Kornimate/medical-research-clean huggingface dataset:
probiotics in pbc patients of poor response to udca

Conditions: Primary Biliary Cholangitis (PBC)

Summary: the safety and efficacy of probiotics in primary biliary cholangitis (pbc) patients with poor ursodeoxycholic acid (udca) response.

pbc patients with poor ursodeoxycholic acid (udca) response are selected and randomly assigned into probiotic group and control group. patients in probiotic group receive probiotic(micro v probiotics) combined udca for 6 months and then continue to take udca alone. patients in control group continue to take udca alone. biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. globe and uk-pbc scoring system are used to assesse prognosis.the feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of pbc patients.

Eligibility criteria:
inclusion criteria: 1. pbc patients (diagnosed with pbc according to 2009 aasld pbc practice guidance), take udca more than 12 months and have poor response; 2. age 18-70 years. exclusion criteria: 1. any other liver disesases (viral hepatitis, hiv positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on); 2. important organ dysfunction such as heart, lung and kidney which affect the life expectancy; 3. have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency. 4. patients allergic to research drugs or excipients; 5. pregnant or lactating women; 6. not signed informed consent; 7. have antibiotics one month before enrollment; 8. microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used before the enrollment; 9. malignant tumors, nerves and mental disorders; 10. those who participated in other drug clinical trials in the past 3 months.

Keywords: probiotics ursodeoxycholic acid (udca)
the effects of injection site cooling and solution buffering on perceived pain during local anesthesia administration

Conditions: Pain

Summary: participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures * any gender, aged 21 - 65 * in good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus * healthy intact skin on the palmar aspect of both left and right forearms * fluent in english exclusion criteria: * current use of any medication * pregnancy * known allergic reactions to components of the local anesthetic such as sulfites * history of vasovagal response to venipuncture or vaccination * history of trauma to the forearms i.e., bone breaks, burns, deep lacerations * decreased sensation to the palmar aspect of either forearm

Keywords: local anesthesia lidocaine bicarbonate pain buffering injection site cooling
sct plus immune therapy in average risk aml/mds

Conditions: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Summary: allogeneic stem cell transplantation followed by targeted immune therapy with gemtuzumab ozogamicin (mylotarg) will be given to patients with average risk aml or mds.

reduced intensity conditioning regimen of busulfan (bu) and fludarabine (flu) + anti-thymocyte globulin (atg ) (unrelated donors only) or reduced toxicity conditioning regimen of bu/flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/flu/alemtuzumab and allosct, followed by gemtuzumab ozogamicin consolidation in patients with average risk aml/mds meeting eligibility criteria.

Eligibility criteria:
inclusion criteria: disease status: * aml 1st cr with a matched family donor * aml 1st cr with unrelated donor * aml 2nd cr or crp * mds and \< or = 5% bone marrow myeloblasts at diagnosis disease immunophenotype: * disease must express a minimum of \> or = 10% cd33 positivity for patients with aml organ function: * adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function exclusion criteria: * patients with active cns aml disease at time of preparative regimen * secondary mds * poor cytogenetics * female patients who are pregnant * karnofsky \<70% or lansky \<50% if 10 years or less * age \>25 years * seropositive for hiv
second molecular event identification by exome sequencing for intellectually disabled patients carrying 16p13.11 cnvs

Conditions: Intellectual Disability

Summary: 16p13.11 copy number variations are considered as predisposition factors for neurodevelopmental disorders but can be inherited from normal parents. seesic aims at identifying seond molecular events by exome sequencing that could modulate the phenotype and explain familial discrepancies.


Eligibility criteria:
inclusion criteria: * patients presenting intellectual disability * patients carrying a 16p13.11 copy number variant * blood dna available without re sampling for the patient and his parents. * consent for genetics analysis already for the patient and his parents. exclusion criteria: - other diagnosis for intellectual disability (apart 16p13.11 copy number variant) already posed
an open-label extension study of xtmab-16 in patients with pulmonary sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: open-label study to evaluate the long-term safety and durability of effect of xtmab-16 in patients with pulmonary sarcoidosis with or without extra-pulmonary involvement


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study if the following criteria apply: * completion of xtmab-16-201 study: completion of week 12 (part a) or week 24 (part b) assessments. * participants from xtmab-16-201 part a and part b should be on a stable steroid dose for at least 2 weeks prior to informed consent/day 1 of xtmab-16-202 (day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of xtmab 16 201 ± 2 weeks). exclusion criteria: participants are excluded from the study if any of the following criteria apply: * evidence of treatment-related aes requiring treatment discontinuation per xtmab-16-201 protocol observed in xtmab-16-201 study. * evidence of treatment failure observed in xtmab-16-201 study per protocol definition.
flumatinib efficacy and safety for new diagnosed chronic phase chronic myeloid leukemia

Conditions: Validity and Safety

Summary: the overall survival (os)of chronic myeloid leukemia (cml) has been significantly improved since the advent of tyrosine kinase inhibitors (tkis) .nevertheless, there still exists a amount of patients who has poor response or intolerance for tki drugs( imatinib, dasatinib, nilotinib). flumatinib has been shown to be a more potent inhibitor of bcr-abl1 tyrosine kinase than imatinib,and it aslo has better security when compared to other tkis(imatinib, dasatinib, nilotinib).it will be a better chioce for cml patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, both male and female; 2. new diagnosed chronic phase chronic myeloid leukemia. 3. within half a year after diagnosis of cml; 4. previous tkis treatment was less than 2 weeks; 5. the pregnant test of female patients was negative (within 7 days before medication before enrollment); 6. informed consent of the patient or his legal representative exclusion criteria: 1. t315i mutation is known to exist; 2. rare atypical transcript types that cannot be standardized internationally; 3. received tki drugs for more than 2 weeks before enrollment; 4. received interferon therapy for more than 3 months before enrollment; 5. received other anti-cml drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation) 6. patients who participate in other clinical studies at the same time; 7. patients who having had major surgery or not recovered from surgery within 4 weeks; 8. patients who having history of malignant tumor 9. woman who is pregnant or nursing 10. eastern cooperative oncology group physical performance status score (ecog ps) \> 3; 11. patients known to be allergic or contraindicated to the study drug (apis and/or excipients). 12. a clear history of neurological or psychiatric disorders, including epilepsy or dementia
active removal of intracerebral hematoma via active irrigation

Conditions: Cerebral Hemorrhage; Intraventricular Hemorrhage

Summary: study evaluating if active irrigation by irraflow® with infusion of tpa will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.

the arch study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with irraflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tpa. this might affect the patient neurological outcome assessed by gcs and mrankin scale.

Eligibility criteria:
inclusion criteria: 1. age \>18 years of age 2. need of evd 3. active treatment 4. signed informed consent obtained a. based on institutional and country laws 5. spontaneous ich with maximum 30 square cm's 6. if needed, normal coagulation profile (pt, ptt, platelet count) 7. treatment within 72 hours of ictus 8. ability to administer 2.0 mg of tpa per day for 3 days exclusion criteria: 1. age \< 18 years 2. no need of evd 3. patient has fixed and dilated pupils 4. coagulopathy uncorrectable 5. vascular pathology (e.g. aneurysm involvement, avm involvement) 6. pregnant women

Keywords: hemorrhage cerebral hemorrhage intraventricular hemorrhage
treatment use study with sunitinib (su011248) for patients with cytokine-refractory metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the primary objective of this protocol is to provide access to su011248 treatment for patients with metastatic rcc who are ineligible for participation in ongoing su011248 clinical studies and have the potential to derive clinical benefit from treatment with su011248 based on the judgment of the investigator.

given that an expanded access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per nih, basic results for such studies are not required to be reported. protocol a6181037 has been identified as an expanded access trial, and has been registered to clinicaltrials.gov, however basic results will not be posted.

Eligibility criteria:
inclusion criteria: * renal cell carcinoma that is not amendable to standard therapy with curative intent exclusion criteria: * current treatment in another therapeutic clinical trial
prevalence of cardiac amyloidosis in patients undergoing surgery for lumbar spinal stenosis.

Conditions: Cardiac Amyloidosis; Spinal Stenosis

Summary: patients undergoing surgery for lumbar spinal stenosis will have biopsies of the ligamentum flavum sent to the department of pathology for histologic screening. if the ligament biopsy contains amyloid, patients will receive an echocardiogram, an ecg, biomarker testing, and a bone tracer scintigraphy diagnostic of cardiac amyloidosis.


Eligibility criteria:
inclusion criteria: * scheduled for surgery for lumbar spinal stenosis * age \> 65 years * informed written consent exclusion criteria: * known amyloidosis * myelomatosis * monoclonal gammopathy of unknown significance, mgus * morbus waldenstrøm
a clinical trial to investigate the safety, tolerability, pharmacokinetics, and food effect of pmk-s005 after oral administration in healthy male volunteers

Conditions: Gastritis; Gastric Ulcer

Summary: the purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of pmk-s005 after oral administration in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * male 20 year ≤ age ≤ 40 year. * weight ≥ 55kg, ibw ±20%. * patients with normal hematology, biochemistry, urinary result. * patients who have not congenital or chronic disease. * provision of written informed consent voluntarily. exclusion criteria: * patients having known hypersensitivity to any component of the study drug. * patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system. * patients with any gastrointestinal disorders. * systolic blood pressure ≥ 150 or ≤ 90 mmhg, diasolic blood pressure ≥ 95 or ≤ 50 mmhg. * drug abuser, alcoholic. * patients taking etc medication within 14 days, otc within 7 days. * patients taking other investigational product within 60 days prior to the participation in the study.
evaluation of alteration by magnetic resonance imaging (mri) in dementia among elderly subjects

Conditions: Dementia; Alzheimer Disease

Summary: capturing the earliest stages of dementia especially alzheimer's disease (ad) is a great challenge. until now the nincds-adrda and the dsm criteria for ad were largely used as diagnostic standards in research. however, the research on ad progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of ad, such as cerebrospinal fluid markers, neuroimaging with positon emission tomography (pet) or magnetic resonance imaging (mri).


Eligibility criteria:
inclusion criteria: * participate in the ami cohort * be aged 65 and older * be retired from agricultural profession * live in rural area in gironde exclusion criteria: * contraindication of mri * left-handed * severe dementia * parkinson's disease * poor health incompatible with the transport to neuroimaging service * to be left handed

Keywords: dementia alzheimer's disease diagnostic biomarkers neuroimaging pet mri mild cognitive impairment
xylitol chewable tablets versus xylitol chewing gum in geriatric bedridden patients

Conditions: Saliva Altered; Plaque

Summary: this study will be conducted to evaluate the effectiveness of using dissolving xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary ph and decreasing bacterial count in both saliva and interdental plaque.

this study will be conducted to evaluate the value of using dissolving xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary ph and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline t0, then after 5minutes t1, then at 15 days t3. salivary ph will be measured by using ph meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin

Eligibility criteria:
inclusion criteria: 1. age range above 65 years old 2. bedridden patients 3. males or females 4. concious patients 5. co-operative patients approving to participate in the trial. 6. subjects who signed informed consent exclusion criteria: 1. individuals had taken antibiotics during the last four weeks or anticipated doing so during the study 2. subjects who wore removable prosthesis 3. patients with systemic diseases that have any oral manifestations 4. history of smoking 5. allergy to any of chewing gum or tablets ingredients 6. evidence of tempromandibular joint disorders 7. presence of intraoral infections 8. currently using any mouth rinse

Keywords: dental plaque , salivary ph
asthma symptom based adjustment of inhaled steroid therapy in african american children

Conditions: Asthma

Summary: african american (aa) children carry a disproportionate burden of mortality and morbidity in asthma. a major contributor to racial disparity in asthma is lack of adherence to guideline-recommended use of daily inhaled corticosteroids (ics). symptom-based adjustment (sba) of ics is a recently described patient-centered approach to asthma therapy in which patients adjust their ics on a day-to-day basis guided by their symptoms. the overall goal of our study is to identify an acceptable, pragmatic and effective approach to asthma management in high-risk aa children. our primary hypotheses are that sba of ics use is more acceptable than provider-based adjustment (pba), equally effective in improving pediatric asthma outcomes, and will reduce the cumulative dose of ics needed for asthma control. therefore, in the asthma symptom based adjustment of inhaled steroid therapy in african american children (asist) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which we will randomly assign 200 aa children to either receive sba or pba for 12 months. the primary outcome is asthma control as measured by the asthma control test (act). we propose that asthma control in the sba group will be equivalent to the pba group after 12 months. secondary outcomes include monthly cumulative ics dose, exacerbation rate, quality of life, lung function, adherence and satisfaction with the treatment plan.


Eligibility criteria:
inclusion criteria: 1. patients 6-17 years old with physician diagnosed asthma for at least 6 months 2. self or parent reported aa race, or mixed race with at least one grandparent with aa race 3. receiving asthma care by the participating primary care pediatrician 4. prescribed low dose ics monotherapy (up to beclomethasone 160mcg for 6-11 y/o, 240 mcg per day for over 12 year old or equivalent), or leukotriene receptor antagonist (ltra), or low dose ics plus laba (for over 12 year old) for at least the past 12 weeks, regardless of adherence (see asist low dose ics inclusion table for conversion of dose) 5. asthma evaluation questionnaire score (aeq)17 0 or 1 on all 3 questions 6. pre-bd fev1 ≥80% of predicted 7. no history or current history of smoking 8. ability to provide baseline information at phone screening and randomization visit 9. ability and willingness to provide informed consent exclusion criteria: 1. pre-bd fev1\<80% of predicted within 3 months 2. asthma requiring daily combination therapy with medium to high dose ics with laba 3. history of intubation, noninvasive ventilation or icu admission for asthma exacerbation 4. chronic oral corticosteroid therapy 5. chronic disease that in the opinion of the investigator/primary care provider would prevent participation in the trial 6. no landline telephone or cell phone to communicate with study staff 7. non-english speaker 8. another participant of asist in the same household
autologous cd34+ stem cell injection for severe intermittent claudication (leg pain)

Conditions: Peripheral Artery Disease; Severe Intermittent Claudication

Summary: the goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. in addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking. this study is a double-blind, randomized study to compare cd34-positive stem cells versus a placebo agent (salt water solution known as normal saline). the patient will have a 3:1 chance of their stem cells versus the placebo. regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.


Eligibility criteria:
inclusion criteria: * males or females equal to or greater than 21 years old * patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable. * patients with symptoms of severe intermittent claudication in at least 1 lower limb persisting for at least 6 months (rutherford class 3). * patients who have a diagnosis of peripheral arterial disease (pad) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months. exclusion criteria: * patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening. * patients with iliac disease amenable to revascularization. * patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed. * patients with critical limb ischemia (cli), rutherford symptom score of 4,5, or 6. * patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.