Kornimate/medical-research-clean huggingface dataset:
antiretroviral activity and pharmacokinetics of deferiprone in healthy volunteers and asymptomatic hiv-infected subjects

Conditions: HIV Infection

Summary: the purpose of this study was to examine the safety, efficacy, and pharmacokinetics of different dosages of deferiprone in subjects with or without hiv infection.

three cohorts were enrolled: two of individuals who were asymptomatically infected with hiv and one of healthy volunteers. dosages were as follows: * cohort 1 (asymptomatic hiv infected subjects): 33 mg/kg deferiprone three times daily for a total of 99 mg/kg/day * cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day * cohort 3 (asymptomatic hiv infected subjects): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day

Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years and ≤ 60 years. * absolute neutrophil count (anc) of \>1000/mm3 for african black population and ≥ 1600/mm3 for all other races. * for cohort 2: hiv-negative * for cohorts 1 and 3: hiv-1 positive; cd4 count of at least 300/mm3; hiv-1 rna copies (viral load) \>10 000 copies/ml serum; and current physical health stable and not requiring antiretroviral treatment * for cohorts 1 and 3: chest x-ray showing absence of active infectious diseases (such as tuberculosis, viral or atypical bacteria or parasitic infection). exclusion criteria: * presence of any severe concomitant disease. * history of or current, recurrent or recent (4 weeks) febrile disease. * history of opportunistic infections, neoplasm or aids-defining conditions. * inability to discontinue any medication from screening onwards, or for at least 2 weeks before the first admission; in particular any antiviral or therapy with immunosuppressive activity. * significant liver impairment: aspartate aminotransferase (ast), alanine aminotransferase (alt) ≥ 2.5 times the upper normal limit. * significant kidney impairment: serum creatinine ≥ two times the upper normal limit. * any concomitant disorder or resultant therapy likely to have interfered with subject compliance or with study procedures. * known hypersensitivity to any of the test materials or related compounds. * positive test for hepatitis b and/or c antibodies. * a history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions. * history of seizures or epilepsy.

Keywords: hiv deferiprone iron chelation
sonoelastography of the supraspinatus tendon

Conditions: Elasticity Imaging Techniques; Tendinopathy; Rotator Cuff Tendinitis; Musculoskeletal Disease

Summary: this study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.

the trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in denmark. the intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals. tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline

Eligibility criteria:
inclusion criteria: * able to read and understand danish * shoulder pain \> 3 months * positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking) * tendinopathy (mri) exclusion criteria: * bmi \> 30 * bilateral shoulder pain * supraspinatus full thickness rupture (us) * biceps rupture (us) * calcification in supraspinatus (x-ray) * pregnancy * glenohumeral arthrosis (x-ray) * frozen shoulder * shoulder symptoms originating from neck * shoulder fracture, operation or luxation * known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondylarthropathy or psychiatric disorders * labrum lesion (mri) * tear (˃1/3 of supraspinatus, vertical height) (mri)
response to periodontal therapy in a chronic kidney disease population

Conditions: Chronic Kidney Disease Stage 5; Periodontal Disease

Summary: this study will evaluate periodontal and systemic parameters of a cohort of chronic kidney disease (stage 5) patients, before and three months after non-surgical periodontal treatment. it does not consider a control group.

dental biofilm is a source of inflammation and infection of periodontal tissues. in the last 20 years the interaction between periodontal infections and systemic conditions has been largely studied, suggesting that the inflammation caused in the periodontal tissues could cause a response in other parts of the body. recent studies suggest that there could be an association between periodontal disease and chronic kidney disease.

Eligibility criteria:
inclusion criteria: * chronic kidney disease patients in stage 5 (candidates to renal transplant) exclusion criteria: * younger than 18 year old.

Keywords: glomerular filtration rate periodontitis chronic kidney disease
the establishment of a survival prediction model for er positive / her-2 negative advanced breast cancer

Conditions: Breast Cancer

Summary: this project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed er + / her2 - advanced breast cancer patients and to establish a prediction model of er + / her2 - advanced breast cancer patients affecting overall survival. this project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for er-positive / her2 negative advanced breast cancer suitable for china's national conditions. according to the survival outcome predicted by the model, the newly diagnosed er positive / her2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.


Eligibility criteria:
inclusion criteria: 1. at the time of signing the informed consent form, 18 years old ≤ 70 years old, female 2. er positive breast cancer confirmed by pathology: er positive (≥ 1%) by immunohistochemistry 3. newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage iv breast cancer at the first visit 4. patients who are willing to receive follow-up treatment in the research center. exclusion criteria: 1. erbb-2 gene amplification was recorded by fish (defined as her2 / cep17 ratio ≥ 2) or chromogenic in situ hybridization (cish) or ihc (defined as ihc3 +, or ihc2 + confirmed by fish or cish) was used to record her2 positive tumors. 2. any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions 3. combined with other malignant tumors or had other malignant tumors in recent 5 years 4. patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state 5. patients with life expectancy less than 3 months

Keywords: breast cancer a survival prediction model
endoscopic vital nerve staining in gastrointestinal diseases

Conditions: Gastrointestinal Neoplasms; Abnormality of Enteric Nervous System Morphology

Summary: in this study, methylene blue (mb) was used as vital nerve staining agent. during gastroenteroscopy, mucosal nerve staining was achieved by endoscopic submucosal injection of mb solution. to observe the staining of nerve fibers, neurons and glial cells in mucosa and submucosa, as well as the morphological changes, density differences and function of mucosal nerve tissues in different gastrointestinal lesions, in order to explore the role of endoscopic vital nerve staining in the diagnosis of gastrointestinal lesions.

this study is a prospective experimental study. the baseline data of the patients were recorded objectively: sex, age, vital signs, body weight, some laboratory examination results (blood routine, liver function, blood coagulation function and electrolytes, etc.) and related medical history (comorbidities, treatment history and life history). mucosal nerve staining was achieved by endoscopic submucosal injection of methylene blue (mb) solution. the following features were identified and then compared between normal, adenoma and neoplastic mucosa on magnifying endoscopy images in vivo: nerve morphology (straight or irregular), nerve diameter, branching patterns and nerve density. immunohistochemistry was used to further confirm the presence and to study the morphology of neural structures (pgp9.5 and gfap staining) and neural attribute (vip, nnos, th, chat and som staining) on tumor, adenoma and normal mucosal sections.the aim of this study was to explore the role of mb based topical submucosal chromoendoscopy in the identification of neural architecture and special morphology in normal gastrointestinal mucosa, adenomas and malignant lesions during routine endoscopy.

Eligibility criteria:
inclusion criteria: 1. diagnosis or suspected diagnosis of one of the following common gastrointestinal diseases: chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, gastric early cancer, advanced gastric cancer; colonic polyps, colonic melanosis, early colon cancer, advanced colon cancer 2. written informed consent exclusion criteria: 1. those who are allergic to nerve dye components (such as methylene blue, etc.) 2. complicated with cardiovascular and cerebrovascular diseases, or severely impaired liver, kidney and hematopoietic system. 3. psychopath 4. there are hemorrhagic diseases 5. platelet count \< 50 × 10 \^ 9 / l 6. those who are allergic to body mass are 7. unable to tolerate or cooperate with endoscopy 8. patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction and perforation, etc. 9. pregnant or lactating women

Keywords: endoscopy gastrointestinal neoplasms enteric nervous system gastric nervous system nerve staining methylene blue
complex care for kids ontario (ccko)

Conditions: Children With Medical Complexity

Summary: there are \~6,200 children in ontario with special and complex healthcare needs requiring multiple services from many different doctors and other healthcare providers. these children are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial burden and stress on families. while small in number (\<1% of ontario kids), these children use 1/3 of all child healthcare resources, and are known to desperately need coordinated care to optimize their health. complex care kids ontario (ccko) brings together researchers, children and families, and healthcare providers from across ontario to develop, implement and evaluate an evidence-based and coordinated model of care for every child with medical complexity in ontario.


Eligibility criteria:
inclusion criteria (meets at least one criterion from each of the following four conditions): * technology dependent and/or users of high intensity care * child is dependent on mechanical ventilators, and/or requires prolonged iv administration of nutritional substances or drugs and/or is to have prolonged dependence on other device-based support. for example: tracheostomy tube care/ artificial airway, suctioning, oxygen support, or tube feeding * child has prolonged dependence on medical devices to compensate for vital bodily functions, and requires daily/ near daily nursing care, e.g., cardiorespiratory monitors; renal dialysis due to kidney failure * fragility * the child has severe and/or life-threatening condition * lack of availability and/or failure of equipment/technology or treatment places the child at immediate risk resulting in a negative health outcome * short-term changes in the child's health status (e.g., an intercurrent illness) put them at immediate serious health risk * chronicity * the child's condition is expected to last at least six more months * the child's life expectancy is less than six months * complexity * involvement of at least five healthcare practitioners/ teams and healthcare services are delivered in at least three of the following locations: home, school/nursing school, hospital, children's treatment centre, community-based clinic (e.g. doctor's office), other (at clinician's discretion) exclusion criteria: * high utilization of hospital level care * ≥ 3 hospitalizations, ≥ 2 icu admissions, ≥ 30 days of total hospitalization in previous 3 months, excluding newborn admission * patient with tracheostomy and home ventilation * medical status is deemed highly fragile and the need for close follow-up is deemed essential by both referring and triaging team * already followed by a complex care team * \>16.0 years of age * inadequate english language skills to comprehend study questionnaires

Keywords: care coordination complex care kids ontario technology-dependent quality of life
a registry to gather real world use data on the cerene® cryotherapy device

Conditions: Heavy Menstrual Bleeding; Abnormal Uterine Bleeding; Menorrhagia

Summary: channel medsystems, inc., the manufacturer of the cerene® cryotherapy device (cerene), is initiating a prospective, observational registry, the progress registry, to gather data during real world utilization of the cerene® cryotherapy device (cerene). the primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of cerene and those obtained during its real-world use.

cerene was approved by the fda in march 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. the primary objective of the progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of cerene (the clarity study) and those observed during its real-world use. the progress registry will gather prospective, observational data on up to 300 women that underwent a cerene treatment. patients and physicians will complete surveys. surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures. patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. the study will end after the last participating patient in completes her 12 month visit.

Eligibility criteria:
inclusion criteria: * scheduled for a cerene treatment * 25 years of age and older * provided informed consent to participate in the registry * english speaking * agrees to complete a survey at specified time points from baseline to 12 months exclusion criteria: * physician discretion * vulnerable populations

Keywords: cerene registry cryoablation
chocolate or sevoflurane: use of parosmia to facilitate more cooperative inhalation inductions in children

Conditions: Anesthesia; Pediatrics

Summary: children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. while less pungent than other volatile agents, sevoflurane at high concentrations and flows used for inhalation inductions still causes children to often repel from the smell. this can lead to an unpleasant interaction and cause heightened anxiety for any subsequent procedures. olfactory senses are processed in the hippocampus and amygdala and tied to emotion and memory. parosmia is the distortion of smell perception which can utilized to the pediatric anesthesiologists advantage. it has been demonstrated that using this phenomenon, the anesthesiologist can induce a better smell for the child leading to improved cooperation during an inhalation induction. however, limitations of this study include lack of randomization, small sample size, and use of a nominal scale of yes or no for face mask acceptance. the investigators identified no other studies to validate this potentially powerful tool to optimize anesthetic induction for pediatric patients. the overall objective of this pilot randomized trial is to determine the feasibility of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia.


Eligibility criteria:
inclusion criteria: * ages of 5-12 years old * american society of anesthesiologist physical status classification system (asa) i and ii * patients coming from home exclusion criteria: * patients undergoing emergent surgery * patients who have not adequately maintained preoperative nothing per mouth/os (npo) status * patients with inability to communicate verbally * tracheostomy patients * asa iii , iv, v patients
a salivary mirna diagnostic test for autism

Conditions: Autism Spectrum Disorder; Developmental Delay

Summary: the goal of this study is to validate a panel of mirnas that distinguish children with autism spectrum disorder (asd) from their non-asd peers with a positive mchat-r. these biomarkers may allow earlier diagnosis of autism, allowing earlier service, and also help us to understand some of the changes in the brains of autistic children.

the central aim of this project is to validate a panel of expressed microrna (mirna) in the saliva of children identified at risk for developing asd by the mchat-r. further, this study aims to assess the value of the current panel as an adjunctive test that may increase specificity of mchat-r positive results, or affirm clinical diagnoses alongside the ados or other objective assessments. the primary endpoints of this study are as follows: 1. evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary microtranscriptome panel for distinguishing children with asd from their non-asd peers. 2. assess stability of the salivary microtranscriptome diagnosis over time, and interrogate longitudinal microtranscriptome levels relative to neuropsychological measures. secondary endpoints are the identification of microtranscriptome features whose concentrations correlate with asd endophenotypes.

Eligibility criteria:
inclusion criteria: * age at enrollment: 24 months to 48 months (inclusive) * mchat-r score of 3 or greater * parent/guardian must be fluent in spoken english (required to complete study specific questionnaires etc) exclusion criteria: * confounding neurological (i.e. cerebral palsy, epilepsy), sensory (i.e. auditory or visual) impairments, and feeding tube dependence. * history of extreme pre-term birth (\< 32 weeks gestation) * wards of the state * autistic subjects with known syndromic autism (attributed to a known genetic mutation)

Keywords: autism asperger's syndrome microrna epigenetic biomarker
study of pemetrexed versus pemetrexed plus erlotinib as treatment of nonsquamous non-small cell lung cancer (nsclc)

Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Summary: this is a multicenter, randomized, phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (nsclc) in a second-line setting (such as progression-free survival \[pfs\], disease control rate, best response rate, time to treatment failure \[tttf\], overall survival \[os\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of locally advanced or metastatic nsclc that is of nonsquamous histology and not amenable to curative therapy. * failure of previous treatment with one prior platinum-based chemotherapy regimen. * good performance status. * adequate bone marrow reserve, renal and hepatic functions. exclusion criteria: * serious concomitant systemic disease. * inability to take oral medication. * inability or unwillingness to take vitamin supplementation and corticosteroids. * pregnancy / breast-feeding. * treatment with certain medicines that prevent blood from clotting.

Keywords: nonsquamous
detachable clip-assisted endoscopic cyanoacrylate injection in the treatment of gastric varices

Conditions: Gastric Varices Bleeding

Summary: a single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.


Eligibility criteria:
inclusion criteria: * the subject voluntarily signs the informed consent for this experiment; according to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; the endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); high risk of gastric varices or has a history of gastric varices bleeding. the initial fluid resuscitation patients before or after the recovery hemodynamic stability; the age of 18 years old or more. exclusion criteria: * \< 18 years old; regional portal hypertension; always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; a concurrent hepatorenal syndrome and/or multiple organ failure; significant impact on survival of malignant tumor; pregnancy or lactation; a known allergy to iodine.