergone more than one bariatric surgery * suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.

Keywords: bariatric surgery cognition satiety hormones brain networks inhibitory control food intake
cp-868,596 and cp-868,596 plus ag-013736 in combination with docetaxel in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: a5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. cp-868,596 is a platelet-derived growth factor receptor inhibitor (pdgfr) and ag-13736 is a vascular endothelial growth factor receptor inhibitor (vegfr). this study will test the use of docetaxel (the standard chemotherapy) with either cp-868,596 or the combination of cp-868,596 and ag-13736.


Eligibility criteria:
inclusion criteria: * be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy. * patients with primary brain tumors are not eligible. * have at least one site of measurable disease. exclusion criteria: * received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin c). * received tamoxifen within 4 weeks prior to study entry.

Keywords: pdgfr inhibition; vegfr inhibition; targeted therapy
effect of different surgical approaches of granulomatous mastitis

Conditions: Breast-conserving Plastic Surgery; Granulomatous Mastitis

Summary: the objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. the patients were divided into traditional surgery group and plastic surgery group.

granulomatous mastitis is a rare benign inflammatory breast disease first described by kessler and wollock in 1972. it resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. treatment methods include steroid therapy, antibiotics and surgical treatment. however, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment. breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. so, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? at present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, v/j breast plasty, grisotti and so on. therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. the postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared. it is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.

Eligibility criteria:
inclusion criteria: only the subjects who meet all the following criteria may be included in this study: 1. ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form; 2. 18≤age≤75 years old, female; 3. histologically confirmed granulomatous mastitis; 4. low and moderate risk for anesthesia. exclusion criteria: the subjects who meet any of the following criteria shall not be included in this study: 1. absolute and relative contraindication for surgery; 2. previous history of breast cancer or other malignancies; 3. pregnancy; 4. any serious complications which caused patients not suitable to participate this study.

Keywords: granulomatous mastitis breast conserving plastic surgery aesthetics scores
posture and spinal mobility in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the primary objective of the study is to compare the results of the postural and mobility analysis obtained with the use of the idiag m360 instrument in adult women with anorexia nervosa and in a control group represented by age-matched normal-weight women. secondary objectives will be to correlate the results obtained from previous postural analyses with anthropometric parameters, the duration and onset of the disease, and the presence/date of onset of secondary amenorrhea.


Eligibility criteria:
anorexia nervosa: inclusion criteria: * female sex * age 18 years and older * anorexia nervosa clinically diagnosed based on the dsm-5 criteria * hospitalized in the division of eating and nutrition disorders (end), istituto auxologico italiano, irccs, piancavallo (vb), italy exclusion criteria: * absence of signed informed consent * musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery) * treatment with anti-inflammatory drugs normal weight: inclusion criteria: * female sex * age 18 years and older * bmi: 18.5-24.9 kg/m2 * recruited from the medical/nursing and research staff exclusion criteria: * absence of signed informed consent * musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery) * treatment with anti-inflammatory drugs

Keywords: anorexia nervosa spinal mobility posture
sequencing mycobacteria and algorithm-determined resistant tuberculosis treatment trial

Conditions: Rifampicin Resistant Tuberculosis; Drug-resistant Tuberculosis; Multidrug Resistant Tuberculosis; Pulmonary Tuberculoses

Summary: the primary aim of this pragmatic trial is to determine the effectiveness of a whole genome sequencing (wgs) drug sensitivity testing (dst) strategy to guide individualised treatment of rifampicin resistant tuberculosis (rr-tb) patients. the primary objective is to determine the effectiveness of this wgs dst strategy in patients diagnosed with rr-tb. we will additionally perform an exploratory health economics evaluation of both arms, and will determine the feasibility of the wgs dst strategy.

the trial will be a single blinded randomised controlled, pragmatic, medical device trial evaluating a whole genome sequencing (wgs) drug sensitivity testing (dst) strategy to guide individualised treatment of rifampicin resistant tuberculosis (rr-tb) patients. a total of 248 patients diagnosed with rr-tb in the south african free state province will by randomised to one of two trial arms. 124 patients will be assigned to the intervention arm, consisting of a wgs dst strategy for diagnosing drug resistance profile and an algorithm-determined individualised rr-tb treatment recommendation. 124 patients will be assigned to the control arm where the diagnosis of mtb drug resistance and individualisation of rr-tb treatment will happen according to the standard of care (soc) procedures.

Eligibility criteria:
inclusion criteria: * diagnosed with rr-tb * diagnosed with pulmonary tb (ptb) or ptb plus extra-pulmonary tb (eptb) * ≥18 years of age * able to sign informed consent * not on tb treatment at time of enrolment exclusion criteria: * patients diagnosed eptb without pulmonary involvement * patients with tb meningitis or tb of the bone. * has any condition that, in the opinion of the investigator or physician, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives or compromise patient safety.

Keywords: whole genome sequencing drug resistant tuberculosis
a study for participants with spinal muscular atrophy (sma) who previously participated in nusinersen (isis 396443) investigational studies

Conditions: Spinal Muscular Atrophy

Summary: the primary objective is to evaluate long-term safety and tolerability of nusinersen (isis 396443) administered by intrathecal (it) injection to participants with spinal muscular atrophy (sma) who previously participated in investigational studies of nusinersen. the secondary objective is to examine the long-term efficacy of nusinersen administered by it injection to participants with sma who previously participated in investigational studies of nusinersen.

this study was initiated and the protocol was registered by ionis pharmaceuticals, inc. in august 2016, biogen assumed responsibility for this study.

Eligibility criteria:
key inclusion criteria: * signed informed consent of parent or guardian and signed informed assent of participant, if indicated per participant's age and institutional guidelines. * completion of the index study in accordance with the study protocol or as a result of sponsor decision (e.g., early termination of the index study) within the preceding 16 weeks key exclusion criteria: * have any condition or worsening condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study * clinically significant abnormalities in hematology or clinical chemistry parameters or electrocardiogram (ecg), as assessed by the site investigator, at the screening visit that would render the participant unsuitable for participation in the study * participant's parent or legal guardian is not willing or able to meet standard of care guidelines (including vaccinations and respiratory syncytial virus prophylaxis if available), nor provide nutritional and respiratory support throughout the study * treatment with another investigational agent, biological agent, or device within one month of screening, or 5 half-lives of study agent, whichever is longer note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: sma smn smnrx isis-smnrx isis 396443 shine ionis-smnrx ionis-smn rx spinraza nusinersen
pain detection and interception in neonates

Conditions: Pain Detection; Pain Intervention

Summary: hypothesis: 1. may the introduction of nidcap during blood sample reduced pain in neonates during blood sample 2. compare the effect of venous and capillary blood sample method

introducing the: newborn individualized developmental care and assessment program

Eligibility criteria:
inclusion criteria: * born gestation age 31-36 exclusion criteria: * infection, respiratory distress

Keywords: pain neonates nidcap venous capillary