Kornimate/medical-research-clean huggingface dataset:
step-down of inhaled corticosteroids (ics) in non-eosinophilic asthmatics

Conditions: Asthma

Summary: there is growing evidence that non-eosinophilic asthmatics are less sensitive to inhaled corticosteroids (ics) than eosinophilic asthmatics. as non-eosinophilic asthmatic patients are treated by ics according to international guidelines for asthma, the investigators would like to investigate whether stepping-down of ics in these patients may be safe. indeed, the investigators can reasonably expect that a progressive cessation of ics is possible in some of these patients without any clinical worsening.

for patients whose asthma is not controlled at the beginning of the study, a step-up of the treatment is planned to the step 4 of global initiative for asthma (gina). this step-up will last for 3 months and will permit to ensure that these patients achieve the best possible level of asthma control. a progressive step-down of the inhaled corticosteroids (ics) will then be achieved. for patients whose asthma is controlled at the beginning of the study, a progressive step-down of the ics will be directly achieved. the progressive step-down of the ics dose will be undertaken every 3 months according to the dose levels defined by gina guidelines (from high to low daily dose) until a complete cessation of the ics for 6 months. other associated asthma treatment of asthma will be kept unchanged. at each quarterly visit, a clinical composite outcome will be measured, for each patient. this composite outcome includes the score of asthma control questionnaire (acq) and the number of exacerbations. this outcome will determine at each visit if patients continue the study (success criterion) or stop the study (failure criterion). the success criterion is defined in the section "current primary outcome"

Eligibility criteria:
inclusion criteria: * at least 18 years of age * physician-diagnosed asthma based on the presence of typical symptoms (wheezing, breathlessness, chest tightness, cough) * asthma confirmed by: * forced expiratory volume in 1 second (fev1) increase of at least 12% and 200 ml after inhalation of 400 mcg salbutamol * and/or a provocative concentration of methacholine causing a 20% fall in fev1 (pc20m) less than 16 mg/ml * sputum eosinophils rate less than 3% * absolute blood eosinophils count less than 400 per mm3 * treatment with a stable dose of inhaled corticosteroid (ics) for the previous three months exclusion criteria: * high risk of asthma-related death, defined by: * near-fatal asthma history, requiring a stay in an intensive care unit * current using or recent discontinuation (four weeks) of oral corticosteroids (ocs) * treatment with omalizumab * pregnant women

Keywords: non-eosinophilic asthma inhaled corticosteroids step-down
impact of palliative transfusions on quality of life in patients with blood cancers on hospice

Conditions: Hematologic Malignancy

Summary: the purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.

this is a non-randomized pilot study to investigate the feasibility of symptom-based blood transfusion in patients with hematologic malignancies enrolling in hospice care. the study will be a case series involving ou medical center (oumc). patients will be identified at the university of oklahoma/stephenson cancer center (ou-scc) where investigators performing the study will consent and monitor patients. integris home hospice agency will provide hospice patients with blood transfusions in those willing to participate, and the oklahoma blood institute (obi) will provide the hospice patients with palliative transfusions at home at no cost to the patient, including blood products, transfusion testing, infusions and the nursing staff. this will be a pilot project including 20 consented patients with hematologic malignancies enrolling in hospice through integris home hospice. the transfusions received will be determined by the hospice team, and will not be based on objective symptom based guidelines. patients will have the option to either be enrolled on this clinical trial, where they may receive home based blood or platelet transfusions, or be enrolled in any other hospice of their choosing, including the other hospice that will provide home based transfusions. information will be collected regarding symptoms, hospice qol scores and transfusion use, reactions, and time in hospice. data will be collected until death.

Eligibility criteria:
patients \>= 18 years irrespective of their race, sex and/or other medical history. inclusion criteria: * all patients \>= 18 years with a primary diagnosis of acute myeloid leukemia (aml), acute lymphoblastic leukemia (all), chronic lymphocytic leukemia (cll), chronic myelomonocytic leukemia (cmml), "high risk" non-hodgkin's lymphoma (nhl), multiple myeloma (mm) and myelodysplastic syndrome (mds) with a life expectancy of \< 6 months who are transfusion dependent. criteria for transfusion dependence is symptom questionnaire symptom grade 2 or higher. the symptom questionnaire is based on ctcae (common terminology criteria for adverse events) v5.0, with criteria modified for palliative care patients. * patients wanting to enroll in hospice. * availability of peripheral iv access line or patient agrees to have semi-permanent iv line placed. exclusion criteria: * patients with \> 6-month survival. * patients unwilling to go on hospice. * patients with antibodies to blood or platelets that would preclude ability to give blood/platelets without prolonged blood typing and or need for anti-hla platelets.

Keywords: hospice
evaluation of clinical and biomechanical correlation during return to sport after anterior cruciate ligament injury

Conditions: ACL Injury

Summary: comparison of two groups of subjets (acl injury who return to sport) and control group non-injured about clinical and biomechanical data : * clinical test * functional test * motion analysis of 2 sport exercises * tibial translation * isokinetic evaluation

acl injury in sport practice is frequent and after surgery subjects want to return to sport. re injury during return to sport is significant and clinical and biomechanical risk factors are described. but no study investigate link between clinical and biomechanical during this risk period. the study will search to highlight correlation between clinical and biomechanical factors. investigators will realize clinical evaluation (pain, translation) and functional tests (single hop test, triple hop test, 6m time hop test, crossover test). for biomechanical data, investigators will test 2 exercises in motion analyse laboratory (drop vertical jump and cutting task), a translation knee test with gnrb and isokinetic evaluation. investigators will compared results of injured subjects with a control group non-injured.

Eligibility criteria:
inclusion criteria: * surgeon repair acl injury ; sport practice ; signed informed consent exclusion criteria: * for injury subjects: pain during cutting tasks ; associated injury with acl rupture * for healthy subjects: history of acl injury

Keywords: acl injury return to sport motion analysis isokinetic evaluation risk factor
relative oral bioavailability of telmisartan / hydrochlorothiazide (hctz) fixed dose combination (fdc) compared with its monocomponents in healthy subjects

Conditions: Healthy

Summary: a study to demonstrate the bioequivalence of telmisartan and hctz administered as fixed dose combination in comparison to the single unit formulations


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice (gcp) and local legislation * age ≥ 18 and ≤ 55 years * broca ≥ -20 % and ≤ +20 % exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram (ecg)) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastro-intestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * supine blood pressure at screening of systolic ≤ 110 mmhg and diastolic ≤ 60 mmhg * history of orthostatic hypotension, fainting, spells or blackouts * chronic or relevant acute infection * history or allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24 hours) ≤ 1 month prior to administration or during the trial * use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on study days * alcohol abuse (\> 60g/day) * drug abuse * blood donation (≤ 1 month prior to administration or during the trial) * excessive physical activities (≤ 5 days prior to administration or during the trial) * any laboratory value outside the reference range of clinical relevance * hypersensitivity to telmisartan and/or hctz and/or related classes of drugs for female subjects: * pregnancy * positive pregnancy test * no adequate contraception (e.g. sterilization, intrauterine device (iud), oral contraceptives) * inability to maintain this adequate contraception during the whole study period * lactation period
immediate mobilization after plate osteosynthesis of proximal tibial fractures - a cohort study

Conditions: Surgery--Complications; Tibia Fracture; Early Ambulation

Summary: the purpose of this study is to investigate if immediate mobilization with weight bearing as tolerated following surgery with plates and screws after a fracture of the shinbone near the knee is possible without increased risk. the investigators hypothesize immediate weight bearing as tolerated following surgery with plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.

the purpose of this study is to investigate immediate mobilization with weight bearing as tolerated following plate osteosynthesis after a proximal tibial plateau fracture is possible without increased risk of loss of reduction and/or failure of the osteosynthesis. subsequently, this may lead to earlier recovery and less risk of thromboembolic complications. the investigators hypothesize immediate weight bearing as tolerated (wbat) following plate osteosynthesis after a proximal tibial plateau fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction. exposure will be defined as surgery with one or two angular stable plates (closed reduction, internal fixation) after a proximal tibial fracture. patients will be allowed immediate weight bearing as tolerated in cases where the osteosynthesis is deemed stable. this represents the current practice at slagelse hospital. typical, all lateral tibia plateau fractures (ao fracture classification 41b1-3) osteosynthesized will be allowed immediate wbat after surgery. other tibia plateau fractures will be allowed immediate wbat if the osteosynthesis is deemed stable by the surgeon perioperatively. fractures are treated with one or several locking plates, and if needed after reduction of the tibial plateau, an impacted allogenic bone graft is used. the bone graft is applied through a cortical window osteotomy distal to the fracture. follow up will be performed at 2 weeks, 6 weeks, 3 months, 6 months and 1 year by any of the authors or a consultant in orthopedics. follow up will be performed at the outpatient clinic.

Eligibility criteria:
inclusion criteria: * patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture exclusion criteria: * non-ambulatory patients, * patients diagnosed with dementia and * patients residing to another hospital
safety and efficacy of yb-1113 in treatment of poi

Conditions: POI

Summary: this phase 1 study is to evaluate the safety and tolerability of yb-1113 administered via intravenous (iv) infusion in the treatment of premature ovarian insufficiency (poi).


Eligibility criteria:
key inclusion criteria: 1. female, 18 to \<40 years old, who are seeking fertility or preservation of fertility 2. oligo/amenorrhea for at least 4 months 3. at least two menopausal fsh levels (≥ 25 iu/l) with 4 to 6 weeks interval. 4. amh levels ≤ 1.0 ng/ml (measured on day 2-5 of the menstrual period). 5. subjects who are generally healthy by laboratory tests (normal complete blood count (cbc), comprehensive metabolic panel (cmp), and urinalysis) at screening 6. for subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (ocp) or more than 6 months after discontinuation of depo provera (or similar) therapies key exclusion criteria: 1. 1. primary amenorrhea or fsh ≥ 40 iu/l 2. presence of contraindications to pregnancy 3. poi due to cytotoxic chemotherapy or radiation therapy 4. subjects with fmr1 premutation (fragile x syndrome), a bmp15 mutation or family history of poi 5. subjects under hormonal treatments including hormone replacement therapy (hrt) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology. 6. washout period less than 3 months for hrt. 7. subjects with a history of breast cancer or other estrogen responsive cancer. 8. subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm. 9. subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease 10. subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (pcos) 11. subjects with endocrinopathies including cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia. 12. subjects under active management for autoimmune disease. 13. subjects with intra-uterine devices (iuds). 14. subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study. 15. subjects who are allergic to low-molecular-weight heparin sodium or human albumin. 16. subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent 17. subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, von willebrand disease, liver disease, vitamin k deficiency, and platelet disorders.
magnesium sulfate versus indomethacin for preterm labor

Conditions: Labor, Premature

Summary: the purpose of this study is to investigate the efficacy of indomethacin compared to magnesium sulfate (mgso4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. the specific aim of the project is to test the hypothesis that indomethacin, compared to mgso4, will decrease the proportion of neonates diagnosed with major complications or death.


Eligibility criteria:
inclusion criteria: * initial episode of preterm labor for enrollment * the diagnosis of preterm labor * gestational age between 24 and 32 weeks * singleton or twin gestation * the ability to understand the requirements of the study exclusion criteria: * cervical dilation \>5 cms * suspected chorioamnionitis * fetal distress * vaginal bleeding * severe pre-eclampsia * history of gastrointestinal bleeding * abnormal renal function * suspicion of fetal malformation by ultrasound * known allergy to, or intolerance of, magnesium sulfate and/or indomethacin * documented rupture of amniotic membranes * multiple gestations of triplets or more.
effect of three different doses of oral cholecalciferol on 25-hydroxyvitamin d changes among epilepsy patients with hypovitaminosis d

Conditions: Epilepsy

Summary: to characterize the effect of three different doses of vitamin d3 supplementation on serum 25-hydroxyvitamin d (25(oh)d) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (eiaeds) versus patients receiving non enzyme-inducing antiepileptic drugs (non-eiaeds), and to determine the prevalence of and risk factors for hypovitaminosis d among thai patients with epilepsy.

a single-blinded prospective, randomized study undertaken at epilepsy clinic of king chulalongkorn memorial hospital. the patients with hypovitaminosis d were included and divided into two groups according to the type of aeds use. patients receiving each aeds type were randomly assigned to receive vitamin d3 1000, 3000 or 6000 iu once daily. the mean increment in serum 25(oh)d levels were measured at 8 and 16 weeks.

Eligibility criteria:
inclusion criteria: * epilepsy patients, age ≥ 15 years, bmi18 - 30 kg/m2 * being treated with either enzyme inducing antiepileptic drugs (eiaeds: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (non-eiaeds: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year. * serum 25(oh)d \<30ng/ml exclusion criteria: * patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin d.

Keywords: antiepileptic drugs vitamin d deficiency asian
comparison of the short-term outcomes of using dst and pph staplers in the treatment of grade iii and iv hemorrhoids

Conditions: Bleeding; Stricture

Summary: the hemorrhoidal disease affects approximately 4.4%-36% of the general population, and it has been estimated that \>50% of the population aged \>50 years experiences hemorrhoidal problems . traditional hemorrhoidectomy, including milligan-morgan, ferguson, and whitehead procedures , are known to cause significant postoperative pain and discomfort and result in a poor quality of life after operation. since the first introduction of the novel procedure hemorrhoidopexy by longo in 1998, it has been considered as a safe procedure causing less postoperative pain and resulting in earlier recovery; furthermore, the patients are able to resume their normal daily life and work. the pph stapler (ethicon endo-surgery, inc. cincinnati, oh, usa) was also first introduced in 1998 as a device to perform this procedure. subsequently, a new device, the dst stapler (covidien, mansfield, ma, usa), was introduced in 2008 with some structural differences, including a detachable anvil, three anchor points over different levels, a larger case, and different agraffe sizes. however, the majority of current studies have been focusing on the use of pph stapler for hemorrhoidopexy, and comparison with the dst stapler has been rarely discussed. one randomized controlled trial that compared between the pph stapler and the dst stapler reported that the dst stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse; however, that trial focused only on bleeding among the postoperative complications. currently, only a limited number of studies have compared these two devices in terms of pain, complications, and anorectal stricture incidence rate. the present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade iii and iv hemorrhoids who were treated with either the pph or the dst stapler. the specimen surface area and the relationships with complications were also analyzed.


Eligibility criteria:
inclusion criteria: * grade iii and grade iv hemorrhoid exclusion criteria: * anal fistula, rectal polyo\\p
a study of jnj-53718678 in participants with hepatic impairment

Conditions: Hepatic Impairment

Summary: the main purpose of the study is to evaluate the pharmacokinetc (pk) of a single oral dose of jnj-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: * a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta-hcg\]) test at screening and on day -1 of the treatment period * contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies * if a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug * a male participant must agree not to donate sperm for the purpose of reproduction from day -1 of the study and for a minimum of 90 days after receiving the study drug * for participants with mild, moderate or severe hepatic impairment: the participants must have a total child-pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). the investigator will determine degree of hepatic impairment exclusion criteria: * known allergies, hypersensitivity, or intolerance to jnj-53718678 or its excipients * donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[ml\]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study * received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled * any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments * preplanned surgery or procedures that would interfere with the conduct of the study
understanding sleep in hospitalized older patients

Conditions: Sleep Deprivation; Sleep Fragmentation

Summary: the overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health outcomes. we hypothesize that environment, healthcare disruptions and patient symptoms will be significantly associated with objective and subjective sleep duration and sleep quality in hospitalized older patients. we also hypothesize that a high level of perceived control will be associated with improved sleep duration and quality in hospitalized older patients. we further hypothesize that shorter sleep duration and quality in hospitalized older adults will be associated with adverse health outcomes, namely higher blood pressure and blood sugar.

this research can lead to a better understanding of the effects of inpatient sleep on health outcomes for hospitalized older patients and can help inform the design and evaluation of interventions designed to improve sleep in hospitalized older patients. this work can also form the foundation for understanding the longer term health effects of inpatient sleep loss for older patients that are potentially modifiable.

Eligibility criteria:
inclusion criteria: * age 50 or above * hospitalized on general medicine service * ambulatory * community dwelling * mmse \>17 exclusion criteria: * transfer from the icu or another hospital * cognitively impaired * not ambulatory * residents of a nursing home or skilled nursing facility * on bedrest * documented sleep disorder in their medical history

Keywords: aged sleep deprivation actigraphy ambulatory monitoring