Kornimate/medical-research-clean huggingface dataset:
fluoride metabolism, bone remodelling and mineral density in hiv patients treated with tenofovir +/- emtricitabine

Conditions: HIV Seropositivity

Summary: hiv+ patients are considered at risk for excessive bone fragility. several factors could contribute: age, male sex, low body mass index (bmi), hiv infection per se, vitamin d deficiency, using tenofovir/a protease inhibitor (time on and/or current use). tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (ftc), licensed as truvada®, or without this analogue, licensed as viread®. ftc closely resembles lamivudine (3tc) but is 5-fluorinated, the daily intake of fluoride is \~15 mg. fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality. the aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (bmd) in hiv+ male patients treated by truvada® or viread® for more than 60 months. the patients will be randomly selected, then matched according to age, ethnic origin, bmi.

fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of p1np. dual x-ray absorptiometry (dxa) will be used to determine the areal bone mineral density (abmd) of the lumbar spine, femoral neck and distal radius. volumetric bmd (v-bmd) and micro-architecture of distal radius and tibia will be studied using a hr-pqct scan (xtreme, scanco).

Eligibility criteria:
inclusion criteria: * hiv+ patients * male patients * patients treated by tenofovir+emtricitabine(truvada®) or tenofovir(viread®) for more than 60 months. exclusion criteria: * chronic use of fluoroquinolones, antifungal agents, steroids * malignancy (current or previous) requiring chemotherapy or radiotherapy

Keywords: male patients treated by truvada® or viread® for more than 60 months
efficacy and safety study of sunpg1623

Conditions: Active Psoriatic Arthritis

Summary: this is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of sunpg1623


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent * subject is ≥ 18 years of age at time of screening * subject must be on stable dose of nsaid for ≥ 4 weeks prior to initiation of imp * subject has a negative evaluation for tb within 4 weeks before initiating imp * subject has a diagnosis of psa (by the classification of psoriatic arthritis \[caspar\] criteria) with symptoms present for at least 6 months. * subject has ≥ 3 tender and ≥ 3 swollen joints at screening and baseline. exclusion criteria: * subject has a planned surgical intervention between baseline and the week 24 evaluation for a pretreatment condition * subject has an active infection or history of infections * subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease * subject has a known history of infection with hepatitis b, hepatitis c, or human immunodeficiency virus
evaluation of therapeutic efficacy in use of chamomilla gel, chamomilla infuse and urea in radiodermatitis

Conditions: Radiodermatitis

Summary: this study aims to evaluate therapeutics interventions in radiodermatitis in patients with breast or head and neck cancer. the data collect is going to begin after determining the better dose in a dose-response curve that is being conduct now in the same institution. to evaluate the skin reaction will be applied scale of the radiation therapy oncology group (rtog) - acute radiation morbidity scoring criteria, common terminology criteria for adverse events (ctcae) and radiation-induced skin reaction assessment scale (risras).

hypothesis: chamomila gel is more effective than urea (usual care); chamomila infuse is more effective than urea (usual care); chamomila gel is more effective than chamomila infuse; chamomila infuse is more effective than chamomila gel; chamomila gel is as effective than urea (usual care); chamomila infuse is as effective than urea (usual care); chamomila gel is as effective than chamomila infuse; chamomila infuse is as effective than chamomila gel.

Eligibility criteria:
inclusion criteria: being an adult, over the age of 18 years old; owning diagnosis of breast or head and neck cancer; being first referred to the radiotherapy protocol; presenting radiodermatitis grades 1 or 2, second rtog score, in the place where is receiving radiation therapy; no history of previous hypersensitivity reaction to chamomile or any plant of the asteraceae or compositae family or urea; demonstrate understanding to continue the intervention in their home environment when necessary. exclusion criteria: medical prescription, during the process of data collection, some kind of intervention to prevent radiodermatitis

Keywords: chamomilla matricaria chamomile chamomila recutita breast neoplasms head and neck neoplasms radiotherapy
trial following subjects bilaterally implanted with mini well ready for 2 years after the second eye implant

Conditions: Cataract

Summary: the study objective is to evaluate the visual performance of mini well ready at 24 months following the second eye implant. the objectives of safety are to evaluate the rate of secondary surgical interventions related to the optical properties of the iol for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the halo \& glare simulator.

the present post-.market follow-up study (psm8 sub-study) is an ancillary study of the psm8 post market clinical trial (nct02740010)

Eligibility criteria:
inclusion criteria: • previous enrolment in the psm8 study in the period from march, 1st 2014 to march, 31st 2016 with the following: * any gender and age above 18 years. * cataract or refractive lens exchange (rle) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position. * symmetrical preoperative keratometric astigmatism \< 1.00 d. * healthy corneas, not surgically treated exclusion criteria: * previous corneal surgery (i.e. pterygium, refractive surgery). * eye diseases with visual acuity \< 20/32. * pseudoexfoliation. * abnormal pupil size and position. * use of contact lens 30 days before the preoperative visit. * corneal warpage.

Keywords: cataract surgery extended depth-of-focus (edof) intraocular lens (iol) presbyiopa correction
evaluation of aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine and cyanocobalamin as therapy for vertigo

Conditions: Vertigo

Summary: the goal of this clinical trial is to assess the efficacy and safety of a combination of aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine and cyanocobalamin as adjuvant therapy for vertigo comparatively to ginger under a double-blind randomized study design.

motion sickness is a chronic condition characterized by vestibular changes in response to stimuli caused either by movement or movement perception triggered by car, train, ship or aircraft transportation, amusement park rides, virtual reality and simulators, walking, exercising, as well as under the absence of gravity in space.the studied combination drug is composed by gaba (gamma-aminobutyric acid), the main inhibitory neurotransmitter of the central nervous system. the former lowers anxiety symptoms. its precursor, glutamic acid, is the amino acid found in greater concentration under free form in the cns; it is closely related to brain metabolism and, in contrast to gaba, it is the main excitatory neurotransmitter; glutamic acid also has anxyolytic therapeutic properties. thiamine or vitamin b1 is a cofactor in the synthesis of acetylcholine, which plays a central role in the initiation and propagation of neural impulse in the cns as well as it does in the skeletal and myocardial muscles. pyridoxine or vitamin b6 plays a role in the synthesis of neurotransmitters such as dopamine as well as in the metabolism of tryptophan, resulting in an increase in serotonin so providing well-being and anxiety relief. pyridoxine is essential for the proper functioning of the cns (including at nausea and vomiting center). cyancobalamin or vitamin b12 plays a role in the growth and repair of nerve fibers. importantly it also improves blood flow in the brain, with secondary vertigo improvement. the combined use of these substances provides relief of vertigo due to motion sickness. zingiber officinale is a species of the zingiberacaea family, widely used in traditional and herbal medicine for the treatment of various clinical conditions such as vertigo.

Eligibility criteria:
inclusion criteria: * clinical kinetosis * female study subjects must agree in using contraceptives during study period * dated informed consent read, understood and undersigned exclusion criteria: * hypersensitivity to the drugs of the study * history of gallblader stones * history of gastric mucosa inflammation * arterial blood pressure \>145/100 mmhg * use of medication for kinetosis other than the study drugs

Keywords: vertigo gamma aminobutyric acid calcium glutamic acid thiamine pyridoxine cyanocobalamin ginger
study to assess the dietary carbohydrate content of indian diabetic population

Conditions: Metabolic Disease; Diabetes Mellitus

Summary: the study is designed as an interventional (as blood investigations will be done) dietary survey of diabetic \& non-diabetic population sample of india to understand \& compare dietary patterns among them.the study objective is to find out amount of carbohydrate content of daily diet of diabetic population study . this study does not intend to study the effect of any drugs. there will be 2 groups : type 2 diabetics and non diabetic population. the study will begin after the study approval by ethics committee. the subject will involved after they sign the consent form. the study involves general examination of patients, collection of data like history of disease, interview by dietitian with the help of questionnaire, blood investigations (only in diabetic population only) and glycaemic control status of only diabetic population.the study is planned to be enroll 800 subjects (400 in each groups) from 10 study centers spread across india. the study data will be analyzed with appropriate statistical methods.


Eligibility criteria:
inclusion criteria: * diabetic population * patients willing to provide signed \& dated informed consent and comply with study * indian diabetic population diagnosed with t2dm for at least 12 months * male and non pregnant female with age18 years or more * non-diabetic population * indian non-diabetic population who are not following any diet plan or dietary advice * patients willing to provide signed \& dated informed consent and comply with study requirements. * male and non pregnant female with age 18 years or more * non-diabetic population should be matched in terms of age, sex and centre exclusion criteria: * patient unwilling to comply with the study procedures. * pregnant \& lactating women * history of cardiovascular event within the previous six months. * patients with specific co morbidities, which may impact the patients diet, e.g malignant diseases, advanced dementia, parkinson's disease and others. * suffering from chronic diseases including but not limited to chronic renal failure, chronic liver disease that might interfere with participation in the study as per physician discretion. * patients on weight management plan e.g. low carbohydrate diet which includes dietary modifications or dietary alterations.

Keywords: carbohydrate, dietary
evaluation of thermocool sf catheter on the common cavo-tricuspid isthmus dependent atrial flutter ablation

Conditions: Atrial Flutter.

Summary: the purpose of this study is to determine whether the thermocool sf ® system is at least as effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of cavo-tricuspid isthmus dependent atrial flutter.

the catheter of biosense webster thermocool sf® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. this allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. there is evidence of greater efficiency of thermocool sf® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter. investigators hypothesize that the thermocool sf® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters. 150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with celsiustmds® 8 mm, 3.5 mm irrigated tip thermocool® or thermocool® sf respectively. after the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ecg-holter examination at the first and 6th month and monthly phone consultation. rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.

Eligibility criteria:
inclusion criteria: * patients with symptomatic common atrial flutter. * electrocardiographic documentation of common atrial flutter. exclusion criteria: * refusal to give consent. * life expectancy less than 6 months. * contraindication for ablation. * previous cavo-tricuspid isthmus ablation.

Keywords: atrial flutter ablation thermocool sf catheter
health and environmental effects of boiler management systems in social housing

Conditions: Hot Water Burns (Scalds)

Summary: the purpose of this study is to evaluate the impact of a passive safety measure, namely a reduction in centrally controlled hot tap water temperatures in social housing using a boiler management system, as an effective public health intervention.

the annual hospital admission rate in england for burns and scalds is 31 children per 100,000 population. while reducing the temperature in domestic hot water tanks is a recommended injury prevention strategy, the uk has been slow to adopt such 'passive' safety measures. however, camden council employs a boiler management system (bms) in boiler houses to centrally set the hot water temperature for parts of its social housing stock, providing the opportunity to evaluate various impacts of a 'passive' safety measure, including quantifying the effects of the bms on average hot water temperatures at delivery, annual energy costs, and annual greenhouse gas emissions; modelling the reduction in scald injuries; identifying the cost-effectiveness of the system as a public health intervention; as well as describing experiences/ perceptions of risk of scalding and identifying health and social benefits of the bms. boiler houses with bms will be randomised to remain at their constant set temperature or to bms reduced temperature and sterilisation programme. a process evaluation will also be undertaken to assess the acceptability of water temperatures to tenants.

Eligibility criteria:
inclusion criteria: * individuals living in social housing in the london borough of camden where the boiler management system has been installed. exclusion criteria: * aged under 18 years

Keywords: tap water temperature social housing scald reduction temperature (degrees celsius) of hot tap water at point of delivery.
effectiveness of periodontal therapy on periodontal bacteria

Conditions: Periodontitis

Summary: in light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either srp in addition to full mouth scaling or quadrant scaling

this trial was conducted in accordance with the world medical association's declaration of helsinki of 1975, and reviewed in 2008. the local ethical committee of the university of messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. in all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility criteria:
inclusion criteria: * presence of at least 15 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
effect of biodex balance training and short foot exercise on myoelectric activity of paraspinal muscles in subjects with flexible flatfoot

Conditions: Flat Foot

Summary: the goal of this study is to see the effect of the combination of biodex balance system and short foot exercise in the treatment of subjects with flexible flat foot. the main question is the effect of biodex balance training and short foot exercise on myoelectric activity of subjects with flexible flat foot experimental participant will receive biodex balance system exercise and short foot exercise for 4 weeks controlled participant will receive short foot exercise and stretching exercise for 4 weeks assessment will be done pre and post treatment by using navicular drop test myoelectric activity of paraspinal muscle dynamic balance pain severity functional ankle instability inder


Eligibility criteria:
inclusion criteria: * 1) sixty subjects from both gender with bilateral flexible flat foot will be selected with their age between 18 to 30years old 2) body mass index (bmi) was ranging from 18 to 25 kg/m2 3) the participants were eligible to be included if had bilaterally fff according to the navicular drop test 4) required participant to have been diagnosed (by an orthopedist) with flexible flat foot exclusion criteria: * repeated lower extremity injuries as fractures or deformities. 2) history of surgery to the lower extremity. 3) history of cerebral concussions, and visual or vestibular disorders. 4) any neurological deficit affecting balance. 5) any medication can affect the balance 6) any problem of lumbar spine( disc,spondylolisthrsis)

Keywords: flat foot, myoelectric activity, biodex balance
respiratory complaints checklist trial

Conditions: Dyspnea; Cough

Summary: this is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

this is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist. study setting: emergency department related acute evaluation outpatient clinic inclusion criteria: 18 years of age or older; patients presenting to the ed reporting cough or dyspnea; exclusion criteria: acute respiratory failure; spo2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; ) primary outcome: need of reassessment in the ed or hospitalization within 1 month of index evaluation (intervention). secondary outcomes: number of complete blood counts ordered in the index evaluation; number of other diagnostic tests ordered in the index evaluation; randomization: block 1:1; stratified by gender and age (\>50 years old). masking will be appllied to: patients; outcome assessors; data analysts;

Eligibility criteria:
18 years of age or older; patients presenting to the ed reporting cough or dyspnea; legally capable. exclusion criteria: acute respiratory failure; spo2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )

Keywords: respiratory complaints dyspnea cough checklist
prophylactic pipac in patients with high-risk colorectal cancer

Conditions: Colorectal Cancer Control and Prevention; Colorectal Cancer; Colorectal Cancer Stage II; Colorectal Cancer Stage III

Summary: in patients with colorectal cancer at high risk for metachronous peritoneal carcinomatosis (pt4 pn0-2 cm0 pmmr colorectal cancer of the colon, colorectal junction or high rectum and/or with positive cytology), we will compare standard surgery (consisting in removal of the primary cancer) followed by 3 months of adjuvant chemotherapy + 3 cycles of oxaliplatin-based pipac (4-6 weeks apart), to standard surgery followed by 3 months of adjuvant systemic chemotherapy, in terms of 1-year peritoneal metastasis-free survival, 3-year.


Eligibility criteria:
inclusion criteria: * patients operated (in emergency or elective surgery) for colorectal cancer (of the colon, colorectal junction or high rectum). * definitive pathological stage pt4 pn0-2 cm0 pmmr and/or pt4 pn0-2 cm0 pmmr with positive cytology and/or pt4 pn0-2 m1c pmmr with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and not other distant lesion * performance status 0-1. * age \> 18 years. * written informed consent. exclusion criteria: * age \<18 year old. * hereditary colorectal cancer. * inflammatory bowel disease. * distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and not other distant lesion. * neo-adjuvant treatment. * pregnancy or lactation. * immunosuppression. * unable to provide informed consent. * previous cytoreductive surgery (crs). * contraindication to laparoscopy (e.g. severe adhesions, peritonitis). * contraindication to and/or no adjuvant chemotherapy. * history of allergic reaction to oxaliplatin or other platinum containing compounds. * renal impairment, defined as gfr \< 50 ml/min, (cockcroft-gault equation). * myocardial insufficiency, defined as nyha class \> 2. * impaired liver function defined as bilirubin ≥ 1.5 x unl (upper normal limit). * inadequate haematological function defined as anc ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l. * dmmr/msi colorectal cancer.

Keywords: colorectal cancer peritoneal carcinomatosis pipac pressurized intraperitoneal aerosol chemotherapy