Kornimate/medical-research-clean huggingface dataset:
nelfinavir and m8 drug-level monitoring in hiv-1 infection

Conditions: HIV Infections

Summary: the purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (nfv) on the clinical and virologic outcomes in a group of hiv-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (haart) regimen.


Eligibility criteria:
inclusion criteria: * antiretroviral naive or currently taking a nelfinavir containing haart regimen where nelfinavir is the first protease inhibitor * patients willing to comply with the protocol * age greater than or equal to 18 years * virologically successful if already on an established regimen exclusion criteria: * prior use of a protease inhibitor exclusive of nelfinavir * required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir * use of immunomodulators or vaccines for hiv disease * intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the hiv rna concentration * baseline alt levels greater than five times the upper limit of normal

Keywords: hiv
thyroxin in subclinical hypothyroidism

Conditions: Sub Clinical Hypothyroidism; Pregnancy Loss

Summary: subclinical hypothyroidism(sch) is the elevated thyroid stimulating hormone (tsh) with normal free thyroxine levels and it is a mild or compensated form of primary hypothyroidism. it has been suggested that sch is more prevalent in infertile women (especially in women with ovulatory disorders.various rates of sch was reported in infertile women in different populations

despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of sch in infertile women . there are few published data on the prevalence of sch and the outcome of treatment of sch in infertile women, many were conducted during ivf cycles . moreover there are inconsistent results in these studies being authors advised to treat sch before ivf and some other articles find out no any benefit regarding treatment with thyroxine in sch

Eligibility criteria:
inclusion criteria: 1. unexplained infertility 2. tsh more than 2.5 and normal t3,t4 levels 3. negative for anti-thyroid antibodies exclusion criteria: 1. current history of overt hypo or hyperthyroidism 2. recurrent pregnancy loss 3. women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor 4. ovarian dysfunction or decreased ovarian reserve 5. abnormal seminal fluid analysis or male factor

Keywords: unexplained infertility, pregnancy rate,hypothyroidism
growth and adiposity in newborns: the influence of prenatal docosahexaenoic acid (dha) supplementation

Conditions: Pregnancy; Nutritional Diseases

Summary: the purpose of this study is to learn if participants in the adore study (nct02626299), who took a dha supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.


Eligibility criteria:
participants for this study are invited from the parent study, adore. eligibility listed reflects criteria for the adore study. inclusion criteria: * agree to consume study capsules and a typical prenatal supplement of 200 mg dha * available by telephone exclusion criteria: * expecting multiple infants * gestational age at baseline \ 20 weeks * unable or unwilling to agree to consume capsules until delivery * unwilling to discontinue use of another prenatal supplement with dha that contains ≥ 200 mg dha * women with allergy to any component of dha product (including algae), soybean oil or corn oil

Keywords: fat mass gestational weight gain fetal adipose tissue
prognostic model of gc/ctx in the treatment of mn

Conditions: Idiopathic Membranous Nephropathy

Summary: the goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (imn) under the treatment of glucocorticoid + cytoxan. the main questions it aims to answer are: * to explore the factors that can predict the prognosis difference in patients with imn under the treatment of glucocorticoid + cytoxan * to establish a clinical prediction model and verify it to provide a reference for the early participants will receive standard glucocorticoid + cytoxan treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy. researchers will compare \[remission group and non-remission group\] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase a2 receptor (pla2r) antibody positive by renal puncture biopsy, and the clinical data were complete; 2. according to the kidney disease: improving global outcomes (kdigo) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss. 3. in general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others; 4. volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form. exclusion criteria: 1. there are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins; 2. at the same time, immunoglobulin a nephropathy (igan), interstitial nephritis, acute nephritis and other renal pathological types were combined; 3. the medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases; 4. during follow-up, the patient cannot actively cooperate or accurately understand and express.
effectiveness of crd-740 in heart failure

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Cardiovascular Diseases; Heart Diseases

Summary: this is a study evaluating the effectiveness of crd-740 in patients with either heart failure with reduced ejection fraction (hfref) or heart failure with preserved ejection fraction (hfpef) after 12 weeks of treatment. the primary objective in part a is to assess the effect of crd-740 compared to placebo in plasma cgmp at week 4 in hfref. part b of the study was not conducted in favor of redesigned new studies.


Eligibility criteria:
inclusion criteria: 1. males or females ≥18 years of age, at screening. 2. diagnosis of clinical heart failure syndrome, new york heart association functional class ii - iii for at least 6 months prior to screening 3. for part a: * ejection fraction ≤40% by echocardiography at screening. * nt-probnp level ≥600 pg/ml at screening. subjects with atrial fibrillation or flutter at screening are required to have an nt-probnp level of ≥1000 pg/ml at screening. 5. stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening. exclusion criteria: 2. recent hf exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening. 3. subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study. 4. acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening. 5. subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or hf secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease. 6. prior or planned orthotopic heart transplantation. 7. presence of or plan for mechanical circulatory support. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pde9 heart failure crd-740 hfpef hfref
a comparison study of feeding prematures in the side-lying position on the right and left side - a pilot study.

Conditions: Bottle Feeding; Premature

Summary: methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology. one of the areas that can help improve feeding is choosing the optimal feeding position for premature babies.

purpose: the aim of the study is to compare the advantages of side-lying positioning on the right (slp-r) and left side (slp-l) of infant's body, during bottle-feeding of preterm infants. method: the study will include eight neonates (n=8) born ≤34 weeks of gestational age. four bottle-feeding sessions will be tested in each of the newborns: two in the slp-r and two in the slp-l. the position for the first study will be randomly assign, then positioning will be change after each feeding session. in one day, only two consecutive feeding sessions will be tested which will be included to the study in order to minimize fatigability as a disrupting factor. the levels of saturation (spo2) and heart rate (hr) will be measured as the parameters indicative of the newborn's physiological stability. the factors determining the qualitative aspect of feeding include the total time of declines of spo2 ≤85%, level of the newborn's alertness according to the neonatal behavioral assessment scale (nbas), and the occurrence of choking episodes. the proportion of milk consumed (volume of milk eaten relative to the expected volume) and the duration of the feeding and feeding session were also will be record. maximum time of feeding session will be 40 minutes. also the posseting during/after feeding and regurgitations will be record in each tested positions.

Eligibility criteria:
inclusion criteria: * circulatory and respiratory stability; * readiness for oral feeding according to each child's speech-language pathologist assessment; * prematurely born infants who will be in the process of transfer from enteral nutrition to full oral feeding and will be fed orally at least 4 times within twenty-four hours; * researcher must be a right handed person (right hand is the dominant hand); * each infant will be fed with one kind of bottle and nipple; * parents will give a informed consent to participate their infant in the study. exclusion criteria: * disorders which could significantly affect the feeding course, such as cleft lip and/or palate, facial paralysis and/or congenital defects of the facial skeleton; * the presence of detected congenital abnormalities and metabolic diseases; * newborns after abdomen chirurgical treatment; * low apgar score (less than 5 points at the 5th and 10th minute of the measurement); * administered analgesics, anticonvulsants and sedatives \<72 hours from extubation prior the trial; * parenterally fed infants; * infants with administered intravenous infusion with glucose; * parents refusal to participate in the study or when bottle-feeding will not be the parental preference.

Keywords: premature infant bottle feeding side-lying position oral feeding
yoga vs. education for veterans with chronic low back pain

Conditions: Recurrent Low Back Pain

Summary: chronic low back pain (clbp) is the most common pain condition in the military, causing substantial physical and psychological suffering, reduction in force readiness, and high economic cost. yoga has been studied in 10 rcts in civilian populations with clbp suggesting it may be effective in reducing pain intensity, improving back-related function, and lowering pain medication use. multiple differences exist between civilian and military populations with clbp, making it necessary to adapt and test yoga for clbp in military populations. this study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military personnel and veterans with clbp through a structured, reproducible 12-week series of hatha yoga classes, supplemented with home practice, compared to an education group. additionally, the enormous mental health burden often shouldered by returning military personnel presents another important distinguishing factor. thus, the study's secondary aim is to assess yoga's capacity to reduce post-traumatic stress symptoms (ptss). the third aim is to evaluate the cost-effectiveness of yoga for clbp at 3 months and 6 months from the perspective of the provider, the veteran, and the veterans health administration. the fourth and final aim is to evaluate the effect of back pain and yoga on marital and family functioning. the proposed rct will (1) establish a structured reproducible yoga protocol uniquely suited to veterans populations with clbp; (2) develop web-based delivery systems to assist veterans in yoga home practice; (3) increase our knowledge of the feasibility and impact of yoga for veterans' clbp and psychological comorbidities. these results will help determine whether yoga is an effective modality for addressing clbp in a veteran population.


Eligibility criteria:
inclusion criteria: * veteran of any branch of military service * current low-back pain present for at least half the days over the past 6 months mean pain intensity for the previous week ≥4 on 0-10 rating scale exclusion criteria: * significant yoga practice in the previous 6 months * have read the back pain helpbook in the previous 6 months * new lbp treatments started within the previous month or anticipated to begin in the next 3 months * known pregnancy * known inflammatory or systemic causes of lbp * severe and/or progressive medical, neurological, or psychiatric comorbidities * inability to understand/speak english * plans to move out of the area in the next 6 months * lack of informed consent * unwillingness to be randomized

Keywords: low back pain yoga education veterans cost-effectiveness military back pain
combined cxl//uv and prk or lasik in forme fruste keratoconus or eyes with potential risk of ectasia

Conditions: Fruste Keratoconus; Risk of Ectasia

Summary: this study is being performed to evaluate the efficacy of ultraviolet-a (uva)-induced cross-linking of corneal collagen (cxl) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (ffkc), corneas that are suspicious for ffkc and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

this study is being performed to evaluate the efficacy of ultraviolet-a (uva)-induced cross-linking of corneal collagen (cxl) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (ffkc), corneas that are suspicious for ffkc and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. cxl is thought to augment the tectonic strength of the cornea by using uva light and the photo-mediator riboflavin. the purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. all excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with fda approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. this can result in ectasia even in patients without pre-existing risk factors.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * up to 4 potential risk factors for ectasia * a. abnormal topography: consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape. * b. corneal thickness of 500 microns or less, as measured by ultrasound, orbscan, or pentacam * c. age 18 to 25 * d. planned residual stromal bed between 250 and 300 microns * ability to provide written informed consent * likely to complete all study visits * best spectacle-corrected visual acuity (bscva) of 20/25 in each eye * patients with and without previous laser vision correction are eligible for participation. exclusion criteria: * frank keratoconus, pellucid, or post-lasik ectasia * less than 20/30 bscva in either eye * corneal scarring that markedly affects vision * contraindications to any study medications or their components * pregnancy or breast feeding * active herpes corneal disease

Keywords: fruste keratoconus ectasia
clinical interventions in respiratory distress syndrome and neonatal lung injury - scor in lung biology and diseases in infants and children

Conditions: Lung Diseases; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Summary: to conduct clinical interventions directed at neonatal lung disease and injury, with a focus on infants having surfactant-deficiency or inactivation as a component of pathophysiology. a major emphasis was on the surfactant-deficient respiratory distress syndrome (rds) of premature infants, and on acute neonatal respiratory failure in term infants with pulmonary edema and potential surfactant inactivation (ards-related).

background: the study was a subproject within a specialized center of research (scor) in lung biology and diseases in infants and children. the clinical interventions studied had significance for respiratory distress syndrome of the newborn and for bronchopulmonary dysplasia, which is the chronic lung disorder of fibrosis, alveolar loss and reactive airway disease that often follows pulmonary disease requiring treatment with oxygen and mechanical ventilation in the newborn period. design narrative: a series of randomized, controlled trials/studies were conducted. in the first clinical study, full term infants with severe respiratory pathology where surfactant inactivation was important were assigned randomly to exogenous surfactant versus control groups to determine if surfactant was efficacious and safe in this kind of lung injury. in the second study, infants of less than 29 weeks gestation received prophylactic exogenous surfactant, but were assigned randomly to receive it immediately following birth or after initial stabilization at 10-15 minutes, to address a then critical current issue in surfactant therapy for rds. in the third study, infants who had moderate rds despite exogenous surfactant therapy were randomly assigned to high frequency jet or conventional ventilation groups to determine if this mode of ventilation therapy would reduce barotrauma and the incidence and/or severity of bronchopulmonary dysplasia (bpd). in addition to these three clinical trials, another study involved therapy using superoxide dismutase (sod) along with surfactant as a multi-modal approach treating premature infants with rds and lung injury secondary to hyperoxia and mechanical ventilation. this study depended on results of animal studies with sod in project 5. finally, the study addressed the long term evaluation and surveillance of survival, rehospitalizations, health status, pulmonary sequelae, and school performance of those infants enrolled in the randomized clinical trials, as necessary for long-term outcome assessments.

Eligibility criteria:
no eligibility criteria
improvement of care for outpatients with type 2 diabetes through self-care multidisciplinary workshop for diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: ninety-six patients with diabetes will be randomly assigned to maintain standard treatment or participate in the self-care multidisciplinary workshop for diabetes. the workshop consists of individual meetings, with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. the workshop will be offered in 3 different modules with 2 to 4 weeks difference between them. the variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.

ninety-six patients with type 2 diabetes from our diabetes outpatient clinic will be randomly assigned to maintain standard treatment or participate in the self-care multidisciplinary workshop for diabetes. the workshop consists of 15-minute individual meetings with each professional of a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. the workshop will be offered in 3 different modules with 2 to 4 weeks difference between them. patients will be followed for 12 months. the variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.

Eligibility criteria:
inclusion criteria: * patients with previous diagnosis of type 2 diabetes, hba1c greater than 7.5% and age greater than 18 years exclusion criteria: * types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop
qva mechanistic efficacy study (receptor effects, etc)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study was to assess global ventilated lung volume in moderate to severe copd patients using mri lung imaging after treatment with qva149 compared to placebo.

the mri approach represented an opportunity to better understand the impact of a potent dual bronchodilator on the small and central airways and thereby increasing ventilated lung volume, gas exchange, and ventilation-perfusion deficits. the study investigated the effect of qva149 on global and regional lung ventilation using mri lung imaging to enhance the understanding of qva pharmacology in copd patients.

Eligibility criteria:
key inclusion criteria: males and females with copd aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed with moderate to severe copd according to gold 2015 criteria were included in the study. patients with airflow limitation indicated by a post-bronchodilator fev1/fvc \< 0.70 and by a post-bronchodilator fev1 ≥ 30 % and \<80 % were included in the study. post-bronchodilator refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose). key exclusion criteria: patients with conditions which could compromise patient safety and compliance (as judged by the investigator), as well as conditions that required oxygen therapy for chronic hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with lower respiratory infections within 6 weeks of screening, and patients with concomitant pulmonary disease were excluded from the study. patients with asthma were also excluded from the study. pregnant or nursing (lactating) women, patients with poorly controlled type i or type ii diabetes, patients with poor renal function, and those who were unable to use a dry powder inhaler or perform spirometry, and had contraindications to mri were also excluded.

Keywords: copd smokers ex-smokers