Kornimate/medical-research-clean huggingface dataset:
online nutrition education to decrease the side effects of chemotherapy in patients with breast cancer

Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Summary: this trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer. patients undergoing chemotherapy are at risk for complications such as diarrhea or constipation which can lead to poor nutritional intake and malabsorption of nutrients. this study is testing the effects of information delivered via the cook for your life website in conjunction with standard clinical care to improve symptom management during chemotherapy treatment for breast cancer, which could serve as a new model for supportive oncology care.

outline: patients are randomized to 1 of 2 arms. arm i: patients receive standard of care consisting of symptom monitoring, scheduled nurse visits, and access to current cook for your life website. arm ii: patients receive standard of care as in arm i and access to enhanced cook for your life information on symptom management.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * stage i-iii breast cancer. * current breast cancer patients scheduled to receive ddac-t(+/-c), tchp, or tcpembro-ac chemotherapy at fred hutch south lake union (can enroll prior to receipt of 2nd cycle). * not pregnant and no plan to become pregnant during chemotherapy treatment. * ability to speak and read english. * access to smartphone, tablet, or computer and internet. * willing and able to complete all study activities through the end of chemotherapy, including completing online questionnaires and telephone assessments. * women must not be pregnant at time of enrollment based on self-report. * able to understand and willing to sign written informed electronic (e) consent in english.
a study to assess the effects of pf-04457845 on bold fmri in subjects with post traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of the study is to evaluate proof of mechanism of pf-04457845, using a well-established neuroimaging paradigm including behavioral tasks selected to activate neuro-circuitry relevant to post traumatic stress disorder. it is hypothesized that pf-04457845 will modulate the blood-oxygen-level dependent functional magnetic resonance imaging signal from the relevant neuro-circuits in patients with post traumatic stress disorder.

this is a phase ii, randomized, placebo-controlled, parallel group design study in male and female subjects with moderate-to-severe post traumatic stress disorder between the ages of 18 and 60 years old. during this study, a dose of 4 mg pf-04457845 will be administered in the morning on days 1-7. on each subject will undergo a resting state fmri (pre and post and day 8), a fearful vs. neutral faces fmri task and a fear extinction fmri paradigm. the emotional faces paradigm and resting state tasks will be performed on day 1 (prior to drug or placebo) and on day 8. acquisition of fear conditioning will be performed during the first imaging session on day 1. after the first imaging session on day 1, subjects will complete behavioral rating scales and then be dosed. approximately six hours after dosing subjects will re-enter the scanner and perform the fear extinction paradigm. on day 2, subjects will perform the fear extinction memory retention task within the scanner. further physiological monitoring, including skin conductance and heart rate, will take place during the fear extinction paradigm. one safety follow-up visit will occur between days 11-18.

Eligibility criteria:
inclusion criteria: * men and women 18-60 years of age with a primary psychiatric diagnosis of post traumatic stress disorder exclusion criteria: * other psychiatric illness requiring current treatment with medication.
the comparison between epidural and intravenous patient-controlled analgesia for laparoscopic gastrectomy

Conditions: Gastric Cancer

Summary: this study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. the investigators hypothesized that epidural pca would be more effective in pain control than iv pca even for laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma in stomach * males or females, aged≥19 years and ≤80 years * scheduled as laparoscopic gastrectomy * patient has given their written informed consent to participate in the study exclusion criteria: * history of hypersensitivity for analgesics * recent history of narcotic analgesics * disability of central nerve system * uncontrolled co-morbidity

Keywords: gastric cancer epidural pca laparoscopy
comparison of two different medications used to treat elevated intracranial pressure

Conditions: Increased Intracranial Pressure

Summary: the overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. the hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.


Eligibility criteria:
inclusion criteria: * documented sah (by computed tomography or lumbar puncture), ich, tbi or brain tumor * patient greater than or equal to 18 years of age * icp monitor in place * icp greater than 20mmhg, not related to a transient noxious stimulus and not responding to standard measures for controlling icp (ventricular drainage, elevation of head of the bed and optimizing paco2) * patient or patient's legally authorized representative has provided written informed consent exclusion criteria: * patient less than 18 years of age * lack of icp monitoring * patient received mannitol prior to placement of icp monitor * baseline serum osmolarity of greater than 310 mosm/l * patient is currently enrolled in another investigational drug or device study * congestive heart failure at time of enrollment * chronic renal failure on hemodialysis * pregnancy
strataxrt in preventing radiation dermatitis in pediatric patients undergoing radiation therapy to the brain or spinal cord

Conditions: Central Nervous System Sarcoma; Ependymoma; Glioma; Malignant Intracranial Germ Cell Tumor; Medulloblastoma; Pineoblastoma; Primary Central Nervous System Neoplasm

Summary: this phase i trial studies the side effects of a silicone topical wound dressing (strataxrt) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. strataxrt may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.

primary objectives: i. to estimate the safety (defined using the common terminology criteria for adverse events \[ctcae\], version 5.0) of strataxrt and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (csi) for central nervous system (cns) tumors. ii. to estimate the efficacy of strataxrt as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton csi for cns tumors. secondary objectives: i. to explore the relationship between dosing and the efficacy of strataxrt. ii. to explore the relationship between the use of strataxrt and parent-reported symptom experience, as measured by the radiation-induced skin reaction assessment scale (risras). iii. to explore compliance with the application of treatment as documented in a study log by participants. outline: beginning first day of csi proton radiation therapy, caregivers apply strataxrt gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (bid) until the last day of radiation therapy.

Eligibility criteria:
inclusion criteria: * pediatric patients between the ages of 2 years old and 17 years old * patients diagnosed with primary cns tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton csi * patients planned to receive at least 20 gy csi at 1.8 - 2.0 gy per fraction * patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the strataxrt and placebo twice a day for the duration of the study and complete the study instruments * informed consent by parents or legal guardian; consent documents will be translated with non-english speaking participants exclusion criteria: * patients who have already started proton csi treatment * patients receiving \> 10 fractions photon therapy * patients with pre-existing dermal scarring, as determined by a clinical member of the study staff * patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18) * patients planned to receive less than 20 gy csi at 1.8-2.0 gy per fraction
a novel tourniquet technic for massive pph

Conditions: Postpartum Hemorrhage

Summary: in this study, the investigators aimed to find out the effect of a novel tourniquet technique, in cases of excessive bleeding during cesarean delivery.

in this retrospective comparative study, the investigators compared the peripartum features of patients who experienced profuse postpartum bleeding during c/s and this novel atraumatic tourniquet technique was used and not used. in this technique; the uterus is exteriorized following the delivery of the baby and before the removal of the placenta to be able to apply the tourniquet technique. in this technique it is not obligatory to push the bladder before the procedure. afterwards, the surgeon and the assistant palpate the ureters with both hands in the two sheaths of broad ligament and try to hear a 'click' sound which comes from ureter sliding out between both fingers. after confirming that the ureters are not in the surgical site, an atraumatic vascular debakey clamp is applied widely including both the infundibulopelvic ligament and uterine arteries. thus, two-sided blood supply of the uterus is reduced significantly and this gives the surgeon some time, for planning further surgical procedures and also serves a minimal bloody surgical site. if the avascular state of the surgical site is needed for a prolonged time, for instance while preparing for a blood transfusion or while waiting until an experienced surgeon is available, the clamps were opened and closed intermittently for a maximum of 10 minutes, as to sustain the blood supply of the ovaries and the uterus.

Eligibility criteria:
inclusion criteria: * the women who experienced profuse postpartum haemorrhage during cesarean section exclusion criteria: * none defined
development and application of a thrombosis risk prediction model in lung cancer patients treated with immune checkpoint inhibitors

Conditions: Lung Cancer; Venous Thromboembolism; Arterial Thromboembolism

Summary: the purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of vte (venous thromboembolism) and ate (arterial thromboembolism) associated with immune checkpoint inhibitors (icis) therapy. the primary questions it aims to address are: 1. what is the real-world incidence of vte/ate in lung cancer patients receiving immune checkpoint inhibitors? 2. what are the risk factors for vte/ate in lung cancer patients receiving immune checkpoint inhibitors? 3. what is the impact of vte/ate on the prognosis of lung cancer patients receiving immune checkpoint inhibitors? researchers will compare the characteristics and biomarkers of patients with and without ici-associated vte/ate to identify novel specific biomarkers for thrombotic events. furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.


Eligibility criteria:
inclusion criteria: * age ≥18 years * histopathologically confirmed lung cancer diagnosis at enrollment * received at least one dose of a china-approved lung cancer immune checkpoint inhibitor * signed informed consent form exclusion criteria: * excluded based on inclusion criteria * cannot comply with follow-up requirements
immunodeficiency in cartilage-hair hypoplasia: sub-project on safety of vaccination against chickenpox

Conditions: Cartilage-hair Hypoplasia

Summary: the investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to varicella (vzv) and immunize patients in a controlled manner with vzv vaccine. patients will be selected on the basis of disease severity and the degree of immunodeficiency (including cd4+ t-cell counts). any potential complication of vzv immunization, such as rash, will be discussed with the patients/caregivers beforehand and acyclovir will be used to treat any vzv related symptoms, consistent with the current practices. the investigators will verify the development of immune response to vaccination by testing for vzv antibodies and cell-mediated immunity.


Eligibility criteria:
inclusion criteria: * genetically confirmed cartilage-hair hypoplasia diagnosis * age \>12 months * no history of chickenpox * informed concent of the patient/caregiver. exclusion criteria: * positive serum igg for varicella zoster virus * low cd4+ cell counts (\<15% or \<200 cells/mm3) * clinical or laboratory signs of severe immunodeficiency * ongoing intravenous or subcutaneous immunoglobulin treatment
perspective evaluation of hormones involved in serum phosphate homeostasis in patients with metastatic renal cells carcinoma or hepatocellular carcinoma treated with sorafenib (sorhorm)

Conditions: Kidney Cancer; Liver Cancer

Summary: the study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. multicenter cohort study. it is a prospective observational study.

several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown. sorafenib is probably the drug in which this metabolic disturbance is most frequent. the aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.

Eligibility criteria:
inclusion criteria: 1. age over 18 years 2. histologically documented kidney cancer or hepatocarcinoma 3. performance status more than / equal to 2 4. life expectancy \> 12 weeks 5. in patients with recent surgery, the wound should be completely healed before taking sorafenib 6. required initial laboratory values: absolute neutrophil count \> 1500/ul platelets \> 100,000/ul., hemoglobin \> 9.0 g/dl, creatinine, sgot, sgpt less than 2.0 x upper limit of normal bilirubin less than/equal to upper limit of normal(uln) 7. appropriate patienty compliance exclusion criteria: 1. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (nyha class iii or higher) or uncontrolled cardiac arrhythmia, 2. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated, 3. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent 4. sintomatic brain metastases 5. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, hiv-positive patients receiving combination anti-retroviral therapy are excluded 6. patients with seizures that need medical treatment 7. history of heterologous transplantation 8. patients with previous or active bleeding 9. dialysis patients 10. patients with history of primary hyperparathyroidism 11. dysphagic patients 12. taking more than four weeks of entry into the study of other bio-chemotherapy treatments 13. previous treatment with sorafenib 14. recent (\<6 months)or concomitant treatment with biphosphonate

Keywords: advanced hepatocarcinoma
covid-19 vaccination in patients with rheumatic diseases

Conditions: Rheumatic Diseases

Summary: the argentine society of rheumatology (sar) set out to develop a national register of patients with rheumatic diseases who have received a sars-cov-2 vaccine in order to assess their efficacy and safety in this population.

this is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for covid-19 in argentine or any country. patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed. the aim of this registry is to evaluate the efficacy and safety of the sars-cov-2 vaccines in patients with rheumatic diseases.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age. * diagnosis of rheumatic disease treated or not with immunosuppressive agents * patients who have received at least one dose of a sars-cov-2 vaccine * signature of informed consent. exclusion criteria: * patients who express their desire not to participate in the study or who are unable to give their informed consent.

Keywords: sars-cov-2 covid-19 vaccines
microwave ablation for treatment of small renal tumors and primary and secondary liver neoplasms

Conditions: Liver Cancer; Liver Metastasis Colon Cancer; Kidney Cancer; Renal Cell Carcinoma

Summary: the goal of this observational study is to collect data on efficacy and safety of microwave ablation (mwa) used to treat subjects with primary and secondary liver malignancies and renal malignancies. the main question it aims to evaluate the short, medium and long-term clinical course of patients treated with mwa. participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path

observational, retrospective and prospective, monocentric study. the objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (mwa) for small renal tumors and primary and secondary liver neoplasms. evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.at the end of the follow-up periods, the data collected will be compared with those available in the literature on mwa, cryoablation (ca), radiofrequency ablation (rfa) and surgical resection.

Eligibility criteria:
inclusion criteria: * \> 18 years with primary or secondary liver tumors or small kidney tumors that are not candidates for surgery or cannot be radically resected by surgery alone * primary liver cancer: up to three liver nodules ≤ 3 cm * secondary hepatic tumours: up to nodules ≤ 3 cm provided that the objective is complete hepatic clearance renal tumours: single or multiple (von hippel lindau syndrome), \< 4 cm exclusion criteria: * pregnant women * non-manageable coagulopathies * extended extrahepatic or extrarenal disease * for liver ablation: presence of bilio-digestive anastomosis

Keywords: mwa
a multi-component weight loss intervention to improve outcomes of total knee replacement

Conditions: Arthropathy of Knee; Obesity

Summary: obesity, specifically bmis ≥35 or 40 kg/m2, are associated with an increased probability of poor outcomes of total knee arthroplasty (tka) including increased pain, risk for infection, poor joint function, and increased rates of hospital readmissions. several orthopedic and public health organizations recommend weight loss prior to tja for individuals with overweight/obesity. however, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of tka is extremely limited and is based primarily on non-randomized observational studies. thus, to gain further insight regarding the feasibility and potential effectiveness of pre-surgical weight loss on outcomes of tka, the proposed pilot trial will randomize 30 patients (age 50-75 yrs., bmi 35\<40 kg/m2) scheduled for tka through the university of kansas health system department of orthopedics and sports medicine (kuortho) to a multi-component weight loss (3-mo. pre-tka, very low-calorie diet) and maintenance intervention (3-mo. post tka, conventional maintenance diet) or standard care control which will include no dietary or weight loss advice. the weight loss/maintenance interventions will include reduced energy intake or energy intake prescribed for weight loss maintenance, increased physical activity, and individual behavior counseling. outcomes will be assessed 1) baseline, i.e., 3 mos. prior to surgery, 2) 3 mos. i.e., at the completion of the weight loss intervention prior to tka, 3) within a minimum of 2 weeks post tka, and 4) 3 mos. post-tka, i.e., after completion of the weight maintenance intervention to assess the feasibility and effectiveness of a remotely delivered multi-component pre-tka weight loss and a post-tka weight maintenance intervention.


Eligibility criteria:
inclusion criteria: * age: 50-75 years * bmi: 35 to ≤40 kg/m2 * patient of ku health system department of orthopedics and sports medicine (kuortho)meeting all requirements for tka surgery. * tka surgical date scheduled ≥3 mos. from consent * own a bluetooth enabled computer, tablet, or smart phone with the ability to join remote telehealth sessions and sync study self-monitoring devices. exclusion criteria: * weight loss ≥10 pounds in previous 6 months * dairy/milk protein allergy * currently pregnant/breastfeeding or planning to become pregnant during the study * currently being treated for an eating disorder or history of an eating disorder diagnosis * pacemaker * current cancer * diabetes type 1 (insulin dependent) * hyperuricemia (untreated) * inflammatory bowel disease (active) * liver disease requiring protein restriction * myocardial infarction within last 3 months * abnormal ecg * renal insufficiency.

Keywords: total knee arthroplasty total knee replacement