Kornimate/medical-research-clean huggingface dataset:
efectiveness of donor il-15-stimulated nk cells post transplant infusion in in acute leukemia

Conditions: ACUTE LEUKEMIA

Summary: clinical trial phase i and ii, single-center, historical control, to evaluate the effectiveness of donor il-15 stimulated nk cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant

this clinical trial wants to study the safety, effectiveness and efficacy of nk cells incubated infusion (cd56 +, cd3) incubated ex vivo with il-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.

Eligibility criteria:
inclusion criteria: 1. more than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical 2. assessable disease by analytic, molecular or image techniques. 3. comorbidity sorror index less than 6. 4. give informed consent according to the legal requirements. 5. dispose of a donor without exclusion criteria. exclusion criteria: 1. positive hiv serology. 2. patients with an active infection or other underlying serious medical statement. 3. any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study. 4. participation of any other interventional clincal trial within 30 days of planned enrollment into this study. 5. women who are pregnant or breastfeeding.
68ga-grazytracer pet/ct of tumor responses to immunotherapy

Conditions: Cancer

Summary: this is an open-label positron emission tomography/computed tomography (pet/ct) study to investigate the safety and clinical predictive value of 68ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.

the investigators recently developed a granzyme b-specific radiotracer named 68ga-grazytracer. this clinical trial aims to investigate whether granzyme b pet imaging using 68ga-grazytracer could early identify tumor responses to immune checkpoint inhibitory therapy or car-t therapy in subjects with solid tumor and lymphoma. pet/ct imaging of 68ga-grazytracer will be performed in subjects after immunotherapy.

Eligibility criteria:
inclusion criteria: 1. participants who were diagnosed with malignant tumors; 2. patients who were scheduled to receive immunotherapy based on a decision made by a multidisciplinary team; 3. participants who had no prior immunotherapy; 4. participants who had no regional therapy within 3 months; 5. participants aged ≥18 years. exclusion criteria: 1. participants with a concurrent disease that would impede the treatment regimen; 2. participants who were unable or unwilling to provide written informed consent.

Keywords: pet/ct immunotherapy immune checkpoint inhibition granzyme b 68ga labeling
emergency ketamine treatment of suicidal ideation

Conditions: Depression; Suicidal Ideation; Suicidal Impulses

Summary: the objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.

the objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment

Eligibility criteria:
inclusion criteria: 1. males and females 2. ages 18-65 3. all races and ethnicities 4. willing and able to provide informed consent 5. a cutoff score of \>3 on the beck scale for suicidal ideation 6. \>2 on the columbia scale for suicide severity rating exclusion criteria: 1. pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test 2. post-partum state (within 2 months of delivery) 3. homicide risk as determined by clinical interview 4. any of the following diagnostic and statistical manual of mental disorders (dsm-iv) diagnoses: 1. any current primary psychotic disorder 2. acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids 3. use of any hallucinogen (except cannabis), in the last month 4. any dissociative disorder 5. pervasive developmental disorder 6. cognitive disorder 7. cluster a personality disorder 8. anorexia nervosa. 5. treatment with any medication known to affect the n-methyl-d-aspartate (nmda) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium) 6. any known hypersensitivity or serious adverse effect with ketamine 7. any clinically-significant medication or condition that would preclude the use of ketamine

Keywords: depression suicidal ideation ketamine emergency department
carotid artery corrected flow time measured by ultrasonography as a predictor of hypotension after induction of general anesthesia

Conditions: General Anesthesia Induction for Elective Surgery

Summary: hypotension often happens immediately after anesthetic induction. particularly in 5-10 minutes after anesthetic induction it is reported to happen more frequently. patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk. however, it is still challenging to assess intravascular volume status in spontaneously breathing patients before anesthetic induction. recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume. the aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography in spontaneously breathing patients before general anesthesia can predict hypotension after induction.


Eligibility criteria:
inclusion criteria: • adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia exclusion criteria: * mean blood pressure \< 70 mmhg before induction of general anesthesia * patients who have currently taken angiotensin-converting enzyme inhibitor * patients who have currently taken angiotensin receptor blocker * the presence of carotid artery stenosis \> 50% * cardiac rhythm other than sinus * unstable angina * a left ventricular ejection fraction of \< 40% * severe vascular disease * implanted pacemaker/cardioverter * autonomic nervous system disorders * anticipated difficult airway * pregnancy
mobile health app to reduce diabetes in latina women with prior gestational diabetes ii

Conditions: Gestational Diabetes Mellitus

Summary: the investigators will conduct a pre-post study to evaluate the effectiveness of the hola bebe intervention on improving self-efficacy for healthy eating and physical activity, and on weight loss among hispanic women with recent gdm. the hola bebe app provides a unique opportunity to provide an effective, culturally tailored lifestyle modification program. the investigators will provide training to health educators at the two participating sites to ensure consistency and fidelity of implementation.

the study builds on the investigators' previous research in which the investigator developed a culturally-tailored spanish and english app for latinas with recent gdm based on social cognitive theory and behavioral economics. the app-based program included 12 audio/visual behavioral and educational modules on healthy eating and physical activity, motivational texts, weight tracking, personalized action plans, tiered badges, videos (easy at-home exercises, user-friendly, easy-to-follow recipes, and building a balanced plate), and an online community to communicate with other participants. all content was in plain-language spanish and english, with spanish and english audio voice-over. graphics were dynamic and incorporated culturally sensitive.

Eligibility criteria:
inclusion criteria: * female; * self-identify as latina; * overweight or obese (bmi \> or =25); * age 18 to 45; * having had a pregnancy complicated by gdm within the prior 5 years. exclusion criteria: * currently has a diagnosis for diabetes (type 1, type 2 or secondary form); * has underlying disease or treatment that might interfere with participation in or completion of the protocol (e.g., cancer, moderate or severe cardiovascular disease, hiv positive, active tuberculosis, lung disease, significant gastrointestinal conditions, renal disease, major psychiatric disorders, and other at the discretion of the study clinician); * has diseases associated with glucose metabolism; * takes certain medications (e.g., glucocorticoids) which interfere with glucose metabolism.
interoceptive training enhanced mindfulness

Conditions: Anxiety Sensitivity

Summary: this pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.

anxiety sensitivity (as), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. cognitive behavioral therapy (cbt), particularly involving interoceptive exposure (ie; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing as but can be hard to tolerate. conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. a hybrid of these two approaches may capitalize on the strengths of each approach. mindfulness training (mt) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. this project will evaluate the feasibility and acceptability of a novel hybrid intervention, interoceptive training enhanced mindfulness (item), which combines ie with mt, evaluate its feasibility and acceptability. forty-eight veterans will be randomized to receive item or ie in six one-on-one sessions delivered via telehealth. they will complete assessments before and after the 6-week intervention period. outcomes related to engagement and compliance with item and ie will be the primary focus. because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.

Eligibility criteria:
inclusion criteria: * veteran status * able to read and speak english * asi-3 score of 23 or higher * clinically meaningful distress/impairment related to an emotional or somatic complaint as determined by a clinical global impression scale (cgi) of 4 or greater * internet access via a device that can support remote study activities and ability to attend in person appointments exclusion criteria: * serious mental illness, including bipolar disorder or psychotic illness * current, untreated alcohol or substance use disorder * moderate-severe suicidality that would likely result in the need for urgent intervention in the next 2 months * current regular meditation practice or treatment for as-related condition * cognitive dysfunction that interferes with the ability to engage in treatment

Keywords: anxiety sensitivity mindfulness interoception
cervical spine focused treatment for patients with persistent concussion symptoms and neck pain

Conditions: Brain Concussion; Neck Pain

Summary: assess the feasibility of recruiting, enrolling and randomizing patients with concussion symptoms and neck pain to receive manual therapy and cervical rehabilitative exercises in addition to standard concussion treatment. in the usual care workflow provided at the participating concussion clinic, cervical spine rehab is not typically introduced until after week 4. the rationale is that neck pain is often a self-limiting condition that may resolve spontaneously, without the need for specific cervical spine rehab. this study is chiefly focused on feasibility aims that revolve around developing changes to barriers in workflow issues at the participating concussion clinic, that would allow for earlier introduction of cervical spine rehab.

this is a a single site pilot randomized controlled trial consisting of a total of 40 participants with concussion and neck pain, randomized to one of two groups (n=20 per group): 1. early cervical spine focused treatment combined with standard concussion care. 2. standard concussion care alone for 4 weeks, followed by delayed introduction (after 4 weeks) of cervical spine focused treatment (which is the usual care workflow at our clinical partner site.) both groups will receive the combination of cervical spine focused treatment and standard concussion care; the only variation being the timing of the introduction of the cervical spine care. the primary endpoint will be 4 weeks from start of cervical rehabilitation intervention. the secondary would be the point of discharge. the duration of active participation in the study will be 8 weeks for the participants.

Eligibility criteria:
inclusion criteria: * diagnosed concussion * patient endorses neck pain or difficulty moving their neck (moderate or severe; score of 2 or 3 for items 16 and 25 from concussion cp screen) * willingness to be randomized * 8-90 days post injury * english speaking exclusion criteria: * previous concussion within the past 6 months * prior history of ischemic/vascular events * previous treatment for current symptoms * prior treatment for neck pain/headaches in the past year * workers' compensation claim and/or litigation associated with injury * diagnosed substance use disorder * prior cervical spine surgery * prior fracture and or dislocation/subluxation of the cervical spine * diagnosed inflammatory arthritis

Keywords: concussion care cervical rehabilitation neck pain
registry for chronic obstructive pulmonary disease with pulmonary hypertension in china

Conditions: COPD; Pulmonary Hypertension

Summary: pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (copd). it is reported that over half of copd patients develop pulmonary hypertension. copd and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in copd is very limited in china. the aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in chinese copd patients and explore the underlying interaction mechanism.


Eligibility criteria:
inclusion criteria: * stable chronic obstructive pulmonary disease (copd) patients exclusion criteria: * patients with other serious respiratory diseases * patients with pulmonary hypertension other than group 3 * patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases * patients with limited life expectancy * patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months * psychopath or addict
trial to assess efficacy and safety of lacosamide in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (lcm) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.

lcm is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of nsaids, cox-2 nsaids and/or paracetamol. this trial will be conducted exclusively in europe. the study has an adaptive 3-stage group sequential design. the trial will last a total of 17 weeks. there will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of lcm up to the target dose of 400mg/day. the target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period. the last subject is expected to be enrolled in december 2007. the study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. it was decided not to continue the trial. no safety concerns were identified.

Eligibility criteria:
inclusion criteria: * subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as acr criteria with symptom duration of at least 6 months. * subject requires therapeutic dose of an nsaid, cox-2 nsaid, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (visit 1). exclusion criteria: * subject is not able to withdraw nsaids, cox-2 nsaids and/or paracetamol * subject is taking analgesic other than nsaids cox-2 nsaids and/or paracetamol * subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial

Keywords: osteoarthritis lacosamide vimpat
remote magnetic navigation for cavotricuspid isthmus ablation

Conditions: Atrial Flutter

Summary: the purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.


Eligibility criteria:
inclusion criteria: * ecg documentation of at least 1 episode of typical atrial flutter exclusion criteria: * prior right atrial ablation * ferromagnetic implants that may interfere with the magnetic navigation system * pregnancy

Keywords: atrial flutter ablation navigation
maximum tolerated dose, safety and efficacy of docetaxel / cisplatin + sti571

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase 1/phase 2 study of sti571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic non-small cell lung cancer (nsclc). this research study has 2 parts to it. the first part (phase 1) is called a dose-escalation. not all subjects enrolled into this phase of the study will receive the same dose. the purpose of the dose-escalation is to determine the highest safe dose of sti571 that can be used in combination with docetaxel and cisplatin. that dose will be used in phase 2.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically recurrent, or advanced nsclc: stage iv disease; or stage iiib due to malignant pleural effusion is allowed- only if successfully pleurodesed. * tumor tissue slides must express phosophorylated pdgf-rb by ihc. * at least one measurable target lesion as defined by recist criteria that has not been irradiated. * no prior chemotherapy treatment for this disease will be allowed. patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment. * ecog performance status 0-1. * meets initial laboratory parameters. * men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. exclusion criteria * any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease. * any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to sti571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin. * patients with: * contrast allergy. * gi bleed ≤ 1 month from study enrollment. * intermittent or chronic oxygen requirements. * pulse oximetry \<90%. * grade 3 dyspnea. * history of poorly regulated anticoagulation with warfarin. * edema or fluid retention grade \>1. * neuropathy grade ≥1. * uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring iv antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia. * psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months. * any type of hearing impairment. * known hiv infection. * receiving other investigational agents.

Keywords: non-small cell lung cancer
a study to evaluate mavacamten in adults with symptomatic obstructive hcm who are eligible for septal reduction therapy

Conditions: HOCM, Hypertrophic Obstructive Cardiomyopathy

Summary: this is a randomized, double-blind, placebo-controlled, multi-center study in the united states (u.s.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (srt) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (ohcm \[also known as hocm\]) who are eligible for srt based on accf/aha 2011 and/or esc 2014 guidelines.


Eligibility criteria:
key inclusion criteria: * at least 18 years old at screening and body weight \> 45 kg at screening * diagnosed with ohcm consistent with current accf/aha 2011 and meet their recommendations for invasive therapies * referred or under active consideration within the past 12 months for srt procedure and willing to have srt procedure * has documented left ventricular ejection fraction (lvef) ≥ 60% at screening * has documented oxygen saturation at rest ≥ 90% at screening key exclusion criteria: * persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening * previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[asa\]) * for individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications \< 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study * any medical condition that precludes upright exercise stress testing * paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening * prior treatment with cardiotoxic agents, such as doxorubicin or similar * has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion