Kornimate/medical-research-clean huggingface dataset:
effect of pre-operative exercise in abdominal aortic aneurysms (aaa) patients.

Conditions: Abdominal Aortic Aneurysm

Summary: an aneurysm is a permanent and localized dilatation of an artery usually more than 50% of its normal diameter. abdominal aortic aneurysms (aaa) is an aneurysm of the main artery of abdomen and affects 5% of men aged 65-74 years. rupture of an aneurysm is the 10th leading cause of death in white men over 65 years of age in industrial countries. treatment of asymptomatic aaa is considered when the diameter of an aaa reaches 5.5 cm. there are two treatment options available: conventional open surgical repair or endovascular repair, which is a less invasive mode of treatment. after the operation heart and lung complications are significant in patients undergoing major abdominal surgery. the commonest causes of death are due to heart problems. there are various studies which have shown benefits of pre operative exercise training in patients undergoing orthopaedic, lung and heart bypass surgery. currently, there is no data available with regards to the effect of pre-operative (before operation) supervised exercise in patients undergoing surgery for an aaa. the main aim of this study will be to determine whether a pre-operative supervised exercise programme improves post-operative (after operation) outcome, compared to standard treatment. patients will be entered in the study once a decision to repair their aaa has been made by the consultant. they will undergo pre-operative assessment and will be divided randomly into two groups. one group will have exercise training for 4-6 weeks before surgery and the other will not. after the operation they will be followed during the post-operative period to determine the presence or absence of complications. it is anticipated that complications will be less in the group which has undertaken exercise training before operation.


Eligibility criteria:
inclusion criteria: * patients undergoing open repair for an asymptomatic peri-renal and infra-renal abdominal aortic aneurysm. * patients undergoing endovascular aneurysm repair (evar). * able to comply with study protocol. * able to give informed consent. exclusion criteria: * patients with severe disabling disorders limiting mobility for example severe osteoarthritis. * patients undergoing emergency repair of abdominal aortic aneurysm. * patients with thoraco abdominal aneurysms. * patients unable to communicate in english.
safety and efficacy of krt-232 in combination with acalabrutinib in subjects with r/r dlbcl or r/r cll

Conditions: Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, combined with acalabrutinib for the treatment of adults with diffuse large b-cell lymphoma and chronic lymphocytic leukemia. participants must be relapsed/refractory (having failed prior therapy)


Eligibility criteria:
inclusion criteria: * cohort 1: confirmed diagnosis of tp53wt dlbcl (who); r/r dlbcl after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant * cohort 2: confirmed diagnosis of tp53wt cll (iwcll); r/r cll after at least 1 prior line of treatment * ecog 0 to 2 * adequate hematologic, hepatic, and renal functions. exclusion criteria: * prior treatment with any mdm2 inhibitor * prior treatment with any btk inhibitor

Keywords: navtemadlin
early diagnosis of intracranial infection after craniotomy

Conditions: Intracranial; Infection, Psychosis, Acute or Subacute

Summary: intracranial infection are serious complications postoperatively in neurosurgical patients. early identification of these complications is essential to minimize the mortality and moribidy. the aim of this study is observe the postoperative dynamic changes of body temperature (bt), procalcitonin (pct), c-reactive protein (crp), and white blood cell (wbc) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy of intracranial infection.

intracranial infection is a serious complications after neurosurgical operation. early identification of intracranial infection is important so that, first, optimal treatment is initiated which may improves outcome, second, inappropriate antibiotic treatment and subsequent resistance are prevented, and third, it will promote shorter hospitalization and less cost. in several previous studies, the values of procalcitonin (pct) and c-reactive protein (crp) in predicting intracranial infection have been evaluated in neurosurgical patients. however, due to the limited number of studies, the results are not convincing enough and more investigations seems warranted to clarify their dynamic changes in neurosurgical patients without intracranial infection and their role in confirming the suspicion of intracranial infection or excluding intracranial infection from the differential diagnosis. the aim of the investigator's study is to observe the postoperative dynamic changes of bt, pct, crp, and white blood cell (wbc) count, and evaluate whether the use of two or more of these markers may improve the diagnostic accuracy for rational decisions about antibiotic treatment.

Eligibility criteria:
inclusion criteria: 1. craniotomy of brain tumor; 2. no clinical manifestations of infection before operation; 3. no other infection such as respiratory tract infection, urinary tract infection and deep vein catheter infection before the definite diagnosis of intracranial infection ; 4. the patients had informed consent to enter the study. exclusion criteria: 1. blood system diseases,respiratory tract infection, urinary tract infection and deep vein catheter infection; 2. malignant tumors with neuroendocrine characteristicsr; 3. aspiration, pancreatitis, etc.

Keywords: procalcitonin c-reactive protein white blood cell count intracranial infection
a study to evaluate the efficacy and safety of dupilumab in adult and adolescent patients with moderate-to-severe atopic hand and foot dermatitis (liberty-ad-haft)

Conditions: Moderate to Severe Atopic Hand and Foot Dermatitis

Summary: the primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis. the secondary objectives of the study are: * to assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related qol, work life impairment) in patients with atopic hand and foot dermatitis * to evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis * to evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis


Eligibility criteria:
key inclusion criteria: * patients with involvement of at least 2 anatomical areas at screening and baseline * patients need to have an iga hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline * patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s) * patients meet the diagnosis criteria for atopic dermatitis (ad) * provide informed consent/assent signed by study patient or legally acceptable representative * patients need to have been compliant with the skin protection measures through the entire duration of the screening period key exclusion criteria: * treatment with dupilumab in the past * patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis * patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis * treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline * known history of hiv/hbv/hcv infection * pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study * women of childbearing potential (wocbp) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study note: other protocol defined inclusion / exclusion criteria apply
macronutrients and gut hormone secretion

Conditions: Type 2 Diabetes

Summary: study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.

in healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein mixture or fat emulsion will be served individually and on a separate occasions a mixed meal will be served. samples will be taken during the following 300 min. concentrations of the gut hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin and glucagon will be determined.

Eligibility criteria:
inclusion criteria: * healthy status or type 2 diabetes with dietary regulation exclusion criteria: * liver disease * kidney disease * thyroid disease

Keywords: gut hormones insulin secretion
short term evaluation of slic screw in treatment of scapholunate injury

Conditions: Acute Scapholunate Injury

Summary: the purpose of this retrospective-prospective clinical evaluation is to determine whether the slic screw system provides provisional fixation to allow biological healing of the scapholunate interval.


Eligibility criteria:
inclusion criteria: * subjects willing and able to comprehend and sign informed consent * subjects who have received the slic screw as part of the treatment for scapholunate ligament repair or scapholunate reduction * subjects with acute scapholunate injury, classified with garcia-elias stage 1-4, or geissler stage 1-3 * subjects \>18 years of age at the time of surgery exclusion criteria: * subject diagnosed with chronic scapholunate injury * subjects who underwent previous scapholunate procedure on the study wrist before implantation of the slic screw system * subjects with active or latent infection at the time of surgery * subjects with sepsis at the time of surgery * subjects diagnosed with osteoporosis at the time of surgery * subjects with insufficient quantity and/or quality of bone * subjects with cartilage degeneration on the bones at the time of surgery * subjects with absence of potential for soft tissue healing at time of surgery, as documented by the investigator. * female subjects known to be pregnant * subjects who were unable to follow postoperative care instructions, specifically, activity levels * subjects who are unable or unwilling to return for postoperative study visits
fimasartan and rosuvastatin for hypertension and dyslipidemia control

Conditions: Cardiovascular Diseases; Hyperlipidemias

Summary: fimasartan and rosuvastatin for hypertension and dyslipidemia control


Eligibility criteria:
inclusion criteria: * hypertension patients who are taking an anti-hypertensive agent, including fimasartan at least 12 weeks or more. * dyslipidemia patients who are taking dyslipidemia drug, including rosuvastatin at least 12 weeks or more * patients who has blood pressure and lipid levels (total cholesterol, ldl-c, hdl-c, non-hdl-c, \* tg) checks 2 weeks before registration exclusion criteria: * patients being hospitalized * patients who stop taking fimasartan or rosuvastatin within 12 weeks 14 or more consecutive days * patients who have more than 400mg/dl triglyceride(tg) at the registration time
ribomustin in the first line therapy of chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: prospective multicenter observational non-interventional study to assess routine clinical practice of bendamustine use in the first line therapy of chronic lymphocytic leukemia


Eligibility criteria:
inclusion criteria: * patients with chronic lymphocytic leukemia (cll) with current or planned first line therapy with ribomustin * informed consent form for personal data handling signed by the program participant exclusion criteria: * any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of cll * currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment * contraindications for ribomustin usage in accordance with product label

Keywords: observational chronic lymphocytic leukemia bendamustine
efficacy of instrumental chiropractic treatment using activator methods for pain and dysfunction in juvenile athletes

Conditions: Pain in Leg, Unspecified; Knee Sprain

Summary: the goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes. a randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed. hypothesis: instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.

pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier. in our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in vas is achieved within the first session of treatment. the following study is thought to prove the efficacy of the chiropractic instrumental treatment performed at our sports-medicine outpatient department.

Eligibility criteria:
inclusion criteria: * functional problems in the lower extremities exclusion criteria: * severe pathology that requires different treatment

Keywords: knee hip ankle foot pain lower limb activator instrumental chiropractic painful functional conditions of the lower extremity
vitamin d and type 2 diabetes study

Conditions: Prediabetes; Type 2 Diabetes

Summary: the goal of the vitamin d and type 2 diabetes (d2d) study is to determine if vitamin d supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin d affects glucose (sugar) metabolism.

the goal of the vitamin d and type 2 diabetes (d2d) study is to determine if vitamin d supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin d affects glucose (sugar) metabolism. researchers at us sites will enroll people with pre-diabetes (people who have higher than normal blood glucose level but not high enough to meet the diagnosis of diabetes). the study will enroll participants over approximately 2 years and participants will be followed for approximately 3 years. participants will receive either vitamin d or a placebo by chance. participants will take 1 pill a day for the duration of the study.

Eligibility criteria:
inclusion criteria: 1. pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit: 1. fasting plasma glucose (fpg) 100-125 mg/dl 2. 2-hour plasma glucose (2hpg) 140-199 mg/dl 3. hemoglobin a1c (hba1c) 5.7-6.4% 2. age ≥ 30 years .(≥25 years for people of the following races: american-indian, alaska native, native hawaiian or other pacific islander). 3. body mass index ≥ 24.0 (22.5 for asians) and ≤ 42.0 kg/m2 4. provision of signed and dated written informed consent prior to any study procedures. major exclusion criteria: 1. diabetes based on either of the following criteria: 1. history (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the fda for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome. 2. meeting the diagnosis criteria for diabetes 2. history (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia. 3. pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. history of gestational diabetes is not an exclusion criterion. 4. currently breastfeeding.

Keywords: prediabetes vitamin d
singulair use in non-allergic rhinitis eosinophil syndrome (nares)

Conditions: Rhinitis

Summary: the purpose of this trial is to determine if patients with nares treated with montelukast (singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

patients will receive either montelukast or placebo in the treatment of nares. 4 visits will be conducted over 12 weeks. a history and physical will be performed at the beginning of the trial and at the end. skin testing will be done at visit 1. nasal smears and lavages will be performed at every visit. patients will be compensated for time and travel.

Eligibility criteria:
inclusion criteria: * aged 18 - 65 years * diagnosed with nares exclusion criteria: * smokers, exposed to passive smoke * diagnosis of seasonal allergic rhinitis (sar), perennial allergic rhinitis (par), or vasomotor rhinitis (vmr)

Keywords: nares eosinophils nasal symptoms
oxidative stress in women treated with atosiban for impending preterm birth

Conditions: Premature Birth

Summary: oxidative stress is recognized as a important factor in the pathogenesis premature birth. preterm birth is defined as delivery before 37 completed weeks of gestation and it is the leading cause of neonatal morbidity and mortality. the investigators conducted this analysis to investigate the safety of administration of atosiban - a reversible, competitive antagonist of the oxytocin receptor in the treatment of preterm labor and its impact on the level of oxidative stress after 48 hours of tocolytic treatment.

atosiban (1-(3-mercaptopropanoic acid)-2-(o-ethyl-d-tyrosine)-4-l-threonine-8-l-ornithine-oxytocin) is licensed for clinical use in women suffering from threatened premature birth and is widely used in clinical practice in europe because of its low side effect profile. the impact of atosiban on pregnancy outcomes in women has been investigated in recent years and the research has shown its ability to reduce intracytoplasmic calcium release and downregulate prostaglandin synthesis as oxytocin receptor antagonist. while a role of atosiban in the modulation of myometrial contractility is well-described, its effect on many other functions is not so well known. the serum and plasma samples take for the measurement of total oxidant status (tos), total antioxidant status (tas), level of 3-nitrotyrosine (3-nt), and carbonyl and thiol groups will be stored at -70°c in aliquots for subsequent biochemical analysis and processed within two months.

Eligibility criteria:
inclusion criteria: * pregnant women between 24-35 weeks' gestation receiving prenatal care due to the risk of premature birth * intact membranes * evidence of premature labor (regular, painful and persistent uterine contractions; cervical changes) exclusion criteria: * acute fetal distress * other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta) * vaginal bleeding, * premature rupture of membranes * chorioamnionitis, * fetal congenital malformations, * intrauterine growth restriction, * the use of any tocolytic drugs during pregnancy before admission to the hospital * circulatory system diseases (e.g. heart defects, hypertension), * symptoms of infection * other diseases that may increase oxidative stress
v-nav usability study: end users trying the vortant indoor navigation tool

Conditions: Blindness and Low Vision

Summary: the study will begin with an explanatory/training session where individuals with low vision will learn to use the v-nav (vortant navigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. the main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the v-nav in their everyday lives. data will be collected from the users to measure the relative advantage of v-nav compared to the user's current indoor navigation method.

the introductory session, emphasizing real-world experiences, will involve a brief training session followed by simulated navigation experiences in a convenient location to the users. participants will use v-nav to record approximately 8 locations, then will be given instructions to find these locations again. the v-nav prototype's logging software will measure distance walked and task time. participants will complete a study-specific tool covering the relevant attributes of the v-nav prototype, as well as a standardized tool, the nasa tlx (task load index). subsequently, participants will complete a take-home trial, during which they will be encouraged to use the v-nav features regularly to support their everyday community navigation activities. participants will be contacted approximately weekly with a "check-in" to answer questions and resolve any emergent technical problems. at the conclusion of the trial, a product-specific tool and an appropriate standardized tool, the piads (psychosocial impact of assistive devices scale) will be administered.

Eligibility criteria:
inclusion criteria: * afb "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees exclusion criteria: * any health condition that may affect safety of individual to participate * any physical, mental, or behavioral impairment that would provide more than minimal risk or hindering ability to comprehend the purpose of the device or otherwise to be a potential user of the v-nav hardware or app.

Keywords: blindness, indoor navigation
a study comparing the safety, tolerability and efficacy of trizivir vs combivir & atazanavir in subjects with hiv

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: the aim of this study was to assess whether trizivir, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs combivir administered twice-daily and atazanavir administered once daily. over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

a phase iv randomized, multicenter, open-label study to compare the safety, tolerability and efficacy of trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) bid vs combivir (lamivudine 150mg and zidovudine 300mg) bid plus atazanavir 400mg qd in antiretroviral naive hiv-1 infected subjects over 48 weeks

Eligibility criteria:
inclusion criteria: * adults with documented hiv-1 infection. * past use of hiv drugs must have been less than 15 days. * plasma hiv-1 rna between 500 and 20,000 copies/ml. * cd4+ cell count greater than 100 cells/mm3. * willing/able to provide written informed consent. exclusion criteria: * have aids at screening. * pregnant or breastfeeding. * underlying medical conditions considered to be significant for this protocol. * participating in other investigational drug trials. * in the opinion of the investigator, would be unable to complete 48 weeks of dosing.

Keywords: safety drug efficacy trizivir tolerability combivir hiv atazanavir