Kornimate/medical-research-clean huggingface dataset:
a multicenter randomized open-label study of chidamide plus hd-dex versus hd-dex in itp

Conditions: Thrombocytopenia

Summary: recently, histone deacetylase inhibitors (hdaci) has been used for their anti-inflammatory and immunomodulatory activities. it has been shown that hdaci can alleviate graft-versus-host disease by enhancing the number and function of foxp3+ tregs. our group found that low-dose hdaci alleviated thrombocytopenia in both passive and active murine models of itp. furthermore, low-dose hdaci attenuated macrophage phagocytosis of antibody-coated platelets, stimulated production of natural foxp3+ tregs, promoted peripheral conversion of t cells into tregs, and restored treg suppressive function in vivo and in vitro. the project was undertaking by qilu hospital of shandong university and other 10 well-known hospitals in china. in order to report the efficacy and safety of the low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone in the management of itp.

primary immune thrombocytopenia (itp) is an autoimmune bleeding disorder with low platelet count. low-dose hdaci alleviated thrombocytopenia in both passive and active murine models of itp. in this multicentre, open-label, randomized controlled trial, newly diagnosed itp patients will be enrolled from 11 tertiary medical centres in china. participants will be randomly assigned into the combination group or the monotherapy group by masked statisticians in a 1:1 ratio. the primary endpoints are sustained response at month 6. the secondary outcomes include initial response, time to response, duration of response, bleeding score, health-related quality of life assessment, and safety issue. this study will compare the efficacy and safety of low dose chidamide combined with high-dose dexamethasone versus high-dose dexamethasone monotherapy in adults with primary immune thrombocytopenia.

Eligibility criteria:
inclusion criteria: * newly diagnosed itp patients need of treatment(s) to minimize the risk of clinically significant bleeding primary itp confirmed by excluding other supervened causes of thrombocytopenia exclusion criteria: * pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment hcv, hiv, hbsag seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Keywords: hd-dex chidamide
patient presented with aki related to pregnancy

Conditions: Acute Kidney Injury

Summary: the primary objective of this study is to identify characteristics of patient with pr aki treated in assiut university hospital secondary outcomes: 1. assessment of pregnancy related aki maternal outcome (complete recovery , partial recovery or progress to esrd) within 3 months duration 2. to identify predictors of unfavorable outcome of patient with pregnancy related aki

acute kidney injury (aki) is a syndrome which is characterized by an rapid deterioration of the kidney function , manifested by increase in serum creatinine level with or without reduced urine output and linked to high rate of morbidity and mortality .aki is considered a major public health problem despite much improvmnent in heakth care and especially, most of them (about 85 %) in developing countries with low resources.pregnancy related aki ( pr -aki ) is a major obstetric complication which may cause termination of pregnancy (top ), intensive care unit ( icu ) admission , need for dialysiy , both maternal and perinatal morbidity and mortality with maternal mortality rang from 9% to 55 % . pr-aki has a major risk factors include preeclampsia which is the most common cause (15-20%) , hyperemesis gravidarum , acute fatty liver of pregnancy and placental abruption , puerperal sepsis and septic abortion .the maternal outcome of pregnancy related aki include complete recovery with return of serum creatinine to normal (\&gt; 1.4 mg /dl ) about (40-75% ), partial recovery(4-9% require dialysis about 4 months after delivery) , progress to end stage renal disease (1.5 - 2.5 %) or maternal mortality . the maternal mortality rate (mmr) increases with increasing severity of pregnancy-related complications and can range from 13 to 24% in developing countries due to pr-aki . timely identification of patients and management of underlying conditions is considered the cornerstone to improve maternal outcome.

Eligibility criteria:
inclusion criteria: * women (\&gt;18 years) who developed aki with or without need for dialysis treatment during pregnancy, childbirth , post abortion period and /or puerperium * aki as defined by kdigo definition as follows: 1. increase in serum creatinine \&gt; 0.3 mg/dl within 48 2. increase in serum creatinine \&gt; 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days. 3. urine volume of \&lt; .5 ml / kg / hours exclusion criteria: * patients with preexisting kidney disease before pregnancy * patients with aki not related to pregnancy. * patients with uncertain history for incident time of aki. * patients refuse to participate in the study

Keywords: aki related to pregnancy aki praki pregnancy related aki
metabolic syndrome in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Metabolic Syndrome

Summary: study the prevalence of metabolic syndrome in patients with knee osteoarthritis and conclude the relationship between metabolic syndrome and the severity of knee osteoarthritis

osteoarthritis is one of the most common clinical conditions causing severe chronic and restrictive disability, especially in elderly people. of those aged 60 years and older, 10% of men and 13% of women had symptomatic knee oa . as the population ages and the prevalence of obesity and overweight generaly rises , the percentage of persons affected with symptomatic knee oa will likely increase. the clinical manifestations in patients are joint pain, stiffness, and functional limitation . among all body joints; knee joint is the most commonly affected joint with osteoarthritis and accounts almost for four-fifth of the osteoarthritis burden worldwide . epidemiological research has shown an encouraging relationship between oa and metabolic syndrome , mets include hypertension, dyslipidemia, hyperglycemia, and obesity .recently, metabolic oa has been nominated as the fifth component of mets . studies reported that adipokines may contribute to the development of osteoarthritis (oa) by increasing inflammatory cytokines and growth factors, modifying insulin sensitivity, and triggering processes that break down cartilage. studies also reported that hypertension can be linked to osteoarthritis through astherosclerosis which cause subchondral bone ischemia accelerating oa progression. furthermore, researches have linked glucose levels to knee osteoarthritis , supporting the possibility of pathophysiological mechanisms such oxidative stress in the chondrocytes and cartilage-associated production of advanced glycation end products (ages) .

Eligibility criteria:
inclusion 1. both males and female . 2. age between 30 and 70 years old. 3. patient fulfill the criteria of knee osteoarthritis . exclusion criteria: 1. patients known to have rheumatological disease . 2. patients with meniscal or cruciate ligament injury . 3. patients with previous knee surgery .

Keywords: knee osteoarthritis metabolic syndrome
allogeneic hematopoietic stem cell transplantation evaluation in high risk myelodysplasia: an observational non-interventional study

Conditions: Myelodysplasia

Summary: the purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without hla compatible (9 or 10 identities / 10) donor. high risk myelodysplasia includes ipss intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. patients are registered when they acquire risk factors.


Eligibility criteria:
inclusion criteria: * 50 to 70 years * for myelodysplasia other than cmml: patients can be included if they have at least one of these criteria: 1. ipssintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality); 2. thrombopenia \< 20x10ex9/l: 3. ipss intermediate 2 or high * for cmml: patients can be included if they have at least one of these criteria: 1. 2 of these criteria: hyperleucocytosis \> 10x10exp9/l, splenomegaly\>18cm, hemoglobin \< 10gr/dl, platelet \< 100x10ex9/l 2. ipss intermediate 2 or high exclusion criteria: * patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including: * renal failure with creatinine clearance \< 30ml/min * cirrhosis or hepatic failure * respiratory disease with vital capacity \< 30% * uncontrolled cardiac failure * uncontrolled neurological disease * poor performance status with karnofsky \< or = 60%

Keywords: myelodysplasia allogeneic hematopoietic stem cell transplantation survival transplantation
a difference in subclavian vein catheterization between supine and lateral tilt position - stage ii

Conditions: Catheterization; Posture

Summary: central venous catheterization is widely used for various purposes during surgery. for central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. the cross - sectional area of the subclavian vein is an important factor to increase success rate. several studies have reported that the trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. however, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. the ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity. in the second stage of this study, the investigators would like to compare the success rate, the number of needle passage, time to complete subclavian vein catheterization in supine and ipsilateral tile position.


Eligibility criteria:
inclusion criteria: - the patients who receive elective neurosurgical surgery and require central venous catheter exclusion criteria: * the patients who have puncture site infection * the patients who have chemoport, pacemaker in right subclavian vein * the patients who had received right mastectomy or right pneumonectomy * other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
a study of renal autologous cell therapy (react) in type 2 diabetics with chronic kidney disease

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease

Summary: to assess the safety and efficacy of up to two react injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with type 2 diabetes mellitus (t2dm) and chronic kidney disease (ckd).

study part 1: multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of react (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as react can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. subjects will be followed through 23 months after the last injection. study part 2: an open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. subjects will be able to roll from study part 2 into a long term follow-up master protocol for up to 5 years

Eligibility criteria:
inclusion criteria for study part 1: 1. the subject is male or female, 30 to 80 years of age on the date of informed consent. 2. the subject has an established diagnosis of type 2 diabetes mellitus. 3. the subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease. 4. the subject has an established diagnosis of chronic kidney disease not requiring renal dialysis, defined as having an estimated glomerular filtration rate (egfr) between 20 and 50 ml/min/1.73m². 5. the subject has blood pressure less than 150/90 at the screening visit. 6. the subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen. 7. a minimum of 2 measurements of estimated glomerular filtration rate (egfr) or serum creatine ratio (scr) should be obtained at least 3 months apart prior to the screening visit or within the previous 18 months to define the rate of progression of chronic kidney disease (ckd). exclusion criteria for study part 1: 1. the subject has a history of type 1 diabetes mellitus. 2. the subject has a history of renal transplantation. 3. the subject has a serum hemoglobin a1c (hba1c) level greater than 10% at the screening visit. 4. the subject has uncontrolled diabetes (defined as metabolically unstable by the investigator). 5. the subject has hemoglobin levels less than 9 g/dl prior to each renal autologous cell therapy (react) injection. inclusion criteria for study part 2: 1. the subject is willing and able to provide signed informed consent. 2. the subject was enrolled into part 1 of the study and received at least one renal autologous cell therapy (react) injection. exclusion criteria for study part 2: 1. the subject is currently receiving renal dialysis.

Keywords: rilparencel
predicting cerebrovascular adverse events post cardiac surgery

Conditions: Cardiac Disease

Summary: the aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.


Eligibility criteria:
inclusion criteria: * age older than 18 years * spontaneous sinus rhythm * no pregnancy * signed informed consent exclusion criteria: * age lower than 18 years * absence of sinus rhythm * autonomic disorders * concomitant carotid intervention * reintervention * contraindication to mri * pregnancy * impossibility of informed consent

Keywords: cerebral autoregulation cardiopulmonary bypass stroke
canine retraction with temporary anchorage devices

Conditions: Class II Malocclusion; Class III Malocclusion; Crowding, Tooth; Bimaxillary Protrusion

Summary: various malocclusions require the extraction of the first premolars and retraction of the canines with the need for maximum anchorage. if the canines are pulled into the extraction space using the molar teeth for support, unwanted tooth movement occurs. this study aims to evaluate the effect of temporary anchorage devices and power arms, which are auxiliary orthodontic appliances in reducing undesirable tooth movements.

in orthodontic patients who require overjet correction, increased facial convexity, or relief of severe crowding, dental extraction followed by canine retraction is indicated. in conventional orthodontic treatment, the molars are used for anchorage and reinforced with intra-oral or extra-oral appliances. although effective, this produces unwanted side effects where the molars move mesially and rotate, taking up some of the extraction space. as the canines move into the extraction space they tip backward requiring further uprighting. power arms are vertical metal extensions placed in the canine brackets. they direct the force to the center of resistance of the tooth to allow bodily movement and prevent canine tipping. temporary anchorage devices (tads) are minimally invasive, small screws, inserted in the jaw bones to act as anchorage units instead of the molars. this study aims to evaluate the effect of the tads and power arms on the efficiency of canine retraction including the rate of canine retraction and canine tipping as well as mesial molar drift and rotation. the null hypothesis is that the use of the power arm and the tads have no effect on the canine retraction rate. this study is a single-arm, single-center study. twenty quadrants in 10 adult patients will be selected from the orthodontic outpatient clinic at the future university in egypt. orthodontic records will be collected including study models, intra- and extra-oral photographs and cone beam computed tomograms. molars will be banded and roth 0.22" brackets will be bonded to the canine and second premolars. power arms, 8mmin length, will be inserted in the vertical slots of the canine brackets. the dental arches will be leveled and aligned using consecutive archwires. tads will be inserted between the second premolars and first molars. the first premolars will then be extracted and canines will be retracted within a week. canines will be retracted along 0.016" x 0.22" stainless steel archwires using 150 g of force applied by an elastomeric chain. the elastic chain will be replaced every 4 weeks. after 6 months of canine retraction, the orthodontic records will be collected for comparison.

Eligibility criteria:
inclusion criteria: * adult orthodontic patient * any malocclusion requiring the extraction of the first premolar and canine retraction * full permanent dentition with the exception of the wisdom teeth. exclusion criteria: * any missing permanent tooth * previous orthodontic treatment * periodontal disease; pregnancy * systemic disease or medication that affects bone metabolism
mobile cbt for negative symptoms

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this randomized controlled clinical trial will test a combined group contact plus mobile cbt-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.

the primary purpose of this project is to determine if mcbtn at the optimal dose from the r61 produces greater reduction in severity of defeatist attitudes than a supportive contact control group in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms. a second aim is to determine whether reduction in defeatist attitudes mediates improvement in experiential negative symptoms and psychosocial functioning in mcbtn. the third aim is to determine whether mcbtn increases pupil dilation and whether changes in pupil dilation (an objective psychophysiological biomarker of effort) are associated with changes in defeatist attitudes and negative symptoms. the final aim is to explore predictors of response to mcbtn, including device use and group session adherence, demographics, neurocognitive impairment, and negative and other symptom severity at baseline.

Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of schizophrenia or schizoaffective disorder. * meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three cains motivation and pleasure domains (mean of 2 -moderate- or greater for items averaged within the social, work or recreational domains) at the beginning and end of a 2-week evaluation phase. * moderate-to-severe defeatist attitudes (dpas \> 50). * ≥ 6th grade reading level on the wide range achievement test-4 reading subtest (needed for reading treatment manual consumer workbook). * clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0). exclusion criteria: * prior cbt in the past 2 years. * greater than moderate panss positive symptoms (p1-delusions, p2- disorganization, p3-hallucinations, or p6-suspiciousness - any item \>5). * severe depression on the calgary depression scale for schizophrenia (cds \>8). * extrapyramidal symptoms. * ocular damage, disease, surgery or medications that affect pupil dilation. * dsm-5 alcohol or substance use disorder in past 3 months. * level of care required interferes with outpatient skills training (e.g., hospitalized; severe medical illness). * unable to adequately see or manually manipulate the mobile device.

Keywords: schizophrenia cbt mobile cbt negative symptoms
single-arm study to evaluate the efficacy and safety of valoctocogene roxaparvovec in hemophilia a patients at a dose of 4e13 vg/kg

Conditions: Hemophilia A

Summary: this phase iii clinical study will assess the efficacy of bmn 270 defined as fviii activity, during weeks 49-52 following intravenous infusion of bmn 270 and assess the impact of bmn 270 on usage of exogenous fviii replacement therapy and the number of bleeding episodes from week 5 to week 52.


Eligibility criteria:
inclusion criteria: 1. males ≥ 18 years of age with hemophilia a and residual fviii levels ≤ 1 iu/dl as evidenced by medical history. 2. must have been on prophylactic fviii replacement therapy for at least 12 months prior to study entry. 3. treated/exposed to fviii concentrates or cryoprecipitate for a minimum of 150 exposure days. 4. no previous documented history of a detectable fviii inhibitor of less than 0.6 bethesda units (bu). exclusion criteria: 1. detectable pre-existing antibodies to the aav5 capsid. 2. any evidence of active infection or any immunosuppressive disorder, including hiv infection. 3. significant liver dysfunction, prior liver biopsy showing significant fibrosis, liver cirrhosis of any etiology or history of hepatic malignancy. 4. evidence of any bleeding disorder not related to hemophilia a. 5. active hepatitis c. 6. prior treatment with any vector/gene transfer agent.

Keywords: hemophilia a gene therapy clotting disorders blood disorder blood coagulation disorders inherited blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases inborn factor viii coagulants
allergy, asthma, and atopic eczema in finland

Conditions: Asthma; Asthma in Children; Allergy; Rhinitis, Allergic; Atopic Dermatitis; Allergen Immunotherapy

Summary: the summary is available at --\> https://www.finnatopy.fi/summary

aims and objectives ---\> https://www.finnatopy.fi/aims-and-objectives methods ---\> https://www.finnatopy.fi/methods

Eligibility criteria:
inclusion/exclusion criteria ---\> https://www.finnatopy.fi/methods