Kornimate/medical-research-clean huggingface dataset:
study comparing reducing the dose of stavudine versus switching to tenofovir in hiv-infected patients receiving antiretroviral therapy

Conditions: HIV Infections; Lipoatrophy

Summary: background: stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. we assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine. methods: clinically stable lipoatrophic hiv-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma hiv rna \<200 copies/ml for at least 6 months were randomized to maintain stavudine 40 mg bid (d4t40 arm), to reduce to 30 mg bid (d4t30 arm), or to switch from stavudine to tenofovir-df (tdf arm) while preserving the remaining drugs. fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.


Eligibility criteria:
inclusion criteria: study eligibility criteria included documented hiv infection, age 18 years or older, moderate to severe clinical lipoatrophy in at least one region upon physical examination (17,18), viral load \<200 copies/ml for at least 6 months prior to inclusion in the study, and a stable triple antiretroviral therapy including d4t 40 mg bid for at least the 6 preceding months, and no prior tdf use. exclusion criteria: prior tdf use, viral load\>200 copies.

Keywords: hiv d4t tdf lipoatrophy treatment experienced hiv-infection
unilateral sequential sympathectomy for palmar hyperhidrosis

Conditions: Palmar Hyperhidrosis

Summary: comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.


Eligibility criteria:
inclusion criteria: * patients suffering palmar hyperhidrosis exclusion criteria: * patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis

Keywords: palmar hyperhidrosis endoscopic thoracic sympathectomy
near infrared (nir) autofluorescence image-guided thyroid surgery

Conditions: Hypoparathyroidism Postprocedural; Hypocalcemia; Surgery--Complications

Summary: the objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative nir(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to: 1. intervention: nir optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence. 2. control: conventional thyroidectomy and parathyroid identification by the surgeon. measurements: pth and ionized-ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up. anticipated 214 patients are included, all of which participate in 3 months follow-up. only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up. an interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.

Eligibility criteria:
inclusion criteria: * able to understand patient information and to give written informed consent * patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign. exclusion criteria: * not able to understand patient information and to give written informed consent * previous parathyroid surgery or other parathyroid decease * age under 18

Keywords: thyroide surgery total thyroidectomy compltion thyroidectomy parathyroidectomy autofluorescense nir near-infrared optical imaging
high-dose ascorbic acid intravenous injection decreases mitochondrial dna damage in chronic fatigue patients: randomized-controlled study

Conditions: Chronic Fatigue

Summary: reactive oxygen species (ros) can cause oxidative damage, resulting in oxidation of lipids, proteins and dna. in fatigue patients, there are some evidences of oxidative damage to dna. ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. the copy number of mitochondrial dna(mtdna) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. there is no evidence ascorbic acid would decrease the mtdna damage in fatigue patients. the investigators hypothesized that decreasing in mtdna copy number in salivary and blood sample may be reversed by high-dose vitamin c intravenous injection in fatigue patients. the investigators will compare the mtdna copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.


Eligibility criteria:
inclusion criteria: 1. adults with above 18 years old and 6 month fatigue duration 2. moderate to severe fatigue scale (brief fatigue inventory-korean version scale ≥ 4) 3. normal limit values in the screening test (white blood cell count, hemoglobin, creatinine, sgot/sgpt, thyroid stimulating hormone, urinalysis) 4. normal limit values in glucose 6 phosphate dehydrogenase level 5. agree the subjects explanation exclusion criteria: 1. pregnancy and lactation 2. acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease 3. previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency) 4. hypersensitivity from ascorbic acid 5. vitamin supplement intake until 2 days ago 6. drug interactions with ascorbic acid ( aspirin, fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid) 7. do not read a consent fom

Keywords: ascorbic acid fatigue mitochondrial dna patient for more than 6 months
a registry study on tanreqing（a chinese medicine injection）used in hospitals in china

Conditions: Pneumonia;; Bronchitis

Summary: this study was advocated by institute of basic research in clinical medicine, china academy of chinese medical sciences in december 2012. the purpose of this study is to make a event monitoring to see whether tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used tanreqing injection in hospitals in china.

it is very common that chinese medicine injection used in hospitals in mainland china. however safety problems rose in recent years. there could be many uncertain factors influence chinese medicine injection in clinical practice. in order to ensure the safety of public drug use and lower drug-induced risks, a registry study for tanreqing injection safety surveillance with 3000 patients will be conducted from jan.2013 to mar.2013.at the same time,patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.the proportion of allergic group and control group is 1:4.all the patients who are selected should draw blood. eligibility criteria patients who will use tanreqing injection in selected hospitals.

Eligibility criteria:
inclusion criteria: * patients using tanreqing injection from january to march 2013 exclusion criteria: -
inflammatory profiles of children at high risk for atherosclerosis

Conditions: Cardiovascular Disease; Metabolic Syndrome X; Hypercholesterolemia; Inflammation

Summary: the purpose of this study is to evaluate levels of inflammatory mediators in children at risk for cardiovascular disease due to family history. we are measuring inflammatory markers in two groups of children and their parents: children with a family history of early atherosclerotic heart disease (cases), and healthy children without such a family history (controls). the design is a cross-sectional study, gathering a fasting blood sample and clinical and behavioral data on children and a parent.

family history is a well known risk factor for early atherosclerosis. whether inflammation plays a role in the increased risk of family history is not known. in this prospective single-center study, we are recruiting children with and without a family history of premature atherosclerotic disease, defined as occurring \< 55 years in males and \<65 years in females. children are recruited primarily from a pediatric preventive cardiology clinic at children's hospital boston. we measure anthropomorphic characteristics, fasting lipid profiles and inflammatory marker levels, including high sensitivity c-reactive protein (hscrp), intracellular adhesion molecule 1 (icam-1), p-selectin, and tumor necrosis factor alpha receptor 2 (tnfαr2). in this sample of high-risk overweight children, lp(a) and inflammatory markers could reflect cardiovascular risk outside lipid profiles.

Eligibility criteria:
inclusion criteria: * age 8-21 years * parent able to participate * fasting state * live locally exclusion criteria: * taking medication that may alter cholesterol levels or inflammatory state * past or present inflammatory illnesses

Keywords: cardiovascular disease metabolic syndrome hypercholesterolemia child family history inflammation
oral calcitriol for reduction of mild proteinuria in patients with ckd

Conditions: Chronic Kidney Disease; Proteinuria

Summary: the safety and efficacy of caltriol on mild proteinuria (\<1.0g/d) reduction in ckd patients.

proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (ckd) progression. emerging evidence in patients with ckd show that vitamin d and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. while some of the studies reported that vitamin d receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of calcitriol in the treatment of mild proteinuria (\<1.0g/d) ckd patients,which has no specific treatment at present.

Eligibility criteria:
inclusion criteria: * aged 18-75 years * clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis * proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ace inhibitor (acei) or angiotensin receptor blocker (arb) treatment for at least 1 year or acei/arb withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month * estimated glomerular filtration rate (egfr)\>60ml/min/1/73m2 * corticosteroid and immunosuppressive agents withdrawal for at least 6 months * normal blood pressure * serum intact parathyroid hormone (ipth) level \>20pg/ml * corrected serum calcium level \< or = 2.55 mmol/l * serum phosphorus level \< or = 1.68 mmol/l * 24 hours urinary calcium excretion level \< or = 7.5 mmol * not receive treatment of vitamin d or its analogue within 6 months * willigness to give written consent and comply with the study protocol exclusion criteria: * history of sensitivity or allergy to calcitriol or other vitamin d analogs * pregnancy, lactating women * history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension * history of malignancy * history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases * patients receiving drugs contains of calcium * patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption * participation in any other trials within 1 month * history of non-compliance

Keywords: mild proteinuria calcitriol renal function blood pressure
quantum molecular resonance effects on patients with dry eye disease

Conditions: Dry Eye Syndromes

Summary: the rexon eye device (resono ophthalmic inc, trieste, italy) is a new device based on qmr technology. quantum molecular resonance (qmr) is a technique in which low-intensity, high-frequency electric currents are administered to a biological tissue through contact electrodes. the device applies stimulation to the epidermis of closed eyelids up to the lid margin by means of specially designed goggles. previous studies have shown that it is relatively safe with high patient satisfaction. preliminary studies have also shown it is effective for accelerating healing in chronic wounds and treating dry eye symptoms.

in this study, the investigators aim to examine the efficacy of the rexon eye device for the treatment of dry eye signs and symptoms in a randomized double-blind placebo-controlled fashion among a cohort of prospectively recruited patients with dry eye. the control group will receive a similar application of treatment with the device goggles disconnected from the device, effectively receiving no treatment. the treatment will be performed by research assistants following thorough instruction by the manufacturing company representatives and/or provided material. participants will be actively questioned on any harms or side effects in every meeting. outcomes will be assessed based on clinical signs and by validated questionnaires on dry eye symptoms (osdi). informed written consent will be obtained from all participants involved in the study prior to enrollment. the goal of the study is to evaluate the rexon device as a possible additional treatment option for patients with dry eye or to establish it has no added benefit.

Eligibility criteria:
inclusion criteria: * patients above the age of 18 years * patients who are willing and able to consent and adhere to the research plan * patients diagnosed with dry eye or patients who are at risk for dry eye exclusion criteria: * active infection of the eyelid or periorbital area * patients who are pregnant or lactating * patients under the age of 18 * those scheduled for (\<30 days) or immediately after (\<30 days) ocular surgery (excluding cataract and eyelid surgery) * patient who do not adhere to all four treatment sessions.

Keywords: cornea dry eye quantum molecular resonance
assessing the bioavailability of leading phytonutrient products

Conditions: Inflammation

Summary: this study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. the study will secondarily look at inflammatory markers in the urine to determine any change.

this study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands meriva, curcelite, lonvida, ultracur, novasol. the study will secondarily look at inflammatory markers in the urine to determine any change.

Eligibility criteria:
inclusion criteria: * age and gender exclusion criteria: * cannot take any phytonutrient or curcumin supplement five days prior to commencement.

Keywords: infalmmation bioavailability
efficacy and safety of ustekinumab in bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: bullous pemphigoid (bp) is an autoimmune subepidermal blistering disease and typically affects the elderly. clinically, bp is an intensely pruritic erythematous eruption with widespread blister formation. bp is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity. bp usually requires on average a 1-year duration of treatment. superpotent topical corticosteroids have been demonstrated to be effective. despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time. overall, whereas bp lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months. newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with bp represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

the aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid

Eligibility criteria:
inclusion criteria : * patient with bullous pemphigoid * patient aged between 18 and 90 * patient with karnofsky performance score \> 60% * patient agreed to participate to the study exclusion criteria : * patient with allergy to corticosteroids * patient with allergy to ustekinumab * patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus * malignancy \< 5 years prior to inclusion * pregnant or nursing (lactating) women, or women of child-bearing potential * active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion * history or presence of infection with hepatitis b or c. * history or presence of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result.

Keywords: bullous pemphigoid ustekinumab superpotent topical corticosteroids efficacy safety
controlling femoral derotation osteotomy with electromagnetic tracking

Conditions: Interna Rotation Gait; Cerebral Palsy; Malrotation; Bone; In-toing

Summary: the study is designed to evaluate the use of electromagnetic tracking in femoral derotation osteotomies. the goal is to raise the precision of the surgical procedure in order to improve the outcome in short- and long term. the electromagnetic tracking system is evaluated against a base line ct scan serving as reference standard.

internal rotation gait is a common deformity in children, especially in those with spastic diplegia. the treatment includes soft tissue and bony correction. especially the bony procedures e.g. femoral derotation osteotomies have proven to be effective both in short term and long term evaluation. nonetheless there is still a relevant number of patients that suffer from over- or under-correction and recurrence over time. the reasons are diverse and include false measurement of the derotation in or. the study now evaluates electromagnetic tracking for femoral derotation to improve these results. the patients are recruited from the outpatients department and included if they meet the criteria. a baseline rotational ct scan and a 3-d-gait analysis are performed and the derotation measured with the emt system in or. the results of the measurement is invisible and unknown to the surgeon as the system unit is controlled by a technician. the surgical procedure follows standard rules and does not need alterations because of the study. after the operation a second rotational ct scan is performed and the derotation precisely evaluated by two raters and later compared to the results of the electromagnetic tracking system.

Eligibility criteria:
inclusion criteria: * functionally impairing internal rotation gait and indication for supracondylar derotation osteotomy (evidence of falling because of internal rotation gait, abnormally increased femoral anteversion, confirmation of internal rotation gait in gait kinematics of hip rotation and foot progression angle and a mid point shift in the clinical examination). exclusion criteria: * severe mental retardation and inability to undertake the ct scan

Keywords: electromagnetic tracking internal rotation gait femoral derotation osteotomy
renactif: reduction of the thrombotic phenotype in renal insufficiency with n-acetylcysteine

Conditions: Chronic Kidney Diseases

Summary: chronic kidney disease (ckd) is a known risk factor of cardiovascular morbidity and mortality. in ckd, decline of renal function results in the accumulation of uremic toxins in blood and tissue, such as indoxyl sulfate (is). is plasma level is predictive of mortality and cardiovascular disease (cvd). patients with ckd have increased oxidative stress and circulating tissue factor (tf) levels. in vitro, is induces an inflammatory, pro-oxidative and pro-coagulant phenotype on endothelial cells and activates tf. n-acetylcysteine (nac) protects endothelial cells from the effects of is. nac reduces oxidative stress and production of activated tf. a prospective study evaluating an oral nac treatment versus placebo in chronic hemodialysis patients showed a better cardiovascular outcome but the physiopathology was unclear. the hypothesis is that nac reduces cardiovascular risk by its effect on uremic toxin-induced pro-coagulant tf production. the primary objective is to compare the effect of nac intravenously administered at each dialysis session (2gram on 3 dialysis sessions per week) to placebo on circulating tf levels in patients with ckd on chronic hemodialysis after 4 weeks of treatment. the objective is to show a 33% decrease in circulating tissue factor (tf) levels in the nac group compared to the control group. it is a randomized, double-blind, placebo-controlled crossover trial that includes chronic hemodialysis patients from la conception hospital (ap-hm) in marseilles, france. this is an interventional biomedical research project. 20 patients will be included in each group and will receive during 4 weeks intravenous injection. this study will give a pathophysiological rationale for the use of nac to reduce thrombotic and cardiovascular risk in patients with ckd. this step will provide the rationale for a clinical trial to reduce the occurrence of major cardiovascular events with iv nac in hemodialysis (hd) patients.


Eligibility criteria:
inclusion criteria: * hemodialysis patients regardless of the etiology of their renal insufficiency for more than 3 months on a cycle of 3 sessions per week * hemodialysis patients at least 4 hours per dialysis session * patients with a weight of more than 40 kilogram * patients capable of giving informed consent, agreeing to participate in the study and having signed a consent * patient able to understand a written questionnaire exclusion criteria: * pregnant or lactating women * persons deprived of their liberty or hospitalized without consent * majors under legal protection or unable to express their consent * possibility of recovery of renal function (scleroderma for example) * chronic progressive infection that may affect their thrombotic risk * patients under 40 kilogram * patient taking oral anticoagulants * patient with a known allergy to the active molecule or to any of its excipients