Kornimate/medical-research-clean huggingface dataset:
evaluation of plasma angiotensin ii and angiotensin ii receptor levels in patients with sepsis and septic shock: a prospective observational study.

Conditions: Sepsis; Septic Shock

Summary: evaluation of plasma angiotensin ii and angiotensin ii receptor levels in patients with sepsis and septic shock: a prospective observational study.

there is an increasing number of experimental publications investigated effects of angiotensin ii and receptors on the pathogenesis and treatment of sepsis and septic shock. however, its level in humans and its relationship with the severity of the disease has not been investigated. if angiotensin ii plays a role in the diagnosis and prognosis of septic shock by evaluating this relationship in our study, it may be a biomarker to be used in future diagnosis, prediction of prognosis and treatment. this will enable early recognition and treatment of this disease, which causes high mortality and cost in intensive care units, thus increasing the survival rate and reducing the cost.

Eligibility criteria:
inclusion criteria: * intensive care unit patient exclusion criteria: * end-stage organ failure, * immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours

Keywords: sepsis septic shock angiotensin ii
peripheral nociceptive effects of levcromakalim

Conditions: Pain; Levcromakalim

Summary: intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated: 1. prevalence and intensity of pain 2. prevalence and intensity of itching 3. occurrence and intensity of local redness and swelling 4. occurrence and intensity of local changes in skin temperature and blood flow


Eligibility criteria:
inclusion criteria: 1. healthy volunteers of both sexes. 2. 18-60 years. 3. 50-100 kg. 4. women of childbearing potential must use adequate contraception. exclusion criteria: 1. a history of serious somatic disease 2. migraine or any other type of headache (except episodic tension-type headache less than once a month) 3. daily intake of any medication except contraceptives
saw lung microbiome study in smokers and never-smokers

Conditions: Smoking Cessation; Chronic Obstructive Pulmonary Disease (COPD); Healthy; Microbial Colonization

Summary: the trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. never smokers serve as a control group and undergo the same sampling procedures once.

the trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. never smokers serve as a control group and undergo the same sampling procedures once. demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. all personal data are encrypted according to the standard operating procedures of the study site. pharyngeal and deep nasal swabs are taken. to avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the german guidelines for bronchoscopy. before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16s ribosomal rna (rrna) to control for residual contaminating bacterial desoxyribonucleic acid (dna). a 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. this sterile brush is sealed in wax and pushed through the wax just before taking the brushing. all samples are immediately frozen and stored at -80°c until further analyses. for cultivations, samples are kept at 4°c and rapidly processed.

Eligibility criteria:
inclusion criteria: * cigarette consumption of at least five cigarettes per day * caucasian ethnicity exclusion criteria: * continous passive smoking exposure * systemic steroid therapy during the previous month * chronic lung disease (exception copd stage global initiative on lung disease (gold) 0/i/ii) * diabetes mellitus * pregnancy or breast feeding * active tuberculosis (currently or previously) * respiratory infection in the previous month * antibiotic therapy in the previous two months * immunosuppression * malignancy * interstitial lung disease * rheumatic disease with lung manifestation * member of a collaborative group of the project
a study of r3421 in patients with moderate to severe chronic plaque psoriasis.

Conditions: Psoriasis

Summary: this study will investigate the safety, efficacy and pharmacokinetics of r3421 in patients with moderate to severe chronic plaque psoriasis. patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)r3421 20mg, b)r3421 120mg, or c)placebo. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-70 years of age; * medically stable, moderate to severe chronic plaque psoriasis. exclusion criteria: * any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions; * confounding or concomitant condition or treatment.
association of polymorphisms in the androgen receptor gene and finasteride response in women with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. this study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.

androgen sensitivity in the cell is determined by the number of cytosine-adenine-guanine repeats in the androgen receptor gene. lower cag repeats have been associated in previous studies with androgenic conditions such as acne, hirsutism and hair loss in men and women. keeping this in mind, we tested women with hair loss in the frontal or vertex area, for their ar genotype. patients were randomized to placebo or 1 mg finasteride therapy for 6 months. global photographs and 2 tatooed areas of 1cm2 each were measured monthly to assess global appearance and hair counts for medication impact.

Eligibility criteria:
inclusion criteria: * women with hair loss exclusion criteria: * pre menopausal, * metabolic or medication or non-androgenetic causes of hair loss, * diffuse hair loss

Keywords: pharmacogenomics, androgen receptor gene, androgen sensitivity, cag repeats, androgenetic alopecia pharmacogenomics in treatment for androgenetic alopecia in women
a phase 3 pivotal trial comparing allovectin-7® alone vs chemotherapy alone in patients with stage 3 or stage 4 melanoma

Conditions: Metastatic Melanoma

Summary: to compare the safety and efficacy of allovectin-7® versus dacarbazine (dtic)or temozolomide (tmz) in subjects with recurrent stage 3 or stage 4 melanoma.

eligible patients will have a 66% chance of receiving allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). the treatment course recommended for patients who receive allovectin-7® is a minimum of 16 weeks. each cycle will consist of weekly injections of allovectin-7® alone for six weeks followed by two weeks of observation and assessments. for patients who receive the chemotherapy alone, their treatment course will follow standard dosing. during the trial all patients' tumors will be closely monitored. patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.

Eligibility criteria:
inclusion criteria (potential study participants must meet the following criteria): * confirmed stage 3 or stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically interferon alpha or interleukin-2) * at least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected * normal blood chemistries and blood cell counts * at least 18 years old and able and willing to provide informed consent to participate exclusion criteria (potential study participants will not be eligible with the following): * previous chemotherapy treatment for melanoma * melanoma lesions in the brain or liver (however, lesions in the lungs are allowed) * if surgical removal of all lesions would be possible and could be curative * any melanoma tumors greater than 10cm x 10cm in size * known condition resulting in a suppressed immune system * female subjects who are pregnant

Keywords: melanoma dtic tmz stage 3 stage 4 metastatic metastatic melanoma (stage 3, stage 4 melanoma)
effects of marijuana on neuropathic pain and spasticity in spinal cord injury patients

Conditions: Spinal Cord Injury

Summary: the goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. the main question is: does the cannabis product from khonkaen university reduce neuropathic pain and spasticity in spinal cord injury patients? the research design is a crossover study. the participants will be randomly into 2 groups: group 1 and group 2. the participants received either cannabis or placebo for 2 weeks. after completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. the outcome measurements are pain and spasticity.


Eligibility criteria:
inclusion criteria: * spinal cord injury more than 6 months * neuropathic pain * pain score \> 3 * do not response to standard medical treatment * given inform consent exclusion criteria: * allergy to cannabis * unstable cardiovascular and pulmonary diseases * chronic kidney and liver diseases * psychological disease * pregnancy or breastfeeding

Keywords: cannabis marijuana spinal cord injury pain spasticity
arcangelo (italian prospective study on cangrelor)

Conditions: Acute Coronary Syndrome

Summary: the sponsor implemented a post-authorisation safety study (pass), category 3, focused in acute coronary syndrome, in order to collect information about the safety of cangrelor in the real clinical practice, evaluating the safety of the transition to all the oral p2y12 inhibitors (cangrelor, ticagrelor and prasugrel).


Eligibility criteria:
inclusion criteria: 1. patients' written informed and privacy consent obtained before or at the end of the pci procedure according to patients' condition but in any case, prior to collection of any study-related data; 2. male or female patients aged ≥ 18 years; 3. patients with acute coronary syndromes undergoing pci; 4. patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor. exclusion criteria: 1. patients with active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension; 2. patients with history of stroke or transient ischaemic attack (tia); 3. patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients; 4. known pregnancy or breast-feeding female patients; 5. patients with stable angina (sa).

Keywords: real-word acs pci
intervention for the prevention of obesity in preschool

Conditions: Childhood Obesity

Summary: the purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. the aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.

obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment. participation of primary care services is key to solve the problem. these services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family. the study is divided in two stages: 1. design of the intervention. the researchers will use qualitative methods to evaluate feeding practices, physical activity and the environment in which such behaviors are generated. in a similar way the care provided by health professionals to overweight and obese children it will be evaluated; this includes the perception that health providers have about this problem. the information will allow identifying risk behavior and healthy behavior, facilitators and obstacles to receive care. the results will serve to define the contents of the intervention. 2. intervention: the study will take place in four family medicine clinics belonging to the mexican institute of social security. two clinics will receive the intervention and two will serve as control. in each clinic, fifty children and their mothers will be recruited. at the intervention clinics, the group of mothers will participate in seven weekly sessions and in two individual sessions at 3 and 6 months after the group sessions finish. during the sessions, the researchers will motivate the mothers to change feeding practices and encourage physical exercise of the children and family, this will improve the chance for their children for healthy growing. the control group will receive the usual care that consists only in the recommendations that the family doctor provides. the evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise.

Eligibility criteria:
inclusion criteria: * children between 2 and 4 years and 11 months of age at the beginning of the study. * overweight children, defined as a bmi score of z \> = 1.5 and \< +3 based on the who standards. * the children's parents accept participation in the study. exclusion criteria: * families who plan on changing their address during the study. * families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations. * children who require a special diet for medical reasons or children with limited motor functioning.

Keywords: nutritional intervention childhood obesity physical activity feeding practices
efficacy and tolerability of an innovative formulation of bak-free latanoprost

Conditions: Primary Open-angle Glaucoma

Summary: this study evaluates the efficacy and tolerability of a new formulation of latanoprost without benzalkonium chloride (bak-free). patients with open-angle glaucoma who were using bak-containing latanoprost ophthalmic solution for ≥6 months, switched to bak-free latanoprost ophthalmic emulsion.

latanoprost is a prostaglandin f2alfa analogue that increases the uveoscleral outflow of aqueous humor, resulting in a intraocular pressure (iop) reduction. benzalkonium chloride (bak) is usually employed in formulations of prostaglandin analogues due to its dual action of preservative and adjuvant in the formulation. however, this preservative has known toxic effects on the ocular surface, causing ocular dryness and discomfort on long-term use. benzalkonium chloride-free (bak-free)latanoprost is a new formulation approved for the use in patients with primary open angle glaucoma /ocular hypertension. in this study, patients that were using bak-containing latanoprost for ≥6 months, switched to a new formulation of bak-free latanoprost ophthalmic emulsion to evaluate its hypotensive action and quantify the changes in ocular surface parameters.

Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years * diagnosed with primary open-angle glaucoma or pseudoexfoliative glaucoma. * receiving containing-bak latanoprost as monotherapy for at least 6 months * pachymetry between 520 and 580 microns * informed consent given exclusion criteria: * history of allergic hypersensitivity or poor tolerance to latanoprost or any components of the formula * angle closure glaucoma or secondary glaucoma * history of recent previous glaucoma surgery or trabeculoplasty (less than 1 year of surgery) * history of cataract surgery during the last 6 months * history of uveitis or intraocular inflammation * corneal alteration * pregnant patients, who wish to conceive or who are in the nursing period.

Keywords: benzalkonium chloride latanoprost bak-free glaucoma ocular hypertension conjunctival hyperemia but osdi schirmer i corneal staining tear meniscus height
subclinical atherosclerosis in patients with familial hypercholesterolemia treated with evolocumab®

Conditions: Hypercholesterolemia, Familial

Summary: protein convertase subtilisin kexin type 9 (pcsk-9) inhibitors demonstrated efficacy in cholesterol reduction and in the prevention of cardiovascular events. the investigators will evaluate changes in lipid profile, oxidation markers and subclinical atherosclerosis in patients with familial hypercholesterolemia (fh) during 12 weeks of treatment with a pcsk-9 inhibitor, evolocumab®.

several studies emphasize the role of high levels of low-density lipoprotein cholesterol (ldl-c) as the main causative factor in atherosclerosis development. among patients with hypercholesterolemia, those with very high levels of ldl-c exhibit increased prevalence of subclinical atherosclerosis and a higher atherosclerosis progression, thus leading to a significantly higher cv risk. endothelial dysfunction is the earliest stage of the atherosclerotic process and even a trigger of cv events. flow-mediated dilation (fmd) is widely accepted as an accurate and non-invasive method to assess vascular reactivity and, in turn, as a surrogate marker of subclinical atherosclerosis and an independent predictor of cv events. it's well known that hypercholesterolemia has been associated with decreased endothelial function and increased oxidative stress. although statin treatment represented for years the gold standard as lipid lowering therapy, the target ldl-c is not always achieved, mainly among patients with very high levels of ldl-c. more recently, pcsk-9 inhibitors demonstrated efficacy in ldl-c reduction, in the prevention from cv events and in atherosclerotic burden regression. some data showed an effect of pcsk-9 inhibitors on endothelial function, but no evidence is available on effect on ldl subfractions. small dense ldl (sd-ldl) are considered an emerging risk factor for cardiovascular disease due to a greater atherogenic potential \[ \] and are important markers for predicting cv risk.

Eligibility criteria:
inclusion criteria: * diagnosis of fh (clinical and/or genetic) * eligibility of patients to start a treatment with pcsk-9 according to 2016 esc guidelines. exclusion criteria: * age \< 18 years * inability to understand or sign the informed consent * high level of transaminases ( \>3x upper normal limit) * hypertriglyceridemia ( \>150 mg/dl) * end-stage renal disease (filtration rate \< 30 ml/min/mq) * current malignant disease or a diagnosis of malignancy in the 2 years prior to the first visit * previous exposure to pcsk-9 inhibitors * presence of hypercholesterolemia secondary to other causes (hypothyroidism, hormone therapies, corticosteroids etc.)
molecular analysis of blood samples in standardized cancer care referrals for scan and cup

Conditions: Neoplasms, Unknown Primary; Cancer

Summary: patients with suspected cancer (scan) and cancer of unknown primary tumor (cup) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. however, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for scan and secondly for cup, and partly to receive suggestions for localization of the primary tumor for primarily cup and secondly scan. there is also a need for prediction of molecularly targeted therapies. new research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. it is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. the aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients. samples will be taken of epithelial cells circulating in the blood, and of the free circulating dna. as a reference, germ-line dna will also be sampled, also from regular blood samples. the analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for scan and cup, or if adaptations in routines, training or equipment need to be introduced. the analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.


Eligibility criteria:
inclusion criteria: * 200 patients who were referred to be investigated and diagnosed at the diagnostic centre (dc) in södertälje, sweden, for suspected cancer (scan) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (cup) and which give informed consent to participate in the study. exclusion criteria: * all patients who have been referred and consented are included.

Keywords: germ line dna, gdna circulating tumor cell, ctc circulating cell free dna, cfdna, ctdna screening diagnostic predictive
neuromodulation parameter efficacy

Conditions: Chronic Pain

Summary: the objective of this study is to determine the efficacy of neuromodulation using various stimulation paradigms in the treatment of several disorders including chronic pain.

different stimulation parameters will be tried in a blinded fashion to compare efficacy.

Eligibility criteria:
inclusion criteria: * patients who are candidates for, and have been consented for, implantation of a neuromodulation device. exclusion criteria: * non-english speaking