Kornimate/medical-research-clean huggingface dataset:
variations in osteoarthritic knee laxity between individuals and populations

Conditions: Knee Arthritis

Summary: severe osteoarthritis of the knee is a condition associated with severe pain, disability and a loss of independence. the most definitive method of surgical treatment for this condition is total knee arthroplasty (tka). total knee arthroplasty aims to provide new metallic bearing surfaces within the knee, in order to alleviate the major source of pain. although total knee arthroplasty is an established surgical treatment option, up to 20% of patients may be dissatisfied with the outcome , and many prostheses fail over time, requiring costly revision surgery. current understanding suggests that soft tissue balancing has a crucial role to play in the outcome of total knee arthroplasty. instability after total knee replacement is an important cause of failure. it is not clear what the normal collateral ligament laxity should be. there is a paucity of current data on normal knee collateral ligament laxity . nevertheless, restoring this may improve patient satisfaction with tka and longevity. it appears that there is considerable variation between individuals, genders , and ethnic groups , when it comes to "normal" laxity. however, much of the existing data relates to healthy young volunteers , and it is not clear how this information should map against the elderly osteoarthritic population who are most likely to be in need of tka. recent advances in computer assisted navigation have provided surgeons with a more precise measure of knee alignment , and knee laxity . orthopaedic surgeons at new cross hospital have been utilising this technology to improve intraoperative placement of total knee replacement implants since 2015. computer navigation is carried out using the stryker precision navigation system. this system records kinematic and static measurements of knee alignment and laxity in patients just prior to the commencement of the total knee replacement procedure. by gathering and analysing data from this machine, on the degree of laxity in osteoarthritic patients about to undergo tka, i this study aims to gain a greater understanding of what can be considered "normal" and whether there are significant differences between individuals, and between ethnic populations in this regard. this will help future surgical decision making about how tight or loose prosthetic knee replacements should be, based on individual characteristics.


Eligibility criteria:
inclusion criteria: * all cases of tka recorded on the 2 stryker navigation machines based at new cross and cannock chase hospitals will be included in the study. duplicates will be identified and removed from the case series. exclusion criteria: * cases in which there is incomplete or inadequate kinematic data recorded in the machine database will be excluded from the study.
early temozolomide in patients with high-grade gliomas in rehabilitation

Conditions: Glioma of Brain

Summary: the purpose of this study is to investigate the feasibility of a possible treatment regimen that could be used to delay tumor progression in patients with glioblastoma. the study is being conducted in patients who qualify for inpatient rehabilitation, as this population is particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in the period between surgical resection and the start of treatment.

this is a pilot study to evaluate the feasibility and safety of early postsurgical temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with glioblastoma who undergo inpatient rehabilitation. the study will be conducted with adult patients who qualify for inpatient rehabilitation following surgical resection of pathologically confirmed grade iv glioma. patients will begin a 21-day cycle of temozolomide starting 14 days after surgery at 75mg per square meter of body surface area daily to serve as bridge therapy. patients will then progress to receive standard therapy following their rehabilitation stay. patients will be assessed for their ability to complete the chemotherapy protocol without dose-limiting toxicity as well as complete inpatient rehabilitation successfully. additionally, we will be assessing for tumor progression between the time of surgery and the time of treatment initiation. if this study shows the expected results, the research team plans to proceed to a larger trial assessing the efficacy of early tmz in patients with glioblastoma (gbm) who are admitted to acute inpatient rehabilitation compared to the current standard of care.

Eligibility criteria:
inclusion criteria: * adult patients, aged 18+ * newly diagnosed world health organization (who) grade iv glioma, confirmed on pathology * karnofsky performance score ≥ 60 * subject has undergone biopsy, subtotal resection, or gross total resection of tumor * subject has been evaluated by physical therapy and thought to be a candidate for acute rehabilitation * subject must be accepted for admission on 5-1200 unit at strong memorial hospital * subject must be able to provide informed consent * subject must meet the following laboratory parameters: * absolute neutrophil count \> 1.5 x103/ul * platelet count \> 140 x103/ul * alanine transaminase \< 135 u/l * aspartate transaminase \< 120 u/l exclusion criteria: * subject has received previous treatment for high-grade glioma * subject has other active malignancy * subject is currently pregnant or breastfeeding * subject is a women of childbearing potential who is not using a reliable method of contraception * subject has history of hypersensitivity to temozolomide
effect of folic acid on endothelial and baroreceptor function in patients with heart failure

Conditions: Heart Failure

Summary: the randomized, double-blind, placebo-controlled study aim to evaluate the effect of 1-month therapy with folic acid (5 mg/day) on endothelial function and baroreceptor function in patients with heart failure. endothelial function will be studied non-invasively with flow-mediated dilation while for eveluating baroreceptor function sympathetic nervous system activity will be measured directly with microneurography in baseline condition and during infusion of sodium-nitroprusside.

endothelial and baroreceptor function are impaired in patients with heart failure. impaired baroreflex control of the heart and peripheral circulation and endothelial dysfunction are thought to play an important pathophysiological role in chronic heart failure and confers a poor prognosis. in patients with essential hypertension we demonstrated an improvement in baroreceptor function after treatment with folic acid. therefore, the aim of the present randomized, double-blind, placebo-controlled study was to evaluate endothelial function and baroreceptor function in patients with heart failure before and after 1-month therapy with folic acid (5 mg) or placebo. endothelial function will be assessed with novel high-resolution ultrasound devices, which allows to investigate endothelial function in vivo. this method makes use of the property of the endothelium to release nitric oxide in response to shear stress and increased flow as previously described. endothelium-dependent flow-mediated dilation (fmd) and endothelium-independent glycerol trinitrate (gtn) (0.4 mg sublingual, nitrolingual spray, pohl-boskamp, germany)-induced vasodilation of the brachial artery will be assessed by a high-resolution ultrasound vessel wall tracking device with a 10 mhz linear array transducer . fmd of the brachial artery is induced by release of a wrist cuff inflated 50 mmhg above systolic pressure for 5 minutes. after sublingual gtn application, used as endothelium-independent stimulus, the diameter will be recorded every 30 seconds for 6 minutes. multifiber recordings of muscle sympathetic nerve activity will be obtained from the peroneal nerve posterior to the fibular head with tungsten microelectrodes. the sympathetic nervous activity will be measured continuously together with ecg, respiration rate and blood pressure. baroreceptor modulation of muscle sympathetic nerve activity and heart rate would be assessed by intravenous infusion of sodium nitroprusside.

Eligibility criteria:
inclusion criteria: * heart failure (min. nyha ll, lvef \<50%) * not smokers * written informed consent exclusion criteria: * unstable heart failure * smoking * unstabile angina pectoris * endocrinologic disease such as diabetes mellitus, hypo- und hyperthyroidism * alcohol abuse * epilepsia * treatment with folic acid antaponists trimethoprim, pyrimethamin, methotrexat.. * participation to one other clinical study within 1 month

Keywords: folic acid endothelial function baroreceptor function heart failure
a new drug for benign prostatic hyperplasia (bph) compared with placebo

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: a new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. the study lasts approximately 20 weeks.

this will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the international prostate symptom score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Eligibility criteria:
inclusion criteria: * males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia. exclusion criteria: * medical conditions that would confound the efficacy evaluation. * medical conditions in which it would be unsafe to use an alpha-blocker. * the use of concomitant drugs that would confound the efficacy evaluation. * the use of concomitant drugs that would be unsafe with this alpha-blocker.

Keywords: benign prostatic hyperplasia, bph, alpha blocker
a clinical trial to evaluate the food effect on pharmacokinetic profiles and safety of ckd-379

Conditions: Type 2 Diabetes Mellitus

Summary: this is a randomized, open-label, single dose, crossover, phase ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of ckd-379 in healthy volunteers

participants were randomly assigned in a 1:1 ratio. the patients are prescribed oral administration of the appropriate ip(2 tablets in single dose: actual medication)

Eligibility criteria:
inclusion criteria: * healthy adults aged 19 to 54 years * bmi measurement result is 18.0 kg/m2 to 30 kg/m2 * written informed consent * other inclusion criteria, as defined in the protocol exclusion criteria: * history of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders * ast or alt or total bilirubin \> 1.5 times the upper limit of normal range * history of regular alcohol consumption \> 21 units/week within 6 months at the time of screening * participated in a clinical trial within 6 months prior to 1st ip dosing * other exclusive inclusion criteria, as defined in the protocol
efficacy and safety of taf in pregnant women with chronic hepatitis b infection

Conditions: Chronic Hepatitis B; Mother-to-child Block; Antiviral Treatment

Summary: the effectiveness of mother-to-child block of chb in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. taf, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.our purpose is to explore the taf for chb the curative effect of pregnant and postnatal security.

after diagnosis at the infection clinic of the third affiliated hospital of sun yat-sen university, the eligible patients were enrolled into the group.each person will sign the informed consent prior to enrollment.

Eligibility criteria:
inclusion criteria: * 25 pregnant women with hbeag (+), hbv dna ≥ 2\*10\^6iu/ml who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis b were pregnant women at 24-28 weeks of pregnancy. * 25 non-pregnant women with hbeag (+), hbv dna ≥ 2\*10\^6iu/ml who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis b. * the enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed. exclusion criteria: * coinfection with hav, hcv, hdv, hev or hiv; * a history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids; * three-dimensional ultrasonography showed fetal malformation; * the spouse is infected with hbv; * history of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms; * history of immune diseases; * a history of serious cardiovascular disease; * other reasons the researchers considered it inappropriate to participate in the trial.
using augmentative & alternative communication to promote language recovery for people with post-stroke aphasia

Conditions: Post-stroke Aphasia; Aphasia

Summary: the currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. this study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. further, this project will help us identify regions of the brain responsible for these changes.

in aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.once a person reaches a plateau in language recovery, aac is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia. the ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how aac could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. this approach, however, this requires a shift in how aac is implemented. with the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use aac as a mechanism for self-cueing, rather than as a tool to replace speaking. based on our pilot data, we hypothesize that this novel method to aac implementation will promote language recovery by coupling the canonical language and visual processing neural networks. this work will also contribute to our ability to identify, a priori, who will respond to this particular aac intervention and who will not, by combining neuroimaging with behavioral and clinical data. this has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the aac treatment that require adjustment to meet their unique needs.

Eligibility criteria:
inclusion criteria: * at least 18 years old * native speaker of american english * compatible for 3 tesla mri * ischemic, left middle cerebral artery stroke * at least 12 months post stroke * pass hearing screening * pass vision screening * diagnosis of aphasia on the western aphasia bedside screen * ability to produce 5-10 intelligible words * no more than a moderate apraxia of speech or dysarthria * minimal or no aac/ipad experience * written consent by self or guardian exclusion criteria: * fails to meet the above * underlying degenerative or metabolic disorder or supervening medical illness * severe depression or other psychiatric disorder * report of pregnancy by women of childbearing age

Keywords: augmentative and alternative communication aphasia fmri dti neuroimaging
the efficacy and safety of hrs9531 injection in subjects with type 2 diabetes， inadequately controlled with diet and exercise alone

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to evaluate the effectiveness of hrs9531 compared to placebo in controlling blood glucose levels after 24 weeks of treatment


Eligibility criteria:
inclusion criteria: 1. males and females, age ≥18 years at the time of signing informed consent. 2. diagnosed with type 2 diabetes mellitus (t2dm) for at least 90 days prior to day of screening. 3. treatment with diet and exercise alone at least 90 days prior to day of screening. 4. 7.5% ≤ hba1c ≤10.0% at screening. exclusion criteria: 1. uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg at screening. 2. diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. history of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.). 4. presence of an endocrine disorder or history that may significantly affect bady weight(e.g., cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ； 5. severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening. 6. participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; or is still in the trial drug within 5 half-lives (whichever is longer).
the beautiful study: effects of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction

Conditions: Coronary Disease; Ventricular Dysfunction, Left

Summary: the aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.


Eligibility criteria:
inclusion criteria: * coronary artery disease * left ventricular systolic dysfunction * sinus rhythm: heart rate (hr) \>= 60 beats per minute (bpm) exclusion criteria: * unstable cardiovascular condition * severe congestive heart failure
a phase 3 study to compare the efficacy and safety of 0.3 mg pegaptanib sodium to sham injections in subjects with diabetic macular edema

Conditions: Macular Edema; Diabetic Mellitus; Retinal Disease

Summary: the purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

during the study, an issue was reported concerning proper maintenance of treatment masking (see result: limitations and caveats)

Eligibility criteria:
inclusion criteria: * type i, or type ii diabetic subjects * subjects must have macular edema that involves the center field of the macula 3. foveal thickness of at least 250 μm 4. best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive exclusion criteria: * eyes with prior panretinal photocoagulation (prp) less than 4 months prior to baseline eyes in which prp is needed now or is likely to be needed within the next 9 months * hba1c level \>12% or recent signs of uncontrolled diabetes * atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy

Keywords: diabetic macular edema macugen sham-controlled study
oral iron vs. placebo in newly diagnosed gynecologic oncology patients who are surgical candidates.

Conditions: Ovarian Cancer; Cervical Cancer; Uterine Cancer; Anemia

Summary: the prevalence of anemia in gynecologic oncology new patients has been seen in previous studies to be as high as 35-59%. this population includes women with several types of gynecologic malignancies. therefore, it is assumed that the origin of the anemia can be due to anemia of chronic disease and iron deficiency anemia. no previous studies have looked at the efficacy of oral iron supplementation with concurrent vitamin c in women with newly diagnosed gynecologic malignancies. hypothesis: in newly diagnosed gynecologic oncology patients who are surgical candidates does treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.


Eligibility criteria:
inclusion criteria: * over the age of 18 * scheduled for primary operative procedure within 3-6 weeks of initial consult clinic visit with endometrial cancer, uterine sarcoma, cervical cancer, ovarian/fallopian tube cancer or patients with pelvic mass and a high suspicion of a gynecologic malignancy. exclusion criteria: * patient with known allergy to ferrous fumarate. * patient's on iv iron or erythropoietin treatment at the time of recruitment * patient's who are not primary surgical candidates. * patient's with a known hemoglobinopathy or a hypoproliferative hematologic disorder * patient who have significant active vaginal bleeding * patient who have a hemoglobin \< 80 g/l will be removed from randomization and referred to blood conservation at sunnybrook health sciences centre.

Keywords: anemia ovarian cancer uterine cancer cervical cancer oral iron