Kornimate/medical-research-clean huggingface dataset:
baerveldt plate area comparison (bpac)

Conditions: Glaucoma

Summary: this research is being done to compare the safety and effectiveness of two sizes of the baerveldt glaucoma implant. a baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. this procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. the baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). it is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters). earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. while both baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. the purpose of this study is to see if one size of device works better with fewer complications.


Eligibility criteria:
inclusion criteria: * age over 18 * intra-ocular pressure (iop) \> 18 mm hg and \< 40 mm hg on medical therapy * previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy) * consent signed exclusion criteria: * unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits * pregnant or nursing * neuro-linguistic programming (nlp) vision * iris neovascularization or proliferative retinopathy * epithelial or fibrous downgrowth * chronic or recurrent uveitis * steroid-induced glaucoma * severe posterior blepharitis * previous cyclodestructive procedure * conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. stevens johnson syndrome, ocular pemphigoid) precluding baerveldt implantation. * functionally significant cataract * need for baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery * prior glaucoma drainage device (tube) implant * prior retinal surgery with remaining silicone oil * prior scleral buckling procedures

Keywords: glaucoma baerveldt implants
study of btk inhibitor loxo-305 versus approved btk inhibitor drugs in patients with mantle cell lymphoma (mcl)

Conditions: Lymphoma, Mantle-Cell

Summary: this is a study for participants with a type of blood cancer called mantle cell lymphoma (mcl). the main purpose is to compare pirtobrutinib (loxo-305) to other drugs that work in a similar way that have already been approved by the united states food and drug administration (us fda). participation could last up to two years, and possibly longer, if the disease does not progress.

this is a phase 3 global, randomized, open-label study comparing pirtobrutinib (arm a) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (arm b) in mcl patients who have received 1 or more lines of therapy and are btk inhibitor naïve.

Eligibility criteria:
inclusion criteria: * confirmed mcl diagnosis * previously treated with at least one prior line of systemic therapy for mcl * measurable disease per lugano criteria * eastern cooperative oncology group (ecog) 0-2 * absolute neutrophil count ≥ 0.75 × 109/l without granulocyte-colony stimulating factor support within 7 days of screening * hemoglobin ≥ 8 g/dl not requiring transfusion support or growth factors within 7 days of screening * platelets ≥ 50 × 109/l not requiring transfusion support or growth factors within 7 days of screening. * ast and alt ≤ 3.0 x upper limit of normal (uln) * total bilirubin ≤ 1.5 x uln. * creatinine clearance of ≥ 30 ml/min according to cockcroft/gault formula exclusion criteria: * prior treatment with an approved or investigational btk inhibitor * history of bleeding diathesis * history of stroke or intracranial hemorrhage within 6 months of randomization * history of allogeneic or autologous stem cell transplant (sct) or chimeric antigen receptor modified t-cell (car-t) therapy within 60 days of randomization * clinically significant cardiovascular disease * prolonged qt interval corrected using fridericia's formula (qtcf) \> 470 ms on 2/3 consecutive ecgs, and mean qtcf\>470 ms on all 3 ecgs * known hiv infection or active hbv, hcv, or cmv infections. (certain participants with controlled hbv infections may still be eligible) * clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (gi) absorption * ongoing chronic treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the cyp3a inhibitor therapy prior to start of study drug treatment. * patients requiring therapeutic anticoagulation with warfarin or another vitamin k antagonist. * vaccination with live vaccine within 28 days prior to randomization

Keywords: bruton's tyrosine kinase inhibitor btki hematologic disease lymphoma, non-hodgkin's lymphoma, b-cell lymphoma pirtobrutinib
virtual reality for power wheelchair training

Conditions: Spinal Diseases

Summary: the objective of this study is to evaluate the impact of vrsim 3.0 on power wheelchair (pwc) driving skills and to obtain qualitative feedback from users on the design of the virtual reality (vr) simulator to inform device development.

a virtual reality platform may lead to better training of people with complex disabilities who desire to be power wheelchair users and thus allow them to benefit from living a more active life. a virtual reality training program could significantly impact the lives of people with disabilities by improving function, reducing abandonment of power wheelchairs, and reducing morbidity and mortality and associated costs occurring from power wheelchair accidents. this new virtual reality training program will reflect improvements in accessibility, customization, simulator sickness, ease of use, and will have report generating capabilities as compared to previous virtual reality training platforms. the investigators expect that virtual reality training will be a superior alternative to standard in-person wheelchair training.

Eligibility criteria:
inclusion criteria: * volunteers must be 14 years or older. * volunteers must have a disability that prevents them from effectively and independently using a manual wheelchair, power assist wheelchair, or scooter. * volunteers must be able to communicate in english, follow simple commands, and give written informed consent. exclusion criteria: * volunteers with active seizures. * volunteers who have active pelvic or thigh wounds. * volunteers who require a test wheelchair but who exceed the weight capacity of the test wheelchair (\>300 lbs). * volunteers who require a test wheelchair but also require specialized seating that cannot be replicated for the training.

Keywords: virtual reality wheelchairs
cryotherapy in the treatment of desmoid tumors

Conditions: Desmoid

Summary: desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of desmoid tumors * age \> 18 years * abdominal and extra-abdominal desmoid tumors exclusion criteria: * contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures * retroperitoneal desmoid tumors * age \< 18 years

Keywords: desmoid tumor; cryotherapy
taxane combined targeted therapy for low-risk her2 positive and lymph node negative breast cancer

Conditions: HER2-positive Breast Cancer

Summary: human epidermal growth factor receptor 2 (her2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis. her2 targeted drugs has greatly improved the prognosis and survival of such patients. at present, for her2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and paltuzumab are concentrated in the group of patients with positive lymph nodes. can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. to explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk her2 positive and lymph node negative early breast cancer.


Eligibility criteria:
inclusion criteria: * 1) treatment in peking university people's hospital for radical resection of breast cancer and had hospitalization records; * 2) postoperative pathology confirmed invasive breast cancer, and the pathological stage was t1a-b (t ≤ 1cm), n0, her2 positive, with high-risk factors (g3, or hormone receptor negative); or the pathological stage is t1c (1cm \< t ≤ 2cm), n0, and there are no high-risk factors (g1/g2, hormone receptor positive); * 3)signed an agreement to participate in the pkuph breast disease cohort study at peking university people's hospital. exclusion criteria: * 1) lack of clinical pathological data (such as imaging data, pathological data); * 2) preoperative neoadjuvant therapy; * 3) patients with metastatic breast cancer or bilateral breast cancer; * 4) failed to undergo curative surgery.

Keywords: taxane target therapy
neuromuscular characteristics of individuals with down syndrome (ds)

Conditions: Down Syndrome

Summary: evaluation of muscle strength and central activation of muscle in individuals with down syndrome


Eligibility criteria:
inclusion criteria: * 18-45 years old * good health with no contraindications to exercise * documented ds (not for control subjects) exclusion criteria: * contraindications to exercise, * severe or profound mr * documented atherosclerotic heart disease * documented atlantoaxial instability * uncorrected congenital heart disease * implanted prosthetic device * implanted pacemaker

Keywords: evaluation of muscle strength and central activation
prospective phase ii study of rabbit antithymocyte globulin (atg, thymoglobuline®, genzyme) with ciclosporin for patients with acquired aplastic anaemia

Conditions: Acquired Aplastic Anaemia

Summary: to assess the tolerability and efficacy of rabbit antithymocyte globulin (atg, thymoglobuline®) with ciclosporin (csa) in the first line treatment of patients with acquired severe aplastic anaemia (saa), and patients with non-severe aplastic anaemia (nsaa) and who are transfusion dependent. to compare the response rate of the combination of rabbit atg (thymoglobuline® and csa from this pilot study with the response rate observed in a series of matched aa patients; treated after 1994 with the combination of horse atg (lymphoglobuline®) and csa; obtained from the ebmt database (comparative study).


Eligibility criteria:
inclusion criteria: 1. to define aplastic anaemia there must be at least two of the following: (1) haemoglobin \< 10g/dl; (2) platelet count \< 50 x 109/l; (3) neutrophil count \< 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy 2. time from diagnosis to study registration ≤ 6mths 3. no prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens. 4. age ≥ 16yrs (≥ 18yrs in germany in accordance with german law), with no upper age limit. exclusion criteria: 1. eligibility for an hla-matched sibling donor transplant for saa patients 2. prior therapy with atg or csa 3. haematopoeitic growth factors more than 4 weeks before study enrollment 4. diagnosis of fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome 5. evidence of myelodysplastic disease 6. paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of pnh associated thrombosis or a pnh clone \> 50% by flow cytometry 7. diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma) 8. subject is pregnant (e.g. positive hcg test) or is breast feeding 9. severe uncontrolled infection or unexplained fever \> 38oc 10. subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
prevalence, clinical features and risk factors of cirrhotic cardiomyopathy assessed by two-dimensional speckle tracking imaging

Conditions: Liver Cirrhosis; Cirrhotic Cardiomyopathy

Summary: the purpose of this study is to assess the prevalence of cirrhotic cardiomyopathy in patients with cirrhosis, and to analyze the correlation between the severity of cirrhosis and cardiac dysfunction. to investigate the risk factors for cirrhotic cardiomyopathy, and raise clinicians' awareness of cirrhotic cardiomyopathy, early assessment and intervention to improve long-term outcomes in patients with cirrhosis.

liver cirrhosis is the terminal stage of the development of chronic liver disease caused by various reasons, and it is often accompanied by multiple complications. late cirrhosis is often accompanied by obvious changes in liver and systemic hemodynamics. patients with liver cirrhosis are in a highly dynamic cycle status: lower arterial blood pressure, increased heart rate, increased cardiac output, peripheral vascular resistance, which often lead to changes in myocardial structure and function, called cirrhotic cardiomyopathy. cirrhotic cardiomyopathy (ccm) is defined as cardiac dysfunction in patients with end-stage liver disease in the absence of prior heart disease. the true burden of ccm among patients with esld is currently unknown. prior studies evaluated ccm prevalence and estimated it to be approximately 50%, however, this estimate was based on the old criteria. in 2020, the cirrhotic cardiomyopathy association updated the diagnostic criteria for cirrhotic cardiomyopathy. at present, the true prevalence of cirrhotic cardiomyopathy still needs to be reassessed. in addition, studies on the risk factors for cirrhotic cardiomyopathy are rare. based on the above research background, carry out this research.

Eligibility criteria:
inclusion criteria: * the clear diagnosis of cirrhosis in patients caused by various reasons exclusion criteria: * history of cardiovascular disease * diabetes * high blood pressure * hepatocellular carcinoma (hcc) or other malignant tumors * patients with the chronic obstructive pulmonary disease * thyroid diseases * severe infection in the last 2 weeks * history of liver transplantation and/or tips surgery * presence of stage 3 or above chronic kidney disease or acute chronic kidney disease * pregnant women * did not sign the informed consent form and refused to participate

Keywords: cirrhosis; cardiac dysfunction;cardiac imaging
endoscopic ethanol ablation of communicating pancreatic cystic neoplasms

Conditions: Neoplasms, Cystic, Mucinous, and Serous; Pancreatic Neoplasms; Ultrasonography, Interventional

Summary: pancreatic cysts are common, and some pancreas cysts have malignant potential. usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (eus) guided ethanol injections. such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. in this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ercp) and/or eus.

subjects will undergo eus and/or ercp as outpatients. for cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ercp. the balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. a pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.

Eligibility criteria:
inclusion criteria: * presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter * cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior ct, mr, ercp, or eus images) * treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy * age at least 18 years * able to give informed consent * surgical treatment has been considered and a surgical consultation offered to the patient, or the subject's cyst does not meet consensus criteria for surgical resection. (current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is \> 6 mm.) exclusion criteria: * known or suspected pregnancy, or nursing * history of pancreatitis within 3 months prior to study endoscopy procedures * cyst has a primarily microcystic architecture on eus

Keywords: intraductal papillary mucinous neoplasm mucinous cystic neoplasm endoscopic ultrasound endoscopic retrograde cholangiopancreatography pancreatic cyst pancreas cyst alcohol
effect of vitamin d supplement on disease activity in sle

Conditions: Vitamin D Deficiency; Hypocalcemia; Hyperparathyroidism; Systemic Lupus Erythematosus (Disorder)

Summary: to study the effect of vitamin d supplementation on disease activity of sle ( sledai-2k ) and il-6 level


Eligibility criteria:
inclusion criteria: * age \> 18 year-old * sle classified by revised acr criteria, slicc 2012 criteria * sle patients who have mild to moderate disease activity ( clinical sledai-2k 3-10 ) and has vitamin d level \< 40 ng/ml * currently treated with stable dose of 1 or more of the following background medication : nsaids, anti-malarial, mmf, azathioprine, methotrexate, cyclosporin for at least 1 month, corticosteroid \</= 20 mg/d of prednisolone or equivalent dose for at least 2 weeks * received calciferol 20,000 iu/wk (1 cap) at least 12 weeks exclusion criteria: * patients with chronic liver disease, ckd stage 3, bed ridden, malignancy * patients who received drug that interfere with vitamin d metabolism * poor drug compliance * overlap with other connective tissue disease or a diagnosis of mctd * hx of vitamin d allergy * hx on mtv or other supplementation

Keywords: hypocalcemia hyperparathyroidism end stage renal disease (esrd) calcitriol systemic lupus erythematosus ( sle )
a double-blind, escalating dose, randomized, placebo-controlled study assessing pk, safety, tolerability in non-ambulant dmd subjects

Conditions: Muscular Dystrophies

Summary: the purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of gsk2402968 in non-ambulant boys with duchenne muscular dystrophy


Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy resulting from a mutation in the dmd gene, confirmed by a sponsor approved dna diagnostic technique covering all dmd gene exons, including but not limited to mlpa (multiplex ligation-dependent probe amplification), cgh (comparative genomic hybridisation), scaip (single condition amplification/internal primer) or h-rmca (high-resolution melting curve analysis), and correctable by treatment with gsk2402968. * age 9 years old or greater at screening; * male; * non-ambulant (at least 1 year in a wheelchair) within the last 4 years; * life expectancy at least three years; * willingness and ability to comply with all protocol requirements and procedures; * qtc \<450msec (based on single or average qtc value of triplicate ecgs obtained over a brief recording period). note: qtc may be either qtcb or qtcf, machine read or manual overread; * subjects must be willing to use adequate contraception (condoms or abstinence), from screening until at least 5 months after the last dose of study drug; * informed assent and/or consent in writing signed by the subject and/or parent(s)/legal guardian (according to local regulations). exclusion criteria: * any additional mutation (such as an additional missing exon for dmd) that cannot be treated with gsk2402968; * current or history of liver or renal disease; * acute illness within 4 weeks of anticipated administration of study medication, which may interfere with study assessments; * use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs, idebenone or other forms of coenzyme q10, within 6 months of the first administration of study medication; * start of glucocorticosteroids within 6 months or non-stable use of glucocorticosteroids within 3 months of the anticipated first administration of study medication; * positive hepatitis b surface antigen (hbsag), hepatitis c antibody test (hcv), or human immunodeficiency virus (hiv) test at screening; * symptomatic cardiomyopathy; * use of alcohol from screening through to the 1 month follow-up visit ; * any child in care.

Keywords: duchenne duchenne muscular dystrophy dmd 968
safety study of bms-823778 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (fpg).


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * drug naive or on stable metformin therapy * hba1c 7-10% * fpg ≤ 240mg/dl exclusion criteria: * history of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study * congestive heart failure * active liver disease * impaired renal function * hepatitis c, b and hiv this list is not inclusive; additional information is provided in the protocol
mri-changes in morphometry and cerebro spinale fluid (csf) flow in spinal cord disorders

Conditions: Spinal Injury

Summary: understanding the onset and progression of spinal cord disorders is an important aim in clinical neurology. an early diagnosis with consequent therapy might prevent the progression of disability. therefore, we aim to determine structural and dynamic changes in the microstructure of the spinal cord and csf, and to explore the relationships between the mri parameters, clinical disability, and electrophysiology. in some patients that undergo decompressive surgery csf pressure will be measured invasive perioperative for 24h to find out if functional limitations and structural changes correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.


Eligibility criteria:
inclusion criteria: * cervical injury * informed consent * age 18-80 * csm exclusion criteria: * no other neurologic disorder and psychiatric disorder * seizure * mri incompatibility * pregnancy