Kornimate/medical-research-clean huggingface dataset:
a phase 2a study to evaluate viral kinetics and safety of telaprevir in participants with genotype 2 or 3 hepatitis c infection

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) c virus (hcv) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 hcv.

this is a phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. the trial will consist of screening period (6 weeks), treatment period (24 or 26 weeks) and follow-up period (24 weeks). the treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. all the eligible participants who were never treated for hcv will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. after this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (peg-ifn)-alfa-2a 180 microgram once weekly and ribavirin (rbv) 400 milligram twice per day. efficacy will primarily be evaluated by hcv viral load quantification. participant's safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants chronically infected with genotype 2 or 3 hepatitis c virus (hcv) with amount of virus in the blood greater than 10,000 international units per milliliter (iu/ml) * participants who were never treated for hepatitis c virus infection * participants without any significant lab abnormalities * participants who agree to the use of two effective methods of contraception * participant who were judged to be in good health exclusion criteria: * participants who had contraindications for starting anti-hcv therapy * participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer) * participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis b virus * females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding * participants who have hypersensitivity to tartrazine

Keywords: hepatitis c, chronic genotype 2 genotype 3 telaprevir
post-exablate pregnancy outcomes registry study: exablate treatment of symptomatic uterine fibroids

Conditions: Uterine Fibroid

Summary: the goal of this registry study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-exablate treatment for their symptomatic fibroids.

this is an observational study only for all consented subjects who undergo an exablate treatment. the exablate procedure is a commercial treatment. the objective of this registry is to collect data about the effect of exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.

Eligibility criteria:
inclusion criteria: - - eligibility is as per the symptomatic fibroids device indication. - all registry-consented patients following the treatment of their fibroid(s) with the exablate system. exclusion criteria: -

Keywords: uterine fibroids exablate
treatment of chronic diabetic foot ulcers by minimally invasive surgery

Conditions: Diabetic Foot Ulcer; Diabetic Foot; Diabetic Foot Infection; Diabetic Foot Ulcer Neuropathic; Deformities Foot

Summary: despite the development of the control of dm and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the minimally invasive surgery (mis) candidates itself to solve this pathologic case. the purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at padua's orthopaedic clinic through mis.

thirty-two patients with chronic diabetic foot ulcers (cdfus) were treated by mis between january 2010 and september 2016. clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the american orthopaedic foot and ankle society (aofas) hallux metatarsophalangeal-interphalangeal scale. the recurrence of the ulcers and complications were recorded. all the ulcers were evaluated with the university of texas diabetic wound classification. we used the radiological maestro's criteria to evaluated the radiographs before and after the operation. also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. the global disability was evaluated with the short form health survey (sf-36) and the satisfaction's level with the visual analogue scale (vas). statistical analysis was carried out using the wilcoxon signed-rank test. statistical significance was set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * diagnosis of dm; * presence of a plantar cdfu, so not healed after 6 months of medical multidisciplinary treatment; * hba1c \< 8,5%. exclusion criteria: * congenital deformities of the foot; * macroscopic signs of local infection of the soft tissues; * alteration of crp\>150 mg/l; * previous foot and ankle surgery; * previous foot and ankle surgery; * rheumatic, neurologic, infective, or psychiatric pathologies.

Keywords: minimally invasive surgery percutaneous distal osteotomy distal metatarsal minimally-invasive osteotomy (dmmo) percutaneous tenotomy forefoot metatarsal bones
children's eye examination and testing at home study

Conditions: Amblyopia

Summary: repeated measures observational study of tablet-based children's visual acuity tests.

the most common disease seen in paediatric eye clinics is lazy eye (amblyopia), which affects 5% of the population. amblyopia is treated using eye patching or eye drop therapy over the course of 6 months to two years. up to half of all children undergoing therapy for amblyopia do not achieve a successful outcome. the outcome measure (visual acuity) is how small a letter the patient can see on a snellen-like chart. visual acuity is measured six-weekly for amblyopia patients in the outpatient clinic and is used to decide when to start therapy and how much therapy to use. recent developments by visual acuity test manufacturers of ipad-based tests have simplified the testing protocol so that it may be performed by untrained staff. it is currently not understood to what level of accuracy a lay-person can perform the test. the present study was conceived to answer questions brought to us by patients and their parents, whom reported in our ppi activities that they feel they could use the ipad themselves to test visual acuity. this study is designed to quantify the correlation between ipad-based visual acuity measurements taken by lay persons and the gold-standard, clinic-based measurements taken by qualified orthoptists using standard of care equipment and protocols. collaboration between the ppi group and researchers expect that the correlation will likely be high and the teams anticipate possible advantages to lay-persons testing the visual acuity including, fewer visits to hospital and better adherence to amblyopia therapy. home visual acuity test has potential to reduce the number of outpatient clinic assessments or allow assessment of patients that could not be assessed during the uk coronavirus epidemic. however, the awarding body, bios, have requested that orthoptists do not instruct patients to use home-based visual acuity tests as the procedure is not covered by indemnity insurance. bios reference a lack of evidence-base. the new aim of the study will be to determine the validity of home-based visual acuity assessments with the possibility of providing such an evidence- base. the study aim will be achieved by measuring the visual acuity in the outpatient clinic as per standard of care and asking the parent or carer to use the ipad to test visual acuity at the same visit

Eligibility criteria:
inclusion criteria: * age under 10 years * able to complete a subjective visual acuity test exclusion criteria: * parent or carer not willing to participate in the study and give written informed consent
sleep behaviour in athletes during home confinement due to the covid-19 outbreak

Conditions: Sleep; Athlete; Training; Exercise; Covid19; Isolation, Social

Summary: it is becoming increasingly evident that sleep plays an essential role for human health, and it represents an important biophysiological variable for athletes' well-being and recovery. the international olympic committee recently highlighted the importance of obtaining sufficient sleep volume and quality among athletes, but acute sleep deprivation is not unusual. several factors, both endogenous and exogenous, are able to negatively influence sleep in athletes: body temperature, altitude, chronotype, training volume, anxiety, westward and eastward travels, and many others. since december 2019, when a new coronavirus (sars-cov-2) was originally revealed by an ophthalmologist in wuhan (hubei province, china), a related severe acute respiratory syndrome - namely covid-19 - has been spreading at a pandemic rate, putting global health systems under unprecedent pressure. italy, as the first western country tremendously hit by this disease outbreak, has become the iconic resilient outpost under international policymakers' attention. when initial clusters were identified, restrictive actions to curb isolated upsurges of infection were taken by the health region system of lombardy, thereafter, were extended to all northern italy and to the entire country. from february 21, when the first italian covid-19 case was diagnosed in southern lombardy, to march 22, when italian's government restrictions to contain the pandemic were extended, prohibiting all non-essential business activities and banning all movements of people nationwide, the country faced an unchartered scenario, from several standpoints, along with the psychosocial one. inevitably, the covid-19 outbreak has largely influenced the daily life of athletes too. therefore, the primary aim of this study was to examine the differences in athletes' sleep quality, quantity and training volumes during the social confinement due to the virus outbreak. for this purpose, a survey will be used. this variables will be evaluated in 3 different time frames: 1) may 2020; 2) september 2020; 3) january 2021.


Eligibility criteria:
inclusion criteria: * male or female gender. * age between 18 and 40 years old. * elite athletes (competing at national or international level). * no cognitive impairments. * at least 6 years of practice of a specific sport discipline. * affiliated to coni (comitato olimpico nazionale italiano). exclusion criteria: * age under 18 years old. * part-time workers. * injury or any clinical condition affecting training routines (and sleep). * pregnant women.
validation of the french warwick-edinburgh mental well-being scale (wemwbs)

Conditions: Human Characteristics; Attitude to Health

Summary: background: despite current popularity, positive mental health is under researched. this is possibly due to a lack of consensus on appropriate measuresthe warwick-edinburgh mental well-being scale (wemwbs) is a 14 positively phrased likert-style list of items developed to measure mental well-being. its validation has been internationally explored. this report presents the french validation of the wemwbs (f-wemwbs) in non-clinical and clinical populations. methods: two non-clinical populations comprised of 319 working adults (work), and 75 students (stud), and one clinical population of 121 patients with remitted schizophrenia (prs) were included in the validation study. participants completed the f-wemwbs as well as complementary measures of psychological constructs potentially related to well-being.

three different populations participated in the study: two non-clinical populations composed of students (stud), and working adults (work) and one clinical population comprised of patients with remitted schizophrenia (prs). the stud population was a convenient sample of 75 first year students (51 females and 24 males); with 45 from a school of business management and 30 from a medical university. the work population was also a convenient sample of 113 (63 females and 256 males) working adults including 217 soldiers from paris fire brigade, 93 nurses and 9 individuals from a research laboratory. the prs population was comprised of 121 remitted schizophrenia patients (39 females and 82 males) who were all clients of the rehabilitation centre for psychotic disorders (le vinatier hospital), situated in lyon, france.

Eligibility criteria:
inclusion criteria: * for stud and work, there were two criteria to be included in the study: (i) , not undergoing medical treatment for psychological issues at the time of the study and (ii) and not having been part of a stress management program prior to recruitment for the current study. * for prs, there were three criteria to be included in the study: (i) a dsm-ivr diagnosis of schizophrenia as confirmed by the mini international neuropsychiatric interview for dsm-iv (mini; 14); (ii) age between 18 and 65 years; and (iii) being clinically stable (i.e. not having required hospitalization or increases in medication as a result of an exacerbation of acute symptoms over the previous three months). exclusion criteria: -

Keywords: well-being, mental health, schizophrenia, quality of life
neobreads: neoadjuvant breast diet study

Conditions: Breast Cancer

Summary: this is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. visits will occur at screening, mid-study, and pre-surgery. anthropomorphic measurements, and patient reported outcomes (pros) will be taken at all three visits. patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. all subjects will receive surgery after approximately 6 months of intervention. total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer; clinical t2-t4c, any n, m0 invasive breast cancer by ajcc 7th edition clinical staging, with goal being surgery to complete excision of tumor in the breast and lymph node. primary tumor must be palpable, largest diameter \>2.0 cm by physical examination or by radiological assessment. * er/pr+; defined as either er and/or pr +, 1+ in 10% of cells * her2 negative; her2 negative is defined by the following criteria: 1. 0 or 1+ by ihc and ish not done 2. 0 or 1+ by ihc or ish ratio (her2 gene copy/chromosome 17) \< 2 3. 2+ by ihc and ish ratio (her2 gene copy/chromosome 17) \< 2 * ability to read, write, and understand english * bmi \>24 kg/m2 * ecog performance status 0-2 * planning to receive neoadjuvant aromatase inhibitor therapy * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * age \> 18 years exclusion criteria: * already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet * medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study * candidate for chemotherapy or her2 directed therapy * treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy, or investigational agent prior to study entry (initiation of ai within 30 days of diet initiation acceptable) * loss of \>10% of body weight within the previous 6 months * clinical or radiographic evidence of metastatic disease. * current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program

Keywords: aromatase inhibitor carbohydrate restricted diet neo-adjuvant treatment low-carb diet low carb diet
relative dose intensity of adjuvant chemotherapy in older women with er+ her2- breast cancer.

Conditions: Breast Cancer

Summary: localized breast cancers are defined as high-risk when they include lymph node involvement, ki67 \>30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic signature result. under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is recommended. patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of side-effects, which may necessitate dose reductions and a reduction in the intensity of chemotherapy. for curative adjuvant treatment, it is recommended to maintain a relative dose intensity (rdi) \> 85%. a few publications have demonstrated the prognostic impact of a relative dose intensity \< 85% for patients aged over 65. for several years now, the need for a specific assessment of elderly patients has been emphasized, prior to initiating oncological treatment (g8 score, onco-geriatric consultation). this study is a retrospective descriptive study of patients aged over 75 treated with adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for rh+ her2 - breast cancer in franche comté. thus the investigators wish to identify patients at risk of receiving sub-optimal relative dose intensity, in order to guide early and targeted supportive care or geriatric co-management interventions.


Eligibility criteria:
inclusion criteria: * women aged 75 or over * patient with localized rh+her2- breast cancer * patient treated with adjuvant chemotherapy in franche comté between january 2012 and december 2019 exclusion criteria: * age \< 75 * patient with metastatic breast cancer * patient who received neoadjuvant chemotherapy * her2+ breast cancer patient * breast cancer patient with missing or negative hormonal status * patient with localized recurrence of breast cancer with indication for new adjuvant therapy
reduction of bladder injection pain with belladonna opiate suppository

Conditions: Overactive Bladder; Urinary Urge Incontinence; Urinary Bladder, Neurogenic; Painful Bladder Syndrome

Summary: the purpose of this study is to test whether using belladonna \& opiate suppositories (b\&os) can improve patient discomfort during onabotulinumtoxin a (bont) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.


Eligibility criteria:
inclusion criteria: * met clinical criteria under outside care or during the principal investigator's routine standard of care for bont injection therapy * no contraindication to bont therapy as outlined by drug manufacturer guidelines * participants have elected to have the bont injection therapy prior to being offered enrollment into the study for either overactive bladder (oab), neurogenic detrusor overactivity (ndo), or refractory interstitial cystitis (ic) exclusion criteria: * currently pregnant * currently nursing a baby * anticipated geographic relocation within the first 3 months following treatment * allergy to morphine, belladonna, or opiates * patients will be excluded if participating in another research study * individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded
treatment of chronic fatigue syndrome (cfs) with iodinated activated charcoal (iodocarb®)

Conditions: Chronic Fatigue Syndrome

Summary: chronic fatigue syndrome (cfs) is a devastating and complex disorder. people with cfs experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. interestingly, many of the symptoms experienced by people with cfs are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism. this study will examine if the mercury binding substance iodocarb(r) can improve the health of patients with cfs.

chronic fatigue syndrome (cfs, which is also sometimes called me, myalgic encephalomyelitis) is a devastating and complex disorder. people with cfs experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. they often function at a substantially lower level of activity than they were capable of before they became ill. besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. often, cfs can persist for many years. researchers have not yet identified what causes cfs, and there are no specific tests to diagnose cfs. the prevalence has been suggested to be around 1-2 %. all humans are exposed to small amounts of mercury every day from the environment. it is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. it is also known that the sensitivity to the toxic effects by mercury differs greatly between people. thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. therefore, the question arises if a reduction of the mercury content in the body of cfs patients can improve their symptoms and problems in daily life. this study will examine if the mercury binding substance iodocarb(r) can improve the health of patients with cfs. this is a double blind placebo controlled parallel group study. patient population: 40 patients diagnosed with cfs will participate.

Eligibility criteria:
inclusion criteria: * chronic fatigue syndrome * 35-60 years old * male * female (not pregnant or breastfeeding, using adequate highly effective contraception consistently and correctly or \>1 year post-menopausal or surgically sterile). exclusion criteria: * iodine allergy * abnormal thyroid function or other thyroid disease such as goiter * severely reduced kidney function (cystatin c \> 1.5 mg/l) * alcohol/drug abuse * severe depression * severe fibromyalgia * severe cardio-vascular disease * other severe disease, according to the clinical investigator * participation in another ongoing clinical trial * participation in drug trial the preceding 3 months