Kornimate/medical-research-clean huggingface dataset:
alternative dosing regimens of subcutaneous azacitidine for myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to determine if azacitidine, combined with best supportive care (bsc), is effective in treating myelodysplastic syndromes (mds) when given according to a different doses and dosing schedules.

comparison/control interventions: the comparison is azacitidine at different doses and schedules. duration of intervention: treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at least one of the following: a)anemia with hemoglobin \<110g/l and requires at least 1 unit packed red blood cell transfusions every 28 days; b)thrombocytopenia with platelet counts \<100 x 10\^9/l; or c)neutropenia with absolute neutrophil count \<1.5 x 10\^9/l. * or, refractory anemia with excess blasts or refractory anemia with excess blast in transformation, according to the french-american-british classification system for mds. * at least 18 years of age. * have a life expectancy of \>7 months. * unlikely to proceed to bone marrow or stem cell transplantation therapy following remission. * have serum bilirubin levels less than or equal to 1.5 times the upper limit of the normal (uln) range for the laboratory. * have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 x uln. * have serum creatinine levels less than or equal to 1.5 x uln. exclusion criteria: * secondary mds. * prior treatment with azacitidine. * any prior history of acute myeloid leukemia (aml). * malignant or metastatic disease within the previous 12 months. * uncorrected red cell folate deficiency or vitamin b12 deficiency. * hepatic tumors. * radiation, chemotherapy, or cytotoxic therapy for non-mds conditions in the previous 12 months. * known or suspected hypersensitivity to azacitidine or mannitol. * prior transplantation or cytotoxic therapy to treat mds. prior use of revlimid and thalomid allowed after 30 day washout. * serious medical illness likely to limit survival to less than or equal to 7 months. * treatment with androgenic hormones during the previous 14 days * active viral infection with known human immunodeficiency virus or vial hepatitis type b or c. * treatment with other investigational drugs with the previous 30 days.
comparison of montelukast and azelastine in treatment of moderate to severe allergic rhinitis

Conditions: Allergic Rhinitis

Summary: comparison of montelukast and azelastine in treatment of allergic rhinitis allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. the importance of studying this disease can be seen from the high prevalence of this diseas. in addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.also finding the best treatment of allergic can help to control of asthma if exists concurrently. inflammation of the nasal mucosa following the release of ige can be shown as symptoms of runny nose, sneezing, nasal congestion.many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. among the treatments for this disease is the use of antihistamine nasal sprays such as azelastine. combination therapies such as combining mometason furoate or fluticasone with azelastine or montelukast can also be mentioned. however, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.


Eligibility criteria:
inclusion criteria: * age 6-50years * moderate to severe allergic rhinitis exclusion criteria: * under any treatment * drug sensitivity
investigating the effect of stochastic resonance vibration on gait and balance and upper extremity function in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.

vibration devices have been used by some patients with cerebral palsy during therapy sessions. researchers believe they have the potential to be even more useful for everyday use, and are doing this study to learn more about what they can do. participate in this study will be asked to complete assessments that test arm motion, muscle tone, motor control, and sensory function. they will then be asked to wear a wristband on each wrist and on their shoulder. these wristbands contain vibrators that can vibrate at different levels. the vibrations are caused by a low-level of sound waves that people may barely be able to hear. while wearing the vibration devices on the wrist and shoulder, participants will be asked to perform two tasks. the first task is called the box and blocks test, which consists of transferring wooden blocks from one box to another. the second test is called the shriners upper extremity evaluation (shuee). in this test participants will perform a series of fine motor tasks with their hands. the shuee test will be video recorded for scoring by a study therapist at a later time on how much and how well participants use their impaired arm to perform the tasks. participants will be asked to complete the box and blocks test and the shuee test 3 times. participation in this study will be one single visit and last approximately an hour to an hour and a half.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy * 3 years to 18 years of age * able to reliably express pain, discomfort or fear as reported by the parent/guardian * manual ability classification scale (macs) levels i, ii or iii exclusion criteria: * any unstable medical condition. an unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services * any medical condition preventing active rehabilitation reported by the parent/guardian such as: o thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis * subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices * skin lesions affecting the areas where the device straps will be attached to the body
maternal antiviral treatment and infants immunoprophylaxis in the prevention of mother-to-child transmission

Conditions: Hepatitis B

Summary: the effective control of nucleos(t)ide analogues for patients infected with hepatitis b has significantly curbed the horizontal transmission of hepatitis b. however, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis b worldwide with the transmission rate up to 80 to 90% among high hbv dna level if untreated. currently, the effective prevention of mother-to-child transmission is credited to the implement of hbv vaccination and hepatitis b virus immunoglobin. to leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. however, the clinical practice can be more complex. therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis b infection in the real world setting.

from 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis b infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. the investigators recommended those pregnant women with hbv dna \> 2\*10\^6 iu/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high hbv dna level. meanwhile, those pregnant women with hbv dna \< 2\*10\^6 iu/ml was assigned as the control group with low hbv dna level. all infants would be instructed to receive hepatitis b vaccine and hepatitis b virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. umbilical cord blood were collected to determine the hbv serological markers and hbv dna level. children were followed every three to four years until december 2018.

Eligibility criteria:
inclusion criteria: * hbsag positive women who were less than 28 weeks pregnant and underwent routine testing for hbv at the department of infectious diseases of taicang first people's hospital at least twice during pregnancy exclusion criteria: * women treated with antiviral drugs during pregnancy. * drug hypersensitivity; * abnormal renal laboratory results; * coinfection with human immunodeficiency virus or other human hepatitis viruses.

Keywords: hepatitis b mother-to-children transmission antiviral treatment immunoprophylaxis
safety/efficacy study to assess whether fviii/vwf concentrate can induce immune tolerance in haemophilia a patients

Conditions: Hemophilia A

Summary: the purpose of this study is to assess the role of a fviii/vwf complex concentrate (emoclot) in successfully inducing immune tolerance (i.t.i.) in patients with haemophilia a with inhibitors, including patients at high risk of failure.

the development of factor viii inhibitors occurs in approximately 30 to 40% of patients with severe haemophilia a. the main negative clinical and cost consequence is the ineffectiveness of replacement therapy in patients with high-titer antibodies, who have a shorter life and greater morbidity than those who do not develop inhibitors. it is known from immunology that a regular and frequent exposure to the antigen of fviii can induce tolerance of the immune system of the patient with inhibitors. this effect, called "immune tolerance induction" (iti) is usually achieved after a prolonged exposure of the patient to fviii, and is a common way of managing the condition of patients with inhibitors as well as the treatment of bleeding episodes with large amounts of hemostatic agents. in vitro and retrospective clinical studies suggest that fviii/vwf complex concentrates may have less immunogenicity with respect to those plasma-derived concentrates purified with monoclonal antibodies (mabs), and recombinant dna factor viii concentrates (rfviii), in both which the von willebrand factor (vwf) is absent. immune tolerance induction (iti) showed to be effective in about 70% of haemophiliacs with inhibitors. poor prognosis factors have been identified by different registries: age ≥ 6 years, iti started \>1 year from inhibitor development, inhibitor peaks \>200 bu, inhibitor titer \>10 bu at the start of iti and previously failed iti. the results of clinical studies suggest that complex concentrates of vwf/fviii can be effective in iti, even in patients at high risk of failure. to explain these findings, a role for vwf (i.e. prolonged antigen exposure) has been hypothesized.

Eligibility criteria:
inclusion criteria: 1. subjects (his/her parent/legal representative), must have given a written informed consent. 2. male children: age \<12 years. 3. severe or moderate haemophilia a (fviii \<2%). 4. high responders (clinical history of inhibitor peak \> 5bu) or low-responders (clinical history of inhibitor peak \< 5 bu) with potential bleedings, assessed by responsible physicians as not to be treated with high fviii doses. 5. any level of inhibitor at study enrollment. 6. willingness and ability to participate in the study. 7. no other experimental treatments (involving or not fviii concentrates). exclusion criteria: 1. any clinically relevant abnormality, in hematological, biochemical and urinary routine examinations, or any condition or treatment which in the investigator's opinion, makes the patient not eligible for the study. 2. intolerance to active substances or to any of the excipients of fviii / vwf concentrates. 3. concomitant systemic treatment with immunosuppressive drugs.

Keywords: von willebrand factor factor viii hemorrhage immune tolerance hemophilia a
new quantitive mri parameters in assessing kidneys of autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease; Kidney Disease

Summary: the purpose of this study is to establish normal magnetic resonance quantitative values (tissues stiffness, apparent diffusion coefficient values and blood oxygen level determination values for both renal cortex and medullary tissues and total renal blood flow) for young autosomal dominant polycystic kidney disease patients with normal renal function, and normal young adult controls without autosomal dominant polycystic kidney disease and normal renal function. hypothesis: newer magnetic resonance quantitative imaging parameters (tissue stiffness, apparent diffusion coefficient, blood oxygen level determination levels, magnetization transfer and renal blood flow) will have different values in young adult adpkd patients as compared to normal volunteers.


Eligibility criteria:
inclusion criteria adpkd participants * male and female subjects between 18-30 years of age * diagnosis of adpkd * glomerular filtration rate (gfr) of \> or = to 60 ml/min (chronic kidney disease-epidemiology collaboration equation) * ability to provide written, informed consent exclusion criteria for adpkd participants * clinically significant concomitant systemic disease * subjects with diabetes mellitus * urinary protein excretion * abnormal urinalysis suggestive of concomitant glomerular disease * subjects having contraindications to, or interference with mri assessments * subjects with supine blood pressure higher than 140/90 mm hg or taking blood pressure medications inclusion criteria for normal volunteers * male and female subjects between 18-30 years of age * glomerular filtration rate (gfr) of \> or = to 60 ml/min (chronic kidney disease-epidemiology collaboration equation) * ability to provide written, informed consent exclusion criteria for normal volunteers * previous personal or family history of kidney disease * clinically significant concomitant systemic disease * subjects with diabetes mellitus * urinary protein excretion * abnormal urinalysis suggestive of concomitant glomerular disease * subjects having contraindications to, or interference with mri assessments * subjects with supine blood pressure higher than 140/90 mm hg or taking blood pressure medications

Keywords: autosomal dominant polycystic kidney disease magnetic resonance imaging parameters magnetic resonance elastography apparent diffusion coefficient blood oxygen level determinations diffusion weighted imaging
long term extension study of tapinarof for plaque psoriasis in adults (3003)

Conditions: Plaque Psoriasis

Summary: this is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. subjects in this study completed treatment in 1 of 2 phase 3 pivotal efficacy and safety studies (study dmvt-505-3001 or study dmvt-505-3002). this study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

at the completion of the week-12 visit of the pivotal study (baseline \[day 1\] in this study), all eligible subjects will be offered enrollment in the long-term extension study. study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). the total duration of study participation will be approximately 44 weeks.

Eligibility criteria:
inclusion criteria: 1. completed the 12-week treatment period in 1 of the 2 parent studies (study dmvt-505-3001 or study dmvt-505-3002); 2. male and female subjects 3. females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance while on the study, and for at least 4 weeks after the last exposure to study treatment 4. capable of giving written informed consent exclusion criteria: 1. used a prohibited concomitant product or procedure to treat psoriasis during parent study 2. had a serious adverse event (sae) that was potentially related to treatment or experienced an adverse event (ae) that led to permanent discontinuation of treatment in the parent study 3. history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study 4. known hypersensitivity to tapinarof

Keywords: tapinarof plaque psoriasis, adult phase 3 topical open-label efficacy safety psoriasis long-term therapeutic aryl hydrocarbon receptor modulating agent
heat shock proteins: a pathogenic driver and potential therapeutic target in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: to investigate the role of heat shock proteins in the mechanism of acute severe pancreatitis. in addition to test the potential treatment target of acute pancreatitis. all patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.

all patients with acute pancreatitis are evaluated according to modified atlanta classification acute pancreatitis severity scores. blood serum, urine and dna samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours. ct is performed in al patients to evaluate necrosis of pancreas day 5-7 since hospital admission. if necrosis is not present follow-up is stopped.

Eligibility criteria:
inclusion criteria: * no prior diagnosis of acute pancreatitis * admission to the hospital within 2 days since the clinical symptoms * confirmed diagnosis of acute pancreatitis exclusion criteria: * chronic pancreatitis * pancreatic cancer

Keywords: heat shock proteins, early diagnosis
does the act of urination during urethral catheterisation in males reduce pain?

Conditions: Pain

Summary: currently, there are no specific guidelines or best practice suggestions for best male catheterization as fat as insertion technique. there is however, information as to reducing infection, and as to recommended lubricant. from our experience, the investigators have noticed that when requesting the patient to attempt urination while inserting a urethral catheter, the level of pain and discomfort is reduced. in this study, the investigators will evaluate the pain level during male urethral catheterization in each technique. our hypothesis is that the level of pain will be much less if the in the study group where the act of urination will be requested from the patient.

this is a randomized prospective study that will compare the pain levels of urethral catheterization in men randomized to requesting to urinate while inserting a urethral catheter to normal catheter insertion. males aged 18 years and older who will be referred for multichannel urodynamic study in order to evaluate lower urinary tract symptoms will be included. patients will be randomized to 2 groups: (1) patients who will be requested to urinate while catheterising the urethra to its full length; (2), patients who will be requested to lie while catheterising the urethra, without further instructions from the medical professional. in both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the urethra. the randomization technique will be employed by a computerized random number generator. a 12f tieman urethral catheter will be introduced in order to measure post-void residual volumes. subsequently, multichannel urodynamic testing (duet encompass system - mediwatch group plc) will be performed using a dual lumen 6f urethral and 9f rectal catheters. filling will be carried out using room temperature saline at a filling rate of 50 ml/min. patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (vas) in different time points: before the procedure (baseline), immediately after gel instillation, immediately after the introduction of the tieman catheter, 15 minutes after the catheter will be taken out. time frame of the study: 30 minutes before the test and 1 hour after the test. since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.

Eligibility criteria:
inclusion criteria: * men aged 18 years and older who will be referred for multichannel urodynamic study in order to evaluate lower urinary tract symptoms. exclusion criteria: * use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), inability to cooperate with pain assessment due to mental disorders.

Keywords: pain catheter urethra urination
performance of cast (cellular antigen stimulation test) in patients with wasp venom allergy: evaluation of neutralizing igg subclasses

Conditions: Wasp Venom Allergic Patients

Summary: to determine which subclass of igg in the serum of patients undergoing sit against wasp venom is able to neutralize the allergen, and therefore to prevent a positive cast


Eligibility criteria:
inclusion criteria: * male and female patient with allergy to wasp venom grade iii and iv according to h.l. müller * 18-75 years * planned sit against wasp venom or finished 5 years sit against wsp venom (10/10) exclusion criteria: * oral corticosteroids * chromogycin * ketotifen * immunosuppressive drugs within the last 2 years
study to evaluate safety, tolerability and pharmacodynamics of kp104 in participants with thrombotic microangiopathy secondary to systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and efficacy of kp104 in participants with systemic lupus erythematosus (sle)-thrombotic microangiopathy (tma). the study consists of 2 parts: part 1 (dose optimization) and part 2 (proof of concept). all participants will receive kp104 in combination with standard of care (soc) for sle-tma.


Eligibility criteria:
inclusion criteria: * meets criteria for sle per the 2019 european league against rheumatism (eular)/american college of rheumatology (acr) criteria. * decrease in platelet count to less than (\<)150,000/microliters (mcl). * abnormal renal function. * females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from screening until 28 days after the end of study (eos) visit. * willing and able to provide informed consent. * evidence of microangiopathic hemolytic anemia exclusion criteria: * diagnosis of other tma syndromes. * a renal biopsy within 7 days of screening that shows exclusively chronic changes of tma. * positive coombs test at the time of tma diagnosis. * active or unresolved neisseria meningitidis infection at screening. only key inclusion and exclusion criteria have been included.

Keywords: systemic lupus erythematosus thrombotic microangiopathy dose selection proof of concept kp-104