Kornimate/medical-research-clean huggingface dataset:
managed problem solving for art adherence and hiv care retention delivered by community health workers

Conditions: HIV/AIDS

Summary: the managed problem solving (maps) behavioral intervention is an ebp for behavior change in people living with hiv (plwh). the investigators propose that maps can be delivered by trained community health workers (chws). the use of chws to deliver maps is justified by their ability to develop trusting relationships with their clients and the need for task shifting in busy clinics. in order to also address retention in care, the investigators will adapt maps to also focus on problem solving activities tailored toward retention in care (now termed maps+). chws will be located in clinics to implement maps+ to improve viral suppression and care retention in plwh. data-to-care allows for identification of people who are lost to care and link these patients back to care. currently, medication adherence and retention in hiv care are not targeted in data-to-care so the investigators will build on this approach to facilitate the identification of plwh who are out of care and not virally suppressed to offer them maps+. the set of implementation strategies include task-shifting the delivery of maps+ to chws, providing the chws training and ongoing support, and increasing communication between the chws and medical care team via standardized protocols. the investigators will conduct a hybrid type ii effectiveness-implementation trial with a stepped-wedge cluster randomized design in 12 clinics to test maps+ compared to usual care using a set of implementation strategies that will best support implementation. each clinic will be randomized to one of three implementation start times. baseline (usual care) data will be collected from each clinic for 6 months, followed by maps+ and the package of implementation strategies for 12 months, in three cohorts of 4 clinics each. aim 1 will test the effectiveness of maps+ on clinical effectiveness outcomes, including viral suppression (primary) and retention (secondary). aim 2 will examine the effect of the package of implementation strategies on reach. implementation cost will also be measured. aim 3 will apply a qualitative approach to understand processes, mechanisms, and sustainment of the implementation approach. the results will guide future efforts to implement behavioral ebps across the hiv care continuum, consistent with the "treat" pillar of ehe, and move the science of implementation services, consistent with nih strategic priorities.


Eligibility criteria:
inclusion criteria: * age 18 or older * a man or woman living with hiv * not retained in care and/or virally suppressed in year prior to trial initiation exclusion criteria: - incarcerated during the duration of the trial
g-poem for treatment of refractory gastroparesis

Conditions: Diabetic Gastroparesis; Idiopathic Gastroparesis; Gastroparesis Postoperative

Summary: this study is performed to assess the efficacy and outcomes of gastric per oral endoscopic myotomy "g-poem" in patients presenting with gastroparesis.

gastroparesis is a chronic digestive disorder best defined as severe nausea, vomiting, bloating, and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction. the most common etiology is idiopathic. some of the identifiable etiologies include diabetes and post-surgical. endoscopic techniques to reduce pyloric tone mainly consisted of botulinum toxin injection but failed to demonstrate significant symptom improvement compared to placebo. another endoscopic method was transpyloric stenting which yielded symptomatic relief but is prone to stent migration and therefore is unlikely to provide a viable long term solution. surgical pyloroplasty has shown to be effective in reducing gastroparesis symptoms, but is associated with a risk of leakage and potential further narrowing of gastric outlet. it also carried all the risks of general anesthesia and requires advanced laparoscopic suturing skills. therefore, the development of a less invasive reliable method of improving gastric emptying is highly desirable. an endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. gastric per-oral endoscopic myotomy (g-poem) is feasible and can be performed by using techniques similar to those of esophageal per-oral endoscopic myotomy. endoscopists who are experienced in esophageal per-oral endoscopic myotomy should be able to perform g-poem because both use similar techniques, principles, and equipment. the investigators theorize that a subset of patients with refractory gastroparesis, diabetic gastroparesis or post-surgical gastroparesis, may respond to endoscopic pyloromyotomy.

Eligibility criteria:
inclusion criteria: • adult patient age greater than 18 years old who are undergoing a standard-of-care g-poem procedure. exclusion criteria: * previous surgery of the esophagus or stomach which has resulted in a resection of the antrum and pylorus * known active gastroesophageal malignancy * prior surgical or laparoscopic pyloromyotomy

Keywords: gastroparesis g-poem gastric per oral endoscopic myotomy
ceritinib (ldk378) for patients whose tumors have aberrations in alk or ros1 (signature)

Conditions: Tumors With Aberrations in ALK or ROS1

Summary: the purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

this was an open label study to determine the efficacy and safety of treatment with ceritinib in patients with a diagnosis of solid tumors or hematological malignancies that had been pre-identified (prior to study consent) to have alk or ros1 positive mutations, translocations, rearrangements or amplifications and whose disease had progressed on or after standard treatment. the study consisted of a treatment phase where all patients received ceritinib capsules for a total dose of 750 mg daily for up to 8 cycles of 28 days. disease assessments for clinical benefit were performed every 8 weeks until disease progression or end of treatment. following discontinuation of treatment for any reason, patients were followed for safety for 30 days. survival information was collected every 3 months until 2 years after the last patient had enrolled into the study. study was amended to allow for discontinuation of survival period if primary endpoint was not met. study was terminated due to low enrollment.

Eligibility criteria:
inclusion criteria: * patient had a confirmed diagnosis of a select solid tumor (except alk+ nsclc) or hematological malignancy and was in need of treatment because of radiologic progression or relapse. * patient must have been pre-identified as having a tumor with an alk or ros1 positive mutation, translocation, rearrangement or amplification. the qualifying alteration must have been assessed and reported by a clia-certified laboratory. alk positivity as assessed by ihc or fish were allowed. * patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options were anticipated to result in a durable remission. * patient had progressive and measurable disease as per recist 1.1 or other appropriate hematological guidelines. * patient had an eastern cooperative oncology group (ecog) performance status ≤ 1. exclusion criteria: * patient had received prior treatment with ceritinib. * patients with symptomatic cns metastases who were neurologically unstable or required increasing doses of steroids within the 2 weeks prior to study entry to manage cns symptoms. * patient had received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-c) prior to starting study drug.

Keywords: hematological malignancy solid tumor malignancy mutation translocation rearrangement amplification alk ros1 nsclc b-cell lymphoma
investigation of acute mood and cognitive performance effects of beverages containing phenolics in healthy adults

Conditions: Cognitive Function

Summary: an acute, randomized, placebo controlled, double blinded crossover study in health subjects. participants will complete 4 intervention arms in random order consisting of a placebo control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with a fruit extract, and a low does phenolic beverage. the primary objective of the study is to assess the effects of the phenolic compounds, at two different levels, alone and in combination with a fruit extract, on mood and cognitive performance during extended periods of cognitively demanding task performance.


Eligibility criteria:
inclusion criteria: * aged 18 to 49 years * self-report of good health * are not excluded on the basis of the following exclusion criteria exclusion criteria: * are a smoker * have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff * currently take medication except the contraceptive pill * have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total) * have sleep disturbances and/or are taking sleep aid medication are employed in a job that includes night shift work * have a body mass index (bmi) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg. * have high blood pressure (systolic over 139 mm hg or diastolic over 89 mm hg) * have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety) * have a history of anxiety or a current diagnosis of anxiety or depression * are pregnant, trying to get pregnant or breast feeding * have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units) * have learning difficulties or dyslexia * have visual impairment that cannot be corrected with glasses or contact lenses * have frequent migraines that require medication (more than or equal to 1 per month) * have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis) * have a heart disorder or a history of vascular illness * have a respiratory disorder that requires regular medication (note: participants with asthma who only take their medication occasionally/as required are eligible for this study) * have a diagnosis of type i or type ii diabetes * have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation * have any health condition that would prevent fulfillment of the study requirements * are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies * have participated in the bpnrc's recent stress study * do not have a bank account (required for payment)
tr-701 fa vs. linezolid for the treatment of acute bacterial skin and skin structure infections.

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Summary: this is a randomized, double-blind, double dummy, multicenter phase 3 study of oral tr-701 fa 200 mg once daily for 6 days versus oral zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of absssi in adults. approximately 75 to 100 sites globally will participate in this study. patients with an absssi caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

the primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral tr-701 fa compared with that of 10-day oral linezolid treatment at the 48-72 hour visit in the itt analysis set in patients with absssi.

Eligibility criteria:
inclusion criteria: * patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (absssi) * diagnosed with cellulitis/ erysipelas, major cutaneous abscess, or wound infections exclusion criteria: * uncomplicated skin infections * severe sepsis or septic shock * absssi solely due to gram-negative pathogens

Keywords: absssi tedizolid phosphate tr-701 acute bacterial skin and skin structure infections
colchicine for diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. the investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.


Eligibility criteria:
inclusion criteria: 1. patients with dm aging 18+, able to sign an informed consent. 2. 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment. 3. hemoglobin a1c in the range of 6-9%, stable for the last year (0.5±) 4. creatinine lower than 1.5 mg/dl. 5. blood pressure lower than 150/90 mmhg on stable anti-hypertensive treatment for at least 3 months. 6. treated with ace \& arb, unless contraindicated exclusion criteria: 1. malignancy or significant heart, lung or liver disease. 2. any gi disease, ibd, malnutrition ( bmi under 18 ) 3. psychiatric disease 4. any muscle disease, history of rhabdomyelysis, myopathy or myositis. 5. any disease causing renal injury/proteinuria apart from dm 6. any inflammatory or autoimmune disease 7. any infection during the last month. 8. use of potentially nephrotoxic drugs. 9. woman in child bearing age that do not use at least one contraceptive device. 10. pregnant or lactating woman. 11. participation in another study during the last 3 months. 12. alcohol or drug abusers 13. anyone whom the investigators conclude are not appropriate 14. any patient receiving steroids. 15. any patient with colchicine allergy, or treated with the drug during the last two weeks.
sphingolipids in asthma pathogenesis

Conditions: Asthma

Summary: the study aims to investigate the relationship between the small molecule metabolite sphingolipids and asthma clinical features and explore its involvement in asthma pathogenesis.


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of asthma exclusion criteria: * 1. combined with chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypopnea syndrome, malignant tumor 2. combined with acute and chronic respiratory failure 3. combined with severe cardiovascular disease 4. pregnant woman.

Keywords: asthma th17 t-cell senescence sphingolipids ceramide
herpes simplex type 2 co-infection in veterans with chronic hepatitis c

Conditions: Hepatitis C Virus Infection; Infection; Herpesvirus 2, Human

Summary: this trial is to determine the safety of valacyclovir in persons with chronic hepatitis c and herpes simplex type 2 infection. participants will be randomized to valacyclovir or matching placebo. after receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. each treatment period will be separated by a two-week period of daily placebo. the hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis c virus ribonucleic acid.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatitis c infection * clinical diagnosis of herpes simplex type 2 infection exclusion criteria: * hiv infection * other forms of chronic liver disease * chronic medical conditions * on immunosuppressive medications

Keywords: herpes simplex type 2 hepatitis c virus valacyclovir herpes simplex virus type 2 infection
electrochemotherapy for desmoid tumors

Conditions: Desmoid Fibromatosis

Summary: the goal of this observational study is to learn about the effects of electrochemotherapy (ect) in patients with desmoid fibromatosis. the main question it aims to answer is: is ect effective in reducing the size of the lesion and improving patients' symptomatology? patients will be followed with mri and quality of life questionnaires at 3, 6 and 12 months after the intervention.

desmoid fibromatoses are rare and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.the current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. nonsurgical approaches remain suboptimal. for asymptomatic disease, current guidelines suggest an initial period of active surveillance. other minimally invasive local treatments such as cryoablation have been shown to be effective; however, certain patients are not candidates for such treatment because of lesion location/characteristics. an additional minimally invasive treatment with currently little evidence in the literature is arterial embolization. however, this procedure cannot be performed in the case of superficial lesions, nor in the presence of shared vasculature between the lesion and other healthy tissues or organs. in the absence of other treatments in use, electrochemotherapy treatment can be performed, which has proven effective on several other types of soft tissue and bone tumors, malignant or benign, treated at our institute. electrochemotherapy is based on the principle whereby reversible electroporation causes the application of short, high-voltage electrical pulses to temporarily align water molecules on the hydrolipid layer of the cell membrane, leading to a reversible local increase in permeability by increasing the intracellular concentration of bleomycin and its toxicity on tumor cells by a factor of up to several thousand.

Eligibility criteria:
inclusion criteria: * symptomatic desmoid fibromatosis and in active phase (documented growth at last follow-up) * patients not eligible for surgery, cryoablation, or embolization * signature of study-specific informed consent. exclusion criteria: * patients with fibromatosis not in active phase, documented clinically and with imaging investigations (mri, ct) * patients with documented active infection * previous treatment for \< 30 days * pregnancy and lactation status * patients of childbearing age without contraceptive use for at least 3 months * presence of metal synthetic media at the site of treatment * copd with fio2 \< 30 mmhg * impaired renal function with egfr

Keywords: interventional radiology electrochemotherapy desmoid tumor
high flow nasal cannulae oxygen therapy in respiratory insufficiency patients

Conditions: Patients With Respiratory Insufficiency

Summary: chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.high-flow nasal cannula (hfnc), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. there is little research on the role of hfnc in oxygen therapy for chronic respiratory insufficiency. our previous studies have found the potential value of hfnc in chronic respiratory insufficiency. the aim of this project is to promote the use of hfnc in the t reatment of chronic respiratory insufficiency in hfrs in shanghai first, second and third grade hospitals in an effort to confirm that hfnc can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.

1. to confirm hfnc used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better. 2. we set up a point of research in the tertiary hospitals, secondary hospitals and primary hospitals to explore the different levels of hfnc in the application of the efficacy of the hospital there are differences and what is better. to further clarify the promotion of hfnc to secondary hospitals and primary hospitals have no meaning. 3. patients with chronic respiratory insufficiency who required long-term oxygen therapy were randomized to a randomized, controlled, multicentre clinical trial of hfnc with nasal oxygen therapy. analysis and comparison of hfnc and general nasal catheter oxygen in the treatment of chronic respiratory insufficiency there is no difference, hfnc in different grades of hospital use is consistent. 4. research methods: 4.1 subjects: chronic respiratory insufficiency required long-term oxygen therapy to shanghai tenth people's hospital and multi-center hospital patients. 4.2 study sample size: 100 samples were collected from each of the three test centers. of which 150 cases of nasal oxygen therapy, hfnc 150 cases.

Eligibility criteria:
inclusion criteria: - patients with chronic respiratory insufficiency who require long-term oxygen therapy. age 18-85 years old. agree to participate in this study. exclusion criteria: - patients with advanced respiratory support (invasive mechanical ventilation, noninvasive mechanical ventilation) indications cardiovascular disease caused by respiratory insufficiency immune dysfunction caused by respiratory insufficiency tumor-induced respiratory insufficiency people with disturbance of consciousness

Keywords: respiratory insufficiency high-flow nasal cannula
effect of premedication with pronase on mucosal cleanliness during egd

Conditions: Esophageal Cancer; Gastric Cancer

Summary: gastric cancer and esophageal cancer are common malignant tumors that threaten people's life and health. esophagogastroduodenoscopy (egd) is an important tool for screening upper gastrointestinal tumors, especially early tumors, and an effective method for detecting other upper gastrointestinal lesions, including ulcers and polyps. however, during egd examination, mucus and foam can reduce the cleanliness of the mucosa and limit the operator's visual field, resulting in missed lesions and misdiagnosis. previous studies have shown that preoperative medication with pronase and dimeticone is correlated with the improvement of upper gastrointestinal mucosal cleanliness. however, the number of samples in such studies is limited, and the artificial judgment is not objective enough to evaluate the cleanliness of upper digestive tract mucosa. and, whether a postural exercise is necessary for premedication with pronase or dimeticone remains unclear. our team design this experiment to examine the efficacy of using premedication of dimeticone/pronase with a postural exercise on visualization of the mucosa before painless egd. the investigators aim to provide new evidence to optimize the use of premedication with egd.


Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 years and ≤70 years; 2. voluntarily participate in the trial and sign the informed consent. exclusion criteria: 1. active gastrointestinal bleeding; 2. esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons; 3. diagnosed malignant tumors of the upper digestive tract; 4. a history of upper gastrointestinal surgery; 5. severe heart, liver and kidney diseases, and the doctor judges that it is not suitable for painless gastroscopy; 6. serious mental illness; 7. pregnancy or breastfeeding; 8. an allergy to pronase or dimeticone; 9. current participation in other clinical trials and in the follow-up or drug washout period; 10. patients considered by the investigator to be unsuitable for this study

Keywords: egd pronase postural exercise mucosal cleanliness