Kornimate/medical-research-clean huggingface dataset:
dermalix efficacy on diabetic foot ulcers

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Summary: (dermalix) (patent number: pct/tr2014/000251) is a bioactive wound dressing that was developed by ege university school of pharmacy department of pharmaceutical technology. this dressing has been categorised as class iii medical device. this clinical study will be conducted in patients with diabetic foot ulcers.


Eligibility criteria:
inclusion criteria: * type 1 or 2 patients diagnosed with diabetic foot ulcers * class i and ii according to wagner classification * no infections confirmed with culture test * no osteomyelitis and gangrene in the foot * hba1c values ≤ % 7.5 * not active smoker * no planned treatment of hyperbaric oxygen * patients who give consent for the study exclusion criteria: * patients with diabetic foot ulcer of class 3,4 and 5 according to wagner classification * patients who are pregnant or breast-feeding or female who are in reproductive age applying no preservative method * patients who have mental conditions that lead to difficulties in comprehension * patients who may have compliance issues * patients who have been included to another interventional study with drug or medical device

Keywords: diabetic foot
a study to assess the efficacy and safety of bivv009 (sutimlimab) in participants with primary cold agglutinin disease without a recent history of blood transfusion

Conditions: Cold Agglutinin Disease

Summary: the purpose of part a was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=)1.5 grams per deciliter (g/dl) increase in hemoglobin (hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (cad) without a recent history of blood transfusion. the purpose of part b was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary cad.

the planned total study duration per participant was approximately 1.5 to 2.5 years.

Eligibility criteria:
inclusion criteria: * body weight of \>=39 kg at screening. * confirmed diagnosis of primary cad based on the following criteria: a) chronic hemolysis, b) polyspecific direct antiglobulin test (dat) positive, c) monospecific dat strongly positive for c3d, d) cold agglutinin titer \>= 64 at 4 degree celsius, and e) immunoglobulin g dat less than or equal to (\<=) 1+, and, f) no overt malignant disease. * hemoglobin level \<= 10.0 g/dl. * bilirubin level above the normal reference range, including participants with gilbert's syndrome. exclusion criteria: * cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy. * history of blood transfusion within 6 months of screening, or history of more than one blood transfusion within 12 months of screening. * clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis c, pneumonia). * clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at screening. anti-nuclear antibodies of long-standing duration without associated clinical symptoms would be adjudicated on a case-by-case basis during the confirmatory review of participant eligibility. * positive hepatitis panel (including hepatitis b surface antigen and/or hepatitis c virus antibody) prior to or at screening. * positive human immunodeficiency virus antibody at screening. * treatment with rituximab monotherapy within 3 months or rituximab combination therapies (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
safety and efficacy of doravirine, tenofovir, lamivudine (mk-1439a) in participants infected with treatment-naïve human immunodeficiency virus (hiv) -1 with transmitted resistance (mk-1439a-030)

Conditions: HIV-1 Infection

Summary: the primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (dor/3tc/tdf; mk-1439a; delstrigo™) consisting of a single fixed-dose combination (fdc) tablet of dor/3tc/tdf 100 mg/300 mg/300 mg in treatment-naïve hiv-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (nnrti) transmitted resistance-associated mutations.

this study had a base study (day 1 to week 96) and an optional study extension (week 96 to week 192).

Eligibility criteria:
inclusion criteria: * is hiv-1 positive within 45 days prior to the treatment phase of this study, and have hiv treatment indicated based on physician assessment. * is naïve to antiretroviral therapy (art) including investigational antiretroviral agents. * prior to screening, have had a genotype performed confirming the presence of only one of the following nnrti mutations: k103n, y181c, or g190a. * is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study). * is highly unlikely to become pregnant or to impregnate a partner exclusion criteria: * is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. * has been treated for a viral infection other than hiv-1, such as hepatitis b, with an agent that is active against hiv-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine. * has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir) * has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent * has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (tnf) antagonists, or other immunosuppressant drugs during the course of the trial. * requires or anticipates requiring any of the prohibited medications * has significant hypersensitivity or other contraindication to any of the components of the study drug * has a current (active) diagnosis of acute hepatitis due to any cause * has evidence of decompensated liver disease or has liver cirrhosis and a child-pugh class c score or pugh-turcotte (cpt) score \> 9 * is pregnant, breastfeeding, or expecting to conceive * is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study
nano drug interventional therapy using digital subtraction angiography（dsa） for lung carcinoma

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（dsa） for lung cancer. the nano drug is made by mixing gemzar® with compound glycyrrhizin injection.

by enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（dsa）for lung cancer. the nano drug is made by mixing gemzar® with compound glycyrrhizin injection. the nano drug's size is detected by laser diffraction particle size analyzer.

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. karnofsky performance status \>60 3. diagnosis of lung cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive interventional therapy 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except lung cancer 2. history of coagulation disorders or anemia

Keywords: lung cancer nano drug
covid-19 ad intervention

Conditions: Social Distance

Summary: this study will provide advertisements to (de-identified) participants and track (de-identified) movement patterns to learn whether the ads increase adherence to stay-at-home orders.


Eligibility criteria:
inclusion criteria: * 18 years of age or older (as identified by company running advertisements); recent visit to a non-essential location; agreed to terms and conditions of websites allowing advertisements exclusion criteria: -
persistent pain to impair daily activities following thoracic surgery

Conditions: Pain

Summary: can pain impairment of daily activities be shown to be procedure specific, and thus used as an alternative to pain scoring.


Eligibility criteria:
inclusion criteria: * age \< 18 years old * elective lung cancer surgery (vats) exclusion criteria: * non-danish residence

Keywords: daily activities
a study of arry-382 in patients with selected advanced or metastatic cancers

Conditions: Metastatic Cancer

Summary: this is a phase 1 study during which patients with advanced cancer will receive investigational study drug arry-382. patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. approximately 50 patients from the us will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * a histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy. * measurable disease or evaluable, nonmeasurable disease. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * hemoglobin ≥ 9.0 g/dl, anc \> 1500/ul and platelet count ≥ 100,000/ul. * ast/serum glutamic oxaloacetic transaminase (sgot) and alt/serum glutamic pyruvic transaminase (sgpt) ≤ 2.5 × the upper limit of normal (uln). * bilirubin ≤ uln. * serum creatinine ≤ 1.5 × uln. * potassium, magnesium and calcium (corrected calcium when serum albumin levels are abnormal) within the normal range. * additional criteria exist. key exclusion criteria: * 12-lead ecg demonstrating a mean qtcf \> 450 msec (triplicate assessment) at the screening visit or history/evidence of long qt syndrome. * history of acute coronary syndromes, including unstable angina, coronary angioplasty, or stenting, within the past 24 weeks. * use of concomitant medications that prolong the qt/qtc interval, as assessed by the investigator, within 14 days prior to first dose of study drug. * use of concomitant medication that is a strong cyp3a inhibitor or inducer within 14 days prior to first dose of study drug. * class ii, iii or iv heart failure as defined by the new york heart association (nyha) functional classification system. * uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days). * active refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease) or significant bowel resection that, in the judgment of the investigator, would preclude adequate absorption (a previous whipple procedure is allowed). * additional criteria exist.

Keywords: csf1r m-csf csf-1 c-fms tumor-associated macrophage macrophage-colony stimulating factor-1 receptor tyrosine kinase inhibitor tumor cell-induced osteolysis
comparison between propofol and fentanyl for prevention of emergence agitation in children after sevoflurane anesthesia

Conditions: Emergence Agitation

Summary: the occurrence of emergence agitation (ea) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. the prevalence of ea varies between 10% to 80% depending on the scoring system for evaluation and the anesthetic technique used. many authors reported various strategies such as use of sedative premedication, change of maintenance technique of anesthesia, or pharmacological agents administered at the end of anesthesia to reduce the incidence and severity of ea, and to allow a smooth emergence from sevoflurane anesthesia. among these strategies, the use of pharmacological agents at the end of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration of anesthesia excessively when these agents are administered as subhypnotic or small dose. the typical agents that can be administered in this way are propofol and fentanyl. previous studies demonstrated that the use of either propofol or fentanyl at the end of anesthesia could reduce the incidence of ea. the purpose of this study is to compare the preventive effect on ea and the characteristics of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane anesthesia.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists i or ii, * 18-72 months of age, * scheduled for ambulatory inguinal hernia repair undergoing general sevoflurane anesthesia exclusion criteria: * developmental delay * psychological and neurologic disorder * sedatives medication * an abnormal airway * reactive airway disease * extreme agitation and uncooperation * previous history of anesthesia
the effect of posterior pericardiotomy on the incidence of atrial fibrillation after cardiac surgery-extended follow-up

Conditions: Atrial Fibrillation

Summary: the purpose of the effect of posterior pericardiotomy on the incidence of atrial fibrillation after cardiac surgery (palacs, nct02875405) trial was to determine if performing posterior left pericardiotomy at the time of cardiac surgery prevents atrial fibrillation after cardiac surgery. the purpose of the posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery-extended follow-up (palacs-ef) study is to evaluate the effect of posterior left pericardiotomy on 5-year clinical outcomes.

post-operative atrial fibrillation (poaf) is a common complication of cardiac surgery which is observed in 30-40% of patients. poaf has also been associated with stroke, systemic embolism or cardiac failure during the years after surgery. several strategies aimed at reducing the incidence of poaf have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. in the randomized prospective clinical trial, the palacs trial, 420 patients were randomized either to the intervention group, which received left posterior pericardiotomy at time of cardiac surgery, or to the control group, which did not receive posterior left pericardiotomy at time of cardiac surgery. posterior left pericardiotomy was associated with a reduction in the incidence of poaf after surgery, but not with improvement in 30-day patient outcomes. this non-interventional, prospective study is an extension follow-up study (palacs-ef) of all patients who were enrolled in the original palacs trial. it is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy (intervention) versus those who did not (control) at median follow-up of 5 years.

Eligibility criteria:
inclusion criteria: * this study will include all the subjects enrolled in the palacs trial exclusion criteria: * not enrolled in the palacs trial

Keywords: postoperative left posterior pericardiotomy prevention cardiac surgery
optimizing care for patients with dementia

Conditions: Alzheimer Disease

Summary: of the 1.4 million nursing home (nh) residents in long term care facilities, more than half have alzheimer's disease or dementia. due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all nh staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. while prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. this project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach. this study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident. this project is important because it will address a key clinical dilemma nh staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. transforming the quality of dementia care in nhs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.


Eligibility criteria:
inclusion criteria: eligible nursing home facilities will * lack any existing dementia program targeting reduction of off-label psychotropic medication use * each serve \>60 long-term care residents with alzheimer's or dementia * meet center for medicare \& medicaid services' minimum requirements for nhs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments). exclusion criteria: facilities will be excluded if they have * less than 60 long-stay residents * an existing formal dementia care program in place * an off-label psychotropic medication reduction program * is located in a state that requires more than the center for medicare \& medicaid services' minimum for staff training requirements on the topic of dementia care

Keywords: long term care residents nursing home care
clinical study for combined analysis of ctc and exosomes on predicting the efficacy of immunotherapy in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this project intends to perform ctc pd-l1 imaging, exosomal pd-l1 protein detection, and exosomal lag-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of hcc patients and comprehensively present the responsiveness of patients to immunotherapy.

liquid biopsy methods such as pd-l1 of ctc, number of peripheral immune cells and their subtypes, and exosomal pd-l1 provide a dynamic monitoring strategy for immunotherapy evaluation. monitoring ctc and immune-related functional markers in peripheral blood can dynamically reflect the multi-dimensional characteristics of tumor microenvironment, comprehensively represent the response of patients to immunotherapy, and provide a new strategy of companion diagnostics for immunotherapy in hcc. this project intends to perform ctc pd-l1 imaging, exosomal pd-l1 protein detection, and exosomal lag-3 protein detection, so as to resolve the functional marker profiles of immunotherapy in the peripheral blood of hcc patients and comprehensively present the responsiveness of patients to immunotherapy.

Eligibility criteria:
inclusion criteria: * having signed informed consent * clinically or pathologically confirmed hepatocellular carcinoma; * liver tumor load not exceeding 50% of liver volume; * expected survival ≥ 12 weeks; * vital organ function meeting enrollment criteria; and (6) no need for pregnancy. exclusion criteria: * patients who have been diagnosed with malignant tumors of other systems or organs; * patients with hematologic disorders and extreme physical failure; * patients with immune deficiencies or organ transplants; * other conditions deemed by the investigator to be inappropriate for participation in this study.
psychosocial issues in insulin pump therapy in children with type 1 diabetes mellitus (dm)

Conditions: Diabetes Mellitus, Insulin-Dependent

Summary: the effect of change in diabetes treatment from multiple daily insulin injection therapy to continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life, diabetes burden, parents stress level, fear, family conflicts) in families with children and adolescents with diabetes mellitus type 1 have been analysed. additionally the effect on metabolic parameters (hba1c, severe hypoglycemia, ketoacidosis) have been analysed.

children and adolescents currently treated with mdi and with an indication for csii were randomized 1:1 to either starting with csii as soon as possible or to continuing mdi while waiting six months for transmission to csii, stratified by center. the primary outcomes were patient-reported diabetes-specific health-related quality of life , and diabetes burden of the main caregiver. we also investigated the impact of csii on main caregiver stress, psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment satisfaction, family conflict, and hba1c.

Eligibility criteria:
inclusion criteria: * type 1 dm * transition to continuous subcutaneous insulin infusion (csii) * meeting the costs by health services * sufficient german literacy exclusion criteria: * remission (diabetes duration \< 6 months, insulin \< 0.5 i.e./kg) * severe learning problems * investigator's children * waiting time not advised for medical reasons
effects of hazelnuts and cocoa on metabolic parameters and vascular reactivity

Conditions: Cardiovascular Diseases; Glucose Metabolism Disorders

Summary: this study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. participants, divided in six groups, will receive one of these breakfast integrations for 14 days: group 1) 30 g peeled hazelnuts; group 2) 30 g unpeeled hazelnuts; group 3) snack with 30 g peeled hazelnuts; group 4) snack with 2.5 g cocoa powder; group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa; group 6) empty snack, control group.

in the last few years, the prevalence of overweight and obesity has increased in all age groups. the european food safety authority stated "cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". several studies reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease. the hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet integrations on vascular reactivity and endocrine-metabolic parameters.

Eligibility criteria:
inclusion criteria: * bmi 18.5-24.9 kg/m2 exclusion criteria: * diabetes mellitus * glucose intolerance * dyslipidemia * metabolic syndrome * allergies

Keywords: hazelnut cocoa flavonoid lipids vascular reactivity