Kornimate/medical-research-clean huggingface dataset:
treating depression among low-income patients with cancer

Conditions: Major Depression; Dysthymia

Summary: the adapt-c collaborative depression care model is designed to: improve depression symptom reduction in the intervention group over the modestly enhanced usual care group of low-income, predominantly hispanic, patients with cancer who are receiving care in an urban public sector care system; and to improve quality of life outcomes among intervention patients over enhanced usual care.

this controlled trial has tested the effectiveness of a socio-culturally tailored depression care program that includes a patient-centered approach to antidepressant medication management or structured psychotherapy (problem solving treatment (pst)), patient/family depression education, treatment maintenance and relapse prevention counseling. intervention enhancements include: depression care management based on a stepped care depression treatment algorithm; extension of the oncology care management team with a master's degreed social worker, who acts as cancer depression clinical specialist (cdcs) and provides pst, treatment follow-up and feedback to the oncologist, and who facilitates patient-provider communication and health system and community resources navigation; a psychiatric consultant, who provides supervision of the cdcs and consultation and antidepressant medication prescription for individual patients; and a didactic for oncologists on depression management. cultural sensitivity and competency enhancements include: patient choice of first line treatment (antidepressant medication/pst) and degree of family participation in their depression care; pst tailored for language and literacy of patients with cancer; bilingual, bicultural cdcs; spanish educational materials; and communication facilitation. enhanced usual care (euc) patients will receive the care and services routinely provided patients with cancer plus an educational/resource pamphlet for patients and for family members(on depression and cancer, depression treatment, talking with your doctor about your depression, and medical center and community mental health care resources). with patient consent, the oncologist is informed if euc patients screen positive for major depression/dysthymia.

Eligibility criteria:
inclusion criteria: - 90 days post cancer diagnosis receiving acute cancer treatment or active follow-up exclusion criteria: - patients with advanced cancer or another medical condition that limited life expectancy to less than 6 months
bridging brain structure and function by correlating structural connectivity, cortico-cortical transmission and direct electro-stimulation

Conditions: Tumor, Brain

Summary: elucidating the structure-function relationship of the brain is one of the main open questions in neuroscience. the capabilities of diffusion mri-based (dmri) techniques to quantify the connectivity strength between brain areas, namely structural connectivity (sc), in combination with modalities such as electroencephalography (eeg) to quantify brain function have enabled advances in this field. however, so far the actual relationship between sc measures and measures of information transport between neuronal patches has not been determined. in this project, we aim to establish a relationship between dmri sc measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ecog), and response elicited by direct electrostimulation of the brain (des). ten patients operated on awake surgery for brain tumor removal will be included. first, a dmri will be acquired prior to the surgery, in order to extract sc indices through probabilistic tractography. then, intrasurgical cortico-cortical electrical measures will be obtained by ecog electrodes positioned on the predefined cortical terminations of the designated bundles. these measures will be correlated to functional responses obtained during the cortical cartography, following the common des procedure. the results of this multi-modal approach combining structure and function explorations of the brain should help to elucidate the relationship between non-invasive (dmri) sc measures and cortico-cortical transmission properties (delays, transfer functions), and should boost the understanding of cognitive function as well as neurosurgical planning for the treatment of pathologies such as brain tumor resection and drug-resistant epilepsy.


Eligibility criteria:
inclusion criteria: * patient eligible at an awake surgery for a brain tumor resection * informed consent of the patient exclusion criteria: * contraindication to mri * withdrawal of the patient's consent
study to assess clinical outcomes in chronic hepatitis c patients previously treated with daclatasvir-based regimens

Conditions: Hepatitis C

Summary: the purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic hepatitis-c (chc)


Eligibility criteria:
inclusion criteria: * males or females 18 years of age or older at initiation of prior dcv-based therapy * previously treated with dcv (manufactured by bms)-based therapy in combination with other hcv direct acting antivirals (daas) for at least 8 weeks * must enroll in this study within 12 months of end of treatment of dcv-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the ai447036 or ai447114 studies exclusion criteria: - n/a
a clinical study to evaluate the efficacy, tolerability, and safety of bempedoic acid

Conditions: Primary Hyperlipidemia

Summary: this trial is a phase iii study to evaluate the efficacy , tolerability, and safety of bempedoic acid tablets in patients with hyperlipidemia not adequately controlled by statins.


Eligibility criteria:
inclusion criteria: * 1. 18 years and older, male or female. * 2. 18 kg/m2 ≤body mass index (bmi) ≤35 kg/m2. * 3. participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes. * 4. fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process. exclusion criteria: * 1. known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution. * 2. fasting triglycerides (tg) ≥ 5.64 mmol/l (≥ 500 mg/dl) at screening. * 3. history of malignant tumors prior to screening. * 4. history of drug, alcohol, amphetamines, or other drug abuse. * 5. participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer). * 6. pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (hcg) pregnancy test. * 7. any other factors that the investigator believes makes the participant unsuitable for the study.

Keywords: bempedoic acid hyperlipidemia efficacy safety
acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting after tace

Conditions: Nausea; Vomiting; Metastatic Liver Cancer

Summary: observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after tace for primary or metastatic liver cancer patients.

* classification of nausea and vomiting, as measured by nci ctc-ae version 3 * the improvement of appetite, as measure by the classification of appetite in accordance with nci ctc-ae version 3. * quality of life: use m. d. anderson symptom scale (the m. d. anderson symptom inventory,mdasi)

Eligibility criteria:
inclusion criteria: * ecog physical status 0,1,2 * would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients; * adult male and female 3, age 18 years old; * the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg; * signed the informed consent and understand the study design; * organ function examination in patients must meet the following laboratory indexes: neutrophil\>500/ul, hemoglobin \> 8 gm/dl, platelet \>100000/ul,creatinine \ 30g/l * understand and complete quality of life scale ; * women of childbearing age urine pregnancy test was negative. exclusion criteria: * the combined use of other venous chemotherapy within 5 days after tace; * skin infection on or near the points; * skin hyperalgesia, unable to withstand electrical stimulation; * other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.); * heart, cerebrovascular accident history or the history of spinal cord injury; * intestinal obstruction lead to nausea and vomiting * installing pacemaker; * cognitive dysfunction, unable to finish scale; * currently using acupuncture therapy.

Keywords: prevention and treatment improvement of the patient's appetite tace
communication regarding organ and tissue donation in intensive care

Conditions: Tissue and Organ Procurement

Summary: the overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices change rates of consent for donation, and other family-based outcomes.


Eligibility criteria:
inclusion criteria: * donation events identified by a patient who is a potential organ and tissue donor in a participating icu or under the care of icu health professionals. * for the primary endpoint only, patients must not have registered their donation wishes. exclusion criteria: * a patient who is not medically suitable for organ or tissue donation. * a patient who does not have next of kin available to participate in donation conversations. * a patient in the icu who is able to provide first person consent for deceased donation, for example a patient with spinal injuries. * a patient who is suitable to donate only tissue after death.
bevacizumab combined with carboplatin plus paclitaxel chemotherapy to treat metastatic mucosal melanoma

Conditions: Melanoma

Summary: mucosal melanoma is rare and associated with extremely poor prognosis.no effective treatment for advanced mucosal melanoma patients.investigators conducted a randomized phase ii study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

mucosal melanoma is rare and associated with extremely poor prognosis.it is the second most common subtype in asians.no effective treatment for advanced mucosal melanoma patients.malignant melanoma is a highly vascular tumor in which vascular endothelial growth factor(vegf) is strongly expressed and seems to play an important role in disease progression.a randomized phase ii study evaluated the activity of bevacizumab in combination with carboplatin plus paclitaxel(cpb arm) in patients with previously untreated advanced melanoma.overall response rates was 25.5%,median overall survival time(os) was 12.3 months in the cpb arm. investigators conducted a randomized phase ii study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment. 2. ecog performance status 0, 1 3. estimated life expectancy of 12 weeks or greater 4. age 18 years or older, male or female 5. at least one measurable site (diameter≥1cm) of disease (recist 1.1). 6. adequate organ function 7. without symptoms of brain metastases and stable in neuro-functions. 8. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures exclusion criteria: 1. mutations in c-kit or braf-v600e, asked for other target treatments 2. pregnant or lactation women 3. acute infections without control. 4. heart disease history, cardiac function class≥nyha ii. 5. hiv positive or chronic hbv/hcv in active stage. 6. brain metastases or primary tumor with positive symptoms 7. need anti-epileptic treatments 8. organ transplantation history 9. hemorrhagic tendency or related history 10. renal dialysis patients 11. diagnosis of any second malignancy within the last 3 years, except for adequately treated. 12. current treatment on another clinical trial 13. the other improper situations which investigator judged.

Keywords: mucosal melanoma bevacizumab carboplatin paclitaxel
a clinical trial of adjunctive and monotherapy prax-114 in participants with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral prax-114 compared to placebo in the treatment of adults with mdd. the study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for mdd. a sub-study to investigate the pharmacokinetics (pk) of prax-114 and metabolites when dosed in the evening in participants with mdd will be conducted in a subset of participants at selected research sites with serial pk sampling capabilities.


Eligibility criteria:
inclusion criteria: 1. recurrent mdd diagnosis with a current episode duration of at least 12 weeks and no more than 24 months. 2. ham-d17 total score of ≥20 at screening and baseline 3. body mass index (bmi) between 18 and 38 kg/m2 (inclusive). 4. adjunctive treatment participants only: inadequate response to treatment in the current mdd episode, defined as \<50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current mde as specified in the atrq. 5. adjunctive treatment participants only: stable regimen of antidepressant treatment for at least 8 weeks prior to baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose ≥25% for tolerability) during that period. exclusion criteria: 1. lifetime history of seizures, including febrile seizures. 2. neurodegenerative disorder (eg, alzheimer's disease, parkinson's disease, multiple sclerosis, or huntington's disease). 3. lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years. 4. any current psychiatric disorder (other than mdd). 5. lifetime history of treatment resistant depression. 6. received electroconvulsive therapy (ect) or vagus nerve stimulation (vns) within the last year or transcranial magnetic stimulation (tms) within the last 6 months prior to screening. 7. daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Keywords: mood disorders depressive disorder depression depressive disorder, unipolar depressive symptoms agents, gaba receptors, gaba-a allosteric regulation
impact of wearing a support garment following parietal gastrectomy

Conditions: Obesity; Obesity, Morbid

Summary: custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. however, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. the objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. the measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. this study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.


Eligibility criteria:
inclusion criteria: * meeting the nih criteria for bariatric surgery * bmi \>= 35 kg/m2 exclusion criteria: * chronic pulmonary obstructive disease * gastric stoma * psychiatric disease contraindicated for bariatric surgery

Keywords: bariatric surgery
dose-escalation of siltuximab in combination with idarubicin and cytarabine chemotherapy in patients with acute myeloblastic leukaemia (aml) with poor prognosis: siltuxilam

Conditions: Acute Myeloid Leukemia (AML)

Summary: this is a phase 1 dose escalation study testing the addition of an anti-il6 (siltuximab) to standard induction chemotherapy for high-risk aml.

administration of siltuximab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * aml with a poor prognosis defined according to the criteria below: lam first line: age \ = 60 years old and intermediate or unfavorable risk according to the eln 2017 lam in relapse: whatever the age * ecog \<= 2 * patient eligible for intensive chemotherapy * informed consent * liver function tests: transaminases \<3x normal, bilirubin \<1.5x normal * creatinine clearance\> 60ml / min * lvef\> = 50% exclusion criteria: * patients with flt3 itd or tkd mutation eligible for flt3 inhibitor therapy * uncontrolled infection * hep b, c, hiv + * history of diverticulosis / diverticulitis * patients at high risk of gastrointestinal perforation * no social security or any other scheme * pregnant women or patient unable to take contraception (pill, abstinence, iud not allowed) in case of fertility. contraceptive pill, abstinence, unauthorised iud) in case of fertility. a patient who cannot continue contraception for at least 3 months after the last siltuximab injection is not eligible for inclusion. * lactating women * minors * adults under guardianship, curatorship or legal protection * hypersensitivity to one of the active substances or to one of the excipients

Keywords: aml il-6 siltuximab
safety of intramuscular injections (im) of allogeneic plx-pad cells for the treatment of critical limb ischemia (cli)

Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Summary: the purpose of this study is to determine the safety of plx-pad, intra-muscular injections for the treatment of cli patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with abi \< 0.6 or/and tbi \< 0.4 2. rutherford category 4-5 3. non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, mra) obtained within 3 months prior screening visit and signed approval of vascular surgeon. the decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study. 4. in the opinion of the investigator, major amputation is not anticipated over a period of three (3) months. 5. those diabetic subjects who are on optimal diabetes medication, with an hba1c \< 8% exclusion criteria: 1. uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmhg or systolic blood pressure \> 180 mmhg during screening). 2. wounds with severity greater than grade 2 on the wagner scale 3. life-threatening ventricular arrhythmia - except if an icd is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged. 4. st segment elevation myocardial infarction and/or tia/cva within six (6) months prior to enrollment.patients with severe congestive heart failure (i.e. nyha stage iv) 5. in the opinion of the investigator, the patient is unsuitable for cellular therapy.

Keywords: peripheral artery disease peripheral vascular disease critical limb ischemia pad cli
a study of intravenous mircera for the treatment of anemia in dialysis patients

Conditions: Anemia

Summary: this study will assess the efficacy and safety of intravenous mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. the anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving iv epoetin for at least 8 weeks before screening. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
nivolumab or nivolumab plus cisplatin, in combination with radiotherapy in patients with cisplatin-ineligible or eligible locally advanced squamous cell head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. the purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. the purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically proven squamous cell carcinoma of the head and neck (scchn) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx * locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach * no previous radiotherapy or systemic treatment for scchn exclusion criteria: * carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary * clinical or radiological evidence of metastatic disease * prior radiotherapy that overlaps with radiation fields other protocol defined inclusion/exclusion criteria could apply
a trial to assess the pharmacodynamic response in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with copd.


Eligibility criteria:
inclusion criteria: * able to understand the requirements of the study and provide written informed consent * a clinical diagnosis of copd * a current or prior history of at least 10-pack years of cigarette smoking * women of child-bearing potential (wocbp) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study exclusion criteria: * a clinical diagnosis of asthma * other significant disease than copd * subjects who radiation or chemotherapy within the previous 12 months * subjects who had any lung resection * qtcb greater than 0.460 seconds * history of illegal drug abuse or alcohol abuse within the past 5 years

Keywords: pulmonary, obstructive, lungs, copd