Kornimate/medical-research-clean huggingface dataset:
a randomized acceptability and safety study of the transfer from subutex to suboxone in opioid- dependent subjects (study p04843)(completed)

Conditions: Opiate Dependence; Drug Dependence

Summary: post-marketing commitment to the european medicines agency to conduct a prospective, controlled study of the transfer from subutex to suboxone.


Eligibility criteria:
inclusion criteria: * subjects must be males or non-pregnant, non-lactating females. * subjects must be at least 15 years of age, of either sex, and any race. * subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules. * subjects must meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria(18) for opioid dependence. * subjects must have been receiving maintenance treatment with subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening. * subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening. * subjects must have an opioid-negative urine drug screening (uds) result prior to randomization. * each subject must confirm that he or she is practicing adequate contraception. * female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hcg) test prior to enrollment in the study. exclusion criteria: * subjects for whom treatment with either subutex or suboxone as required in the protocol would be inconsistent with national labeling. * subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study. * subjects who are participating in any other clinical study in which medication(s) are being delivered. * subjects with known allergy or sensitivity to naloxone. * subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. * subjects must not have serious untreated axis i dsm-iv-tr psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification. * human immunodeficiency virus (hiv)-positive subjects with clinical acquired immunodeficiency syndrome (aids). * subjects treated with generic buprenorphine.
evaluation of the diagnostic contributions of nerve ultrasound in chronic inflammatory demyelinating polyneuropathy associating systemic diseases (cidp echo-nerf)

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Summary: chronic inflammatory demyelinating polyradiculoneuritis (cidp) is an autoimmune disorder of the peripheral nervous system, most commonly affecting the myelin sheath. the pathophysiology of cidp is not completely understood, but both humoral and cellular immunity appear to be involved in the genesis of this disease. some diseases are particularly associated with cidp such as diabetes, monoclonal gammopathies and hematological diseases. cidp can occur before, after or simultaneously with the onset of systemic diseases. the systemic diseases most often seen in association with polyneuropathies are lupus, gougerot-sjögren's syndrome and sarcoidosis. ultrasound of peripheral nerves is a useful and accessible tool. in cidp, this examination can reveal diffuse or segmental nerve hypertrophy. in addition to the size of the nerve, this exploration analyzes the echogenicity and the aspect of the different fascicles within the nerve. s. goedee et al have shown that nerve ultrasound has very good diagnostic parameters and low interobserver variability in the diagnosis of cidp. f. härtig et al suggests that nerve ultrasound can predict the therapeutic response and describes 3 main patterns: hypoechoic enlargement (active inflammation), nerve enlargement with hyperechoic add-on fascicles (axonal degeneration) and almost no enlargement ("cured" cidp).

cidp may be progressive or relapsing, most frequently clinically symmetric, sensorimotor with proximal and distal involvement developing over at least 8 weeks but variants as distal, multifocal, focal, motor or sensory cidp have been also described. cell-mediated and humoral mechanisms act together in an aberrant immune response to cause damage to peripheral nerves but, by molecular mimicry it causes other autoimmune system diseases. this paper focuses on the intersection of cidp and other autoimmune disease with an emphasis on shared pathology and mutually characteristics.

Eligibility criteria:
inclusion criteria: * patients followed at nîmes university hospital between 2012 and 2021 * age \> 18 years * diagnosis of definite cidp or possible cidp according to the new efns/pns 2021 criteria * diagnosis of definite cidp/cidp possible with systemic diseases and respectively diagnosis of definite cidp/cidp possible for the control group confirmed by electroneuromyography, concordant with the clinical examination
fgf19 overexpression combination unified study in hcc-19

Conditions: HCC - Hepatocellular Carcinoma

Summary: this study is designed prospectively to investigate the safety and efficacy of absk-011 and absk043 in patients with previously treated unresectable or metastatic hepatocellular carcinoma (hcc) harboring fgf19 overexpression. absk-011, an oral, selective fgfr4 inhibitor which can irreversibly bind to the target. absk043, is an orally available, selective and potent inhibitor targeting the interaction of pd-1 and pd-l1, safety, tolerability, and preliminary efficacy of absk-011 or absk043 were explored in a phase 1 trial absk-011-101 (nct04906434) and absk043-101 (nct04964375) trial, respectively. this trial focuses on the efficacy of the combination of absk-011 and absk043 in patients with previously treated unresectable or metastatic hcc harboring fgf19 overexpression.

the patients that meet the inclusion and exclusion criteria will treat with absk-011 rp2d and absk043 rp2d until the disease progression

Eligibility criteria:
inclusion criteria: 1. patients with hcc confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for hcc as the aasld or guidelines for the diagnosis and treatment of primary liver cancer (china). 2. progression of disease confirmed by imaging after receiving at least one line of systemic therapy 3. the central laboratory test report for fgf19 overexpression positive. 4. ecog performance status of 0 or 1; 5. adequate organ and marrow function defined by study-specified laboratory tests; exclusion criteria: 1. has received prior therapy with fgfr4 or pan-fgfr inhibitors; 2. hypersensitivity for any constituent of absk-011 or absk043; 3. past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment 4. have other malignant tumors that are currently in a progressive stage or require effective treatment 5. has a known history of human immunodeficiency virus (hiv) (hiv 1/2 antibodies)
serplulimab combined with anti-vegf antibody in advanced lung adenocarcinoma

Conditions: Lung Adenocarcinoma; Stage IV Non-small Cell Lung Cancer; PD-1 Inhibitor; VEGF

Summary: in order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used serpluimab combined with bevacizumab and platinum-based chemotherapy in previously untreated egfr/alk-negative advanced non-squamous nsclc patients, to evaluate the efficacy and safety of this regimen.


Eligibility criteria:
inclusion criteria: * fully understood this study and voluntarily signed the informed consent form (icf); -≥ 18 years and ≤ 75 years old; * ecog score 0-1; * non-squamous nsclc; * stage iv; * egfr and alk negative; * treatment-naive; * according to recist1.1 criteria, there are measurable or evaluable lesions. exclusion criteria: * tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer; * patients with severe organ dysfunction were indicated by examination, exclude subjects with any active, known or suspected autoimmune diseases; * the estimated survival time is less than 3 months.
palliative care teaching sessions for family caregivers of patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer. purpose: this clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.

objectives: i. test the effects of a family caregiver palliative care intervention (fcpci) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (fc) in a usual care situation. ii. test the effects of a fcpci for informal caregivers of patients with early and late stage lung cancer on fc in a usual care situation. iii. describe early and late stage fc self care behavior, comparing the usual care and fcpci groups. iv. describe resource use by early and late stage fc comparing the usual care and fcpci groups. v. identify subgroups of fc who benefit most from the fcpci in relation to sociodemographic characteristics, clinical/functional factors. v. identify subgroups of fc who benefit most from the fcpci in relation to sociodemographic characteristics, clinical/functional factors. outline: family caregivers (fc) are assigned to 1 of 2 groups. group i: fc complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use. group ii: fc undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of fc distress; social and spiritual needs of the patient and fc; the continuing role of the fc in caring for the patient; and development of a personalized wellness plan. fc then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. fc also complete questionnaires as in group i. after completion of the educational intervention, a sample of fc undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.

Eligibility criteria:
inclusion criteria: * the primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (nsclc) participating in project 1 and 2 * patients having been accrued to project 1 or project 2

Keywords: recurrent non-small cell lung cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
the effects of binaural beats on pain, anxiety, and procedure tolerance in patients undergoing colonoscopy without sedation

Conditions: Anxiety State; Patient Satisfaction; Tolerance

Summary: the purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation

it is a prospective randomized, controlled, single-blind procedural study included 92 turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. the patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). the binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. anxiety levels (vas-anxiety scale) were measured both before and after the procedure, and pain levels (vas-pain) were measured following the procedure. hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.

Eligibility criteria:
inclusion criteria: - between 18-70 years old who had scheduled colonoscopy appointments exclusion criteria: * anxiety and panic disorders * urgent endoscopic intervention * advanced dementia * hearing problems * anatomical or inflammatory disorders in the external ear canals
a study to learn about the relationship between hepatic impairment and myelosuppression (decreased bone marrow function) in breast cancer patients treated with the study medicine palbociclib (pal-bow-sai-klib)

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine palbociclib. this study is seeking participants: * treated with the study medicine palbociclib * having any breast cancer records in same month as the index date (the first prescription date) * having prescription records of palbociclib from 20 december 2016 to 29 february 2024 the study design is a cohort study. this study design uses de-identified patient data from a hospital based electronic medical record and claim database in japan. one of the important side effects of taking palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell). in this study, the relationship between neutropenia caused by palbociclib and hepatic impairment was studied after it was released to the market. to do that, the study gathered details of breast cancer patients newly treated with palbociclib from 23 hospitals and 10 medical institutes across japan. the below patient details were collected: * dose of palbociclib * other medicines prescribed for cancer * age * gender * past information on cancer treatments * laboratory findings at baseline the result was based on the neutrophil count collected from the laboratory data. around 1300 patients newly treated with palbociclib for breast cancer was calculated by the medical information database network (mid-net) in 6 years from 15 december 2017.


Eligibility criteria:
inclusion criteria: * having prescription records of palbociclib from 15 december 2017 to 29 february 2024. * having any breast cancer records in same month as the first prescription date. * having laboratory tests and visit records (ss-mix2) on or before 180 days prior to the first prescription date * having ss-mix2 hospital-visit records within 180 days before the first prescription date exclusion criteria: * having an absolute neutrophil count (anc) less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib * having any records of anti-her2 medication

Keywords: safety database study in japan ibrance palbociclib hormone receptor-positive (hr+)/human epidermal growth factor receptor 2-negative (her2-) inoperable or recurrent breast cancer
breathing for adolescent stress reduction feasibility rct

Conditions: Anxiety; Stress

Summary: the purpose of this study was to test a simple slow breathing curriculum for reducing stress among high school students. the curriculum was developed by the health and human performance foundation and implemented for this study at a public high school in colorado, united states.

nearly 1 in 3 us adolescents meet the criteria for anxiety, an issue worsened by the covid-19 pandemic. untreated adolescent stress and anxiety can adversely affect teenagers' development, education, and physical and mental health. although stress-management strategies may seem abundant, many are unscalable or inaccessible for today's youth. slow diaphragmatic breathing reduces stress and anxiety by downregulating the body's stress response, and is a recommended adolescent stress management strategy. schools are under pressure to support students in reducing stress, yet diaphragmatic breathing practices are rarely used in school settings. the investigators developed and implemented a 5-week curriculum during covid-era hybrid learning to conduct the first randomized controlled trial of slow diaphragmatic breathing for stress reduction in a us high school setting.

Eligibility criteria:
inclusion criteria: students were eligible to participate in this study if they: 1. were enrolled at study start (baseline period) in one of four senior (12th grade) english classes taught by the teacher who was recruited for the study; 2. accepted participation in the study, including willingness to abide by the randomization process, by signing student assent on the consent form; 3. had parental permission to participate in the study, indicated by their signing their consent on the consent form. exclusion criteria: students were excluded from the study and data collection, but not from class, if they: 1. chose not to participate; or, 2. did not receive parental permission.
loading vancomycin doses in the emergency department

Conditions: Infectious Disease

Summary: in 2008, our ed administered an average of 245 doses of vancomycin per month. currently there is no consistency in the ed practice in regards to vancomycin dosing. in 2009, the idsa put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. it has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. methicillin resistant staphylococcus aureus (mrsa) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. vancomycin is one of only a few antibiotics that are effective for treating mrsa. it is imperative that the ed physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. it is believed this study will reveal that the new dosing recommendations by the idsa will lead to the achievement of therapeutic levels more rapidly. this information will in turn help to convince ed physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.

recently, the infectious disease society of america (idsa) has released new dosing recommendations for intravenous (iv) vancomycin. these new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. currently in the emergency department (ed) some practitioners are using the new idsa dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. there is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ed will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * treated in christiana emergency department * receiving vancomycin for an infection or presumed infection * being admitted to christiana hospital * planned continued use of vancomycin after admission. exclusion criteria: * less than 18 years of age * weight greater than 120 kg. * concurrent use of aminoglycosides or acyclovir * sepsis patients being admitted to icu with presumed diagnosis of pneumonia * patients currently undergoing dialysis * pregnant or breast feeding * no plan to continue vancomycin after admission. * creatinine clearance less than 50ml/min.

Keywords: vancomycin therapeutic levels infectious disease recommendations
local anesthesia versus combined local anesthesia with single dose analgesia on pain control during thoracic ultrasound guided procedures

Conditions: Pleural Neoplasms; Aspiration, Respiratory; Pleural Effusion; Lung Neoplasms; Pneumothorax; Pyothorax

Summary: this study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during trans ultrasound guided procedures. it also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.

interventional thoracic ultrasonography (tus) includes both diagnostic and therapeutic procedures. fine-needle aspiration biopsy , tru-cut pleural or lung parenchymal biopsy and cope or abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures. thoracic ultrasound guided procedures are safe and tolerable. pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of tus guided procedures. lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia. to reduce pain, analgesia should be considered as premedication. despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.

Eligibility criteria:
inclusion criteria: * adult patients of both genders. * patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention exclusion criteria: * children and patients less than 18 years old. * pregnant and lactating ladies. * patients with disturbed level of consciousness. * patients with known bleeding disorders. * patients with advanced liver and kidney disorders. * patients with known hypersensitivity to nsaids. * patients with chronic chest diseases. * patients who refuse to participate in the trial