Kornimate/medical-research-clean huggingface dataset:
a study of lebrikizumab (ly3650150) in adult and adolescent participants with moderate-to-severe atopic dermatitis previously treated with dupilumab

Conditions: Atopic Dermatitis

Summary: the study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (ad) previously treated with dupilumab.


Eligibility criteria:
inclusion criteria: * all participants must have prior treatment with dupilumab meeting one of the following conditions: * participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months. * participants who stopped dupilumab treatment due to intolerance or adverse events (aes) to the drug may enter the study with no required prior length of dupilumab treatment. * participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment. * participants who have chronic ad that has been present for ≥1 year before screening. * have easi ≥16 at baseline * have iga score ≥3 (scale of 0 to 4) at baseline * have ≥10% body surface area (bsa) of ad involvement at baseline * have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. * adolescents body weight must be ≥40 kg at baseline. exclusion criteria: * history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. * have a current infection or chronic infection with hepatitis b virus (hbv) at screening (that is, positive for hepatitis b surface antigen and/or polymerase chain reaction positive for hbv dna * have a current infection with hepatitis c virus (hcv) at screening (that is, positive for hcv rna * have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator. * have uncontrolled asthma that * might require bursts of oral or systemic corticosteroids, or * required the following due to ≥1 exacerbations within 12 months before baseline * systemic (oral and/or parenteral) corticosteroid treatment, or * hospitalization for \>24 hours. * have known liver cirrhosis and/or chronic hepatitis of any etiology. * had dupilumab treatment within 4 weeks prior to baseline * had prior treatment with tralokinumab. * treatment with topical agents: corticosteroids, calcineurin inhibitors, janus kinase (jak) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline * treatment with any of the following agents within 4 weeks prior to the baseline * systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, ifn-gamma, azathioprine, methotrexate, and other immunosuppressants) * small molecules (e.g. jak inhibitors) * phototherapy and photochemotherapy for ad

Keywords: eczema
bone marrow aspirate concentrate for anterior cruciate ligament tear treatment.

Conditions: Anterior Cruciate Ligament Tear

Summary: a single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia.

the anterior cruciate ligament (acl) is key to the functional stability of the knee joint and is highly susceptible to injury, especially in athletes engaged in high-impact sports. conventional treatment for partial tears may involve conservative management; however, complete tears often necessitate surgical reconstruction. in seeking alternative treatments, this study investigates the potential of bone marrow aspirate concentrate bmac-a regenerative medicine approach-to promote healing and restore functionality to completely torn acls. the regenerative properties of bmac, attributed to the presence of stem cells and growth factors, may facilitate ligament repair and regeneration. the team aim treating 1st and 2nd degree anterior cruciate ligament tear without retraction.

Eligibility criteria:
inclusion criteria: 1- confirmed diagnosis of complete or partial acl tear via clinical examination and imaging studies. 2. aged between 20 and 55 years, to encompass the typical age range of patients with sports-related acl injuries. exclusion criteria: 1- patients with a history of bleeding disorders, as this could complicate the aspiration and injection procedures. 2. individuals with a history of malignancy, due to the potential risks associated with growth factors present in bmac. 3. critically ill patients or those with comorbidities
safety, tolerability and pharmacokinetics study of stp1 in a subgroup of patients with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: the main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with autism spectrum disorder (asd). in addition, pharmacokinetics and pharmacodynamics, as well as efficacy of stp1 are being explored.

after obtaining written informed consent, those patients who are deemed eligible for the study, will be randomized on day 1, in a double-blinded manner, in a 3:1ratio to receive either oral stp1 (twice daily) or placebo (twice daily). the total study duration is 6 weeks, including a screening phase of up to 2 weeks, a treatment phase of 2 weeks and a post-treatment follow-up phase of 2 weeks.

Eligibility criteria:
key inclusion criteria: 1. male or female individuals, between 18 and 40 years, diagnosed of asd. 2. patients will be assessed for specific developmental anthropometric \& anatomical criteria as well as personal and family medical history as assessed by the asd-phen1 semi structured interview form. 3. patients must have a parent or reliable caregiver who can provide information about the pre-natal period and early developmental period, as required by the protocol. 4. patient and/or parent or legal guardian willing and consenting to participate. 5. patients with asd and comorbid seizure disorder should be seizure-free for at least 6 months prior to screening. 6. before enrolling in the study, subjects must agree to use double-barrier birth control methods if they engage in intercourse. key exclusion criteria: 1. patients with an identified genetic cause of asd in their medical record will be excluded from the study. 2. history of traumatic head injury, cerebrovascular disorder, congestive heart failure, hepatic or renal disease. 3. thrombocytopenia. 4. type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus, or latent autoimmune diabetes of the adult. 5. a significant risk for suicidal behavior. 6. initiation of, or a major change in psychological / behavioral intervention within 4 weeks prior to randomization. 7. patient with any active infection. 8. systolic blood pressure (sbp) \<80 mmhg or diastolic blood pressure (dbp) \<40 mmhg or a drop in sbp of ≥20 mm hg, or in dbp of ≥10 mm hg, during the orthostatic recordings. 9. clinically relevant electrocardiogram (ecg) abnormalities. 10. clinically significant abnormal laboratory test. 11. active clinically significant disease. 12. history of malignancy. 13. pregnant (confirmed by laboratory testing) or lactating female patient.

Keywords: asd autism spectrum disorder
prospective randomized study comparing the spherika® (medacta) and origin® (symbios) prostheses during total knee replacement using the kinematic alignment technique

Conditions: Knee Osteoarthritis

Summary: the traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. a newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient\&#39;s knee. the kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient\&#39;s experience of his or her prosthetic knee. as a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. a "made-to-measure" total knee prosthesis (origin® - symbios, yverdon-les-bains, switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. another manufacturer opted to develop a generic total knee prosthesis implant (spherika® - medacta, castel san pietro, switzerland), but with a design optimized for the kinematic alignment technique. these two models of total knee prosthesis each offer advantages and limitations that need to be assessed. the main aim of this study is therefore to compare the joint perception of these 2 prostheses. it will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.


Eligibility criteria:
inclusion criteria: * patient with indication for initial total knee replacement * patient affiliated to a social security scheme * patient informed of the study and formally included (informed consent signed) before the first research examination. exclusion criteria: * patient with complex osteoarthritis (e.g. bone loss, history of patellar instability) * patient with contralateral knee prosthesis * patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee * patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality * patient deprived of liberty by judicial or administrative decision, * patient of legal age under legal protection or unable to express consent.

Keywords: total knee arthroplasty kinematic alignment joint perception biomechanics
lentiviral gene therapy for x-linked chronic granulomatous disease (x-cgd)

Conditions: Granulomatous Disease, Chronic, X-linked, Variant

Summary: chronic granulomatous disease (cgd) is a rare inherited disorder in which patients suffer from severe infection and inflammation. the first indication of disease usually appears in early childhood. the basic defect found to be lie in specialised white blood cells called phagocytic cells, which are responsible for engulfing and destroying germs. in cgd, there is a defect in an enzyme (known as nadph-oxidase) that is responsible for generating bleach like substances that are important for killing some important germs. in the form of the disease known as x-cgd (which accounts for two thirds of patients), there are defined mistakes in a gene called gp91-phox, which is a key part of the nadph-oxidase. in many cases, patients can be protected from infection by constant intake of antibiotics. however, in others potential life-threatening infections break through. in some cases patients also develop serious inflammation requiring high doses of drugs such as steroids. cgd can be cured by bone marrow transplant, but the best results are available when there is matched donor available. transplant from unmatched donor have a much worse outcome. gene therapy of cgd can be performed by introducing a normal copy of human gp91-phox gene into the blood forming stem cells of patients' bone marrow by using a gene carrier (in this study called lentiviral vector). after treatment of the bone marrow cells in a specialised laboratory are given back to the patient and will grow into functional phagocytic cells.


Eligibility criteria:
inclusion criteria: * history of at least one severe infection requiring hospitalisation despite standard antimicrobial prophylaxis and/or inflammation complications including one of the following: oesophageal obstruction, gastric outlet obstruction, bladder outlet obstruction or colitis * molecular diagnosis confirmed by dna sequencing and supported by laboratory evidence for absent or significantly reduced biochemical activities of the nadph-oxidase * parental/guardian and where appropriate child's signed consent/assent exclusion criteria: * 10/10 hla identical (a,b,c,dr,dq) family or unrelated or cord blood donor unless there is deemed to be an unacceptable risk associated with an allogeneic procedure * contraindication for leukapheresis (anaemia hb \<8g/dl, cardiovascular instability, severe coagulopathy) or for administration of conditioning medication

Keywords: chronic granulomatous disease gene therapy x-cgd nadph-oxidase gp91-phox
determining optimal free dose combination of tiotropium bromide and bi 1744 cl in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to determine the optimum once daily dose of bi 1744 cl and tiotropium in free dose combination (delivered by the respimat inhaler) after four week treatment in patients with copd.


Eligibility criteria:
inclusion criteria: 1. all patients must sign an informed consent 2. all patients must have a diagnosis of chronic obstructive pulmonary disease (copd) must meet the following spirometric criteria: a post-bronchodilator forced expiratory flow in 1 second (fev1) =\<30% of predicted normal and \<80% of predicted normal and a post bronchodilator fev1 / forced vital capacity (fvc) \<70% at visit 1 4. male or female patients, 40 years of age or older. 5. patients must be current or ex-smokers with a smoking history of more than 10 pack years exclusion criteria: * patients with a significant disease other than copd; * patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; * patients with a history of asthma or a total blood eosinophil count \>=600/mm3. * patients with any of the following conditions: a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years * patients who have undergone thoracotomy with pulmonary resection * patients being treated with the following concomitant medications: medications that prolong the qt/qtc interval oral beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day - pregnant or nursing women
comparison of immunization schedules of inactivated hepatitis a vaccine and combined hepatitis a and hepatitis b vaccine

Conditions: Hepatitis A; Hepatitis B

Summary: the purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis a vaccine (hav) and/ or combined hepatitis a and b vaccine (habv) in healthy chinese infants.

this study is a randomized double-blind, single-center, phase iv clinical trial. the purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis a vaccine (hav) and/ or combined hepatitis a and b vaccine (habv) in healthy chinese infants between 18 and 24 months old. the subjects were randomly assigned into 3 groups. subjects in group 1 each received 2 doses of hav with a 6-month interval (at day 0 and month 6); subjects in group 2 each received 1 dose of hav at day 0 and 1 dose of habv at month 6; subjects in group 3 each received 2 doses of habv with a 6-month interval (at day 0 and month 6).

Eligibility criteria:
inclusion criteria: * healthy infants between 18 and 24 months old; * have not received hepatitis a vaccine before; * completed hepatitis b vaccine full immunization schedule; * written consent of the guardian of each participant; exclusion criteria of the first injection: * history of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain; * autoimmune disease or immunodeficiency; * any acute disease that made the conditions of the person unsuitable for vaccination * administration of any live attenuated vaccine within 14 days prior to the injection; * administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection; * administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study; * body temperature \> 37.0 °c before injection; * based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study; exclusion criteria of the second injection: * any acute infectious disease, body temperature \> 38.5 °c or acute attacks of chronic diseases within 3 days prior to the second injection; * administration of blood product or other investigational drug during this study; * occurrence of adverse event at grade 3 or higher and the event was related to the first injection; * the investigator or the ethic committee decided that the subject should be excluded;
long-term safety of rivastigmine capsule and patch in patients with mild to moderately-severe dementia associated with parkinson's disease (pdd)

Conditions: Parkinson's Disease Dementia

Summary: the purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of parkinson's disease (pd), in patients with mild to moderately severe dementia associated with pd.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease, according to the uk parkinson's disease society brain bank criteria * diagnosis of parkinson's disease dementia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic parkinson's disease * mini mental state examination score of ≥10 and ≤ 26 (at screening visit only) exclusion criteria: * an advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations * a score of 5 (wheelchair bound or bedridden) in the "on"-state on the modified hoehn and yahr staging (updrs part v) * a current diagnosis of any primary neurodegenerative disorder other than idiopathic pd * a current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin b12 or folate deficiency) that is verified by the investigator to be the cause of dementia. * a current diagnosis of probably vascular dementia according to the national institute of neurological disorders and stroke and the association international pour la recherche et l'enseignement en neurosciences (ninds-airen) criteria * a current diagnosis of a major depressive episode according to dsm-iv criteria * a history of stereotaxic brain surgery for parkinson's disease * a known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds other protocol-defined inclusion/exclusion criteria may apply.

Keywords: parkinson's disease dementia cholinesterase inhibitor rivastigmine
mobile application for self-management of type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of this randomized controlled trial is to study the effect of mobile application on glycemic control of type2 diabetes mellitus. the main questions aim to answer are: * the effect of mobile application on glycemic control and quality of life of diabetes mellitus patients * the satisfaction of mobile application of diabetes mellitus patients who used it participants will be received education about diabetes mellitus and separated into two groups, intervention group(using mobile application) and control group(not using mobile application but also receive standard treatment of diabetes mellitus. researchers will compare intervention group to control group about glycemic control including hba1c, complications of diabetes mellitus etc. and quality of life.


Eligibility criteria:
inclusion criteria: * type2 diabetes mellitus who have hba1c above 7% * can use application on smartphone * age 18 years old or more (relatives are accept if participants have age more than 65 years old and cannot use smartphone) * consent to participate the research exclusion criteria: * refuse to participate the research * pregnancy * using continuous glucose monitoring system or insulin pump * disability in sight or hearing * have been using the mobile application(ramadiabetes) in the past
a clinical study that will evaluate how well sep-363856 works and how safe it is in people with schizophrenia that switch to sep-363856 from their current antipsychotic medication

Conditions: Schizophrenia

Summary: this study will evaluate how well sep-363856 works and how safe it is in people with schizophrenia that switch to sep-363856 from their current antipsychotic medication.

this is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study. following a screening period of up to 21 days, eligible participants will take part in the study. in the 8-week treatment period, participants will be treated with sep-363856 while continuing to take the full dose of their pre-switch antipsychotic. after the end of the treatment period, participants will be required to complete the follow-up visit, 7 days after the last dose of sep-363856.

Eligibility criteria:
inclusion criteria: this list is not all inclusive * participants meets diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for a diagnosis of schizophrenia. * participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the investigator for at least 8 weeks prior to baseline. * participants must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy. * participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to screening. exclusion criteria:this list is not all inclusive * participant has a current dsm-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment. * participants are at significant risk of harming self or others based on investigator's judgment. * participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the participant's ability to complete and/or participate in the study. * female participant who is pregnant or lactating. * participant tests positive for drugs of abuse at screening.

Keywords: schizophrenia