Kornimate/medical-research-clean huggingface dataset:
radiotherapy with neoadjuvant chemotherapy and immunotherapy in rectal cancer

Conditions: Rectal Cancer; Radiotherapy; Immunotherapy; Organ Preservation

Summary: this is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant chemotherapy with camrelizumab, an anti-pd-1 antibody drug following short course radiotherapy in patients with rectal cancer.

patients with rectal cancer are assigned to receive preoperative 5 × 5 gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-pd-1 antibody drug. the primary objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.

Eligibility criteria:
inclusion criteria: 1. patients who personally provided written consent for participation in the study 2. treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the av before crt 3. histologically confirmed adenocarcinoma of rectum (non-metastatic, \>t2n0 or low t2n0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation 4. patients with the ecog performance status of 0 or 1 at the time of enrollment 5. women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy 6. male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug 7. patients must have acceptable organ and marrow function as defined below: absolute neutrophil count (anc) \>1,500/ul hg \> 8.0 g/dl; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion platelets \>100,000/ul total bilirubin \ 50 by cockcroft-gault exclusion criteria: 1. patients with recurrent rectal cancer or a history of pelvic radiation 2. patients with a history of inflammatory bowel disease 3. patients with a history of pneumonitis or interstitial lung disease 4. patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 5. patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study 6. patients with a history of thyroid dysfunction 7. patients with a history or finding of cardiovascular risk 8. patients who are positive for any of the following: hiv1 antibody, hiv2 antibody, htlv1 antibody 9. patients who are pregnant or lactating or who may be pregnant 10. patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
gx-i7 in combination with bevacizumab in recurrent glioblastoma (gbm) patients

Conditions: Recurrent Glioblastoma

Summary: the purpose of this study is to evaluate the efficacy and safety of gx-i7 in combination with bevacizumab in subjects with recurrent glioblastoma.

this is a phase 2 study designed to evaluate the efficacy and safety of gx-i7 in combination with bevacizumab in subjects with recurrent glioblastoma. a total of 20 patients will be enrolled in the study and administered bevacizumab gx-i7. the study treatment will be continued for up to 6 cycles or until a progression of disease or unacceptable toxicity is confirmed.

Eligibility criteria:
inclusion criteria: 1. age ≥ 19 years 2. histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (rt/ccrt and/or adjuvant chemotherapy (tmz)) 3. karnofsky performance status; kps ≥ 60 or ecog status 0-2 4. life expectancy \> 12 weeks 5. adequate hematologic and end organ function exclusion criteria: 1. malignancies other than disease under study within 5 years prior to the first dose of study drug 2. subjects who have received bevacizumab or other vegf inhibitors prior to study participation 3. body mass index (bmi) ≥ 30 kg/m2 4. subjects confirmed intracranial hemorrhage with non-contrast ct or mri 5. clinically significant cardiovascular disease 6. history of arterial or venous thromboembolism 6 months prior to study participation 7. uncontrolled hypertension (blood pressure ≥ 150/90 mmhg with appropriate antihypertensive therapy) 8. history of hypertensive crisis or hypertensive encephalopathy 9. subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin) 10. pregnancy or breastfeeding. 11. subjects with active virus infection 12. subjects with autoimmune disease/ syndromes 13. administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live attenuated vaccine will be required during the study 14. history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 15. severe infections during the screening period, including but not limited to complications of infection, bacteremia or severe pneumonia 16. prior allogeneic bone marrow transplantation or prior solid organ transplantation
development of targeted rna-seq for amyotrophic lateral sclerosis diagnosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: genetic diagnosis of amyotrophic lateral sclerosis (als) could identify the origin of the disease, potentially allowing the patient to pursue targeted/gene therapy. however, many familial forms of als are genetically undiagnosed, either because no variant has been detected in the genes of interest, or because the detected variant(s) have uncertain significance. currently, molecular diagnosis takes place in two stages: 1) search for the ggggcc expansion in the c9orf72 gene by rp-pcr; 2) analysis of the coding regions by high-throughput sequencing of a panel of 30 genes involved in als. many of these variants of uncertain significance affect splicing. their impact can be predicted using in silico tools, but only an analysis of the patient's rna can confirm their pathogenic nature. currently, the analysis of transcripts is only done a posteriori, when a variant predicted to impact splicing is detected on the patient's dna. rt-pcr followed by sanger sequencing then verifies the impact of the splice variants. this method confirmed the impact of certain splice variants in patients. however, this method is time-consuming and requires custom development, and is mutation/gene/patient-dependent. in contrast, high-throughput rna sequencing (rna-seq) simultaneously analyzes the splicing of numerous genes, with a global approach, applicable to all patients. this approach avoids the custom design of primers, which can be biased by the interpretation of splicing predictions, while rna-seq systematically captures and sequences all the transcripts. finally, rna-seq provides additional information compared to dna sequencing such as the detection of exon skipping, intron inclusion, and the creation of fusion transcripts. in the gtex project (gtex consortium, 2013), expression levels of human genome transcripts were quantified by rna-seq. using these results, the study investigators measured expression of transcripts of known als genes in whole blood. applying a threshold value of 0.5 transcripts per million reads (tpm), 25 of the 30 als genes currently analyzed by ngs in routine diagnostics at nîmes university hospital could be eligible for a complete analysis by rna-seq. none of the french laboratories carrying out genetic analyzes of als has yet developed rna-seq as a routine diagnostic tool. the study laboratory receives more than 600 requests for genetic diagnosis of als patients per year. the aim of this study is therefore to develop a global method for analyzing rna transcripts of als genes to categorize the mutations to improve the diagnostic management of patients.


Eligibility criteria:
inclusion criteria: * have a prescription for a genetic diagnosis of als (or familial hypercholesterolemia for the control cohort) * have given their informed consent for the genetic study and the biobank * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * the patient is under safeguard of justice or state guardianship
prevention of postoperative delirium in elderly patients

Conditions: Postoperative Delirium

Summary: prevention of postoperative delirium in the care of elderly patients. a monocentric, prospective intervention study with the question of whether the incidence, length and severity of postoperative delirium can be reduced by implementing a standardised, multidimensional delirium management protocol.

within the framework of a six-month observation period, the investigators intend to identify risk factors of the patient collective for the development of postoperative delirium. for this purpose, a preoperative risk assessment is performed, which includes cognitive and physical performance as well as premedication and concomitant diseases. included are patients of at least 65 years of age of defined specialties. postoperatively, patients who have undergone the assessment are tested for delirium once per shift until the third postoperative day and severity and duration are documented. after completion of the observation period, risk factors favoring the development of postoperative delirium will be identified. in the subsequent intervention period, patients from the age of 65 years with an additional identified risk factor will receive standardized, targeted perioperative care. this includes both adherence to preventive measures in accordance with guidelines and the recommendation of therapeutic measures if a delirium is diagnosed. through the standardized, interprofessional and interdisciplinary application of the described approach, the investigator aim to reduce the incidence, duration and severity of postoperative delirium. furthermore, the evaluation of the identification of the weighting of risk factors as well as the identification of risk factors by the tests performed, length of hospital stay, three-month mortality and daily living skills after three months. in addition, a baseline eeg (standardized awake eeg before initiation) is recorded in a subgroup to determine whether patients at risk for delirium can be identified and whether intraoperative eeg parameters support the delirium risk assessment.

Eligibility criteria:
inclusion criteria: * \>= 65 years * intervention in one of the following departments: general and visceral surgery, urology, vascular surgery, orthopedics, trauma surgery, * written consent by patient or legal guardian exclusion criteria: * foreign language patients without interpreter * non-consenting patients without a legal representative

Keywords: delirium, prevention and control post operative delirium delirium, risk factors delirium, risk assessment baseline-eeg cognitive tests eeg, intraoperative
registration of tobacco, coffee and substance use among acutely admitted psychiatric patients

Conditions: Substance Abuse; Tobacco Use Disorder

Summary: this is a study of the registration of tobacco, coffee and substance abuse among acutely admitted psychiatric patients.

we will include all patients acutely admitted to østmarka psychiatric hospital to register this population's use of coffee, tobacco and substances. we will determine whether this differs from other populations, between diagnoses, age, etc. we will also compare results of substance in immunologic rapid urine tests taken by the nurse at the hospital with substance in urine tested in laboratory with lc/ms (liquid chromatography/mass spectrometry).

Eligibility criteria:
inclusion criteria: * all patients acutely admitted to østmarka psychiatric hospital exclusion criteria: * dementia * serious brain damage

Keywords: emergency services, psychiatric tobacco use cessation coffee use cessation substance use detection substance abuse detection
micrometastases in axillary lymph nodes in breast cancer, post-neoadjuvant chemotherapy

Conditions: Micrometastases; Neoadjuvant Chemotherapy

Summary: this study aims to investigate the significance of minimal residual axillary disease following nac, with a particular focus on micrometastases (ypnmi), in comparison to pathologic lymph node-negative (ypn0) or macrometastases (ypn+). the investigators will further explore the prognostic implications of slnmi for the prediction of axillary ln status and survival outcomes.

this study aims to investigate the significance of minimal residual axillary disease following nac, with a particular focus on micrometastases (ypnmi), in comparison to pathologic lymph node-negative (ypn0) or macrometastases (ypn+). the investigators will further explore the prognostic implications of slnmi for the prediction of axillary ln status and survival outcomes.

Eligibility criteria:
inclusion criteria: * stage ii or iii primary breast cancer patients * patients who performed neoadjuvant chemotherpay * patients who underwent axillary lymph node dissection with or without sentinel lymph node biopsy exclusion criteria: * patients who performed upfront surgery * de novo stage iv patients
prospective cohort of transitional urology patients

Conditions: Spina Bifida; Myelomeningocele; Meningocele; Bladder Exstrophy; Genitourinary Congenital Anomalies; Cloacal Exstrophy

Summary: a transitional urology database was created in parallel with national spina bifida registry to follow patients with complex congenital urogenital anomalies and be able to prospectively evaluate them. the investigators obtained the standardized questionnaires to collect long-term data regarding patients' genitourinary status including urine and fecal continence, sexuality, fertility, and pelvic health.

the care and management of pediatric patients with congenital genitourinary anomalies transitioning to adolescents and later adults is undergoing a period of profound transformation. due to improvements in surgical and nonsurgical interventions, children with diverse congenital disease affecting the genitourinary tract are surviving into adulthood at far higher rates than in the past. as an example, up to 70-75% of children born with a myelomeningocele and consequent neurogenic bladder are living past the age of twenty. these new expectations, especially in the areas of sexual function, fertility and reproductive health, are creating previously unseen challenges for health care providers attempting to transition adolescents from pediatric to adult care. as this patient population continues to grow, the transitional process for urological care of congenital anomalies is progressively becoming a topic of vital importance. we plan to advance adolescence clinical and research care and pioneering a unique and novel opportunity in transitional care. this database will help us: 1. to develop and revise (as necessary) standards of care and treatment best practices for patients transitioning to adolescents with congenital genitourinary malformation. 2. to share evidence-based information between physicians across the country, advancing best practices for the secondary conditions of spina bifida, exstrophy, neurogenic bladder and bowel, and hydrocephalus. 3. to implement benchmarks to improve care in transitional urology clinics. 4. evaluate the clinical cost-effectiveness of care offered.

Eligibility criteria:
inclusion criteria: - primary diagnosis of congenital genitourinary abnormality leading to neurogenic bladder such as myelomeningocele, exstrophy, cerebral palsy, posterior urethral valve, congenital cardiac anomalies, chromosomal abnormalities, etc. exclusion criteria: - non congenital neurogenic bladder

Keywords: spina bifida, neurogenic bladder, myelomeningocele
biological adaptations of strength training.

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: a two-trial repeated measures design will be employed in this investigation. both the control trial and the exercise trial will last for 3 months. during a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. this range of measurements will be repeated the ended each month for both trials. control trial succeeds exercise trial. an exercise intervention program will take place in the second trial, three times a week.

a sample size of 30 volunteers, aged 35-45 years, will participate in the present study. of them, 15 will be normal weight and 15 will suffer from fatty liver disease (bmi 29-35 kg/m2, waist size \>102 cm). the exclusion criteria will be a) medication, b) musculoskeletal problems that will prevent participation in the training program, c) known condition or medical condition preventing participation in the program e.g. hypertension, d) bmi\> 35kg / m2, (e) a severe family medical history up to first degree relatives with cardiovascular disease and / or diabetes at the age of less than 65 for women and less than 55 years for men and (f) smoking. after informing and receiving a questionnaire and medical history, volunteers will sign for their participation in the survey. a two-trial repeated measures design will be applied in this investigation. both control and exercise trials will last for 3 months. during the week preceding the commencement of the study, participants will complete dietary recalls and will have their habitual physical activity monitored, by utilizing accelerometers. thereafter, body composition, ultrasound imaging of muscle and liver, biochemical and hematological markers will be measured. the same measurements will be repeated at the end of each month, in both trials. control trial will be executed prior to exercise trial. an exercise intervention program, combining strength and cardiovascular exercises performed three times a week, will take place in the exercise trial.

Eligibility criteria:
inclusion criteria: * no use of medication * free of musculoskeletal limitations * absence of a known condition or medical condition preventing participation in the program (e.g. hypertension) * absence of a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men * non-smokers exclusion criteria: * use of medication * musculoskeletal limitations that will prevent participation in the training program * known condition or medical condition preventing participation in the program (e.g. hypertension) * a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men * smoking

Keywords: obesity, training, inflammation, liver, oxidative stress
breathing and decision-making

Conditions: Quality of Life; Behavior; Stress, Psychological

Summary: the study aims to investigate how slow breathing with prolonged exhalation (i.e., prolex breathing) modulates decision-making under risk in healthy participants. to do this, a short-term breathing intervention is combined with a decision-making paradigm while neural, physiological, and behavioral data are recorded.

this interventional study investigates the modulatory effect of slow breathing with prolonged exhalation (i.e., prolex breathing) on decision-making under risk. using functional magnetic resonance imaging (fmri), the researchers seek to identify brain regions influenced by the breathing intervention during the decision-making task. sixty healthy participants will be invited to perform prolex breathing during a risky decision-making task. after initial preparations, each individual's spontaneous breathing rhythm will be determined (i.e., eupnea, control condition). this step is to i) ensure a natural breathing pace for each participant and ii) incorporate cue-assisted breathing into the control condition to allow comparability across conditions. to further investigate the effect of prolex on sympathovagal tone, physiological measures of respiration, electrocardiogram, pulse, electrodermal activity, and pupil are acquired. during scanning, the participant will perform a decision-making task based on the paradigm by tom et al. (2007). the breathing intervention is applied simultaneously with continuous cue-assisted breathing for both conditions (eupnea, prolex) throughout the duration of the task. the experiment follows a block design with counterbalanced orders to control for confounding effects. after completion of the scans, the participants fill out additional questionnaires.

Eligibility criteria:
inclusion criteria: * healthy men and women * normal vision (no glasses or contact lenses required) exclusion criteria: * smokers * extreme athletes * extensive lung function (e.g., professional musician, abnoedivers) * excessive stress * former or current physical or psychological illness (e.g., lung diseases) * current or previous medication within 2 weeks before the appointment * left-handedness * claustrophobia * tinnitus * non-removable metal parts or implants inside or on the body (e.g., hip replacements, copper iud) * non-removable ferromagnetic objects inside or on the body (e.g., joint replacements) * non-removable magnetic objects inside or on the body (e.g., artificial eye) * large tattoos * young (\>18 years) or old (\>40 years) subjects * over- or underweight (bmi \ 25 kg/m2) * pregnancy * abnormal circadian rhythm (e.g., during shift work) * excessive alcohol consumption * illegal drug consumption within 2 weeks before the appointment * missing consent to participate * missing consent to receive incidental findings (mri)

Keywords: breathing relaxation decision-making stress management
mood and diabetes empowerment & improvement training

Conditions: Diabetes Mellitus, Type 2

Summary: in this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income latino diabetics. the investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.

the phase i pilot recruited older latinos from dr. mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. drs. mangione and miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. the study manuals were modified following this phase i pilot intervention. the final intervention manual was tested in a randomized trial in phase ii, compared the mood and diabetes empowerment and improvement training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (hb)a1c with recommendations for improving care for their provider). the target population was low-income latinos with depression and poor glycemic control. both mood and diabetes outcomes are evaluated.

Eligibility criteria:
inclusion criteria: * latino men and women age 50 and older * must speak english or spanish * hb a1c greater than or equal to 8% * currently not taking medication for depression * a score of 5 or greater on the geriatric depression scale (gds) exclusion criteria: * persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident * do not have sufficient hearing or cognitive function

Keywords: diabetes depression self care empowerment behavioral intervention cognitive behavioral therapy diabetes mellitus, type 2