Kornimate/medical-research-clean huggingface dataset:
validation and reproducibility of the six-minute step test in individuals with obstructive sleep apnea treated with cpap

Conditions: Obstructive Sleep Apnea

Summary: introduction: the obstructive sleep apnea (osa) is characterized by obstructed superior airway during sleeping period promoting intermittent hypoxia-reoxygenation events. these events cause consequences such as cardiorespiratory and peripheric muscle structure alterations, which can cause reduction of the exercise tolerance. in this sense the continuous positive airway pressure (cpap) is important to decrease the repercussions of the illness and cooperate to maintain the exercise functional capacity. to measure this capacity, one good option is the six-minute step test (6mst), that is low cost and submaximal, in addition to being adaptable and portable. however, there are doubts if it´s really capable to determinate the functional capacity of exercise of individuals with osa treated with cpap. objective: evaluate the validity and reproducibility of 6mst to determine the functional capacity of exercise in individual with osa treated with cpap and develop a model of a reference equation for the performance of the test in this population. material and methods: this is an observational, prospective and cross-sectional study, in which will be evaluated 132 volunteers (66 men and 66 women), with age between 18 and 65 years, diagnosed with osa of moderate and severe degree, treated with cpap for a minimum of three months, recruited of the ambulatory of pneumology of otávio de freitas hospital. initially will be collected personal and anthropometric information, answered to sleep questioners, quality of sleep and physical exercise, also respiratory muscle strength and lung function. the realization of the tests to evaluate the functional capacity of exercise will be done in two days with a maximum of seven days between the tests. in each day, the volunteers will do two 6mst and two six-minute walk test (6mwt), which order will be determined by randomization. expected results: it is expected that the 6mst to be showed as reproducible and capable to quantify the functional capability of exercise in individuals with osa treated with cpap.


Eligibility criteria:
inclusion criteria: * individuals with age between 18 and 65 years; * obstructive sleep apnea on moderate and severe degree (diagnosed by polysomnography); * bmi bigger then 18 and less than 35 kg/m2; * treatment with cpap at least three months, with use of the equipment for a time interval superior of 4h/night during five days per week. exclusion criteria: * individuals with comorbidities such as uncontrolled hypertension and diabetes, orthopedic and neurologic alterations, respiratory disorders such as copd and asthma, or any cardiovascular and respiratory which won't permit the realization of the tests.
d-cycloserine for major depressive disorder

Conditions: Major Depressive Disorder

Summary: for many depression patients treatment changes are required, including switching to another antidepressant and addition of a second antidepressant or a non-antidepressant agent ("augmentation"). the need to modify treatment is usually necessary because of partial or no response to first-line monotherapy or the failure to achieve remission although treatment response (improvement) has been obtained. these caveats of presently available antidepressant drugs highlight the need for innovative pharmacological treatment strategies. recent data suggest that n-methyl-d-aspartate receptor (nmdar) antagonists and partial agonists at the nmdar-associated glycine binding site may represent a novel type of antidepressant medications. these types of compounds protect vulnerable neurons against a variety of insults, including stress-induced damage, and may serve to enhance and maintain normal synaptic connectivity. in animal models, these compounds mimic the effects of clinically effective antidepressants. furthermore, down-regulation of the glycine site of the nmdar was found to be a common feature of currently used antidepressant medications. d-cycloserine (dcs , seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the nmdar-associated glycine site. beneficial antidepressant effects have been reported with 500-1000 mg/day dcs regimens in depressed tuberculosis patients and recent preliminary findings suggest that dcs may also be beneficial in the treatment of major depressive disorder. the antidepressant effects of dcs seem to reflect consequences of its capacity to reduce nmdar receptor function. in the present project, it is proposed to assess, using a random assignment, parallel-group, double blind, placebo controlled design, the effects of a nmdar -antagonist dcs dose regimen, 250 --\> 1000 mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive disorder patients. the study methodology includes the assessment of dcs effects upon symptoms profile, neurocognitive tests performance, amino acids serum levels, and brain electrophysiology parameters associated with the prepulse inhibition-startle response paradigm. it is hypothesized that significant beneficial dcs treatment effects will be registered.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of major depression . * hamd scale score of ≥20 despite at least two adequate antidepressant treatment trials during the current episode. exclusion criteria: * underwent ect treatment during the 3 months preceding the study. * change in psychotropic medications doses during the 3 weeks preceding the study. * concurrent unstable medical or neurological illness. * patients are judged to be potentially violent towards themselves or others, or have a history of drug/alcohol abuse.

Keywords: major depressive disorder nmda receptor treatment-resistant d-cycloserine
a multicenter study to evaluate safety, tolerability, and clinical responses of dsp-1083 into subjects with parkinson's disease

Conditions: Parkinson's Disease

Summary: the goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of dsp-1083. study enrolls both male and female patients in 2 cohorts.this study will be held in approximately 5-6 study sites in north america

this is a multicenter first-in-human (fih) study designed to evaluate the safety, tolerability, and clinical responses following implantation of dsp-1083 compared with sham surgery. safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks. ss1 cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. ss2 and ss3 will undergobilateral implantation of dsp-1083 in a single surgical procedure.

Eligibility criteria:
1. men or women aged ≥ 40 and \< 70 years with a clinically establisheddiagnosis of parkinson's disease in accordance with the movement disorder society (mds) clinical diagnostic criteria for parkinson's disease. 2. subject has a diagnosis of pd for ≥ 5 years. 3. subject has suboptimal control of pd symptoms, or intolerable side-effects with optimized oral antiparkinsonian medication regimen for ≥ 3 months, including treatment with l-dopa and at least one medication that increases the effects of l-dopa . 4. subject has a l-dopa response of ≥ 30% without the influence of antiparkinsonian medications at screening. 5. subject has a modified hoehn and yahr stage 3 - 4 in the off medication state. 6. subject has a pretreatment 18f-dopa pet scan consistent with pd. 7. subject has both on and off states as demonstrated by the mds-updrs part iii and the hauser patient daily diary. 8. subject must meet the following ethnicity criteria: * ss1 will either be asian defined as having both parents and 4 grandparents who are ethnically asian, or non-asian. * ss2 and ss3 will be asian defined as having both parents and 4 grandparents who are ethnically asian. * cohort 2 subjects will be of any ethnicity. 9. subject is approved by the sponsor eligibility committee following review of all required information collected during screening and prior to surgery on day -1.
study to evaluate safety, tolerability, and pharmacokinetics of bfkb8488a in otherwise healthy overweight and obese participants with likely insulin resistance

Conditions: Insulin Resistance

Summary: this study will evaluate the safety and tolerability profile of bfkb8488a following subcutaneous (sc) administration in overweight and obese participants (body mass index \[bmi\] greater than \[\>\] 27 to less than or equal to \[\</=\] 40 kilograms per square meter \[kg/m\^2\]) with markers of insulin resistance. single ascending fixed doses of bfkb8488a will be evaluated. participants will be randomized into 7 sequential ascending fixed-dose cohorts of bfkb8488a sc or placebo and safety reviews will be performed before escalation to higher dose cohorts. additionally, following the ascending fixed-dose sc cohorts, a separate cohort will open to evaluate the pk of bfkb8488a after intravenous (iv) administration.


Eligibility criteria:
inclusion criteria: * participants with bmi \>/=30 kg/m\^2 and \ 27 kg/m\^2 and \ 3.60 or waist circumference \>100 centimeters (cm) (males) or 88 cm (females) or fasting plasma insulin \>/=15 milli international unit per liter (miu/l) or fasting plasma glucose \>/=100 milligrams per deciliter (mg/dl) and \ 5.6 percent (%) and \<6.5% * negative pregnancy test exclusion criteria: * a diagnosis of type 2 diabetes mellitus at any time * pregnant, lactating or intending to become pregnant during the study or within 3 months after the study dose is administered * uncontrolled intercurrent illness or any psychiatric illness * participants actively involved in a weight loss or dietary program within the last 6 months * history of surgical procedures for weight loss * history of eating disorder * uncontrolled hypertension (systolic \>/=140 millimeter of mercury \[mmhg\] or diastolic blood pressure \>/=90 mmhg) either on or off therapy at screening or day -2 * fasting triglycerides \>500 mg/dl (5.64 millimoles per liter \[mmol/l\]) or low density lipoprotein (ldl) \>160 mg/dl (4.14 mmol/l) at screening * any serious medical condition or abnormality in clinical laboratory tests
lifestyle interventions for the treatment of non-alcoholic fatty liver disease in overweight and obese adults

Conditions: Non-Alcoholic Fatty Liver Disease; Obesity

Summary: lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (nafld) patients. weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. however, the options for treatment in the clinics are limited. therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in nafld patients.

this is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (nafld) patients. in this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (le), and intensive lifestyle intervention with low-carbohydrate diet (ili), aiming to induce a loss ≥ 10% of initial weight in 3 months. the remainder will chose the treatment which they prefer according to the clinical practice. at the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of nafld in different lifestyle intervention groups.

Eligibility criteria:
inclusion criteria: * man or women aged 18-65 years; * confirmed diagnosis of nafld according to the 2018 chinese guidelines for prevention and treatment of nafld; * body mass index (bmi)of 25.0 to 35.0 kg/m2; * patients without medicine for treatment of nafld; exclusion criteria: * patients with other diseases that can lead to fatty liver; * patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months; * patients with serious liver dysfunction (ast or/and alt \>3 times of the upper limit of normal), or renal dysfunction (serum creatinine \>the upper limit of normal); * patients with diseases that need control of dietary protein intake; * patients with diseases that affect food digestion and absorption; * patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/l and/or random blood glucose ≥11.1 mmol/l); * patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment; * patients with secondary obesity; * patients with cancer, active tuberculosis, aids and other infectious diseases; * pregnancy or lactation; * physical disability.

Keywords: lifestyle interventions low-carbohydrate diet
proquad® intramuscular vs subcutaneous

Conditions: Measles; Mumps; Rubella; Varicella

Summary: primary objective: to demonstrate that two doses of proquad® administered by im route are as immunogenic as two doses of proquad® administered by sc route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of proquad® secondary objectives: * to describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of proquad® administered by im or sc route, * to describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of proquad® both administered by im or sc route, * to describe the safety profile of two doses of proquad® both administered by im or sc route.


Eligibility criteria:
inclusion criteria: * healthy participant of either gender, * age 12 to 18 months, * negative clinical history of measles, mumps, rubella, varicella and zoster, * consent form signed by both holders of the parental authority or by the legal representative * holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the diary card. exclusion criteria: * prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination, * any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster * any recent (≤3 days) history of febrile illness * any severe chronic disease, * active untreated tuberculosis, * known personal history of seizure disorder, * any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems, * any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, * any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid \[any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days\] or other immunosuppressive therapy, * any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through visit 3, * any recent (≤7 days) tuberculin test or scheduled tuberculin test through visit 3, * any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through visit 3,
radiation therapy as palliative treatment of gist

Conditions: Sarcoma

Summary: gastrointestinal stromal tumors (gists) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. limited clinical experience suggests that selected gist patients may benefit from palliative radiation therapy. the purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in gist patients who have progressive gist during or after tyrosine kinase inhibitor therapy.

radiation therapy planning must be based on computerized tomography (ct). external beam radiation must be used. both 3d and imrt plans are acceptable. the cumulative radiation dose may range from 30 to 40 gy as administered in 1.8 to 2.0 gy fractions, 5 fractions per week. the dose is specified as defined by the icru (international commission on radiation units and measurements) report 50. response is evaluated using ct 6 and 12 weeks after irradiation. adverse effects are evaluated using the common terminology criteria for adverse effects (ctcae)version 3.

Eligibility criteria:
inclusion criteria: * histologically verified gist. * metastatic or locally advanced, inoperable disease. * adequate systemic treatment has been administered. * one or more growing gist metastasis present during of after tki therapy. * the target lesion(s) is measurable. * a written informed consent exclusion criteria: * who performance status is 4. * estimated life-expectancy less than 3 months. * radiation planning target volume greater than 3 dm3. * unmeasurable target lesion. bone and brain metastases are not accepted target lesions. * radiation therapy cannot be delivered (e.g. active infection or restlessness.) * pregnancy. * systemic gist treatment with unknown efficacy. * copies of ct images cannot be sent for central review.

Keywords: gastrointestinal stromal tumor gist sarcoma radiation therapy radiotherapy
observational study of persistence on bafiertam treatment in routine clinical practice

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (rrms) prescribed bafiertam (monomethyl fumarate) as their treatment.

monomethyl fumarate (mmf) is the active metabolite of the fumarate class of drugs used for the treatment of rrms. bafiertam is a formulation of mmf and does not require enzymatic conversion after oral administration. adult participants with a diagnosis of rrms who have been receiving continuous treatment with bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. their satisfaction with bafiertam treatment will be assessed using a 9-item treatment satisfaction questionnaire for medication (tsqm-9). to be included in the study, patients.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female aged 18 years and older. 2. participants diagnosed with relapsing forms of multiple sclerosis r(rms) and satisfy the approved therapeutic indication for bafiertam per the approved product labeling. 3. participants may enroll if they are within 90 days of initiating therapy with bafiertam. 4. female participants of childbearing potential must practice effective contraception from day -1 and be willing and able to continue contraception for the duration of the study. 5. willing and able to sign the informed consent form (icf) approved by the institutional review board (irb). 6. willing and able to complete all the study procedures and communicate meaningfully with study personnel. exclusion criteria: 1. known hypersensitivity to fumarates including dimethyl fumarate, tecfidera, and/or diroximel fumarate (vumerity) or bafiertam. 2. participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.
evaluation of fluid volume in patients with refractory hypotension (fresh-er)

Conditions: Undifferentated Shock

Summary: the objective of the study is to observe the change in hemodynamic variables (i.e. co, sv, hr, sv) as assessed during rapid fluid bolus.

the noninvasive starling sv (baxter healthcare) is a portable, non-invasive, cardiac output detector system. the starling sv system measures the cardiac output by employing electrical bioreactance. bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. in the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. the relevant fluid is blood. the objective of the study is observe the change in hemodynamic variables (i.e. co, sv, hr, sv) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective rct of sv-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration. this study is a prospective feasibility study. patients will be evaluated by the emergency room team for inclusion/exclusion criteria. if the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.

Eligibility criteria:
inclusion criteria: primary criteria 1. map \<65 2. sbp \<90 or bp rapidly trending lower secondary criteria 3. low urine output acute change in urine output less than 50ml/4 hours 4. persistent hyperlactatemia 5. a new vasopressor started 6. acute change in hr less than 50 or greater than 120 7. new onset chest pain or chest pain different then admission assessment 8. acute bleeding 9. fever \> 39 degrees 10. significant change in mental status: confusion, agitation, delirium, etc. 11. unexplained lethargy 12. crt \>2 seconds - exclusion criteria: 1. primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma 2. known aortic insufficiency, or aortic abnormalities 3. requires immediate surgery 4. advanced directives restricting implementation of the resuscitation protocol 5. known intraventricular heart defect, such as vsd or asd 6. prisoner 7. pregnancy 8. age \<18 9. known allergy to sensor material or gel 10. suspected intra-abdominal hypertension 11. inability to obtain iv access 12. patient should be excluded based on the opinion of the clinician/investigator 13. patient has an unstable airway

Keywords: resuscitation
retrospective evaluation of a commercially available hydrogel spacer (bp-009)

Conditions: Prostate Cancer

Summary: dosimetry efficacy of the hydrogel spacer.

single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. study utilized pre and post gel insertion ct images to determine endpoints.

Eligibility criteria:
inclusion criteria: * males * at least 18 years of age * undergone external beam or brachy radiation therapy with a hydrogel spacer in place exclusion criteria: * clinical and pathological data are not available * invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Keywords: prostate prostate cancer spacer perirectal spacer