Kornimate/medical-research-clean huggingface dataset:
safety and pk study of cvx-060 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors; Neoplasms; Carcinoma; Cancer; Malignancy

Summary: the purpose of this study is to determine the safety and tolerability of cvx-060 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy. * adequate coagulation, liver, and renal function. * candidate for dce-mri evaluations. * ecog (eastern cooperative oncology group) performance status of 0 or 1. exclusion criteria: * evidence of significant bleeding problems. * history of certain gastrointestinal problems including fistula and abscess. * chronic, uncontrolled hypertension. * patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.

Keywords: phase 1 tumors cvx-060
ventilator hyperinflation and manual rib cage compression

Conditions: Pulmonary Atelectasis

Summary: this is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. in addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.

ventilator hyperinflation is widely used in hypersecretive patients. it consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. a randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. patients were evaluated through compliance and resistance of the respiratory system.

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation * diagnosis of pulmonary infection * hypersecretive exclusion criteria: * haemodynamic instability (heart rate \> 130 bpm and mean arterial pressure \< 60 mmhg) * acute bronchospasm * acute respiratory distress syndrome * untreated pneumothorax

Keywords: ventilator hyperinflation expiratory rib cage compression physical therapy mechanical ventilation
cell mediated immunity and the prediction of cmv infection in solid organ transplant recipients

Conditions: Transplant

Summary: cytomegalovirus (cmv) is a common cause of illness in patients who have undergone a transplant. serious infections due to cmv can affect many parts of the body including the lungs, the gut, and the liver. since transplant recipients are at risk for cmv or have evidence of infection with cmv, they are given an antiviral drug (usually ganciclovir or valganciclovir). despite this, there are a chance that cmv infection may cause problems in the future. the purpose of this study is to assess how well patients'immune systems responds to the cmv virus, so that in the future it may be possible to predict which patients are at highest risk of cmv.


Eligibility criteria:
inclusion criteria: * male or female patients who fulfill the following criteria are eligible for inclusion. * cmv d+/r- liver, kidney and heart recipient * cmv r+ liver,kidney and heart recipients who have received thymoglobulin induction therapy. * d+/r- and r+ lung transplant recipients. * able to give written informed consent * are willing and able to comply with the protocol * age \>=18 years exclusion criteria: * patient unwilling or unable to give informed consent

Keywords: liver transplant lung transplant kidney transplant heart transplant cmv cmi
low dose supplemental external radiation with pd-103 versus pd-103 alone for prostate cancer

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 gy of external beam radiation therapy versus prostate implant with 0 gy of external beam radiation therapy. patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.

approximately 250,000 men are currently diagnosed with prostatic cancer in the united states each year. of those, 70% have stage t1 or t2 disease (apparently limited to the prostate gland). clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. patients with a psa above 10 ng/ml or gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure. implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer. establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs.

Eligibility criteria:
inclusion criteria: * patients with previously untreated prostatic cancer. * must have psa 10-20 ng/ml, gleason 7 to 9 exclusion criteria: * patients with proven regional lymph node involvement will be excluded.

Keywords: prostatic cancer brachytherapy prostatic neoplasm radiation therapy
testing the protective and caring effect of a water-in-oil formulation in patients suffering from urinary and/or fecal incontinence and requiring incontinence care products

Conditions: Incontinence, Urinary; Incontinence, Fecal

Summary: the aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.

patients receive at least two applications of the test product in the application area daily for two weeks. an additional washing product is used during the entire application time. the caring and skin protecting effects, the skin tolerability and cosmetic efficacy of the test product will be assessed by a physician, a nurse and the patient.

Eligibility criteria:
inclusion criteria: * patient is capable of understanding the information given to them and providing informed consent * 70 years of age and older * patients with incontinence (fecal and/or urinary), requiring incontinence protection material * skin type on fitzpatrick scale: between i to iv exclusion criteria: * current cancer treatment such as chemotherapy, irradiation * documented allergies to skin care and / or skin cleansing products * wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation * incontinence-associated dermatitis (iad) stage \>1a * active skin disease at the test area * any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study * mini-mental-status-test (mmst) \< 20
prognostic value of the sga and nutric in the icu

Conditions: Critical Illness; Malnutrition

Summary: there are two nutrition assessment tools that are commonly used in the icu, namely the subjective global assessment (sga) and modified nutrition risk in critically ill score (mnutric). it has been proposed that both assessments should be performed in the icu but their combined prognostic ability has not been adequately assessed. this study aimed to: 1) determine the agreement between sga and mnutric scores, and 2) quantify their utility in discriminating and quantifying hospital mortality risk both independently and in combination.

this prospective observational study will be conducted in a 35-bed mixed icu in ng teng fong general hospital, and all the intensivists and nurses will be blinded to the objectives of the study. all patients admitted to the icu will be consecutively included in the study. for patients readmitted to the icu during the same hospitalisation, only data from the first admission will be collected. as per routine care, all patients will have their nutritional status assessed by the dietitian within 48 hours of icu admission. information required for the nutritional assessment (sga) will be obtained from the patients or their main care givers, and nutritional status will be dichotomized into well-nourished and malnourished. the electronic medical records automatically and prospectively collects all data required to calculate the mnutric. at the end of the study, the mnutric will be retrospectively calculated. patients with values of "0-4" will be classified as low-mnutric and "5-9" as high-mnutric. the primary outcome will be hospital mortality and all patients will be followed until discharge or death, for up to one year after admission to the icu. agreement and mortality discriminative value (i.e. discrimination) of the 2-category classification of mnutric (low- and high-mnutric) and sga (sga-a and sga-b/c) will be assessed by kappa statistics and c-statistics respectively. a multivariate logistic regression will be used to generate the adjusted odds ratios that quantify the association between high-mnutric, malnutrition, and their combination (mnutric ≥ 5 and sga-b/c) with hospital mortality.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old who had ≥ 24 hours length of stay in the icu * received a nutrition assessment (sga) from a dietitian within 48 hours of admission to the icu exclusion criteria: * nil

Keywords: subjective global assessment nutrition risk in critically ill score critical illness
association of mean platelet volume and cardiovascular disease in children with end stage renal disease.

Conditions: Cardiovascular Diseases; Carotid Intimal Media Thickness; Left Ventricular Hypertrophy; Mean Platelet Volume; End Stage Renal Disease; Hemodialysis Complication; Peritoneal Dialysis Complication; Children

Summary: cardiovascular disease (cvd) is the major risk factor for death in end stage renal diseases (esrd). approximately 80% of esrd patients have some degrees of left ventricular abnormalities at initiation of dialysis. carotid intima media thickness (cimt) has been widely accepted as an useful marker to assess cvd in esrd children. in addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. however, measuring cimt and cardiac mechanics parameters are expensive and difficult to perform as a routine method. mean platelet volume (mpv) is a hematological index which shows the size of platelets. uremic state causes inflammatory condition that affects mpv. previous studies on people with normal renal function have shown that this parameter can also have association with cvd. however the data in children with esrd is scarce. the aim of this study is to find a simple hematologic marker to use regularly in esrd children finding patients at risk of cvd. therefore, we will investigate the relationship between mean platelet volume and cimt and cardiac mechanic parameters in children with esrd.


Eligibility criteria:
inclusion criteria: * children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group. * age and gender matched healthy children who have been referred for routine medical examination. exclusion criteria: * patients with uncontrolled hypertension (until being stabled) * patients on any kind of antithrombotic agents or nsaids * severe obesity * diabetes patients * patients with a past history of cvd or stroke in the last 6 months * passive smokers who contacted daily with high smokers in their houses * patients with known hematologic diseases or malignancies (such as fanconi anemia) * uncontrolled hypothyroid or hyperthyroid patients * patients with recent (in the last 4 weeks) catheter or exit -site infection.
study to determine the pharmacokinetic behavior of antiretroviral drugs in patients infected by hiv

Conditions: HIV Infections

Summary: the purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (nnrtis) and protease inhibitors (pis), and the influence of the individual characteristics on the pharmacokinetic parameters in the spanish population of hiv-infected subjects.

the antiretrovirals were administered conventionally according to fixed dosage systems, or depending on the weight of the individual in the case of certain agents. however, the plasma levels of antiretrovirals following the administration of a fixed dose present a marked interindividual variability. moreover, a significant proportion of the patients on treatment with pis presented plasma levels regarded as suboptimal in previous studies. moreover, for the correct modification of the dosage of a drug, populational data on its pharmacokinetic behaviour during the dosing interval is required. only by integrating this information with the specific characteristics of each individual is it possible, using mathematical models, to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration. however, populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment, and have not always been obtained in populations similar to the one to which they are to be applied. thus, knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest, since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients.

Eligibility criteria:
inclusion criteria: 1. age higher than 18 years. 2. documented hiv infection (at least one positive western-blot) 3. stable antiretroviral treatment with pi or nnrti, no changes over the last 4 weeks. 4. women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or negative pregnancy test. exclusion criteria: 1. subjects on treatment with more than one pi or with combinations of pi and nnrti (the use of ritonavir in doses below 400 mg bid will not be regarded as a second pi). 2. treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks. 3. unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks). 4. presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication. 5. active consumption of alcohol (\>50 grams/day) or illegal drugs (except cannabis). 6. in the case of women, pregnancy or breastfeeding. 7. record or suspicion of inability to cooperate properly

Keywords: protease inhibitors non-nucleoside analog reverse transcriptase inhibitors pharmacokinetic models treatment experienced hiv
the effect of pregnant-controlled sacral massage on mothers' labor pain, perception, process and midwives' satisfaction

Conditions: Labor Pain; Labor

Summary: our study aims to determine the effect of pregnant-controlled automatic sacral massage on mothers' labor pain, perception, process and midwives' satisfaction. the research was planned as a randomized controlled experimental study. a total of 112 women, 56 pregnant women in the experimental and control groups, will be included in the study. in this project, an automatic massage device will be used during the active phase (when the cervical opening is between 5-6 cm and 10 cm) and a massage device in line with the pregnancy-controlled sacral massage application protocol. pregnant women are followed throughout the active phase of labor and indicators reflecting labor pain, progress of labor, and the health status of the mother and the baby are used with the "individual identification form", "visual comparison scale", "labor monitoring form", "mother's birth perception scale (adas)". the satisfaction of midwives will be evaluated with the "evaluation of satisfaction status of midwives form".


Eligibility criteria:
inclusion criteria: * participating in the study voluntarily * having a cervical dilatation of 5-6 cm, * being between 38-40 weeks of pregnancy,- being a single fetus, having a cephalic presentation, * having a fetal weight between 2.5-4 kg, * having no vision-hearing problems, * having communication and cooperation skills exclusion criteria: * having pregnancy complications * those who have acute inflammatory problems in soft tissues, skin or joints, burns, nerve injuries, open wounds, rheumatoid and gouty arthritis, * those who have used any non-pharmacological methods will not be admitted.
prostaglandin e2 as a critical mediator of sex disparities in asthma

Conditions: Asthma

Summary: this study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.


Eligibility criteria:
inclusion criteria: * subject must be able to understand and provide informed consent * age 18-50 * a history of physician-diagnosed asthma well controlled as assessed by acq-6 \ 70% of predicted and fev1 \>1.5 liters. * asthma must be persistent, defined by the requirement of a daily controller agent. * use of a stable dose of daily inhaled corticosteroids for the prior 3 months. * female subjects of childbearing potential must have a negative pregnancy test upon study entry and at each study visit. exclusion criteria: * inability or unwillingness of a participant to give written informed consent or comply with study protocol. * hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (pcos), exogenous hormonal supplements or contraception. * any chronic lung condition outside of asthma including chronic obstructive pulmonary disease (copd), interstitial lung disease, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis. * inability or unwillingness to hold the following medications prior to mannitol and methacholine inhalational challenge(s): short-acting beta 2 agonists \>8 hours, inhaled corticosteroids and anticholinergic bronchodilators \>12 hours, phosphodiesterase inhibitors or adenosine receptors \>24 hours, long-acting beta 2 agonists \>36 hours, long-acting anticholinergics or short-acting antihistamines \>48 hours, long-acting antihistamines \>72 hours, and leukotriene-receptor antagonist or 5-lipooxygenase inhibitors \>4 days. * for males, a screening morning serum total testosterone level (obtained between 8-10 am) below the normal reference lab value. * current pregnancy, breast-feeding, or plans to become pregnant during the study period. * oral or systemic corticosteroid use or biologic agent for asthma in the previous 3 months or ed/hospitalization for asthma within 6 months. * use of investigational drugs within 12 weeks of participation. * known hypersensitivity or allergy to mannitol, gelatin or methacholine. * upper or lower respiratory tract infection within the proceeding 6 weeks. * a history of uncontrolled hypertension, coronary artery disease, stroke, epilepsy, urinary tract obstruction, untreated thyroid disease, or a chronic lung disease other than asthma. * daily use of a beta-blocker. * intolerance to anticholinergic medications. * inability to produce an adequate sputum sample. * past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
evaluation of the remineralizing and antibacterial effect of natural versus synthetic materials on deep carious dentin

Conditions: Dentin Caries

Summary: the present study will be performed to evaluate: 1. the remineralizing effect of natural materials versus synthetic materials on deep carious dentin after selective caries removal. 2. the antibacterial effect of natural materials versus synthetic materials on deep carious dentin.

this study will be conducted on 64 teeth selected from patients according to inclusion and exclusion criteria. they will be selected from the dental clinic in faculty of dental medicine, al-azhar university. the procedure will be explained and written informed consent will be obtained from each patient. the possible discomforts, risks, and benefits will be fully explained to the patients. ethical committee approval will be obtained. protocol of caries removal will be removed subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin will be then excavated, leaving the last carious affected dentin layer. sample grouping: the patients will be randomly assigned into four main groups according to the material used (16 for each) then each group will be subdivided into two subgroups (n=8) according to time of treatment (b1) after one month,(b2) after three month. a1: cavities will be treated by propolis extract then sealed directly by temporary conventional glass ionomer. a2: cavities will be treated by hesperidin then sealed directly by temporary conventional glass ionomer. a3: cavities will be treated with silver diamine fluoride then sealed directly by temporary conventional glass ionomer. a4: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment. evaluation of the microbiological effect dentine samples will be collected from the base of the cavity using sterile spoon excavator from the four groups for baseline bacteriological assessment immediately after excavation, then another sample will be taken after one month for each subgroup (b1)and three months of treatment for each subgroup (b2). evaluation of the remineralization effect each group will be assessed radiographically immediately at base line (b0), after one month (b1) and three months (b2) to evaluate the dentin remineralization.

Eligibility criteria:
inclusion criteria: * subject must have active deep carious lesion. * clinical and radiographic examinations of carious lesions. exclusion criteria: * teeth with pulpal involvement * teeth with abscess * teeth with pain or swelling * teeth with developmental disorders * teeth with adjacent soft tissue lesions * patients with systemic illness will be excluded

Keywords: remineralization carious dentin natural products antibacterial effect