Kornimate/medical-research-clean huggingface dataset:
biomarkers of brain injury: magnitude and outcome of mild and moderate tbi

Conditions: Brain Injuries, Traumatic

Summary: the purpose of this study is to determine if specific brain injury biomarkers have utility as blood-based traumatic brain injury (tbi) diagnostic and monitoring tools. this will be accomplished by examining the relationships between potential serum-based tbi biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate tbi as well as in orthopedic control subjects.


Eligibility criteria:
mild/moderate tbi group inclusion criteria: 1. 18 years or older 2. gcs 9-15 3. ct scan as part of clinical evaluation 4. experienced some level of altered mental state at time of injury 5. determination of study eligibility within 4 hours of injury exclusion criteria: 1. pregnant females 2. prisoners 3. anemia or significant blood loss (hemoglobin \< 12 mg/dl and/or hematocrit \< 35%, and/or clinical state requiring resuscitation with more than 6l of colloid or crystalloid fluid) 4. no clear history of trauma as primary event 5. previous history of stroke, or head injury requiring hospitalization 6. dementia or psychotic illness or neurological condition which may affect outcome 7. unable to speak or understand english orthopedic control group inclusion criteria: 1. 18 years or older 2. isolated extracranial orthopedic injury, including fractures 3. stable vital signs on presentation to ed (pulse \ 100 mmhg) exclusion criteria: 1. evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury 2. not enrolled within 4 hours of injury 3. pregnant females 4. prisoners 5. anemia or significant blood loss (hemoglobin \< 12 mg/dl and/or hematocrit \< 35%, and/or clinical state requiring resuscitation with more than 6l of colloid or crystalloid fluid) 6. previous history of stroke, or head injury requiring hospitalization
recurrent salivary gland infections in covid-19

Conditions: Recurrent Salivary Gland Infections in Covid-19

Summary: the aim of this study is to find out the role of covid-19 in salivary gland infection and its recurrence.

this is a prospective clinical study of 60 patients. the study will be performed in the otolaryngology department, faculty of medicine, benha university during the duration from june 2023 to december 2023. inclusion criteria: adult patients aged ≥18 years. exclusion criteria: * patients with known autoimmune diseases, * diabetes mellitus * history of cancer in the region of the head and neck or previous radio and/or chemotherapy. * history of facial nerve palsy, * oral and dental diseases including chronic sialadenitis or sialolithiasis. * previous oral surgery. patients were divided into two equal groups each of 30 patients according to the cause of infection. group (1) comprises 30 patients with covid-19 infection representing the study group covid-19 diagnosis will be based on a positive sars-cov-2 nasopharyngeal swab on real-time reverse transcription-polymerase chain reaction (rt-pcr) in the presence of clinical and/or radiological signs and group (2) comprises of 30 patients with non-covid-19 infection as a control group. all patients will be submitted to full ent and intraoral clinical examination. we will compare both groups as regards patients' characteristics, risk factors, etiology, symptoms, and rate of recurrence of sialadenitis.

Eligibility criteria:
inclusion criteria: * adult patients aged ≥18 years with a history of civid-19 infection in the study group and of similar age without a history of covid-19 infection. exclusion criteria: * patients with known autoimmune diseases, * diabetes mellitus * history of cancer in the region of the head and neck or previous radio and/or chemotherapy. * history of facial nerve palsy, * oral and dental diseases including chronic sialadenitis or sialolithiasis. * previous oral surgery.
study to determine the efficacy and safety of docetaxel and doxorubicin with ingn 201 in locally advanced breast cancer

Conditions: Locally Advanced Breast Cancer (LABC)

Summary: a maximum of 60 subjects will be enrolled in the trial. it is a non-randomized, open label, single center study. all subjects undergo ingn 201 injection and iv chemotherapy: doxorubicin and docetaxel. this is done on the first 2 days of a 3-week cycle. after completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.


Eligibility criteria:
documented late stage breast cancer: stage iii a-b (excluding inflammatory breast carcinoma) or localized stage iv breast cancer male or female 18 years or older adequate bone marrow, liver, and kidney function
a comparison of emergence agitation by sevoflurane for intraoperative sedation associated with caudal block

Conditions: Emergence Agitation

Summary: this study was performed to compare the incidence of ea between two dose of sevoflurane for sedation with caudal block in children, and intended to find the optimal dose for prevention of sevoflurane induced emergence agitation

after approval institutional review board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. by a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (group ls) or the high dose (2.5%) end tidal concentration of sevoflurane group (group hs). the patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. then the patients were into the operating room, applied electrocardiography (ecg), pulse oximetry, and noninvasive blood pressure. respiratory rate and end tidal carbon dioxide (co2) were monitored via face mask. after baseline vital signs were monitored, the patient was posed in lateral sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 g needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. all of these procedures were performed by one skilled anesthesiologist who blinded about the study group. after caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. if oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. if analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly. in the postanesthetic care unit (pacu), the investigators observed ea episodes at 5 and 30 min after pacu arrival using four-point agitation scale and pediatric anesthesia emergence delirium (paed) scale, and if a total score of paed scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. ea was considered as an four-point agitation scale \> 3 or paed scale \> 10.

Eligibility criteria:
inclusion criteria: * patients undergoing elective subumbilical surgery, american society of anesthesiologist physical status classification 1 exclusion criteria: * children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.

Keywords: emergence agitation sevoflurane children
prophylactic substrate ablation in post-myocardial patients undergoing defibrillator implantation.

Conditions: Heart Failure; Myocardial Infarction; Ventricular Tachycardia

Summary: prophylactic substrate ablation in post-mi patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

background in patients with ventricular tachycardia (vt) and structural heart disease, the implanted cardioverter defibrillator (icd), provides a significant protection against the risk of sudden death, however it does not prevent arrhythmia recurrences \[1-7\]. icd therapies, especially shocks, pose several risks, including decreased quality of life, increased mortality among patients who suffer icd shock compared with patients who do not and clinically significant anxiety and depression as a result of recurrent icd shocks, which has been found to occur in more than 50% of patients \[8-12\]. furthermore, icd implantation has been found not to protect against sudden cardiac death in 3-7% of patients \[13\]. the benefit of novel icd programming in reducing inappropriate icd therapy and mortality was demonstrated in multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (madit-rit) \[14\]. catheter ablation has been considered a plausible curative therapy for vt prevention, especially in patients with vt episodes \[15\]. the substrate mapping and ablation in sinus rhythm to halt ventricular tachycardia (smash-vt) and the ventricular tachycardia ablation in coronary heart disease (vtach) found that prophylactic catheter ablation reduces the incidence of appropriate icd therapy in patients who had undergone icd implantation as a means of secondary prevention and had a history of myocardial infarction (mi) \[16,17\]. it was also shown in a small retrospective study that prophylactic catheter ablation for induced vt reduced the incidence of appropriate icd therapy in primary prevention post-mi patients \[18\]. aim of the study - statement of hypothesis prophylactic substrate ablation in post-mi patients undergoing defibrillator implantation reduces appropriate defibrillator therapies.

Eligibility criteria:
inclusion criteria: * post-mi patients eligible for icd implantation in the setting of primary prevention exclusion criteria: 1. nyha iv or ambulatory nyha iv 2. acute coronary syndrome in the last 40 days 3. stable angina not eligible to revascularization 4. revascularization in the last 3 months (except mi) 5. antiarrhythmic therapy other than b-blockers 6. lvef\<20% 7. gfr\<30ml/min/1.73m2 8. systematic illnesses

Keywords: ventricular tachycardia ablation myocardial infarction heart failure
study of vinorelbine and cyclofosfamide among patients with refractory tumours or in relapse

Conditions: Rhabdomyosarcomas; Neoplasms, Connective and Soft Tissue; Ewing Tumor; Osteosarcomas; Neuroblastomas; Medulloblastomas

Summary: this is a phase ii study to determine the antitumor activity of vinorelbine and cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.


Eligibility criteria:
inclusion criteria: * age \> 12 months and \< 25 years * measurable disease * score of lansky \> 30 or world health organization (who) score \< 2 * life expectancy \> 2 months * satisfactory hematologic conditions: * polynuclear neutrophiles \> 1 x 10\^9/l. * platelets \> 100 x 10\^9/l or \> 50 x 10\^9 in the event of medullary invasion. * creatinine \ 70 ml/min/1.73 m2 * normal hepatic function: * bilirubin \< 3 n * asat and alat \< 2,5 n). * absence of toxicity of bodies (rank \> 2 according to coding national cancer institute-common toxicity criteria \[nci-ctc\] version 2.0) * absence of antecedent of hematuric cystitis to repetition * written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects exclusion criteria: * does not satisfy the criteria of eligibility

Keywords: soft parts tissue
skeletal muscle energetics and fatiguability in older individuals

Conditions: HIV; HIV Infections

Summary: the investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without hiv are associated with decreased abilities to exercise.

this research is being done to better understand why some older people living with hiv experience more fatigue and difficulty exercising than older people without hiv. this is important because fatigue and problems exercising are predictors of disability and hospitalization in older individuals. we will use non-invasive magnetic resonance imaging (mri) and spectroscopy (mrs) of the leg muscle to measure muscle metabolites and fat content, as well as blood samples measures levels of inflammation.

Eligibility criteria:
inclusion criteria: * participants who are \>= 60 years of age * hiv serostatus positive participants on stable antiretroviral therapy (art) (no regimen change in last month) with undetectable hiv viral load (\<100 copies). * hiv serostatus negative participants exclusion criteria: * unable to understand the risks, benefits, and alternatives of participation and give meaningful consent * contraindications to mri * significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity * significant lower extremity peripheral vascular disease. * weight greater than 350 lbs * cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.
prospective observational study of adjuvant hormone treatment in estrogen-receptor positive premenopausal early breast cancer patients

Conditions: Early Breast Cancer

Summary: this will be a prospective, multicenter, observational study. the primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + lhrh, aromatase inhibitors + lhrh) in premenopausal patients with estrogen-receptor positive breast cancer. the secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (t size, lymph node status, grade, receptor level, ki67, her2 status) and patient characteristics (age, prior chemotherapy treatment).


Eligibility criteria:
inclusion criteria: 1. - premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery 2. - age \>18 years 3. - no previous hormonal treatment 4. - written informed consent exclusion criteria: 1- patient's inability to provide written informed consent 2 - stage iv disease
mental stress symptoms in family caregivers of palliative patients

Conditions: Family Caregivers; Palliative Patients

Summary: receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. new perspectives often arise, as well as feelings of worry, sadness and powerlessness. caregiving is often an extreme physical challenge, but above all a psychological one. aims of the study 1. to investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety. 2. to investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints. 3. to investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.


Eligibility criteria:
inclusion criteria: * women and men between 18 and 90 years of age * current palliative care situation of a relative with a life-limiting diagnosis. exclusion criteria: * persons incapable of giving consent (e.g. dementia, delirium, etc.) * failure to meet the inclusion criteria
patient characteristics, treatment patterns, and clinical outcomes in patients diagnosed with hr+/her2 advanced/metastatic breast cancer on palbociclib + aromatase inhibitor (ai) combination therapy

Conditions: Breast Cancer

Summary: the study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with hr+/her2- a/mbc who received palbociclib combination therapy with ai as first-line treatment in the us community oncology setting.


Eligibility criteria:
inclusion criteria: * female or male sex. * diagnosis (confirmed by clinical review) of a/mbc, defined as breast cancer at stage iiib, stage iiic, stage iv or identified as having distant metastasis. * age ≥18 years at a/mbc diagnosis. * initiated palbociclib in combination with an ai as first-line therapy after a/mbc diagnosis on or after 03 february 2015 through 31 july 2019. note that the date of the start of the inclusion period reflects the month of palbociclib us fda approval. * evidence of er or pr positive disease, or absence of any indication of er and pr negative disease closest to a/mbc diagnosis (ie, patients are eligible without affirmative indication of er/pr+ status as long as er/pr- indication is not present). * evidence of her2 negative disease, or absence of any indication of her2 positive disease closest to a/mbc diagnosis (ie, patients are eligible without affirmative indication of her2- status as long as her2+ indication is not present). exclusion criteria: * enrollment in an interventional clinical trial for a/mbc during the study observation period. * evidence of prior treatment with any cdk4/6 inhibitor in the adjuvant setting. * evidence of another primary cancer within 3 years prior to the initial line containing palbociclib.
impact of cross-training on induction treatment response in acute lymphoblastic leukemia adults

Conditions: Acute Lymphoblastic Leukemia, Adult B-Cell

Summary: despite advances in the treatment of acute lymphoblastic leukemia, the prognosis in adults is still poor, largely due to the resistance of treatment at diagnosis or early relapse. among the strategies associated with the treatment of acute lymphoblastic leukemia is rehabilitation and physical medicine in order to improve the quality of life, body composition, fitness, strength and improve the attachment and acceptance of their treatment

previous evidence had shown that among the beneficial effects of an exercise intervention in cancer is the reduction of adverse events associated with treatment, such as nausea and fatigue. also, the overexpression of interleukin-15 in cancer is related to a poor prognosis, biologically the implementation of a cross-training exercise routine can function as a regulatory pathway for its expression due to its consumption at muscular level. finally, the time to consider a relapse with a very poor prognosis is during first three months of treatment, so implementation of an exercise strategy during this period could reduce the proportion of early relapses mediated by interleukin-15 expression

Eligibility criteria:
inclusion criteria: * ability to walk without support. * life expectancy greater than 7 days * previous authorization of treating hematologist for participation * acceptance and signing of informed consent form exclusion criteria: * patients with neutropenia, infections and / or bleeding on admission to hospitalization. * patients that are unable to perform physical activity. * central nervous system diseases that make movement impossible. * cardiac function alterations assessed by electrocardiogram and echocardiogram * patients in relapse * patients referred from another hospital and who are been attended in our hospital

Keywords: acute lymphoblastic leukemia interleukine-15 cross-training body composition physical performance
pulmonary perfusion heterogeneity in patients with cteph using functional pet imaging

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: this study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment.

specifically, we will evaluate the length-scale or size of blood flow alterations using filtering techniques with the objective of identifying the size of blood vessels that are obstructed by clot (large vessels versus small vessels).

Eligibility criteria:
inclusion criteria: 1. subject is diagnosed with chronic thromboembolic pulmonary hypertension (who group iv) and planning to undergo pulmonary thromboendarterectomy. 2. subject is male or female aged \> or =18 years of age and \< or = 70 years. 3. subject has undergone rhc within six months of entering the study. 4. the subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 5. a signed and dated written informed consent is obtained from the subject. 6. available to complete the study. 7. able to lie flat and able to perform a 30 second breath hold. exclusion criteria: 1. fev1 and/or tlc \< 70% predicted. 2. inability to perform the study (by primary md or investigator assessment). 3. inability to perform the respiratory maneuvers necessary for the exam. 4. subjects who have a past or present disease, which as judged by the investigators may affect the outcome of this study. 5. the subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit. 6. the subject is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test. 7. subject with clinical instability in the judgment of the investigator, with a heart rate \> 120 bpm, respiratory rate \> 24, spo2 \ 140/90 or fever \> 101, or subjects with hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study. 8. subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, or copd. 9. subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study. 10. the subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the mgh radiation safety committee.
real world evidence of the effectiveness of paritaprevir/ritonavir, ombitasvir, ± dasabuvir, ± ribavirin in patients with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (pro) and work productivity data of the interferon-free regimen of paritaprevir (ptv)/ritonavir (r) + ombitasvir (obv), +/- dasabuvir (dsv), +/- ribavirin (rbv) in chronic hepatitis c virus infected patients.


Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female patients with confirmed chc, genotype 1 or 4, receiving combination therapy with the interferon-free abbvie regimen ± rbv according to standard of care and in line with the current local label. * if rbv is co-administered with the abbvie regimen, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy). * patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study. * patient must not be participating or intending to participate in a concurrent interventional therapeutic trial exclusion criteria: -none

Keywords: chronic hepatitis c dasabuvir paritaprevir/r/ombitasvir observational study quality of life fibrosis cirrhosis work ability