Kornimate/medical-research-clean huggingface dataset:
a study comparing non myeloablative (flu-tbi) and reduced intensity (flu-bu-atg) conditioning in allogenic transplantation

Conditions: Allograft; Allogeneic Cell Transplantaion; Hematological Malignancy; Solid Tumor

Summary: this study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (ric). flu-bu-atg (study a) associated fludarabine (30mg/m²/5 days), oral busulfan (8 mg/kg over 2 days) and thymoglobuline (2.5 mg/m²/1day). flu-tbi (study b) consisted of fludarabine (25mg/m²/ 3 days) and 2 gy total body irradiation (tbi). a randomization of 2 phase study according to the methodology developed by liu et al (liu, 1993 and 2001) for the evaluation of multiple innovative approaches. primary endpoint is one year overall survival (os). stopping rules included excessive engraftment failure and trans-plant related mortality ratio. data are yearly reviewed by an independent safety review board (isrb). inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (sct), aged between 18 and 65, with a suitable hla identical sibling. all patients and donors are included after giving written informed consent. protocol was submitted and accepted by the ethical committee and the affssaps cellular therapies committee (national agency).


Eligibility criteria:
inclusion criteria: * hematological malignancy or solid tumor, * eligible for non myeloablative allogenic transplantation, * aged between 18 and 65, * with a suitable hla identical sibling exclusion criteria: * contra-indication to allogenic transplantation * pregnant women or breast feeding * active infection
complex abdominal aortic aneurysm repair with fenestrated stent grafts

Conditions: Juxtarenal Aortic Aneurysms; Suprarenal Aortic Aneurysms; Type IV Thoracoabdominal Aortic Aneurysms

Summary: the purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type iv thoracoabdominal aortic aneurysms using custom-made cook zenith® fenestrated aaa endovascular graft.

this is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.

Eligibility criteria:
general inclusion criteria * a patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made zenith® fenestrated aaa endovascular graft: * juxtarenal, suprarenal or type iv thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter * aneurysm with a history of growth ≥ 0.5 cm per year * saccular aneurysms deemed at significant risk for rupture based upon physician interpretation. general exclusion criteria * less than 18 years of age * unwilling to comply with the follow-up schedule * inability or refusal to give informed consent by the patient or a legally authorized representative * pregnant or breastfeeding * life expectancy \< 2-years * additional medical restrictions as specified in the clinical investigation plan * additional anatomical restrictions as specified in the clinical investigation plan

Keywords: aortic aneurysm
assessing neurocognitive effects of gluten exposure

Conditions: Celiac Disease; Neurobehavioral Manifestations

Summary: many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. however, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. the investigators predict that patients with celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as confusion, forgetfulness and difficulty concentrating. the goals of this study are to determine the prevalence of neurocognitive symptoms after exposure to gluten in patients with celiac disease and to characterize the nature of these symptoms both in terms of their duration and severity.


Eligibility criteria:
inclusion criteria: 1. male or female 2. 18-50 years of age 3. celiac disease group: positive small intestinal biopsies meeting marsh ii or iii histologic criteria for celiac disease at least six months since the time of study entrance as well as positive iga anti-tissue transglutaminase antibody or positive iga/igg anti-deamidated gliadin peptide (dgp) with normal serum iga 4. non-celiac gluten sensitive group: negative small intestinal biopsies and negative iga anti-tissue transglutaminase (ttg) or negative iga/igg anti-deamidated gliadin peptide (dgp) with normal serum iga, but with symptomatic response to gluten withdrawal 5. subject should have well controlled celiac disease and have been on a gluten-free diet for at least six months prior to study enrollment 6. subject must provide informed consent, as approved by the institutional review board, and agree to complete required study visits, blood work neuropsychological testing and a urine pregnancy test (if applicable). 7. subject agrees to use appropriate birth control for the duration of the study. exclusion criteria: 1. subject has other food intolerances or food allergies (other than gluten) that would interfere with the conduct of the study (e.g. corn starch, soy). 2. subject has a history of severe, acute symptomatic reactions to sporadic gluten ingestion 3. subject has any chronic active gastrointestinal disease other than celiac disease (e.g. crohn's disease, irritable bowel syndrome, autoimmune enteropathy, eosinophilic enteritis). 4. subject should not have daily symptoms concerning for brain fog such as mental confusion or difficulty concentrating, at baseline. 5. subject has symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study. 6. subject should not have been on corticosteroids or other immunosuppressive agents in the past 3 months. 7. significant other co-morbidity as determined by the principal investigator 8. subject is deemed inappropriate by the principal investigator. 9. subject is pregnant or breast-feeding at time of participation. 10. subject weighs less than 110 pounds.

Keywords: celiac disease gluten fog attention
ecological effect of arginine dentifrice on oral microbiota

Conditions: Dental Caries; Oral Bacterial Infection; Microbiota

Summary: caries-free (cf) individuals caries-active (ca) individuals (dmft ≥ 6) will be recruited. subjects will be instructed to brush their teeth twice daily for 3 min using colgate® sensitive pro-relief® toothpaste (containing 8% arginine and 1450 ppm naf) for 2 weeks. supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before and after the treatment for laboratory analyses.

21 caries-free (cf) individuals with no clinical evidence of caries experience \[decayed, missing and filled teeth (dmft) = 0\] and 21 caries-active (ca) individuals (dmft ≥ 6) will be recruited in the clinical trial. the exclusion criteria are: smoker or former smoker, presence of any systemic disease that could alter the production or composition of saliva, treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months, and presence of dental prostheses or orthodontic devices. subjects will be instructed to brush their teeth twice daily for 3 min using colgate® sensitive pro-relief® toothpaste (containing 8% arginine and 1450 ppm naf) for 2 weeks. volunteers are asked to refrain from brushing and flossing their teeth, eating, and drinking anything other than water for 12 h prior to sample collection visits at the end of both phases. supra- and subgingival plaque (15 subjects in each group), saliva (21 subjects in each group), and in situ plaque samples (3 subjects in each group) will be collected before and after the treatment. scraped plaque and saliva samples will be immediately transferred to and dispersed in sterile micro-centrifuge tubes containing 1×phosphate-buffered saline (pbs), and stored at -80 °c until needed for analysis. the in situ plaque samples will be transferred into 4% paraformaldehyde, kept under 4 °c for 16 h, and then stored in 50% (v/v) ethanol at -20 °c.

Eligibility criteria:
inclusion criteria: * caries-free individuals with no clinical evidence of caries experience \[decayed, missing and filled teeth (dmft) = 0\] and caries-active individuals (dmft ≥ 6) were recruited exclusion criteria: * smoker or former smoker, presence of any systemic disease that could alter the production or composition of saliva, treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months, and presence of dental prostheses or orthodontic devices.
a study to evaluate abicipar pegol for safety and treatment effect in participants with neovascular age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: the objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * male or female participants, 50 years of age or older at the time of informed consent * best corrected visual acuity (bcva) ≤ 78 and ≥ 24 letters (20/32 to 20/320 snellen equivalents, respectively) at screening and at baseline (day 1, prior to treatment) visits in the study eye * bcva of 34 letters (snellen equivalent 20/200) or better at baseline (day 1, prior to treatment) in the non-study eye exclusion criteria: * active periocular, ocular, or intraocular infection at baseline (day 1) (either eye) * previous or concurrent macular laser treatment (study eye) * cataract or refractive surgery within 3 months prior to baseline (study eye)
dose-defining study of tirapazamine combined with embolization in liver cancer

Conditions: Hepatocellular Carcinoma; Gastrointestinal Cancer Metastatic; Neuroendocrine Tumors

Summary: this phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. liver cancer patients who are child-pugh score a, suitable for embolization with tumor no more than 4 nodules are eligible. tirapazamine will be given by intra-arterial injection before embolization. treatment effect is evaluated by mri based on mrecist criteria. repeat treatment is necessary only if disease progression. dose escalation cohort has been completed. expansion cohort is open for metastatic liver dominant neuroendocrine tumor.

the study is a 3+3 design for dose escalation. each cohort will have 3-6 patients based on tolerability. patients will receive escalated doses of tirapazamine until maximally tolerated dose. embolization is performed per standard practice using lipiodol and gelfoam under x-ray guidance. once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. adverse events are evaluated by ctcae vs. 5.0 and efficacy is evaluated by mri using modified recist criteria and recist criteria. the dose escalation part has been completed. only the third cohort or neuroendocrine tumor remains active for future patient enrollment.

Eligibility criteria:
inclusion criteria: 1. patients with well-differentiated net and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic. 2. no limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume. 3. patients are allowed to have prior us food and drug administration (fda)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic net. 4. age 20 or higher, ecog functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction. 5. are candidates for tae or tace and without portal vein occlusion per treating interventional radiologists. 6. anc no less than 1000 /μl. hemoglobin ≥ 9 gm/dl. platelets no less than 50,000 /μl. creatinine no more than 2.0 mg/dl. ast, alt no more than 5x upper limit of normal. bilirubin no more than 2.5 mg/dl. pt prolongation ≤ 4 sec above upper limit of normal. 7. woman of child-bearing potential (wocbp) should use highly effective contraception during trial participation and for 6 months after the last dose of tirapazamine and men who are partners with wocbp should use highly effective contraception, including barrier contraception, during trial participation and for 3 months after the last dose of tirapazamine.

Keywords: hypoxia embolization tirapazamine
topera c-firm registry

Conditions: Atrial Fibrillation

Summary: this is a control registry to the e-firm registry to track conventional atrial fibrillation (af) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. conventional af ablation is defined as pulmonary vein isolation (pvi) and any additional ablation for af according to the standard routine of the center. data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

prospective and retrospective enrollment possible

Eligibility criteria:
inclusion criteria: * reported incidence of at least 2 documented episodes of symptomatic af (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial af ablation * attempt of at least one class i or iii anti-arrhythmia drug with failure defined as recurrence of symptomatic af or adverse drug effect resulting in stopping medication exclusion criteria: * women who are pregnant as this is a registry only data of patients will be included who have been treated according to the current af guidelines and the daily routine of the center.
prediction model for anemia after bariatric surgery

Conditions: Anemia; Bariatric Surgery

Summary: to develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.

this study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and roux-en-y gastric bypass, using preoperative clinical and laboratory data.

Eligibility criteria:
inclusion criteria: * aged between 16-70 years; * body mass index (bmi) ≥ 27.5 kg/m2; * complete preoperative and follow-up data. exclusion criteria: * vegetarian; * other bariatric procedures; * renal failure at baseline; * postoperative bleeding (it was defined as a drop in hemoglobin levels \> 3 g/dl or a confirmed blood loss requiring treatment after surgery); * incomplete preoperative and follow-up data.

Keywords: anemia bariatric surgery prediction model
the integrated traditional chinese and western medicine treat middle stage dkd

Conditions: Diabetic Nephropathy Type 2

Summary: efficacy and safety of treatment with traditional chinese medicine shenqidihuang decoctions in patients with middle stage of diabetic kidney disease.

the study is a multi-center, randomized, double-blind, placebo-controlled trial. it is performed in longhua hospital, shanghai university of traditional chinese medicine, shanghai jiao tong university affiliated sixth people's hospital, putuo hospital affiliated to shanghai university of traditional chinese medicine, and shanghai baoshan district hospital of integrated traditional chinese medicine and western medicine, china.

Eligibility criteria:
inclusion criteria: 1. identify the diagnosis of type 2 diabetes; 2. it meets the medical history of diabetic kidney disease, according to the mogensen diagnostic staging standard dkd iv; 3. egfr ≥ 30 ml / min / 1.73 m2; 4. age 18-75 years old, gender ＆ethnicity are not limited; 5. glycated hemoglobin ≤ 10%; 6. blood pressure is controlled below 130/80mmhg exclusion criteria: 1. combine other acei and arb application indications other than hypertension; 2. combine severe primary diseases related to heart, brain, liver and hematopoietic system; 3. patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month; 4. patients who hbv serological indicators except hbsab are positive and persistent liver function test transaminase abnormalities; 5. patients with malignant tumors or history of malignant tumors, history of hiv infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents; 6. patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states; 7. pregnant or lactating women; 8. patients who accepted other clinical trial studies on going ; 9. patients who combined with serious diseases and dysfunctions in other organs.

Keywords: diabetic kidney disease，traditional chinese medicine
somatostatin receptor imaging in cardiac sarcoidosis

Conditions: Cardiac Sarcoidosis

Summary: the purpose of the trial is to determine the accuracy of cu-64 labelled dotatate for diagnosing cardiac sarcoidosis using pet/ct or pet/mri.


Eligibility criteria:
inclusion criteria: group a: suspected cardiac sarcoidosis group b: known cardiac sarcoidosis, clinical follow-up group c: myocarditis or dilated cardiomyopathy (non-cardiac sarcoidosis) exclusion criteria: infection pregnancy severe claustrophobia weight \>140 kg
role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. it is a single blinded randomized controlled trial using non-probability convenient sampling. data is collected from university physical therapy and rehabilitation clinic, university of lahore, pakistan. alternate hypothesis: there is a significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy. null hypothesis: there is no significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy. .

it will be a prospectively registered, parallel designed, randomized controlled trial with concealed allocation, conducted in university physical therapy and rehabilitation clinic, lahore, pakistan. patients who met the eligibility criteria will be informed about the aim of the study. all eligible participants who will agree to participate in the study signed the consent form. eligibility of the participants will be determined by the two members of the research team before the randomization. after baseline assessment, eligible patients will be randomly assigned (in a 1:1 ratio) into two groups (group a and group b). randomization will be done by one of the research team members using fish bowl method. randomization assignments will be kept in opaque, sealed envelopes and unsealed by the researchers after baseline testing. outcome assessor will be masked to group allocation and patients will be instructed not to talk about the content of their exercise program during the post intervention visit and could contact their therapists in case of any problems during trial participation. help of female physiotherapist will be taken for the female patients. the sample size was calculated as 76 participants (38 per group), allowing statistical power of 80%, an alpha level of 5% and attrition rate of 20% having mean difference of 1.1 and sd of 1.48 and 1.63.

Eligibility criteria:
inclusion criteria: * male and female patients with age between 20 to 45 years * patients having pain for more than 4 months * patients having positive upper limb neurodynamic test * patient with positive spurling test. exclusion criteria: * patients with trauma of upper limb and cervical spine * dizziness * upper limb circulatory disturbance * malignancy * patients with bilateral symptoms

Keywords: cervical radiculopathy neuromobilization pain disability
radiation field, dose and fractionation related to mandibular complications

Conditions: Head and Neck Neoplasms; Osteoradionecrosis; Radiotherapy; Complications

Summary: radiotherapy is inhibiting the healing capacity of the mandibular bone. late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. a factor that could be involved in the development of complications is field of radiation. there are limited number of studies investigating this relation. retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. patients will be related to the university hospitals in lund, umea, orebro, stockholm. a thorough analysis of the medical journals in this group of patients will be performed. included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. at least 12 months follow up period is needed for inclusion. the scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of the head and neck malignancy * must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery exclusion criteria * less than 12 months follow up * under 18 years of age