Kornimate/medical-research-clean huggingface dataset:
sp16 as a therapeutic for covid-19 induced ards

Conditions: SARS CoV 2 Infection; Pneumonia

Summary: this randomized, double-blind, placebo-controlled, phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of sp16, an anti-inflammatory drug, in patients with pneumonia due to sars-cov-2 infection. the study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of sp16 (6 mg or 12 mg) or placebo by subcutaneous injection.

sars-cov-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. sp16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. sp16's mechanism of action is through targeting lrp1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. the main objective of this study is to determine the safety and tolerability, and effects on inflammation of sp16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). sp16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. the study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both spo2 \> 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the intensive care unit (icu).

Eligibility criteria:
inclusion criteria: to be considered eligible to participate in this study, the subject must meet all of the inclusion criteria listed below: * hospitalized patients age ≥ 18 with diagnosis of sars-cov-2-infection based on positive * pcr test result and can provide informed consent * diagnosed with pneumonia due to sars-cov-2 * respiratory rate ≥ 25/minute and spo2 ≤ 93% * review of chest radiograph, chest computed tomography (ct) scan, or chest ultrasound consistent with bilateral infiltrates. * horowitz index (partial pressure of oxygen/fraction of inspired oxygen \[pao2/fio2\]) ≤ 300. if a subject does not have an arterial line in place, a spo2/fio2 ≤ 315 may be used. exclusion criteria: to be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below: * age \< 18 * pregnant or lactating women * history of heart failure * clinically significant cardiac dysrhythmia, as determined by investigator * history renal impairment * presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2000 mm3, aspartate aminotransferase

Keywords: pneumonia due to sars-cov-2
comparison of train of four, tetanus 50 and 100 hz recovery after rocuronium block reversed by sugammadex

Conditions: Postoperative Residual Curarization

Summary: despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. while this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 hz stimulation showed a marked fade. this result has been observed in absence of reversal agent administration. therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 hz and tetanus 100 hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). the sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted. two questions have to be investigated. first, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? the attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.


Eligibility criteria:
inclusion criteria: * asa clinical status 1 to 3 * informed consent obtained before anesthesia induction exclusion criteria: * asa clinical status 4 * emergency surgery; scheduled surgery in prone position, * hepatic or renal disease, * bmi higher than 35, * allergy to rocuronium or sugammadex
extension study to assess safety and efficacy of ain457 in patients with active non-infectious uveitis

Conditions: Uveitis

Summary: the purpose of the extension study was to provide patients completing the 28-week core study (nct01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.


Eligibility criteria:
inclusion criteria: * patients who have completed the entire treatment period of the 28-week core study * patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension study exclusion criteria: * inability or unwillingness to undergo repeated subcutaneous injections * inability to comply with study or follow-up procedures * any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\> 5 miu/ml) * women of childbearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, unless * they are using simultaneously double barrier or two acceptable methods of contraception * they are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing * they have undergone reliable surgical sterilization at least six (6) months prior to initial dosing * their career, lifestyle, or sexual orientation precludes intercourse with a male partner * partners have been sterilized by vasectomy or other reliable means other protocol-defined inclusion/exclusion criteria may apply

Keywords: active uveitis intermediate uveitis panuveitis posterior uveitis uveitis
evaluating endostatin plus tc regimen in secondary malignant neoplasm of liver using contrast enhancement ultrasonography

Conditions: Non Small Cell Lung Cancer; Nasopharyngeal Cancer; Liver Metastasis

Summary: contrast enhancement ultrasonography（ceus）could be used to evaluate the blood flow perfusion liver cancer. in this clinical trial, ceus was used to evaluated the changes of blood flow perfusion of secondary malignant neoplasm of liver after treated with endostatin plus paclitaxel and carboplatin regimen.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of nasopharyngeal carcinoma or nsclc * with an evaluable secondary malignant neoplasm of liver, diameter≥2cm * without transcatheter arterial chemoembolization (tace) treatment * performance status of 0 to 1 on the eastern cooperative oncology group (ecog) scale. * estimated life expectancy of at least 3 months * patient compliance and geographic proximity that allow adequate follow-up. * adequate organ function including the following: bone marrow: absolute neutrophil count (anc) \>or= 1.5x10\^9/l, platelets \>or= 100x10\^9/l, hemoglobin \>or= 9g/dl. hepatic: bilirubin \ 45 ml/min. * men or women of at least 18 years of age. * signed informed consent from patient. exclusion criteria: * women who are pregnant or in lactation * systemic treatment for another cancer within the year prior to study entry * known hypersensitivity to any of the study drugs or to drugs with similar chemical structures * use of investigational agents within 28 days of the baseline visit, or participating simultaneously in any other clinical studies * severe co-morbidity of any type that may interfere with assessment of the patient for the study

Keywords: nsclc npc
ovarian cancer hemoscope trial

Conditions: Ovarian Neoplasms

Summary: this is a prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor dna. this observational pilot trial will also be used to examine the genetic variants/mutations present in the tumor tissue dna.


Eligibility criteria:
inclusion criteria: case group * patients with ovarian cancer undergoing surgery (all stages) * over 18 years old control group * patients with a benign gynecological condition undergoing surgery * over 18 years old exclusion criteria: * previous cancer diagnosis (all) * radiation therapy before surgical treatment * bone marrow transplant * chemotherapy before surgical treatment * invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
impact of care transition on medication adherence in cardiac patients

Conditions: Acute Coronary Syndrome

Summary: background: medication adherence following acute coronary syndrome (acs) is often sub-optimal. poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. after a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. the impact of care transition on medication adherence has not been studied in acs. objectives: this study will explore how an acs patients' journey from hospital into primary care affects medicines use. further, to understand how medicine information is communicated and how this influences patient beliefs about medicines. methods: this is an interview study with recently hospitalised acs patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. patients will be recruited from guy's and st thomas' nhs foundation trust and telephone interviews will be scheduled 3-4 weeks post-discharge. an inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached. dissemination: the primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an acs. the in-depth patient data collected in this current study will contribute to the design and development of the intervention. understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.


Eligibility criteria:
inclusion criteria: * over 18 years of age * have a confirmed index diagnosis of acs * have sufficient spoken english to partake in an interview exclusion criteria: * under 18 years of age * lack the level of spoken english required to be interviewed

Keywords: qualitative care transition medication
thyroid hormone replacement for subclinical hypothyroidism and dyslipidemia in ascvd (thyroheart-lipid study)

Conditions: Dyslipidemia; Subclinical hypothyroïdism; Statin; ASCVD

Summary: in ascvd patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (ldl-c\>1.8mmol/l) is usually higher than that in population with normal thyroid function. the present study aims to randomly compare two lipid-lowering therapeutic strategies (statins only vs. statins combined with thyroid hormone supplement).


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female; 2. stable or unstable angina with evidence of myocardial ischemia; coronary angiography reveals stenosis lesions; 3. subclinical hypothyroidism defined as mild tsh elevation within 5-10miu/l and normal serum thyroid hormone levels within reference ranges; 4. level of ldl-c is more than 1.8mmol/l before randomization. 5. participate in the trial voluntarily and signs the written informed consent form. exclusion criteria: 1. those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit; 2. symptoms of severe heart failure (nyha class iii and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventricle ngiography); 3. pregnant or lactating women; 4. complicated with severe organ dysfunction: large number of pericardial effusion; acute myocardial infarction; acute myocarditis; acute left heart failure; cardiogenic shock; severe arrhythmia, such as ventricular tachycardia, ventricular fibrillation, frequent atrial / ventricular premature beat, poor control of fast ventricular fibrillation, and bradycardia requiring pacemaker therapy, etc. 5. patients who are unable to withstand lipid-lowering therapy or thyroid hormone replacement due to allergy to statins or levothyroxine; 6. serum ast/alt is three times higher than the upper limits of normal. 7. patient's life expectancy is less than 12 months; 8. those waiting for heart transplantation; 9. patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Keywords: thyroid hormone replacement subclinical hypothyroidism dyslipidemia ascvd statin
pilot study of hepatitis c virus entry inhibitor (itx 5061) in liver transplant recipients

Conditions: Hepatitis C; Evidence of Liver Transplantation

Summary: this is a phase i pilot study to determine the safety and preliminary efficacy of a novel hepatitis c virus (hcv) entry inhibitor (itx 5061) in patients with hcv infection undergoing liver transplantation.

hepatitis c virus (hcv) infection is common and treatment options at present are limited. recurrence of hcv infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver. studies of itx 5061 in vitro have shown it to be a potent inhibitor of hcv entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor bi suggesting it may reduce graft re-infection rates after liver transplant. there are no studies of treatments to block host receptors for hcv and the investigators hypothesize that itx 5061 will modulate hcv kinetics in the early phase post liver transplant.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, ≤ 65 years old * plasma hcv rna positive at time of listing for liver transplantation * accepted for liver transplantation for any of: * end-stage liver disease due to hcv infection * end-stage liver disease due to hcv infection and alcohol related liver disease (ald) * hcc due to hcv exclusion criteria: * refusal or inability to give informed consent * viral co-infection with either hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * pregnancy or breastfeeding * women, of child-bearing potential, who are not willing to practice effective contraception * men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception * any situation that in the investigator's opinion may interfere with optimal study participation * participation in any clinical study of an investigational agent within 30 days of recruitment * transplantation with a donor organ from a hcv positive individual

Keywords: hepatitis c virus entry scavenger receptor-bi high density lipoprotein liver transplantation
simulation-based caregiving skills training for family members of high grade glioma patients

Conditions: Glioma

Summary: family caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. it is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. this project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.

trial 1 (single-arm study) • aim 1: examine the usability of the intervention content and trial assessments in 10 caregiver-patient dyads to refine study procedures as needed. trial 2 (rct) aim 1 (primary aim): determine the feasibility of implementing a caregiving intervention using a randomized controlled design in 50 caregiver-hgg patient dyads. aim 2: evaluate the initial evidence for intervention efficacy relative to a wlc group regarding patient and caregiver psychological symptoms (primary outcome), caregiver caregiving efficacy and role adjustment, and patient cancer-related symptoms and healthcare utilization (secondary outcomes). aim 3: understand caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research.

Eligibility criteria:
inclusion criteria: * fcgs (e.g., spouse/partner, parent, adult child) of patients diagnosed with hgg receiving any form of cancer treatment (including palliative intent) at mdacc. * patients must have a karnofsky performance status (kps) of 100 to 50. if the patient's karnofsky performance status drops below 50 both patient and caregiver will be removed from the study. * both fcgs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak english and (3) provide informed consent. exclusion criteria: * fcgs who regularly participate in psychotherapy with a licensed professional (self-reported). * patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record. * children under the age of 18 will not be included in this trial. first and foremost, it is unlikely that a person under the age 18 is diagnosed with an hgg. * childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population. additionally, the assessment tools are not validated for minors. * while pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes). it is unlikely that patients diagnosed with an hgg will be pregnant. moreover, the current caregiver intervention is not designed to address the care needs of pregnant cancer patients.
docetaxel, androgen deprivation and proton therapy for high risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.


Eligibility criteria:
inclusion criteria: \* adenocarcinoma of the prostate. exclusion criteria: * previous prostate cancer treatment such as chemotherapy and/or pelvic radiation. * active inflammatory bowel disease (diverticulitis, crohn's disease or ulcerative colitis) affecting the rectum. (non-active diverticulitis and crohn's disease not affecting the rectum are allowed.) * history of hip replacement. * prior intrapelvic surgery. this includes the following: * transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding * transabdominal pelvic surgery * bladder surgery * prior myocardial infarction (mi) or congestive heart failure (chf). * taking saw palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Keywords: prostate cancer, proton radiation
study of a reduced-toxicity "submyeloablative" conditioning regimen prior to allogeneic stem cell transplantation in patients with hematological malignancies

Conditions: Hematological Malignancies

Summary: the goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - trm-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.


Eligibility criteria:
inclusion criteria: * patients affiliated to a social security reimbursement system * adults (men or women) aged between 18 and 65 years * negative test for pregnancy * ecog 0-1 or karnofsky index ≥ 70% * availability of an hla-identical sibling donor, or an hla-matched unrelated donor (10/10 hla compatibility in a, b, c, drb1, dqb1 (a single allelic mismatch at the level of cw can be accepted) * life expectancy \> 6 months * signed informed consent * diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation exclusion criteria: * pregnant woman or not willing to take effective contraception * classical contra-indications to the allogeneic stem cell transplantation procedure * any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics * patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen * an hla-matched sibling donor who has a contra-indication for stem cell mobilization and collection * history of uncontrolled psychiatric condition * patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.

Keywords: allogeneic stem cell transplantation reduced-intensity conditioning reduced-toxicity conditioning hematological malignancies iv busulfan
a study of the use of acellular dermal matrix for breast reconstruction

Conditions: Breast Cancer

Summary: the researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when acellular dermal matrix (adm) is used compared to when adm is not used. these complications include infections, the need for tissue expander (te) or implant removal, and other conditions that lead to additional surgery.


Eligibility criteria:
inclusion criteria: * females aged 21-60 years * planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer * planning to undergo immediate two-stage prosthetic breast reconstruction with te placement as the first stage * planning to undergo nipple-sparing or skin-sparing mastectomy * adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion * intraoperative confirmation of prepectoral plane viability by operating physician exclusion criteria: * history of radiotherapy to the operative breast * current smoker * non-english speaking patients * planning to undergo direct-to-implant reconstruction * prior sternotomy

Keywords: acellular dermal matrix breast reconstruction mastectomy 22-071