Kornimate/medical-research-clean huggingface dataset:
assessing cpr quality during in-hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: using an investigational monitor/defibrillator that passively records cpr quality parameters, including chest compression rate and depth and ventilation rate and volume, we are prospectively recording cpr quality during sequential in-hospital cardiac arrests at the university of chicago hospitals. using an audio feedback system linked to this device, we are studying whether such audio feedback improves cpr quality when provided to rescuers trained in the use of the device.

patients who suffer cardiac arrest during their hospitalization at the university of chicago hospitals are given cpr and other resuscitation measures by trained physician and nurse teams. this care is given with the use of defibrillators to monitor cardiac rhythm as well as provide defibrillation as needed. we have worked closely with engineers at laerdal medical corporation to develop a defibrillator that passively monitors the quality of cpr via additional external sensors (see details in the following reference: abella bs, alvarado jp, myklebust h, edelson dp, barry a, o'hearn n, vanden hoek tl, becker lb. quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. jama. 2005;293:305-10). patients who suffer in-hospital arrest are enrolled (provided they are over 16 years of age, are not pregnant, and are not in the operating room or emergency room setting) with mechanisms to satisfy irb waiver of consent provisions. these patients receive the same care as before the study, but cpr parameters are recorded by the device. in addition, the device provides audio/visual "coaching" in cpr, based on the actual performance of cpr as measured. we hypothesize that this coaching will improve cpr quality and hopefully improve survival from cardiac arrest. the first phase of investigation is now complete, where patients were enrolled and studied without feedback ("baseline" group). now we are enrolling patients into a second group with feedback provided. enrollment is nearly complete for this second group. we will then evaluate the baseline and feedback groups to ascertain whether cpr improved over the two cohorts.

Eligibility criteria:
inclusion criteria: * adult patient with cardiac arrest hospitalized at university of chicago hospitals exclusion criteria: * pregnant * arrest in er or or * pediatric patient * patient dnr, no cpr given * no cpr given for other reasons (e.g. shock only)

Keywords: cardiac arrest cpr
a trial of two electrosurgical conizations: histopathological analysis of excision margins

Conditions: Cervical Intraepithelial Neoplasia

Summary: the purpose of this trial is to evaluate if straight wire excision of the transformation zone (swetz) is superior to (large loop excision of the transformation zone) lletz cone in reducing the incomplete excision of disease.

cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease. the standard procedure, large loop excision of the transformation zone (lletz-cone), is performed with a large loop electrode of 20-25 mm depth. the experimental intervention is straight wire excision of the transformation zone (swetz), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease. both procedures were previously studied in another clinical trial(nct00995020), but the histological analysis were inconclusive for many outcomes. swetz were superior to lletz cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size. this study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.

Eligibility criteria:
inclusion criteria: * patients were eligible if the colposcopist decided that a cone biopsy was indicated. * common indications for a cone biopsy included: * high-grade squamous intraepithelial lesion in a type 3 transformation zone, * suspicion of micro-invasive or invasive carcinoma and * suspicion of glandular disease. exclusion criteria: * patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.

Keywords: conization cervical intraepithelial neoplasia cervix dysplasia therapy electrosurgery
psychological predictors in colorectal cancer surgery recovery

Conditions: Colorectal Cancer

Summary: this is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal cancer surgery.

preliminary evidence suggests that there are multiple variables that may influence the functional recovery following colorectal cancer surgery, some of which deal with the psychological domain. distress and depression can negatively affect the perceptions of functional ability, while resilience and effective coping styles promote a better psychological adaptation to challenging situations. furthermore, psychosocial prehabilitation and interventions have been proposed as a feasible and cost-effective way to positively influence the recovery after surgery in association with the enhanced recovery after surgery (eras) protocol. in particular, mindfulness is proved to be associated with higher quality of life in different medical conditions, including oncological patients and has been also associated with improved clinical outcomes. the aim of the study is to investigate the association of mindfulness and other psychological predictors with functional and quality of life outcomes in patients undergoing colorectal surgery for oncological condition.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old (both males and females). * patients diagnosed with colorectal cancer. * patients scheduled for elective open or laparoscopic surgery for curative intent. exclusion criteria: * patients unable to give the written informed consent. * patients \< 18 years old. * patients undergoing surgery in emergency setting. * patients with pre-operative evidence of metastatic cancer or colorectal cancer recurrence. * pregnant or breastfeeding patients. * any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia).

Keywords: mindfulness psychological predictors colorectal surgery eras
a study to determine if bhv-7000 is effective and safe in adults with refractory focal onset epilepsy

Conditions: Focal Epilepsy

Summary: the purpose of this study is to determine whether bhv-7000 is effective in the treatment of refractory focal epilepsy.


Eligibility criteria:
key inclusion criteria: 1. male and female participants 18 to 75 years of age at time of consent. 2. diagnosis of focal onset epilepsy at least 1 year prior to screening visit defined by 2017 international league against epilepsy (ilae) classification and based on requirements of epilepsy adjudication criteria. a. focal seizures i. focal aware seizures with clinically observable signs and/or symptoms ii. focal impaired awareness seizures iii. focal to bilateral tonic-clonic seizures 3. subject meets the 2009 ilae definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (asm) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 4. ability to keep accurate seizure diaries 5. current treatment with at least 1 and up to 3 asms and 4 epilepsy treatments in total key exclusion criteria: 1. history of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired consciousness for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure. 2. history of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase. 3. resection neurosurgery for seizures \<4 months prior to the screening visit. 4. radiosurgery performed \<2 years prior to the screening visit. 5. subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal eeg correlation with clinical symptoms. 6. any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the investigator

Keywords: focal epilepsy epilepsy seizure refractory epilepsy partial epilepsy
induced-t cell like nk cells for b cell malignancies

Conditions: B Cell Leukemia; B Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Summary: relapsed and refractory b cell malignancies show unfavorable prognosis, especially for adult patients. now, there is no standard management for these patients. induced-t cell-like nk cells with chimeric antigen receptor (car-itnk cells) is a promising treatment option for treating b cell derived malignancy. the purpose of this study is to evaluate the efficacy and safety of car-itnk cells infusions in patients with relapsed and refractory b cell malignancies.


Eligibility criteria:
inclusion criteria: * patient with cd19 positive b-cell acute leukemia * eastern cooperative oncology group (ecog) performance status \<2 * alt/ ast \<3 x normal * bilirubin \< 2.0 mg/dl * creatinine \< 2.5 mg/dl and less than 2.5x normal for age * lvef\< 45% * accept white blood cell collection * provide informed consent exclusion criteria: * previous treatment with investigational gene or cell therapy medicine products * active hepatitis b , hepatitis c or hiv infection * uncontrolled active infection * presence of grade 2-4 acute or extensive chronic gvhd * active cns involvement: epilepsy, paresis, aphasia, stroke, severe head trauma, * dementia, parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc. * any uncontrolled active medical disorder that would preclude participation as outlined. * received non-diagnostic purposes major surgery within the past 4 weeks * participated in any other clinical study within the past 4 weeks * used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * pregnancy or breast-feeding women * use of prohibited drugs: * steroids: therapeutic doses of steroids must be stopped \> 72 hours prior to itnk cells infusion * allogeneic cellular therapy: any donor lymphocyte infusions (dli) must be completed \> 4 weeks prior to itnk cells infusion * gvhd therapies: any drug used for gvhd must be stopped \> 4 weeks prior to itnk cells infusion * any situation that may increase the risk of the test or interfere with the test results

Keywords: itnk cells car b cell malignancy
study comparing the pathkeeper system for pedicle screw positioning in spine surgery with traditional care

Conditions: Scoliosis; Scoliosis; Adolescence; Scoliosis Kyphosis; Scoliosis Lumbar Region; Scoliosis Thoracic Region; Pathologic Fracture

Summary: the goal of this is to evaluate performance of the pathkeeper surgical system. the main question\[s\]it aims to answer are: 1) evaluate pedicle screw position participants will in compare experimental arm: pathkeeper system (pks) with control arm

trial design * allocation: randomized * interventional model: parallel assignment (double armed) * interventional model description: dual center, prospective, randomized cohort study. * masking: none (open label) * primary purpose: treatment * enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out). study arms 1. experimental arm: pathkeeper system (pks) one to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under pks intraoperative navigation guidance. interventions: medical devise - pks. the pks spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. 2. control arm: free-hand technique guided by intra-operative 2d fluoroscopy one to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2d fluoroscopy. interventions: pedicle screws will be placed using the free-hand technique with 2d fluoroscopy as the intraoperative imaging modality. primary endpoints: evaluate and classify the pedicle screw positions as per the gertzbein-robbins classification scale based on a low-dose post-operative ct scan, in each study arm and comparatively. number of misaligned screws as per the gertzbein-robbins classification scale (gertzbein and robbins, 1990) class e screws class d screws class c screws class b screws class a screws secondary endpoints: 1. evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively. 2. evaluate time-per-screw for the experimental device arm (pks) arm. 3. length of stay - (non-critical) 4. estimated blood loss (ebl) - (non-critical) 5. number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized

Eligibility criteria:
inclusion criteria: * men and women * 16 and above years old * patients who are about to undergo open, instrumented spinal surgery * signed informed consent form exclusion criteria: * men and women * 16 and above years old * patients who are about to undergo open, instrumented spinal surgery * signed informed consent form

Keywords: fusion screw positioning screw insertion
quality of recovery in parturients consumed preoperative carbohydrate fluid for elective cesarean delivery

Conditions: Quality of Life; Breastfeeding; Postoperative Pain; Postoperative Nausea

Summary: the establishment of the enhanced recovery after cesarean protocols resulted in to the production of specific care pathways with the aim of optimizing recovery after cesarean delivery (cd) and to reduce the costs to the health care system. carbohydrate rich fluids are offered in this aspect to enhance postoperative quality of recovery. the primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on obstetric quality of recovery after elective cesarean section.

the 10-item obstetric quality-of-recovery scale is a validated patient-reported outcome questionnaire that evaluates recovery quality after delivery. carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. the shortened pre-operative fasting period, in addition to the positive metabolic effects, enhance the post-operative recovery and shorten the hospital stay. postoperatively, it is also crucial for the mother to heal rapidly and be able to care for her child on her own. although a lot of effects of the preoperative carbohydrate loading has been studied yet, the oqr-10 scale and after carbohydrate loading has not been investigated yet. all mothers undergoing a planned cd in the karaman training and research hospital will be invited to participate. mothers will be divided into two groups. one group will receive carbohydrate solution ( carb group) and the other will consume same amount of placebo fluid (noncarb group). the aim of this study is to determine the effect of carbonhydrate rich solutions on quality of recovery of parturients undergoing elective cd with obstetric quality of recovery-10 (obsqor-10) scoring tool.

Eligibility criteria:
inclusion criteria: * women aged 18 years old and over * term singleton pregnancy * undergoing planned caesarean delivery at karaman training and research hospital * patients who have given informed written consent exclusion criteria: * patients who have refused, are unable to give or have withdrawn consent * patients with american society of anesthesiologists (asa) classification of 4 or greater * patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse * patients who have refused spinal anesthesia, or those in whom it is contraindicated. * pregnancy with preeclampsia or eclampsia * pregnancy with gestational diabetes mellitus or diabetes mellitus

Keywords: cesarean delivery quality of recovery preoperative carbonhyrate fluid
laser therapy for the prevention of radiodermatitis in breast cancer patients

Conditions: Breast Cancer

Summary: up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (rd). currently, there is a wide variety of strategies to manage rd, including creams, gels, ointments, wound dressings. however, up to now, there is still no comprehensive, evidence-based consensus for the treatment of rd. low-level laser therapy (lllt) is a promising, non-invasive technique for treating rd. in a recent pilot study conducted in our research group, lllt prevented the aggravation of rd and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. this pilot study was the first prospective study investigating the potential of lllt for rd. in the current study, we want to investigate the efficacy of lllt as a tool for the prevention of radiodermatitis in breast cancer patients.


Eligibility criteria:
inclusion criteria: * diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3a) breast adenocarcinoma * treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy * scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 gray to the whole breast followed by a boost of 8 fractions of 2 gray to the tumor bed, 5/week) * signed informed consent exclusion criteria: * previous irradiation to the same breast * metastatic disease * concurrent chemotherapy * required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
behavioral therapy for reduction in smoking craving

Conditions: Smoking Cessation; Tobacco Dependence

Summary: the objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.

the objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. the specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fmri paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. a secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. participants completed questionnaires and a brief computer-based cognitive testing paradigm. participants also underwent a fmri scan at quit day (week 5). a randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). the study has thus used self-report measures, cognitive testing (stroop task), and fmri (functional magnetic resonance imaging) assessments.

Eligibility criteria:
inclusion criteria: * currently be cigarette smokers who desire to quit in the next 30 days (preparation phase). * subjects must smoke at least 10 cigarettes per day * must be at least 18 years old * english speaking * able to read, understand, and complete a written questionnaire * must be willing to attend 8 sessions of behavioral therapy and perform daily home practice * must not currently be using pharmacologic therapy to quit * must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment. * only strongly right-handed subjects will be included exclusion criteria: * pregnant women * have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work) * weigh over 300 pounds * known problem of claustrophobia

Keywords: smoking cessation tobacco dependence mindfulness fmri craving
consequence of open versus closed tracheostomy immediately after decannulation

Conditions: Tracheostomy

Summary: tracheostomy is performed for prolonged mechanical ventilation. ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. this study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.

see protocol document.

Eligibility criteria:
inclusion criteria: * tracheostomy for minimum 7 days * age \> 18 years * capped uncuffed tube size 7 or 8 for at least 24 hours exclusion criteria: * cognitive dysfunction (patients who are not able to cooperate with investigation)

Keywords: tracheostomy respiratory insufficiency respiratory function tests mechanical ventilators rehabilitation critical care