Kornimate/medical-research-clean huggingface dataset:
radiation dose in humans from orally administered tc99m-heparin

Conditions: Eosinophilic Esophagitis

Summary: this is a research study of a new agent used for evaluation of inflammation in the gi tract. this agent is investigational and thus is being studied to determine appropriate dosing and administration in both normal controls (i.e. people without gastrointestinal complaints) and patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in their bodies with a certain cell called an eosinophil). the study will test whether the radiolabeled agent will bind to the inflammation of eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which shows the striking deposition of eosinophil granule proteins is not available.


Eligibility criteria:
inclusion criteria: * 10 patients with diagnosed eoe (greater than 20 eosinophils per hpf) on esophageal biopsy will be included as the diseased population * 7 controls (subjects without gi symptoms and known gi disease) exclusion criteria: * bleeding diathesis or contraindication to esophageal biopsies * severe sleep apnea * incarceration * pregnancy * inability to lie flat for 2 hours * history of bleeding disorder * use of steroids * breast feeding * allergy to heparin or history of severe reaction to heparin * allergy to mucomyst or severe asthma
evaluate the safety and effect of thiscart19a in patients with aids related b cell lymphoma/lympholeukemia

Conditions: AIDS Related Lymphoma and Lympholeukemia

Summary: this is an open label, phase i study to assess the safety and efficacy of thiscart19a in patients with aids related b cell lymphoma/lympholeukemia.


Eligibility criteria:
inclusion criteria: * age 18-65. * patients with aids-associated b-cell lymphoma/leukemia, including but not limited to diffuse large b-cell lymphoma (dlbcl), follicular lymphoma tranferring to dlbcl, mantle cell lymphoma (mcl), follicular lymphoma 3b (fl-3b), original mediastinal (thymus) large b-cell lymphoma, high-grade b-cell lymphoma and leukemia. * at least received first line treatment. * had available evaluation lesion. * ecog(eastern cooperative oncology group) ≤ 1 or karnofsky ≥ 60%. * had good organic function within 4 weeks before enrollment: alanine aminotransferase(alt)≤5×uln(upper limit of normal) and total bilirubin(tbil)\ 30 ml/min/1.73 m2. * confirmed cluster of differentiation(cd)19 positive by biopsy for the patients who received cd19 target therapy before. * confirmed human immunodeficiency virus(hiv)-1 infection. * hiv virus loading \< 200 copy/ml within 4 weeks before screening. * cd4+t cell counts \>50 cells/mm3 within 4 weeks before screening. * patients with tbil≤ 1.5 mg/dl, aspartate aminotransferase(ast) and alt ≤ 3×uln, and hepatitis b virus(hbv) dna \<2000 iu/ml can be enrolled for hbv positive patients(defined as hepatitis b virus surface antigen(hbsag) positive and hepatitis b core(hbc)-total positive ) and hepatitis c virus(hcv) positive patients(defined as hcv antibody positive) . patients with cirrhosis are excluded. * hepatitis b core antibody(hbcab) positive patients enrolled in this trial have to taking anti-hbv drugs during the whole research. exclusion criteria: * known for allergic to the preconditioning measures. * uncontrollable bacterial, fungal, viral infection before enrollment. * patients with pulmonary embolism within 3 months prior enrollment. * intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases. * imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases. * receive allogeneic hematopoietic stem cell transplantation. * systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iintermittent use of topical, inhaled or intranasal steroids recently or currently. or systemic disease requiring long-term use of immunosuppression drugs. * excluded the patients received influenza vaccinations within 2 weeks prior to lymphodepletion (received severe acute respiratory syndrome-corona virus disease(sars-cov)19 vaccines could be included. received inactivated, live/non-live adjuvant vaccines could be enrolled). * excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. male subjects planning pregnancy within 1 year after infusion should be excluded.
diagnostic efficacy of eus-fna/b versus ercp with or without pocs-tb in patients with suspected hilar cholangiocarcinoma

Conditions: Klatskin Tumor; Cholangiocarcinoma; Biopsy, Fine-Needle; Endoscopic Retrograde Cholangiopancreatography

Summary: this is an observational study with a prospective cohort design. this study enrolled patients with suspected hilar cholangiocarcinoma on imaging. this study aims to evaluate the histopathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle aspiration/biopsy (eus-fna/b) and endoscopic retrograde cholangiopancreatography (ercp) with or without peroral cholangioscopy targeted biopsy (pocs-tb) in patients with suspected hilar cholangiocarcinoma. in addition, the incidence of complications was compared between the eus-fna/b and ercp with or without pocs-tb. the impact of the histopathological diagnosis on survival outcomes in patients with suspected hilar cholangiocarcinoma was evaluated.


Eligibility criteria:
inclusion criteria: 1. 18-90 years old; 2. newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination exclusion criteria: 1. patients with a definite diagnosis of cholangiocarcinoma by imaging (enhanced ct, mri, or mrcp) and surgical candidacy within 3 months; 2. patients scheduled for liver transplantation; 3. patients with previous gastroduodenal diversion or biliary surgery; 4. patients with hilar bile duct stenosis caused by tumor or lesion outside the bile duct; 5. pregnant or lactating women; 6. patients who cannot tolerate intravenous general anesthesia due to various reasons; 7. patients with severe coagulation dysfunction, or patients who cannot stop antiplatelet/anticoagulant therapy for a short time and are unsuitable for low molecular weight heparin replacement therapy; 8. patients who refused to sign informed consent.
infasurfaero™ versus sham treatment in preterm newborns with rds

Conditions: Respiratory Distress Syndrome (Neonatal); Intubation Complication; Death; Neonatal

Summary: the purpose of this clinical study is to determine the effectiveness and safety of infasurf® administered through the infasurfaero™, a novel oral airway delivery device specifically designed to give infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

this single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with rds stable on non-invasive nasal respiratory support. enrolled clinical study subjects will be randomly allocated to receive respiratory air with infasurf® (intervention arm) or respiratory air alone (sham control arm) through the infasurfaero™. the objectives of this clinical study are to i) assess the effectiveness of a single dose of infasurf administered through the infasurfaero in preventing cpap failure, and ii) assess the safety of infasurf administered through the infasurfaero. subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

Eligibility criteria:
inclusion criteria: inclusion criteria include all of the following: 1. written informed consent obtained by parent or legal representative prior to or after birth 2. gestational age at birth ≥ 29 0/7 and ≤ 35 6/7 weeks 3. birthweight ≥ 1,000 and ≤ 3,500 grams 4. age ≥ 1 hour and ≤ 6 hours 5. clinical diagnosis of surfactant-deficient rds, with either i. a silverman-anderson retraction score ≥ 5 (in room air), or ii. signs of respiratory distress (tachypnea, retractions, grunting) and radiographic confirmation 6. require cpap 7. respiratory severity score (rss) ≥ 1.25 and ≤ 2.4 8. if subject is \>346/7 weeks' gestation a chest radiograph is required exclusion criteria: exclusion criteria are any of the following: 1. surfactant administration prior to randomization 2. mechanical ventilation prior to randomization 3. major congenital anomaly (suspected or confirmed) 4. abnormality of the airway (suspected or confirmed) 5. respiratory distress presumed secondary to an etiology other than rds (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) 6. apgar score \< 3 at 5 minutes of age 7. umbilical cord gas ph \ 10 8. any condition that, in the opinion of the investigator, would place the neonate at undue risk

Keywords: infasurf calfactant inhalation nebulization preterm infasurfaero respiratory distress syndrome neonatal nicu cpap intubation aerosol cpap failure
efficacy and safety of fiasp compared to insulin aspart in combination with insulin glargine and metformin in adults with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and north america. the aim of the trial is to compare fiasp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - treated with basal insulin for at least 6 months prior to screening (visit 1) - current once daily treatment with insulin nph (neutral protamine hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (su) or glinide or dpp-iv (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (agi) with unchanged dosing for at least 3 months prior to screening (visit 1). the metformin dose must be at least 1000 mg - hba1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other oad (oral antidiabetic drug) (su, glinide, ddp-iv inhibitors, agi) combination group at the screening visit (visit 1) - body mass index (bmi) equal to or below 40.0 kg/m\^2 exclusion criteria: - any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - use of glp-1 (glucagon-like peptide-1) agonists and/or tzds within the last 3 months prior to screening (visit 1) - recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure new york heart association (nyha) class iii or iv, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty
psychometric properties of the self-care assessment scale for 3-6 year old children with cerebral palsy-parent form

Conditions: Cerebral Palsy; Self Care

Summary: this study is a methodological study to develop the self-care assessment scale-parent form of children with cp aged 3-6 years and test its validity and reliability. q1. is the self-care assessment scale for 3- to 6-year-old children with cp a valid scale? q2. is the self-care assessment scale for 3- to 6-year-old children with cp a reliable scale?

this methodological research was conducted with the parents of 127 children with cerebral palsy aged 3-6 years old who were receiving education in special education and rehabilitation centers. data were collected using the child-parent information form and the self-care assessment scale for children with cp aged 3-6 years parent form (spçörs-ef). descriptive statistics, kruskal-wallis, cronbach alpha, test-retest, kaiser-meyer-olkin (kmo) test, bartlett test, explanatory factor analysis and confirmatory factor analysis were used to analyze the data. the research was conducted with the parents of children aged 3-6 years old with cerebral palsy who came to nine special education and rehabilitation centers in four provinces in western turkey to receive physical therapy between june 5 and december 5, 2023. the sample of the study was calculated by taking at least five times the total number of items in the scale (25 items\*5=125, n=125). non-probability random sampling method was used in sample selection. the research was completed with the participation of 127 parents. according to post hoc power analysis, this sample size was confirmed to be sufficient for 97% power (with a medium effect size d = 0.3 and α = 0.05 type i error). criteria for inclusion in the study; the children were between the ages of 3-6 (36-72 months), lived with their parents, and the parents were at least literate and able to speak and understand turkish. this study was conducted in accordance with the helsinki declaration and was approved by aydın adnan menderes university nursing faculty non-interventional ethics committee (date: 27.04.2023, number: 2023/350). verbal consent of the participants was obtained. written permission was obtained from the special education and rehabilitation centers where the research was conducted.

Eligibility criteria:
inclusion criteria: being between 3-6 years old (36-72 months) living with their parents exclusion criteria: be at least literate he/she was able to speak and understand turkish.
multidisciplinary therapy in the temporomandibular joint dysfunction in patients with fibromyalgia syndrome

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: the purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

design: randomized clinical trial. objective: to compare the therapeutic effects of physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome. methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. the experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. baseline demographic and clinical variables will be examined between both groups with independent student t-test for continuous data and chi-square tests of independence for categorical data. separate 2x3 model anova with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia syndrome * agreement to attend evening therapy sessions * a chief complaint of acute pain (duration \< 6 months) in the temporomandibular joint on at least one side. * the presence of joint clicking during jaw opening that was eliminated on protrusive opening. exclusion criteria: * history of recent trauma. * therapeutic co-interventions during treatment. * indication for surgical treatment of temporomandibular joint. * edentulism. * physical or mental illness that precludes attendance at therapy sessions.

Keywords: pain temporomandibular joint manual therapy physical therapy fibromyalgia syndrome
lipoaerosol© inhalation after tracheostomy

Conditions: Other Tracheostomy Complication

Summary: patients after tracheostomy represent a substantial part in the ear nose throat clinic. long-term intubated patients in intensive care units also profit from tracheostomy due to an improved respiratory toilet. however, after tracheostomy patients demonstrate shunt ventilation bypassing the sinonasal and pharyngeal system. the physiological moistening, cleaning and warming of the breathing air fail resulting in a respiratory inflammation. beside a variety of supportive medical devices no general recommendation exists at present. recently, we demonstrated the beneficial application of local phospholipids in sjoegren's syndrome and antineutrophil cytoplasmatic antibody associated sinonasal vasculitis. in the current monocentric, two-armed, double-blinded, randomized parallel group study we would like to evaluate the beneficial application of lipoaerosol© when compared with standard physiologic saline inhalation. lipoaerosol© is a licensed, tradable medical device and will be applied as part of its intended use. liposomal inhalation solution provides moistening, cleaning and warming of the upper and lower respiratory tract and supports the natural moistening film in airway irritations and diseases. blood parameter (leucocytes and c reactive protein) and tracheobronchial secretion (lymphocyte subpopulation, c reactive protein, lactate dehydrogenase, granulocyte macrophage colony stimulating factor, interferon γ, interleukins 10, 12 (p70), 13, 1β, 2, 4, 5, 6, 7, 8, tumor necrosis factor α) will be collected 1, 3, and 10 days after tracheostomy. in addition, medical examination records the number of suction maneuver (0 points: none; 1 point: 5-10x/d; 2 points: 10-20x/d; 3 points: \>20x/d), flexible-optical assessment of tracheo-bronchial redness (0 point: none; 1 point: peristomal; 2 points: tracheal; 3 points: tracheo-bronchial) and flexible-optical assessment of mucous congestion (0 point: none; 1 point: fluent; 2 points: tenacious; 3 points: barky). subjective estimation of the respiratory impairment will be analyzed via visual analogue scale (subjective overall impairment, coughing frequency, breathlessness, mucous congestion, color of sputum, consistency of sputum). the study is designed without any additional invasive or incriminating clinical examination. aim of the study is to maintain the functional integrity of the tracheo-bronchial system after tracheostomy using lipoaerosol© resulting in a general therapeutic recommendation.


Eligibility criteria:
inclusion criteria: * patients ≤24h after tracheostomy and regular patient's consent exclusion criteria: * no regular patient's consent * known allergy for ingredients * patients \>24h after tracheostomy * patients with acute or imminent sepsis * patients with existing bronchopulmonary inflammation * patients with immunosuppressive therapy * patients with poorly adjusted pulmonary disease * patients with chronic respiratory insufficiency

Keywords: tracheostomy inflammation mucous congestion inhalation therapy phospholipids
magnetic resonance imaging in evaluating response to radiationtherapy in patients with high grade glioma

Conditions: Brain Tumor

Summary: rationale: diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. purpose: this clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.

detailed descriptionobjectives: i. to develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional mri, mr diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model. ii. to assess treatment response to tumor and normal tissue changes. outline: patients undergo multimodality mri imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.

Eligibility criteria:
inclusion criteria: * patients being treated for diagnosed with high grade glioma (who grade iii or iv) at the university of pennsylvania medical center who will be undergoing radiation therapy to the brain * patient or legal representative able to provide written informed consent * adult males and nonpregnant females exclusion criteria: * vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants) * patients with renal failure * patients with any condition considered a contraindication to mri

Keywords: adult brain tumor
human papillomavirus and pregnancy

Conditions: HPV-infection in Pregnant Women

Summary: purpose our study involves two hypotheses. one is that genital infection with hpv is associated with increased risk of miscarriage and preterm birth. the second hypothesis is that human papillomavirus can ascend from the vagina to the uterus through the cervix and cross the placental barrier. we wish to verify these hypotheses in our studies. this study will determine the prevalence of hpv in danish pregnant women and examine hpv's role in the aetiology of spontaneous abortion and preterm birth.

background studies have shown significantly higher prevalence of hpv in tissue from miscarriages (60%) than from induced abortions (20%). hpv-infection in the extravillous trophoblasts in the placenta has furthermore been shown to induce cell death and cause dysfunction of the placenta, which can lead to adverse outcome of the pregnancy, e.g. preterm birth and hereby related neonatal mortality and morbidity. spontaneous abortion and preterm birth are adverse events of the pregnancy, with for the biggest part unknown aetilogy, an area worth trying to elucidate by means of research. method 6 groups of each 91 women will be included: * a group of early pregnant women at the nuchal translucency scan around gestational week 12 and a similar group undergoing chorion villous sampling in relation to prenatal diagnostics of the fetus * a group of women with spontaneous abortion before gestational week 22 and a group with preterm birth gestational week 22-32 * a group delivering spontaneously at term and a group undergoing elective cesarean at term the women will be examined by cervical swab to analyze for and do a genotyping of hpv if present. a vaginal swab will be done for the purpose of vaginal microbiome examination later. furthermore analysis for hpv in placental tissue from chorion villous sampling or evacuation of the uterus after miscarriage. cervical swabs and placental tissue will be analyzed by means of pcr (polymerase chain reaction) for the 35 types of hpv most frequently found in the anogenital area. blood samples will be collected from all the patients and analyzed for hpv-antibodies.

Eligibility criteria:
inclusion criteria: * pregnant women gestational week 10-42 exclusion criteria: * vaccinated against cervical cancer