Kornimate/medical-research-clean huggingface dataset:
a phase i/ii study of the safety and efficacy of topical 1-(s)-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine dihydrate (cidofovir; hpmpc) in the treatment of refractory mucocutaneous herpes simplex disease in patients with aids

Conditions: Herpes Simplex; HIV Infections

Summary: to evaluate the safety and tolerance of topical cidofovir (hpmpc) therapy for refractory mucocutaneous herpes simplex virus disease in aids patients. to determine whether topical hpmpc therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in aids patients. to evaluate the virologic effects of topical hpmpc therapy on herpes simplex virus shedding from refractory lesions.

patients are randomized to receive topical therapy with placebo (vehicle alone) or hpmpc at either 0.3 or 1.0 percent once daily for 5 days. patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical hpmpc for up to 6 months.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral therapy with azt, ddi, ddc, or d4t. * oral trimethoprim/sulfamethoxazole. * dapsone. * atovaquone. * fluconazole. * rifabutin. * clarithromycin. patients must have: * hiv seropositivity. * mucocutaneous herpes simplex virus (hsv) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous). * measurable lesions. * consent of parent or guardian if less than 18 years of age. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: active medical problems sufficient to hinder study compliance or assessment of treatment effect. concurrent medication: excluded: * acyclovir. * immunomodulators (such as corticosteroids or interferons). * lymphocyte replacement therapy. * biologic response modifiers. * ganciclovir. * foscarnet. * vidarabine. * topical trifluridine. * other investigational drugs (except d4t). * amphotericin. * intravenous therapy for pcp. * chemotherapeutic agents. prior medication: excluded within 14 days prior to study entry: * immunomodulators (such as corticosteroids or interferons). * lymphocyte replacement therapy. * biologic response modifiers. * ganciclovir. * foscarnet. * vidarabine. * topical trifluridine. * other investigational drugs with potential anti-hsv activity. * amphotericin. * intravenous therapy for pcp. excluded within 4 weeks prior to study entry: * chemotherapeutic agents. required: * at least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous). substance abuse.

Keywords: herpes simplex acquired immunodeficiency syndrome antiviral agents cidofovir
efficacy of shinabro in hand osteoarthritis

Conditions: Hand Osteoarthritis

Summary: gcsb-5 ("shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. this study is aimed at investigating efficacy of shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.

osteoarthritis (oa) as a common musculoskeletal disease affects more than 30% of the elderly population. it frequently involves knees, hips, spines and hands. in hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. the chronic progressive nature of the disease requires a life-long treatment. the mainstay treatment of hand oa targets pain control. non-steroidal anti-inflammatory drugs (nsaids) are often used. however, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics. shibaro is a mixture of purified oriental herbs consisting of ledebouriellae radix, achyranthis radix, acanthopanacis cortex, cibotii rhizoma, glycine semen, and eucommiae cortex. these herbs have been used for the treatment of diverse inflammatory conditions in chines traditional medicine. all 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. as such, given the excellent safety profile, anti-inflammatory and analgesic effects, shinbaro might be ideal in the treatment of oa. this study will investigate the efficacy and safety of shinbaro in the treatment of hand oa in a placebo-controlled, randomized, double-blind, multi-center trial.

Eligibility criteria:
inclusion criteria: * age of 40 years or older * osteoarthritis according to acr 1990 criteria * mean joint visual analog pain score (vas) \> 30mm in the preceding 48 hours * patients who are will to participate exclusion criteria: * any prior surgery of hand joints * prior history of shinbaro use * intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months * pregnancy or active breast feeding * prior hypersensitivity reaction to herbal medications * ast or alt elevation \> 3 of upper normal limit * grf (mdrd) \< 30 mg/min/1.73m2 * nephrotic syndrome, other signficant kidney disease * patients who seem not to tolerate the study at investigator's discretion * patients who refuse to participate

Keywords: osteoarthritis hand shinbaro gcsb-5
distinguishing alcohol intoxication, cannabis intoxication and co-intoxication using electroencephalography (eeg)

Conditions: Cannabis Use; Alcohol Use, Unspecified

Summary: this is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (eeg) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. if eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.


Eligibility criteria:
inclusion criteria: * 21-50 years old * heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women) * regular users of legal-market flower cannabis (at least 2x/week in past 3 months) * report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months * english speakers. exclusion criteria: * daily tobacco users * diagnosed with or seeking treatment for alcohol use disorder (aud) or other substance use disorder (sud) * females cannot be pregnant, breastfeeding or trying to become pregnant * meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) current use of psychotropic (except anti-depressants) * report illicit drug use in past 60-days or fail drug screen on the day of the study appointment * major medical condition contraindicating alcohol and/or cannabis consumption.
comparing an investigational medication versus an approved medication in reducing cholesterol levels (0653-025)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.


Eligibility criteria:
inclusion criteria: * elevated cholesterol levels exclusion criteria: * liver disease * unstable medical conditions
differences in care provided in intensive care units (icus) with physician versus nurse practitioner first responders

Conditions: Critical Illness

Summary: the purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has nurse practitioners as the direct care deliverer, a pulmonary fellow, and an attending.

this will be a retrospective cohort study that is performed between two medical intensive care units (icu). the goal is to compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including a resident, pulmonary fellow and attending and a nontraditional model which has nurse practitioners as the direct care deliverer, a pulmonary fellow, and an attending. outcomes that will be measured include icu length of stay, hospital length of stay after icu discharge, ventilator days, daily spontaneous breathing trials, and daily awakening trials, as well as mortality in hospital and after discharge.

Eligibility criteria:
inclusion criteria: * patients admitted to designated icu between september 1, 2007 and september 30, 2010. exclusion criteria: * not admitted to designated icu.
marine oils and arthritis

Conditions: Rheumatoid Arthritis

Summary: nsaids are associated with adverse gi effects and cox-2 inhibitors have cardiovascular risk. long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (r.a) patients, with reduced need for nsaids, in addition to being cardioprotective. the aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with r.a (primary outcome). patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. patients are called for interview after 6 and 12 weeks. secondary outcomes are e.g. morning stiffness, quality of life and functional level

not relevant

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis patients according to american college of rheumatology criteria (with active disease and in remission). intensity of joint pain last week (30 mm or more on 100 mm visual analogue scale). stable use of dmards and no corticosteroid injections last 4 weeks before study and during study. exclusion criteria: * non-norwegian speaking/reading or not understanding study design or non-compliance. pregnant/lactating women. bleeder disease, known hiv or hepatitis, medication with marevan (blood thinner). not willing or possible to stop taking regular omega-3 supplements during study.
therapeutic effect of colla corii asini on improving anemia and hemoglobin composition in pregnant women with thalassemia

Conditions: Thalassemia

Summary: seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. patients in the treatment group were given 15 g of colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. levels of hemoglobin(hb), serum iron (si), serum ferritin (sf) and three types of hemoglobin components \[adult hemoglobin (hba), fetal hemoglobin (hbf), minor adult hemoglobin (hba2)\] were measured before and after treatments.


Eligibility criteria:
inclusion criteria: * pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate β- thalassemia; * patients with mild anemia (80 g/l≤ hb\<110 g/l) prior to study enrollment; * singleton pregnancy; * patients having not received blood transfusion or any forms of anti-anemia treatment in western medicine or traditional chinese medicine in the last 12 weeks; * informed consent obtained. exclusion criteria: * patients with severe thalassemia; * patients with severe anemia (hb\<80 g/l) prior to study enrollment; * twin or multiple pregnancies; * patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system; * allergic to two or more drugs; * patients with mental illness or poor compliance to medical treatment; * patients having received blood transfusion or any forms of anti-anemia treatment in western medicine or traditional chinese medicine in the last 12 weeks; * no informed consent obtained.
the expression of aquaporin 3, 8 and 9 in placenta in normal and preeclamptic pregnancies: perinatal and neonatal outcomes.

Conditions: Preeclampsia

Summary: the etiologic agent responsible for the development of preeclampsia remains unknown. aquaporins, members of integral membrane proteins, are responsible of water molecules movements through the plasma membrane channels, energy metabolism and associated with changes in cellular volume during apoptosis. i̇n such placental pathology as preeclampsia, characterized with superficial implantation and increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of aquaporins important role in energy homeostasis and apoptosis maybe suggested.

the investigators are carrying out a study of 210 pregnant women , from whom 105 will have pregnancy complicated with preeclampsia and 105 with normal pregnancy. the investigators aim is to investigate the role of the placenta, umbilical cord and amniotic membrane aquaporin expression in etiopathogenesis of preeclampsia. the investigators will compare aquaporin levels in preeclamptic and normal placentas, umbilical cords and amniotic membranes , and investigate relation between aquaporin levels and perinatal ( maternal blood pressure, proteinuria, maternal-fetal doppler ultrasound, amniotic fluid index, fetal intrauterine growth) and neonatal ( apgar score, biometry, complications) finding.

Eligibility criteria:
inclusion criteria: * preeclamptic pregnants * normal non-complicated pregnants exclusion criteria: -pregnants with another obstetric complications

Keywords: preeclampsia aquaporins placenta
a phase ii, double blind study of 2 doses of zactima™(zd6474) in combination with folfiri vs folfiri alone for the treatment of colorectal cancer in patients

Conditions: Colorectal Cancer

Summary: the purpose of this study is to assess the efficacy and safety of 2 doses of zactima™ (zd6474) in combination with folfiri vs folfiri alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal cancer * have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as: * progression on or following treatment for metastatic colorectal cancer * progression within 12 months of adjuvant chemotherapy for colorectal cancer exclusion criteria: * previous treatment with small molecule tyrosine kinase inhibitors of vegfr or egfr eg, erlotinib, gefitinib. prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab. * previous adjuvant therapy with irinotecan within 12 months of randomization * more than one prior course of chemotherapy for treatment of metastatic colorectal cancer.

Keywords: colon cancer rectal cancer
study of the risk of pharyngocutaneous fistula in a population of patients undergoing total laryngectomy and creation of a score for pre-operative risk stratification.

Conditions: Laryngeal Cancer

Summary: multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.

evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk pcf pharyngocutaneous fistula. analyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx the results obtained from the present study will allow patients to be stratified into low and high risk for pcf to undergo total laryngectomy, so as to reduce this surgical complication

Eligibility criteria:
inclusion criteria: patients undergoing lt surgery with direct closure of the pharynx in case of: * naïve laryngeal neoplasm (ct1-t3 and ct4a without extension to the esophagus or hypopharynx or oropharynx); * recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (co2 laser limited within the larynx or ophl); * recurrence of laryngeal neoplasm after rt or ch-rt treatment; * lack of functionality of the larynx induced by (ch-)rt treatment; * availability of data according to the assessments that will have to be made, including a fu period of 2 months. exclusion criteria: * use of flap, pedicled / free, on-lay / in-lay at the same time as lt surgery. patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.
safety and efficacy study of transdermal oxybutynin to treat overactive bladder with a neurological condition

Conditions: Detrusor Hyperreflexia

Summary: this study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

this study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Eligibility criteria:
inclusion criteria: * pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition; * use clean intermittent catheterization * on stable dose of oral oxybutynin before participation exclusion criteria: * have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency * have any medical condition that precludes their participation in the study or may confound the outcome of the study
molecular surveillance of artemisinin resistance malaria in myanmar

Conditions: Drug Resistance; Plasmodium Falciparum Malaria

Summary: efficacy and safety of the artemisinin combination therapy (act) in uncomplicated falciparum malaria patients in myanmar and artemisinin molecular markers analysis

the investigators assessed the efficacy and safety of the act in uncomplicated falciparum malaria in different sentinel sites in myanmar. the recruited patients were follow-up until day 28 or day-42 based on the acts. day-0 samples were analysed for artemisinin molecular markers, (k13 kelch propeller, pfmdr2, pffd and pfarps10).

Eligibility criteria:
inclusion criteria: * plasmodium falciparum mono infection by microscopy * presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours * ability to swallow oral medication * ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule * informed consent from the patient or from a parent or guardian in the case of children exclusion criteria: * presence of signs of severe falciparum malaria according to the definitions of world health organisation (who) * mixed or mono-infection with another plasmodium species detected by microscopy * presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm) * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, human immune deficiency virus (hiv)/acquired immune deficiency syndrom (aids) * regular medication, which may interfere with antimalarial pharmacokinetics * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s) * a positive pregnancy test or breastfeeding * unable to or unwilling to take a pregnancy test or contraceptives
med-south lifestyle program implementation study

Conditions: Healthy Lifestyle

Summary: the purpose of this study is to determine the processes by which a previously proven lifestyle intervention (the med-south lifestyle program) can most effectively and efficiently be translated into public health and clinical practice to positively impact chronic disease risk reduction among mostly minority, rural, and medically underserved populations.

purpose: although lifestyle behavior change interventions are widely recommended to improve health, they are not being implemented sufficiently or equitably on a national scale, particularly in rural communities. the research team has developed and tested multiple lifestyle interventions, which have culminated in the med-south lifestyle program (mslp), an evidence-based behavior change intervention that translates the prevention with mediterranean diet (predimed) dietary pattern for a southeastern us population and includes support for increased physical activity. in this research, the investigators propose to identify the most effective and efficient way to scale-up the mslp for use in public health and clinical practices settings so that it reaches minority, rural, and medically underserved populations. in phase 2, the investigators will apply an effectiveness-implementation hybrid design to compare two formats for scaling up mslp on implementation outcomes (primary aim) and confirm the mslp's impact on behavioral and clinical outcomes (secondary aim). participants: phase ii participants include: staff at 20 rural north carolina sites (10 health departments and 10 federally qualified health centers) and participants from each site (15 each, 300 total) procedures (methods): test the effects of scaling up mslp using two different formats. using an effectiveness-implementation hybrid type 3 design, the investigators will randomize 20 sites (10 health departments and 10 federally qualified health centers (fqhcs)) to 1 of 2 formats for delivering scale up strategies: distance (webinar and phone) vs. a blended in-person/distance collaborative format. each site will collect data on 15 patients (n=300). aim 1: site level: compare the relative effects of the 2 scale-up formats on implementation outcomes (reach, acceptability, feasibility, fidelity, and cost). aim 2: participant-level: assess changes in behavioral and clinical outcomes: (1) self-reported diet and physical activity and (2) weight from baseline to follow-up (4 and 10 months). compare outcomes across the 2 scale-up delivery formats.

Eligibility criteria:
inclusion criteria: * male or female * english speaking (spanish-speaking only in selected sites with bilingual staff) * ages 18-80 exclusion criteria: * malignancy * advanced kidney disease (estimated creatinine clearance \< 30 ml/min)