Kornimate/medical-research-clean huggingface dataset:
valid biomarkers in blood to predict the response to therapy in prostate cancer patients

Conditions: Prostate Cancer

Summary: participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry. in all patients, 12 ml of blood sample will be collected in edta tube for analysis of biological biomarkers in different time points.

participants to the study will be assigned to 5 cohorts according to the stage of disease and planned antitumor treatment at time of study entry. group 0 (set-up): blood sampling and rectal swab will be collected at a single time-point during the pc treatment. no follow-up is required. group 1a (control): the first blood sampling will be performed within 4 weeks since the negative biopsy; subsequent samplings will be done according to a schedule comparable to that of group 1 up to 1 year or evidence of tumor, whichever occurs first. group 1, group 2 and group 3: the first blood sampling will be performed before radical treatment or ht start or ct start, on the basis of the planned antitumor therapy; subsequent sampling will be done after radical intervention at 4 weeks (only for group 1) and then every 3 months (or more frequently if clinically indicated), up to 3 years or evidence of tumor recurrence/progression (radiological or biochemical), whichever occurs first. at the time of recurrence/progression, patients of group 1 could become part and could be followed as per group 2, and patients of group 2 could become part and could be followed as per group 3.

Eligibility criteria:
inclusion criteria: general inclusion criteria (for entering all groups) * age ≥ 18 years * histological diagnosis of prostate adenocarcinoma at different stages of disease (see section 6.2) for which a treatment is indicated * written informed consent inclusion criterion only for entering group 0 • patients with a known diagnosis of cspc or crpc inclusion criterion only for entering group 1a • patients that underwent biopsies for a suspect of pc, but resulted negative for cancer exclusion criteria: general exclusion criteria (for entering all groups) * active infection requiring treatment * decrease of general condition * concomitant severe comorbities * difficult socioeconomic conditions making regular follow up unfeasible. * need of concomitant steroids at study entry and during the study * diagnosis of second tumor in the previous 5 years exclusion criterion only for entering group 0 • no antibiotic treatments in the previous 2 months before enrollment exclusion criteria only for entering group 1 * previous radical surgery and / or radical radiotherapy * previous hormonal treatments exclusion criteria only for entering group 2 * no antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics) * previous hormonal treatments for advanced disease exclusion criterion only for entering group 3 • no antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)
stigma, self-management, & quality of life in scd

Conditions: Sickle Cell Disease; Quality of Life; Stigma, Social; Disease Self-Management

Summary: many individuals with sickle cell disease experience both a poor quality of life and stigma. individuals with scd often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. the purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in scd in the united states and jamaica. the findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve scd self-management.

the goal of the proposed study is to explore the complex relationships between perceived stigma, demographic and clinical characteristics, sickle cell disease (scd) self-management strategies, and quality of life (qol) in adults with scd in the united states (us) and jamaica, countries with important differences relevant to this study. proposed is a cross sectional study that will use a convergent parallel mixed methods design (individual interviews and self-report surveys). participants will be interviewed about scd self-management strategies and how sources of stigma influence these strategies. quantitative measures will be used to assess perceived stigma \[scd health-related stigma scale (scd-hrss)\] and qol \[adult sickle cell quality of life measures (ascq-me): emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity\]. the primary outcome of the study is stigma and the secondary outcome is qol(emotional impact, pain episodes, pain impact, sleep impact, social functioning impact, and stiffness impact; disease severity). the specific aims of this study are to: aim 1: determine the influences of perceived stigma and demographic and clinical characteristics on scd self-management and qol in adults with scd in the us and jamaica. question 1: what are the influences of perceived stigma and demographic and clinical characteristics on scd self-management? question 2: what are the influences of perceived stigma and demographic and clinical characteristics on qol? aim 2: describe the relationship between scd self-management strategies and qol.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age, 2. ability to understand english, 3. diagnosis of scd based on one of the following genotypes (icd-10-cm code): hbss (d57.0-d57.02), hbsc (d57.2-57.21), hb ss/bthalassemia+ or hb ss/a-thalassemia- (d57.1, d57.4-d57.41, d57.8-d57.819).
the interrelation of the vasculature, endothelium, bone metabolism and uremic toxins in peritoneal dialysis

Conditions: Chronic Kidney Disease

Summary: despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. as in the normal population, the majority of deaths are related to cardiovascular disease. mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. this relation is present from early stages of chronic kidney disease on. several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. in peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking. the investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients


Eligibility criteria:
inclusion criteria: * age \> 18 * maintenance peritoneal dialysis exclusion criteria: * no informed consent * peritonitis

Keywords: peritoneal dialysis endothelium endothelial dysfunction
multimodal assessment of knee conditions

Conditions: Osteoarthritis; Injury of Anterior Cruciate Ligament; Knee Injuries and Disorders

Summary: the purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.


Eligibility criteria:
inclusion criteria: * age 45 - 65 exclusion criteria: * rheumatoid arthritis * weight over 110 kg * previous total knee replacement surgery * contraindications to mri
antibody based tests for sarscov-2 covid-19) - evaluation of patients and healthcare providers in the confines of healthcare settings

Conditions: Covid19

Summary: this study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry sars-cov-2 antibodies.

this study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry sars-cov-2 antibodies. the blood test data will be collected as allowed by the eua using the coronacidetm covid-19 igm/igg rapid test and the premier biotech covid-19 igm/igg rapid test. both covid-19 igm/igg rapid tests are intended for over-the-counter/professional use as a screening aid in the diagnosis of primary and secondary sarscov-2 infections, and are only for use under the fda's eua. the rna test data will be collected via a nasopharyngeal swab and processed using the abbott id now covid-19 diagnostic test.

Eligibility criteria:
inclusion criteria: * patient is under the care of texas cardiac arrhythmia, and presenting to the hospital or presenting to a clinic conducted by texas cardiac arrhythmia or * an employee of texas cardiac arrhythmia or * an employee or healthcare professional working with patients receiving cardiac electrophysiology care at a hospital. or a professional first responder to include emergency medical services (ems), police or fire departments. exclusion criteria: * any person who refuses to undergo study procedures
emotional regulation in individuals with autism

Conditions: Autism; Autism Spectrum Disorder

Summary: the objective of the study is to learn about and manage emotions such as anxiety and anger. the activities are aimed at identifying and managing emotions such as anxiety and anger, through the recognition of the changes that occur at a physiological, cognitive, behavioral and communicative level. in the first sessions, children will be exposed to the emotion of happiness through pleasant activities and involved in relaxation exercises. in subsequent sessions, anger and then anxiety will be addressed first. social tools will be introduced and ways of thinking and perspective useful to children will be addressed. furthermore, they will learn to use all the tools and strategies necessary to face and overcome the various emotions and situations in a functional manner. in the final sessions, children will work to design a cognitive-behavioral intervention program for themselves and other group members to improve the management of anxiety and anger. the expected results concern the acquisition of adequate emotional regulation; the construction of functional thoughts, social tools, thinking and perspective tools, adequate strategies for managing emotions; the design of a cognitive-behavioral intervention program in daily life and the strengthening of relational, social, empathic and resilient skills within the peer group and families.


Eligibility criteria:
inclusion criteria: * proven diagnosis of autism; * qs ≥ 75; exclusion criteria: * presence of other medical disorders

Keywords: autism children emotional regulation anxiety
hypocaloric vs. full energy enteral feeding in critically ill patients

Conditions: Enteral Feeding

Summary: underfeeding in the critically ill patient is a common observable fact throughout intensive care units. patients who develop caloric deficit during their stay in the icu have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.

therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.

Eligibility criteria:
inclusion criteria: * anticipated mechanical ventilation for at least 72 hrs. * need for enteral feeding * men and woman aged 18 or older. exclusion criteria: * abdominal surgery with inability to feed enterally. * fio2 greater than 80% * bronchopleural fistula * hemodynamic instability in spite the use of vassopressors.

Keywords: indirect calorimetry hypocaloric feeding
structural and functional repercussions of pulmonary tuberculosis sequelae

Conditions: Pulmonary Tuberculosis

Summary: the study assesses patients with cured pulmonary tuberculosis by compulsory notification data of uberlândia (minas gerais state - brazil) from 2012, 2013, 2014 and 2015. these patients will be invited by telephonic contact. after eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

this study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

Eligibility criteria:
inclusion criteria: * pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment); * treatment finalized at least one year before. exclusion criteria: * physically impaired to perform the functional tests; * coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis); * pregnants.
combination paclitaxel, carboplatin and temozolomide

Conditions: Lung Diseases; Cancer

Summary: the purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.

the objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).

Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years 2. karnofsky performance status (kps) of greater than or equal to 70 (appendix b) 3. laboratory values (performed within 14 days prior to study drug administration, inclusive). 1. absolute neutrophil count (anc) \>1500/mm3 2. platelet count \>100,000/mm3 3. hemoglobin \>10 g/dl or 100 g/l 4. bun and serum creatinine \<1.5 times upper limit of laboratory normal 5. total and direct bilirubin \<1.5 times upper limit of laboratory normal 6. sgot and sgpt \<3 times upper limit of laboratory normal 7. alkaline phosphatase \<3 times upper limit of laboratory normal 4. a life expectancy of greater than 12 weeks 5. subjects must give written informed consent. 6. biopsy proven small cell lung cancer. 7. ct of chest, abdomen, pelvis and mri of head 8. patients with brain metastases should be asymptomatic to enter the study exclusion criteria: 1. no recovery from all active toxicities of prior therapies. 2. subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics. 3. frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). 4. concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible. 5. known hiv positivity or aids-related illness. 6. pregnant or nursing women. 7. women of childbearing potential who are not using an effective method of contraception. women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions. 8. men who are not advised to use an effective method of contraception. 9. progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination. 10. known hypersensitivity reaction to taxoid or platinum compound.

Keywords: extensive or recurrent small cell lung cancer phase i paclitaxel, carboplatin, temozolomide
treatment of anal fissure by activated human macrophages

Conditions: Biological Therapy for Chronic Anal Fissure; Treatment by Biological Factors - Activated Macrophages; Interventional Study

Summary: chronic anal fissure is a linear tear in the distal anal canal. most chronic fissures require intervention to heal. surgical sphincterotomy is currently performed. however, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. current topical treatment or " chemical sphincterotomy" is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in israel without any side effect.macrophages have key function in almost every stage of wound healing. they help in the digestion of bacteria, in a later stage, they secret il-6, which influences endothelial cell proliferation and the initiation of angiogenesis. the study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.


Eligibility criteria:
inclusion criteria: * consecutive symptomatic adults with chronic idiopathic anal fissure exclusion criteria: * pregnant women * acute fissures * anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease) * immunosuppressed patients
survival outcome of egfr-tki in uncommon egfr mutant advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this study aims to explore survival outcome of egfr-tki in uncommon egfr mutant advanced non-small cell lung cancer in china

inclusion criteria uncommon egfr mutant advanced non-small cell lung cancer egfr g719x, exon 20 insert mutation without any anti-cancer treatment history

Eligibility criteria:
inclusion criteria: * 18，advanced non-squamous non-small cell lung cancer confirmed by histopathology * uncommon egfr mutant advanced nsclc exclusion criteria: * patients with contraindication of chemotherapy * pregnant or breast feeding women
rapid maxillary expansion for residual pediatric

Conditions: Obstructive Sleep Apnea

Summary: randomized controlled trial comparing rapid maxillary expansion with standard clinical practice in patients with residual pediatric obstructive sleep apnea syndrome after adenotonsillectomy.

cure rate of pediatric obstructive sleep apnea syndrome (osas) after gold-standard-treatment adenotonsillectomy is 50-80%. treatment alternatives are scarce, poorly effective and based upon low scientific evidence. this means one out of five patients will remain exposed to the well-known neurocognitive, behavioral and quality of life adverse effects of disease. rapid maxillary expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion, has recently shown promising results in the treatment of pediatric osas based upon its effect on craniofacial and upper airway growth, usually limited in these patients. the investigators propose a randomized, prospective, controlled trial in patients with pediatric osas non-responding to adenotonsillectomy. the aim of the study is to enhance the treatment success rate avoiding morbimortality associated to disease persistence during childhood and development during adult life.

Eligibility criteria:
inclusion criteria: * children (boys and girls) between 4 and 9 years of age. * residual osas after adenotonsillectomy (described as an apnea hypopnea index over 3 objectively measured by means of polysomnography). * rapid maxillary expansion indication. * parents or tutors sign informed consent. exclusion criteria: * craniofacial syndromes or neurologic disease diagnosis. * adenoid residual hypertrophy occluding \>50% nasal airway as measured by means of nasal flexible fiberoptic endoscopy and or tonsillar residual hypertrophy \>2 as measured by direct intraoral physical exam.
surgical extrusion: volumetric and insertion analysis at 6 months.

Conditions: Tooth Extruded; Tooth Extrusion; Tooth Avulsion; Tooth Fracture

Summary: the aim is to clinically evaluate the changes that occur in teeth that have undergone surgical extrusion treatment. three parameters will be recorded before and 6 months after treatment: the position and the volume of the soft tissue, and the level of periodontal attachment.

after informing the patient and obtaining his or her consent to surgical extrusion treatment, a model of the pre-treatment situation will be obtained by intraoral scanning and the attachment levels will be recorded by periodontal probing at 6 points around the tooth. the dimensional and positional changes of the soft tissue will be analyzed by superimposing both digital impressions in each patient. in the same way, periodontal attachment levels before and 6 months after treatment will be compared. the data will be analyzed statistically and conclusions will be drawn regarding the surgical extrusion treatment.

Eligibility criteria:
inclusion criteria: * tooth with a subgingival residual dentine margin. * patients refusing tooth extraction and dental implant placement as first choice. exclusion criteria: * patients in whom surgical intervention is contraindicated. * teeth with vertical fractures up to the apex. * teeth with pocket depth \>4 mm in any of their walls. * failure of the treatment leading to the loss of the extruded tooth.

Keywords: surgical extrusion oral surgery tooth extrusion
different regulation of immune cells in patients with preeclampsia

Conditions: Preeclampsia; Pregnancy

Summary: adaptation of the maternal immune system to accommodate the semi-allogeneic fetus is necessary for pregnancy success. dysregulation of this immune adaptation is implicated in reproductive disorders as infertility, recurrent miscarriage, fetal growth restriction, and preeclampsia. the mechanisms being responsible for fetal tolerance are not known. several t cell subsets have been implicated in fetal tolerance. the effects of preeclampsia on memory cells are not known. the main objective of this study is to analyze the effect of preeclampsia on levels of immune cells.


Eligibility criteria:
inclusion criteria: * healthy * written informed consent * 18-40 years exclusion criteria: * smoking * immune related disorders (other than preeclampsia) * fever / illness within the last month * infertility * body mass index \ 30
outcome of tka using customized cutting block compared with conventional intramedullary cutting guide

Conditions: Knee Osteoarthritis

Summary: customized cutting block and conventional cutting guide are both effective in improving accuracy and function of oa knee patients.

customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Eligibility criteria:
inclusion criteria: * age 60-90 * diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following: * painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved; * correction of varus or valgus. * willing to participate and return for follow-up study visits. exclusion criteria: * vascular insufficiency * previous deep vein thrombosis and pulmonary embolism * previous osteotomy * previous patella fracture or surgery * previous healed tibia or femur fractures * previous joint replacement surgery

Keywords: knee osteoarthritis total knee arthroplasty customized cutting block conventional intramedullary cutting guide