Kornimate/medical-research-clean huggingface dataset:
the microbiome in (non-) obese pregnancy and pregnancy outcomes

Conditions: Obesity, Maternal; Pregnancy Complications; Gut Microbiota

Summary: this research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.

with the increasing global prevalence of obesity, pregnancy problems related to maternal obesity are increasingly occurring. microbial gut symbiosis plays an important role in health, with dysbiosis being associated with diseases such as obesity. of interest are pregnancy, dietary patterns and pre- or probiotics that affect the composition of the gut microbiome. the microbiome itself can influence many physiological processes, such as immune responses (production of microbial products) and the nutrient-dependent one-carbon metabolism. it is hypothesized that gut dysbiosis, due to maternal obesity, during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism. both processes result in excessive oxidative stress, detrimental to cell replication, differentiation and epigenetic programming of maternal and infant tissues. together, these biological disturbances contribute to placental and vascular dysfunction, leading to an increased risk of preeclampsia or gestational diabetes mellitus. vertical (during pregnancy) and horizontal (during delivery) transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children. therefore, the differences between the gut and vaginal microbiome, maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed.

Eligibility criteria:
inclusion criteria: * participation in predict study * preconceptional women who wish to become pregnant or pregnancy \<13 weeks of gestational age. * bmi \> 30 kg/m2 or 18-25 kg/m2 * understanding of dutch in speaking and reading * willingness to give written informed consent exclusion criteria: * age \ 45 years. * ≥13 weeks of gestational age * multiple pregnancy * smoking * gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases. * use of antibiotics \< 2 weeks before sampling * pre-existent diabetes mellitus
study to evaluate the effectiveness of high dose statin loading in acute heart failure patients

Conditions: Acute Heart Failure

Summary: this is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.


Eligibility criteria:
inclusion criteria: * dyspnea at rest or minimal activity * tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest x-ray exclusion criteria: * acute coronary syndrome * hospitalization plan for ptca or cabg * cardiogenic shock (systolic blood pressure \< 80mmhg) * uncontrolled hypertension (systolic blood pressure \> 180mmhg) * allergy, adverse drug reaction, hypersensitivity to statin * troponin \> 5 times upper limit of normal (uln) * creatinine kinase-mb level \> 3 times uln * ast, alt \> 3 times uln or acute hepatitis * current or past history of muscle disease, rhabdomyolysis * life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis) * pregnancy or women at age of childbearing potential
slos: the effect of simvastatin in patients receiving cholesterol supplementation

Conditions: Smith-Lemli-Opitz Syndrome

Summary: the purpose of this study is to determine if simvastatin improves development and behavior in patients with smith lemli-opitz syndrome (slos) receiving dietary cholesterol supplementation.

patients with slos receiving dietary cholesterol supplementation are given simvastatin, a drug that decreases the activity/expression of hmg-coa reductase, an enzyme that controls the first step of the cholesterol synthesis pathway, reduces the accumulation of toxic 7-dehydrocholesterol (immediate metabolic precursor of cholesterol) and improve neurocognitive and behavioral outcomes.

Eligibility criteria:
inclusion criteria: * male or female over 1 years old * subject has confirmed diagnosis of smith-lemli-opitz syndrome * subject is currently receiving cholesterol supplementation exclusion criteria: * subjects too ill to travel to the study site * subjects who are unable to safely undergo study procedures * pregnant women

Keywords: slos cholesterol supplementation simvastatin
omega-3-polyunsaturated fatty-acids (n3-pufa) in patients with peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the principal aim of the study is to determine the effects n3-pufa on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with pad. treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion. primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound. secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.


Eligibility criteria:
inclusion criteria: * severity of disease: rutherford category ii or iii - moderate to severe stable intermittent claudication * ankle brachial index\<0.9 * age ≥18 years * adequate pad therapy according to current aha guidelines exclusion criteria: * current treatment with omacor or other fish oil products * planned vascular intervention * known hypersensitivity to the study drug * rest pain or ischemic ulcer * exercise tolerance limited by factors other than pad * inability to perform treadmill test * dual antiplatelet therapy (aspirin and clopidogrel) * previous myocardial infarction * known liver diseases, except fatty liver * known bleeding diathesis * women of childbearing potential who do not practice a safe contraception method * current participation in another intervention study. * previous participation in another study with an intervention within the last 3 months

Keywords: omega-3 polyunsaturated fatty-acids peripheral arterial disease endothelial function inflammation platelet function
starvation in the treatment of diabetic ketoacidosis

Conditions: Diabetes Mellitus; Diabetic Ketoacidosis

Summary: diabetic ketoacidosis (dka) and hyperosmolar hyperglycemic state (hhs) are common, but serious metabolic disorders are often encountered in intensive care. in the intensive care setting, it is common to withhold food from patients during treatment of dka. however, there is no evidence or current literature supporting this practice. the following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.


Eligibility criteria:
inclusion criteria: * males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dl, arterial ph less than 7.3, serum bicarbonate less than 15 meq/l, and the presence of ketonemia or ketonuria) * age between 18-89 * admission to the medical intensive care unit * able to provide informed consent exclusion criteria: * pregnant and breast-feeding women * institutionalized patients or prisoners * patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, peg tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.
prevalence of internal pudendal artery disease in patients with erectile dysfunction undergoing diagnostic coronary angiography

Conditions: To Assess the Presence of Internal Pudendal Artery Disease in Patients With Erectile Dysfunction Undergoing Coronary Angiography

Summary: subjects in this study have recently had or are scheduled for a coronary angiography as part of their normal, routine medical care. this procedure uses x-ray imaging to see the inside of the heart's blood vessels. this research study will evaluate the possible relationship between erectile dysfunction and vascular disease (diseases of the veins). in order to look at this possible relationship, subjects will complete a questionnaire which will ask questions regarding their sexual activity. additionally, we will gather information from their medical records and take extra images during the coronary angiography procedure.


Eligibility criteria:
inclusion criteria: 1. male 2. age \>40 years exclusion criteria: 1. creatinine clearance \< 60ml/min/1.73m2 2. age\>85 3. history of penile prosthesis 4. history or pelvic radiation or trauma

Keywords: pudendal artery disease erectile dysfunction coronary angiography coronary disease cardiac
the emotional impact of surveillance for pancreatic cancer

Conditions: Pancreatic Cancer; Psychological Distress

Summary: due to its rarity a population screening program for pancreatic cancer is not possible. for this reason, considering background data on genetic predisposition and familiarity for this lethal tumor, efforts have been pushed to build up surveillance programs for subjects at high-risk of pancreatic cancer, due to familiarity and/or genetic predisposition. these programs are based on radiological examinations (such as mri or endoultrasonography) and laboratory tests. however, little is known about the psychological burden of these programs. only a handful of studies investigated, in various ways, how the participation in surveillance programs for pancreatic cancer may burden the psychological status, with a consequent possible impairment of the psychological wellbeing, and a higher risk of withdraw from the surveillance program itself. the aim of this study was to assess the psychological and emotional impact in high-risk individuals participating in a surveillance program for pancreatic cancer due to familiarity and/or to genetic predisposition, using specific psychological tools, such as multiple psychological questionnaires, investigating different functioning areas, administered by a clinical psychologist.


Eligibility criteria:
inclusion criteria: * being enrolled in the institutional surveillance program for pancreatic cancer * ability to understand the details and implications of a study protocol. exclusion criteria: * none
micbt for non-underweight adults with eating disorders

Conditions: Eating Disorders; Maladaptive Personality Trait; Emotion Regulation; Personality; Personality Disorders; Social Interaction; Perfectionism; Self Esteem; Cognitive Dysfunction; Dysfunctional Behavior, Psychology

Summary: eating disorders (ed) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. there is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. here the investigators explored if a combination of cbt-focused plus metacognitive interpersonal therapy (mit) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ed. mit targets some aspects of ed such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ed that is cbt-e. it is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness

the study is a pilot randomized controlled trial that aims to evaluate the feasibility and effectiveness of weekly mit in addiction to cbt-f in a group of adults diagnosed with ed. specifically, the investigators will investigate in a sample of non-underweight adults presenting with ed whether once compared to cbt-e, a treatment combining mit and cbt-f is a) feasible, b) well-tolerated and c) potentially effective on eating disorders symptoms and other outcomes. the investigators expect that the experimental group cbt-f+mit would be able to have high treatment adherence and retention on the ground of previous studies of mit for personality disorders. they will also expect good outcomes in the primary outcome. given the small sample this is just a pilot study so any conclusions about other outcomes will be considered preliminary. results will provide new evidence that may lead to consider cbt-f+mit a treatment option for ed deserving investigations in larger trials.

Eligibility criteria:
inclusion criteria: * ed diagnosed in the past 6 months * seeking treatment for eating disorder * able to provide written, informed consent * bmi \> 18.5 exclusion criteria: * acute psychotic episode, psychotic symptoms, bipolar i disorder; antisocial personality disorder * suicidal ideation * substance abuse * previous psychological intervention for other eating disorders * currently involved in other ongoing treatment
a pilot project for multifidus muscle evaluation in patients with multiple sclerosis

Conditions: Multiple Sclerosis; Back Pain

Summary: this research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with multiple sclerosis (ms).

since the multifidus muscle helps to stabilize the lumbar spine, the investigators hope to learn if there is dysfunction and/or atrophy of this muscle in ms patients who also have back pain. the main objective is to study if it is possible to do a home-exercise program in patients with ms younger then 50 years old and who do not need any assistance to walk. another objective is to further characterize the multifidus function in those patients. this will be by by measuring the size of muscle at the beginning and end of the study, and also by physical exam. as an exploratory aim, the investigators would like to evaluate the relation between compliance with the home-exercise program and the change in the size of the multifidus muscle and the change in pain.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis by an uams neuro-immunologist of relapsing-remitting ms or primary progressive ms or secondary progressive ms * age between 18 years old and 50 years old on consent * complain of low back pain or severe axial back pain * english-speaking exclusion criteria: * patients that also have the diagnosis of thoracic or lumbar radiculopathy or history of prior thoracic or lumbar spinal surgery. patients that are currently pregnant edss over 5.5 or less than 1.0 patient younger than 18 years old or older than 50 years old knee total extension of less than 100 degrees
seated time for 90% incidence of hypotension

Conditions: Cesarean Section Complications

Summary: the study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

the study will use a biased coin design (bcd), up-and-down sequential method, to determine the et90 for absence of hypotension during cesarean delivery. in this methodology, the first patient will be assigned an a priori initial seated time. any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. if the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). if no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: the same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). the choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.

Eligibility criteria:
inclusion criteria: * patients with singleton pregnancies scheduled for elective cesarean delivery exclusion criteria: * bmi\>35 * unable to communicate in study language * asa greater than 2 * hypertensive disease of pregnancy
outcomes of hcc (hepatocellular carcinoma) patients treated with tace (transarterial chemoembolization) and early, not early or not at all followed by sorafenib

Conditions: Carcinoma, Hepatocellular

Summary: this study will collect data of patients who are treated with tace followed by sorafenib for hepatocellular carcinoma (hcc) or patients without sorafenib after tace. in contrast to a prior observational study on sorafenib (gideon study), where pre-treatment with tace was documented retrospectively, this study will collect more detailed information about the tace treatment and the status of a patient when treatment with sorafenib is started.


Eligibility criteria:
inclusion criteria: * patients with histologically/cytologically documented or radiographically diagnosed hcc. radiographic diagnosis needs typical findings of hcc by radiographic method i.e. on multi-dimensional dynamic ct, ct hepatic arteriography (ctha)/ct arterial portography (ctap) or mri. * patients with bclc (barcelona clinic liver cancer staging) stage b or higher. * patients in whom a decision to treat with tace has been made at time of study enrollment. patients that have received one tace in the past also can be enrolled, if the tace was done at the same site and all required data about such previous taces are available. tace includes both conventional tace with lipidiol (or similar agents) and chemotherapeutic agent(s) and tace with dc beads excluding tae without chemotherapeutic agent. * patients with unresectable hcc (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation) * patients must have signed an informed consent form * patients must have a life expectancy of at least 8 weeks exclusion criteria: * patients who have received tace in the past but the data about tace required in this protocol are not available * patients who received any systemic anti-cancer therapy prior to the first tace * patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy * hospice patients * all contra-indications according to the local marketing authorization should be considered.
mandibular furcation ii regeneration

Conditions: Furcation Defects; Periodontal Diseases

Summary: teeth with furcation grade ii defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.


Eligibility criteria:
inclusion criteria: * subject must be ≥ 20 years * subject must have periodontal disease as determined by the world workshop 2017 criteria * subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade ii with ppd \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level * competent to give consent exclusion criteria: the following must not be present at the time of enrolment; * previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment * present or past use of bisphosphonate treatment * pregnant or nursing subjects * patients classified as \> class 2 according to the asa (american society of anesthesiologists) physical status classification * previous surgical therapy of included furcation defects * inability to comprehend and respond to the quality of life questionnaire * dental restorations or prosthesis involving the furcation area * root fractures or suspected infractions * caries lesions in the furcation area * no systemic antibiotic treatment within 3 months prior to intervention
clearing lungs with epithelial sodium channel (enac) inhibition in cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: the goal of the study is to evaluate the safety and tolerability of p-1037 and to determine whether the combination of p-1037 with hypertonic saline or p-1037 alone has a greater effect on lung function in patients with cf than placebo (0.17% saline).


Eligibility criteria:
inclusion criteria: * male or female, 12 years of age or older. * diagnosis of cystic fibrosis as determined by the 1997 cf consensus criteria (nih consensus statement, 1997) * non-smoker * fev1 at screening visit 1 between 40% and 90% * stable regimen of cf medications and chest physiotherapy for the 28 days prior to screening. must be willing to discontinue use of hypertonic saline for the duration of the study. * clinically stable for at least 2 weeks * all females of child-bearing potential must have a negative serum pregnancy test and if sexually active must agree to practice a highly effective form of contraception throughout the study and for 28 days after the last dose of study medication. exclusion criteria: * history of any organ transplantation or any significant disease or disorder * use of diuretics (including amiloride) or renin-angiotensin antihypertensive drugs or trimethoprim in the 28 days prior to screening * history of significant intolerance to inhaled hypertonic saline, as determined by the investigator * known hypersensitivity to the study drug or amiloride * any clinically significant laboratory abnormalities at screening visit 1 as judged by the investigator, or any of the following: * potassium ≥ 5 milliequivalent per liter (meq/l) * abnormal renal function * abnormal liver function, defined as ≥ 3 x upper limit of normal (uln) * hemoglobin level \< 10.0 g/dl * female who is pregnant or lactating * history of sputum or throat swab culture yielding burkholderia species or mycobacterium abscessus within 2 years of screening * has previously participated in an investigational trial involving administration of any investigational compound or use of an investigational device with 28 days prior to screening * currently being treated with any ivacaftor containing regimen
exercise and respiratory training as supportive treatments for patients with chronic pulmonary hypertension

Conditions: Chronic Pulmonary Hypertension

Summary: background -pulmonary hypertension (ph) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. the present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic ph. methods -patients with ph on stable disease-targeted medication will be randomly assigned to a control and a primary training group. medication will remain unchanged during the study period. primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the short form health survey quality-of-life questionnaire. changes in who functional class, borg scale, and parameters of echocardiography and gas exchange also will be assessed. prospects -we hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe ph.


Eligibility criteria:
inclusion criteria: * patients with severe chronic ph who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate. additional inclusion criteria will be age of between 18 and 75 years and world health organization (who) functional class ii to iv. exclusion criteria: * patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.