Kornimate/medical-research-clean huggingface dataset:
expanded access to b-domain deleted recombinant porcine factor viii (obi-1) in the treatment of acquired hemophilia a due to factor viii inhibitory auto-antibodies

Conditions: Acquired Hemophilia A

Summary: to provide emergency access to obi-1 for patients with acquired hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the obi-1-301 study.


Eligibility criteria:
inclusion criteria: * written informed consent from participant or their legal representative. * participants with acquired hemophilia with autoimmune inhibitors to human factor viii. * has a serious bleeding episode, as documented by the investigator. * be willing and able to follow all instructions and attend all study visits. * participants taking anti-thrombotics may be included depending on the time elapsed since taking such medications. * life expectancy of at least 90 days prior to the onset of the bleeding episode. exclusion criteria: * hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy. * has an established reason for bleeding that is not correctable. * bleeding episode assessed likely to resolve on its own if left untreated. * anti-obi-1 inhibitor that exceeds 20 bu (prospectively or retrospectively). * subsequent bleeding episode at the site of the initial qualifying bleeding episode within 2 weeks following the final obi-1 dose for the initial qualifying bleeding episode, or subsequent bleeding episode at a different site than the initial qualifying bleeding episode within 1 week following the final obi-1 dose for the initial qualifying bleeding episode will not be considered "new" qualifying bleeding episodes. * prior history of bleeding disorder other than acquired hemophilia. * known major sensitivity (anaphylactoid reactions) to pig or hamster products. * use of hemophilia medication within 3 to 6 (depending on medication) hours prior to obi-1 administration. * participation in any other clinical study within 30 days of the first obi 1 treatment. * anticipated need for treatment or device during the study that may interfere with the evaluation. * abnormal baseline findings * inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures.

Keywords: factor viii inhibitory auto-antibodies
association of long-term conditions with survival following heart attack in england and wales

Conditions: Acute Myocardial Infarction; Diabetes Mellitus; Peripheral Vascular Disease; Chronic Heart Failure; Cerebrovascular Disease; Chronic Renal Failure; Chronic Obstructive Pulmonary Disease

Summary: this study aims to determine the extent to which pre-existing long-term conditions are associated with survival following a heart attack (acute myocardial infarction) using observational data from the uk's national heart attack register.

using observational data from the myocardial ischaemia national audit project (minap) of all hospitalisations for acute myocardial infarction in all acute hospitals in england and wales, this study aims to determine the extent to which pre-existing long-term conditions are associated with survival following acute myocardial infarction. the study will include an investigation of individual long term conditions for patients with acute myocardial infarction, including chronic heart failure, cerebrovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, chronic renal failure or peripheral vascular disease as well as the combination of such conditions and their resulting impact on long term all-cause mortality (up to 8.4 years). in addition, an investigation of the association of receipt of guideline recommended care for acute myocardial infarction patients with pre-existing long term conditions will be made.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or older exclusion criteria: * patients for which mortality data are missing
a study of nd0801 in attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit and Hyperactivity Disorder

Summary: a multicenter, open label, escalating dose study to assess the tolerability and the safety and to explore the efficacy and the pharmacokinetics of nd0801 in adult patients with attention deficit/hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: * outpatients. * men and women 18-55 years of age. * primary dsm-iv diagnosis of adult adhd confirmed by senior physician * capable and willing to provide informed consent * able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy for the treatment of adhd prior to the beginning of the study treatment and during the study drug treatment. * subjects must be able to read, hear, write and speak the local language. * subject has signed a written informed consent to participate in the study. exclusion criteria: * unstable or significant medical disorder. * current (within 12 months of baseline) primary or secondary depression. * history of substance abuse or dependence within the past 6 months * any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features * bipolar disorder * eating disorder * obsessive compulsive disorder * post-traumatic stress disorder * current generalized anxiety disorder * presence of a personality disorder * individuals with a significant other neurological disorder. * use of any investigational drug within 4 weeks of the randomization visit * known or suspected pregnancy * women who are breast-feeding * women of childbearing potential and not using a medically accepted form of contraception
a study in evaluating bioequivalence between test and reference formulations of vadadustat tablets in healthy adults

Conditions: Healthy

Summary: this study is to assess the bioequivalence of a test formulation of vadadustat (a) compared to a reference formulation of vadadustat (b)

this is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. blood samples for vadadustat pk will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.

Eligibility criteria:
inclusion criteria: * between 18 and 55 years of age, inclusive, at time of informed consent. * healthy subjects per investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ecg), clinical laboratory assessments, and general observations. * minimum weight of 45 kg with body mass index (bmi) between 18 and 29.5 kg/m2, inclusive. * understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure * willing and able to comply with the requirements of the study protocol. exclusion criteria: * current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, history of cancer (except non-melanoma skin cancer) or history of chemotherapy use. * any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers. * history of severe allergic or anaphylactic reactions. * chronic daily medication use. * history of drug abuse * excessive alcohol consumption * smoking and the use of nicotine-containing products * consumption of grapefruit or grapefruit juice, pomelo, star fruit, seville or moro (blood) orange, or their associated products * participation in another clinical trial or exposure to any investigational agent. * donation of blood or significant blood loss or plasma donation. * any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.

Keywords: vadadustat akb-6548 hypoxia-inducible factor hif hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi
operative mitral valve reconstruction in functional mv insufficiency with reduced systolic ventricle function

Conditions: Mitral Valve Insufficiency; Left Ventricular Systolic Dysfunction; Mitral Valve Prolapse

Summary: functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (lv) dilation and reduced lv ejection fraction (ef). the registry will document the underlying pathology by using transthoracal echo cardiography (tte) with analysis of common tenting parameters. op strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and macce outcomes after 6 months, 1 and 2 years.

prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. exact analysis of the underlying pathology using tte with analysis of tenting parameters. in patients without contraindications, functional preoperative mrt to determine the functional reserve of ventricular function. documentation of the quality of life of the patients using the sf12 questionnaire before and after intervention. documentation of follow-up data (sf12, tte, nt-pro bnp) at 6 months, 1 and 2 years. development of operative strategies to improve long-term outcomes in patients with severe lv dilation (typically accompanied by function mitral insufficiency type iiib).

Eligibility criteria:
inclusion criteria: * functional mitral valve insufficiency with reduced mobility of leaflets during systole (type iiib) - effective regurgitation orifice area \> 20 mm2 / regurgitant volume \> 30 ml/beat * left ventricular ejection fraction \ = 60 mm * tenting of the proximal and / or anterior mitral leaflets exclusion criteria: * prolaps of leaflets (type ii mitral regurgitation) * combination intervention with aortic valve repair or replacement * re-operation at mitral valve

Keywords: annuloplasty mitral valve reduced lv function
prognostic factors affecting duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: determination of prognostic factors affecting ambulation of duchenne muscular dystrophy

duchenne muscular dystrophy is the most common herditary muscular disease , it lead to loss of ambulation in early teenageers . it lead to early death at the mean age of 19 years

Eligibility criteria:
inclusion criteria: * any male pt diagnosed as duchenne muscular dystrophy by typical clinical picture \&shooting serum cpk level \&emg study or biopsy \& age 10 to 18yrs old exclusion criteria: * female patient ' age below 10 yrs old or above 18 yrs old .patient with autoimmune disease or malignancy
sub-acute exercise following sport-related concussion

Conditions: Sport-related Concussion

Summary: determine the safety and efficacy of sub-maximal aerobic exercise during the subacute phase of recovery following sport-related concussion.

the main objective of the proposed study is to determine is exercise during the first 3-7 days following a sport-related concussion can help improve the systemic neurological dysfunction following a concussion while examining the safety and efficacy of a 20-minute, low- to moderate-intensity (40-60% of hrmax) controlled treadmill aerobic exercise as a therapeutic modality to improve cardiovascular, psychological, vestibulo-ocular, autonomic, and cognitive function.

Eligibility criteria:
inclusion criteria (concussed): * high school student-athlete * suffered a diagnosed concussion * evaluated between day 3 and day 7 since injury inclusion criteria (healthy): * high school student-athlete * no diagnosed concussion within the last year * matched with concussion participant for age and gender exclusion criteria: * physical limitation prohibiting treadmill walking * reports dizziness or lightheadedness * presents with any contraindication for exercise participation as defined by american college of cardiology (acc), american heart association (aha), or american college of sports medicine (acsm) guidelines.

Keywords: concussion aerobic exercise sub-acute
comparison of clinical outcomes on trifocal iols finevision pod f gf and finevision pod f in asian eyes

Conditions: Cataract; Lens Opacities; Presbyopia

Summary: prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal iols with different material (hydrophobic and hydrophilic) from the same manufacturer. implantation of the iols is bilaterally.

this is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. the patients will either be implanted with the hydrophobic iol finevision pod f gf or the hydrophilic iol finevision pod f (both lenses: (physiol, liège, belgium). the devices under investigation (finevision pod f gf and pod f) are trifocal glistening-free acrylic intraocular lenses (iols) manufactured by the sponsor of this study physiol sa/nv. the main difference between the lenses is the material (hydrophobic and hydrophilic). the iols will be implanted as part of the routine cataract surgery on patients suffering from cataract development. subjects participating in the trial will attend a total of 12 study visits (1 preoperative, 2 operative and 9 postoperative) over a period of 36 months. subjects would have the option for unscheduled visits if required medically. primary endpoint data will be collected at the 3 months follow up visit and secondary endpoint data will be collected at the 3, 12, 24 and 36 months follow up visits. data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * unrealistic expectation * age of patient \<45 years * irregular astigmatism * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * age-related macular degeneration (amd) suspicious eyes (determined by oct) * complicated surgery

Keywords: intraocular lens trifocal hydrophobic hydrophilic
a safety and efficacy study for infliximab (remicade) in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the effectiveness and safety of infliximab (remicade) in patients with ulcerative colitis. infliximab (remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

this study is designed to investigate the safety and effectiveness of infliximab in adult patients with active ulcerative colitis. the purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication infliximab, and what dose is needed to do that safely.patients will receive infusions of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, 14, and 22 up to week 164. safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. patients will receive infusions (into the vein) of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks up to week 164.

Eligibility criteria:
inclusion criteria: * patients must have had ulcerative colitis of at least 3 months' duration at screening, confirmed by the biopsy taken at screening * patients must have active colitis confirmed during the screening sigmoidoscopy * patients must have active disease. exclusion criteria: * patient must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study * patient must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

Keywords: ulcerative colitis infliximab remicade
collection of blood and bone marrow from patients with aplastic anemia for analysis of adhesion molecules, chemokines and their receptors

Conditions: Aplastic Anemia; Healthy

Summary: this study is designed to collect bone marrow and/or peripheral blood cells and plasma, for the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine


Eligibility criteria:
inclusion criteria: * patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70 years exclusion criteria: * patients complicated with diabetes, tumor, pregnancy, active infection, or connective tissue diseases, such as systemic lupus erythematosus.
causes of peripheral hypotonia in assiut university children hospital

Conditions: Infant Floppy

Summary: hypotonia is a common manifestation in infants and children.it includes several clinical conditions that do not always lead to a favorable outcome .thus, it is important to make early diagnosis to decide on the treatment and follow up of these cases. hypotonia is a state of low muscle tone (the amount of tension or resistance to stretch on a muscle), often pointing to reduced muscle strength. hypotonia is not a specific medical disorder, but a potential manifestation of several diseases and disorders, that affect motor nerve control by the brain or muscle strength.

criteria of peripheral hypotonia are : absent or depressed tendon reflexes , failure of movements on postural reflexes ,fasciculation with or without muscle atrophy .a sequential scheme of localization would begin with the anterior horn cell (ahc), and progress to the peripheral nerve , neuromuscular junction (nmj) and the muscle itself. electroneuromyography (enmg) provides useful information on many neuromuscular diseases. in addition nerve conduction study is also helpful to identify the most common peripheral disorders causing hypotonia in these children. the initial approach to hypotonia is to determine whether the problem is due to central or peripheral origin.this is of crucial importance when forming a plan for diagnostic investigations and management. many muscle diseases share common clinical features that may lead to laboratory diagnosis by using enzyme levels that are affected in some of these diseases(e.g creatine phosphokinase ). however the use of serum creatine phosphokinase level may not possibly differentiate between various muscle diseases . the selective involvement of certain muscles is a key to the diagnosis of muscle disease\]. high resolution ultrasound allows visualization of the muscle, nerve and adjacent structures and can offer real-time information regarding neuromuscular diseases. it can be used as a helping tool to electrodiagnosis with estimation of the serum creatine phosphokinase levels of these cases. the aim of this work :is to give a profile of the causes of peripheral hypotonia in infant and children attending assiut university children hospital during one year of the study . besides full clinical assessment of the cases including birth history , developmental history, age, sex, and duration of illness as well as age of onset of observed weakness will be recorded. full neurological examination will be done in all cases .cases will have serum creatine phosphokinase levels, electromyography and nerve conduction studies done as indicated.cases will also have real time muscle ultrasonography done. * our results will be compared with the results obtained by other investigators . * statistical analysis : correlation studies will be done between the various methods of investigations used .chi2 test will be used to indicate the prevalence of the various causes of hypotonia found in the study .

Eligibility criteria:
inclusion criteria: * all infant and children with peripheral hypotonia exclusion criteria: * central causes of hypotonia
study of apatinib in metastatic esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to assess the efficacy and safety of apatinib in metastatic esophageal cancer.

eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.

Eligibility criteria:
inclusion criteria: 1. age: 18 to75 years old; 2. pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral ct scan, satisfying the criteria in recist 1.1); 3. failed in first-line chemotherapy or radiotherapy treatment; 4. ecog ps of 0-1; 5. an expected survival of ≥ 3 months; 6. no treated by molecularly targeted therapy. if have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored; 7. major organ function has to meet the following criteria: anc ≥ 1.5 × 109 / l; hb ≥ 90g / l; plt ≥ 100 × 109 / l; alb≥30g / l; tbil≤1.5 times the upper limit of normal (uln); alt and ast\<2 × uln; plasma cr\<1.5 × uln 8. patient has to voluntarily join the study and sign the informed consent form for the study; 9. researchers believe that patients can benefit; exclusion criteria: 1. pts with other malignant tumor at the same time or in the past. 2. pregnant or lactating women; 3. subjects with poor-controlled arterial hypertension (systolic blood pressure\>150 mmhg and diastolic blood pressure\>100 mm hg) despite standard medical management; coronary heart disease greater than classii; echocardiography: lvef (lvef)\<50%; 4. factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 5. subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months; 6. associated with cns (central nervous system) metastases; 7. abnormal coagulation, with tendency of bleed; 8. with psychotropic drug abuse history and can't get rid of or mental disorder patients; 9. anastomotic recurrence; 10. participated in other clinical trials within 4 weeks; 11. any other condition that might place the patient at undue risk or preclude a patient from completing the study; 12. other conditions regimented at investigators' discretion.