Kornimate/medical-research-clean huggingface dataset:
a study of sotorasib in people with brain tumors

Conditions: Brain Tumor

Summary: the researchers are doing this study to find out how effective sotorasib is at getting into kras g12c+ brain tumors. the researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of kras g12c+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy * patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy * for all cohorts: no limit on prior cns radiation or systemic therapykps ≥ 60 * life expectancy \>12 weeks * adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the investigator * adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment): * absolute neutrophil count (anc) ≥1.0 × 10\^3/μl (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to c1d1) * platelet count ≥10.0x10\^4/μl. note: participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10\^4/μl are not eligible. (platelet transfusion is not allowed within 1 week prior to c1d1) * hemoglobin ≥ 7.0 g/dl (≥ 8 g/dl in gastric cancer / gastroesophageal cancer indications). note: participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dl are not eligible (red blood cell transfusion is not allowed within 1 week prior to c1d1) * creatinine clearance ≥30 ml/min, as calculated using the cockcroft-gault equation * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3 × upper limit of normal (uln) (\<5x uln in participants with liver metastases) * total bilirubin ≤1.5 × uln) if no liver metastases or \<3 × uln in the presence of documented gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline exclusion criteria: * known allergy or hypersensitivity to study treatment or any of the study drug excipients. for patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the principal investigator; reactions will be managed per standard institutional protocol * multiple primary malignancies within 3 years, with the exception of: * adequately resected non-melanoma skin cancer * carcinoma in situ of the cervix * smoldering pre-malignant or malignant conditions with minimal concern for cns or extracranial progression during treatment such as cll or mgus based on the assessment of the treating provider * curatively treated in-situ disease * other solid tumors curatively treated * for patients with metastatic breast cancer: contralateral breast cancer

Keywords: sotorasib kras g12c cns-brain advanced 24-111
ideal time of oxytocin infusion during cesarean section

Conditions: Blood Loss, Surgical; Postpartum Hemorrhage; Bleed Pregnancy; Pregnancy Related; Cesarean Section Complications

Summary: this study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. we hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the united states. this medication helps to reduce overall blood loss, by functioning as a uterotonic. currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries. this study will evaluate both estimated and quantitative blood loss for both groups of patients. it will also compare the change from pre-operative to post-operative hemoglobin levels.

Eligibility criteria:
inclusion criteria: * women undergoing cesarean section at loyola hospital * women who read and speak the english and/or spanish language * women age 18 or older exclusion criteria: * women who deliver vaginally * gestation under 37 weeks and 0 days * women with coagulopathies * multiple gestation pregnancies * antepartum hemorrhage for example abruption * placental abnormalities for example previa, accreta
silymarin (milk thistle extract) in treating patients with acute lymphoblastic leukemia who are receiving chemotherapy

Conditions: Drug/Agent Toxicity by Tissue/Organ; Leukemia

Summary: rationale: silymarin (milk thistle extract) is an herb that may be effective in treating liver disorders caused by cancer therapy. purpose: randomized phase ii trial to study the effectiveness of silymarin in treating patients who have acute lymphoblastic leukemia with chemotherapy-related side effects to the liver.

objectives: * determine the effect of silymarin, in terms of liver function tests, in patients with acute lymphoblastic leukemia receiving hepatotoxic chemotherapy. * determine the effect of this drug on free and conjugated serum silibinin values in these patients. * determine the serum antioxidant capacity by oxygen radical absorbance capacity in patients treated with this drug. * determine the oxidative damage, as determined by 8-oxodeoxyguanosine adducts, in patients treated with this drug. outline: this is a randomized, double-blind, placebo-controlled study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral silymarin daily for 28 days. * arm ii: patients receive oral placebo as in arm i. patients are followed at day 56. projected accrual: a total of 50 patients (25 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphoblastic leukemia (all) * currently receiving maintenance or continuation phase chemotherapy for all * regimen comprising intrathecal and oral methotrexate; vincristine iv; oral prednisone or dexamethasone; and oral mercaptopurine * elevated liver function tests, evidenced by 1 of the following criteria: * bilirubin greater than 1.5 times upper limit of normal (uln) * ast greater than 2.5 times uln * alt greater than 2.5 times uln patient characteristics: age * 2 to 21 performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * see disease characteristics renal * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * see disease characteristics radiotherapy * not specified surgery * not specified

Keywords: drug/agent toxicity by tissue/organ childhood acute lymphoblastic leukemia
study evaluating nasal symptoms induced by a nasal allergen challenge (nac) to house dust mite allergen

Conditions: Allergic Rhinitis

Summary: a multi-center study evaluating the nasal allergic symptomatology induced by a nasal allergen challenge (nac) in a dust mite population


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * positive st to dust mite * history of allergic rhinitis exclusion criteria: * no active infections * no disallowed medications * no nasal anatomical deformities or nasal surgical interventions in the past
forreal: forxiga prescription event monitoring program (pemp)

Conditions: Type 2 Diabetes

Summary: the study purpose is to assess adverse events in patients with type 2 diabetes who have newly been prescribed forxiga for the management of glycemic control

observational model: other: a post-marketing evaluation of the safety of forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice

Eligibility criteria:
inclusion criteria: patients with type 2 diabetes who are: * prescribed forxiga for glycaemic management and * who have the ability to provide informed consent exclusion criteria: patients with whom use of forxiga is contraindicated: * patients with type 1 diabetes * patients with moderate to severe renal impairment \[creatinine clearance (crcl) \<60 ml/min or estimated glomerular filtration rate (egfr) \<60ml/min/1.73m²\] additional exclusion criteria: * age \>75 years * concomitant use of loop diuretics or pioglitazone * patients who are currently on another sglt2 inhibitor
steroid withdrawal in pediatric renal transplant recipients under cyclosporine (cya) and mycophenolate mofetil (mmf)

Conditions: Kidney Diseases

Summary: the present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.

the present protocol aims to investigate the steroid-saving potential of mmf in pediatric patients after ntx. over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase): branch a: cya + mmf + withdrawal of steroids over a three-month period following randomization branch b: cya + mmf + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day after two years of observation, steroids in the control group (branch b) can be withdrawn optionally in conformity with the same protocol as in branch a (uncontrolled second study phase). it is to be expected that part of the patients will decide in favour of a withdrawal of steroids. in the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.

Eligibility criteria:
inclusion criteria: * age \< 18.0 years * bone age of boys \< 15 years, of girls \< 13 years * patients 12-24 months after renal transplantation with stable transplant function * first or second kidney transplant, living or cadaver kidney donation * triple immunosuppression with cyclosporine (cya), mmf, and daily steroids at study entry * patients and parents, respectively, have given their written consent after enlightenment (informed consent) exclusion criteria: * irreversible rejection of former transplant within 6 months * highly reactive (\> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation * anamnestically steroid-resistant rejection of current transplant * more than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry * glomerular filtration rate (gfr) \< 40 ml/min/1.73 m² (schwartz formula) at study entry * acute rejection reaction or unstable transplant function (increase of serum creatinine \> 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction * suspected insufficient medication compliance * patients receiving a basic immunosuppression other than that prescribed in this protocol * simultaneous therapy with growth hormone after renal transplantation

Keywords: pediatric renal transplantation steroid withdrawal mycophenolate mofetil cyclosporine a stable graft function children renal transplantation
double-method comparative study in order to predict the use of co-receptors from type 1 hiv: phenotypic study (trofile esta®) and virologic response to a ccr5 antagonist in the short term

Conditions: HIV Infections

Summary: the summary of the study is to compare two methods in order to predict how the 1-hiv will use a co-receptor: the use of an accredited test (trofile esta®) and the viral response to a ccr5 antagonist in the short term.


Eligibility criteria:
inclusion criteria: * patients willing to give, sign and date the informed consent form to participate in the study and to donate their samples for cell and molecular studies, after receiving the appropriate information about the study design, the main objective of the study and the potential risks. * patients aged \>18. * patients with chronic hiv infection * patients with no previous haart (naïve patients). * patients that do not meet haart starting criteria. * viral load \>1.000 hiv rna copies/ml * patients able to understand the study objectives and able to perform frequent visits to the study site. exclusion criteria: * prior haart (regardless of the haart type). * pregnancy or willingness to get pregnant during the study.
clinical study on the safety and efficacy of the minimally invasive ennovate® method for pedicle screw placement

Conditions: Cervical Spine Disease; Pain, Postoperative

Summary: the study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the ennovate® cervical spinal system.


Eligibility criteria:
inclusion criteria: * all patients with minimum 18 years of age receiving ennovate® cervical internal fixation device within the vertebral bodies c2-th3 to ensure the restoration and stabilization of the cervical spine exclusion criteria: * all patients not willing to sign the patient consent are excluded. also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded. absolute contraindications according to the ifu: * severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, paget's disease, bone tumors etc. * metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system. * suspected allergy or sensitivity to the implant materials. * acute or chronic vertebral infections of a local or systemic nature. * poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity.

Keywords: posterior cervical fusion pedicle screw
radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy

Conditions: Breast Neoplasm

Summary: this pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). the radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.

primary objectives: i. to obtain human clinical data in order to demonstrate that the radiofrequency identification (rfid) localization system performs as intended as a localization device for marking and retrieving a surgical target in the breast. secondary objectives: i. to solicit feedback from the radiologists and surgeons regarding the process and use of the rfid system. outline: patients undergo radiofrequency-guided localization comprising rfid tag placement before lumpectomy and interactive detection of tag using rfid reader during lumpectomy.

Eligibility criteria:
inclusion criteria: * have had stereotactic or ultrasound-guided biopsy with marker placement * have a lesion or biopsy marker that is visible under ultrasound * have a surgical target =\< 6 cm from the skin when lying supine * have a discreet surgical target * have a lesion in which the center/focal area is defined * have the ability to understand and the willingness to sign a written informed consent document * eastern cooperative oncology group (ecog)/karnofsky performance status will not be used as an inclusion criterion * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * require more than one localization needle for localization of the surgical target (bracket localization) * have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast * have a prosthesis/implant in the operative breast * have a cardiac pacemaker or defibrillator device * be contraindicated for surgery * be pregnant
chronic total occlusion registry

Conditions: Chronic Total Coronary Occlusions

Summary: the aim of this cto registry is to gather data including patient demographic date, cardiac risk factors, procedural technical data and procedural success/outcome rates. furthermore, we aim to evaluate the safety and performance of various cto specific guidewires, devices (such as the crossboss/stingray dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). the incidence of recognized complications (dissections, perforations, cardiac tamponade, vascular complications, radiation injury, acute kidney injury) will also evaluated. the investigator will assess clinical outcome at 1 year after successful cto procedures.

this objectives of this single-center cto registry are to: 1. gather prospective clinical data on all consecutive patients undergoing complex difficult cto pci procedures including patient demographic date, cardiac risk factors, procedural technical data (contrast volume, radiation exposure, procedure time and procedural success/outcome rates. 2. evaluate the safety and performance of various cto dedicated guidewires, devices (such as the crossboss/stingray anterior dissection re-entry device) and other recognised and approved techniques (retrograde wire escalation, retrograde dissection re-entry techniques). 3. evaluate the incidence and severity of recognized complications such as coronary dissections, coronary perforations (+/- need for emergency pericardiocentesis), acute kidney injury, radiation injury, access site vascular complications. 4. evaluate the medium-term outcome (recurrence of symptoms, major cardiovascular events (cardiac death, myocardial infarction, target lesion revascularization, target vessel revascularization) during a routine out-patient consultation (planned as part of normal standard care) at 1 year post successful cto pci. after this consultation, the patient may choose to have cardiology follow-up at the uz leuven or with his/her referring cardiologist.

Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing an elective attempt at percutaneous revascularization of a chronic total occlusion are eligible for inclusion in the cto registry. a chronic total occlusion is defined as an occluded coronary artery with timi 0 flow that has been occluded for 3 months or more. by definition all patients will have been judged to be acceptable candidates for an attempt at revascularization before consenting to be part of the cto registry. exclusion criteria: * there are no specific exclusion criteria. if the patient does not wish to consent to having his personal data kept in a registry the patient will not be included in the cto registry.
functional restoration after abdominal and pelvic laparoscopic surgery: effect of perioperative intravenous lidocaine

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Summary: this is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. the aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery. twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (pca) and twenty patients will receive only pca. hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

this is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. the first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will pca alone and the last group will receive spinal analgesia. functional restoration assessed by self-administered quality of life questionnaires (sf-36, champs, icfs) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo laparoscopic colonic resection exclusion criteria: * patients who have trouble to understand, read or communicate either in french or in english * dementia * patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity * patients suffering from severe cardiac or respiratory disease (status asa iv) * patients suffering from metastatic carcinoma * patients who have a history of chemoradiation within the six months preceding surgery * allergy to lidocaine * morbid obesity
the effect of simple gymnastics training for parkinson's patients in the community

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to explore the impact of simple gymnastics training on limb motor function and mental health in parkinson's patients in the community (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of parkinson's diseases among community-dwelling elderly individuals, and 2) the effects of simple gymnastics training on limb motor function and mental health in community-dwelling parkinson's patients. all patients are required to undergo a continuous three-week (21 days) simple gymnastics training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 30 minutes each.

in the early stages of parkinson's disease, many patients do not seek medical attention. the goal of this clinical trial is to explore the impact of simple gymnastics training on limb motor function and mental health in parkinson's patients in the community (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of parkinson's diseases among community-dwelling elderly individuals, and 2) the effects of simple gymnastics training on limb motor function and mental health in community-dwelling parkinson's patients. all patients are required to undergo a continuous three-week (21 days) simple gymnastics training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility criteria:
inclusion criteria: * age \>60 years. * meeting the diagnostic criteria for parkinson's disease developed by the neurology branch of the chinese medical association in 2006. exclusion criteria: * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. * complicated with severe liver and kidney failure, tumors, or hematological disorders.: