Kornimate/medical-research-clean huggingface dataset:
development and evaluation of a web based decision aid for patients with hip osteoarthritis

Conditions: Hip Osteoarthritis; Osteoarthritis

Summary: the main goal of this study is assess the effectiveness of a ptda for patients with hip osteoarthritis

background: osteoarthritis (oa) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. in this sense, patient decision aids (ptda) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving person-centred care (pcc). previous research has focused almost exclusively on knee oa, and therefore the aim of this study is to develop and evaluate the effectiveness of a ptda for patients with hip oa. methods: the general design consists of two phases: 1) design a web-based ptda for patients with hip oa, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an advisory committee composed of health professionals and patients; 2) to evaluate the impact of the ptda on hip oa patients' decision-making process related with their treatment. for that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip oa in tenerife (spain) comparing intervention or usual care. discussion: ptdas have been recommended as a useful and effective resource for improving pcc in many health conditions. the intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. this study will contribute to the scientific knowledge about effectiveness of ptdas in hip oa, in order to improve the quality of health care offered to these patients.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of hip osteoarthritis exclusion criteria: * patients younger than 18 years * previous hip arthroplasty * patients with terminal illnesses * non-fluent spanish language * mental or sensory alterations that impede or hinder the response to the measurement instruments or do not have the capacity to make decisions.

Keywords: hip osteoarthritis patient decision aids person-centred care randomized controlled trial shared decision-making web-based intervention
carbonic anhydrase inhibitors and carbonation: a novel approach to reduce soda consumption

Conditions: Obesity

Summary: acetazolamide is a drug that is approved by the fda for treating various conditions like epilepsy, altitude sickness, and glaucoma. acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which is important for many essential processes in our body. for example, carbonic anhydrase is needed to transport carbon dioxide in our blood which is essential for respiration. one of the interesting effects of acetazolamide is that it reduces the taste of carbonation, making carbonated drinks like soda taste flat and or like soapy water. this effect has been noticed by hikers using the drug for mountain sickness treatment. it's believed that carbonic anhydrase inhibitors decrease the levels of carbonic acid in our mouths, which in turn reduces and changes the perception of carbonation taste. it was hypothesized that this side effect of acetazolamide could be used to help people cut down on soda consumption. since soda has been linked to health issues like obesity and type 2 diabetes, reducing its intake could be beneficial. in a case study, a person who took low-dose acetazolamide for six weeks experienced weight loss and found it easier to avoid carbonated drinks. we are proposing a study to explore the effects of using acetazolamide as an oral rinse to decrease soda intake. the use of acetazolamide as an oral rinse has yet to be tested and is a possible way to decrease the taste of carbonation while also decreasing the side effects of the drug. our plan is to use different doses of the rinse on participants and monitor their soda consumption and body mass index changes. in summary, acetazolamide, a drug with various medical uses, could potentially help people reduce soda consumption by altering the taste of carbonation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. consumes on average ≥ 7 sodas per week 3. healthy and without a history of significant neurological, liver, renal, cardiac or pulmonary disease. 4. no allergy to sulfa drugs or aspirin (contained in alka seltzer). 5. ability to provide informed consent. exclusion criteria: healthy adults, ua students, ua faculty and staff exclusion criteria: 1. pregnant or lactating women. 2. prisoners. 3. refugees. 4. cognitive impairment. 5. chronic illness. 6. allergy to sulfa drugs or aspirin.
the humanized monoclonal antibody milatuzumab for refractory chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine whether milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.

the aim of this study is to determine whether the anti-cd74 monoclonal antibody milatuzumab provides benefit to subjects with cll in advanced stage or progressive disease. the primary objectives of this study are to assess response rate to the agent, as well as the safety in cll, using different doses: overall response (or), complete response (cr) and partial response (pr) will be determinate according to the nci criteria. the secondary objectives are to determine: duration of response, time to progression, overall survival, and the range of doses in which efficacy is seen and mtd not reached. this study will be done in parallel with other phase i-ii studies conducted by immunomedics. the study design will take into account that the high levels of circulating cd74expressing cells in cll may affect both the acute (although probably not long term) toxicity and the efficacy of the study medication. this could translate to a different mtd and a different cumulative dose of milatuzumab, needed to achieve response.(either a higher dose or longer treatment period.). the study will be divided into two treatment phases. in the first phase we aim to address whether the dose of 120 mg/m2 is effective in cll, and also if it is safe. in the second phase we will assess the safety and possible efficacy of higher doses, in those patients that did not achieve a significant response in the first phase. this will be done by gradual dose escalations, not to exceed 600 mg, or the mtd reached in other studies. in addition, the study will aim at gaining further understanding of the effect of milatuzumab on the biological in-vitro function of cll cells.

Eligibility criteria:
inclusion criteria: * b-cll confirmed according to nci criteria * cll relapsed or refractory to prior antineoplastic therapy * signs of progressive disease; at least one: * b symptoms * lymphocyte doubling time of \< 6 months * symptomatic lymphadenopathy or splenomegaly * cytopenias due to bone marrow failure) * age \> 18 years, and less then 80 * serum alat, asat, bilirubin, creatinine \< 2x upper limit of normal * life expectancy \> 6 months * patient's written informed consent exclusion criteria: * active bacterial or viral infection * hypersensitivity to humanized monoclonal antibodies * concurrent antineoplastic treatment for cll or other malignant disease * absolute neutrophil count \< 1.5 k/

Keywords: humanized monoclonal antibody
combined management in ali ( image guided thrombectomy with open transfemoral access )

Conditions: Limb Ischemia

Summary: acute limb ischemia (ali) is a sudden decrease in limb perfusion due to either an embolic or a thrombotic vascular occlusion, defined as the presence of symptoms within two weeks of onset. the profound ischemia represents an emergency in which delayed treatment results in limb loss and, potentially, death. therefore, timely diagnosis and proper treatments for ali are important. both surgical thrombectomy and endovascular treatment have benefits and drawbacks. surgical thrombectomy using fogarty embolectomy catheter has been the standard therapy because it is rapid and effective in cases of embolic ali. however, blind surgical thrombectomy can result in poor revascularization or unexpected vascular injury in the presence of underlying arterial atherosclerosis or in the presence of subacute and chronic thrombi. in addition, thrombosis of runoff vessels is difficult to remove. endovascular management using catheter-directed thrombolysis (cdt) has emerged as an alternative to surgery. it is less invasive, and does not directly damage the vascular endothelium with the capacity to clear thrombus in the small vessels. however, long treatment duration may worsen the clinical situation. besides, a thrombus of more than two weeks does not respond well to the thrombolysis, and it is difficult to determine the exact stage of thrombus according to the clinical history. these problems may be minimized by combined treatment, which includes surgical thrombectomy and endovascular treatment.

the aim of our research is to evaluate the effectiveness and safety of combined treatment (surgical thrombectomy and endovascular treatment) for ali with various clinical considerations

Eligibility criteria:
inclusion criteria: * patients with acute onset of lower limb pain with various degrees of movement compromise. * history of intermittent claudication with a sudden worsening of claudication and pain at rest for less than one month. * patients with duplex or msct angiography of the lower limbs showing embolic events on healthy vessels or thrombosis of diseased vessels with or without collateralization. * thrombus in a poor location that is difficult to be removed by surgical thrombectomy alone. * acute lower limb ischemia due to acute arterial graft occlusion exclusion criteria: * - medically compromised patients, not fit for the intervention. * patients with critical chronic limb ischemia (grade iii, iv). * patients with known vasculitis or lab investigations suggesting vasculitis before treating the cause. * patients who refused the intervention.
non-invasive measurement of cerebrovascular reactivity after traumatic brain injury

Conditions: TBI

Summary: the investigators will longitudinally measure cerebrovascular reactivity (cvr) by functional near-infrared spectroscopy (fnirs) in acute (≤3 days from injury), subacute, and chronic phases after tbi as a biomarker of tcvi as compared to healthy controls. cvr will be measured by fnirs response to hypercapnia. the investigators hypothesize that cvr will be decreased after tbi and that these decreases will correlate with clinical outcomes. furthermore, the investigators predict that administration of a vasodilatory medication (sildenafil) will augment cvr after tbi.


Eligibility criteria:
inclusion criteria: 1. men and women, aged ≥18 2. ct evidence of tbi-linked abnormality * traumatic subarachnoid hemorrhage * intracerebral hemorrhage/contusion * subdural/epidural hematoma 3. ability to undergo fnirs testing with hypercapnia challenge 4. subject able to provide informed consent 5. attending of record agrees to include subject in study exclusion criteria: 1. unstable respiratory or hemodynamic status 2. evidence of penetrating brain injury 3. tbi requiring craniotomy or craniectomy 4. evidence or risk of icp crisis 5. history of disabling pre-existing neurologic disorder (e.g. dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe tbi, or other disorder that confounds interpretation of nirs testing or neuropsychological results) 6. history of pre-existing disabling mental illness (e.g. major depression or schizophrenia) 7. exclusion criteria for sildenafil administration: * history of melanoma * current use of organic nitrate vasodilators * current use of ritonavir (hiv-protease inhibitor) * current use of erythromycin, ketoconazole, or itraconazole; current use of cimetidine * current use of alpha-blockers such as doxazosin (cardura), tamsulosin (flomax), and terazosin (hytrin) prazosin (minipres) * resting hypotension (systolic bp \<90) * severe renal insufficiency * hepatic cirrhosis * acute ischemic stroke within past 2 months * acute myocardial infarction within past 2 months * unstable angina pectoris * acute or chronic heart failure * retinitis pigmentosa * pregnant or breastfeeding female * known hypersensitivity or allergy to sildenafil 8. unstable cardiac status that constitutes a contraindication to sexual activity 9. inability to read and communicate in english (necessary to obtain reliable neuropsychometric data) 10. nursing mothers

Keywords: tbi cvr hypercapnia fnirs
adaptive treatment for acute myeloid leukemia based on d14 mrd results

Conditions: AML; MRD

Summary: this is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on mrd results on day 14 of the first cycle.

azacitidine and venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. based on mrd results on c1d14, mrd negative patients will go on azacitidine and venetoclax regimen and for patients with mrd positive, selinexor 60mg on d15 and d22 will be added. patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.

Eligibility criteria:
inclusion criteria: * known and written informed consent voluntarily * age ≥ 18 years * newly diagnosed aml patients (per who 2022 classification criteria for aml diagnosis), who are not suitable for intensive chemotherapy: * 75 years or aged 18 to 74 years with at least one of the following comorbidities: eastern cooperative oncology group (ecog) performance status score of 2 or 3 or 4; cardiac history of congestive heart failure (chf) requiring treatment or ejection fraction \ = 30 ml/min to \ 1.5 to \<= 3.0 × upper limit of normal (uln); any other comorbidity that the physician judges to be incompatible with intensive chemotherapy . * liver function meets the following criteria: aspartate aminotransferase (ast) ≤ 3.0×uln\*; alanine aminotransferase (alt) ≤3.0×uln\*; bilirubin≤1.5×uln\*; for subjects \<75 years old, the bilirubin level can be ≤3.0×uln; unless due to leukemic organ involvement. * renal function meets the following criteria: creatinine clearance ≥ 30 ml/min (cockroft-gault formula) * life expectancy ≥ 4 weeks exclusion criteria: * history of any malignancies prior to study entry with exception noted in the protocol. * participant has known hiv infection, active hepatitis b virus (hbv) and/or hepatitis c virus (hcv) . * participant has known active central nervous system (cns) involvement with aml. * must not have received prior anti-aml treatment except for hydroxyurea

Keywords: untreated aml mrd results selinexor
clinical efficacy of single-use of peroxyl mouthwash for reducing bacteria in saliva and bioaerosol contamination

Conditions: Healthy

Summary: to evaluate the anti-bacterial, pre-procedural, clinical efficacy of peroxyl mouthwash (1.5% hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash (0.0% hydrogen peroxide)

qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. all collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.

Eligibility criteria:
inclusion criteria: * potential subjects must meet all of the following criteria: * subjects, ages 18-70, inclusive. * availability for the duration of this clinical research study. * good general health. * at least 20 natural teeth. * gingivitis index 1.0 (löe-silness). * signed informed consent form exclusion criteria: * potential subjects must not have any of the following conditions: * symptoms consistent with covid-19 or have tested positive. * presence of orthodontic bands. * tumor(s) of the soft or hard tissues of the oral cavity. * advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or peri-implantitis. * five or more carious lesions requiring immediate restorative treatment. * use of antibiotic one-month prior to entry into the study. * participation in any other clinical study or test panel within the one month prior to entry into the study. * dental prophylaxis during the past two weeks prior to baseline examinations. * history of allergies to oral care/personal care consumer products or their ingredients. * on any prescription medicines that might interfere with the study outcome. * an existing medical condition that prohibits not eating or drinking for periods up to 4 hours. * history of alcohol or drug abuse. * self-reported pregnant or lactating subjects.

Keywords: mouthwash saliva bioaerosol bacteria gingivitis
prevention of overfeeding during infancy

Conditions: Obesity

Summary: the overall goal of this project is to identify strategies to prevent overfeeding during infancy. one objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. this will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. the second objective is to evaluate the relationship between parental feeding styles and infant intake.


Eligibility criteria:
inclusion criteria: * infant born at \> 37 weeks gestation * infant weighed \>2500 g at birth * infant is apparently healthy * mother speaks english * mother is 18 years of age or older * mother/infant pair lives within a 10-mile radius around the uc davis medical center in sacramento, ca * mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.
use of extracorporeal co2 removal in case of moderate to severe ards to apply an ultraprotective mechanical ventilation strategy

Conditions: Acue Respiratory Distress Syndrome

Summary: the extracorporeal co2 removal (ecco2r) has been recently proposed in case of acute respiratory distress syndrome (ards) in order to reduce pulmonary injuries induced by the mechanical ventilation. a reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. however, most of existing devices of ecco2r can apply only a limited extracorporeal flow, often less than 1l/min, which limits the co2 exchanges and does not allow to reach an ultraprotective ventilation. an extracorporeal flow higher should logically maximalize co2 removal and allow reducing intensity of mechanical ventilation. works focused on high-flow ecco2r (2-3 l/min) in setting of ards are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.

this is a prospective interventional study focused on a cohort population. the included patients will be those affected by a severe ards (berlin definition) requiring an aggressive mechanical ventilation and whom a high-flow ecco2r was implemented. the high-flow ecco2r will be proposed in all patients with inclusions criteria with the 15 first days following their admission. the day of initiation of the high-flow ecco2r will considered as day 0 in our study. a data collection will be focused on the respiratory parameters, clinical complications until icu discharge and outcome, extracted from medical records. the main endpoint will be the perrcentage of patients whom an ultraprotective ventilation could be applied successfully during more than 12h. ultraprotective ventilation is defined in our work as follows: tidal volume ≤ 3 ml/kg and respiratory rate ≤ 16/min associated with a paco2 ≤ 45mmhg and a pao2 ≥ 55 mmhg. the secondary endpoints will be durations of mechanical ventilation, icu stay and hospitalization, as well as rheological behavior of extracorporeal circulation, respiratory parameters under high-flow ecco2r, specific complications and mortality.

Eligibility criteria:
inclusion criteria: * aged from 18 years old * patient suffering from ards including the 3 following parameters during more than 12 hours: pao2/fio2 ≤200 driving pressure ≥15 cmh2o, tidal volume = 6 ml/kg pit respiratory rate ≥ 28/min - or patient hospitalized for severe bronchospasm or copd exacerbation associating a persistent capnia ≥ 50 mmhg despite maximal mechanical ventilation (vt = 6ml/kg pit, respiratory rate ≥ 24/min) exclusion criteria: * patients protected by law (art.l 1121-5, 1121-6, 1121-8 du code de la santé publique) * consent refusal from the patient or his/her next of kin and the impossibility to enrol using the emergency procedure * pregnant or breast feeding patient * absence of a french health care insurance coverage

Keywords: ards ecco2r ultraprotective ventilation respiratory extracorporeal support mechanical power driving pressure
cirrhotic ascites treatment with satavaptan in patients with ascites due to cirrhosis of the liver (cats)

Conditions: Ascites; Liver Cirrhosis

Summary: primary:to evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. secondary:to evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites. the one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (pasccal-2).


Eligibility criteria:
inclusion criteria: * participants with cirrhosis of the liver * participants with clinically evident ascites primarily managed by diet and/or diuretics * stable treatment of ascites for at least the previous 2 weeks without paracentesis * participants having undergone no more than one therapeutic paracentesis in the previous 6 months. exclusion criteria: * participants with an existing functional transjugular intrahepatic portosystemic shunt (tips) or other shunt * known hepatocellular carcinoma * participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma * participants previously exposed to satavaptan in the past 12 months

Keywords: ascites liver cirrhosis