Kornimate/medical-research-clean huggingface dataset:
eye pressure lowering surgery

Conditions: Glaucoma

Summary: the purpose of this study is to determine if lowering the pressure inside the eye improves blood flow to the eye.

using high-speed ocular coherence tomography (oct) systems, we have developed new methods to image and measure optic nerve head (onh) and retinal blood flow. preliminary results have shown that visual field (vf) loss is more highly correlated with retinal blood flow as measured by oct than any neural structure measured by oct or other imaging modality. accordingly, the goal of the proposed project is to improve the diagnostic and prognostic evaluation of glaucoma by further developing novel functional oct measurements using ultrahigh-speed (70-100 khz) oct technology. retinal blood flow, onh circulation, optic disc rim volume, peripapillary nerve fiber layer volume, and macular ganglion cell complex volume are all pieces of the same glaucoma puzzle. this project will develop novel imaging methods that allow us to look at the whole picture using one tool - ultrahigh-speed oct.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with perimetric open angle glaucoma or chronic angle closure glaucoma. * subjects scheduled to undergo trabeculectomy or tube shunt surgery exclusion criteria: * best-corrected visual acuity less than 20/40 * age \ 85 years * refractive error of \> +3.00 d or \< -7.00 d * previous vision correction surgery such as laser-assisted in situ keratomileusis (lasik) or photorefractive keratectomy (prk) * previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation * diabetic retinopathy * history of heart failure, myocardial infarction, transient ischemic attack or stroke * other diseases that may cause vf loss or optic disc abnormalities * inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil * inability to perform reliably on automated vf testing * life-threatening or debilitating illness making it unlikely patient will successfully complete the study. * refusal of informed consent or of commitment to the full length of the study

Keywords: iop glaucoma trabeculectomy
efficacy and safety of dapagliflozin and dapagliflozin plus saxagliptin in combination with metformin in type 2 diabetes patients compared with sulphonylurea

Conditions: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control

Summary: this study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.


Eligibility criteria:
inclusion criteria: main inclusion criteria: 1. is male or female and ≥18 and \<75 years old at time of informed consent. 2. has a hba1c of ≥7.5% and ≤10.5% based on central laboratory results from visit 1, with individual need for therapy escalation. 3. currently treated with a stable maximum tolarated dose (mtd) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to enrolment visit. 4. has a bmi of ≤45 kg/m2 at enrolment visit. 5. has a c-peptide laboratory value of ≥1.0 ng/ml (0.33 nmol/l; 333.3 pmol/l) based on central laboratory results from visit 1. main, exclusion criteria: 1. clinically diagnosed with type i diabetes, known diagnosis of maturity onset diabetes of the young (mody), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (gad65) antibodies. 2. patients who, in the judgment of the investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data. 3. clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure during the course of the study. 4. concomitant treatment with loop diuretics

Keywords: diabetes mellitus type 2, metformin, saxagliptin, dapagliflozin, glimepiride, inadequate glycaemic control
hallux valgus correction using the metal screw or the human allogeneic cortical bone screw (shark screw).

Conditions: Hallux Valgus

Summary: the goal of this clinical trial is to compare the treatment of hallux valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (shark screw®) in adult patients with confirmed hallux valgus. the main questions it aims to answer are: can the new method obtain comparable results as the conventional method in regard to union rate and time to union? are the number of complications lower with the new method? participants will be operated either with the metal screw or with the shark screw®. the assignment to the groups is randomized.

the planned prospective study will investigate whether the use of the human allogenic cortical bone screw (shark screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. furthermore, it will be investigated whether rotational stability is possible with the bone screw. the measurement of the hva angle and the ima angle should provide information on whether the correction is stable over time. a comparison of the aofas forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results. initial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . a retrospective study by hanslik-schnabel et al has shown initial positive results in the treatment of hallux rigidus. in addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3d gait analysis/pedobarography and is also matched with another healthy cohort. at the preoperative time point and after 12 and 24 months, a 3d gait analysis with a foot model is conducted to record the joint kinematics and kinetics. in the study by canseco et al. , the proximal gait pattern changes remained unchanged. hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux mp joint in the terminal standing phase.

Eligibility criteria:
inclusion criteria: * between 18 and 85 * confirmed hallux valgus exclusion criteria: * \ 85 years * known underlying oncological disease * pregnant women or breastfeeding mothers * alcohol and drug abuse * foreseeable compliance problems * foreseeable loss of responsibility as a study doctor * neoplastic diseases * active osteomyelitis * ulcerations in the area of the skin of the surgical site * immunosuppressive medication that cannot be discontinued

Keywords: hallux valgus human allogeneic cortical bone screw shark screw® hva ima aofas time to union union rate ffi
evaluation of power doppler us technique for the diagnosis of spondylarthropathy

Conditions: Spondylarthropathy; Ankylosing Spondyloarthitis; Spondyloarthritis

Summary: the purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis

spondylarthritis (spa) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. because the characteritic signs of spa, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of spa for the patient and the confirmed diagnosis can be very long (up to 8 years). previous studies proved that patients who are affected by spa are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. ultrasonography in b mode combined with power doppler (pdus) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of spa's symptomatology. using pdus as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of spa and reduce the cost of diagnosis for patient and health insurances.

Eligibility criteria:
inclusion criteria: * patients \ 3 months duration * patients consulting for arthritis or tenderness joints \> 3 months duration * patients \ 3 months duration * patients with uveitis and hla-b27 positivity * relatives of spa patients consulting for symptoms suggestive of spa exclusion criteria: * patient with confirmed diagnosis of rheumatic disease (included spa) * patient protected by law (patient \<18 years old, pregnant woman) * patient who can't atempt the rmi * patient who will have difficulties to complete the two years of follow-up
day 3 embryo biopsy versus blastocyst biopsy in pgs cases

Conditions: Infertility; Embryo Biopsy

Summary: preimplantation genetic diagnosis (pgs) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities. at present, it has not been proved that the usage of pgs really improves the live birth rate in ivf cycles. however, it has been stated that the reason of not having better results when using pgs is that the methodology applied is not adequate. several authors propose that the optimal methodology for pgs includes the application of comparative genomic hybridization (cgh) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. nevertheless, most ivf centres still applies the day 3 embryo biopsy as a daily routine. despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy. the purpose of this clinical study is analysing the results of the ivf cycles with embryo biopsy for pgs. live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing ivf cycles with pgs. in one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.


Eligibility criteria:
inclusion criteria: patients under 49 years undergoing ivf cycles with pgs for one of the following reasons: * advanced maternal age * recurrent implantation failure * recurrent abortion * severe male-factor infertility exclusion criteria: * not being able to sign the informed consent to participate in the study * patients undergoing preimplantation genetic diagnosis

Keywords: embryo biopsy blastocyst stage day 3 preimplantation genetic screening
prevalence of mood and anxiety disorders in adult patients with pulmonary langerhans cell histiocytosis

Conditions: Pulmonary Langerhans Cell Histiocytosis

Summary: pulmonary langerhans cell histiocytosis (plch) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.the clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. however, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.the aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult plch patients. this study should allow: * to assess the prevalence of psychiatric disorders co-morbid in plch patients * a targeted and more effective management of patients * a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.


Eligibility criteria:
inclusion criteria: * patients of 18 years of age or older with plch diagnosed at adulthood * patients affiliated to the french health care system * informed patients exclusion criteria: * patient unable to understand the interview (language barrier) * patient under guardianship or curatorship * patient under ame (french medical help for foreigners)
swedish multicenter trial of outpatient prevention of leg clots

Conditions: Achilles Tendon Rupture; Ankle Fractures; Venous Thromboembolism

Summary: lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (vte) and failed healing. pharmacoprophylaxis of vte is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. thus, there is a need for novel treatments. this study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (ipc) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces vte incidence and improves healing.

the proposed intervention, intermittent pneumatic compression (ipc) is an evidence-based prevention for vte in hospitalized patients and used in daily practice. ipc is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of vte during long term leg-immobilization. plaster cast and orthosis treatments are currently used in daily practice on achilles tendon ruptures and ankle fractures. at present there is no consensus about using vte prophylaxis in leg-immobilized patients. since pharmacoprophylaxis has shown low- or no vte preventive effects in leg-immobilization, is not recommended by some guidelines. furthermore, since all patients will undergo clinical examinations and have dvt-screening performed with compression doppler ultrasound (cdu) removal of leg immobilization this will comprise an extra security for the included patients to detect a vte. if a vte is detected clinical guidelines will be followed by initiating chemical vte-treatment.

Eligibility criteria:
inclusion criteria: * acute unilateral achilles tendon rupture or isolated ankle fracture * treatment starts within 10 days in a hospital setting exclusion criteria: * inability or refusal to give informed consent for participation in the study * inability to comply with the study instructions * known kidney disorder * heart failure with pitting oedema * presence of known malignancy * current bleeding disorder * pregnancy * planned follow-up at another hospital * pilon fracture

Keywords: achilles tendon microdialysis immobilization wound healing intermittent pneumatic compression ultrasonography
determinants of alpha-aminoadipic acid (2-aaa) and relationship to diabetes: study 3

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-aaa in healthy humans.

the purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-aaa), which may influence the risk of diabetes. 2-aaa has been identified as a novel predictor of diabetes development in humans, identifying at-risk individuals before any detectable glucose abnormalities. 2-aaa is a naturally occurring metabolite in the body, and it has no known adverse effects at normal physiological levels. 2-aaa is generated in the body from the breakdown of lysine. lysine is one of the twenty essential amino acids, meaning that it is essential for human function, but that our body cannot manufacture it. thus, it is acquired from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily intake of 30 mg/kg/day. amino acids are the building blocks of proteins, which are what allow our cells, organs and body to maintain structure and function. the investigators are interested in whether 2-aaa is increased in the body after consumption of lysine.

Eligibility criteria:
inclusion criteria: -prior participant in 2-aaa dietary study. exclusion criteria: * newly diagnosed disease, including cardiovascular, renal, liver disease, or diabetes mellitus. * individuals who are pregnant or lactating. * inability to provide written or electronic informed consent. * inability to fast for 8 hours.

Keywords: lysine
non-interventional, post marketing surveillance study of xultophy™ (insulin degludec/liraglutide) to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in india

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in india.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. some specific historical data collected before informed consent is obtained can be used as baseline data (hba1c, fpg/fbg and others) * the decision to initiate treatment with commercially available xultophy™ has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study * male or female, age at least 18 years at the time of signing the informed consent * patients diagnosed with type 2 diabetes mellitus * patients who are scheduled to start treatment with xultophy™ based on the clinical judgement of their treating physician exclusion criteria: * known or suspected hypersensitivity to xultophy™, any of the active substances, any of the excipients or any related products * previous participation in this study. participation is defined as signed informed consent * mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation * females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months * patients who are participating in other studies or clinical trials. * any disorder which in the opinion of the physician might jeopardise subject's safety or compliance with the protocol
a phase 1 study of brentuximab vedotin combined with multi-agent chemotherapy for hodgkin lymphoma

Conditions: Disease, Hodgkin

Summary: the purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive stage iia or iib-iv hodgkin lymphoma. it is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.


Eligibility criteria:
inclusion criteria: * treatment-naive hodgkin lymphoma, stage iia or iib-iv * measurable disease of at least 1.5 cm * eastern cooperative oncology group performance status \<3 exclusion criteria: * history of another primary malignancy that has not been in remission for at least 3 years * known cerebral/meningeal disease

Keywords: antibodies, monoclonal antibody-drug conjugate antigens, cd30 disease, hodgkin hematologic diseases immunotherapy lymphoma monomethyl auristatin e
preservative-free tafluprost (mk-2452) for the treatment of open-angle glaucoma or ocular hypertension (mk-2452-002)

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will test the hypothesis that preservative-free tafluprost (mk-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (iop) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension * has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening) * able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study) * best-corrected early treatment of diabetic retinopathy study (etdrs) visual acuity of 20/80 or better in each eye * willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing * willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications * participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study * able to refrigerate study drug at home. exclusion criteria: * mean iop \>36 mmhg in either eye at screening * unable to use study medication in the affected eye(s) * history of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening * history of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease * significant visual field loss or evidence of progressive visual loss within the last year * intraocular surgery in either eye in the last 4 months * any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye * currently on two or more anti-glaucoma medications (except cosopt™ or its generic formulation) * previously used tafluprost * history of cardiovascular disorder within 6 months of screening * history of bronchial asthma, wheezing, chronic obstructive pulmonary disease (copd) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.

Keywords: tafluprost glaucoma ocular hypertension timolol eye disorder preservative-free prostaglandin analogue
a study of tofacitinib in patients with ulcerative colitis in stable remission

Conditions: Ulcerative Colitis

Summary: this study is a follow up study for subjects with ulcerative colitis (uc) in stable remission designed to evaluate flexible dosing of cp-690,550.


Eligibility criteria:
inclusion criteria: * currently enrolled in study a3921139 receiving cp-690,550 10 mg bid for at least 2 years consecutively. * in stable remission on cp-690,550 10 mg bid * agree to use highly effective contraception * negative pregnancy test * comply with visits, treatments, lab tests, diary and other study procedures * signed and dated informed consent document. exclusion criteria: * subjects who were initially assigned to tofacitinib 10 mg bid at baseline of study a3921139 whose tofacitinib dose was reduced to 5 mg bid due to safety or efficacy. * presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of crohn's disease * likely to require surgery for ulcerative colitis during study * expected to receive any prohibited medication * expected to receive live or attenuated virus vaccination during study * women who are pregnant or breastfeeding or planning to become pregnant during the study * evidence of colonic malignancy or any dysplasia * acute or chronic medical or psychiatric condition that may increase risk of participation * investigator site staff member * subjects likely to be uncooperative or unable to comply with study procedures * participation in other studies involving investigational drugs during study * subjects with any of the following risk factors for pulmonary embolism at baseline as defined by ema's prac: * has heart failure; * has inherited coagulation disorders; * has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism; * is taking combined hormonal contraceptives or hormone replacement therapy; * has malignancy (association is strongest with cancers other than non-melanoma skin cancers); * is undergoing major surgery

Keywords: ulcerative colitis inflammatory bowel disease