Kornimate/medical-research-clean huggingface dataset:
a phase 1 safety study of sanguinate™ in patients with acute severe anemia.

Conditions: Acute Anemia

Summary: in this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dl, but who are unwilling or unable to receive red blood cell (rbc) transfusion, will receive one or more infusions of sanguinate as are deemed necessary by the investigator for survival of the acute anemic episode.

data collection for each patient during the in-patient portion of the study will be required for up to a maximum of 14 days while under critical care, with additional collection of safety-related findings at 7 days and 14 days after the last infusion of sanguinate. each patient will thus have up to 28 days participation in the trial. a minimum of 100 subjects are to be enrolled and to receive at least one infusion of sanguinate, with 14-day follow-up after the last infusion. because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ecg (e.g., by telemetry) before, during, and after all study drug infusions.

Eligibility criteria:
inclusion criteria: 1. the patient would otherwise receive rbc transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive rbcs 2. hemoglobin ≤ 5 g/dl, or hemoglobin ≤ 7 g/dl following a decline of ≥ 5 g/dl over less than 7 days 3. age ≥ 18 years 4. receiving or willing to receive supplemental iron therapy (unless contraindicated) 5. receiving or willing to receive erythropoiesis-stimulating agent (epo) therapy 6. patient or legally authorized representative provided consent to participate 7. investigator determination that the patient is an appropriate candidate for study enrollment exclusion criteria: 1. hemoglobin ≤ 2 g/dl 2. presence of severe trauma (e.g., injury severity score (iss)/new injury severity score (niss) score ≥ 25) 3. unable to provide sufficient blood sample volume for screening assessments; or 4. pregnant; or 5. investigator determination that the patient is not an appropriate candidate for study enrollment
a efficacy and safety study of r935788 in the treatment of persistent/chronic immune thrombocytopenic purpura (itp)

Conditions: Immune Thrombocytopenic Purpura

Summary: the purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic immune thrombocytopenic purpura (itp).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of persistent/chronic itp for at least 3 months. * average platelet count \ 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts exclusion criteria: * clinical diagnosis of autoimmune hemolytic anemia * uncontrolled or poorly controlled hypertension * history of coagulopathy including prothrombotic conditions

Keywords: persistent immune thrombocytopenic purpura chronic immune thrombocytopenic purpura
self-expandable metallic stent versus multiple plastic stents in post orthotopic liver transplantation biliary stenosis

Conditions: Biliary Anastomotic Stenosis; Biliary Stricture

Summary: biliary complications are one of the most common problems after orthotopic liver transplantation (olt),occurring in up to 24% of patients. anastomotic strictures have been endoscopically managed with plastic stents placement. recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. the investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.

patients with biliary stricture after olt will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (sems) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups. final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.

Eligibility criteria:
inclusion criteria: * post-olt biliary anastomotic stenosis (at least 1 month post-operative) * jaundice, cholestasis and/or biliary tree dilation on us exclusion criteria: * biliary fistulae * non-anastomotic stricture * combine anastomotic and non-anastomotic stricture

Keywords: biliary anastomotic stricture orthotopic liver transplantation ercp
estimation of pulmonary vascular resistance by contrast echocardiography

Conditions: Pulmonary Arterial Hypertension

Summary: an echocardiogram using definity contrast can provide the same information as the standard right heart catheterization.


Eligibility criteria:
inclusion criteria: * adult patients scheduled to undergo right heart catheterization at the george washington university hospital exclusion criteria: * patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to definity or hypersensitivity to perflutren

Keywords: pulmonary arterial hypertension pulmonary vascular resistance right heart catheterization
mindfulness based stress reduction in copd

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: the objective of this study is to test the efficacy of a mindfulness based stress reduction program in copd on quality of life, dyspnea, daily physical activity and mindfulness during daily life.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd * clinically significant dyspnea, as determined by a score of \>=2 on the medical research council of dyspnea score questionnaire (0-4). exclusion criteria: * patients with a high likelihood of not completing the program (active chemical dependency) * patients with an inability fo provide good data or to follow commands (neurologic or psychiatric condition). * poor motivation or lack of interest in program

Keywords: chronic obstructive pulmonary disease copd
stress-induced vascular dysfunction: evaluation of endothelial function in a cohort of patients with takotsubo syndrome

Conditions: Takotsubo Syndrome

Summary: the aim of this prospective single-center study is to evaluate endothelial function, arterial compliance, sympathetic nervous activity at rest and after mental and physical stress, carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion in patients with apical ballooning syndrome and age-matched controls.

the aim of this prospective single-center study is to evaluate endothelial function, arterial compliance, sympathetic nervous activity at rest and after mental and physical stress, carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion in patients with takotsubo syndrome (apical ballooning syndrome/broken heart syndrome) and age-matched controls.

Eligibility criteria:
inclusion criteria: we plan to include male or female subjects, age 18-80 with a diagnosis of takotsubo syndrome (according to standard clinical criteria\[strony, j., et al., analysis of shear stress and hemodynamic factors in a model of coronary artery stenosis and thrombosis. am j physiol, 1993. 265(5 pt 2): p. h1787-96.\]) in the last 10 years. moreover, patients matched to the takotsubo patients for age and cardiovascular risk factors will be included in the control group. all patients will signed an written informed consent exclusion criteria: * long acting nitrates, or pde-5-hemmer * alcohol or drug abuse, * malignancy (unless healed or remission \> 5 years) * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * pulmonary hypertension * participation in another study within the last month

Keywords: takotsubo syndrome apical balooning syndrome stress-cardiomyopathy endothelial function sympathetic nervous activity platelet adhesion arterial compliance
pharmacokinetics and dynamics of dexmedetomidine as adjuvant in tap block

Conditions: Postoperative Pain

Summary: tap-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.


Eligibility criteria:
inclusion criteria: * 24 asa i-ii * patients (age 18-60 years * weight 50-89 kg exclusion criteria: * a known allergy to the study drugs * significant cardiac * respiratory, renal or hepatic diseases * bleeding diathesis
efficacy of ultrasound-assisted caudal epidural pulsed radiofrequency for anal pain in cancer patients,

Conditions: Perineal Pain

Summary: our primary goal will be to investigate the analgesic efficacy of ultrasound (us)-assisted caudal epidural prf (pulsed radiofrequency)( stimulation in patients with perineal or anal pain cancer patients using (visual analog scale (vas) scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and intervention related side effects.


Eligibility criteria:
inclusion criteria: * american society of anesthesiology physical status of i or iii (asa), of both sex * cancer-related anal or perineal pain exclusion criteria: * coagulopathies * allergies to the contrast dye * patients with moderate or significant cardiac/respiratory disease or hepatic
feasibility of gamma transcranial alternating current stimulation to reduce beta-amyloid load and improve memory

Conditions: Mild Cognitive Impairment

Summary: this project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.

thirteen individuals with amci received eight 60-minute sessions of 40-hz (gamma) transcranial alternating current stimulation (tacs) in a single-arm design. outcome measures were assessed pre- and post-intervention.

Eligibility criteria:
inclusion criteria: * english speaking * grade 12 or more education * normal or corrected to normal vision and hearing * ability to complete cognitive tasks * ability to cooperate and comply with all study procedures * ability to tolerate tacs * self-reported memory complaint * diagnosed with mild cognitive impairment * amyloid positive exclusion criteria: * neurological or psychiatric disorders other than mild cognitive impairment * receiving investigational medications or have participated in a trial with investigational medications within last 30 days * family history of epilepsy * implanted electronic devices (e.g., pacemaker) * prior head trauma * pregnant * iq \< 80 * taking cholinesterase inhibitory, memantine, or psychotropic medication * taking anti-depressants or anti-anxiety medication * color blind * substance abuse * glaucoma * macular degeneration * amblyopia (lazy eye) * strabismus (crossed eyes)
interest of care rule to exclude the hypothesis of an acute coronary syndrome without bioassay - icare

Conditions: Chest Pain

Summary: acute coronary syndrome (acs) is a major health problem and its diagnosis remains a challenge for the emergency physician. the management of a suspected acs is well codified, based on troponin assays, renewed if necessary. conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the emergency department are unclear. the fear is, firstly, to miss a potentially life treating diagnosis and, secondly, exposing many patients to unnecessary examinations. the advent of highly sensitive troponin assays also increases the risk of over-investigation by a larger number of elevations of the biomarker in non-coronary circumstances leading to a prolongation of hospitalization and, possibly, unnecessary treatments and invasive investigations. care rule could help to streamline this first step. it is established by assigning a value from 0 to 2 to the items: characteristic of pain, age, risk factors and ecg. the search for an acs is not justified if the sum of points is ≤1 (negative rule) and, conversely, a troponin should be performed if the sum is \> 1 (positive rule). indeed, care rule corresponds to the first 4 items of the heart score (the latter standing for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding acs with a risk of false negatives \<2%. a negative care rule always corresponds to a heart score ≤3. our study aims to confirm the interest of care rule to streamline the search for an acs in chest pain as an observational european multicenter prospective study.

care rule was evaluated in a prospective study of routine care on 641 patients among which 9.8% had a major adverse cardiac event (mace). 200 patients (31%) had a negative rule and none showed mace during the 45-day follow-up (0% \[0-1.9\]). among these 200 patients, 119 had a standard troponin assay, a single dosage was increased. the main objective is to demonstrate the reliability of care rule to exclude acs in chest pain, using an observational franco-belgian multicenter study in routine care. if the reliability of care rule is confirmed in emergency departments, it could be evaluated to be used in other circumstances such as in pre-hospital or in private practice for the general practitioner or cardiologist. in summary, the icare study is intended to allow a rationalization of the management of patients with chest pain, limiting the use of unnecessary investigations while ensuring the safety of care.

Eligibility criteria:
inclusion criteria: * patient admitted to the emergency department or chest pain * patient admitted in a non-scheduled manner * non-traumatic chest pain * no formal diagnosis after frontline examinations exclusion criteria: * patient with an ecg showing a coronary syndrome st + * patient for which a 6-weeks follow-up would be impossible * patient refusing to participate

Keywords: acute coronary syndrome
diffusion weighted magnetic resonance imaging in chronic kidney disease

Conditions: Renal Disease

Summary: chronic kidney disease (ckd) is a common global public health problem and the average incidence of end-stage renal disease in developing countries is 150 per million population, which is lower than that in the developed world

since renal parenchymal disease is accompanied by renal dysfunction, monitoring renal function permits assessment of disease progression, and periodic assessment of renal function is necessary for optimal management of a patient with suspected/proven renal disease. serum creatinine (s cr), blood urea (bu), and estimated glomerular filtration rate (egfr) derived from creatinine clearance are useful for monitoring renal function; however, these indirect measures of renal filtration are imperfect and cannot assess single kidney function. keeping in view the limitations of serum markers, imaging may play an important role in the evaluation of renal parenchymal disease. ultrasonography (us) and computed tomographic (ct) scan provide good anatomic images but limited functional information. although us may show changes in renal echogenicity, it suffers from operator dependency and lacks objectivity. in addition to exposure to ionizing radiation, computed tomography (ct) scan requires use of iodinated contrast material, which is undesirable in patients with renal dysfunction. magnetic resonance imaging (mri) has the unique ability to show both structure and function objectively without any radiation exposure to the patient. functional mri techniques such as diffusion-weighted imaging (dwi), blood oxygen level-dependent (bold) imaging have potential utility in the evaluation of renal function .

Eligibility criteria:
inclusion criteria: * patients in different age and sex groups with ckd detected by clinical and laboratory examination. exclusion criteria: * patients with any general contraindication to mri as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia and arrhythmic patients.
precision analgesia for cardiac surgery

Conditions: Analgesia; Cardiac Surgery

Summary: the proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. this research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.

cardiac surgery patients often experience significant acute postoperative pain, and untreated or undertreated pain has consequences. each year, 900,000 painful cardiac surgeries occur in the us alone. pain associated with cardiac surgery results from surgical incision, sternal retraction, internal mammary artery harvesting, saphenous vein removal, placement of mediastinal and chest drains, sternal wires, and release of pro-inflammatory mediators after tissue injury. one study reported that 49%, 62%, and 78% of patients reported severe pain at rest, movement, and coughing, respectively after coronary artery bypass surgery (cabg). another study showed that 61.4% of patients undergoing cardiac surgery reported moderate to severe pain. inadequate pain treatment is common in cardiac surgery due to health care providers' fears of causing cardiorespiratory compromise. poor pain control can trigger sympathoadrenal responses leading to cardiac arrhythmias and myocardial ischemia, restrict mobility to cause venous thrombosis, impair clearance of secretions leading to pulmonary complications such as atelectasis and pneumonia, decrease patient satisfaction and predispose to the development of chronic, persistent surgical pain (cpsp). improving clinical practice by shifting paradigms: our research is transformative and will evolve current reactive clinical practice towards proactive precision methods based on genetic risks for surgical pain and orade in elderly vulnerable population. this is the first effort to move in the direction of personalizing perioperative opioid use with precise dosing to improve safety and efficacy in cardiac surgery. preoperative genotyping-based clinical decisions are expected to support clinical implementation in real-world settings. importantly, investigators will be able to reach beyond the current best-in-class outcomes with precision multi-dose methadone analgesia based on proactive genetic risk identification to maximize safety and efficacy of opioids in all cardiac surgical patients and positively impact socio-economic outcomes in the future. by addressing these critical barriers, this research will help physicians identify patients at risk and improve the safety and efficacy of opioids and surgical pain management while preventing od, misuse, overdose, and deaths.

Eligibility criteria:
inclusion criteria: * elderly cardiac surgical patients over 60 years of age exclusion criteria: * methadone allergy * morbid obesity (bmi \>40kg/cm2) * severe sleep apnea * severe pulmonary disease requiring oxygen therapy * preoperative mechanical circulatory support * emergency surgery * liver disease (liver enzymes more than two times normal) * end-stage renal disease requiring dialysis * serum creatinine more than 2.0mg
prospective nasopharyngeal carcinoma screening using plasma epstein-barr virus dna analysis

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma epstein-barr virus dna analysis would result in the detecting npc cases at earlier stages and improve survival.

epstein-barr virus (ebv) infection is an important etiological factor for nasopharyngeal carcinoma (npc). in a pilot study, we have shown that the analysis of epstein-barr virus (ebv) dna in blood can detect early and asymptomatic npc. however, it is unlcear if npc screening can improve the prognosis of the screened npc subjects. 20,000 male subjects aged from 40 to 62 will be recruited because the incidence of npc is higher in this target group. twenty millilitres of venous blood will be collected from each subject at enrolment for plasma ebv dna analysis. subjects who have initial positive results for plasma ebv dna will have another testing at approximately 4 weeks. subjects who have persistently positive results for the two plasma ebv dna analyses will be investigated using nasal endoscopic examination and mri of the nasopharynx. after the initial screening, all participants will be phone interviewed yearly to update their cancer status. a second round of screening will be carried out at 3 to 5 years after the initial round of screening. subjects will be screened with plasma ebv dna as in the first round of screening. subjects with initial positive results will be retested and those with persistently positive results will be investigated using nasal endoscopic examination and mri of the nasopharynx.

Eligibility criteria:
inclusion criteria: * age 40 to 62 years * ethnic chinese * male exclusion criteria: * history of nasopharyngeal carcinoma * currently having a malignant disease * active autoimmune disease * hiv infection * on systemic steroid treatment * on immunosuppressant treatment

Keywords: npc cancer screening plasma ebv dna
accelerated rtms for treatment-resistant major depression

Conditions: Major Depressive Disorder

Summary: high frequency repetitive transcranial magnetic stimulation (hf-rtms) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. accelerated hf-tms (ahf-rtms), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. in the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel ahf-rtms protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). for this, depressed outpatients will receive the ahf-rtms protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.


Eligibility criteria:
inclusion criteria: * presence of a current major depressive disorder (according to the dsm-iv-tr) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode; * baseline score ≥ 13 on the qids-c * stable medication regimen (\>= 4 weeks) prior to study enrolment exclusion criteria: * psychotic features in the current episode * lifetime history of psychotic disorders and/or bipolar i or ii disorders * substance or alcohol abuse/dependence in the past 6 months * lifetime history of a major neurological disease (e.g., parkinson's, stroke) * uncontrolled medical disease (e.g., cardiovascular, renal) * pregnancy and/or lactation * presence of a specific contraindication for rtms (e.g., personal history of epilepsy, metallic head implant) * hearing loss