Kornimate/medical-research-clean huggingface dataset:
milk products in the treatment of hypophosphatemic rickets

Conditions: Hypophosphatemic Rickets

Summary: the aim of this study was to investigate the feasibility and efficacy of a high intake of milk and/or cheese products compared to phosphate tablets in patients with hypophosphatemic rickets when evaluating the s-phosphate levels as a main effect parameter. the study was designed as a randomized, multiple crossover study.

objectives: standard treatment of hypophosphatemic rickets consists of oral phosphate tablets and vitamin d analogous. due to their rapid absorption, serum-phosphate fluctuations can occur and secondary hyperparathyroidism may be a consequence. our aim was to evaluate, if phosphate supplement administered as milk or cheese is superior or equal to phosphate tablets in patients with hypophosphatemic rickets study population: patients with genetic verified hypophosphatemic rickets were included in the period from august 2015 to june 2016. patients were excluded from the study if they presented with tertiary hyperparathydoism, were treated with cinacalcet or suffered from milk allergy. study design: the study was designed as a randomized, multiple crossover study with three treatment periods consisting of the regular oral phosphate supplement, a high milk intake or a high cheese intake (randomization.com). patients were instructed to discontinue their regular treatment, except for their usual doses of d vitamin analogs, three days prior to sample collection and instead engage in the study treatment. furthermore, they should follow their normal eating habits while undergoing the study treatment, which was controlled by food and liquid registrations. at the phosphate supplement session, the patients were treated with an 800 mg oral phosphor supplement distributed over five times a day independently of any prior treatment dose. at the cheese session, the patients were treated with an estimated phosphate content of 800 mg distributed over 5 meals. at the milk session, the patients were treated with 800 ml of milk daily corresponding to approximately 800 mg phosphor per day. sampling: after three days of treatment, the patients visited our clinic for anaerobically handled blood samples, which were collected 5 times through out one day for calcium, phosphate, parathyroid hormone, fibroblast growth factor 23 and basic phosphatase. urine samples for calcium and phosphate was collected in containers from 0800 to 1200 and from 1200 to 1600. a 24-hour urine samples was obtained from the day before the sampling from 0800 to 0800 hours the following morning.

Eligibility criteria:
inclusion criteria: * genetic verified hypophosphatemic rickets. * in treated with oral phosphate tablets. exclusion criteria: * tertiary hyperparathydoism. * in treatment with cinacalcet. * suffered from milk allergy.
prothrombotic biomarkers and ovarian stimulation

Conditions: Sterility, Female; Reproductive Technology, Assisted

Summary: the aim of this study is to assess the impact of different protocols used for ovarian stimulation during in vitro fertilization procedures (ivf) on prothrombotic biomarkers (blood coagulation markers associated with thromboembolic events) in the units of reproductive medicine in two university hospitals (hug, geneva and chuv, lausanne).

hemo-stim is a prospective multicentric cohort study of subfertile women undergoing art. it is an epidemiologic observational study. all women older than 18 years attending the reproductive medicine unit (umreg, geneva, hug or umr, lausanne, chuv) and undergoing an ivf have been and will be recruited consecutively and included. the type of stimulation protocol used is recorded. all measurements (specific haemostasis test with a thrombin generation assay before and after adjunction of apc) that are part of the study will be performed in the hug laboratories in order to limit inter-dosage variability. the 1st blood test will be performed at inclusion in the absence of any hormonal treatment (t1). a 2nd blood test will be performed on the day of ovulation triggering (t2). a 3rd blood test will be performed 7 days after ovulation triggering (t3). the comparison of different protocols has never been performed and data on the effect of antagonist protocols for ivf on haemostasis are lacking. the measurement of intermediate biomarkers of thromboembolic risk during different ivf stimulation protocols (agonists and antagonists) would allow the comparison of their thrombotic profile and to optimize the risk/benefit ratio during art by prescribing protocols at lower vascular risk, in particular in women identified as being at risk for thromboembolic events.

Eligibility criteria:
inclusion criteria: * women older than 18 years * sub-fertile and undergoing ivf exclusion criteria: * \>43 years old

Keywords: ovarian stimulation thrombin generation haemostasis thrombosis
prevalence of two major geriatric syndromes: sarcopenia and frailty

Conditions: Sarcopenia; Frailty; Frailty Syndrome

Summary: sarcopenia and frailty are two major syndromes in older adults. they are shown to be associated with low levels of functioning and higher rates of morbidity and mortality. in this study, we aim to report the prevalence of sarcopenia and frailty by using simple assessment methods such as sarc-f and frail, respectively.


Eligibility criteria:
inclusion criteria: * being at the age of 65 or older exclusion criteria: * \<24 points on mini-mental state examination * 12 points or higher on geriatric depression scale
postoperative complications following total knee arthroplasty

Conditions: Arthroplasty, Replacement, Knee

Summary: the aim of this study is to investigate the effect of combined spinoepidural and general anesthesia on the incidence of postoperative complications following total knee arthroplasty

total knee arthroplasty is known to cause complications (pulmonary thromboembolism, acute kidney injury, arryhthmias and infection). the investigators aimed to study the effects of two different anesthesia techniques, i.e. combined spinoepidural anesthesia and general anesthesia on the incidence of postoperative complications such as arrhythmia, pulmonary thrombeoembolism, infection, acute kidney injury and mortality.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective unilateral total knee arthroplasty exclusion criteria: * patient refusal * scheduled for bilateral or unilateral unicondylar knee arthroplasty * known history of allergy to drugs used in the study * severe systemic disease * morbid obesity (bmi\>30) * history of renal dysfunction

Keywords: total knee arthroplasty general anesthesia neuraxial anesthesia complications
lipid layer thickness pre and post lid scrubs with cliradex

Conditions: Dry Eye

Summary: tears play a vital role in vision. a thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision. there are several layers to the tear film, and the outer most layer is comprised of lipids. this lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye. cleaning eyelids with cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with cliradex wipes.


Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. have not worn contact lenses in the past month; 5. has symptomatic dry eye with speed questionnaire score ≥6; 6. corneal staining grade ≥2 on the oxford scale. exclusion criteria: 1. has any known active ocular disease and/or infection; 2. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 3. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 4. have used rewetting drops for a period of 2 days prior to screening visit; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment by verbal confirmation at the screening visit; 7. is aphakic; 8. has undergone refractive error surgery; 9. has taken part in another (pharmaceutical) research study within the last 30 days.
liposomal bupivacaine versus bupivacaine plain for operative pain management of forefoot surgery

Conditions: Liposomal Bupivacaine; Postoperative Pain; Forefoot Surgery; Opioid Use; Bunion

Summary: prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine hcl for postoperative management. upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/ml) of bupivacaine hcl or 8cc (13.3 mg/ml) liposomal bupivacaine, both considered routine care procedure. thereafter, postoperative pain will be assessed and measured using a visual analog scale (vas) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. in addition, the amount of oral morphine equivalents (ome) required postoperatively and time to first use of ome will be measured. our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less omes.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, greater than 18 years of age * asa class i or ii * ability to take oral medication in order to assess the patient's opioid regimen postoperatively * forefoot surgery, including bunionectomy +/- digital surgery * for females of reproductive potential: hcg levels will be determined during the pre-operative period. females of childbearing age require a hcg level below 5miu/ml in order to participate in the study. hcg levels above 25 miu/ml is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study exclusion criteria: * chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week * prescription for ssris, gabapentin, duloxetine within 3 days of surgery * systemic glucocorticoids within 1 month of study enrollment * history of hepatitis * history of peripheral vascular disease * history of diabetes mellitus type 1 or 2 * pregnancy or lactation * allergic to opioids * known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to paba * bmi \> 40
a study of incb050465 in relapsed or refractory mantle cell lymphoma previously treated with or without a bruton's tyrosine kinase (btk) inhibitor

Conditions: Lymphoma

Summary: this is a phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (mcl) previously treated either with or without a bruton's tyrosine kinase (btk) inhibitor.


Eligibility criteria:
inclusion criteria: * men and women, aged 18 years or older. * documented failure to achieve at least partial response (pr) with, or documented disease progression after, the most recent treatment regimen. * radiographically measurable lymphadenopathy or extranodal lymphoid malignancy. * eastern cooperative oncology group (ecog) performance status of ≤ 2. exclusion criteria: * history of central nervous system lymphoma (either primary or metastatic). * prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (pi3kδ) inhibitors, or a pan pi3k inhibitor. * allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment. * active graft-versus-host disease. * liver disease: participants positive for hepatitis b surface antigen or hepatitis b core antibody will be eligible if they are negative for hepatitis b virus-deoxyribonucleic acid (hbv-dna). participants positive for anti-hepatitis c virus (hcv) antibody will be eligible if they are negative for hcv-ribonucleic acid (rna).

Keywords: mantle cell lymphoma non-hodgkin lymphoma bruton's tyrosine kinase (btk) phosphatidylinositol 3-kinase (pi3k)
reducing 30-day admissions in post-discharge subjects (readmit)

Conditions: Acute Decompensated Heart Failure

Summary: the purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (hf) changes in physiologic data are expected to correlate with 30-day readmission rates in this population

this is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic hf subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge the data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the united states and one (1) study site in australia the study objectives are: * collect and characterize physiologic data from subjects with acute decompensated heart failure. * characterization of data related to health care utilizations within 30-days post-discharge * correlation between patch monitor collected data and inpatient clinical data * correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)

Eligibility criteria:
inclusion criteria: * subject with acute decompensated heart failure * subject (or legal guardian) willing to give consent for their participation * subject ≥18 years of age exclusion criteria: * subject who is expected to receive a heart transplant or a ventricular assist device within 6 months * subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ecg lead ii orientation) * subject with known allergies or hypersensitivities to adhesives or hydrogels * subject with implantable devices with active minute ventilation sensors. * subject who will not comply to study protocol requirements. this includes completing required data collection, and attending required follow up study visits.

Keywords: heart failure
single dose pharmacokinetics of repaglinide, metformin and combination tablet in healthy volunteers

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to compare repaglinide and metformin administered as an individual tablets with repaglinide and metformin administered as a combination tablet.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers (female not pregnant, lactating or breastfeeding) * bmi (body mass index) between 19-29 kg/m\^2, both inclusive * fasting plasma glucose from 70-115 mg/dl * subject is judged to be in good health on the basis of their medical history, physical examination, ecg (electrocardiogram), and routine laboratory data exclusion criteria: * any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease * clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening * positive results on screening for hepatitis b surface antigen, hepatitis c antibody and hiv (human immunodeficiency virus) antibody * positive results on the drug abuse/alcohol screen * any regular use of prescription or nonprescription drugs, including mega-vitamin, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to visit 2 (trial product administration) and for the duration of the study * subject is currently a smoker (more than one cigarette per day or equivalent) * use of grapefruit or grapefruit juice within 7 days of trial product administration * blood donation, surgery or trauma with significant blood loss (500 ml) within the last 2 months prior to dosing
neural and cognitive correlates of pragmatic abilities

Conditions: Right Hemispheric Stroke; Left Hemispheric Stroke; Traumatic Brain Injury; Right Hemispheric Brain Tumor; Left Hemispheric Brain Tumor; Mild Cognitive Impairment; Healthy

Summary: pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. disorders in the pragmatics of language are prevalent in various clinical populations. they are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation. this study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective rehabilitation plans.

to delineate the pragmatic deficit profile for each pathology group, eligible participants will undergo a neuropsychological assessment, subdivided into as many sessions as per the participant's availability and tolerance. assessment tools will include: * apacs (a test for the assessment of pragmatic abilities and cognitive substrates; arcara and bambini, 2016) * set (story-based empathy task, dodich et al., 2015) * coast (communication outcome after stroke, bambini et al., 2016) * pwb (psychological well-being scales, sirigatti et al., 2009) * other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the institution. resulting test scores will be statistically analyze to provide pragmatic and cognitive profiles for each pathology.

Eligibility criteria:
inclusion criteria: * presence of objective neuropsychological assessment using standardized tests used in clinical routine. * ability to knowingly provide written informed consent and , therefore preserved comprehension skills and good understanding of simple verbal requests (for the experimental phase). * being a native speaker of italian. exclusion criteria: * presence of disability that impairs participation in research. * insufficient knowledge of the italian language. * refusal to participate in the research. * other relevant prior neurological or psychiatric conditions (other than those determining membership in the experimental group). * comorbidity of multiple conditions that would determine membership in more than one experimental group. * comorbidity with other neurological conditions. * presence of prior psychiatric conditions.
posterior assisted levitation of dropped nucleus

Conditions: Cataract

Summary: dropping of nucleus is a common complication during cataract extraction by phacoemulsification. the investigators describe a new technique to retrieve the dropped nucleus by using an instrument called pars plana levitator (asico-llc, usa).

upon recognition of posterior capsular rupture and dropping of nucleus phaco prob will be withdrawn, status of the nucleus will be visualized by posterior segment non contact lens and if the nucleus found floating, pars plana levitator will be introduced through temporal pars plana, its prongs will be opened and nucleus will be grasped between prongs. nucleus will be lifted up till the anterior chamber where phacoemulsification will be performed in a usual manner and a posterior chamber intraocular lens will be implanted if possible in the remaining bag.

Eligibility criteria:
inclusion criteria: * patients during cataract surgery whose nucleus will be dropped during phacoemulsification exclusion criteria: * completely dropped nucleus touching the posterior pole

Keywords: posterior assisted levitation pars plana dropped nucleus cataract complication of surgery
1068gcc evaluate efficacy & explore mechanism of acupuncture in treating bortezomib-induced peripheral neuropathy (bipn) in multiple myeloma

Conditions: Peripheral Neuropathies; Multiple Myeloma

Summary: patients are asked to be in this study if they have multiple myeloma and are having tingling, numbness and pain from taking bortezomib (velcade®). patients who have been diagnosed with multiple myeloma often take bortezomib (velcade®). this research is being done to find out if acupuncture can reduce the nerve pain, tingling, and/or numbness patients experience due to bortezomib (velcade®). acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. it has been used widely to treat pain, such as lower back pain and nerve pain. in this study we will see if acupuncture can be used to ease nerve pain and tingling, numbness that is caused by bortezomib.

information gained from this clinical trial will provide insight into the efficacy and mechanism of acupuncture in reducing bortezomib-induced peripheral neuropathy (bipn) in multiple myeloma patients. it will examine the effect of acupuncture on serum proinflammatory cytokine and β-endorphin levels to further understand the mechanism of acupuncture on a molecular level. this study is the first clinical trial studying the effect of acupuncture on treating bipn. it is also the first study to explore the mechanism of acupuncture through frequent small amount of blood draws at six time points to detect changes in proinflammatory cytokines and β-endorphins. it has the potential to identify a minimal risk non-pharmacological intervention to alleviate bipn symptoms, and to significantly improve our understanding of the mechanism of acupuncture.

Eligibility criteria:
inclusion criteria: * documented diagnosis of multiple myeloma. * greater than or equal to grade 2 bipn as defined by the national cancer institute - -common toxicity criteria (nci-ctc) 4.0. * bipn symptoms persist after bortezomib has been discontinued. * eastern cooperative oncology group (ecog) performance status 0-3. * men and women who are ≥ 18 years old * the patient is aware of the nature of his or her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. exclusion criteria: * prior acupuncture within the past month. * life expectancy is \< 3 months. * plan to go on experimental drug for multiple myeloma that is known to cause peripheral neuropathy in the next 14 weeks. * concomitant treatment with chemotherapy, unless approval is given by the principal investigator.

Keywords: acupuncture therapy bortezomib-induced peripheral neuropathy