Kornimate/medical-research-clean huggingface dataset:
viral kinetics of treatment with peginterferon alpha-2a, ribavirin and epoetin β in patients coinfected hcv/hiv

Conditions: HIV Infections

Summary: the purpose of this study is to compare the early virological response (evr = undetectable \[ribonucleic acid-hepatitis c virus\] rna-hcv or a reduction of \> 2 log10) of patients with chronic hepatitis c coinfected with hiv treated with induction doses of peginterferon alpha-2a (40 kd) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 kd) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 kd) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.

this study seeks to ascertain whether treatment with higher doses of pegasys (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. this would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected hcv patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response). therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of pegasys, and 1600 mg and 1000-1200 mg of ribavirin.

Eligibility criteria:
inclusion criteria: * serological evidence of chronic hepatitis c infection in an anti-hcv antibody test * detectable rna-hcv plasma level genotype 1 and 4 * alt serum activity above the upper limit of normality * chronic liver disease consistent with chronic hepatitis c infection in a biopsy obtained during the two years prior to inclusion in the study * serological evidence of hiv-1 infection, diagnosed by enzyme-linked immunosorbent assay (elisa) and confirmed by western-blot. * patients with cd4 cell count \> 200 /µl * stable status in hiv-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study. * patients treated with stable anti-retroviral therapy (haart), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment * patients that do not receive haart therapy * negative pregnancy test in urine or blood exclusion criteria: * women currently pregnant or in the lactation period. * patients whose companion is pregnant. * therapy with interferon (ifn) or ribavirin at any previous time. * patients with cirrhosis in the hepatic biopsy. * documented suspicion by ultrasound of hepatocarcinoma.

Keywords: chronic hepatitis c co-infection induction dose hiv hiv infections
postoperative balloninflation after evacuation of csdh

Conditions: Chronic Subdural Hematoma

Summary: in this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (csdh) recruited, who were surgically treated. initially, we would divide the patients randomized into two groups: patients with supervised blow-maneuver and without. after surgical treatment of csdh with insertion of a subdural drain, one group would perform a supervised blow maneuver ("valsalva maneuver") every hour for five minutes from 10:00 to 20:00. in the other group, the standard care would be performed. the subdural drain would be explanted 2days after operation and a postoperative ct scan would routinely be performed. after hospital discharge, the patient would be rechecked in an ambulant setting and would receive ct scan as clinical standard. recurrence of hematoma is defined as recurrent hematoma which should be reoperated. after 3 and 6 months we would evaluate the outcome of patients.


Eligibility criteria:
inclusion criteria: * age over 18 years * surgically treated csdh * patients with an operatively implanted subdural drainage exclusion criteria: * age under 18 years * admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours * conservative treatment of csdh * patients without an operatively implanted subdural drainage * patient cannot be consented * participation in other clinical trials

Keywords: recurrence rate of csdh outcome
predictability of part-time wearing of removable clear aligner therapy versus full time

Conditions: Malocclusion, Angle Class I

Summary: 14 patients with mild to moderate crowding and spacing will be selected according to inclusion criteria. treatment planning will be done on maestro® software. an impression will be taken and scanned by an extra-oral scanner. the models will be 3d printed and aligner trays will be fabricated to be delivered on biweekly basis to be worn 16 hours per day for one group and 22 hours for the other group. superimposition of the achieved clinical model over the predicted model will be done. linear and angular measurements will be calculated for each tooth.

clear removable retainers could be related to clear aligners. wearing time of retainers has been suggested that it could be changed from full time to part-time during the night only. a similar approach could be done to determine the effect of wearing time of clear aligners on treatment outcome. the standard duration per day for wearing the appliance is 22 hours. however, is part-time wearing (16 hours) would have the same effect? therefore, a randomized clinical trial is needed to compare the effect of partial wearing of the aligner versus full time. moreover, studying the predictability and accuracy of treatment using maestro software.

Eligibility criteria:
inclusion criteria: 1. permeant dentition 2. mild to moderate crowding and spacing in maxilla and mandible according to little's irregularity index 3. non-extraction cases exclusion criteria: 1. severe crowding and spacing 2. systematic diseases 3. compromised periodontal health 4. craniofacial syndromes
using psma pet-ct as a diagnostic tool for detection of prostatic cancer at an early stage

Conditions: Prostate Cancer

Summary: the aim of the study is the evaluation of the possible role of psma pet-ct in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

the aim of the study is the evaluation of the possible role of psma pet-ct in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management. consequently, use of psma pet-ct in patients with suspicious psa changes may improve our knowledge whether the prostate tumor is clinically significant or not (for the development of psma pet-ct with 68 ga ligand allows to visualize prostate cancer with aggressive patterns), and improve clinical decision making for performing prostate biopsy or selecting patients for observation only. in light of the above, we are of the opinion that this proposed study has the potential to significantly alter the medical practice of how prostate cancer is diagnosed, which even today suffers from real clinical dilemma.

Eligibility criteria:
inclusion criteria: 1. men aged 40-75 2. with or without suspicious dre, 3. were referred by their treating physicians for prostate cancer biopsy based on either an elevated psa result, a suspicious dre exam, or both 4. 4 \< psa ≤ 10 ng/ml - exclusion criteria: 5. a previous diagnosis of prostate cancer 6. underwent previous prostate biopsy 7. previous radiation to pelvis for any reason -
fascial tissue response to manual therapy: implications in long covid-19

Conditions: COVID-19

Summary: according to the world health organization (who), as of mid-september 2022, more than 21 million brazilians have recovered from covid-19. however, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long covid. therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long covid.

participants reported to have long covid, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals will be evaluated. the treatment of participants will be carried out at the cefid-udesc physiotherapy school clinic, where they will undergo assessment of the biomechanical and viscoelastic properties of tissues, postural control, pain and quality of life. for normality analysis, the shapiro-wilk test will be applied, and according to the distribution of the data, parametric or non-parametric tests will be used. pre- and post-assessment and treatment data will be compared using descriptive statistics and student's t-test with a significance level of p=0.05 for parametric data or wilcoxon for non-parametric data.

Eligibility criteria:
inclusion criteria: * participants diagnosed with long covid, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals. exclusion criteria: * participants with suspected deep vein thrombosis; participants with neurological disorders.

Keywords: long covid manual therapy fascia rehabilitation
pulse checks using femoral artery b-mode ultrasound with compressibility assessment

Conditions: Cardiac Arrest, Out-Of-Hospital

Summary: the goal of this prospective observational study is to investigate b-mode point-of care ultrasound with arterial compressibility assessment on the femoral artery as a method to determine the presence of a pulse and to compare it with concurrently conducted manual pulse checks.

in this prospective observational study, a dedicated research team will be dispatched to cardiac arrest patients treated in the prehospital environment by emergency medical services (ems). the team will use a portable ultrasound device to identify the femoral artery and employ b-mode ultrasound during rhythm checks. these ultrasound pulse checks will be conducted in parallel with the normal treatment of the patient, including manual pulse checks, and will only be conducted if ultrasound is possible without interference in the resuscitation. all treatment decisions will rest with the treating ems team.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest treated by ems * minimum age of 18 years exclusion criteria: * pregnancy or suspected pregnancy * disapproval of the treating ems team * adults under legal guardianship * inability to perform femoral artery doppler ultrasound due to limited access to the patient and possible interference with the treating ems team * inability to perform femoral artery doppler ultrasound due to injuries or anatomic abnormalities in the femoral region or necessary emergent medical interventions in the femoral region * decision to transfer the patient to the hospital with ongoing cpr for emergent procedures such as extracorporeal cpr before femoral artery doppler ultrasound could be attempted * inability to safely perform femoral artery doppler ultrasound due to environmental hazards

Keywords: cardiac arrest out-of-hospital cardiac arrest ohca ultrasound point-of-care ultrasound pocus pulse check pocus pulse check b-mode ultrasound femoral artery arterial compressibility assessment
korean study on safety and effectiveness of oad triple therapy in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of oad triple therapy in korean type 2 diabetic mellitus patients.

the study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin. participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a dpp-4i or sglt2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: sglt-2i, dpp-4i, or tzd. the 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of sglt-2i, dpp-4i, or tzd(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.

Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes who are 19 years of age or older at the time of enrollment. 2. continued dpp-4i or sglt-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment. 3. 7.0% ≤ hba1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment. 4. voluntarily give written informed consent after being told about the study. exclusion criteria: 1. patients with type 1 diabetes and secondary diabetes. 2. patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment. 3. requiring treatment with insulin, glp-1, etc. in addition to oral hypoglycemic agents during the study. 4. end-stage renal disease and hemodialysis patients. 5. diabetic ketoacidosis patients. 6. pregnant and lactating women. 7. patients who are contraindicated by any of the "precautions for use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice. 8. patients with a history of hypersensitivity to the investigational drug or any of its components or excipients. 9. anyone else deemed by the investigator to be unsuitable for participation in the study.

Keywords: type 2 diabetes mellitus korean patients observational study oad triple therapy
evaluation of continuity of care at a health service organization

Conditions: Diabetes Mellitus

Summary: this project was conducted with patients at a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients in northern ontario. it investigated continuity of care for patients with diabetes in the areas of barriers and potential solutions to, and correlates of continuity; and variability in costs associated with continuity of care and patient outcomes.

continuity of care is a concept that has been garnering increased attention in the last few years. there have been multiple methods proposed by researchers for measuring continuity of care, most of which are based on proportions or ratios of visits to the same health care provider or centre. while a consistent method for measuring continuity of care is lacking, increased continuity of care using various definitions and measurement tools has been related to better well being, lower health care costs, better glucose control, and higher satisfaction but has also not been found to improve health outcomes in other scenarios. whether a patient is better served by high sequential access to one provider or any provider within the same system or management team is controversial. finally, patients' perceptions of continuity of care have not been generally evaluated or correlated with current measurement methods. this project was conducted with patients at the group health centre in sault ste marie, ontario, a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients

Eligibility criteria:
inclusion criteria: * adults (\>18 years) * diagnosis of diabetes mellitus (according to the definition used in 1999 by the canadian diabetes association exclusion criteria: * gestational diabetes * could not communicate in english * life expectancy or residency expectancy in sault ste marie of less than three years

Keywords: diabetes continuity of care patient perspective health service organization
influence of the covid-19 pandemic on stress, and screening procedures (covistress screening)

Conditions: COVID-19 Screening

Summary: coronavirus has caused containment of more than a third of the world's population. some countries have used a major screening strategy. screening procedures, such as waiting (or resulting) for the test, can be stressful and can attract the most stressed people. however, there is currently no data on the relationship between stress and screening for sars-cov2

this is an observational study by redcap questionnaire® via a flyer deposited in the waiting room of the covid screening centres. no incentive to complete the questionnaire will be made. the self-survey will assess stress and its relationship to sars-cov2 screening procedures, socio-demographic factors or lifestyle habits. this screening questionnaire includes 31 questions.

Eligibility criteria:
inclusion criteria: * all volunteers who are screened exclusion criteria: * none

Keywords: covid-19 screening stress
to accurately assess lymph node response to nact by wire localization of clip-marked lymph nodes

Conditions: Neoplasm, Breast; Neoadjuvant Chemotherapy; Lymph Node Metastases; Response

Summary: the investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage n1 (cn1) breast cancer patients. accuracy of sentinel lymph node biopsy (slnb) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. new model to predict lymph node pathological complete remission (pcr) so as to safely avoid axillary lymph node dissection in cn1 breast cancer patients is sought for.

the investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cn1 breast cancer patients. in brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (nact) and continuously monitored through out the course of chemotherapy with ultrasound. after the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. during surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. axillary lymph node dissection (alnd) will be performed in all participants. accuracy of slnb alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. axillary ultrasound and ct scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. by assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pcr (auc \>0.85) so as to safely avoid axillary lymph node dissection in cn1 breast cancer patients.

Eligibility criteria:
inclusion criteria: * between the age of 18 and 65 * eastern cooperative oncology group (ecog) score 0 or 1 * pathologically proven positive axillary lymph node * enough renal and liver function to sustain chemotherapy * informed consent obtained exclusion criteria: * inflammatory breast cancer * being pregnant or nursing * neoadjuvant chemotherapy not planned

Keywords: neoplasm, breast neoadjuvant chemotherapy lymph node metastases response
on-track feasibility study of a rehabilitation system for stroke patients

Conditions: Cerebrovascular Accident

Summary: feasibility study of on-track - a digital system for upper limb rehabilitation after stroke. population - stroke patients over 18 years old.

title feasibility study of on track - a digital system for upper limb rehabilitation after stroke design \& methods mixed methods aims assess the feasibility of 'on-track' (a new arm rehabilitation system), for use by patients, and therapists in stroke rehabilitation services. outcome measures various. (including functional and self-reported measures) population stroke survivors, their family/carers, clinicians, professionals and lay people working with stroke survivors. eligibility participants will be stroke survivors, relatives/carers of stroke survivors, frontline healthcare workers who treat stroke survivors, managers responsible for stroke service provision and lay people with an involvement in stroke care/delivery. participants will be over 18. duration 1- 2 years

Eligibility criteria:
inclusion criteria: * adults (aged 18 or over). * stroke diagnosis less than 6 months previously (first or recurrent). some participants will be recruited from an in-patient rehabilitation ward, hence the 6-month poststroke limit. * arm impairment of any type or level (including weakness-including dense hemiplegia, neglect and sensory deficits). this enables better understanding of which impairment level groups could benefit or not from using the intervention, especially considering the impact it may have on people's motivation regardless of their level of impairment. * ability to provide informed consent. * reliability to communicate (verbally or non-verbally) and understand english. * ability to read a predefined short message. exclusion criteria: * unstable medical condition. * self-reported 'severe' pain in the arm affected either at rest or during movement. * severe oedema in the arm affected by their stroke, judged by the consenting therapist. * known discharge plans to a hospital other than the recruitment site or residential care in less than 7 weeks (a small proportion of patients in in-patient rehab may be in hospital for up to 12 weeks). * participants who are unable to engage with the intervention for a period of more than 7 consecutive days will be reviewed in a case-by-case basis by the members of the team responsible for delivering the intervention to determine if study continuation is appropriate.

Keywords: cerebrovascular accident
study of lumasiran in healthy adults and patients with primary hyperoxaluria type 1

Conditions: Primary Hyperoxaluria Type 1 (PH1)

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (sad) and multiple-ascending doses (mad) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (ph1). in part a, single ascending dose (sad) part, healthy adults were dosed with lumasiran or placebo once. in part b, multiple ascending doses (mad) part, patients with primary hyperoxaluria type 1 (ph1) were dosed with lumasiran or placebo. all patients that initially received placebo received lumasiran after completing placebo dosing.


Eligibility criteria:
inclusion criteria for parts a and b: * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. * willing to provide written informed consent and to comply with study requirements. additional inclusion criteria for part b: * confirmation of ph1 disease * meet 24 hour urine oxalate excretion requirements * estimated glomerular filtration rate (gfr) of \>45 ml/min/1.73m\^2 * if taking vitamin b6 (pyridoxine), must have been on stable regimen for at least 90 days exclusion criteria for parts a and b: * clinically significant health concerns (with the exception of ph1 for patients in part b) * clinically significant electrocardiogram (ecg) abnormalities * abnormal for aspartate aminotransferase (ast)/alanine aminotransferase (alt) and any other clinical safety laboratory result considered clinically significant * received an investigational agent within 3 months before the first dose of study drug or are in follow-up of another clinical study * known history of allergic reaction to an oligonucleotide or n-acetylgalactosamine (galnac) * history of intolerance to subcutaneous injection

Keywords: ph1 primary hyperoxaluria rnai therapeutic sirna agt