Kornimate/medical-research-clean huggingface dataset:
impact of cotrimoxazole prophylaxis for hiv-infected adults on antifolate resistance

Conditions: HIV; Malaria; Diarrhea; Pneumonia; Opportunistic Infections

Summary: at least three studies in sub-saharan africa have demonstrated a decrease in morbidity or mortality among hiv-infected adults who took daily cotrimoxazole (trimethoprim sulfamethoxazole) \[ctx\] prophylaxis. because of the demonstrated beneficial effect, high tolerability and low cost of ctx, the united nations programme on hiv/aids (unaids) recommends that hiv-infected persons with symptomatic hiv or depressed cd4 counts receive daily ctx. the effect of this recommendation on subsequent development of antimicrobial resistance to antifolates among important pathogens needs to be evaluated. the investigators measured the change in the prevalence of markers of antifolate resistance among p. falciparum, and the change in the prevalence of ctx resistance among s. pneumoniae, and e. coli in hiv-infected individuals receiving ctx daily prophylaxis. in addition, the investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal carriage of ctx resistant s. pneumoniae among children living in households where an hiv-infected adult was receiving ctx daily prophylaxis.

we conducted this study in kisumu, kenya where hiv prevalence is high and malaria is highly endemic. hiv infected and uninfected adults were assigned to receive daily ctx if cd4 cell count was \ = 350 or if the client was hiv negative. all clients were then followed for a total of 6 months. at specified scheduled and sick visits, clients received a physical exam, blood smears, nasopharyngeal swabs and stool samples or rectal swabs. samples collected at baseline and during follow-up were used to measure the change in ctx resistance among p. falciparum parasites, pneumococcus isolates, and commensal e. coli.

Eligibility criteria:
inclusion criteria: clients presenting to the crc hiv counseling and testing site in kisumu were eligible for the study if they met the following inclusion criteria: * 15 years of age or older * able to make all follow-up visits (i.e. do not plan to leave kisumu during the next 6 months, are not homebound) * able to understand and give informed consent. exclusion criteria: clients were not eligible for the study if they met any of the following exclusion criteria: * known allergic reaction to sulfa medications (i.e. ctx, sulfadoxine- pyrimethamine) * women in their first trimester of pregnancy or planning to become pregnant in the next 6 months * clients taking daily antibiotics for treatment of a chronic illness; or prophylaxis, excluding tuberculosis treatment.

Keywords: hiv malaria e. coli s. pneumoniae drug resistance antifolate opportunistic infections africa kenya east africa
study of inhaled rct1100 in adults with pcd caused by pathogenic mutations in the dnai1 gene to measure mucociliary clearance

Conditions: Primary Ciliary Dyskinesia (PCD)

Summary: this is a multi-dose study with rct1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.

the primary objective of this study is to determine the impact of multiple doses of inhaled rct1100, administered via nebulizer, on mcc with adult participants with primary ciliary dyskinesia caused by pathogenic mutations in the dnai1 gene.

Eligibility criteria:
major inclusion criteria: * the participant is a male or female, 18 to 75 years of age, inclusive, at the time of consent. * participant has disease-causing (pathogenic and/or likely pathogenic) mutations in the dnai1 gene. * the participant has a percent predicted forced expiratory volume in 1 second (fev1pp) of at least 40% predicted. exclusion criteria: * history or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease. * history of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin. * predisposition to bleeding or clinically meaningful hemorrhagic event in the 12 months prior * medically significant hemoptysis. * anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening. * active tuberculosis infection. * 12-lead ecg with qt interval \&gt;450 msec (or \&gt;480 msec for bbb) * laboratory abnormalities in clinical laboratory tests at screening: 1. serum creatinine level 2. total bilirubin, aspartate aminotransferase or alanine aminotransferase values 3. hematological or coagulation values outside the normal reference range * any medical history of disease that has the potential to cause a rise in total bilirubin over the uln. * covid-19 infection within 4 weeks of screening or receipt of covid-19 vaccine within 2 weeks prior to first dose of rct1100. * receipt of vaccine with live virus, attenuated live virus, or live viral components within 2 weeks prior to first dose of rct1100 or to receive these vaccines during treatment or within 8 weeks of completion of study treatment. other protocol defined inclusion/exclusion criteria may apply.

Keywords: primary ciliary dyskinesia pcd kartagener syndrome
eras for pediatric acute appendicitis

Conditions: Pediatric Disorder; Complicated Appendicitis

Summary: this multicenter, prospective randomized controlled study is designed to applicate perioperative enhanced recovery after surgery (eras) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.

the purpose of this study is through multi-center prospective rct research, to discuss the application of eras in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. the major outcome is whether it can reduce the length of stay in hospital (los), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.

Eligibility criteria:
inclusion criteria: * ages\<14; no gender limitation; * alvarado scores ≥7; * preoperative radiography examination indicated complicated appendicitis; * patients or their legal representatives have signed "informed consent" exclusion criteria: * complicated life-threatening disease; * perioperative exploration not appendicitis; * recently participated in other clinical trials within 3 months; * researchers found not fit to participate in this trial for any condition

Keywords: eras pediatric surgery emergency both of systolic and diastolic will be measured
lenalidomide in patients with chronic myelomonocytic leukemia

Conditions: Chronic Myelomonocytic Leukemia

Summary: in a phase i study the investigators plan to investigate safety and toxicity of lenalidomide in patients with chronic myelomonocytic leukemia (cmml). a phase ii study will be started once an optimal dose has been found. the primary endpoint will concern the efficacy of lenalidomide in patients with cmml according to the who diagnostic criteria.


Eligibility criteria:
inclusion criteria: 1. cmml according to the who diagnostic criteria. 2. understand and voluntarily sign an informed consent form. 3. age \>=18 years at the time of signing the informed consent form. 4. able to adhere to the study visit schedule and other protocol requirements. 5. all previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (pdgfrb) can be included if standard treatment with imatinib failed. 6. ecog performance status of \<= 2 at study entry. 7. laboratory test results within these ranges: * creatinine clearance \> 30ml/min * ast (sgot) and alt (sgpt) \<= 2.5 x uln 8. disease free of prior malignancies for \>= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. 9. female subjects of childbearing potential must: * understand the study drug is expected to have a teratogenic risk * agree to use two effective contraception 10. male subjects must * agree to use condoms * agree not to donate semen 11. all subjects must * agree to abstain from donating blood * agree not to share study drug with another person exclusion criteria: 1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide). 3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. use of any other experimental drug or therapy within 28 days of baseline. 5. known hypersensitivity to thalidomide. 6. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 7. any prior use of lenalidomide. 8. concurrent use of other anti-cancer agents or treatments. 9. known positive for hiv or infectious hepatitis, type a, b or c.

Keywords: chronic myelomonocytic leukemia cmml lenalidomide revlimid
bicycling and mortality among individuals with diabetesnutrition (epic)

Conditions: Diabete Mellitus

Summary: the primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from european countries. a secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.

aims the primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from european countries. a secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality. methods study design and setting the study is a nested cohort study in european prospective investigation into cancer and nutrition (epic) cohort. in epic, 29 centers in 10 western european countries have collected information on nutrition, lifestyle, anthropometrics and medical history from more than 521 000 study individuals participating in this prospective cohort study. dietary, medical history and lifestyle were assessed by questionnaires. blood samples from the participants were taken at the study centers. baseline (first examination) information was collected 1992-2000 and second examination for exposure has since been obtained at least once in every cohort. exposure data has subsequently, to the two examinations, been linked to information on vital status and on cause of death were obtained through record linkages with national, regional or local registers, regional health departments, physicians or hospitals, active follow-up or health insurance. study population this nested prospective cohort study, sampled individuals with prevalent diabetes in the epic cohorts at the baseline assessments in the years 1992-2000. self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin\>=6.0%, five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses. no information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison. the nested cohort for this study comprised 12,848 individuals with self-reported and/or confirmed diabetes. mean (sd) follow-up time was 14.6 (4.8) years. among the 12,848 prevalent diabetes cases, 5,809 cases were confirmed at baseline as described above. for further detail, please see the predefined statistical analysis plan (sap). it can be accessed through the url: http://aktivsundhed.dk/images/docs/sapmrl.pdf

Eligibility criteria:
inclusion criteria: * confirmed or self-reported diabetes at first examination exclusion criteria: * none

Keywords: exercise physical activity bicycling
mary duol repair balm in the prevention or reducing antineoplasic agents' skin toxicity

Conditions: Dermatitis, Adverse Drug Reaction

Summary: capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . the impact in patients' quality of life is great, so we had decided to conduct a randomized clinical trial to evaluate the effectiveness mary d' uol balm preventing dermatologic toxicity in patient treated with capecitabine . design: randomized clinical trial phase ii, in parallel and double-blind groups target population : patients with colon cancer stage ii or iii ( dukes' c ) , who will initiate treatment with capecitabine monotherapy. inclusion criteria: over 18 years, ii or iii colon (dukes' c) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent. primary endpoint: dermatologic toxicity (yes / no) statistical analysis: the primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model

intervention: preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with xeloda, capecitabine + oxaliplatin, adriamycin liposomial or cytarabine the product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. it is applied twice daily (after showering and evening), gently massaging the area until completely absorbed. the product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. if not enough (because the patient has greater surface area) will be supplied more. each time you start a new cycle 3 new packages will be delivered. the patient will not apply any other cosmetic product in the treated areas. in addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs. the study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. in these patients the total duration of the study must be sufficient to end the eighth cycle. if the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.

Eligibility criteria:
inclusion criteria: * over 18 years. * sign the informed consent exclusion criteria: * patients with neoadjuvant treatment. * patients with dermatologic diseases. * patients treated with corticosteroids.

Keywords: capecitabine dermatologic toxicity
model-free time curves for longitudinal data analysis

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to enhance statistical methods for epidemiological studies by extending the disturbed highest derivative polynomial (dhdp) to models for binary-logistic and poisson data and by including random subject effects in the gaussian model.

design narrative: in previous work the investigator had developed the disturbed highest derivative polynomial (dhdp) as a model-free time curve and had published the theoretical development for its use as the overall time curve in a linear gaussian model for longitudinal data with fixed covariate effects and autocorrelated errors but without subject effects. for the logistic model, the dhdp would replace the constant which appeared in the log odds in the non-longitudinal case. the first-order dhdp was a straight line whose slope received random disturbances over time. as such, it was capable of fitting a rich variety of arbitrarily changing time curves. the second-order dhdp would generally provide a fit with smaller high frequency variation. there are a number of longitudinal data analysis methods currently available for gaussian and binary-logistic data. they all have in common the requirement to explicitly model the overall time curve--usually by a low order deterministic polynomial. the main significance of this proposal was to represent the overall time curve by a dhdp, thereby allowing the possibility for fitting arbitrarily changing time curves without explicitly modeling the form of the change over time. the order of the dhdp can be selected by a modification of the akaike information criterion. the poisson model should be useful in fitting the periodic reported incidence of a rare disease. the relationship of the dhdp to the smoothing polynomial spline (sps) was shown and methods were developed for using a sps instead of a dhdp in analysis. robustness of the methods were examined by computer simulation studies which evaluated and compared the ability of the dhdp and sps models to estimate covariate effects and time curves when the time curves were generated by processes other than dhdp. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety study of two regimen for sedation for transesophageal echocardiography

Conditions: Hypotension

Summary: the purpose of this study is to determine whether sedation with a combination of pethidin hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in relation to blood pressure drops during an transesophageal echocardiographic examination (tee).

randomisation is done immediately after information of the patient and obtaining of the informed consent. the average time for a tee study is about 30 minutes. data collection occurs during this time frame. ecg monitoring and data collection (blood pressure, heart rate, so2) for the study protocol starts 6 minutes before the application of the sedation. at -6, -4, -2 minutes before the application of the sedation, baseline data are collected. the average systolic blood pressure of these three measures is taken as the reference blood pressure. this is the reference value to calculate the blood pressure drop during the examination. blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the examination (tee) is finished. the questionnaire (for second end points) is filled out by the patient within two hours after the examination. the patient will be followed for the duration of about one hour after the examination, if he is from the outpatient clinic. patients from the hospital (inpatients) will be followed routinely in the clinic.

Eligibility criteria:
inclusion criteria: * all patients scheduled for tee in our department who have signed the informed consent except those younger than 18 years and patients with a second or third etc. tee exclusion criteria: * \< 18 years * intensive care patients * emergency department patients * breast feeding women * pregnant women * patients with an allergy to propofol or its ingredient soy oil, pethidin or midazolam

Keywords: sedation in tee blood pressure drop during tee safety of sedation in tee
the effects of xalatan, travatan and lumigan on skin pigmentation near the eye

Conditions: Glaucoma; Application Site Pigmentation Changes

Summary: the purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: xalatan, travatan or lumigan.

one uncommon side effect of prostaglandin eye drops is a change in color of the skin around the eyes, which is reversible. there are three different brands of the medicine which are equally effective in lowering eye pressure but their likelihood of changing skin color is unknown. qualifying patients will be randomly assigned to use one of the three eye drops. we will take skin color measurements from several locations on the face over one year to measure pigmentation changes.

Eligibility criteria:
inclusion criteria: * patients recently diagnosed with primary open angle glaucoma or ocular hypertension * caucasian and african american ethnicities * male and female * age 30 and above exclusion criteria: * a history of ocular medication use within the last 12 months * inflammatory/ allergic skin diseases or dermatitis * presence of periocular hyperpigmented skin lesions * systemic pigmentation disorders * use of systemic drugs that can affect skin pigmentation * visitation of tanning salons, or use of self tanning products * pregnancy or patients planning to become pregnant in the near future

Keywords: periocular skin pigmentation lumigan travatan xalatan latanoprost bimatoprost travoprost
dose ranging study of spl7013 gel for treatment of bacterial vaginosis (bv)

Conditions: Bacterial Vaginosis

Summary: the purpose of this study is to determine the efficacy of spl7013 gel in the treatment of bacterial vaginosis.


Eligibility criteria:
inclusion criteria: * women aged 18-45 years with a diagnosis of bv according to amsel's criteria and a nugent score of ≥4 * otherwise healthy exclusion criteria: * no active stis

Keywords: spl7013 vivagel bacterial vaginosis bv
creatinine height index in elderly

Conditions: Malnutrition in Elderly

Summary: evaluation of the efficacy of two different age adjusted calculations of chi compared to other nutritional indicators in the elderly medical patients upon hospital admission.

cross sectional study involving one hundred hospitalized elderly (\>60 years), anthropometric measurements, mini- nutritional assessment, hand grip strength, cbc, total protein, albumin, total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured within 24 hours of hospital admission calculation of chi using 2 age adjusted modification was done accuracy of each measurement in detecting malnutrition was evaluated

Eligibility criteria:
inclusion criteria: * medical elderly patients (\>60 years) * within 24 hours of hospital admission exclusion criteria: * sepsis * fever * malignancy * liver cirrhosis * renal impairment * critically ill patients * those with any hemodynamic instability were excluded from the study * patients receiving diuretics * patients can't stand to obtain their weight and height * those can't collect 24 hour urine * the patients refused to participate in the study

Keywords: anthropometric measurements, creatinine height index lean body mass mini- nutritional assessment hand grip strength