Kornimate/medical-research-clean huggingface dataset:
evaluation of a lopinavir/ritonavir monotherapy vs a triple therapy as maintenance regimens in hiv-1 infected patients

Conditions: HIV Infections

Summary: a 2-year multicenter, phase ii/iii, randomized active-controlled trial to evaluate the efficacy and tolerance of two maintenance strategies in hiv-1 infected patients with hiv rna below 50 copies/ml : a monotherapy with lopinavir/ritonavir or a single-tablet triple therapy (efv/ftc/tdf).

today, one of the challenges of hiv treatment is to overcome side effects and toxicity of long term antiretroviral therapy. a promising approach may be the simplification of treatment maintenance strategies, sparing certain antiretroviral drug classes. this is a two-year prospective phase ii/iii, multicenter randomized trial to evaluate the efficacy and tolerance of a lopinavir/ritonavir monotherapy as a maintenance regimen in hiv-infected adults. enrolled patients must have had stable antiretroviral treatment and hiv-1 rna below 50 cp/ml over the previous 12 months, and no prior treatment failure. provided informed consent, 420 patients are randomized in a 1:1 ratio to two open-label treatment groups and receive either lopinavir/r 800/200mg per day or efv/ftc/tdf 600/200/245 mg per day (fixed dose combination). the main objective is to assess treatment efficacy and tolerance after 2 years. in 80 patients, repeated dexa measurements are performed during the trial in order to evaluate changes in bone mineral density and in body composition.

Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection * stable antiretroviral treatment over 6 months * hiv-1 rna \< 50 cp/ml for at least 12 months * lymphocytes cd4+ \> 200/mm3 * lymphocytes cd4+ nadir \> 100/mm3 * absence of prior treatment failure (defined by two successive hiv-1 rna ≥ 50 cp/ml under nnrti or pi treatment) * absence of documentation of a mutation conferring nrti or nnrti resistance or a primary mutation in the protease gene * written informed consent * patient affiliated to a social security scheme exclusion criteria: * woman of child bearing potential without efficient contraception * pregnant or breastfeeding woman * hbv infection (hbs ag+) * hbc infection requiring specific treatment during the trial * liver cirrhosis child-pugh c * hiv-1/hiv-2 co-infection or isolated hiv-2 infection * ongoing interleukin or interferon treatment * co-administration of contraindicated treatments * hypersensibility to efavirenz or lopinavir/r * absolute neutrophil count \ 3 uln, cd4 nadir \< 100/mm3. * participation in another clinical trial interfering with the study drug assignment in dream * subject under legal guardianship or incapacitation

Keywords: undetectable hiv infections monotherapy lopinavir/ritonavir protease inhibitor treatment experienced
effect of fentanyl on pain severity and duration of labor

Conditions: Decrease Labor Pain

Summary: background: there are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. it is necessary to be known effect of these drugs on the mother and fetus during labor adverse. therefore, the purpose of this study was determination of effect of fentanyl intravenously on pain severity during the active phase of labor.


Eligibility criteria:
inclusion criteria: * multiparas pregnant women (gravid 2-7), * term singleton pregnancy, * cephalic presentation, * low risk pregnancy with no history of drug tolerance (addiction), * medical and mental diseases. exclusion criteria: * respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).

Keywords: fentanyl analgesia duration of the active phase pain severity
an observational study of first-line capecitabine based chemotherapy in participants with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.


Eligibility criteria:
inclusion criteria: * participants with newly diagnosed mcrc who have started first-line capecitabine-based chemotherapy in accordance with the current hungarian label exclusion criteria: * history of serious or unexpected reaction to fluoropyrimidine therapy * hypersensitivity to the active ingredient of xeloda or to any of the excipients of the product, or to fluorouracil * known dihydropyrimidine dehydrogenase deficiency * pregnancy or lactation * inadequate bone marrow, hepatic or renal function * treatment with sorivudine or its chemical analogues (for example, brivudine) * if any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
investigation of the accuracy of temporal artery thermometers

Conditions: Sepsis

Summary: the purpose of this study is to determine whether temporal artery thermometers are accurate tools in temperature measurements of patients presenting to the emergency department. the investigators´ hypothesis is that there is a difference of \> 0,3 degrees centigrade (bland-altman) between the temperatures measured with the temporal artery thermometers used at the investigators´ hospital (exergen tat-5000) and those measured with rectal thermometers (omron mc-341-e), which is considered to be the gold standard in denmark defined by the danish center for clinical guidelines. the investigators furthermore hypothesize that the difference between these measurements is greater if measured in a patient with hyperthermia (temperature \> 37,9 degrees centigrade).

accurate temperature measurement on patients presenting to the emergency department is of great importance since it has significant influence on the further treatment of the patient. at bispebjerg hospital temporal artery thermometers are being implemented as they provide a fast and comfortable temperature measurement compared to rectal thermometers, who are considered to be the gold standard, defined by the danish center for clinical guidelines. the scientific proof for their accuracy compared to rectal thermometers in adult patients is insufficient though. the purpose of this study is to determine the difference between temperatures measured by a temporal artery thermometer (exergen tat-5000) and a rectal thermometer (omron mc-341-e) in patients presenting to the emergency department at copenhagen university hospital: bispebjerg. the investigators hypothesize that there will be an average difference of at least 0,3 degrees centigrade between those two types of measurements (bland-altman). based on a significance of 5% and a power of 80% the number of patients was calculated to 385, including an estimated 10% dropout.

Eligibility criteria:
inclusion criteria: * given informed consent exclusion criteria: * constipation * anal disorders
68ga-ha-dotatate imaging of suspected somatostatin receptor positive tumors

Conditions: Neuroendocrine Tumors

Summary: somatostatin receptor (ssr) imaging is a critical component of clinical care for many patients being investigated for or with confirmed ssr positive tumors. in the past, 111in-octreotide imaging has been used for this purpose but it has been recently supplanted globally by ssr positron emission tomography (pet) imaging due to better image quality and higher diagnostic accuracy. this study will assess the safety and diagnostic effectiveness of 68ga-ha-dotatate produced a the edmonton radiopharmaceutical centre (erc).

a single centre non-randomized, non-blinded phase ii prospective cohort study evaluating the safety and efficacy of 68ga-ha-dotatate pet/ct imaging in patients with known or suspected somatostatin receptor positive tumors. up to 600 scans will be included over 6 years. all patient ages (pediatric and adult) will be included. individual patients may have more than one scan during the study period. safety evaluation will consist of an adverse event assessment whil in the nuclear medicine department at the university of alberta hospital. efficacy evaluation will consist of a comparison to ct and/or mri accuracy based on 1 year follow-up clinical evaluation.

Eligibility criteria:
inclusion criteria: * patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma * a standard clinical ct or mri is obtained within 6 months of enrollment * ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker) exclusion criteria: * weight \> 225 kg (weight limit of the pet/ct scanner) * inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging * any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation * previous allergic reaction to dotatate or somatostatin analogues * lack of intravenous access
ocular surface microbiome

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.

"dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. in this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.

Eligibility criteria:
inclusion criteria: * subjects with ocular surface discomfort with an ocular surface disease index score of greater than 60 * subjects with and ocular surface disease index score less than 30 * males and females age 18 or older exclusion criteria: * contact lens wear * use of oral or topical antibiotics in past 6 months * use of prescription eye medication in past 6 months * penetrating ocular or keratoplasty surgery in last 12 months * children under the age of 18

Keywords: dry eye microbiome
effects of face masks on cardiopulmonary capacity in healthy individuals

Conditions: Covid-19

Summary: the aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. the results of our study will show the effects of face masks commonly used during the pandemic period.

the aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. the results of our study will show the effects of face masks commonly used during the pandemic period. the hypotheses we will test for this purpose; h1: face masks affect cardiopulmory capacity in healthy individuals h2: face masks affect heart rate in health individuals h3: face masks affect oxygen saturation in healthy individuals h4: face masks affect respiratory frequency in healthy individuals

Eligibility criteria:
inclusion criteria: * 18 years old to 30 * healthy young individuals exclusion criteria: * having cardiovasculary conditions * having respiratory conditions * having inflammatory conditions * any contraindicated situations for cardiopulmonary tests

Keywords: covid19 cardiopulmoary exercise capacity face masks
magnet ingestion in children

Conditions: Foreign Bodies

Summary: one year national observational surveillance study of children who ingest a magnetic foreign body

the study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.

Eligibility criteria:
inclusion criteria: * magnetic foreign body ingestion * 16 years of age or less exclusion criteria: * non ingested foreign body
a pilot study simulating multifocal intraocular lenses in healthy subjects

Conditions: Lenses, Intraocular; Contrast Sensitivity; Visual Acuity

Summary: age related cataracts are responsible for about 51 percent of blindness worldwide and according to the who affect about 20 million people, according to the wh . as cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (iol). as for this study, the investigators seek to compare four different iol designs in in a psychophysiological setting, allowing to assess the impact of these iols on vision and psychological processing of visual information. as these iols also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. the healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different iols. this would allow subjective testing of iols before surgery.


Eligibility criteria:
inclusion criteria: men and women aged between 18 and 35 years * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, between -1 and +1 diopters exclusion criteria: * \> 0,5 diopters of cylinder * abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day
the safety/efficacy of rifaximin with/without lactulose in participants with a history of recurrent hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Cirrhosis

Summary: the purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (he) in participants with cirrhosis who have had a previous episode of he.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old. * in remission from demonstrated overt he (conn score 0 or 1). * have had one or more episodes of overt he associated with cirrhosis within 6 months prior to screening visit (day -7 to -1). * participant has a close family member or other personal contact who is familiar with the participant's he and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial. exclusion criteria: * participant has been diagnosed with human immunodeficiency virus (hiv) as determined by medical history. * history of tuberculosis infection. * participant has been diagnosed with chronic respiratory insufficiency. * participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics. * renal insufficiency requiring routine dialysis. * participant has an active spontaneous bacterial peritonitis(sbp) infection. * intestinal obstruction or inflammatory bowel disease. * participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised. * current gastrointestinal (gi) bleeding or has a history of a gi hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit. * participant is anemic, as defined by a hemoglobin of less than (\<) 8 grams/deciliter (g/dl). * scheduled to receive a liver transplant within 1 month of screening.

Keywords: liver failure hepatic insufficiency liver diseases brain diseases rifaximin cirrhosis
study of cyclosporine inhalation solution (cis) in improving bronchiolitis obliterans syndrome-free survival following lung transplantation

Conditions: Lung Transplant

Summary: a phase iii, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of cyclosporine inhalation solution (cis)in improving survival and preventing bronchiolitis obliterans syndrome (bos) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.


Eligibility criteria:
inclusion criteria: * a recipient of a single or double lung transplant (including heart-lung transplant) * age 18 years or older * able to produce a forced expiratory volume in one second (fev1) of greater than one liter at randomization * eligible subjects must be enrolled within 70 days after receiving a lung transplant * clinical status sufficiently stable to enable routine post-transplant bronchoscopy with bronchoalveolar lavage (bal) and chest x-ray (or equivalent i.e., chest computerized tomogram (ct)) prior to screening exclusion criteria: * lung re-transplantation * documented allergy to propylene glycol and/or cyclosporine * documented respiratory or anastomotic infections unless on appropriate antimicrobial therapy with evidence of clinical response * women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant * women who are breastfeeding * clinically significant bronchial stenosis unresponsive to dilation and/or stenting * malignancies diagnosed within one year prior to screening (with the exception of non-melanomatous skin cancers)

Keywords: lung transplant lung transplant recipient bronchiolitis obliterans syndrome bronchiolitis obliterans single lung transplant double lung transplant heart-lung transplant aerosol
identifying the gaps in the diagnosis and management of hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to identify the gaps in diagnosing and managing hepatitis c infected patients so that interventions can be targeted to address these problem areas in order to optimize care of these patients.


Eligibility criteria:
inclusion criteria: * every patient diagnosed with hepatitis c exclusion criteria: * patients younger than 18 years old
survey to assess why people are not responding to treatment in hypertension

Conditions: Arterial Hypertension

Summary: this study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients


Eligibility criteria:
inclusion criteria: * men or women over 18 * hypertensive patients * uncontrolled hypertension (blood pressure \>/=140/90 mmhg on the day of consultation or \>/=130/80 mmhg in diabetic patients or in patients suffering from kidney failure, or in elderly patients with a systolic blood pressure \>/=150 mmhg (in the absence of orthostatic hypotension) * patients treated with a combination, fixed or not, of renin-angiotensin system blocker (rasb) + hydrochlorothiazide (hctz) * patients examined in common medical care practice, whatever the reason for consultation * patients informed of the study

Keywords: arterial hypertension
aldosterone, microvascular function and salt-sensitivity

Conditions: Abdominal Obesity; Metabolic Syndrome; Sodium-sensitivity; Insulin Resistance; Hypertension

Summary: currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. the association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. during recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. the underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. in addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower no-availability, which is characteristic of microvascular dysfunction. in addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population. the investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of no-availability. this microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.


Eligibility criteria:
inclusion criteria: obese individuals * age 18-65 years * caucasian * waist circumference \> 102 cm (men)/\> 88 cm (women) lean individuals * age 18-65 years * caucasian * waist circumference \< 94 cm (men)/\< 80 cm (women) exclusion criteria: obese/lean individuals * cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) * diabetes mellitus/impaired glucose metabolism (fasting glucose values \> 5.6 mmol/l * stage 3 hypertension (blood pressure \> 180/110 mm hg) * unstable or severe pulmonary disease * unstable or severe thyroid disorders * inflammatory diseases * smoking * alcohol use \> 2 u/day (women)/\> 3 u/day (men) * use of antihypertensive, lipid-lowering or glucose-lowering medications * use of corticosteroids and regular use of nsaids * egfr\< 60 ml/min * impairment of hepatic function * pregnancy or lactation
the comparative efficacy of an over the counter light therapy mask vs over the counter topical benzoyl peroxide 2.5% and used in combination with over the counter adapalene gel 0.1% for mild to moderate acne

Conditions: Acne

Summary: this is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the neutrogena® light therapy acne mask an over the counter (otc) blue/red light led mask, as compared to the combination of topical otc benzoyl peroxide 2.5% gel and otc adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. this will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. the two arms will be: (1) neutrogena® light therapy acne mask (mask), (2) topical otc benzoyl peroxide 2.5% gel and otc adapalene 0.1% gel (top). both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. all products will be purchased through commercial sources.


Eligibility criteria:
inclusion criteria: * diagnosis of acne vulgaris as determined by the study physician * mild-to-moderate acne defined as a grade 2 or 3 on the fda investigator global acne assessment (iga) for acne vulgaris (appendix 1)19 * if female, * negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits * agreement to comply with medically acceptable forms of birth control with heterosexual intercourse * agreement to comply with the study protocol and attend all study visits exclusion criteria: * is unwilling to participate in the survey * outside of specified age range * patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the iga scale * females who are pregnant or breastfeeding * known allergy to any ingredients in the test products or history of photosensitivity * pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions * excessive facial hair or scarring that could interfere with quantification of acne lesions * does not have decision making capacity