Kornimate/medical-research-clean huggingface dataset:
imatinib mesylate in patients with various types of malignancies involving activated tyrosine kinase enzymes

Conditions: Hypereosinophilic Syndrome; Systemic Mastocytosis; Chronic Myelomonocytic Leukemia; Dermatofibrosarcoma

Summary: this trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. the objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

condition diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases. not included: patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-kit-positive), some systemic mastocytosis (if c-kit d816v mutation), brain, prostate, breast or lung cancers.

Eligibility criteria:
inclusion criteria: 1. malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate. 2. spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin. 3. malignant tissue showing activation of certain tyrosine kinases (abl, arg, kit (cd117), or pdgf-r alpha or beta) \& preferably within 6 weeks of entry. exclusion criteria: 1. certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-kit-positive) or certain systemic mastocytosis (if c- kit d816v mutation). 2. a primary prostate, breast, lung or brain tumour, 3. patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response. other protocol-defined inclusion / exclusion criteria may apply.

Keywords: imatinib mesylate tyrosine kinases imatinib sensitivity diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases. not included: patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-kit-positive), some systemic mastocytosis (if c-kit d816v mutation), brain, prostate, breast or lung cancers.
a clinical study of the v116 vaccine for children and teenagers (v116-013)

Conditions: Pneumococcal Infection

Summary: the purpose of this study is to evaluate the safety, tolerability, and immunogenicity of v116 compared to ppsv23 in children 2 through 17 years of age. researchers want to learn if v116 is as good as, or is better than the ppsv23 vaccine in terms of the antibody immune response. v116 and ppsv23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (ipd).


Eligibility criteria:
inclusion criteria: * has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease. * has completed pneumococcal conjugate vaccine regimen (pcv7, pcv10, or pcv13) at least 8 weeks before study enrollment. exclusion criteria: * has previously received ppsv23 vaccine * has a history of active hepatitis within 3 months before study vaccination * history of invasive pneumococcal disease within 3 years before study vaccination
multiparametric mri for prostate cancer localization and characterization: new methods

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the ability of several new mri techniques (mr elastography, dynamic contrast-enhanced mri with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. ex-vivo mri will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo mri and whole mount prostatectomy specimens. the investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of mri for detecting clinically significant prostate cancer.


Eligibility criteria:
inclusion criteria: * male patients diagnosed with t1c or t2 prostate cancer, awaiting prostatectomy exclusion criteria: * unable to give informed consent * contraindication to mri or mri contrast agent * claustrophobia * renal impairment * prior hormonal or radiation therapy for prostate cancer * active prostatitis * moderate to severe rectal inflammation * previous rectal surgery * prostate biopsy within 4 weeks of planned mri

Keywords: prostate cancer mri elastography gadofosveset
safety and efficacy evaluation of brl-101 in subjects with transfusion-dependent β-thalassemia

Conditions: Beta-Thalassemia

Summary: this is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in subjects with transfusion-dependent β-thalassemia (tdt). the study will evaluate the safety and efficacy of autologous crispr-cas9 modified cd34+ human hematopoietic stem and progenitor cells (hhspcs) (brl-101)

this clinical trial is a multi-center, single-arm, single-dose, open-label study without dose escalation. the proposed dose is ≥ 3 × 106 cd34 + cells/kg administered as a single intravenous infusion. the primary objective of phase 1 is to explore the safety of the study drug in different age groups. for subjects of each age group, myeloablative conditioning and dosing of the remaining subjects was initiated only after completion of dosing and safety observations and assessments in sentinel subjects. the phase 2 primary objective was to determine the effectiveness of brl-101 administered intravenously to patients with tdt.

Eligibility criteria:
key inclusion criteria: * fully understand and voluntarily sign informed consent. 3-35years old. at least one legal guardian and/or subjects to sign informed consent. * clinically diagnosed as β-thalassemia major, phenotypes including β0β0, β+β+, β+β0, βeβ0 genotype. * subjects with no affection with hiv, tp, hbv, hcv, cmv and ebv. * subjects body condition eligible for autologous stem cell transplant. key exclusion criteria: * subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor. * active bacterial, viral, or fungal infection. * treated with erythropoietin prior 3 months. * immediate family member with any known hematological tumor. * subjects with severe psychiatric disorders to be unable to cooperate. * prior hematopoietic stem cell transplant (hsct). other protocol defined inclusion/exclusion criteria may apply.

Keywords: transfusion-dependent β-thalassemia
the influence of fortified pomegranate juice (punica granatum) on seasonal influenza and swine flu patients

Conditions: Influenza A; Swine Flu

Summary: it has been shown in laboratory studies that pomegranate juice contains anti-viral action against influenza. the researchers wish to investigate the effect of pomegranate juice on patients suffering from influenza a (seasonal or swine flu).


Eligibility criteria:
inclusion criteria: * individuals confirmed and suffering from influenza a exclusion criteria: * individuals suffering from influenza included in the high risk group
postpartum glycemia in women at risk for persistent hyperglycemia

Conditions: Gestational Diabetes

Summary: gdm is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. women with gdm are at significant risk for overt t2dm later in life, and postpartum insulin sensitivity and secretion in women with gdm has not been quantified, limiting our ability to optimize screening for overt t2dm. in addition, compliance with currently recommended postpartum t2dm screening by ogtt is poor. quantification of postpartum insulin sensitivity and secretion in women at high risk for t2dm will inform strategies to improve diagnostic strategies. continuous glucose monitoring (cgm) is a new technology that may be useful to identify women with persistent hyperglycemia. understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt t2dm.


Eligibility criteria:
inclusion criteria for early gdm women: * live singleton gestation with no fetal anomalies at 34-40 weeks gestation * gestational diabetes mellitus identified at \< 20 weeks' gestation requiring pharmacologic treatment (class a2) exclusion criteria for early gdm women: * history of prediabetes or polycystic ovarian syndrome * history of pregestational type 2 diabetes mellitus * skin conditions which prevent wearing a continuous glucose monitor inclusion criteria for 3rd trimester gdm women: * live singleton gestation with no fetal anomalies at 34-40 weeks gestation * gestational diabetes mellitus identified at \>= 24 weeks' gestation requiring pharmacologic treatment (class a2) exclusion criteria for 3rd trimester gdm women: * history of prediabetes or polycystic ovarian syndrome * history of pregestational type 2 diabetes mellitus * skin conditions which prevent wearing a continuous glucose monitor
postcapillary blood gas analysis in wedge position (wedge-bga)

Conditions: Pulmonary Hypertension

Summary: if pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. as part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. one of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. to measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. in this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. to do that, two blood samples (totaling approximately 4 ml of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. in addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. the results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. this could help to develop new therapeutic strategies in some subgroups in the future.


Eligibility criteria:
inclusion criteria: * patients who have a clearly defined indication for right heart catheterization. * age \> 18 years * informed consent for participation in the study will sign exclusion criteria: * individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study * pregnancy and lactation
renal autotransplantation; case series

Conditions: Renal Vascular Disease; Nutcracker Syndrome, Renal; Pelvic Trauma; Loin Pain-Hematuria Syndrome; Renal Tumor; Congestion, Venous

Summary: renal autotransplantation (rat) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.rat is a relatively new technique; the first ever rat procedure in the us was performed in 1963. advances in preservation and transplantation techniques have made rat a modality that can be utilized in complex renal diseases. rat is indicated for conditions such as renal vascular disease, nutcracker syndrome, pelvic venous congestion, pelvic trauma, refractory stone disease and, in some cases, loin pain hematuria syndrome and conventionally unresectable renal tumors. irrespective of the excellent outcomes shown by rat, the conventional open approach requires a large midline xiphoid-to-pubis or flank incision for donor nephrectomy with a second pelvic incision for renal transplantation into the iliac fossa.the current gold standard approach to rat is a laparoscopic nephrectomy followed by open auto-transplantation. however, this approach still requires a large pelvic incision. robotic technology enables us to perform more complex minimally invasive surgery. gordon et al. performed and reported the first completely intracorporeal robotic rat to repair a ureteral injury in 2014.

this is a retrospective chart review case series study of all consecutive cases in which robotic rat was performed that meet the study inclusion and exclusion criteria. the case series will be performed starting from january 2018 until june 2021 to include all cases of robotic rat procedures. perioperative and short-term clinical data will be obtained from the emr. all the data variables will be documented in the case report forms. because the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required.

Eligibility criteria:
inclusion criteria: * subject was 18 years or older at the time of the procedure * subject who has undergone robotic rat irrespective of the underlying etiology. exclusion criteria: * subjects who do not meet the inclusion criteria
illness crisis adapting in early or middle phase of patient with chronic disease: study of meta-cognition model

Conditions: Drug or Chemical Induced Diabetes Mellitus

Summary: patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. the investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.

patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. they need adjust themselves and their crisis lives, and some plan they had made the near or distant future. the investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.research methods will separate three year project to describe. first year project will use qualitative methods from bio-psychosocial aspects to interview participants who may suffer illness after diagnosis or stable treatment during middle phase of illness. second year will invite diabetes and hypertension patients from different phase of illness with different levels of health anxiety trait, meta-cognitive and control strategies if derived different coping and emotions outcome. the third year will design motivational psycho-education program for patients to alleviate the emotions and use cold meta-cognition to due good health behavior and self care with their illness. the expected results will like to test the investigators new model in caring chronic disease patients.

Eligibility criteria:
inclusion criteria: * adults aged 20 and above, with hypertension or diabetes or both diseases. exclusion criteria: * adults with other severe physical diseases. * adults with relevant psychological diseases.
efficacy of n-acetylcysteine in preventing radiotherapy-induced oral mucositis in head and neck cancer patients.

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Summary: a prospective, randomized, controlled, parallel clinical trial will be conducted at clinical oncology and nuclear medicine center at mansoura university hospital to assess the efficacy of n-acetylcysteine in the prevention of radiotherapy induced oral mucositis in head and neck cancer patients.


Eligibility criteria:
inclusion criteria: 1. adults \>18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (primary or postoperative) of at least 50 gy with or without concurrent chemotherapy. 2. individuals with healthy mucosa. 3. adequate bone marrow function (hemoglobin level ≥10 g/dl, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter). 4. patients with ecog performance ≤2 exclusion criteria: 1. history of chemotherapy or radiotherapy. 2. signs of systemic infections. 3. pregnant and lactating women. 4. individuals receiving systemic analgesics. 5. liver disorders and renal failure with egfr \<30 ml/min/1.73m2 (by the mdrd equation). 6. inability to follow instructions and complete the questionnaires.

Keywords: oral mucositis, radiotherapy, n-acetylcysteine
identifying changes in food behaviors associated with beginning glp-1 medication

Conditions: Weight Loss; Food Selection

Summary: in recent years, glp-1 medications have become a widely employed approach by physicians to address weight concerns in patients and lead to weight loss. little is known, however, about how these medications may alter an individual's attitude towards food, food reactivity, or the specific types and amounts of foods an individual will choose. the purpose of this study is to observe the changes an individual experiences in their relationship and reaction to food and in their food selection prior to or within the first two weeks of taking glp-1 medication to after three months on the medication. the researchers of this study believe that an understanding of such changes can inform questions seeking to ensure maintenance of appropriate nutrient balance within individuals on weight loss medications.


Eligibility criteria:
inclusion criteria: * adults (18+) with overweight or obesity (bmi \>25 kg/m2) * not currently taking an incretin-based medication at baseline * recently (within two weeks) prescribed a glp-1, can be included if they have a obesity-related co-occurring condition (diabetes, hypertension, cardiovascular disease, dyslipidemia) * have had no prior diagnosis of cognitive or physical disability, dyslexia, or epilepsy. * fluent in english exclusion criteria: * adults (18+) without overweight or obesity * \<18 years of age at time of testing * adults not taking a glp-1 medication * adults taking a compound glp-1 * adults on glp-1 medication for longer than 2 weeks at baseline * have had a prior diagnosis of cognitive or physical disability, dyslexia, or epilepsy. * not fluent in english

Keywords: glp-1 weight loss virtual reality food behavior
a study of nasal glucagon (ly900018) in pediatric participants with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (baqsimi) in pediatric participants with type 1 diabetes (t1d) aged 1 to less than 4 years. blood tests will be performed to check how much nasal glucagon gets into the bloodstream. blood sugar will also be measured to understand the effect of the drug on blood sugar levels. the study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. the study will last up to 9 days, not including the screening period.


Eligibility criteria:
inclusion criteria: * have a type 1 diabetes diagnosis for at least 6 months * have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening * have a hba1c level of ≤ 9.5% at screening * have sufficient venous access for collection of blood samples * have good general health, apart from their type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly exclusion criteria: * have a presence or history of glucagon hypersensitivity * have a history of pheochromocytoma * have a history of epilepsy or seizure disorder * have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose * are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit * have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit

Keywords: severe hypoglycemia nasal powder hypoglycemia rescue therapy ready to use glucagon
noninvasively predicting gene status of glioma

Conditions: Glioma of Brain

Summary: malignant gliomas are the most common and deadly primary brain tumors in adults. the clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. specifically, isocitrate dehydrogenase gene mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. amide proton transfer (apt) imaging is a noninvasive molecular mri technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. preliminary studies have shown that apt-weighted (aptw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. the purpose of this study was to investigate the value of amide proton transfer imaging (apt) in the noninvasive evaluation of isocitrate dehydrogenase (idh) gene status in glioma.

materials and methods: the whole brain mri examinations were performed on a 3.0-t mri system (discovery mr750, general electric medical system, milwaukee, wi, usa) with an eight-channel head coil (general electric medical system). conventional mri, contrast-enhanced mri, dwi and amide proton transferimaging were performed in regular sequence during the same examination. finally, contrast-enhanced t1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (omniscan; ge healthcare, co. cork, ireland). mri data processing and image analysis: all data were transferred to a workstation (advantage workstation 4.6, general electric medical system, milwaukee, wisconsin, usa) for processing.the mr imaging of all the patients were assessed independently by two experienced neuroradiologist (hyc and ylf, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. next, a region of interest (roi) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on apt image. statistical analysis: categorical data obtained from image were calculated using the fisher's exact test. quantitative data were denoted as the mean and standard deviation. the kolmogorov-smirnov (k-s) test was used to assess the normality of data distribution.apt-weighted (aptw) signal intensity were tested for differences between the idh mutation and the idh wild-type by using independent sample t test.

Eligibility criteria:
inclusion criteria: * no hypertension or cerebral vascular diseases * no use of corticosteroid drugs * no mri contraindication * no allergic constitution exclusion criteria: * pregnant wowan * motion cause poor image quality

Keywords: glioma apt mri