Kornimate/medical-research-clean huggingface dataset:
crizotinib (xalkori) expanded access protocol for the treatment of adult or pediatric patients

Conditions: Neoplasm

Summary: this is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age \<18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the alk or ros1 gene or an activating genetic alteration involving the cmet gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

crizotinib is indicated in the u.s. for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test. commercially available dosage forms are 250 mg and 200 mg capsules. this expanded access protocol (eap) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the alk or ros1 gene or an activating genetic alteration involving the c met gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg ntrk3 etv6 fusion gene may be considered on a case by case basis subject to approval by the sponsor). * inability to swallow crizotinib capsules, adult patients of whom must either have a feeding tube in place or have completed clinical evaluation of dysphagia without any reversible causes identified. * at least 12 months of age (patients \<12 months of age will be evaluated on a case by case basis and discussed with the sponsor). exclusion criteria: * currently receiving crizotinib, another alk inhibitor, or an investigational product. * adult patients who have been previously treated with crizotinib.

Keywords: chromosomal rearrangement activating mutation activating genetic alteration genetic aberration alk ros1 cmet crizotinib oral formulation
using multiphase optimization strategy (most) to optimize a cost-effective, sustainable and scalable smoking cessation package for smokers in hiv clinical care

Conditions: Human Immunodeficiency Virus (HIV); Smoking Cessation

Summary: this study's long-term goal is to improve clinical outcomes among smokers living with hiv (slwh) by providing smoking cessation interventions in hiv clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with hiv.

this study will utilize multiphase optimization strategy (most) to optimize a smoking cessation treatment for hiv clinical care by directly targeting patient barriers to quitting and clinical care barriers to reaching and effectively treating a broad heterogeneous population of smokers living with hiv. the four intervention components will be aimed at barriers to quitting among smokers living with hiv and include motivational interviewing; peer mentoring; text-messaging; combination nicotine replacement therapy. these components have shown promise in research but are under-utilized to help smokers living with hiv quit and have not been tested in an optimization trial. this study will also incorporate data to evaluate the fidelity, acceptability and feasibility of the interventions in the hiv clinical care context in order to identify the most cost-effective, sustainable and scalable tobacco treatment package for the care environment.

Eligibility criteria:
inclusion criteria: * status as hiv+ * age 18 or older * currently smokes ≥ 5 cpd, on average, in past month * positive for salivary cotinine * able to understand the nature of the study and the consenting process * is engaged in hiv clinical care * living in larger nyc metropolitan area currently and for the next 6-8 months exclusion criteria: * suffers from any medical condition or contraindication precluding use of nicotine replacement therapy * current use of any tobacco cessation medications (varenicline, nrt patch, nicotine gum, lozenge, spray or inhaler, or bupropion) * currently participating in a smoking cessation program * pregnant or nursing and plans to be in next 6 months * has schizophrenia/schizo-affective disorder * does not have a functioning mobile phone that can receive text messages

Keywords: most multiphase optimization strategy implementation hiv clinical care
histological and imaging assessment of the structural characteristics of the femoro-popliteal arterial segment

Conditions: Chronic Limb Ischemia

Summary: the femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. its management is mainly endovascular (standard and coated-balloon angioplasty, stenting). however, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment. there is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * men and women * patient with chronic limb ischemia that is scheduled for transfemoral amputation in the university hospital of strasbourg * patient giving his -non-opposition to the explantation and use of the femoro-popliteal arterial segment exclusion criteria: * refusal to give his consent * impossibility to give clear information to the patient * pregnant and breastfeeding women * patient under administrative protection
loads, injuries and illnesses among elite handball players

Conditions: Injuries; Illnesses Systemic; Illness, Chronic; Illnesses, Occupational; Psychological; Physical Illness; Physical Stress; Physical Injury; Physical Trauma; Social Stress; Athletic Injuries

Summary: primary goal of the research is to determine whether injury/illness occurrence is influenced by the academic, training and competition loads, as well as the overall load (sum of academic/work, training and competition loads) in elite handball athletes to examine whether subjective measures of perceived overall stress correlate with objectively measured levels of stress. determine the benefits of certain biomarkers to monitor stress, load and injury/illness occurrence in athletes.

the current structure and organizational initiatives do not meet the needs of athletes as they face different challenges throughout their careers. there is a need for better health surveillance, load monitoring and support services with a focus on injury/illnesses prevention and rehabilitation. the main goal of the research is to determine how specific loads affect the occurrence of injuries and illnesses in elite handball players and how much of the total load an athlete can withstand before an injury/illness occurs. thus, the study will attempt to identify athletes at risk of injury/illness by monitoring their workload with subjective (perceived stress) and objective (biomarkers, hours of workload) measurements. one of the goals is also to determine the correlation between objective measures of stress (biomarkers) and subjective measures of stress (athlete's stress assessment). the results will not only be important for the medical and sports community for development of new injury prevention and rehabilitation strategies, but also for structuring the correct policy recommendations for athletes' general health. the research will be carried out on approx. 250 elite handball players (the entire 1st men's handball league) during one handball season. in addition to other parameters (monitoring of load, injuries and illnesses), blood samples will be taken from athletes at five time points according to their training cycle.

Eligibility criteria:
inclusion criteria: * at least national-level handball players above 18 years of age, who are in a dual-career setting. * handball players older than 18 years old, who are competing at least at national level and are not in a dual-career setting will be matched by their demographic characteristics and included in the control group. exclusion criteria: * not fulfilling inclusion critieria
local control with reduced-dose radiotherapy for high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to give 12t a smaller dose of radiation in order to decrease these late side effects.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of neuroblastoma (international classification of disease for oncology \[icd-o\] morphology 9500/3) confirmed by mskcc pathologic review * patients must have high-risk neuroblastoma as defined by the cog risk stratification schema o patients with international agreement on staging (inss) stage 4 are eligible with the following: * mycn amplification, regardless of age or additional biologic features * age \>18 months, regardless of biologic features or * age 1-18 months, with any of the 3 following unfavorable biologic or features: mycn amplification, unfavorable pathology, and/or dna index = 1 o patients with inss stage 3 are eligible with the following: * mycn amplification, regardless of age or additional biologic features or * age \> 18 months with unfavorable pathology, regardless of mycn status o patients with inss stage 2a or 2b are eligible with the following: * mycn amplification, regardless of age or additional biologic features o patients with inss stage 4s are eligible with the following: * mycn amplification, regardless of additional biologic features patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial. * age at time of enrollment of ≥1 month and ≤18 years * female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start. * female patients who are lactating must agree to stop breast-feeding. * sexually active patients of childbearing potential must agree to use effective contraception. exclusion criteria: * patients with gross residual tumor after surgical resection * patients who have received prior radiotherapy at or adjacent to the primary tumor bed * patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.

Keywords: reduced-dose radiotherapy 14-186
pradaxa study in non-valvular atrial fibrillation patients with severely impaired renal function

Conditions: Atrial Fibrillation

Summary: the goal of this study is to assess dabigatran pharmacokinetics in nvaf subjects with severe renal impairment defined as creatinine clearance between 15 and 30 ml/min calculated by cockcroft-gault formula. the dabigatran etexilate dose of 75 mg bid was approved by the fda for nvaf patients with severe renal impairment (crcl 15-30 ml/min) , based on pharmacokinetic modeling and simulation.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy, * subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 ml/min by cockcroft-gault formula, * male and female patients, age =18 years at entry exclusion criteria: * contraindications to pradaxa (history of a serious hypersensitivity reaction to pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve), * creatinine clearance \<15ml/min or patients with end stage renal disease on dialysis, * creatinine clearance \>30 ml/min, * pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner, * patients who are participating in another drug study, * patients who have participated in another drug study within 6 weeks, * patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview, * any condition the investigator believes would not allow safe participation in the study,
adrenal artery ablation for uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: the activation of the renin-angiotensin-aldosterone system (raas) plays a key role in uncontrolled hypertension or resistant hypertension. surgery and and medicine are the main treatment for primary aldosteronism(pa) by the current guidelines. however, only a small part of patients with pa meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of raas have to take spironolactone or other antihypertensive drugs for long time. on the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. moreover, hyperaldosterone is still not corrected by spironolactone, which causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized. with the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(aaa) was observed with significant decrease of blood aldosterone and blood pressure in patients with pa, which made it promising that uncontrolled hypertension could be relieved by selective aaa.


Eligibility criteria:
inclusion criteria: * male or female, aged between 30-60 years old. * patients with poorly controlled hypertension (office blood pressure ≥130/80 mmhg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks * positional blood aldosterone ≥100pg/ml. * informed consent signed and agreed to participate in this trial. exclusion criteria: * hyperkalemia or hypokalemia. * secondary hypertension. * history of depression, schizophrenia or vascular dementia. * renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome. * adrenergic insufficiency. * heart failure with nyha grade ⅱ-ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events. * acute infections, tumors and severe arrhythmias, psychiatric disorders, * drugs or alcohol addicts. * liver dysfunction or the following history of liver disease: ast or alt 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history. * fertile woman without contraceptives. * coagulation dysfunction. * pregnant women or lactating women. * participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial. * any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug. * allergy or any contraindications for the study drugs, contrast agents and alcohol. * refused to sign informed consent

Keywords: uncontrolled hypertension resistant hypertension aldosterone ablation adrenal gland
a study of bms-986482 alone or as combination therapy in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to test the safety and efficacy of bms-986482 alone and as combination therapy in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * all participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by recist v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant. * participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the icf. * participants in part 1a may have nsclc, scchn, mss-crc, gastric/gej adenocarcinoma, urothelial carcinoma, pdac, melanoma or breast cancer (tnbc and er+her2-). * participants in part 1b1 and 2b1 must have nsclc and, if known, should have documented status for egfr, kras, alk, ros1, ret, ntrk, met exon 14 skipping mutations, and braf v600e.participants must have received platinum-based chemotherapy and anti-pd-(l)1 therapy, if eligible and available. * participants in parts 1b2, 2b2, and 1c must have cutaneous, acral, mucosal, or unknown primary melanoma. participants with uveal/ocular melanoma are excluded. participants must be melanoma 2l+. * participants in part 1b3 must have advanced or metastatic mss-crc. * participants in part 2a may have advanced solid tumors (advanced, unresectable, or metastatic nsclc, advanced, unresectable, hormone resistant er+her2-breast cancer or pancreatic adenocarcinoma \[pdac\]) based on emerging data. * participants in part 2b3 must have advanced or metastatic mss-crc. * for all participants in part 1c cohort, a tumor sample from a ("fresh") biopsy \[core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen\] must be obtained (obtained within 1 month of the start of the screening, if there are tumor sites that can be biopsied with acceptable clinical risk). exclusion criteria: * history of life threatening immune mediated toxicity related to prior t-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures. * any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: immuno-oncology regulatory t cells tregs
choosing opioid management for pain and analyzing acute chest syndrome (acs) rates equally

Conditions: Pain; Sickle Cell Disease

Summary: the pathophysiology of sickle cell disease (scd) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (voc). these painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. painful episodes are the most common cause of hospitalization, morbidity, and impairment for scd patients. there is no therapy that completely prevents or directly aborts painful events for all patients. consequently, treatment for acute voc is primarily supportive using hydration and medicinal pain control. every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. the primary hypothesis to be tested in this double blind, randomized controlled trial is that nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. the investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. further hypotheses to be tested is ability to recruit patient participants while being treated in the emergency department and that continuous infusion of nalbuphine with accompanying patient controlled analgesia (pca) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.


Eligibility criteria:
inclusion criteria: * patients with sickle cell disease (ss, sc, sβthal) who are hospitalized for acute painful episodes * 6 years old and \< 19 years old * normal baseline chest radiograph * normal renal and hepatic function within the previous 12 months exclusion criteria: * previous patient participation in this clinical trial * any patient on chronic transfusion any patient with pulmonary infiltrate on chest radiograph on admission * any patient with dsm diagnosis, excluding those with attention deficit disorder, on or off treatment * any patient with documented allergy to either study drug * any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as: * hepatic dysfunction (3x alt), * renal dysfunction (cr \> 1 children/adolescents, cr \>2 adults), * pulmonary hypertension (trj \>3.0), * cardiac dysfunction. * any patient with symptoms of an acute stroke. * any patient known or suspected to be pregnant. * any patient with priapism * the patient or guardian who will not give consent or assent to be randomized.

Keywords: pain sickle cell nubain morphine acute chest side effects
ultrasound guided trigeminal nerve block in maxillofacial surgeries

Conditions: Maxillofacial Injuries

Summary: this study aims to evaluate the perioperative analgesic effect of usg trigeminal nerve block in adult patients undergoing maxillofacial surgery. we hypothesized that giving usg-guided tnb in patients undergoing maxilla-facial surgery could reduce the requirements of opioids perioperatively and avoid the side effects of opioids used. the aim of this double-blind study is to evaluate the effect of usg-guided tnb intra- and post-operatively in terms of pain relief, opioid consumption and adverse effects in patients undergoing such elective surgeries.

nerve block using various agents has been proposed as a part of the multimodal analgesia to decrease consumption of intravenous opioids and also decrease its complications such as respiratory depression. recent research has focused on the role of trigeminal nerve blocks (tnb) for management of facial pain . this block was found to be effective in trigeminalneuralgia , palate surgeries and oral and dental surgeries. anatomically, the gasserian ganglion lies in the middle cranial fossa within the meckel's cave and gives rise to three branches (1) ophthalmic, (2) maxillary, and (3) mandibular which exit from skull through three distinct foramina: the superior orbital fissure, the foramen rotundum, and the foramen ovale. the injection anterior and medial to lateral pterygoid plate into the upper part of pterygopalatine fossa (ppf) will place the injectate in close vicinity to foramen rotundum from where drug migrates into the middle cranial fossa. since the ppf is extremely vascular, visualizing vascular and soft tissue structures in real time minimize the potential inadvertent complications. fluoroscopy-guided blocks have long been considered the gold standard practice in head and neck pain management. alternatively, computed tomography-guided procedures provide a useful option but expensive and have radiation hazard. lately, ultrasonography (usg) has been used extensively for perioperative pain relief providing excellent visualization of soft tissue and vasculature with real-time needle placement. to date, very few published studies had evaluated the value of usg-guided tnb for control of perioperative pain in maxillofacial surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesia (asa) criteria i/ii * scheduled for elective unilateral maxillo-facial surgery exclusion criteria: * patients with polytrauma and fracture base of skull. * patients with known allergy to the study drugs. * patients with coagulopathy. * patients with infection at puncture site. * patients necessitating postoperative ventilation from the start, since it will be difficult to assess respiratory depression and postoperative pain.