Kornimate/medical-research-clean huggingface dataset:
trial to evaluate the sirolimus-eluting collagen implant on av fistula outcomes

Conditions: Complication of Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Complication of Hemodialysis; Vascular Access Complication; Arteriovenous Fistula

Summary: the objective of this study is to evaluate efficacy and safety outcomes following use of the sirolimus-eluting collagen implant (seci) in subjects undergoing surgical creation of an av fistula for vascular access (index procedure).

the objective of this study is to evaluate efficacy and safety outcomes following use of the sirolimus-eluting collagen implant (seci) in subjects undergoing surgical creation of an av fistula for vascular access (index procedure). following successful creation of the av fistula, the cohort randomized to the treatment group will receive the seci; the control group will not receive an implant. the primary hypothesis is that the proportion of subjects that meet requirements for fistula suitability for dialysis six months following the index procedure will be higher in the treatment group in comparison to the control group.

Eligibility criteria:
inclusion criteria: * currently on hemodialysis for ≤12 months or expected to initiate hemodialysis within approximately 6 months of the creation of the av fistula. * vascular anatomy suitable for creation of the av fistula, determined by pre procedure duplex ultrasound * successful creation of a single stage radiocephalic or brachiocephalic end to side fistula exclusion criteria: * prior av access created on the limb where the fistula surgery is planned * st-elevation mi or cerebrovascular accident within 30 days of the index procedure * known hypersensitivity to the following: sirolimus, beef or bovine collagen * hypotension with systolic blood pressures \<100 mm hg at the time of screening * known or suspected active infection at the time of the av fistula surgery * known to be hiv positive * prisoner, mentally incompetent, and/or alcohol or drug abuser

Keywords: dialysis end stage renal disease end stage kidney disease esrd chronic kidney failure chronic renal failure chronic kidney disease hemodialysis vascular access arteriovenous fistula av fistula avf nephrology vascular surgery dialysis access
mental health services for foster and adopted children

Conditions: Problem Behaviors; Attention Deficit Hyperactivity Disorder; Depression

Summary: this study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. in the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. this study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care. children are randomly assigned to either an experimental group or to a treatment control group for 3 years. the experimental group focuses on relational issues; the control group focuses on cognitive development. caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. caregivers in the treatment control group receive training designed to enhance children's cognitive development. caregivers in both groups will receive 10 home visits. observations of children and parents are used to assess participants.

Eligibility criteria:
inclusion criteria: * toddler placed into foster care * resident of delaware and surrounding counties in pennsylvania and maryland exclusion criteria: * significant medical problems

Keywords: attachment intervention prevention
sildenafil effects on pulmonary haemodynamics and gas exchange in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Summary: sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. sildenafil modulates the nitric oxide (no) pathway in the vessel wall. since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (ph) associated with chronic obstructive pulmonary disease (copd), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. however, in copd sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. the research project is aimed to evaluate these effects. it is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. subjects: 20 patients (10 in each group). measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.


Eligibility criteria:
inclusion criteria: * copd (fev1/fvc\<0.7) * age 40-75 * pulmonary hypertension (vmax ti\>=2.8m/sec) exclusion criteria: * treatment with cyp3a4 inhibitors, nitrates, pde-5 inhibitors * coronary disease * ischemic optical neuritis

Keywords: copd
music imagery for patients receiving chemotherapy for leukemia or non-hodgkin's lymphoma

Conditions: Leukemia; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-hodgkin's lymphoma.

standard treatment for acute leukemia and high-grade non-hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. patients treated in isolation units may experience elevated levels of psychological distress. both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-hodgkin's lymphoma patients. this study will evaluate the effect of music imagery on these patients. participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. all participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.

Eligibility criteria:
inclusion criteria: * admitted to indiana university hematologic malignancy program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-hodgkin's lymphoma * able to read and understand english

Keywords: music therapy anxiety depression
trichloroacetic acid as a topical treatment for actinic cheilitis

Conditions: Actinic Cheilitis

Summary: actinic cheilitis is a condition of the lower lip characterized by grayish-white areas of discoloration and blunting of the demarcation between the cutaneous lip and the mucosa. while many studies have compared treatment options for actinic cheilitis, there is still significant debate over how to best manage this condition. the chosen treatment regimen must result in complete remission while also preventing recurrence and malignant transformation. current treatment options are vast, including both non-surgical and surgical options. common topical therapies include 5-fluorouracil, imiquimod, ingenol mebutate and diclofenac. more recently, photodynamic therapy has been brought forward as a potential treatment modality. from a surgical perspective, a vermilionectomy is typically the procedure of choice. tca is a popular topical treatment for treat fine rhytides, hyperpigmentation, photodamage, and premalignant changes, such as actinic keratoses. despite this, tca is not commonly used for actinic changes on the lips. here, the investigators propose an expansion of the application of tca to be used in the treatment of actinic cheilitis.

the proposed study will be a prospective cohort study of all patients with actinic cheilitis presenting to the study institution, the queen elizabeth ii health science center in halifax, from march 1st 2021- march 1st 2023. patients will be consented to participate at the time of their initial consultation. they will fill out the demographics form, a preliminary survey and have the required photographs taken on that same day. a biopsy will be performed prior to treatment to establish the histological grade of their actinic cheilitis based on the degree of dysplasia. after the treatment is received, they will follow-up in 1 month for reassessment. at this point, a second treatment will be offered if clinical remission has not been achieved. patients will continue tca treatments at 1-month intervals until clinical remission is reached. once remission is achieved, they will fill out the post-treatment questionnaire and have their second set of photos taken. final follow-up will occur 6 months post remission. at this point patients will be assessed for clinical recurrence. a third set of photos will be completed during this appointment.

Eligibility criteria:
inclusion criteria: * inclusion criteria will include all patients with actinic cheilitis that do not meet exclusion criteria. exclusion criteria: * exclusion criteria will include patients younger than 18 years of age and patients with a biopsy proven malignancy of the lip.
maximal use study of tapinarof cream, 1% in adults with extensive plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.


Eligibility criteria:
inclusion criteria: * male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study * bsa involvement ≥ 20% * pga score of ≥ 3 at screening * females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study * capable of giving written informed consent exclusion criteria: * psoriasis other than plaque variant * any sign of infection of any of the psoriatic lesions * evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (cv) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results * ultraviolet (uv) light therapy or prolonged exposure to natural or artificial sources of uv radiation within 4 weeks prior to the baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis * use of any prohibited medication within the indicated period before the first dose of study drug * pregnant females or lactating females * the subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug * current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix * previous known participation in a clinical study with tapinarof
a culturally sensitive intervention for tbi caregivers in latin america

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) patients in latin america experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. to improve tbi rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive transition assistance program for informal caregivers of patients with tbi in latin america during the patient's transition from hospital to home. this study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for tbi caregivers in latin america and in the u.s.


Eligibility criteria:
tbi patient inclusion criteria: * will be discharged home and not to a nursing home * give permission for their caregiver to participate * sign an informed consent * have the ability to communicate over the phone for data collection * are between 18-60 years of age caregiver inclusion criteria * have a telephone in the home or cellular phone and are able to talk on the phone * sign an informed consent * score at least a 13 on a health literacy screening tool * are between 18-85 years of age

Keywords: brain injuries caregivers intervention studies latin america
the effects of instrument cervical manual therapy methods and proprioceptive neuromuscular facilitation techniques

Conditions: Neck Pain

Summary: the location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". the annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. neck pain usually lasts longer than 3 months and results in a high cost to society

movement in one plane in the cervical spine is due to the contribution of vertebrae from other planes. this complicates the kinematics and injury mechanism of the cervical region. considering the mechanism of injury, demographic information to be obtained from the person is very important.

Eligibility criteria:
inclusion criteria: * those with neck pain * being between 20-60 years old exclusion criteria: * high blood pressure * cardiopulmonary disease * malignant * operation, injection, etc. for the neck in the last 3 months. those with a history of treatment * spine surgery * psychological disturbance * neurological and orthopedic deficits

Keywords: pain
antibiotic prophylaxis for early ventilator-associated pneumonia in neurological patients

Conditions: Ventilator Associated Pneumonia

Summary: this study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. for this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment. our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.

ventilator-associated pneumonia (vap) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27% patients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%. these data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise. then we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.

Eligibility criteria:
inclusion criteria: * all patients admitted to intensive care units,with score in the glasgow coma scale less than nine. * requiring mechanical ventilation for more than 48 hours * includes all patients with structural or metabolic coma exclusion criteria: * pregnant women * history of allergic reactions to ampicillin sulbactam * patients admitted as potential organ donors * patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously. * hospital stay for more than 48 hours before intubation.

Keywords: ventilator associated pneumonia coma brain injuries intensive care units antibiotic prophylaxis
the stabilization of atherosclerotic plaque by initiation of darapladib therapy trial

Conditions: Atherosclerosis

Summary: this study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. average time in the study for an individual subject is expected to be about 3 years.

Eligibility criteria:
inclusion criteria: * men or women at least 18 years old. women must be post-menopausal or using a highly effective method for avoidance of pregnancy. * current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject. * chronic coronary heart disease * at least one of the following: * at least 60 years old * diabetes requiring treatment with medication * low hdl cholesterol ("good cholesterol") * currently smoke cigarettes or stopped smoking within the past 3 months * diagnosed mild or moderate reduction in kidney function * cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) or peripheral arterial disease. exclusion criteria: * planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure. * liver disease * severe reduction in kidney function or removal of a kidney or kidney transplant * severe heart failure * blood pressure higher than normal despite lifestyle changes and treatment with medications * any life-threatening disease expected to result in death within the next 2 years (other than heart disease) * severe asthma that is poorly controlled with medication * pregnant (note: a pregnancy test will be performed on all non-sterile women prior to study entry) * previous severe allergic response to food, drink, insect stings, etc. * drug or alcohol abuse within the past 6 months or mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study. * certain medications that may interfere with the study medication (these will be identified by the study doctor) * participation in a study of an investigational medication within the past 30 days * current participation in a study of an investigational device

Keywords: heart disease lp-pla2 inhibitor cardiovascular disease coronary heart disease cv risk atherosclerosis
bortezomib in intrahepatic cholangiocellular carcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: this study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.half of participants will receive bortezomib while the other half will receive best supporting care.

there's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients. previous study indicated high mutation/deletion rate of pten gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with pten mutation/deletion. the investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with pten mutation/deletion. so the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with pten mutation/deletion

Eligibility criteria:
inclusion criteria: 1. patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage iv; 2. have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）; 3. the previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment; 4. measurable disease according to response evaluation criteria in solid tumors (recist), version 1.1; 5. eastern cooperative oncology group performance score (ecog): 0-2; life expectancy of at least 12 weeks; 6. normal liver,kidney and bone marrow function； 7. subjects who understand and voluntarily signed a written informed consent form. exclusion criteria: 1. history of other malignancy within 3 years. patients with central nervous system metastases or brain metastasis 2. there is any contraindication to use bortezomib 3. patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, iii-iv level cardiac insufficiency, severe liver and kidney dysfunction). 4. a previous history of interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence. 5. pregnant or lactating women. 6. history of radiation within 4 weeks prior to enrollment.

Keywords: bortezomib
multidisciplinary team approach to prescribe antithrombotic therapy in older people with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: antithrombotic drugs, which include antiplatelet and anticoagulant therapies, are used to prevent and treat many cardiovascular disorders. with the increase in prevalence of cardiovascular diseases and medical progress, these treatments are increasingly being prescribed, particularly in older patients. one of the main indications of antithrombotic drugs is atrial fibrillation (af), a disease highly prevalent in older people, a population at high risk of adverse drug events. notably, antithrombotic drugs are the first involved in serious adverse drug events, among which 40-70% may be preventable. in this context, six units of the hospital group "assistance publique - hôpitaux de paris" have created a multidisciplinary team which assesses antithrombotic prescriptions in older patients with af. this team, gathering geriatricians, cardiologists, neurologists and haematologist specialized in haemostasis, evaluates the patient medical profile and suggests the most appropriate antithrombotic treatment based on their expertise and the available recommendations. here we want to look at patients outcomes in light of the intervention of this multidisciplinary team.

the primary objective of this study is to evaluate the impact of the multidisciplinary team on the composite outcome of all-cause mortality, ischemic event or bleeding event at 3 months. secondary objectives are to evaluate this composite outcome at 6 months and all-cause mortality, occurrence of ischemic event, occurrence of bleeding event, at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * 75 years old patients or more * diagnosis of af * hospitalized in one of the 6 geriatrics unit participating in the study and / or whose clinical file is reviewed by the multidisciplinary team exclusion criteria: * opposition to data collection for research purposes

Keywords: atrial fibrillation frail elderly anticoagulants platelet aggregation inhibitors multidisciplinary team