Kornimate/medical-research-clean huggingface dataset:
accuracy of portable colposcopy and hpv genotypes among hiv+ women

Conditions: Cervical Cancer; Human Papillomavirus; Human Immunodeficiency Virus

Summary: this study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and visualization inspection with acetic acid (via, with 1x magnification, the accepted low-resource method). half the participants will be evaluated for cervical pathology by portable colposcopy after via assessment, while the other half will be evaluated by conventional colposcopy. this study also will use collected lab specimens for human papillomavirus (hpv)-positive women to determine those hpv genotypes most prevalent among higher grade disease cases (cin ii+) and among the sub-group of human immunodeficiency virus (hiv)-positive women.

this research is a randomized, prospective trial designed to evaluate the value of magnification in making a diagnosis of high grade intraepithelial lesions of the cervix. the overall goal is to evaluate a cervical cancer screening protocol that provides the highest level of care possible for low-resource communities and hard-to-reach areas. currently, a national cervical cancer screening and diagnosis program does not exist within haiti. all women meeting inclusion criteria will be randomized to portable (8x magnification with the cerviscope) or conventional (25x magnification) colposcopy. after application of acetic acid to the cervix, the physician will record naked eye observations of the cervix by: 1) recording the location of all white lesions; 2) describing the vascular pattern; and 3) stating his/her clinical impression of a diagnosis. the physician will then follow-up with use of either the portable or the conventional colposcope to: 1) record the location of all white lesions; 2) describe the vascular pattern; and 3) state a clinical impression of diagnosis. women will have biopsies in all four quadrants of the cervix even if no cervical lesions are seen to evaluate the accuracy of the visualization techniques against the gold standard of biopsy pathologic results. treatment options will be dictated by biopsy results. biopsy material will also be evaluated for specific hpv genotype using lab-based measures. results of these genotypes will be compared between women with high-grade disease vs. low-grade disease and in the subset of women with hiv compared to the hiv-negative population.

Eligibility criteria:
inclusion criteria: * female * 25-60 years old * pre-tested as positive for human papillomavirus (hpv) exclusion criteria: * pre-tested as negative for human papillomavirus (hpv) * pregnant at time of enrollment * prior hysterectomy * \ 60 years old * male

Keywords: cervical cancer colposcopy human papillomavirus human immunodeficiency virus
effects of d-chiro-inositol combined with metformin on insulin resistance in people with overweight or obesity and t2dm

Conditions: Type 2 Diabetes; Overweight and Obese Adults

Summary: this study evaluates the efficacy of d-chiro-inositol (dci) as an add-on therapy to metformin in improving insulin resistance, measured by the homa index, in people with overweight or obesity and type 2 diabetes mellitus (t2dm). secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.

the diachiro trial is a randomized, double-blind, crossover clinical trial assessing the impact of dci combined with metformin versus metformin plus placebo on insulin resistance in people with overweight or obesity and t2dm. the primary outcome is the change in the homa index. secondary outcomes include glycemic variability parameters (e.g., time in range), oxidative stress markers, indirect calorimetry, respiratory quotient, and hba1c levels. participants are monitored using flash glucose monitoring (fgm) systems.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus. 2. age between 18-75 years. 3. bmi ≥25 kg/m². 4. hba1c \< 9%. 5. stable dose of metformin for at least three months prior to enrollment. exclusion criteria: 1. use of antidiabetic drugs other than metformin within three months prior to enrollment. 2. history of ketoacidosis or severe hypoglycemia within six months prior to enrollment. 3. significant renal or hepatic impairment (egfr \ 2× uln). 4. pregnancy or lactation.

Keywords: d-chiro-inositol type 2 diabetes mellitus insulin resistance metformin glycemic variability
sle therapy changes in pregnancy and relation to pregnancy outcome

Conditions: Fetal Growth Retardation

Summary: to review the changes to sle medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease.

this was a retrospective study of pregnancies in sle patients. these patients had confirmed sle diagnosis according to the american college of rheumatology (acr) criteria (5). the diagnosis of sle was confirmed by consultant rheumatologist. these patients were followed up by consultant rheumatologist and obstetrician. the pregnancies' data were curated using the patients' medical files and notes, both paper-based and electronic, antenatal records, rheumatology and hematology clinic notes in addition to delivery and postpartum records. these data were collected including id numbers, ages, duration of the sle, their sle medications before the pregnancy (names, doses and frequency) and whether the sle was active or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease activity index (sledai) score. the investigators studied hydroxychloroquine (hcq), prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and low molecular weight heparins (lmwh) enoxaparin 40 mg subcutaneously once daily) as these were the most commonly used medications. the use of these medications in the different pregnancy periods were noted and analyzed (bpg, before pregnancy; dpg, during pregnancy; pg, pregnancy; pp, post-partum). changes in these medications were also recorded. the data was then analyzed to find out the rates of changes and discontinuation. the postpartum period was also studied similarly. the investigators correlated these alterations to the following feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction (iugr) and intra-uterine fetal death (iufd). the 6 months-pre-conceptual sledai score was recorded and investigated in relation to the above mentioned feto-maternal outcomes and postpartum relapse. we divided the pregnancies into 2 groups; group a, inactive sle and sledai score of 0-3; group b, active sle and sledai score of 4-24.

Eligibility criteria:
inclusion criteria: * confirmed sle * completed data exclusion criteria: * doubtful diagnosis of sle * those with missing data * those with medications other than prednisolone, hcq and anticoagulants * those with multifetal pregnancies * those patients with confirmed other medical diseases including diabetes mellitus, hypertension, thyroid disorders, anti-phospholipid antibody syndrome (apas), cardiac disease * those with confirmed deep vein thrombosis (dvt) or pulmonary embolism (pe) * those with associated hematological diseases including sle-associated thrombocytopenia.
pericervical analgesia versus analesia with nitrous oxide (n2o) in outpatien operative hysteroscopy with miniresector

Conditions: Hysteroscopy

Summary: this research will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature in the control of pain caused during outpatient operative hysteroscopy maneuvers with miniresector.

pain is the primary cause of hysteroscopy failure. it can be attributed to multiple causes, such as manipulation of the cervical canal , uterine distention due to the liquid distension media used during the procedure , operating procedures on the endometrium (as a possible cause of uterine contraction) , until the release of prostaglandins following manipulation of the cervix and uterine distension. there are few studies in the literature that have compared the various methods of pain control during the hysteroscopic examination. among these, ahmad et al., for example, compared the use of the paracervical block and inhalation anesthesia during hysteroscopy: although both proved to be effective in controlling pain, the paracervical block was associated with a greater number of complications. more recently, solano et al. they defined how the administration of nitrous oxide was equally effective (but with many more advantages) to the paracervical block with 1% lidocaine in controlling pain during hysteroscopy performed using the bettocchi hysteroscope. however, for the purposes of this research it is important to take two aspects into consideration: * all the studies in the literature that compared the various pain control methods during hysteroscopy were conducted using the bettocchi hysteroscope and not the miniresector; * more in detail, there are no studies comparing the use of nitrous oxide and pericervical analgesia during outpatient operative hysteroscopy with miniresector. objective this clinical trial will have the aim of evaluating and comparing the effectiveness of two methods (analgesia with nitrous oxide and pericervical analgesia, excluding the use of paracervical block due to the increased risk of complications reported in the literature1) in the control of pain caused during outpatient operative hysteroscopy maneuvers with miniresector.

Eligibility criteria:
inclusion criteria: * nulliparous or primiparous women (a previous spontaneous vaginal birth -ps- or a previous cesarean section -tc- the latter comparable to nulliparous women as no previous cervical dilation -) * age between 25 and 50 years exclusion criteria: * age \ 50 years * multiparity * positive history of previous operations on the cervical canal (e.g. conization)

Keywords: hysteroscopy pain control pericervical anesthesia nitrous oxide
botox® open-label treatment in pediatric lower limb spasticity

Conditions: Pediatrics; Muscle Spasticity; Cerebral Palsy

Summary: this study will evaluate the long-term safety of botox® (botulinum toxin type a) for the treatment of pediatric lower limb spasticity.


Eligibility criteria:
inclusion criteria: * minimum weight of 10 kilograms (kg)/22 pounds (lb) * cerebral palsy with dynamic muscle contracture of the ankle exclusion criteria: * muscular dystrophy, myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease * uncontrolled epilepsy * botulinum toxin therapy of any serotype for any condition within the last 3 months * history of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study
evaluate use of gravitational platelet separation system on leg wound healing in coronary bypass surgery

Conditions: Coronary Heart Failure

Summary: the aim of platelet rich plasma (prp) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation. this is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. this prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.

postoperative wound disturbances, particularly surgical site infection of the chest and leg incision site following cardiac surgery are associated with increased morbidity, mortality, and costs. a recent dissertation from the national hospital in norway showed a 20% infection rate in wounds after bypass surgery, this is probably representable nation wide. prophylactic interventions that reduce postoperative wound disturbances and infection would have inherent value in cardiothoracic surgery. ideally, a specific intervention would demonstrate improved patient outcomes while reducing the output of hospital resources. the aim of platelet rich plasma (prp) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation. it is hypothesized that the elevated cytokine levels will elucidate an accelerated healing response of the affected tissue. ppp application has also been advocated as a tissue sealant for topical hemostasis. this is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. this prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.

Eligibility criteria:
inclusion criteria: * patient undergoing a cardiothoracic procedure requiring a leg vein harvest * patient signature of informed consent form exclusion criteria: * pregnancy * \< 18 years of age * history of amenia (hemoglobin \< 11.0) * history of bleeding disorder * un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations * hypothyroidism * history of any blood disorder * patient with an active infection * patients taking cox ii inhibitors. * heparin-induced thrombocytopenia
a comparison of two techniques for choosing the best place to put a pacing lead for cardiac resynchronisation therapy

Conditions: Heart Failure

Summary: cardiac resynchronisation therapy (crt) using biventricular pacing (bivp) is established as an effective treatment for heart failure. unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. reducing the proportion of non-responders has become the key research focus in crt. targeting the position of the left ventricular (lv) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to crt. several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (ahr) to bivp occurs. both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information. the relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal ahr. it is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed. this study will also be able to contribute towards several important secondary questions. in particular the investigators will study the possibility of using non-invasive cardiac output monitoring (nicom) to assess haemodynamic response rather than an intravascular pressure monitor wire. the investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.


Eligibility criteria:
inclusion criteria: * with ejection fraction \<35% * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * indication for cardiac resynchronisation therapy exclusion criteria: * left ventricular ejection fraction \>35% * severe peripheral vascular disease (that would make arterial access more risky) * haemodynamic instability (such that a longer procedure is inadvisable)

Keywords: cardiac resynchronisation therapy pacing
evaluation of proprioception

Conditions: Proprioceptive Disorders

Summary: the osteoarthritis (oa) is a chronic and degenerative disease which brings articular cartilage degeneration. as a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty. several studies demonstrated the correlation between oa, proprioception reduction and increased risk of falling. the aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.


Eligibility criteria:
inclusion criteria are patients with asa: 1, 2 or 3; patients who have given their informed written consent to participate in the study; patients live in bologna and neighboring areas. exclusion criteria are patients with previous osteotomy of the lower limbs; patients with post-traumatic arthrosis; patients with severe preoperative valgus deformity (hip knee ankle angle\> 10 °); patients with bmi\> 40 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with walking diseases (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with severe arthrosis of the ankle (kellgren-lawrence\> 3); patients with severe coxarthrosis (kellgren-lawrence\> 3); patients with severe postural instability; patients with cognitive impairments, patients with concomitant neurological diseases

Keywords: total knee arthroplasty proprioception osteoarthritis
a study to evaluate effectiveness of imiquimod 5% cream in superficial basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: the purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod


Eligibility criteria:
inclusion criteria: * have one superficial bcc - primary tumour * minimum tumour area of 0.5cm2, maximum diameter of 2.0cm. * if female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception. exclusion criteria: * evidence of clinically significant, unstable medical conditions. * evidence of gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site. * have received defined treatments in tumour site or surrounding area. * any dermatological disease in the target tumour site or surrounding area. * have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.

Keywords: aldara superficial basal cell carcinoma long-term study
assessment of temperature by infrared thermography and blood conduction velocity by doppler after applying shortwave diathermy and microwave - correlations with cardiovascular and hemodynamic parameters

Conditions: Healthy Individuals

Summary: the deep heat therapies are increasingly frequent in daily physical therapist for the treatment of musculoskeletal diseases. the use of such procedures is justified by their analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. however, studies on the cardiovascular effects of these therapies are still incipient. therefore, this study has as objectives: map the skin temperature changes in the lower limbs in different areas and positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic cardiovascular parameters, and investigate the occurrence of changes in conduction velocity superficial blood resulting from the application of these thermal features. the study will be conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit the inclusion and exclusion criteria of the study. the analysis by infrared thermography will be held in a room with temperature maintained at 23 ± 1°c and humidity average 50%. the volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize skin temperature with temperature of the room. after this period will be held applying diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb regions of the hamstrings and triceps surae in extension and flexion to 180° to 90°. the records beat to beat blood pressure and heart rate to autonomic and cardiovascular hemodynamic evaluation will be performed by means of equipment finometer (finapress medical systems, inc.) and electrocardiogram (adinstruments, inc.), respectively, before and after application of diathermy. on the other hand, the images will be processed using flir thermoscan and blood flow data will be collected through the doppler ultrasound. the results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (random effects and fixed), with p≤0.05.


Eligibility criteria:
inclusion criteria: * age group aged between 18 and 30 years * no previous disease-order circulatory or nervous and did not have metal implants in areas to be studied, * are not menstruating or even a week before, due to the change of blood flow in these periods exclusion criteria: * individuals who are using antipyretic medications * with a history of pain, injury or surgery on joints studied
interferon/ribavirin-free sofosbuvir based treatment (auric)

Conditions: Chronic Hepatitis C; Cirrhosis

Summary: since the availability of interferon free direct acting antivirals (daa) the centers authorized to prescribed these drugs in austria submitted their data to a central data base (auric) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (f3/4)

from end of 2013 303 hcv-monoinfected patients with advanced liver disease (f3/4) were treated with interferon (ifn)-free and rbv-free sof-based regimens. during this period only 7 patients received additional rbv. these patients were not included in this analysis. only patients who completed 12 weeks of treatment-free follow up until july 2015 were included in this analysis. in austria, prescription of daas is restricted to specialized treatment centers. data are obtained by 6 participating centers and submitted to the central database forming for of the austrian ribavirin- and interferon-free cohort (auric). incoming data are reviewed by the staff of the hepatitis study group of the dept. of medicine iii, medical university of vienna.the treatment regimens consisted of sof/dcv, sof/smv, and sof/ldv. the duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks). sixty six patients who had started therapy before august 2014 received smv or dcv as part of a named patient program, sof was prescribed. for the remaining patients all drugs were prescribed and paid for by the austrian social insurance. this study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis c: sustained virologic response (svr) defined as undetectable hcv-rna after 12 weeks of treatment free follow up virological breakthrough/relapse defined as reappearance of hcv on treatment/during follow up impact of viral kinetics on prediction of treatment efficacy: viral load measured repeatedly (at baseline, on days 2,7,14,21,28,and than every 4 weeks until end of treatment) allows to study the rapidity of viral clearance. this parameter was used to assess whether length of treatment can be modified. plasma hcv rna levels were quantified by one signal amplification (versant hcv rna 3.0), adverse event recording (using standard gcp criteria) longterm outcome after svr based on examining patients with svr in six monh intervals. examination will include liver sonography, elastography, routine blood chemistry including alpha1-fetoprotein

Eligibility criteria:
inclusion criteria: * all adult patients (age 18 or older) being treated with antiviral hcv treatment regimens exclusion criteria: * other disease with poor prognosis (ie. metastatic cancer, heart failure) * participation in a clinical trial

Keywords: hepatitis c sofosbuvir ledipasvir daclatasvir simeprevir