Kornimate/medical-research-clean huggingface dataset:
a safety study of balsamic bactrim in pediatric participants with acute bronchitis

Conditions: Bronchitis

Summary: this pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (balsamic bactrim) in pediatric participants with acute bronchitis. administration of treatment will be according to treating physician's recommendation under local labeling.


Eligibility criteria:
inclusion criteria: * participants starting treatment with bactrim balsamic suspension * participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria exclusion criteria: * participants who have started treatment with another antibiotic at the time of the visit * participants with no respiratory infections * participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria * participants with severe hepatic parenchymal damage * participants with severe renal failure making it difficult to monitor drug plasma concentration * participants with hypersensitivity to any of balsamic bactrim active ingredients, excipients, and/or sulfas
leo 29102 cream in the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a proof of concept and dose finding phase ii trial comparing 5 dose strengths with vehicle and an active comparator (elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis defined according to hanifin and rajka * iga assessment scored as mild (2) to moderate (3) atopic dermatitis * treatment lesions located on the trunk and limbs * treatment lesions involving 3% to 10% of the total body surface area * patients of either gender between 18 years and 65 years of age exclusion criteria: * systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks prior to randomisation * topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks prior to randomisation * topical treatment with corticosteroids from who groups ii, iii or iv within 1 week prior to randomisation * use of topical or systemic antibiotics within 2 weeks prior to randomisation * puva or uvb therapy within 4 weeks prior to randomisation * clinical infection (viral, fungal or bacterial) on the treatment area * known or suspected severe renal insufficiency or severe hepatic disorders * patients with history of an immunocompromised disease (e.g., lymphoma, hiv, wiskott-aldrich syndrome) * patients with concomitant serious disease (e.g., cancer) which might affect the ad treatment in this trial * females who are pregnant or are breast feeding * females intending to temporarily or permanently stop their hormonal contraceptive regime during and up to one month post study termination visit
improving patient memory for treatment for mild cognitive impairment

Conditions: Memory Impairment; Sleep Disorder

Summary: the main empirical question to be addressed is: what types of memory support are most potent for patients who are experiencing a mild cognitive impairment (mci) relative to non-mci patients?

people experiencing mild cognitive impairment (mci) may benefit from adding memory support to treatment-as-usual. adding memory support may be an innovative way to improve patient memory for treatment, adherence to treatment and outcome. the key question is: what types of memory support are most potent for mci patients relative to non-mci patients? the aim of the proposed research is to assess patient memory for treatment and the impact of adding memory support for people who are and are not experiencing mci. the investigators will also compare the effectiveness of constructive vs. non-constructive memory supports for people who are experiencing mci compared to people who are not experiencing mci. hypotheses: 1. recall of the content of treatment will be lower in the mci group relative to the non-mci group. 2. constructive memory support will be more effective for the non-mci group relative to the mci group. 3. non-constructive memory support will be more effective for the mci group relative to the non-mci group. the outcomes are: (1) patient memory for the content of treatment session and (2) the number and accuracy of thoughts and applications of the therapy points delivered. the investigators will also collect ratings of the acceptability of the treatment and the memory supports that are delivered. this dataset will also be used to better understand the sleep and circadian challenges that people with and without mci report via the scid for sleep disorders and the promis scales.

Eligibility criteria:
inclusion criteria: 1. participants 60 years and older will be recruited. 2. fluent in english. 3. experiencing some difficulties relating to sleep and circadian functioning and (d) a score of 19-25 on the montreal cognitive assessment (for the mci group) and score 26-30 on the montreal cognitive assessment (for the non-mci group) (e) have a computer to use and an internet connection and (f) be able to attend sessions weekly and on the same day each week. exclusion criteria: 1. presence of an active and progressive mental or physical illness or neurological degenerative disease; 2. night shift work \>2 nights per week in the past 3 months; 3. not able and willing to participate in and/or complete the assessments and participate in the treatment.

Keywords: mild cognitive impairment sleep and circadian functioning improving treatment outcome
pyloric or pseudopyloric metaplasia of the corpus mucosa in autoimmune gastritis

Conditions: Autoimmune Diseases; Helicobacter Pylori Gastritis; Anemia, Pernicious; Metaplasia; Gastritis, Atrophic

Summary: the study is aimed to investigate the different rates of pyloric/ pseudopyloric metaplasia or spasmolytic polypeptide-expressing metaplasia (spem) of corpus between autoimmune gastritis and h. pylori-infected non-ulcer dyspepsia.

autoimmune gastritis is not an uncommon disease among northern european ancestry, but its prevalence rates are unclear in other populations, including taiwanese. a study showed that near 2% of persons more than 60 years old have undiagnosed pernicious anemia, one of the complications of autoimmune gastritis. believed to be undiagnosed, patients are at risk of gastric malignancy and vitamin b12 deficiency-related complications until the end stage. therefore, use of available diagnostic tools to diagnose patients with autoimmune gastritis has been important. however, autoimmune gastritis has a silent course and is not easy to be early recognized. early recognition is important because in the late stage, vitamin b12 replacement treatment may correct pernicious anemia only but not neurologic disorders. fundus and corpus atrophy with parietal cells loss presented 2 to 3 decades before anemia develops in autoimmune gastritis. it is no doubt that autoimmune gastritis could be diagnosed if vitamin b12 deficiency with megaloblastosis and anemia developed; however, it could be diagnosed earlier if the gastric pathological finding was noticed to be a diagnostic clue. nevertheless, fundus and corpus atrophy is presented not only in autoimmune gastritis but also in h. pylori-related gastropathy. therefore, we need a pathologic feature which could help physicians differentiate autoimmune gastritis from h. pylori-infected gastropathy. here, we propose that pyloric or pseudopyloric metaplasia of corpus is distinct from h. pylori-infected gastropathy. we believe that this specific pathologic feature will be helpful to diagnose patients with autoimmune gastritis.

Eligibility criteria:
inclusion criteria: * patients who present with relevant symptoms or signs of upper gastrointestinal diseases, including, but not limited to the following: impaired gastric emptying, epigastric discomfort, postprandial bloating, early satiety, epigastric pain, acid regurgitation, dyspepsia, anemia, or vitamin b12 deficiency, or iron deficiency, are candidates to be enrolled to receive gastroscopy. exclusion criteria: * the exclusion criteria are as follows including use of aspirin, non-steroidal anti-inflammatory drugs, or cyclooxygenase-2 selective inhibitors for more than 3 months, or diagnosis with upper gastrointestinal cancer including esophagus, stomach, duodenum, mucosa-associated lymphoid tissue lymphoma, other gastric lymphoma, or pancreas.

Keywords: anemia, pernicious helicobacter pylori gastritis metaplasia intestinal metaplasia autoimmune diseases
spiritual needs of european patients with inflammatory bowel disease and their caregivers

Conditions: Inflammatory Bowel Disease (Crohn&#39;s Disease and Ulcerative Colitis)

Summary: a european-wide cross-sectional non-interventional study, initiated by a pilot study in italy, will be conducted. the first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the spiritual needs questionnaire (spnq-ev) and the interpretation of illness questionnaire (iiq) adopting the methodology \[3\] described in figure 1. to ensure they are both valid and user-friendly, the thinking out loud (tol) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. tol involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. the second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated spnq-ev and iiq developed in phase 1. the european study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. eligible participants include adolescents and adults with ibd, as well as their caregivers, recruited via nurses and patient associations.


Eligibility criteria:
inclusion criteria: * adolescents and adults of all ages clinically diagnosed with cd, uc, or any other form of ibd (such as indeterminate colitis or ibd unclassified).
follow up of thai adult volunteers with breakthrough hiv infection after participation in a preventive hiv vaccine trial

Conditions: HIV-1

Summary: this protocol will study the clinical course of hiv-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of alvac-hiv and aidsvax b/e prior to hiv-1 infection in reference to study nct00223080 rv144. the study will assess whether those who received the experimental vaccine combination have a slower progression of hiv disease compared to those who received the placebo injection.

prospective cohort study of the clinical course of hiv-1 infection occurring after candidate hiv-1 vaccination (breakthrough infection) with alvac-hiv (vcp1521) and aidsvax b/e in reference to study nct00223080 rv144. this study will enroll volunteers who become hiv-infected during the course of follow up in a phase iii preventive hiv vaccine trial conducted in rayong and chon buri, thailand. volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers. after enrollment in rv152, follow-up visits were scheduled at 0, 1, 3, and 6 months, and every 3 months thereafter. after month 12, cd4+ t cell counts and viral load were obtained at 6-month intervals until the cd4+ t cell count declined to \ 350/ul, a study endpoint was not registered and the volunteer resumed a normal visit schedule. a single genital fluid collection for viral load was obtained at the first rv152 visit. clinical and laboratory data from rv144, including cd4+ t-cell and hiv-1 plasma viral load measurements, were linked to rv152 to inform primary and secondary protocol analyses as well as volunteer care and treatment.

Eligibility criteria:
inclusion criteria: * all individuals who become hiv-infected after receiving experimental vaccine or placebo in the rv144 clinical trial if they received at least one injection. * the volunteer must give written, informed consent. exclusion criteria: * persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent. * persons who become hiv-infected after the completion of the rv144 protocol.

Keywords: hiv-1 natural history hiv vaccine thailand
klex versus fs-lasik for the treatment of myopia and compound myopic astigmatism

Conditions: Myopia; Astigmatism; Myopic Astigmatism

Summary: femtolasik is a type of laser eye surgery used to correct vision problems such as nearsightedness, farsightedness, and astigmatism. it involves two main steps: creating a flap and reshaping the cornea. refractive lenticule extraction, (klex) is another laser eye surgery method to correct vision issues, which involves creating and extracting a lenticule without the need of a flap. the investigators will evaluate and compare the efficacy and safety of these two procedures.

keratorefractive lenticule extraction (klex) is a refractive surgery technique that does not require the creation of a flap to correct the defects. the potential advantages of this technique are related to the absence of a flap, which could make it the gold standard of refractive surgery. on the other hand, femtosecond-assisted laser in-situ keratomileusis (fs-lasik) is the most widely practiced refractive surgery worldwide, as it offers excellent visual outcomes but does require the creation of a flap to correct the defects. the objective of this study is to evaluate the effectiveness and safety of klex versus fs-lasik as a treatment option in patients with myopia or compound myopic astigmatism. this is a prospective randomized study. a total of 80 participants will be randomized into two groups, the klex group and fs-lasik group. following randomization, participants will be followed on the first day after the surgery, 1 week, 1, 3, 6, and 12 months. the primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative spherical equivalent within ± 0.5 diopters of the intended target. secondary outcome parameters include quality vision measurements, refraction, visual acuity, and adverse events.

Eligibility criteria:
inclusion criteria: * age 21 years or older * corneal tomography without alterations * myopia between -0.50 and -12.00 d * astigmatism between -0.50 and -6.00 d exclusion criteria: * previous eye surgeries * pregnancy * progressive or unstable myopia and/or compound myopic astigmatism * ocular surface disease

Keywords: klex lasik fs-lasik refractive surgery astigmatism myopia
efficacy and safety of inhaled zanamivir in treatment of influenza a and b virus infections in china

Conditions: Influenza A Virus Infection; Influenza B Virus Infection

Summary: the aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza a and b virus infections in china.


Eligibility criteria:
inclusion criteria: * who had fever (\>38.0ºc) * at least two of the following symptoms: chills, headache, myalgia, fatigue, nasal symptoms, sore throat, cough * started therapy within 48 hours of onset of influenza-like illness * written informed consent exclusion criteria: * respiratory diseases, such as asthma or copd * woman with a positive urine pregnancy test * woman without contraception during the study * allergic to zanamivir, paracetamol or lactose * wbc ≥ 10.5×109/l; neutrophil percentage ≥ 80% * hepatic function impairment: ast ≥ 2×uln, alt ≥ 2×uln * renal function impairment: cr \> 221μmol/l * influenza vaccination in the 12 months prior the beginning of the study * history of tumor, psychiatric disorders, epilepsy or drug abuse * patients receiving corticosteroids, immunosuppressants * hiv positive
cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: studying samples of tissue from patients with or without cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this laboratory study is looking at cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer.

objectives: * determine cyclooxygenase-2 (cox-2) levels in biopsy or surgical specimens from patients with normal cervical epithelium, cervical intraepithelial neoplasia, or microinvasive squamous cell carcinoma of the cervix. * correlate cox-2 levels with histological diagnosis and parameters of invasion (i.e., matrix metalloproteinase, microvessel count, and vegf). outline: paraffin-embedded tissue samples are analyzed by immunohistochemistry for evaluation of cyclooxygenase-2 levels, microvessel count, and matrix metalloproteinase and vegf expression. medical data for study analysis is obtained by retrospective review of patient charts.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * underwent hysterectomy with removal of a normal cervix for diagnosis unrelated to cancer or cervical dysplasia * underwent cervical biopsy or removal of cervical tissue and diagnosed with cervical intraepithelial neoplasia (cin) grades 1-3 * underwent cervical biopsy and diagnosed with microinvasive squamous cell carcinoma of the cervix * paraffin-embedded tissue samples of normal cervical epithelium, cin, or microinvasive squamous cell carcinoma of the cervix must be available for examination patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: cervical squamous cell carcinoma stage ia cervical cancer stage 0 cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
carac & pdt combination in the treatment of actinic keratoses

Conditions: Actinic Keratoses

Summary: to demonstrate if carac treatment after pdt treatment of actinic keratoses leads to superior clinical improvement when compared to carac or pdt treatment alone. this will be done by manual counts and through photography.

carac has been shown to be highly effective for the treatment of actinic keratoses. photodynamic therapy (pdt) has also been shown to be highly effective for the treatment of actinic keratoses. both treatments are fda approved. the mechanism of action of each therapy is different. in general a more vigorous, but less cosmetically acceptable appearance is seen after carac treatment as compared to pdt treatment. the purposes of this study are to determine 1) if the use of carac, followed by pdt treatment, of actinic keratoses leads to an enhanced clinical improvement as compared to pdt treatment alone; 2) if the cosmetic appearance of the skin during carac is improved with pdt pre-treatment; 3) evaluate histologic changes induced by combined carac/pdt treatment as compared to carac treatment alone and pdt treatment alone.;4) evaluate safety of treatments in terms of potential for infection and scarring

Eligibility criteria:
inclusion criteria: * males/females,, aged 40-70 * must have 5 or more documented facial/anterior scalp actinic keratoses * read, understood, and signed informed consent form * willing and able to comply with all follow-up requirements exclusion criteria: * previous treatment of facial keratoses with any modality of treatment within 3 months of study enrollment * contraindications to the use of either carac and/or pdt treatment * exclusion of biopsy proven skin cancer in the area * active infections or dermatitis in the treatment area

Keywords: actinic keratoses
treatment of ibs in primary health care.

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to retrospectively evaluate treatment strategies for ibs used within primary health care in örebro region.

the defining features of ibs comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the rome iv criteria. the spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. despite the prevalence of ibs, its management remains a challenge for global healthcare systems. treatment of ibs comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics. since the majority of patients with irritable bowel syndrome (ibs) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (gps) to recommended therapeutic approaches for ibs. in this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in örebro region. patients will be identified by icd-code k.58. the used treatments will be categorized in grade of recommendation as well as in strength of evidence. the efficacy of the used treatments will be evaluated, if possible. over the counter agents, and lifestyle adjustments will not be evaluated. the used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). the eventual use of inappropriate treatments will be recorded as well. the efficacy of the used treatments will be, if possible, evaluated from the patient registers. the standardized and validated questionnaires ibs-symptom severity score and ibs-quality of life scores are not routinely used within the primary health care. for this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect". descriptive statistics will be used.

Eligibility criteria:
inclusion criteria: * all adult patients (both sexes) who were diagnosed with ibs according to icd-10 in region örebro county 2013-2017. exclusion criteria: * patients \ 65 years.

Keywords: irritable bowel syndrome functional gastrointestinal disorders
e-cigarettes versus nrt gum for smoking cessation

Conditions: Nicotine Addiction; Smoking Cessation

Summary: this is a randomized trial comparing electronic cigarettes (e-cigarettes) to nicotine gum for smoking cessation. participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. all participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. quit status will be determined at 12 weeks after the quit date. continued use of nicotine replacement (either e-cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.


Eligibility criteria:
inclusion criteria: * smokes at least five cigarettes per day * no current or previous regular use of e-cigarettes * ready to quit smoking exclusion criteria: * use of smokeless or pipe tobacco * smoke more than 40 cigarettes per day * pregnant or breastfeeding * unable to chew gum due to dental or jaw problems * myocardial infarction (heart attack) within the previous 12 months * hypersensitivity to propylene glycol or nicotine gum

Keywords: smoking cessation nicotine addiction e-cigarette electronic nicotine delivery device electronic cigarette nicotine replacement therapy