Kornimate/medical-research-clean huggingface dataset:
development of automated molecular diagnostic platform for tuberculosis diagnosis (new assay tb)

Conditions: Tuberculosis Infection

Summary: it is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized for patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using xpert tb/rif, additionally, diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using a new diagnostic method, and check the test results. check whether the tuberculosis bacteria were actually cultured in the sample in the future, and compare the sensitivity and specificity in each test. validation in animal model in an animal model (rat) with chronic obstructive pulmonary disease that shows similar characteristics to tuberculosis destructive lung, it will be investigated whether the hi method can be validated by separating and concentrating microbiome for various pathogens including mycobacterium tuberculosis using hi method. confirm.

usefulness of pulmonary tuberculosis diagnosis a comparison of the new diagnostic method with the xpert tb/rif test, which is widely used in clinical practice, that can quickly diagnose pulmonary tuberculosis within 1-2 days. ; considering the sensitivity of the xpert tb/rif test as 70% and the sensitivity of the new diagnostic method as 90%, the number of patients with pulmonary tuberculosis required to confirm that the new diagnostic method is useful is estimated as 90 (study power 90%, alpha error = 0.05). and, if 200 patients with suspected pulmonary tuberculosis are registered, it is possible to verify the clinical usefulness compared to xpert tb/rif even in 60 afb smear negative patients. in addition, for the same reason, if 150 additional patients who underwent bronchoscopy were enrolled, it would be possible to compare the diagnosis rate and utility of sputum and bronchoscopy fluid. waiting for the tuberculosis bacteria culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis -usefulness of extrapulmonary tuberculosis diagnosis millet tuberculosis is disseminated tuberculosis through blood, and there are numerous millet-like lesions in the lungs, but in fact, the positive rate of afb smear is low due to paucibacillary tb. it is planned to prove the usefulness of the new test method in 35 people with millet tuberculosis.

Eligibility criteria:
inclusion criteria: * pulmonary tb * extrapulmonary tb exclusion criteria: * under 19

Keywords: new diagnostic platform,tb
pharmacokinetic and pharmacodynamic study in healthy subjects comparing the interactions between e5501 and verapamil and cyclosporine.

Conditions: Idiopathic Thrombocytopenic Purpura (ITP)

Summary: 36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. the study will consist of a pre-treatment phase and a treatment phase. the pre-treatment phase will include screening and baseline period 1. the treatment phase consists of 4 treatment period: treatment period 1 - administration of the first e5501 oral dose; treatment period 2 - administration of verapamil and the second e5501 oral dose; treatment period 3 - administration of the third e5501 dose; treatment period 4 - concomitant administration of cyclosporine and the fourth e5501 dose. a baseline period will precede each treatment period. the screening period will be up to 13 days in duration. after fulfilling screening requirements, subjects will check into the clinic on day -1 for baseline assessments. they will be domiciled in the clinical testing facility for 6 days for treatment periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. they will be domiciled in the clinical testing facility for at least 14 days for treatment period 2 and will return intermittently for study procedures for 7 outpatient visits.


Eligibility criteria:
inclusion: * healthy adult men and women (age 18 to 55 years) * body mass index greater than or equal to 18kg/m2 and less than or equal to 32kg/m2 at the time of screening and at each baseline * platelet count between 120x109/l and 300x109/l at baseline * women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the treatment phase of the study exclusion: * evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pk of the study * agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration * evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy * history of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). known family history of hereditary thrombophilic disorders (e.g., factor v leiden, antithrombin iii deficiency, etc.) * hemoglobin less than the lower limit of normal levels (women, 7.1 mmol/l; men, 8.1 mmol/l) in addition, other standard criteria for healthy volunteers will be used.
comparative evaluation of results of allogeneic hematopoietic stem cells versus ponatinib in cml patients carrying a mutation t315i

Conditions: Leukemia

Summary: effective treatment options for chronic myeloid leukemia (cml) or philadelphia-positive (ph+) acute lymphoblastic leukemia (all) patients with the t315i mutation are few. this study compared overall survival (os) between cml and ph+ all patients treated with ponatinib versus allogeneic stem cell transplantation (allo-sct).


Eligibility criteria:
inclusion criteria: * cml any phase with t315i mutation * ph+ all with a t315i mutation * being treated in the pace trial according to the criteria of this phase ii trial * or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen. exclusion criteria: * ph negative patients * patients under 18 years

Keywords: chronic myeloid leukemia (cml) philadelphia-positive (ph+) acute lymphoblastic leukemia (all)
characteristics of injury claims by chronic pain patients

Conditions: Social Functioning; Chronic Pain; Injuries; Disabilities Multiple

Summary: chronic pain is associated with injuries and disabilities. this prospective observational study explores the injury or disability claims made by chronic pain patients. it evaluates the socio-demographics of the patient population. it explores the impact of pain clinic services on the patients' injury rehabilitation, insurance claim outcome, and socioeconomic situation.

chronic pain is associated with injuries, disabilities, psychological disorders, and unemployment. chronic pain patients usually make insurance claims for injury, disability, and unemployment. this prospective observational study explores the injury, disability, and compensation claims made by chronic pain patients. the study evaluates the socio-demographics of the patient population; including their gender, age, ethnicity, occupation, employment status, income, education level, family status, and home location. it explores the impact of pain clinic services on the patients' injury rehabilitation course, insurance claim outcome, and socioeconomic situation.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients * patients with injury claim exclusion criteria: * pediatric patients * patients without injury claim

Keywords: injury claim disability claim
the effect and mechanism of hyaluronan on the mucociliary differentiation of human respiratory epithelial cells

Conditions: Respiratory System Defect

Summary: the mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. therefore, it is important to maintain intact inner respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the development of tissue engineering trachea. hyaluronan derivatives, which are biodegradable and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes. however, the feasibility of use as a scaffold for respiratory epithelial cells remained unexplored. the aim of the study is to investigate the effect of hyaluronan including concentrations and molecular weight on the mucociliary differentiation of human respiratory epithelial cells (hrec). if hyaluronan is able to promote mucociliary differentiation of hrec, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials for respiratory tissue engineering and tissue-engineered trachea in the future.


Eligibility criteria:
inclusion criteria: * patients underwent septomeatoplasty

Keywords: hyaluronan including concentrations molecular weight mucociliary differentiation human respiratory epithelial cells
preservation of venous valvular function after pmt for acute dvt

Conditions: Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Summary: to evaluate the venous valvular function after pharmacomechanical thrombectomy (pmt) for acute femoral-popliteal venous thrombosis.

all patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via angiojet devices or anticoagulation alone were included in this study.

Eligibility criteria:
inclusion criteria: * patients with acute symptomatic proximal dvt involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in china. patients were treated with pcdt via zelante device (boston scientific). exclusion criteria: * participants were excluded if they had symptoms for more than 14 days.
action on covid-19: a study to test whether bi 764198 helps lung health of people hospitalised with covid-19

Conditions: COVID-19

Summary: this study is open to adults with covid-19 infection who are in hospital and receive oxygen. participants need to be 50 years of age or older and need to be at risk of further worsening of their condition. the purpose of the study is to find out whether a medicine called bi 764198 helps people with covid-19 infection and breathing problems. bi 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with covid-19 infection. participants are put into 2 groups by chance. one group of participants gets bi 764198 capsules and the other group gets placebo capsules. the placebo capsules look exactly like the bi 764198 capsules but do not contain any medicine. participants take 1 capsule per day. participants are in the study for about a month. at study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. during the study, the doctors collect information on any health problems of the participants.


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * sars-cov-2 infection positive confirmed by pcr or approved point-of-care test * a score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen by non-invasive ventilation or high flow), but not previously ≥7, on the who clinical progression scale. * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial. * male or female patients. women of childbearing potential (wocbp) and men able to father a child must abstain from male female sex or must use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly during hospitalisation for at least 7 days after last trial drug intake exclusion criteria: * alanine aminotransferase (alt)/aspartate aminotransferase (ast) \>5 × the upper limit of normal (uln). * known active infection with hiv or hepatitis b or c. * pulmonary oedema/respiratory failure due to cardiogenic insult. * previous to hospitalisation, on long-term oxygen therapy. * a confirmed baseline prolongation of qtc interval to greater than 450 ms in males or 470 ms in females according to the bazett formula, or any other relevant ecg finding at screening, or concomitant use of medication prolonging qt interval. * stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr \<30 ml/min/1.73 m2). history of the following cardiac conditions: * myocardial infarction within 3 months prior to the first dose * unstable angina * history of clinically significant long qt features on electrocardiogram (ecg) or history of familial long qt * anticipated transfer/discharge to another hospital or care facility other than their place of residence * further exclusion criteria apply
low dose decitabine in combination with tirelizumab comparison of tirelizumab in the first-line treatment of advanced esophageal squamous cell carcinoma

Conditions: PFS

Summary: to evaluate the efficacy and safety of low-dose decitabine combined with tirelizumab in the treatment of patients with advanced esophageal squamous cell carcinoma who did not progress in first-line immunotherapy combined with chemotherapy.


Eligibility criteria:
inclusion criteria: subjects voluntarily participate and sign written informed consent; age ≥18 years; confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; at least one measurable lesion according to ajcc 8th staging and recist 1.1 solid tumor evaluation criteria. those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g., paclitaxel + cisplatin) in the first line, and the disease has not progressed; good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart disease, that is, the relevant indicators within 14 days before treatment meet the following requirements: * anc≥1.2×109/l and lymphocyte count ≥0.5×109/l without the support of granulocyte colony stimulating factor; * without blood transfusion, patients with platelet count ≥100×109/l and hemoglobin ≥90g/l can meet the criteria through blood transfusion; * ast, alt and alp≤2.5× upper limit of normal (uln), total bile red ≤1.5×uln, except the following conditions: for known gilbert patients: total bilirubin ≤3×uln, creatinine ≤1.5×uln, albumin ≥25g/l; * for patients not receiving anticoagulant therapy: inr and aptt≤1.5×uln. estimated survival ≥3 months; score of ecog physical strength: 0\~1; the ability of patients to follow the study protocol according to the judgment of the investigator. exclusion criteria: previous immunotherapy; no measurable lesions; there are small cell carcinoma, adenocarcinoma or mixed carcinoma components in the histology; complete esophageal obstruction; any nci ctcae≥ grade 2 toxicity that has not recovered after previous chemotherapy; high risk of esophageal fistula was found through clinical evaluation or imaging examination, such as history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; had positive detection for eb virus (ebv) capsid antigen igm during screening (pcr method); if a patient requires analgesic treatment, the treatment regimen used at the time of enrollment must be stable; the men who have hiv positive results at the time of screening; people who test positive for hepatitis c virus (hcv) during sieving; hbv positive screening, and cccdna≥500 iu/ml; any of the following diseases in the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident; pregnant or lactating women or fertile but did not take contraceptive measures; suffer any other serious physical or mental problem of an acute or chronic nature; judging by the researchers, that doesn't fit to participate in the study. -
'hi-4-tu' study: health improvement for teen ugandans study

Conditions: Pregnancy; Human Immunodeficiency Virus; Sexually Transmitted Diseases

Summary: this randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both hiv/sti's and subsequent unplanned pregnancies. the study population is pregnant adolescents who are attending antenatal care in kampala, uganda the acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. the study participants will be individually randomized to one of three arms.

the overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. in each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver reproductive health education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). the control group will consist of 215 adolescent mothers randomized to routine care as provided at mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard pmtct services including routine opt-out hiv c\&t and availability of partner c\&t. syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care. the 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (arms 2 and 3) will have additional visits at 36 weeks antepartum, delivery, 6 and 10 weeks postpartum, quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and hiv/sexually transmitted infection status.

Eligibility criteria:
inclusion criteria: * pregnant at ≥28 weeks of gestation * agreeing to provide written informed consent to be screened for and take part in the study * agreeing to provide adequate locator information with residence within 30 km * agreeing to a home visit * agreeing to come for follow up visits and to receive study follow up phone calls exclusion criteria: * serious illness or social conditions that would prevent adherence to study requirements * high risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)

Keywords: adolescent reproductive health
long term safety study of orfadin treatment in ht-1 patients in standard clinical care

Conditions: Hereditary Tyrosinemia, Type I

Summary: the purpose of this study is to look at the long term safety profile of orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (ht-1). patients included in the study will use orfadin according to normal clinical practice.

the planned study is a non-interventional study that will look at the long-term safety of orfadin treatment in patients suffering from hereditary tyrosinemia type 1. orfadin will be used according to normal practice . there is an ongoing post-marketing surveillance (pms) program to monitor hepatic, renal, hematological, neurological and ophthalmic status in all patients treated with orfadin. the committee for medicinal products for human use (chmp) has required this program and have looked at the data for approximately 400 patients and found the benefit-risk ratio to be positive. the present study (pass) will replace the ongoing pms. the transition of countries will be gradual; starting in 2013.the study will include ht-1 patients on orfadin treatment in standard clinical care as well as newly diagnosed patients just starting with orfadin treatment.

Eligibility criteria:
inclusion criteria: * all ht-1 patients receiving orfadin treatment are eligible for entry. exclusion criteria: * no exclusion criteria

Keywords: ht-1 hereditary tyrosinemia, type i hypertyrosinemia type 1 orfadin long term safety hereditary tyrosinemia type 1
response to slt vs. alt in patients under 60 years of age

Conditions: Glaucoma

Summary: laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (alt) or selective yag (slt) lasers. the effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. the study hypothesis is that there will be no difference between the two laser types.

forty-two young patients (age 29 to 60) had one eye randomized to alt (n = 22) or slt (n = 20). intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.

Eligibility criteria:
inclusion criteria: * age \< 60 years * intraocular pressure not adequately controlled exclusion criteria: * prior laser treatment

Keywords: glaucoma laser trabeculoplasty intraocular pressure
prevention of severe hypoglycemia in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with type 1 diabetes. the aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in type 1 diabetes. following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. it is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.

the unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions: 1. a non-targeted approach whereby pre-prandial glycaemic targets are raised from 4.5-7mmol/l to 7.2-8.3mmol/l and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5 2. optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles 3. insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles

Eligibility criteria:
inclusion criteria: * type 1 diabetes * recurrent severe hypoglycemia within the preceding 6 months * attending the newcastle diabetes centre exclusion criteria: * previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen * previous use of continuous subcutaneous insulin infusion pump * alcohol or drug abuse * seizures unrelated to hypoglycemia.

Keywords: csii insulin analog severe hypoglycaemia altered hypoglycaemia awareness diabetes quality of life cgms