Kornimate/medical-research-clean huggingface dataset:
acceptability of human papillomavirus (hpv) vaccine in female sex workers

Conditions: Human Papillomavirus Infection

Summary: the primary objectives of this study are to determine the acceptance and potential for the effective use of hpv vaccine in the standard and a modified schedule in female sex workers. secondary objectives include ascertaining the prevalence of hpv types among female sex workers by age and sexual experience.

fsws are at higher risk of hpv infection and presumably cervical cancer, and the recently available vaccine has been shown to protect against persistent infection from these types. if this study gives evidence showing the vaccine is acceptable in preventing cervical hpv infection by types 16 and 18 in this population, then the burden of cervical cancer and cancer precursors could be drastically decreased through widespread vaccination of this target group. vaccination at the point of entry of brothel based sex work may become a requirement to lower the burden of cervical cancer among fsws and also among all other sex partners of clients of fsws. a modified schedule may prove beneficial for fsws in peru to complete the vaccine regimen.

Eligibility criteria:
inclusion criteria: * between the age of 18 and 26 years * registered female sex worker living in lima * healthy with no known immune deficiency * willing to participate in a study of hpv vaccine including a pap smear, three pregnancy tests, blood draws, and three vaccine administrations over 7 months * willing to provide informed consent exclusion criteria: * currently pregnant or planning to get pregnant in the next six months * known immune deficiency disorder * current receipt of immunosuppressive drugs * allergy to yeast or known contraindication to hpv vaccine * women who have had their cervix removed * previous hpv vaccination * current fever over 100 degrees fahrenheit

Keywords: female sex worker peru cervical infection cervical abnormality serum antibody vaccine acceptance alternative schedule viral infections human papillomavirus vaccine human papillomavirus (hpv) non inferiority
cyclosporine and combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: some cancers become resistant to chemotherapy drugs. combining cyclosporine with chemotherapy may prevent resistance to the drugs and allow the cancer cells to be killed. purpose: randomized phase ii trial to study the effectiveness of adding cyclosporine to combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.

objectives: i. evaluate whether the addition of cyclosporine (cysp) to mitoxantrone (dhad) and etoposide (vp-16) increases the response rate and duration of response in adults with refractory or relapsed acute myelogenous leukemia (aml). ii. correlate response to this treatment with the presence of p-glycoprotein (p-gp) multidrug resistance (mdr) and the degree of in vitro modulation of leukemic blasts, including cd34+ blasts. iii. correlate response with the presence of other resistance mechanisms, such as atypical mdr and non-p-gp phenotype. iv. evaluate the toxicity of this treatment in aml patients. v. study the effect of cysp on dhad and vp-16 pharmacokinetics and metabolism and, potentially, on intracellular drug accumulation. outline: randomized study. the following acronyms are used: cysp cyclosporine, nsc-290193 dhad mitoxantrone, nsc-301739 vp-16 etoposide, nsc-141540 arm i: 2-drug combination chemotherapy. dhad; vp-16. arm ii: 2-drug combination chemotherapy with drug resistance inhibition. dhad; vp-16; with cysp. projected accrual: at least 25 patients/arm will be entered over approximately 3 years.

Eligibility criteria:
disease characteristics: acute myelogenous leukemia (aml) in the following categories: refractory to initial standard therapy consisting of idarubicin/cytarabine and amsacrin/cytarabine (on protocol hovon 29) first or subsequent relapse following complete response to standard chemotherapy (on protocols hovon 4/4a or 11 or any other protocol) at least 6 months between mitoxantrone/etoposide and relapse no myelodysplasia patient characteristics: age: 18 and over performance status: not specified hematopoietic: not applicable hepatic: bilirubin no greater than 2 x normal alkaline phosphatase no greater than 2 x normal renal: creatinine no greater than 1.7 mg/dl (150 micromoles/liter) or creatinine clearance at least 60 ml/min cardiovascular: no uncontrolled hypertension no other severe cardiac disease pulmonary: no severe pulmonary disease other: no known intolerance to any study drug no uncontrolled severe infection not hiv seropositive no severe neurologic or metabolic disease no concomitant malignancy except: nonmelanomatous skin cancer in situ cervical carcinoma no pregnant women prior concurrent therapy: see disease characteristics

Keywords: recurrent adult acute myeloid leukemia
augmentative and alternative communication (aac) and lexical gain in children with down syndrome

Conditions: Down Syndrome

Summary: children with down syndrome (ds) have language development particularities that have negative effects in the communication capacity. by this way, augmentative and alternative communication (aac) is indicated to this population. the aim of this study was to verify the aac impact in the lexical gain of children with ds.

five children with ds, with the same cognitive level, participated in this study. longitudinal follow-up of twelve months of speech-language therapy with aac use was undertaken. a lexical evaluation was done at the beginning and the end of this follow-up. correct responses in the lexical evaluation were increased, but not necessarily in the spoken modality. the comparisons showed significant results in use of substitutions processes, and to no-answers.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of down syndrome * be at the preoperational period * good health conditions * expressive language impairment (communication by vocal and gestures, predominantly) exclusion criteria: * presence of major malformations * presence of another genetic syndrome * severe neonatal asphyxia, hearing impairment or visual

Keywords: down syndrome communication aids for disabled language development disorders vocabulary gestures language tests child
effect of antineoplaston therapy on the qt/qtc interval in subjects with diffuse, intrinsic, brainstem glioma

Conditions: Brain Stem Glioma

Summary: the primary objective of this protocol study is to investigate the effect of antineoplaston therapy on the qt/qtc interval in study subjects age 3 to 21 years with newly-diagnosed, diffuse, intrinsic brainstem glioma. this investigation is to be conducted in parallel with a phase 3 efficacy and safety study of combination antineoplaston therapy + radiation vs. radiation alone (bri-bt-52).

qt/qtc interval prolongation is investigated during the first two weeks of subject participation in the parallel phase 3 study. the pre-cordial leads and lead ii will be utilized to determine qt/qtc prolongation. descriptive information is provided on changes in t and u wave morphologies. the percentage of subjects in each therapy group who have worsening of the t and u wave morphology is documented. discrete u waves are excluded from the qt/qtc interval measurement. except for the pre-therapy ecgs, all ecgs are performed during one anp therapy infusion daily, that being an afternoon infusion to account for diurnal variation in the qt/qtc interval. the study subject is at rest in the supine position for 30 minutes prior to the ecg study. the baseline qtc is derived from 3 ecgs taken on day 1 during the hour preceding the first antineoplaston therapy infusion or the first radiation session.

Eligibility criteria:
inclusion criteria: * enrolled in bri-bt-52 exclusion criteria: * not enrolled in bri-bt-52

Keywords: diffuse, intrinsic brain stem glioma qt/qtc interval radiation antineoplaston therapy
community-based cervical cancer prevention and education among women living with hiv

Conditions: Cervical Cancer

Summary: the long-term goal is to build a sustainable, community-based outreach program to promote cervical cancer screening among women living with hiv (wlh), thereby reducing related morbidity and mortality. the strategy for achieving this goal is to develop an intervention incorporating health literacy approaches and principles of community-based participatory research. health literacy is a relatively new concept that has been applied mainly toward identifying high-risk individuals rather than toward changing health behaviors and outcomes. the proposed intervention is the first to integrate health literacy into educating wlh to promote cervical cancer screening. community health workers (chw) support has also rarely been incorporated into cancer screening interventions targeting wlh, making the proposed intervention a uniquely comprehensive approach. building on recent successful testing by the investigators of a health literacy-focused intervention to promote cervical cancer screening in recent immigrant women, the investigators will test whether health literacy-focused interventions delivered by trained chws will be effective in promoting health literacy and increasing pap test rates in a new population, wlh. the investigators hypothesize that, compared to wlh in the control group, wlh who receive the health literacy-focused chw intervention will demonstrate: (1) higher rates of pap test, (2) greater levels of health literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.


Eligibility criteria:
inclusion criteria: * hiv infection able to read and write english 12+ months since pap test willing to provide written consent to allow the team to audit medical records for pap test use exclusion criteria: * had undergone a hysterectomy pregnant
anodal transcranial direct current stimulation and cognition in stroke

Conditions: Stroke

Summary: pervious literature shows the effects of tdcs and rehacom on cognition in chronic stage of stroke and only short-term effects were seen, but detailed evidence-based study on cognition in subacute and acute stages of stroke is spare and there is limited number of studies are available on effects of tdcs in cognition in both acute and subacute stages of stroke. some polite studies were done in acute stage of stroke and only short-term effects of tdcs were evaluated along with other outcome measures including upper and lower limb motor recovery, balance and improving activity of daily living. the long-term effects of transcranial direct stimulation only for the improvement of cognition in subacute stage of stroke are yet to be seen. this study will help us in evaluating the long-term effects of atdcs and rehacom cognitive therapy on cognition in subacute stage of stroke.

previous literature showed that, the brain has a capacity to recover the loss that comes after brain damage within subacute stage, as in this stage there is high excitation-inhibition phenomena in neural circuit, this excitation-inhibition spectacles may reflect to upsurge the activity of neurotransmitter concentration within cortex that put subtle effect for developing neural plasticity. more innovative therapies are used worldwide in patient's cognitive rehabilitation after stroke, for cognitive training including physical movement, paper-and-pencil activities, manipulatives training programs or other aids such as playing cards or a combination of multiple training, along with transcranial direct current stimulation (tdcs) and rehacom cognitive therapy which shows significant effects with (p \< 0.05) in acute and chronic stages of stroke. most of the studies used a different type of therapy in therapeutic protocols for other functional improvement including motor recovery exercises for both upper and lower limb balance training, postural stability exercises, manipulative training programs with significant improvement (p \< 0.05) in real time (tdcs)

Eligibility criteria:
inclusion criteria: * first ischemic stroke of frontal cortex * subacute stroke * age 40-60 years of both genders * individual with 10 years formal education * mmse score between 19 and 24 * moca score is minimum10 * fim score between 84 and 99 * beck depression inventory ranged between 0 and 10 exclusion criteria: * hearing and visual loss/ deficit * recurrent cva * neurological condition affects the cognition * receiving the drugs affect the cognition like anti-depressant, anti-epileptics etc * wound at skull * presence of shunt * brain tumors
effect of yogurt added with bifidobacteria and soluble fiber on bowel function.

Conditions: Inflammatory Bowel Diseases

Summary: the aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. a product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

the use of probiotics and prebiotics has become popular in human nutrition and food product development. the most common probiotics are lactobacillus and bifidobacterium species. bifidobacteria spp are dominant in the intestinal microflora and are considered to be beneficial to the host, for this reason research efforts have focused on increasing their proportion in the intestinal microflora through oral administration of mixtures containing bifidobacteria or oral supplementation with prebiotics. an important limitation for the effectiveness of oral probiotics is that they might be destroyed during digestion in the gastrointestinal tract therefore and adequate vehicle could improve its potential benefits. yogurt is a suitable vehicle for the administration of bifidobacteria, due to its physicochemical properties, such as ph and nutrients content, as well as the organoleptic properties that contribute to its increasing consumption. thus simultaneous administration of probiotics and prebiotics in a suitable vehicle could act synergistically and may have potential for improving gut health. few clinical trials have been performed using prebiotics and probiotics. the aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. a product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.

Eligibility criteria:
inclusion criteria: * age between 18 and 55 years, * be free of known gastrointestinal diseases, * desist of consuming prebiotic and/or probiotic-containing foods or dietary supplements during the entire duration of the study, * agree to avoid any medication that produced changes in gastrointestinal function, diarrhea or constipation until completion of the study, * be willing to complete all necessary study questionnaires, * accept voluntary participation and sign a written informed consent before inclusion in the study. exclusion criteria: * subjects receiving any kind of treatment that may had altered bowel function; * intake of laxatives, * a concomitant sever gastrointestinal disease; * that were consuming probiotics and/or prebiotics-containing foods or dietary supplements within the two previous weeks; * subjects were also excluded if they had received any antimicrobial medication during the previous 2 months.

Keywords: bowel function functional foods
impact of bmi on cdk4/6 inhibitors efficacy and safety in advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: exploring the impact of body mass index on the efficacy and safety of cdk4/6 inhibitors combined with endocrine therapy in advanced breast cancer.

body mass index (bmi) is strongly associated with the development and progression of breast cancer. despite the widespread use of cyclin-dependent kinase (cdk) 4/6 inhibitors combined with endocrine therapy (et) in hormone receptor (hr)-positive advanced breast cancer, the effect of bmi on therapeutic outcomes remains poorly understood. here, we present real-world evidence to substantiate the association between bmi and cdk4/6 inhibitors efficacy and safety.

Eligibility criteria:
inclusion criteria: * 18 years of age and above; * women of any menstrual status; * histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage iv or locally advanced inoperable; * patients with histological pathology that is clearly hr-positive/her2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (those with er intensity \>1% cellular nuclear staining) * patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record. exclusion criteria: * cdk4/6 inhibitors as neoadjuvant or adjuvant therapy; * significantly missing diagnostic and treatment data from patients' medical records; * participation in other clinical trials before and during the data collection period.

Keywords: bmi cdk4/6 inhibitors
study of glycerol phenylbutyrate & sodium phenylbutyrate in phenylbutyrate naïve patients with urea cycle disorders (ucds)

Conditions: Urea Cycle Disorder

Summary: this is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of ravicti® as compared to sodium phenylbutyrate (napba) in urea cycle disorder subjects not currently or previously chronically treated with phenylacetic acid (phenylacetate; paa) prodrugs. the study design will include: 1) baseline period; 2) initial treatment period; 3) a ravicti only transition period 4) a ravicti only maintenance period; and 5) a ravicti only safety extension period. the study will run for approximately 25 weeks.

study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * signed informed consent given by the subject or the subject's parent/legal guardian for those under 18 years of age or the age of consent by local regulation. * male and female subjects with a suspected or confirmed ucd diagnosis of any subtype, except n-acetylglutamate synthetase (nags) deficiency. * suspected diagnosis is defined as having experienced a hyperammonemic crisis (hac) or a documented high ammonia of \>=100 µmol/l * confirmed diagnosis is determined via enzymatic, biochemical, or genetic testing. * requires nitrogen-binding agents according to the judgment of the investigator * birth and older. * all females of childbearing potential and all sexually active males must agree to use an acceptable method of contraception from signing the informed consent throughout the study and for 30 days after the last dose of study drug. acceptable forms of contraception are (oral, injected, implanted or transdermal), tubal ligation, intrauterine device, hysterectomy, vasectomy, or double barrier methods. abstinence is an acceptable form of birth control, though appropriate contraception must be used if the subject becomes sexually active. exclusion criteria: * subject has received chronic treatment with an oral phenylbutyrate (ravicti, napba, pheburane, or other) longer than 14 consecutive days within one year prior to enrollment. * temporary use of napba for acute management of a hyperammonemic crisis in the past is acceptable. * any concomitant illness (e.g., malabsorption or clinically significant liver or bowel disease) which would preclude the subject's safe participation, as judged by the investigator. * has undergone liver transplantation, including hepatocellular transplant. * subjects on sodium benzoate (nabz) at baseline will be excluded if they are viewed by the investigator as being unable to undergo nabz transition to a paa prodrug during the initial treatment period. * known hypersensitivity to phenylbutyric acid (pba) or any excipients of the napba/pba formulations. * pregnant or breast-feeding patients. women of childbearing potential must have a pregnancy test performed at the baseline visit prior to the start of study drug.

Keywords: urea hyperammonemic crisis (hac)
first human dose trial of nnc0215-0384 in subjects with rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of nnc0215-0384 in subjects with active rheumatoid arthritis (ra) on background methotrexate (mtx) treatment.


Eligibility criteria:
inclusion criteria: * active ra, characterised by a das28 (crp)(disease activity score based on 28 joints and crp) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening * concomitant treatment with mtx (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing exclusion criteria: * subjects with chronic inflammatory autoimmune disease other than ra * history of or current inflammatory joint disease other than ra such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or lyme disease * any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation * clinically significant cardiac or cardiovascular disease * past or current malignancy * latent or active tuberculosis (tb) as documented by: a positive quantiferon® test (test can be performed up to 2 months prior to dosing). one retest is allowed in case of inconclusive results.- a history of active tb within the last 3 years even, if treated effectively. - a history of active tb more than 3 years ago, if there is no documentation that the prior anti-tb treatment was appropriate in duration and type
school-based intervention to address climate change emotions

Conditions: Eco-anxiety

Summary: the goal of this study was to qualitatively document the social validity of an intervention combining creative arts and philosophy inquiry and to examine its acceptability, the perceived goals, and perceived benefits for children's mental health and ability to cope with climate change from the perspective of one elemetary-school class students and their teacher. the guiding research question was: how do children and their teacher perceive the acceptability, the goals and the benefits of the intervention? the participants were asked to participate in a seven-week creative arts and philosophical inquiry intervention. once a week, a research assistant led a workshop using creative arts and group philosophical inquiry to discuss the topic of climate change and the emotions that can arise. students participated in a brief individual interview after the intervention. the teacher also participated in an individual online interview.


Eligibility criteria:
inclusion criteria: * elementary school students between the ages of 8 and 12 years old who's teacher accepted to participate in the study * elementary school teacher

Keywords: eco-anxiety in children creative arts intervention philosophical inquiry intervention school-based intervention