Kornimate/medical-research-clean huggingface dataset:
prophylactic cranial irradiation (pci) versus no pci in non small cell lung cancer after a response to chemotherapy

Conditions: Brain Metastases

Summary: 1. patients with confirmed advanced nsclc and any response to 3-6 cycles of chemotherapy, were randomized to receive pci (30 gy/10fr) or no pci. 2. the primary endpoint was the cumulative incidence of symptomatic brain metastases (bm) . 3. the study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).

1. prophylactic cranial irradiation (pci) significantly reduces the risk of brain metastases (bm) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy . 2. pci has also demonstrated to reduce or delay the incidence of cns failure in non small cell lung cancer patients after primary therapy. 3. but its impact on overall and disease free survival is uncertain.

Eligibility criteria:
inclusion criteria: 1. patients were required to have histologically or cytologically documented nsclc and no brain metastasis documented by magnetic resonance imaging (mri)within 21 days after confirmed response (rr+sd) to chemotherapy 2. no previous history of radiotherapy and surgery of brain 3. agree to radiotherapy 4. age \> 18 and \<75 years 5. ecog performance status 1 or less 6. good renal and hepatic and haematological (absolute neutrophils count 15 x1o9/l and platelet count 90 x 109/l,hb\>=80g /dl) functions 7. have provided informed consent exclusion criteria: 1. seizure cannot be controled by the drugs 2. combined with other disease of the brain such as tumour or infarction 3. hypersensitivity to mr enhancer

Keywords: nonsmall cell lung cancer brain metastasis prophylactic cranial irradiation
detection of cervical lymph node metastases with a high-resolution positron emission tomography (pet) imaging system

Conditions: Head and Neck Cancer

Summary: the goal of this clinical research study is to learn if using the pemflex solo ii, a high-resolution camera for pet scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine pet/ct. researchers will compare the images taken using the pemflex solo ii to the images taken during your scheduled routine pet/ct scan, as well as any additional routine ct scan(s), magnetic resonance imaging (mri) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

if you agree to take part in this study, right after your already scheduled routine pet/ct scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine pet/ct scan was just performed. you will then sit in a chair as a study staff member positions the pemflex solo ii on either side of the part of the neck that has, or is suspected to have cancer. it will take about 20 minutes to set up the pemflex solo ii and take the pet scan images. length of study: after the pet scan images have been taken using the pemflex solo ii, your participation in this study will be over. this is an investigational study. the pemflex solo ii is commercially available for pet scan imaging of the breast. using the pemflex solo ii for imaging any other parts of the body is investigational. up to 10 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. a signed informed consent. 2. known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including ct, mr, ultrasound, or prior pet. 3. known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy. 4. scheduled for routine clinical imaging at the acb pet/ct facility. 5. participant must be at least 18 years of age. exclusion criteria: 1. prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract. 2. prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation. 3. uncontrolled blood glucose levels (\>200 mg/dl). 4. patient is unable to comprehend the requirements of the study. 5. patient is unable to undergo scanning of the neck with the pem (pet) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Keywords: cancer cervical lymph node metastases high-resolution pet imaging system upper aerodigestive tract head neck hr pet imaging system high-resolution pet pet/ct pemflex solo ii positron emission tomography/computed tomography (pet/ct)
impulsivity, brain function, and substance abuse treatment in cocaine dependent individuals

Conditions: Cocaine Abuse; Cocaine-Related Disorders

Summary: cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. the purpose of this trial is to evaluate aspects of treatment response in cocaine dependent individuals.

cocaine is a strong central nervous system stimulant that is widely abused throughout the united states. due to its widespread use, it is important to develop an effective treatment for cocaine dependence. the purpose of this study is to determine how impulsivity and prefrontal cortical function are related to treatment response in cocaine dependent individuals. participants in this study will complete four separate experiments, each with a different aim and testing panel \[cognitive function tests with and without functional magnetic resonance imaging (fmri)\]. the first experiment will examine memory, attention, cognitive function, and impulsivity; the aim is to determine the relationship between impulsivity and cognitive function in cocaine dependent individuals receiving treatment. the second experiment will examine the relationship between impulsivity and the prefrontal cortical structure and function. participants will complete an fmri during the second experiment. the third experiment will consist of cognitive function tests and will examine the prefrontal cortex in relation to treatment response, based on four different treatments: 1) l-dopamine, 2) naltrexone, 3) modafinil, and 4) placebo. the fourth experiment will examine the effect of cocaine dependence treatment on prefrontal cortex, focusing on participants receiving modafinil.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for cocaine dependence * met inclusion criteria for other cocaine dependence studies within the center grant exclusion criteria: * current or history of dsm-iv axis i disorders, other than substance abuse or dependence * lifetime diagnosis of alcohol dependence * serious non-psychiatric medical illness requiring ongoing medical treatment or one that affects the central nervous system * positive urine drug screen test for drugs of abuse other than cocaine at the time of study entry * aids-defining illness * intelligence quotient (iq) below 70 * pregnant * uses a pacemaker, metal or electromechanical implants, or metallic foreign bodies

Keywords: cocaine abuse cocaine-related disorders
thyroid and adrenocortical hormone replacement in organ donors

Conditions: Brain Death

Summary: brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. in addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function. trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids. the specific aims of this study include: 1. to quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls) 2. to document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls) 3. to quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).


Eligibility criteria:
inclusion criteria: cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs. recipients of these cadaveric organs exclusion criteria: cadavers failing to meet inclusion criteria
short term outcomes from minimally invasive surgery for the treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. at 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. episodes of atrial fibrillation will be documented during this time. the overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Eligibility criteria:
inclusion criteria: * 18 or older * paroxysmal, persistent, or permanent atrial fibrillation exclusion criteria: * concomitant heart surgery requiring open thoracotomy

Keywords: surgery ablation radiofrequency minimaze transtelephonic monitoring
comparison of erector spinae block and combined deep and superficial serratus anterior plane block

Conditions: Analgesia; Pain, Postoperative; Thoracic; Anesthesia

Summary: objective: the authors hypothesized that combined deep and superficial serratus anterior plane block (sapb) is as effective as erector spinae plane block (espb) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery. design: a prospective randomized controlled study. participants: adult patients undergoing elective video-assisted thoracoscopic surgery. interventions: preoperative sapb or espb implementation.

plane blocks implemented on preoperative course on 35 patients for each group. postoperative visual analogue scale (vas) scores (0-10), intraoperative and postoperative analgesic consumption was measured using mann-whitney test. in the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) classification i-ii scheduled for elective vats exclusion criteria: * patients who did not give consent * local anaesthetic allergy * known or suspected coagulopathy * i̇nfection at the injection site * history of thoracic surgery * severe cardiovascular disease * hepatic or renal insufficiency (glomerular filtration rate \<15 ml/min/1.73 m2) * severe neurological or psychiatric disorders * chronic opioid use

Keywords: serratus anterior plane block video-assisted thoracoscopic surgery erector spinae block postoperative analgesia
ai evaluation of covid-19 sounds (ai-echos)

Conditions: COVID-19; COVID-19 Respiratory Infection; Cough; Breathing Sound; Breathing, Mouth

Summary: in this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for covid19. the investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make covid19 diagnosis from these sounds in order to avoid to use swabs to test the general population.


Eligibility criteria:
inclusion criteria: * adults who tested positive for sars-cov-2 currently admitted to hospital at the study site * adults who tested negative for sars-cov-2 and are admitted for any respiratory condition (eg copd or asthma flare-up, pneumonia..) * healthy volunteers exclusion criteria: * patients under the age of 18. * patients unable to read in italian. * patients unable to give informed consent to participate. * patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.) * patients who are pregnant

Keywords: covid-19 artificial intelligence machine learning sound cough breath voice diagnosis automation ai ml pneumonia symptoms airways sars-cov-2
retrospective study with patients treated with stalif® c or m and ti or flx implants for 1 and 2 levels

Conditions: Degenerative Disc Disease; Grade 1 Spondylolisthesis; Retrolisthesis; Symptomatic Cervical Disc Disease

Summary: this is a retrospective, observational multi-center study, utilizing patients diagnosed with up to a grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with stalif® c, or m, ti and/or flx implants at one or two levels.

the study is intended to codify the performance of the stalif family of products. its design is to provide retrospective data derived from the patient's medical and surgical chart and prospectively assess the treating surgeon and patient on their level of satisfaction post-operative up to present. all subjects who sign an informed consent will be included in the prospective data collection via chart review at the individual investigational sites. the prospective data will come from subjects who complete the designated patient assessments as well as the treating surgeon. the data collection period will include surgeries performed between 2014 to present. the analysis will support the safety profile of the product family and allow for comparison to the available literature as well as between device types (ti versus flx). furthermore, data from this study will support post-market surveillance requirements for the stalif family of products.

Eligibility criteria:
inclusion criteria: * diagnosed with up to a grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery. * 2 levels, between: * c: c2-t1 (neck) * m: l2-s1 (low back) * skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine. exclusion criteria: * subject who had surgery with the stalif devices at more than 2-levels. * in the investigator's opinion, the subject diagnosed with a disease or condition, which precludes the possibility of healing at the time of surgery

Keywords: retrolisthesis grade 1 spondyloisthesis degenerative disc disease symptomatic cervical disc disease
a clinical study of trazodone hydrochloride prolonged-release tablets for treatment of depression

Conditions: Depression

Summary: this is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in chinese population.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65, males and females, outpatients or inpatients; 2. single episode or recurrent depression according to dsm-iv (version 4) criteria; 3. scores \> 18 on 17-item ham-d at screening and baseline visits with a decrease not exceeding 20% between the two visits; 4. symptoms of depression for at least 1 month; 5. patients or their dependents/guardians providing signed informed consent forms. exclusion criteria: 1. serious suicide attempts (≥ 3 on item 3 'suicide' of hamd); 2. depressive episode, with psychotic symptoms; 3. refractory depression; 4. depressive episode secondary to other mental or physical disorders; 5. bipolar disorder; 6. significant reduction in body weight and malnutrition induced by major depression; 7. serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;

Keywords: losing interest and feelings of guilt poor concentration loss of appetite suicide
the effect of extra virgin olive oil in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is an open label feasibility trial to examine the effect of a complementary treatment with high phenolic extra virgin olive oil (hpevoo) on the cognitive and mental health of people with multiple sclerosis (ms), while receiving their standard medical treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ms * must be between 18 to 65 years of age * both males and females are eligible for participation * must have at least five years of education * must be fluent in greek language exclusion criteria: * other neurological, psychiatric or chronic condition * enrollment in other trials/drug studies * experiencing side effects from previous treatments * inadequate visual and auditory acuity
multi-cycle prolon diet

Conditions: Healthy Volunteers

Summary: evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (sts) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. furthermore, sts improves risk factors associated with aging and age-related disease in rodent models. prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. we have developed a fasting-mimicking diet (fmd) that was well accepted in a pilot human trial. the objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. the investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.

the phase i part of the study is designed as a randomized cross-over trial, including two arms: a control arm and a multi-cycle special 5-day dietary regimen (diet, 3 cycles) arm. after 3 cycles, the control and diet groups are crossed over such that the control group will under-go dieting and the diet group will return to normal diet. participants will be monitored for body weight and physiological changes, as well as the adherence to the dietary intervention. the phase ii part of the study is an expansion of the phase i to ascertain the impact of the dietary intervention on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases. statistical methods: paired samples t-test and mann-whitney test will be used to compare between control and diet groups as well as pre- and post-diet values.

Eligibility criteria:
inclusion criteria: * generally healthy adults * bmi \>19 kg/m\^2 exclusion criteria: * severe hypertension (systolic bp \> 200 mm hg and/or diastolic bp \> 105 mm hg). * underweight (bmi \< 19 kg/m\^2) * females who are pregnant or nursing * special dietary requirements incompatible with the study interventions * significant food allergies which would make the subject unable to consume the study food * alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
screening of cardiac abnormalities in the first trimester of pregnancy by volumetric acquisition

Conditions: Pregnancy; Ultrasound; Fetal Conditions; Cardiac Abnormalities

Summary: ultrasound is one of the most important tools in pregnancy both for its diagnostic capacity, but also because it is not invasive. for physiological pregnancy, the italian guidelines provide for the execution of 3 ultrasounds: one in the first trimester (between 11 and 14 weeks), one in the second trimester (between 20 and 22 weeks) and one in the third (between 30 and 36 weeks). weeks). screening for cardiac abnormalities is done during second trimester ultrasound, also called structural ultrasound. however, the development of three-dimensional (3d) sonography has represented a dramatic shift in obstetrics as it allows for the acquisition of a volume of data rather than conventional planar or 2d scans. this method has allowed considerable progress in the study of the fetus in the initial stages of development and has opened new windows in the knowledge of anatomical malformations at an early age. the possibility of detecting structural anomalies already during the first trimester of pregnancy allows, in fact, to provide the patient with additional time for counseling and for any genetic tests.


Eligibility criteria:
inclusion criteria: * patients referred to the obstetric ultrasound clinic for the execution of the first trimester ultrasound between 11+0 and 13+6 weeks of gestation exclusion criteria: * less than 18 years old * multiple gestations * women with an altered state of consciousness, seriously ill, with mental handicaps;

Keywords: pregnancy ultrasound fetal abnormalities cardiac abnormalities
nla101 in adults receiving high dose chemotherapy for aml

Conditions: Leukemia, Myeloid, Acute

Summary: phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of nla101 to reduce the rate of infections associated with cin in adult subjects with aml.

phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of nla101 to reduce the rate of infections associated with chemotherapy induced neutropenia (cin) in adult subjects with aml. eligible subjects with untreated de novo or secondary aml and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 investigational arms (standard of care \[soc\] chemotherapy + low, medium, or high dose nla101) or a control arm (soc chemotherapy). subjects randomized to an investigational arm will be eligible to receive a single fixed assigned dose of nla101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one nla101 infusion per cycle). subjects randomized to the control arm will be followed for up to 3 cycles of chemotherapy. all subjects will be followed for 84 days following randomization, or 30 days post final infusion of nla101, or 30 days post the day after the last chemotherapy infusion for control arm, whichever is longer.

Eligibility criteria:
key criteria: inclusion criteria: * age ≥ 18 (or legal age of majority for sites outside us). * untreated de novo or secondary acute myeloid leukemia (aml), including aml that has progressed from myelodysplastic syndrome (mds), and histologically documented diagnosis * eligible for at least 2 cycles of standard of care aml chemotherapy that will result in moderate to severe myelosuppression and have curative intent * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 or karnofsky status of 50 to 100. * adequate cardiac, renal, and hepatic functions. exclusion criteria: * extramedullary disease in the absence of bone marrow or blood involvement * acute promyelocytic leukemia (apl) with pml-rara * prior aml therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma. * concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation * prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant * known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (dmso) * active/chronic human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b virus (hbv) infection

Keywords: chemotherapy-induced neutropenia bacterial infections fungal infections