Kornimate/medical-research-clean huggingface dataset:
a comparison of two dose levels of didanosine used in combination with stavudine in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the effectiveness of taking didanosine (ddi) once a day plus stavudine (d4t) twice a day with taking ddi twice a day plus d4t twice a day. this study also examines the safety of giving ddi with d4t in the short-term.

patients are randomized to receive ddi given either qd or bid in combination with d4t given bid (no doses specified).

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count of at least 100 cells/mm3. * plasma hiv rna count of 10,000 copies/ml or more within 14 days prior to study entry. exclusion criteria co-existing condition: patients with the following conditions and symptoms are excluded: * presence of a newly diagnosed aids-defining opportunistic infection requiring acute therapy at the time of enrollment. * bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to grade 2 at the time of screening. * inability to tolerate oral medication. * any other clinical condition that would preclude compliance with dosing requirements. patients with the following prior conditions are excluded: * history of acute or chronic pancreatitis. * intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry. * proven or suspected acute hepatitis within 30 days prior to study entry. 1. potent neurotoxic drugs, such as vincristine and thalidomide. * other anti-hiv therapy. 1. prophylaxis for pneumocystis carinii pneumonia (pcp) is strongly recommended for patients with cd4 cell counts less than or equal to 200/mm3 or who have had a prior episode of pcp. * immunizations recommended by acip for routine practice. * erythropoietin and g-csf are allowed if myelosuppression emerges on study. 1. any antiretroviral therapy. * agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. 1. any prior antiretroviral therapy. * agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry. active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.

Keywords: didanosine drug therapy, combination stavudine reverse transcriptase inhibitors
assessment of postop hypospadias pain

Conditions: Hypospadias

Summary: one of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. a survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. using a validated questionnaire, the investigators aim to quantify how much opioid pain medication boys undergoing hypospadias repair require and if opioid pain medication can be eliminated from the routine postoperative medication regimen.

postoperative pain scores, as measured by the parents' postoperative pain measure scale, will not be statistically different in boys who receive opioid pain medication postoperatively compared to boys who do not. the long-term objectives of this study are to understand if pre and postoperative counseling and education along with proper surgical technique will result in less opioid prescriptions following hypospadias repair. children with suspected hypospadias will be seen and examined in clinic and offered surgery if appropriate. if the families elect for surgery, this will be performed by one of the investigators between 6-12 months of age. the surgical technique may vary among the investigators. patients with severe hypospadias may require multiple surgeries for correction. on the day of surgery, patients will be randomized to receive one of two pain medication regimens: 1. acetaminophen (15 mg/kg) q6h and ibuprofen (10 mg/kg) q6h 2. acetaminophen q6h, ibuprofen q6h, and oxycodone 0.1 mg/kg q6h prn breakthrough pain for 10 doses home dosing regimens will be started six hours after the last hospital dose of each medication. the families will be instructed as to when they can give oral medications at home. lastly, families of both children in both groups will be instructed to contact the clinic or urologist on call if their children are experiencing uncontrolled pain. this may necessitate evaluation in person or adjustment of the current pain regimen. any deviation from to prescribed pain regimen will be recorded for the study. patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated questionnaire, the parents' postoperative pain measure scale, to objectively quantify how much discomfort boys in both groups experienced.

Eligibility criteria:
inclusion criteria: all boys undergoing hypospadias repair at our institution between june 2020 and june 2021 exclusion criteria: boys who have a contraindication to caudal block or acetaminophen, ketorolac, ibuprofen, or oxycodone use. boys over 2 years of age.

Keywords: pediatric hypospadias repair
peak study - a study of pegasys (peginterferon alfa-2a (40kd)) in combination with copegus (ribavirin) in interferon-naive patients with chronic hepatitis c (chc).

Conditions: Hepatitis C, Chronic

Summary: this study will examine the viral kinetics and pharmacokinetics of pegasys plus ribavirin and peg-intron plus ribavirin in interferon-naive patients with chc. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * chc infection, genotype 1 * use of 2 forms of contraception during study in both men and women exclusion criteria: * previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents * medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure) * decompensated liver disease * women who are pregnant or breastfeeding
a prospective comparison of robotic and endoscopic smg resection via retroauricular approach

Conditions: SMG Resection in Comparison to Endoscopic SMG Resection

Summary: traditional transcervical incision of the upper neck is a safe and effective approach for resection of the submandibular gland (smg). however, external scar at the highly visible area may be a burden for the patients and sometimes may lead to disfiguring hypertrophic scar or keloid. recently, the investigators reported our surgical technique of 'endoscope-assisted' and 'robot-assisted' smg resection, which was feasible and showed excellent cosmetic outcomes since the scar was hidden by the auricle and hair. in our previous feasibility study of robot-assisted smg resection, the investigators proposed that robot-assisted technique may overcome the limitations of endoscopic instruments with rigid and straight nature without articulation and surgical view of two-dimension. in addition, the ergonomically designed operating system was more convenient for the surgeon considering the frequent collision of the endoscopic instruments and reversed hand-eye coordination in endoscope-assisted surgery. however, clinical trial comparing the surgical outcomes of the two techniques has not been reported in the literature. in this study, the investigators made a prospective comparative study of robot-assisted versus endoscope-assisted smg resection to determine whether robot-assisted technique has benefits regarding early surgical outcomes.


Eligibility criteria:
inclusion criteria: * patients diagnosed as pleomorphic adenoma or chronic sialadenitis from preoperative ultrasound-guided fine needle aspiration biopsy (fnab) exclusion criteria: * past history of neck surgery or radiation * possible malignancy expected from fnab or image study * gland with severe adhesion to surrounding tissue on preoperative physical examination

Keywords: submandibular gland robotic endoscopic face lift hairline
nepal undifferentiated febrile illness trial

Conditions: Undifferentiated Febrile Illness

Summary: the purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in nepal

fever is one of the most common presenting symptoms of patients presenting to health centers in nepal. many of the times, it is difficult to diagnose the cause of the fever by initial history, clinical examination and basic laboratory tests and the patents are treated as presumed enteric fever or fever without focus needing antimicrobials. in fact there are various causes of similarly presenting febrile illnesses including typhoid, paratyphoid, murine typhus, scrub typhus etc. many of the traditionally used drugs including fluoroquinolones are now resistant against enteric fever in south asia. oral azithromycin is now commonly used to treat undifferentiated febrile illness and remains effective against enteric fever. many physicians now also use co-trimoxazole as it was very commonly used in the treatment of enteric fever in the past. resistance to co-trimoxazole emerged two decades ago, but has subsequently largely disappeared and nearly all salmonella typhi and paratyphi a strains from nepal are now susceptible. anecdotal reports claim that it seems to work very well against undifferentiated febrile illness in nepal; it is largely stocked in government health facilities and is a popular and cheap treatment option. both azithromycin and co-trimoxazole are available in nepal and are extensively used in the treatment of undifferentiated febrile illness. therefore it is important to know the better oral option to treat enteric fever and other febrile illnesses and also to have an alternative oral treatment in case resistance to azithromycin emerges. the investigators purpose to conduct a head to head, parallel group, 1:1, double blinded randomized controlled trial to compare azithromycin and co-trimoxazole for the treatment of undifferentiated febrile illness and determine the best empirical treatment for undifferentiated febrile illness in nepal.

Eligibility criteria:
inclusion criteria: * fever of ≥ 38.0°c and for ≥4 days without a focus of infection * ≥ 2 years and \<65 years of age * able to take tablets orally * patient residing in kathmandu valley * able to come for follow up * can be reached by telephone/mobile phone 24 hours a day. * written informed consent to participate in the study including assent for minors in addition to parental consent. exclusion criteria: * fever \>14 days * pregnancy * obtundation * shock * visible jaundice * presence of signs of gastrointestinal bleeding * history of hypersensitivity to either of the trial drugs * patient requiring intravenous antibiotic or hospital admission for any reason. * contraindication of drug for any reason (e.g. drug interactions). * any patient fulfilling inclusion criteria but already on antimicrobials and responding clinically to the treatment

Keywords: undifferentiated febrile illness azithromycin cotrimoxazole efficacy enteric fever fever clearance time
the effect of preoperative ketamine on the emergence characteristics in children undergoing entropion surgery

Conditions: Entropion

Summary: the investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

this study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. general anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. after surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist class 1 patients * 3-6 years children undergoing entropion surgery exclusion criteria: * do not agree with participate this study

Keywords: anesthesia agitation extubation
real world evidence study on metastatic prostate cancer in the pirkanmaa hospital district in finland

Conditions: Metastatic Castration Sensitive Prostate Cancer (mCSPC); Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in finland is lacking. this study will address the following questions: * what are the demographic and clinical characteristics of metastatic prostate cancer patients? * how are metastatic prostate cancer patients currently treated and how effective are these treatments? * how does the development of castration-resistance affect patient outcomes? * what is the economic burden of metastatic prostate cancer?


Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer between 1/1/2007 - 12/31/2022 * resident of pirkanmaa at index date (diagnosis of mcspc and/or mcrpc) * detection of metastatic prostate cancer exclusion criteria: * prevalent mcspc and mcrpc patients (mcspc or mcrpc diagnosis date before 1/1/2014 * patient has another cancer diagnosis or the patient has received chemotherapy other than docetaxel or cabazitaxel within 2 years of mpc diagnosis.

Keywords: mcrpc metastatic prostate cancer registry study rwe real world evidence finland metastasis prostatic neoplasms prostate cancer
feasibility study of preoperative cognitive training in cardiac surgical patients

Conditions: Postoperative Cognitive Dysfunction

Summary: the purpose of this study is to evaluate the feasibility of administering a 20-day preoperative cognitive training intervention (cog-train) to a widely inclusive sample of cardiac surgical patients.

cognitive outcomes remain poor after cardiac surgery. data from the field of cognitive neuroscience suggests that cognitive training, which harnesses the brain's adaptive plasticity to improve, maintain, or restore function in a target area, can be used to strengthen brain resilience and improve cognitive outcomes following challenge. while its effectiveness has been demonstrated in older adults as well as in other (nonsurgical) patient populations, no training intervention like this has ever before been used in any surgical patient in the preoperative period. the purpose of this study is to evaluate the feasibility of administering a 20-day cognitive training intervention (cog-train) to a widely inclusive sample of cardiac surgical patients before their surgery. data obtained will be used to design a full-scale randomised controlled trial (rct) on cog-train's effectiveness in improving postoperative cognitive outcomes.

Eligibility criteria:
inclusion criteria: * scheduled for elective cardiac surgery with cardiopulmonary bypass at papworth hospital * aged 60+ years exclusion criteria: * surgery scheduled for sooner than 21 days * 'off-pump' surgery being considered * inability to obtain informed consent * sensory or motor impairments impeding use of task * communication barriers impeding administration of study procedures * inability to demonstrate understanding of task and/or study procedures * inability to make time commitment

Keywords: cognitive training brain training plasticity-based training cardiac surgery preoperative cognitive function
galeazzi spine surgery registrygaleazzi spine registry: prospective study for clinical monitoring

Conditions: Patients Undergoing Spine Surgery; Scoliosis; Disc Disease; Disc Injury; Myelopathy; Spinal Stenosis; SPINAL Fracture; Spinal Fusion

Summary: the spinereg study is a prospective observational registry. eligible patients are subjects undergoing spine surgery at the participating institutions. baseline health status and follow-up health status are recorded at pre-established steps.

the spinereg study is a prospective observational study. eligible patients are subjects undergoing spine surgery at the participating institutions. baseline health status and follow-up health status are recorded at pre-established steps. data from surgery and patients proms are registered on the database; the main timepoints are: pre-surgery, surgery, 3-6 month after surgery, 1-2-5-10-15-20 years after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing spine surgery in the participating centers exclusion criteria: * patients only in conservative treatment * patients to refuse to enter the study

Keywords: registry scoliosis disc disease spinal fracture spinal fusion spine surgery
randomized, open, parallel, active controlled study on fracture prevention in antiosteoporosis treatment (of study)

Conditions: Osteoporosis

Summary: to investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.


Eligibility criteria:
inclusion criteria: inpatient or outpatient is not asked. if using any anti-osteoporotic agent other than calcium preparations (i.e., contraindicated for concomitant use stipulated in the protocol of this post-marketing study), such agent must be discontinued. even after the discontinuation, calcium dosing is permitted with a condition that the subsequent use is started after a 8-week elapse from the discontinuation. * patients with primary osteoporosis (diagnosed according to "diagnostic criteria for primary osteoporosis issued by the japanese society for bone and mineral research (1995)." * post-menopausal patients aged 50 years or older. * patients who agree to participate in a 4-year follow-up observation. * patients who provide written informed consent. exclusion criteira: * patients on warfarin potassium (warfarin®) therapy. * patients with hypercalcemia. * patietns with renal calculus. * patients with a known history of hypersensitivity to calcium or menatetrenone preparations. * patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system. * patients who underwent bilateral ovariectomy. * patients with radiotherapy in the pelvis or para-aortic area. * patients with the following x-ray findings; 1. patients showing osteophytes connecting with adjacent vertebral osteophytes 2. patients showing hyperostosis of ligament around the vertebral body 3. patients showing inter-body fusion 4. patients who experienced surgical intervention(s) in the spine 5. patients with scoliosis which disturbs a diagnosing of vertebral fracture * patients who have been treated with anti-osteoporotic agents, other than calcium preparation, within 8 months prior to the study treatment (but not applied to the following; if discontinued, non-treated, or shifted to calcium monotherapy for 8 weeks or longer before starting the study treatment). * patients who experienced bisphosphonates in the past. * patients who are likely to show insufficient absorption of liposoluble agents such as biliary atresia, impaired bile secretion, etc. * other patients who are judged to be ineligible for study entry by the investigator or investigator.
a phase ib/ii trial of belotecan and ifosfamide in patients with extensive disease of small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: phase 1 : to evaluate mtd(maximal tolerated dose)and dlt(dose limiting toxicity) of belotecan and ifosfamide. phase 2 : to analyse efficacy and toxicity of belotecan and ifosfamide.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed extensive disease of small cell lung cancer * no prior chemotherapy or radiotherapy for lung * measurable lesion for recist * over 18 years * ecog 0\~2 * expected life span more than 3 months exclusion criteria: * acute or active infection * uncontrolled cerebral nerve symptoms or metastasis * significant myocardial infarction or cardiac disease within 12 months

Keywords: sclc belotecan ifosfamide
bioavailability study of fixed dose combination (fdc) formulations of dapagliflozin and metformin xr versus individual component coadministered to healthy subjects in a fasted state

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: to assess the relative bioavailability of dapagliflozin and metformin from the two fdc formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin xr, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg glucophage® xr tablets, in healthy subjects in a fasted state.


Eligibility criteria:
inclusion criteria: * men and women ages 18 to 45 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ \[height (m)\]2 exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * glucosuria at screening * abnormal liver functions tests (alt, ast or total bilirubin \> 10% above uln) * presence of edema on physical exam * history of diabetes mellitus * history of heart failure * history of renal insufficiency * history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months * history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections * estimated creatinine clearance (clcr) of \< 80 ml/min using the cockcroft gault formula * history of allergy or intolerance to metformin or other similar agents
viral shedding, symptoms and exposure of sars-cov-2 in non-hospitalized children with covid-19

Conditions: Covid19

Summary: data on covid-19 in children are still scarce, and their role in sars-cov-2 transmission is poorly described. furthermore, documentation of the best sars-cov-2 sampling methods in children are limited. in adults, saliva seems like a promising specimen to collect by noninvasive procedure to diagnose and monitor viral load of sars-cov-2, but this has not been tested in children yet. we want to test the following hypothesis: 1. shedding load and duration of sars-cov-2 in children are related to age, gender, clinical symptoms and exposure 2. salvia samples have equal or higher sensibility than nasal swaps in children for detection of sars-cov-2 3. parental home testing of saliva and feces is feasible in children the study is a prospective cohort study of sars-cov-2 pcr-positive children from two test centers in the capital region of denmark. children aged 0-17 years with a pcr-positive sars-cov-2 test from a nasal or pharyngeal swab is included from may 2020 to january 2021 and followed-up for a period of 28 days with weekly sample collection and questionnaires. samples include a saliva sample, a nasal swap and a rectal swap for children under four years of age. a semiquantitative rt-pcr method, will identify positive and negative samples and provide a ct value estimating viral load. saliva and fecal samples will be analyzed from november 2020-february 2021. shedding duration will be related to medial history, clinical presentation, exposure, gender and age.


Eligibility criteria:
inclusion criteria: * a pcr-positive sars-cov-2 test exclusion criteria: -