Kornimate/medical-research-clean huggingface dataset:
efficacy of artemisinin combination therapies for the treatment of uncomplicated p. falciparum in pregnancy in brazil

Conditions: Malaria

Summary: data on the burden of mip in low transmission areas, such as latin america, are very limited; there is even less information on the efficacy of case management of mip. the treatment recommendations for mip in latin american countries have been changing rapidly in recent months; currently, either artemether-lumefantrine (al) or mefloquine-artesunate (ma) is the first line treatment for p. falciparum (depending on country); however, no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in latin america to support their use. we propose a multi-center 2-arm open-label randomized phase 4 clinical trial to assess safety and efficacy of the present therapies, al and ma. we hypothesize that the drugs will both be efficacious for use in pregnant women in brazil.


Eligibility criteria:
inclusion criteria: 1. gestational age \>16 weeks (determined by lmp and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus 2. normal fetal heart beat detected by doppler 3. presence of any p. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film) 4. willing to sign or thumb print informed consent 5. willing to return for scheduled follow up visits for treatment and observation until delivery 6. willing to deliver in health facility exclusion criteria: 1. pregnancy \< 16 weeks 2. microscopically confirmed p. vivax or mixed infection/ parasitemia (p. falciparum and another species of plasmodium, i.e. p. vivax, p. ovale, or p. malariae) 3. history of allergy or hypersensitivity to interventional drugs 4. exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including al and ma) 5. patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin) 6. history or family history of epilepsy or psychiatric disorder 7. presence of signs and symptoms of severe malaria 8. hemoglobin \< 7 g/dl 9. inability to tolerate oral medication (repeated vomiting, impairment of consciousness). 10. history of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, hiv or aids, known hemoglobinopathy 11. participant's inability to return for follow up visits 12. age \<15 years

Keywords: malaria plasmodium falciparum treatment brazil
effects of cardiac rehabilitation on high mobility group box-1 levels after acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: this purpose of this study is to examine the relationship between hmgb-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac rehabilitation program.

exercise-based cardiac rehabilitation after acute myocardial infarction (ami) has beneficial effects on cardiovascular functional capacity, quality of life, risk factors modification, and morbidity and mortality. mounting evidences suggest that inflammation plays a key role both on initiation and progression of atherosclerosis. several markers of systemic inflammation appear to be active effectors in the pathophysiology of athero-thrombotic disease leading to the occurrence of ami. the high mobility group box 1 (hmgb-1) is a ubiquitous nuclear protein constitutively expressed in quiescent cells, and it has been implicated in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to dna sequences. hmgb-1 has been recently recognized as a critical mediator of inflammatory diseases. in fact, the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. specifically, hmgb-1 binds to the receptor for advanced glycation end products (rage) and, in turns, it activates mitogen-activated protein-kinase (mapk) and nuclear factor-κb (nf-κb). this intracellular pathway leads to the production of several pro-inflammatory cytokines. interestingly, increased levels of hmgb-1 have been observed in atherosclerotic lesions, suggesting that hmgb-1 might be involved in the pathophysiology of atherosclerosis. this study was designed to investigate the relationship between hmgb-1 and strong postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac rehabilitation program.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction exclusion criteria: * bmi higher than 30 and lower than 18 * residual myocardial ischemia * severe ventricular arrhythmias * iib or iii degree atrio-ventricular block * valvular disease requiring surgery * pericarditis * severe renal dysfunction (i.e. creatinine \>2.5 mg/dl) * severe concomitant non-cardiac disease such as cancer * liver dysfunction (alanine aminotransferase/aspartate aminotransferase level \>1.5 times the upper normal limit) * dementia * any systemic disease limiting exercise * inability to participate in a prospective study for any logistic reason

Keywords: cardiac rehabilitation high mobility group box proteins inflammatory markers cardiopulmonary functional capacity maximal oxygen consumption echocardiography left ventricular ejection fraction left ventricular chambers dilation left ventricular remodeling left atrium remodeling cardiac remodeling exercise training
effect of vitamin d on periodontal disease

Conditions: Vitamin D Deficiency; Periodontal Diseases

Summary: background. vitamin d has both direct effects on bone metabolism and an antimicrobial effect on periodontopathogens. it also inhibits inflammatory mediators that contribute to periodontal destruction. the purpose of this study was to evaluate the association between serum 1.25-hydroxyvitamin d (1.25(oh)2d3) and 25(oh)d levels and periodontal inflammation. methods. this study included 28 subjects with chronic gingivitis, 29 subjects with chronic periodontitis and 25 periodontally healthy subjects. blood samples were collected from the participants to determine serum levels of 25(oh)d, 1.25(oh)2d3, tumour necrosis factor α (tnf-α), c-reactive protein (crp) and interleukin 6 (il-6). clinical parameters were recorded. results were statistically analysed with a shapiro-wilk's test, mann-whitney u test, kruskal-wallis h test, wilcoxon test and post-hoc multiple comparison test.

the subjects included in the study were selected from among patients who applied to our clinic, for routine periodontal examinations. individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin d and systemic diseases were excluded from the study. in addition, since the region's level of sunlight exposure may have an effect on the level of vitamin d, participants were required to live in the region for the last five years. a total of 82 subjects, including 25 as a periodontally healthy control group, 28 with chronic gingivitis and 29 with chronic periodontitis, were included in the study. clinical criteria for chronic periodontitis are the formation of plaque and calculus and ≥ 5 milimeter (mm) pocket depth or attachment loss in more than 30% of the teeth. diagnosis criteria for chronic gingivitis are the formation of plaque and/or calculus in the mouth, bleeding, and no loss of pocket or attachment. the diagnosis criteria for periodontally healthy individuals are having clinically healthy periodontal tissues or minimal periodontal inflammation, with no loss of pocket or attachment.

Eligibility criteria:
inclusion criteria: * live in the region for the last five years. exclusion criteria: * individuals who had been using immunosuppressive drugs and antibiotics for the past three months, smokers, individuals who had periodontal treatment within the past six months, and individuals with additional or supplementary vitamin d and systemic diseases.

Keywords: periodontitis gingivitis vitamin d
closed-loop control of glucose levels (artificial pancreas) for 12 days in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. the objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with t1d for 12 days in outpatient settings. the investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. the subject will have been on insulin pump therapy for at least 3 months. 4. hba1c ≤ 12%. exclusion criteria: 1. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator 2. recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery 3. warfarin chronic treatment if inr monitoring cannot be evaluated (can increase the risk of bleeding) 4. chronic use of acetaminophen. acetaminophen may interfere with glucose sensor readings 5. pregnancy (ongoing or current attempt to become pregnant) 6. breastfeeding 7. no nearby party for assistance if needed 8. plans to go abroad or travel at more than 2 hours distance from montreal during the trial period 9. severe hypoglycemic episode within two weeks of screening or during the run-in period 10. severe hyperglycemic episode requiring hospitalization in the last 3 months 11. current use of glucocorticoid medication (except low stable dose and inhaled steroids) 12. known or suspected allergy to the trial products 13. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator 14. anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)

Keywords: type 1 diabetes artificial pancreas closed-loop system hypoglycemia insulin
a study comparing maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks mircera versus epoetin beta in dialysis patients with chronic renal anemia.

Conditions: Anemia

Summary: this two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of mircera versus epoetin beta in dialysis patients with chronic renal anemia. patients will be randomized to receive either subcutaneous mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. in both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * male or female patients, \>=18 years of age; * chronic renal anemia; * hb concentration 10.0 - 12.0 g/dl during the screening period; * continuous subcutaneous maintenance therapy with epoetin at the same dose and same dosing interval for at least 12 weeks before and throughout screening. exclusion criteria: * blood transfusion within the previous 8 weeks; * poorly controlled hypertension; * significant or acute or chronic bleeding; * active malignant disease; * congestive heart failure (nyha class iv).
a safety, efficacy and pharmacokinetics study of a recombinant fusion protein linking coagulation factor ix with albumin (rix-fp) in children with hemophilia b

Conditions: Hemophilia B

Summary: this study will examine the pharmacokinetics, safety and efficacy of rix-fp for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia b.


Eligibility criteria:
inclusion criteria: * male subjects, younger than 12 years old. * severe hemophilia b (factor ix \[fix\] activity of ≤ 2%). * body weight ≥ 10 kg. * subjects who have received fix products (plasma-derived and/or recombinant fix) for \> 150 exposure days (eds) (6 to \ 50 eds (\< 6 years). * no history of fix inhibitor formation, no detectable inhibitors at screening and no family history of inhibitors against fix. * written informed consent for study participation. exclusion criteria: * known hypersensitivity to any fix product or hamster protein. * known congenital or acquired coagulation disorder other than congenital fix deficiency. * kidney or liver disease. * recent life-threatening bleeding episode.
gdm post partum screening

Conditions: Diabetes; Gestational Diabetes; Diabetes Mellitus, Type 2

Summary: immediate postpartum screening for diabetes mellitus in women with gestational diabetes the objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.

1 overview the purpose of the project is to determine if screening for diabetes mellitus, in women with gestational diabetes, can be done 24 hours postpartum versus 6-12 weeks postpartum. primary objective: to compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum. design and project type prospective cohort study. women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 dm done 24 hours after delivery. they will also have routine screening for type 2 dm done at 6-12 weeks postpartum. description of intervention the intervention is early screening for type 2 dm which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement. instruments fingerstick testing will be done with statstrip glucose hospital meter (nova biomedical). this device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).

Eligibility criteria:
inclusion criteria: * pregnant, or recently postpartum, women with the diagnosis of gdm requiring medication therapy after 20 weeks, * \>18 years-old (yo)yo, * english speaking. exclusion criteria: * have pre-existing type 2 dm, * did not require anti-hyperglycemic medication therapy (gdma1), * early onset gdm (\<20 weeks). * do not speak english .
comparison of two surgical sequences "cataract surgery then vitrectomy" versus "vitrectomy then cataract surgery" under local-regional anesthesia

Conditions: Cataract; Vitreous Disorder

Summary: cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. to date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. however, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. this randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.

cataracts and vitreo-retinal conditions are frequently associated, such as epimacular membranes, vitreomacular tractions, macular holes, or even macular edema. cataract is also a frequent complication of posterior vitrectomy. surgical treatment for pre- or post-vitrectomy cataract is corneal phacoemulsification with intraocular lens implantation. many patients undergoing vitrectomy alone consult five to ten years later, without useful vision due to a dense cataract that might be more complicated to treat at a late stage. indeed, if the phacoemulsification on a previously vitrectomized eye is not an issue in the first years, the intervention can be complicated ten years later, due to nuclear hardness and zonular weakness. to date, there are no recommendations regarding the surgical sequence for the combination of cataract surgery and vitrectomy. the most-used sequence is to start with cataract surgery and then to perform the vitrectomy most often in 25 gauges (retinal surgery). when we start with cataract surgery under locoregional anesthesia, we often have (in about 15% of cases) iris hernia, which causes intraoperative discomfort (need to put stitches on the cornea), intraoperative miosis, pigments release, which can interfere with visualization during vitrectomy and which require dilating agents use. the hypothesis of this study is that reversing the order of interventions and starting with vitrectomy could in particular reduce the incidence of intraoperative and postoperative complications.

Eligibility criteria:
inclusion criteria: * man or woman aged 18 years old or more * patient with macular disease requiring vitrectomy * patient with cataract requiring surgery * patient suitable for local-regional anesthesia * patient suitable for undergoing both surgical procedures consecutively and in any order * patient that have given informed consent before performing any study-related procedure * patient affiliated to a social security scheme exclusion criteria: * pseudophakic patients * contra-indications to local-regional anesthesia * pregnant or breastfeeding patients * patients under legal protection
evaluation of a new pain management protocol involving intranasal sufentanil in the emergency room.

Conditions: Acute Pain

Summary: until now, the mulhouse emergency department used a protocol for severe pain based on morphine titration. in order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil. the primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. this new pain management protocol has been updated as part of the upcoming french high authority for health hospital certification, for which pain management is one of the priority criteria. this research does not change the routine care given to the patient.

secondary objectives: 1. to assess the rapidity of pain relief with intranasal sufentanil compared to intravenous morphine titration 2. to compare the evolution over time of the pain with the old and new pain management protocol. 3. to assess the safety of sufentanil and morphine titration conduct of research: when a patient is admitted to the mulhouse emergency department with pain greater than or equal to 4 on the numerical scale, the triage nurse or doctor checks the eligibility criteria. if eligible, the nurse or doctor ensures that the patient does not object to the reuse of their data for this research. an information letter is also given to the patient. pain will be measured by numerical rating scale at initial assessment by the triage nurse (baseline), at 15mins, 30mins, 60mins and 2hours.

Eligibility criteria:
inclusion criteria: * patient admitted to the emergency department of mulhouse with a numerical pain rating scale \> 3 ; * patient who did not receive any analgesic except paracetamol in the 4 hours prior to admission ; * initial pain assessment with the triage nurse ; * patient does not object to the collection of data for the study. exclusion criteria: * patient admitted directly to the shock room ; * initial pain assessment not performed in triage zone ; * numerical scale \> 3 not corroborated by caregiver assessment: algoplus \<2 * onset of pain after triage nurse visit ; * patient with drug intoxication, altered consciousness, alcohol or drug use.

Keywords: sufentanil emergencies
phosphate in blood pressure regulation

Conditions: Hypertension

Summary: high dietary phosphate intake in the general population is associated with a higher risk for developing kidney disease and cardiovascular disease with an increased overall mortality. whereas the effects of high phosphate intake on general health become clearer, almost nothing is known about underlying mechanisms. more recently, the investigators and others found in animal models that fgf23 stimulates the renal nacl cotransporter ncc, the target of thiazide diuretics, and that increased ncc activity may increase blood pressure. the investigators could also show that increasing dietary phosphate intake in mice, increases fgf23 and ncc activity within 3 days. thus, the objective of this single-centre observational cross-over study including 20-45 year old healthy male probands is to elucidate the role of dietary phosphate on blood pressure regulation and renal handling of sodium chloride in healthy subjects. further the impact of dietary phosphate intake on the regulation of phosphaturic hormones and other factors regulation blood pressure will be investigated. in addition, the investigators will examine whether phosphate intake modulates gut microbiome composition. the primary outcome in this study is the change in blood pressure in healthy subjects on low-phosphate diet compared to healthy subjects on high-phosphate diet. in addition, to assess changes in ncc activity as the main mechanism of phosphate-sensitive blood pressure regulation, renal sodium chloride excretion after administration of hydrochlorothiazide will be measured. the secondary outcomes of this study are: changes in renal phosphate, calcium and potassium excretion, changes in phosphate regulation hormones such as 25-oh-vit. d, 1,25-(oh)2-vit. d, pth, fgf23, dopamine in plasma and urine, changes in plasma and urinary aldosterone levels, changes in sodium/chloride-cotransporter ncc and napi-iia assessed from urinary exosomes, and changes in stool phosphate excretion and gut microbiome composition.


Eligibility criteria:
inclusion criteria: * 20-45 year old healthy male subjects exclusion criteria: * - kidney disease (defined by egfr \ 30mg/d)) * diabetes mellitus * hypertension (rr \> 140/85 mmhg) * hypotension (rr \< 90/60 mmhg) * any regular medication * non-western type diet e.g. vegetarian, vegan etc. * history of kidney stones * allergy to sulphonamides or penicillins * hereditary fructose intolerance * known hypersensitivity or allergy to class of drugs used in this study * glaucoma * vitamin d deficiency (\< 20 ng/ml) * hyper- or hypoparathyroidism * hypo- or hyperaldosteronism * participation in any other study