Kornimate/medical-research-clean huggingface dataset:
does omeprazole decrease intestinal calcium absorption?

Conditions: Osteoporosis; Achlorhydria; GERD; Hip Fracture

Summary: the purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. up to 25 postmenopausal women will participate in this study. the primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. the secondary outcomes include the change in urine n-telopeptide. we will interview women and review their medical records to determine eligibility. eligible subjects will undergo three calcium absorption studies. the first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg of omeprazole daily for 30 days. women will present to the research unit in the early morning and receive an oral and intravenous calcium tracer with breakfast. over the next 24 hours, we will collect all urine for measurement of its calcium content. during the first stay, we will measure each subject's gastric ph by collecting gastric fluid from a temporary nasogastric tube. in consenting subjects we will collect one tube of blood, isolate its dna.

Eligibility criteria:
inclusion criteria: * women at least 5 years past menopause, defined as the last date of menses exclusion criteria: * allergy/intolerance to orange juice * allergy/intolerance to omeprazole or other ppi therapy * use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin \& tacrolimus * use of antacids, ppi or h2-blocker therapy within the past two months * intestinal conditions associated with malabsorption or low gastric acid levels including crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month * known stage 4 or 5 chronic kidney disease, defined as an estimated gfr \<30 cc/minute * use of medications known to interfere with calcium metabolism, including oral steroids or anticonvulsants

Keywords: calcium absorption fractional calcium absorption omeprazole stable calcium isotopes proton pump inhibitor intestinal absorption of calcium
leukocytes - obesity - spontaneous labour

Conditions: Pre-conceptional Obesity

Summary: this is a single-centre observational, prospective study carried out at the maternity unit of dijon chu. it will include pregnant women with a pre-conception bmi ≥ 30 kg/m² and will evaluate in these patients, the activation and migration capacities of circulating leukocytes and their association with the onset of spontaneous labour. patients who meet the inclusion criteria will be informed about the study during their consultation at the 7th or 8th month, and their gynecologist will invite them to take part. if the answer is positive, the patients will be seen again at a specific consultation for the study between the 37th and 38the weeks of amenorrhea at the maternity unit of dijon chu. during this consultation, the gynecologist will conduct a medical examination, while the plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and 1 x 7ml tube). if labour has not started by 41 weeks of amenorrhea, the patients will be seen at another consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood sample (1 x 6ml tube and 1 x 7ml) will be taken. the patients will be followed until childbirth and will be split into two groups according to whether or not they gave birth after the onset of spontaneous labour.


Eligibility criteria:
inclusion criteria: * patient has given its written consent * please affiliated to a social security scheme * body mass index preconception ≥ 30 kg / m² * age\> 18 years * unique pregnancy * having a plot of normal fetal heart rate exclusion criteria: * pathology changing the mode of delivery or induction of labor (pre-eclampsia, chronic hypertension or gestational, diabetes under unbalanced diet, ...) * scheduled caesarean * infectious disease suspected or proven, including hiv infection, hepatitis c, hepatitis b * pathology inflammatory or autoimmune * anti-inflammatory or immunosuppressive therapy * patient under guardianship * patient in safeguarding justice • secondary exclusion criteria: * caesarean section before labor * delivery before 37 weeks of amenorrhea * anti-inflammatory or immunosuppressive therapy during study participation * fetal heart rate abnormal during study participation * premature rupture of fetal membranes without formal labor spontaneously within 48 hours * induction of labor or cervical ripening before 41sa
hepatic fibrosis assessment using multiparametric magnetic resonance imaging

Conditions: Fibrosis; Cirrhosis

Summary: the purpose of this study is to assess degree of hepatic fibrosis using multiparametric mri for investigating difference between normal or early fibrosis and advanced fibrosis.

in patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. referred patients undergo multiparametric mri including perfusion, diffusion, elastography and fat quantification before surgery or biopsy. the pathophysiologic changes are evaluated using multiparametric mri, and compared between normal/early fibrosis and advanced fibrosis.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo liver resection for focal liver lesion * patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease * liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection * and patients/living donor candidates who sign informed consent exclusion criteria: patients who have at least one of followings are excluded. * patients who are contraindication for mri contrast enhanced mri. * premenopausal female patients who are pregnant. * patients who are physically compromised to acquire liver mri

Keywords: fibrosis cirrhosis mri
a study of ly2510924 and durvalumab in participants with solid tumors

Conditions: Solid Tumor

Summary: the main purpose of this study is to evaluate the safety and tolerability of chemokine (c-x-c motif) receptor 4 (cxcr4) peptide antagonist ly2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors.


Eligibility criteria:
inclusion criteria: * phase 1a: have histologic or cytologic confirmation of advanced solid tumor * have at least 1 measurable lesion assessable using standard techniques by response evaluation criteria in solid tumours (recist) v1.1 * have adequate organ function * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ≤3 years since last documented progression of disease * have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator exclusion criteria: * have a serious concomitant systemic disorder including human immunodeficiency virus (hiv), active hepatitis b virus (hbv), active hcv, active autoimmune disorder or disease requiring high dose of steroids * have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea * have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis * have an active infection requiring systemic therapy * have had prior therapy with an anti-programmed cell death 1 (pd-1), anti-pd-l1, anti-pd-l2, or anticytotoxic t lymphocyte-associated antigen-4 antibody * moderate or severe cardiovascular disease * have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment * have received a live vaccine within 30 days before the first dose of study treatment

Keywords: immuno-oncology
individual sensitivity for interstitial lung diseases

Conditions: Interstitial Lung Diseases

Summary: interstitial lung diseases (ild) is a collective noun for various chronic lung diseases, including sarcoidosis and idiopathic lung fibrosis (ipf). sarcoidosis is a multi-systemic disease that includes damage to the lungs in 90% of the patients. generally, the disease can be described as a systemic, granulomatous and antigen-driven disorder. ipf is a disease of only the lungs, in which an unknown cause induces a strong inflammation reaction leading to acute lung damage that ultimately results in the formation of scar tissue and stiffness of the lungs. unfortunately, the exact cause of ild is still unknown. it is suggested that environmental and work-related exposure to various triggers can exert an effect on the course of the diseases. examples of such triggers include bacteria, organic agents such as pollen and cotton dust and inorganic agents like metals and talc. due to this unknown cause, it is difficult to treat ild. consequently, the current guideline is no medication or anti-inflammatory agents in severe cases. unfortunately, this therapy is not completely effective. triggers that are suggested to cause ild can exert their effects via various mechanisms. on the one hand, they can induce an inflammatory reaction as we recently demonstrated for various triggers including instillation material and sicila. during such an inflammatory reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between the formation of and the protection against reactive oxygen species (ros). on the other hand, ild-inducing triggers may directly cause an increased ros production that subsequently can evoke an inflammatory reaction. the objective of the current study is to investigate the individual sensitivity for the development of ild after exposure to various triggers. main focus will be the differences in the formation of and the protection against ros as well as the occurring inflammatory reaction after exposure to such triggers. furthermore, a simple blood test will be developed to study and eventually even predict the individual reaction of subjects to various triggers. finally, to fully characterize the development of ild after exposure to various triggers, the exhaled air of patients will be studied in order to identify specific markers of oxidative stress and damage.


Eligibility criteria:
inclusion criteria: * ild diagnosis confirmed by lung biopsy, x ray or balf analysis exclusion criteria: * smoking * pregnancy or lactation * use of vitamins or nutritional supplements

Keywords: sarcoidosis fibrosis oxidative stress inflammation triggers individual sensitivity
small intestinal mucosal abnormalities in systemic sclerosis using capsule endoscopy

Conditions: Systemic Sclerosis

Summary: the aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. the investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.


Eligibility criteria:
inclusion criteria: * written informed consent * systemic sclerosis based on the acr diagnostic criteria exclusion criteria: * patients with other connective tissue diseases * pregnancy * absence of contraception in women * patients with pace maker * patients with intestinal pseudo-obstruction
non-invasive ventilation and physical activity

Conditions: Neuromuscular Diseases

Summary: as fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in patients with neuromuscular disorders and thoracic deformations, we hope, by starting non-invasive ventilation and improving these symptoms, to increase their physical activity.

patients with neuromuscular disorders and thoracic deformations develop alveolar hypoventilation during their disease progression. at that time, non-invasive ventilation(niv) can be started as treatment. fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation. niv has the intention to improve these symptoms but no research has been performed whether these improvements also objectively improve physical activity. further on, no research has been performed on muscle strength and muscle fatigue. patients' physical activity, physical capacity and sleep quality will be measured before niv initiation, after 3 months and 1 year of niv use. to start niv, patients will be admitted to our sleep laboratory for 5 days/4 nights. polysomnography will be used during niv titration. physical activity will each time be measured by 2 activity monitors during 5 days.

Eligibility criteria:
inclusion criteria: * restrictive pulmonary function test and * symptoms of nocturnal alveolar hypoventilation or * increased daytime pressure of arterial co2 (paco2) (\>45 mmhg) or * \>= 10 mmhg increase in paco2 during sleep in comparison to a normal awake supine value exclusion criteria: * patients \< 16 years * severe cardiac arrythmias or conduction disturbances * severe mental disturbances * amyotrophic lateral sclerosis * total wheelchair-dependent patients

Keywords: noninvasive ventilation physical activity
health needs of patients with kallmann syndrome

Conditions: Kallmann Syndrome; Congenital Hypogonadotropic Hypogonadism; Idiopathic Hypogonadotropic Hypogonadism

Summary: kallmann syndrome (ks), also known as congenital hypogonadotropic hypogonadism (chh), is a rare endocrine disorder that is characterized by failure to undergo puberty combined with infertility. ks/chh patients face a number of psychosocial burdens related to delays in diagnosis, inadequate access to expert care, and lack of information about the condition. as such, there is some evidence to suggest that ks/chh patients have unmet health needs. this study aims to identify the needs of patients and understand the issues that must be overcome to achieve improved health and quality of life.

this study aims to examine the experiences of patients diagnosed with kallmann syndrome (ks)/congenital hypogonadotropic hypogonadism (chh). the study includes two parts: * online survey (less than 30 minutes to complete) * focus groups with ks/chh patients the aim of this project is to better understand what health needs are not presently being met for these patients and to identify targets for improving the care of patients diagnosed with ks/chh

Eligibility criteria:
inclusion criteria: * diagnosed with congenital hypogonadotropic hypogonadism: i.e. kallmann syndrome or idiopathic hypogonadotropic hypogonadism * primary language is english/capable of responding to a written questionnaire in english * consenting to participate in the study exclusion criteria: * other diagnosis of hypogonadism: i.e. hypergonadotropic hypogonadism (klinefelter syndrome), adult onset hypogonadism, etc.

Keywords: rare disease community-based participatory research health promotion quantitative research qualitative research focus group
multifactorial fall prevention program

Conditions: Frail Elderly Syndrome

Summary: the main objective is evaluate the effectiveness of a multifactorial pilot program on the prevention of falls in people aged 65 or over during 4 years at gerencia de atención integrada de talavera de la reina.

introduction: falls are a major global public health problem. falls are the second leading cause of death from unintentional injuries in the world. the highest mortality rates correspond to 60 years old people. 20-30% suffer from moderate-serious injuries (hip fractures, head injuries...), that reduce mobility and independence, increasing the risk of premature death. moreover, there are more than 400 risk factors. most can be modified to decrease the risk of falling. objective: to evaluate the effectiveness of a multifactorial pilot program on the prevention of falls in people aged 65 or over during 4 years at gerencia de atención integrada de talavera de la reina. material and methods: randomized clinical trial with 264 patients is carried out. 65 years old or older patients are recruited from primary care (≥ 1 positive response in the frailty screening test, or ≥ 3 in the downton test and \> 90 in the barthel index). falls risk is assessed using validated scales. experimental group receive multifactorial intervention (based on the gbpc "prevention of falls and reduction of injuries derived from falls" - rnao). control group receive recommendations (physical exercise, health education on risk factors, footwear, exercise, home adaptation, nutrition, ...). variables are presented with their frequency distribution. qualitative variables as median and range, and quantitatives with their mean and standard deviation. association between qualitative variables are evaluated with pearson's chi-square test. student's t test be used when the distribution of the variable adjusts to normality. the null hypothesis will be rejected with an error α less than 0.05. expected benefits: it is expected to reduce the risk of falls in 30-35% of 65 years old people or older in the urban area of talavera de la reina. it would mean great savings and improve the quality of life. it is expected to increase the years of healthy life. it is intended to provide health professionals with a tool to make clinical decisions based on evidence on the prevention of falls to be used as a unified work protocol at gerencia de atención integrada de talavera de la reina.

Eligibility criteria:
inclusion criteria: * 65 years old or older patients * live in talavera de la reina * ability to walk at the health center * ≥ 3 in the downton test * \> 90 in the barthel index * sign the informed consent exclusion criteria: * patients with an intense physical activity * use of a wheelchair * amputations or prosthetic limbs * deafness * blindness * moderate or severe cognitive impairment * vertebral, pelvic or lower limb fractures in the 12 months prior to entering the program * absolute contraindication to physical exercise

Keywords: risk of falls prevention clinical trial
prostate cancer screening in men with germline brca2 mutations

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the incidence of prostate cancer in men with the brca2 gene mutation as an independent indicator for prostate cancer screening.

this is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of brca2 carriers. all men identified to have a brca2 mutation as part of the yale cancer genetic counseling program will be approached and offered participation in the study via our program newsletter, brca listserv, facebook page and a targeted mailing. standard of care screening at the yale cancer center for men with a normal prostate cancer risk consists of a psa test and prostate physical examination beginning at age 50 years and if either is abnormal an mri of the prostate followed by fusion-targeted biopsy of the prostate is performed.

Eligibility criteria:
inclusion criteria: * all men ≥30 years of age with at least a ten-year life expectancy * a known brca2 mutation * ability to have an mri * able to give informed consent will be approached to participate in the study exclusion criteria: * if a man has received or is currently receiving treatment for prostate cancer
platelet rich fibrin combined with simvastatin for treatment of intrabony defect in chronic periodontitis

Conditions: Three Wall Intrabony Defects in Chronic Periodontitis

Summary: the purpose of the present study was to investigate the efficacy of autologous platelet rich fibrin (prf) or prf and simvastatin (smv) with open flap debridement (ofd) in the treatment of three wall intrabony defects in comparison to ofd alone.

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). control group consisted of the sites treated with ofd and test groups sites were treated with ofd with autologous prf or prf with smv. site-specific plaque index (pi), sulcus bleeding index (msbi), probing depth (pd), relative attachment level (ral) and intrabony defect (ibd) depth reduction was measured at baseline and 9 month after surgery.

Eligibility criteria:
inclusion criteria: * subjects with the diagnosis of chronic periodontitis * presence of three walled intrabony defects (ibd) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph \[iopa\]) * interproximal probing depth (pd) ≥ 5 mm following scaling and root planing (srp) in asymptomatic tooth exclusion criteria: * subjects, with the diagnosis of aggressive periodontitis, * with known systemic illness and taking medications known to affect the outcomes of periodontal therapy * insufficient platelet count (\< 200,000/mm3), * pregnancy / lactation * use of any form of tobacco * unacceptable oral hygiene (if plaque index \[pi\] (silness \& loe 1964) \>1.5) after the reevaluation of phase i therapy * teeth with furcation defects * non-vital * mobility of tooth ≥ grade ii
second echelon node study with methylene blue

Conditions: Breast Cancer; Melanoma

Summary: the investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

after lymphatic mapping of the sln with tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the sln with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (figure 1). for our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. the blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). a second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. the number of second echelon lymph nodes was recorded. the second-echelon lymph node(s) was not removed.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary cutaneous melanoma located on the extremity or trunk * patients with clinically stage i-ii melanoma * histologically confirmed invasive ductal or lobular carcinoma * patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative exclusion criteria: * melanoma located on the head or neck, uveal or mucosal * previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin * preoperative biopsy proven regional lymph node involvement * failure of lymphatic mapping with radioactive colloid * women who are pregnant or nursing * prior ipsilateral axillary surgery or radiation * inflammatory breast cancer * no lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen * stage iv breast cancer

Keywords: breast cancer melanoma sentinel lymph node biopsy lymphadenectomy