Kornimate/medical-research-clean huggingface dataset:
mandibular advancement device on sleep quality in obstructive sleep apnea patients

Conditions: Sleep Apnea, Obstructive

Summary: sleep is an important factor that influences long-term quality of life with known health consequences. obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public health problem. treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. there is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. this pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.

design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. the care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. demographic and anthropometric data will be collected. the dental status of the temporo-mandibular joint will be assessed. radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of obstructive sleep apnea syndrome * opt for mandibular advancement device as 1st treatment alternative * opt for mandibular advancement device due to intolerance to continuous positive airway pressure exclusion criteria: * patient with orthodontics, malocclusion and periodontal or temporomandibular joint disease who, after assessment by dentistry contraindicates it. * central sleep apnea (more than 50% of central events in the baseline polygraph). * under 18 years old. * pregnancy * comorbidities that can potentially alter sleep architecture. * psychophysical inability to complete questionnaires. * not obtaining informed consent.
management of hyperglycemic patients in emergency medicine department

Conditions: Hyperglycemia; Diabetes Mellitus; Emergencies

Summary: the main purpose of this study is how to manage hyperglycemic patients in emergency departments, to determine the conditions that require blood glucose regulation and to examine the prognosis of the patients in the next 30 days, depending on the regulation method.

the study will be conducted between 15.12.2020 and 15.03.2021. patients over the age of 18 who applied to the emergency department with any complaint and whose blood glucose level\> 300 mg / dl in the examinations (as the finger tip and / or blood biochemistry examination parameter) performed in case of clinical necessity will be included in the study. patients or their relatives (for patients who are unable to give consent) will be asked to read and sign the informed consent form if they accept it. patients' age, gender, history, whether they are diagnosed with diabetes, medications used, vital signs, complaints of admission to the emergency room, hospitalization and definitive diagnosis will be recorded. the study form for the followed-up patients will be added to each patient's file and filled in by the physicians in the patient's follow-up. the following parameters will be included in the work form; 1. age of the patient 2. gender 3. biography 4. presence of diabetes diagnosis, drugs used, if any 5. other medications 6. the complaint of applying to the emergency room 7. whether treatment for hyperglycemia is applied in the emergency department, what treatment is applied 8. how much iv fluid and / or insulin therapy is applied 9. duration of stay in the emergency department 10. results of routine blood tests 11. weight 12. the trend of blood glucose levels in patients treated for hyperglycemia 13. presence of acute complications due to hyperglycemia 14. application and discharge bg levels 15. whether there are classical symptoms of dm before admission to the emergency department 16. whether hypoglycemia develops or not 17. was medication prescribed for dm at the time of discharge? 18. whether he was hospitalized or not. patients will be called 30 days after leaving the emergency room (er). within this period, whether they applied to the emergency service again, if they did, the application complaint, the diagnosis of er discharge, and the treatment method used will be questioned.

Eligibility criteria:
inclusion criteria: * patients over the age of 18, presenting to the emergency department with any complaint and with a glucose level\> 300 mg / dl in blood tests will be included in the study. exclusion criteria: * pregnant, under 18 years of age, patients who were referred to the emergency department by referral from another center, patients who received intravenous glucose treatment, patients using systemic glucocorticoids, hepatic insufficiency, renal failure, adrenal insufficiency, pancreatitis, metastatic carcinoma, patients receiving chemotherapy, patients with instability criteria will not be taken into work.
efficacy of shitali respiratory rehabilitation program in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea has a negative impact on blood pressure of patients, sleeping quality, and respiration

in this study, patients (n=40) with obstructive sleep apnea will participate in this study to be divided in to group i and group ii with an equal number of patients (n = 20 for the group). group i will administer six cycles of 5-min shitali respiratory pranayama exercise rehabilitation training (the rehabilitation will be repeated or applied at morning, afternoon, and also at evening) for 12 week as a daily performance, the other group, group ii, will act as control group.

Eligibility criteria:
inclusion criteria: * non-obese patients * obstructive sleep apnea (mild and moderate form) exclusion criteria: * cardiac patients metabolic diseases kidney diseases
using sodium lactate ringer's injection resuscitate septic shock patients

Conditions: Severe Sepsis With Septic Shock; Lactate

Summary: using sodium lactate ringer's injection resuscitate septic shock patients and compared with other solution, in order to make clear whether can improve the prognosis.

experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. however, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans. the investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation. inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class c , use linezolid anti-infection treatment, pheochromocytoma patients, cvvh therapy patients, malignant tumor patients, using epinephrine. the investigators will use sodium lactate ringer's injection resuscitate septic shock patients and compared with other solution, the organ function monitoring include heart, kidney,and brain. others study endpoints include 28-day mortality,hospitalized mortality.

Eligibility criteria:
inclusion criteria: * diagnosis in patients with septic shock exclusion criteria: * pregnant women and nursing mothers * severe liver failure with child class c * using linezolid * pheochromocytoma * hematologic malignancy * using epinephrine * during cvvh treatment

Keywords: severe sepsis with septic shock, lactate
study to evaluate immunogenicity, reactogenicity and safety of rotarix™ vaccine in korean infants

Conditions: Infections, Rotavirus; Rotavirus Vaccines

Summary: the aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (hrv) rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination. * written informed consent obtained from the parents or guardians of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive. * subjects for whom the vaccination history is available from vaccination diary cards or medical charts. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * gastroenteritis (ge) within 7 days preceding the study vaccine administration. * previous confirmed occurrence of rv ge. * previous vaccination with rotavirus vaccine or planned use during the study period.

Keywords: gastroenteritis
study of ciforadenant in combination with daratumumab in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2a receptors (a2ar), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting cd38, in relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * relapsed or refractory myeloma. * must have been exposed to at least 2 cycles of an imid containing regimen and pi containing regimen and must be refractory to at least one of the two. * must have completed and tolerated 2 cycles of daratumumab or other anti-cd38 targeting antibodies. * active myeloma requiring systemic treatment. * measurable disease per protocol. * ecog performance status of 0 - 2. * life expectancy of at least 3 months. exclusion criteria: * poems syndrome; non-secretory myeloma (no measurable protein on sflc assay); amyloidosis. * history of select prior malignancies. * previous intolerance to daratumumab or any study drug. * received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant. * have an active infection or serious comorbid medical condition. * any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis b or hepatitis c. * female participants pregnant or breast-feeding. * screening chemistry and blood counts within protocol limits * treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
intensified dosing of cellcept (mycophenolate mofetil) in kidney transplantation

Conditions: Acute Rejection of Renal Transplant

Summary: the primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (mmf) results in a greater proportion of individuals adequately exposed as measured by drug levels (area under the curve of \> 40 mg\*hr/l).

several studies have shown that early exposure to adequate levels of immunosuppression are required to reduce acute rejection rates in kidney transplantation.(1, 2) our center has shown that early exposure of mycophenolate mofetil (mmf or cellcept) is associated with acute rejection rates and that many patients are underexposed in the early transplant period.(2) in a recently completed multicenter canadian (clear) study we found that higher doses of mycophenolate mofetil (mmf 3 grams daily versus 2 grams daily) were associated with better early exposure by day 5 and that this was associated with less rejection but no increase in toxicity.(3) the best cut point that discriminated between low and high rejection rates was a mycophenolic acid (mpa) 12 hour area under the curve (auc) of 40 mg\*hr/l. patients below this level experienced rejection rates of 50% compared to \<16% for those above this level. even with the higher dose 26% of subjects were inadequately exposed. since medication adjustments based on drug levels is hampered by steady state conditions and the turn around time of mpa testing we are interested in exploring even higher initial doses of mmf with the aim to maximize the numbers of patients achieving adequate early exposure to mpa. objectives: the primary objective of this study is to determine whether 4 gms daily of mmf results in a greater proportion of individuals adequately exposed as measured by a day 5 mpa auc of \>40 mg\*hr/l. the secondary objectives of this study are to assess the ability of this strategy to achieve target mpa auc exposure of 40-60 mg\*hr/l by day 14 and to determine the distribution of mmf doses that are necessary to achieve this level of exposure. safety data (hemoglobin and wbc counts, need for further dose changes based on gastrointestinal intolerance, acute rejection, renal function, and wound infection) will be also collected over the first 3 months post transplantation.

Eligibility criteria:
inclusion criteria: * patients undergoing single organ kidney transplantation. * age \> 18 years old. * patients who would normally receive our standard therapy of basiliximab, tacrolimus, mmf and steroids. * all patients will be required to sign informed consent. exclusion criteria: * patients will be excluded if they require anti-thymocyte induction therapy, have documented gastroparesis, have known intolerance to mmf, or are prescribed cyclosporine. * as a standard policy all women of childbearing age will be informed about the risks of all immunosuppressive drugs on fetal outcomes and will be required to use 2 forms of birth control.

Keywords: renal transplantation adequate exposure acute rejection mycophenolate mofetil immunosuppression
colorectal polyps screening with low-dose ct colonoscopy

Conditions: Polyps; Colorectal Neoplasm

Summary: this preliminary clinical trial aims to evaluate the performance of the low-dose ct colonoscopy (ctc) with computer aided detection (cad) on polyps detection compared with optical colonoscopy (oc), and explore the possible clinical routine for integrated use of ct colonoscopy and optical colonoscopy oc in colorectal cancer screening.

ct colonoscopy (ctc), also referred to as virtual colonoscopy (vc), utilizes computer virtual-reality techniques to navigate inside a three-dimensional patient-specific colon model reconstructed from abdominal ct images, looking for colonic lesions, full bowel preparation and colon inflation are needed to perform ctc examination. the clinical trial consists of two major parts: 1. comparative study on the performance of ctc and oc: 50 subjects will be recruited in this part with written consents. with full bowel preparation, all the volunteers receive ct scans first with inflated colon, then oc followed by the same day, and necessary pathological analysis thereafter. the performance of ctc based on high-resolution ct data, including the number of polyps detected, size, position, etc, will be validated by that of oc with the paired comparison. 2. integrate use of low-dose ctc with oc for colorectal cancer screening: after the validation of ctc performance, in this part, another 50 subjects will be recruited to explore the integrated use of ctc with oc as a possible and efficient workflow for colorectal cancer screening. in this part, a combination of normal dose and low-dose scan protocols will be employed (e.g., normal dose on supine, low-dose on prone), low-dose ctc based on the low-dose ct scanning protocol and an artifacts reduction technique will be introduced to reduce the radiation risk in screening.

Eligibility criteria:
inclusion criteria: * subjects with gastrointestinal symptoms potentially suggestive of colorectal cancer, such as diarrhea, constipation, abdominal pain or discomfort, rectal bleeding, iron-deficiency anemia, and unintended weight loss. * subjects with pathological confirmed colorectal cancer or polyps that need follow-up examination. * subjects with written consents exclusion criteria: * subjects with acute colitis * acute diverticulitis * inguinal hernia including colon * colorectal surgery or endoscopic biopsy or resection of polyps within 6 months * known or suspected as colon perforated * complete intestinal obstruction * pregnant or lactating women
a real-world study of selinexor-based regimens for treatment of non-hodgkin lymphoma

Conditions: Lymphoma; DLBCL; T Cell Lymphoma

Summary: this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with non-hodgkin lymphoma

this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with dlbcl or t cell lymphoma. this study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. the medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria:
inclusion criteria: * know and voluntarily sign the informed consent form (icf) * clinically confirmed dlbcl, t or nk cell lymphoma * patients with dlbcl or t or nk cell lymphoma who have used selinexor-based therapy in the past 3 months are included * cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials exclusion criteria: * previously received selinexor * poor patient compliance * physicians evaluate that patients are not suitable for enrollment

Keywords: selinexor lymphoma
new oral anticoagulant therapy for the prevention of blood clots following hip or knee replacement surgery

Conditions: Total Knee Replacement; Total Hip Replacement

Summary: ly517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. leg and lung blood clots occur commonly after patients have surgery to replace a hip or knee joint. these clots often occur while patients are in bed in the hospital after hip or knee joint surgery. the purpose of this study is to test if different dose strengths (amount of drug in the capsules) of ly517717 can prevent blood clots from forming and to determine if ly517717 is safe. this study will compare ly517717 to enoxaparin, another blood thinner. enoxaparin is one of the standard medications given after hip or knee joint surgery.


Eligibility criteria:
inclusion criteria: * are scheduled for total knee or hip replacement surgery (only one side, first time joint replacement) * are at least 18 years of age and no more than 75 years of age. * have a body weight more than 50 kg and less than 120 kg. * sign an approved eli lilly and company informed consent document. exclusion criteria: * have had hip or knee replacement surgery in the non-surgical leg or any surgical procedure in the surgical leg within 6 months prior to enrollment. * other surgeries (brain, spinal cord, eye within 12 months; chest or abdominal surgery within 1 month). * have taken drugs that might increase possibility of bleeding. * other risk factors for bleeding (bleeding disorders, abnormal results on blood tests, ulcers) * increased risk for blood clots.

Keywords: elective primary unilateral
health impact study of aquatabs in tamale, ghana

Conditions: Diarrhea

Summary: the purpose of this study to determine whether aquatabs, a water treatment tablet, reduces diarrheal diseases in a peri-urban population of tamale, ghana.


Eligibility criteria:
inclusion criteria: * households with at least one child under 5 years old exclusion criteria: -

Keywords: sodium dichloroisocyanurate water purification disinfection ghana
cardiovascular evaluation of adult pha 1 patients

Conditions: Pseudohypoaldosteronism Type 1

Summary: vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). the study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. the investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

the study includes adult patients with mineralocorticoid receptor mutation as compared with not affected relatives. it includes also relatives of adult relative of patients with pha1 in whom no mutation was found. cardiovascular evaluation is conducted with cardiac and vascular ultrasound assessment and cardiac nmr, ambulatory blood pressure measurement. protocol duration is 2 days . detailed genetic study is conducted in family without identified mutation in mineraloreceptor.

Eligibility criteria:
inclusion criteria: * age over 18 * male or female gender * genotype in the pha1.net network exclusion criteria: * not membership to a regime of social security or to a cmu * against indication in the realization of a mri * cardiac nmr not possible * known cardiovascular disease for person not carrying mr mutation

Keywords: pseudohypoaldosteronism type 1 mineralocorticoid receptor aldosterone cardiovascular disease