Kornimate/medical-research-clean huggingface dataset:
phase 3 trial for aml patients in cr2 comparing 8gy tbi /fludarabine to conditioning with tbi 12gy/cyclophosphamide

Conditions: Acute Myeloid Leukemia

Summary: for patients with acute myeloid leukemia (aml), allogeneic hematopoetic stem cell transplantation (hsct) is one of the most potent treatment options currently available. in order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic hsct are currently being explored in various hematological malignancies including aml. at least for allogeneic hsct in aml, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. the investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 gy tbi and fludarabine in aml patients considered ineligible for conventional conditioning in a phase 2 trial (data published in blood by stelljes et al., 2005). the results suggest that with 8 gy tbi/fludarabine, conditioning related and unrelated donor transplants can be performed in aml patients in first or second complete remission (cr) with a remarkably low 2-year non relapse mortality (nrm) and satisfactory disease control. based on these data a randomized phase 3 trial for patients with aml in cr≥2 is currently being conducted by the cooperative german transplant study group comparing tbi 8 gy/fludarabine to conventionally dosed conditioning with tbi 12 gy/cyclophosphamide.


Eligibility criteria:
inclusion criteria: * patients with aml in second complete remission * hla-identical related (hla \* a, b, and dr) or hla-compatible unrelated donor with maximum of one ag mismatch * ages 18-60 years * written informed consent from the patient * written informed consent from the donor * no major organ dysfunction exclusion criteria: * cardiac failure (new york heart association \[nyha\] grade ii-iv) * renal failure (creatinine \> 2.0 mg/dl) * hepatic failure (total bilirubin \> 3 mg/dl) * severe neurological/psychiatric disorder * previous allogeneic hsct * contra-indications for used drugs * hiv infection * non-compliance to processing of personal data according to the protocol

Keywords: aml allogeneic hsct reduced intensity conditioning randomized trail
acetic acid guided biopsies compared with high definition endoscopy in the detection of barrett's esophagus

Conditions: Barrett's Esophagus

Summary: specialized columnar epithelium (sce) is considered as pathognomonic for barrett's esophagus. chromoendoscopy after local acetic acid application enables recognition of the mucosal surface architecture. the new available epki processor (pentax, japan) enables hd+ resolution above hdtv standard. aim of the study is to test the efficacy of hd+ endoscopy in conjunction with i-scan or acetic acid to diagnose barrett's esophagus. the primary endpoint of the current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies. patients with visible columnar lined lower esophagus (cle) are included. after standardized ppi therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application or i-scan. biopsies are taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies are taken.

specialized columnar epithelium (sce) is considered as pathognomonic for barrett's esophagus and can be recognized by new endoscopic techniques. aim of the study is to test the efficacy of hd+ endoscopy in conjunction with i-scan (newly developed post processing digital filter) or chromoendoscopy (acetic acid) to diagnose barrett's esophagus. patients with visible columnar lined lower esophagus (cle) or known barrett's esophagus are included. after standardized ppi therapy (14 days; standard dosage) patients are randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application (10-15ml; 1.5%) or hd+ endoscopy in conjunction with i-scan. mucosal surface structure within cle is graduated according to guelrud's classification (type 1-2: endoscopic prediction: gastric epithelium; type 3-4: barrett's epithelium). biopsies are taken in a targeted fashion (type 1-4) in both groups and subsequently 4-quadrant biopsies were taken. primary outcome analysis's to investigate the diagnostic yield of the different biopsy protocols.

Eligibility criteria:
inclusion criteria: * patients with cle * patients with known barrett's esophagus exclusion criteria: * pregnancy * severe coagulopathy * known malignancies

Keywords: acetic acid virtual chromoendosopy
a bioequivalence study of l04td3 compared to administration of l04rd1 in healthy volunteers

Conditions: Essential Hypertension

Summary: this is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of l04rd1 or administration of l04td3 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * a subject aged 19 to less than 65 years at the time of the screening visit * a subject with a body weight of 55kg or higher and a body mass index (bmi) of 18.0 kg/m2 to 29.9 kg/m2, inclusive * a subject considered appropriate to participate in the study according to the results of lab tests such as the hematological test, blood chemistry test, serum test, urinalysis, etc. and ecg set and conducted by the principal investigator (or a delegated study physician) according to the characteristics of the investigational product * a subject who agreed to exclude the possibility of pregnancy by having themselves, their spouses, or partners use medically appropriate contraceptive methods and not to provide sperm or egg from the first dose to 7 days after the last dose of ip administration * a subject who voluntarily signed the informed consent form after listening to and understanding sufficient explanation on the purpose, content of this clinical study, the characteristics of the investigational product, expected adverse events, etc. exclusion criteria: * a subject who has clinically significant diseases in the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otolaryngeal system, skin system, and ophthalmic system or has had the diseases * a subject who had gastrointestinal surgery (excluding simple appendectomy or hernia surgery) which may affect the absorption of drugs or have gastrointestinal diseases * a subject who took drugs that induce and inhibit drug metabolizing enzymes such as barbiturates within one month from the first administration date or drugs that might affect this clinical study within 10 days from the first administration date (subjects may participate depending on the pharmacodynamics and pharmacokinetics such as the interactions with the investigational product, half-life, etc.) * a subject who participated in another clinical study or bioequivalence study where they were administered the investigational product within 6 months prior to the first dose of the investigational drug * a subject considered by the principal investigator (or a delegated study physician) as inappropriate to participate in this clinical study due to reasons other than the above inclusion and exclusion criteria
bladder perforation post-turbt: definition, incidence and natural historystudy

Conditions: Bladder Cancer; Bladder Urothelial Carcinoma; Trauma; Injuries; Perforation of Bladder; Recurrence Tumor; Resection Margin; Seeding, Neoplasm

Summary: in view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following transurethral resection of bladder tumour (turbt). we aim to correlate the relation between the site, depth and extent of resection with bladder perforation. also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor


Eligibility criteria:
inclusion criteria: * papillary bladder tumor (denovo or recurrent) * resectable nodular bladder tumor exclusion criteria: * refuse to complete study requirements * muscle invasive bladder tumor

Keywords: perforation of bladder bladder cancer resection margin
promoting full oral feeding in preterm infants less than 30 weeks gestational age

Conditions: Preterm Infants

Summary: the investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

in the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. at this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. and oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

Eligibility criteria:
inclusion criteria: * preterm infants with gestational age less than 30 weeks * the parents are positive to treat the infants exclusion criteria: * fetal edema * very critical with oi more than 40 * apgar score less than 5 at ten minutes after birth * the parents refuse to treat the infants * severe ivh (more than grade iv ) * pvl * died before oral feeding starts
a study on safety and efficacy in patients with soft tissue sarcomas

Conditions: Sarcoma, Soft Tissue

Summary: the purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.


Eligibility criteria:
inclusion criteria: - participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice exclusion criteria: - none

Keywords: sarcoma, soft tissue halaven injection e7389
towards understanding the relationship between meals and blood biomarkers

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to establish the reasonableness of using food-based photo diaries and continuous glucose monitors (cgm) to engage in counterfactual thinking strategies. these strategies may improve food choices among participants diagnosed with prediabetes (intervention group).

the long-term objective of this project is to create a counterfactual-based lifestyle intervention that curtails the progression of prediabetes to t2dm through management and knowledge of food choices. this is a significant objective since 70% of prediabetes patients go on to develop t2dm. the project addresses a major objective of paths-up in general and thrust 4 in particular, by developing an innovative behavior-change intervention that will eventually make use of information from the lab-on-your-wrist device. to our knowledge, this is the first project to (1) propose an intervention based on counterfactual thinking for diabetes prevention and (2) combine continuous glucose monitors (cgms) and food photography to promote a better understanding of how food choices affect blood glucose.the specific aim of this project is to establish the validity of leveraging photo-based food diaries and cgms to engage counterfactual thinking strategies that improve food choices amongst prediabetes participants. this will be measured by changes in (1) eating attitudes and behaviors, (2) behavioral intentions to improve healthy eating behavior, (3) motivation to improve eating behavior, (4) increased self- efficacy for healthy eating, and (5) number of glucose excursions and time-in-range.

Eligibility criteria:
inclusion criteria: * ability to walk, sit down and stand up independently * family history of type 2 diabetes * overweight/obese status (bmi\>= 25) * subject is judged to be in satisfactory health based on medical history, physical examination * willingness and ability to comply with the protocol * hba1c levels are within the pre-diabetic range (5.7-6.4%) or fasting plasma glucose 100-125 mg/dl * access to a smartphone device and willing to use whatsapp to communicate with research personnel exclusion criteria: * subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study * planned medical procedures that are documented to interfere with cgm readings, such as: * xylose absorption testing (oral sugar testing) * ct * mri * x-ray * diathermy treatment (high-frequency electric current to stimulate heat generation within body tissues) * established diagnosis of malignancy * presence of acute illness or metabolically unstable chronic illness * any other condition according to the pi, nurse, or study coordinator that was found during the screening visit, that would interfere with the study or safety of the patient * failure to give informed consent or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

Keywords: continuous glucose monitoring dietary habits counterfactual thinking
genetic polymorphisms of interleukin-10 and tnf-α on outcome of hcv-related chronic liver disease

Conditions: Hepatitis C Virus Infection; Chronic Liver Disease

Summary: the prognosis of chronic hepatitis c virus (hcv)infeciton varies from minimal progressive disease to cirrhosis or hepatocellular carcinoma. host genetic factors contribute to disease severity. it is known that cytokine gene (including tumor necrosis factor-alpha (tnf-alpha) and interleukin-10 (il-10) polymorphism affect disease prognosis.this study aims to assess the effect of tnf-alpha and il-10, and their interaction,on prognosis of hcv-related chronic liver disease


Eligibility criteria:
inclusion criteria: * anti-hcv-positive patients exclusion criteria: * anti-hcv-negative patients
radioiodine-avid bone metastases from thyroid cancer without structural abnormality

Conditions: Bone Metastases; Thyroid Cancer

Summary: bone radioiodine (rai) uptake without structural abnormality in thyroid cancer (tc) patients may be related to false positive or to microscopic foci of metastatic tissue. in such cases, outcome is reported to be excellent. indeed, robenshtok et al. reported a serie of patients with rai-avid bone metastases of tc without structural abnormality on imaging studies who have more favorable long-term prognosis than those harbouring structurally visible bone metastases and do not undergo skeletal-related complications. the investigators report the case of mrs d., who had been operated for a pathologic tumor stage 3: pt3(m) poorly differentiated tc at the age of 43. the first post-therapeutic whole body scan revealed 3 foci of bone uptake (right clavicle, l2, l3). the elevated level of thyroglobulin (157ng/ml) favoured the hypothesis of bone metastases despite the absence of any structural lesion on ct and mri. she received 7 courses of radioiodine therapy. the right clavicle rai uptake persisted, and subsequent ct disclosed an osteolytic lesion which was treated by radiofrequency and external beam radiation. twenty-five years after the diagnosis, she has a persistent morphological disease with a 30x8mm progressive lesion on the right clavicle, for which surgery is planned. the aim of the present study is to describe the natural history and evolution of radioiodine avid bone metastases from thyroid cancer without structural abnormalities and to identify prognosis factors.


Eligibility criteria:
inclusion criteria: * differentiated thyroid cancer * ablation therapy with post dose scintigraphy * at least one radioiodine bone uptake without structural correlation on high-resolution imaging exclusion criteria: * a single radio iodine bone uptake with structural correlation on imaging * diagnosis of bone metastasis after a skeletal related event including spinal cord compression, pathological fracture, need for external beam radiation, surgery to bone, or development of hypercalcemia of malignancy * follow up less than 6 months * missing data in medical record

Keywords: radioiodine bone metastases thyroid cancer
safety, tolerability, pharmacokinetics and efficacy of spr720 for the treatment of patients with mycobacterium avium complex (mac) pulmonary disease

Conditions: Mycobacterium Avium Complex; Non-tuberculous Mycobacterium Pulmonary Disease

Summary: to evaluate the pharmacokinetics (pk) of spr719, the active moiety, generated from the orally (po) administered spr720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (ntm-pd)


Eligibility criteria:
inclusion criteria: * has a diagnosis of ntm-pd due to mac * had at least 1 prior positive culture (sputum or bronchoalveolar lavage) positive for mac in the previous 6 months * has an induced sputum culture at screening positive for mac by at least one of the following methods performed by the microbiology laboratory: quantitative culture on solid agar or growth on liquid media (mgit) * is either treatment naïve and has not received any prior treatment for mac, or if previously treated for mac, has culture evidence of persistent, recurrent, or relapsed disease and has been off therapy for at least 6 months * in the opinion of the investigator, is ready to initiate treatment (treatment naïve) or reinitiate treatment (previously treated) within the next 3 months, and for whom a delay, in order to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable * had clinical signs and symptoms within the 6 weeks before the date of consent that are consistent with ntm-pd with at least two of the following: 1. chronic cough 2. fatigue 3. frequent throat clearing 4. shortness of breath (dyspnea) 5. coughing up of blood (hemoptysis) 6. excessive mucus (sputum) production 7. fever 8. night sweats 9. loss of appetite 10. unintended weight loss 11. wheezing 12. chest pain * has a measured forced expiratory volume in 1 second (% predicted fev1) ≥30% on pulmonary function test within 3 months prior to consent * has a chest radiograph (cxr) or computed tomography (ct) scan within 6 months prior to consent with findings consistent with ntm-pd. if no cxr or ct scan is available, a cxr or ct scan should be performed at screening to confirm eligibility. * other inclusion criteria per protocol exclusion criteria: * has disseminated or extrapulmonary ntm * has end-stage ntm-pd or treatment-refractory ntm-pd and is unlikely to respond to protocol-specified soc treatment * had isolation on sputum cultures of any species of mycobacterium other than a species included in mac within the past 6 months * had prior isolation of mac with macrolide resistance * has received any systemic (oral or iv) or inhaled antibiotic with activity against mac between consent and randomization * has a potentially confounding underlying pulmonary disease, including but not limited to cystic fibrosis, active pulmonary malignancy (primary or metastatic), ntm-hypersensitivity disease pneumoconiosis, or another advanced lung disease with a % predicted fev1\<30% * other exclusion criteria per protocol
disability and health outcomes in copd

Conditions: Chronic Obstructive Pulmonary Disease; Lung Diseases

Summary: to test a conceptual model of how disability develops in chronic obstructive pulmonary disease (copd).

background: background. copd is a common chronic health condition. because current medical treatments have minimal impact on disease progression, a strategy to prevent copd-related disability would have important clinical and public health benefits. design narrative: the study will test a specific conceptual model of how disability develops in copd. the aims are: (1) to evaluate the impact of respiratory impairment, especially pulmonary function impairment, on the risk of functional limitation in copd. using a control group, to elucidate the prevalence of respiratory impairment, functional limitation, and disability that is directly attributable to copd. (2) in adults with copd, to delineate the longitudinal effect of functional limitation on the risk of incident disability. the investigators hypothesize that development of functional limitation, and not pulmonary function impairment, is the major determinant of disability. (3) to determine the prospective impact of disability on the risk of future adverse health outcomes. the investigators will assemble a prospective cohort of 1200 randomly sampled adults with copd who are members of a large regional health maintenance organization. a matched control group of 300 subjects will be recruited. subjects will undergo a detailed physical assessment that measures respiratory impairment (e.g., pulmonary function) and functional limitation (e.g., lower extremity function, muscle strength, exercise performance, and cognitive function). structured telephone interviews will ascertain disability outcomes at baseline and 18-month prospective follow-up. the investigators will also study the modulating effects of specific risk factors and protective factors on the progression from functional limitation to copd-related disability, including psychological factors, environmental exposures, and health care process factors.

Eligibility criteria:
inclusion: 1. copd diagnosis and 2. medication use for cases exclusion: 1. withdrew from kaiser plan prior to baseline contact
phase ii dose-finding study of sk-0403 with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of sk-0403 in patients with type2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * treatment-naive subjects diagnosed with type 2 diabetes mellitus * stable diet program for at least 8 weeks * criteria for hba1c are met exclusion criteria: * type 1 diabetes * patients treated with other antidiabetic drugs or insulin