Kornimate/medical-research-clean huggingface dataset:
m8891 first in human in solid tumors

Conditions: Advanced Solid Tumors; Metastatic Renal Cell Carcinoma

Summary: the purpose of this study was to determine the maximum tolerated dose (mtd), safety, tolerability, pharmacokinetic (pk), pharmacodynamic and clinical activity of m8891 as single agent in participants with advanced solid tumors in part 1.


Eligibility criteria:
inclusion criteria: * participants must be refractory to or intolerant of existing cancer therapy(ies) known to provide clinical benefit. * histologically confirmed advanced solid tumors with no clear curative treatment options available after at least 1 prior systemic anticancer therapy. * tumor accessible for biopsies and agreement to conduct pre-dose and post-dose fresh tumor biopsies. * male or female subjects at least 18 years of age * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 at screening * histologic or cytologic evidence/proven of metastatic renal cell carcinoma (mrcc) with clear cell component * part 2a: participants should have progressed to 1 or more previous lines of systemic anticancer therapy, excluding treatment with cabozantinib * part 2b: participants should have progressed to 1 or 2 previous lines of systemic anticancer therapy, excluding treatment with cabozantinib. participants should have failed to only 1 previous tki for metastatic disease. adjuvant therapy with sunitinib will be considered as 1 line of therapy for metastatic disease in the case that disease progression occurs during or within 3 months of the completion of the treatment. * other protocol defined inclusion criteria could apply exclusion criteria: * ecog ps \>= 2 * extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years of study start. * severe bone marrow, renal or liver impairment. * tumor in contact with, invading or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions * uncontrolled hypertension defined as sustained blood pressure (bp) \> 150 millimeters of mercury (mm hg) systolic or \> 100 mm hg diastolic despite optimal antihypertensive treatment * participant is pregnant or breastfeeding * part 2a and 2b: previous use of cabozantinib or a metap2 inhibitor, tumor in contact with invading or encasing major blood vessels or radiographic evidence of significant cavitary pulmonary lesions * other protocol defined exclusion criteria could apply

Keywords: advanced solid tumors metastatic renal cell carcinoma m8891 methionine aminopeptidase 2 inhibitor
stenosis of arteria-venous fistula in maintenance hemodialysis patients: early intervention trial

Conditions: Uremia; Arteriovenous Fistula; Stenosis

Summary: the purpose of this study is to compare the effect of dsa guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of stenosis of arteria-venous fistula in maintenance hemodialysis patients.

eligibility criteria: 1. patients with long-term maintenance hemodialysis with avf as the vascular access; 2. positive clinical examination signs of avf stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur. 3. doppler ultrasound /dsa/magnetic resonance angiography show the diameter of avf fistula is \>50% narrow than the adjacent segment of the fistula lumen. 4. blood flow of the avf is \ 25%. 5. patient signed the informed consent.

Eligibility criteria:
inclusion criteria: 1. patients with long-term maintenance hemodialysis with avf as the vascular access; 2. positive clinical examination signs of avf stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur; 3. doppler ultrasound /dsa/mra show the diameter of avf fistula is \>50% narrow than the adjacent segment of the fistula lumen; 4. blood flow of the avf is \ 25%; 5. patient signed the informed consent. exclusion criteria: 1. allergic to the iodine contrast or gadolinium contrast agent; 2. local infection; 3. the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine); 4. the presence of severe artery steal syndrome; 5. stenosis of immature fistula or fistula \<2 month after vascular anastomosis; 6. severe central venous stenosis; 7. discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant); 8. severe cardiac dysfunction (new york heart association cardiac functional classification iii or worse), unstable angina pectoris, myocardial infarction, severe left ventricular hypertrophy, or severe vascular embolic disease; 9. participated in other clinical trials within 12 weeks; 10. alcohol and/or drug abusers, mental disorders; 11. patients not suitable as the subjects of this trial under the consideration of researchers.
study to determine the anti-plaque efficacy of commerical toothpastes and an oral rinse

Conditions: Dental Plaque

Summary: calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. all products are commercially available.

Eligibility criteria:
inclusion criteria: * be aged 18 to 65 years inclusive * have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present * give written informed consent * be in good general health * no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study * if of childbearing potential and on birth control (diaphragm, birth control pills, birth control implants, iud (intrauterine device), condoms) exclusion criteria: * medical condition which requires pre-medication (antibiotics) prior to dental * visits/procedures * allergy to chlorhexidine * advanced periodontal disease (gum disease) * 5 or more decayed, untreated dental sites (cavities) * diseases of the soft or hard oral tissues (gums or palate) * orthodontic appliances that interfere with plaque rating * abnormal salivary function * use of drugs that can affect currently salivary flow or production * use of antibiotics one (1) month prior to or during this study * use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn) * pregnant or breastfeeding. * participation in another research study in the month preceding this study * allergic to common toothpaste or mouth rinse ingredients. * immune compromised individuals (hiv, aids, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
analysis of clinical characteristics of hemodialysis patients with omicron infection

Conditions: COVID-19

Summary: by collecting the clinical data of hemodialysis patients with omicron infection in renji hospital from april 7, 2022 to june 10, 2022, the clinical characteristics of this population were analyzed. and to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population.

this study was a single-center, retrospective, observational study. the research subjects were hemodialysis patients admitted to the hemodialysis center of renji hospital affiliated to shanghai jiaotong university school of medicine because of omicron infection during the omicron epidemic period from april 7, 2022 to june 10, 2022. 65 cases were included in the study after excluding those patients who underwent hemodialysis due to acute kidney injury. and they were compared with 195 non-dialysis patients admitted to the hospital in the same period,who were randomly selected, according to the ratio of 1:3.

Eligibility criteria:
inclusion criteria: * hemodialysis patients due to chronic kidney disease stage 5 with omicron infection exclusion criteria: * patients on hemodialysis due to acute kidney injury

Keywords: hemodialysis
sildenafil effect after ovulation induction

Conditions: Infertility

Summary: 100 women with infertility classified into 2 groups. group a: included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. group b: included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

100 women with infertility classified into 2 groups. group a: included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. group b: included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day. folliculometry was assessed by: * transvaginal ultrasound: it was done on day 11th of the cycle to detect number of follicles and endometrial thickness. when the follicles reach ≥18 ml, injection of 5000 iu of hcg im to trigger ovulation to both groups. pregnancy was assessed by: * beta hcg test: (radioimmunoassay)

Eligibility criteria:
inclusion criteria: 1. infertile women whether it's primary or secondary infertility 2. woman's age: (18-35 years old) 3. menstrual cycle from (24-35 days) 4. normal semen analysis exclusion criteria: 1. age more than 35 years old 2. ovarian cysts 3. abnormal hormonal profile (e.g hyperprolactinaemia) 4. significant cardiovascular disease 5. serious liver disease or renal failure 6. poorly controlled diabetes mellitus

Keywords: sildenafil citrate induction of ovulation pregnancy rate
determine the utility of liquid biopsies and tumor molecular profiling in predicting recurrence in endometrial cancers

Conditions: Endometrial Clear Cell Adenocarcinoma; Endometrial Dedifferentiated Carcinoma; Endometrial Mucinous Adenocarcinoma; Endometrial Serous Adenocarcinoma; Malignant Uterine Neoplasm; Uterine Corpus Carcinosarcoma

Summary: this study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with endometrial cancer. a liquid biopsy is a blood test that may be able to find cancer cells. collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.

primary objectives: i. compare tp53, fbxw7, and other mutated gene variant allele frequencies (vaf) in serial circulating cell free deoxyribonucleic acid (ccfdna) samples obtained from patients with endometrial cancer subtypes during the primary treatment course, which may include pretreatment, post-surgical removal, post adjuvant treatment, and at time of recurrence. ii. compare the findings from the liquid biopsy mutational analysis to next generation sequencing from the primary tumor. exploratory objectives: i. to estimate the presence of malignant cells in the vagina before and after minimally invasive hysterectomy among patients with endometrial cancer. ii. characterize the immune profile and single cell ribonucleic acid (rna) sequencing (scrnaseq) profile of endometrial cancer subtypes. iii. estimate time to progression (ttp), and investigate potential correlations between mutated gene variant allele frequency (vaf) ccfdna samples and progression. iv. compare the efficacy of experimental ccfdna assays to approved ccfdna assay using the same samples. outline: patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. patients also undergo collection of tissue samples during hysterectomy. patients may also undergo pap smears before and after hysterectomy.

Eligibility criteria:
inclusion criteria: * women age 18 years and older * histologic diagnosis of endometrial cancer * candidate for primary surgical treatment or has recently had prior primary surgery * willing and able to provide informed consent exclusion criteria: patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. note: patients with a history of other cancers may be enrolled after discussion with the pi if it is determined that they are at low risk for recurrence or metastasis.
same day discharge for wedge resection

Conditions: Surgery; Minor; Lung Cancer

Summary: monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection

determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery. this will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery. the investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.

Eligibility criteria:
inclusion criteria: patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung. exclusion criteria: 1. pulmonary function tests demonstrating forced expiratory volume in 1 second (fev1) \<50% predicted, fev1 \<1.5l and/or diffusion lung capacity of carbon monoxide (dlco) \<50% predicted. 2. patient receives an intraoperative pleurodesis. 3. conversion to open thoracotomy or mini thoracotomy intraoperatively. 4. active pregnancy. 5. thoracic revised cardiac risk index score (thrcri)8 \>2. 6. underlying cognitive disorder resulting in inability to complete activities of daily living.
evaluating and comparing two surgical methods for treatment of early stage breast cancer

Conditions: Breast Neoplasms; Breast Cancer; Breast Tumors; Cancer of Breast; Cancer of the Breast; Human Mammary Carcinoma; Neoplasms, Breast

Summary: the goal of this study is to compare two different types of breast surgery. in the first type, the doctor removes only the tumor. in the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. the amount of breast tissue removed is similar. the removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. the primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. at present, most breast surgeons remove the tumor without the additional margins. for all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation. at present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. if the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).


Eligibility criteria:
inclusion criteria: * female patients with the diagnosis of stage 0, i, ii and iii breast cancer diagnosed/treated at the avon foundation comprehensive breast center (afcbc) of grady memorial hospital * age: no limit exclusion criteria: * stage iv breast cancers

Keywords: breast cancer tumors or cancer of the human breast breast tumors cancer of breast cancer of the breast human mammary carcinoma neoplasms, breast
pharmacist interventions in cholesterol management of very high risk patients

Conditions: Hyperlipidemia; Coronary Artery Disease

Summary: the primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.

studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (ldl). this evidence explains why ldl targets for secondary prevention have continued to be lowered. cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. however, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.

Eligibility criteria:
inclusion criteria: * diagnosis of coronary artery disease * low-density lipoprotein (ldl) \> 55 * primary care physician at 1 of 6 identified clinics exclusion criteria: * patients who are no longer an active patient of one of the internal medicine practices * patients whose cholesterol is managed by another practice * women of childbearing age/potential * patients residing in hospice/long term care facilities * end-stage liver disease

Keywords: pharmacist intervention hyperlipidemia treatment secondary prevention of cardiovascular disease
framing clinical trial enrollment for patients with peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: it is uncertain whether opt-out framing will increase participation in a clinical trial intended to promote physical activity in patients with peripheral artery disease (pad). this study will test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the study and the demographic characteristics of enrolled patients.

the gamepad study is a two-arm randomized controlled trial aimed at evaluating whether a home-based walking program with automated coaching augmented with gamification and behavioral economic principles improves functional capacity in patients with pad. gamepad will be conducted using the way to health platform, and patients will enroll and consent for participation online, with available help from a study coordinator by telephone. the present study will leverage the gamepad enrollment process to test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the gamepad study and the demographic characteristics of enrolled patients. eligible patients will be contacted via email to determine their interest in participation in the gamepad study. patients will be randomized 3:1 to an email message framing trial participation in a standard opt-in manner versus an email message framing trial participation in an opt-out manner. patients randomized to opt-in framing will be instructed to visit the way to health website to enroll in the game pad study, or to call or email the study coordinator with questions or for assistance in enrolling. patients randomized to opt-out framing will be informed that a study coordinator will be calling them in the coming days to discuss enrollment in the study. baseline characteristics of patients randomized to each framing method will be abstracted from the electronic health record and penn data store, and will include age, sex, race/ethnicity, and medical comorbidities. whether contacted patients created an account on the way to health website and/or ultimately consented for enrollment in the study will be captured. for all outcomes, we will compare patients initially presented with study participation via opt-in framing versus opt-out framing. the primary outcome will be the proportion of patients that enroll in the gamepad study. we will also report the proportion of enrolled patients that failed to complete the gamepad study among those patients that ultimately enrolled.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * have been seen in the university of pennsylvania health system * have an icd-10 code consistent with peripheral artery disease (i70.2x, i70.3x-i70.7x, i73.9) or peripheral artery disease on their problem list * have an email address on file with the university of pennsylvania health system exclusion criteria: * previously indicated unwillingness to be contacted by email for participation in research studies
goal-directed therapy in high-risk surgery

Conditions: Perioperative/Postoperative Complications; Hypovolemia; Hypoxia

Summary: there is growing evidence that the risk of postoperative complications can be decreased by optimizing the amount and type of infusion fluids given during surgery, steered by goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk patients. this study is undertaken subsequently to test the hypothesis that the intraoperative goal-directed strategy based on flotrac/vigileo, a minimally invasive monitor, can partially prevented postoperative complications and shorten hospital stay in the elderly high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .

after sedated with iv 0.02 mg/kg midazolam, all patients will receive arterial, central venous, and l3-4 intrathecal catheterizations. a t12 sensory level block was attained with ropivacaine through the intrathecal catheter. besides currently recommended monitoring during the intraoperative period, arterial blood pressure, stroke volume (edwards lifesciences, irvine, calif.), and central venous oxygen saturation (edwards lifesciences) will be measured and recorded. all patients will receive intranasal oxygen 2 ml/min and be kept normothermic (body temperature \> 36°c). patients in both groups receive 8 ml/kg/hour of ringer's lactate solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when the rate will be decreased to 100 ml/hour. in addition, boluses of colloid will be given to different protocol group according to the study arm to which the patient allocated.postoperative care and discharge criteria were predefined using the hospital care map and protocol.

Eligibility criteria:
inclusion criteria: * 1. adult patients scheduled for total hip replacement at this institution. * 2. american society of anaesthesiologists (asa) physical status of iii or vi. * 3. two or more risk factors according to risk index of lee . exclusion criteria: * 1. age under 70years old * 2. idiopathic coagulopathy: with warfarin or heparin * 3. systemic or local infection * 4. unable to cooperate * 5. spinal trauma or severe low back pain history * 6. patient refusal.

Keywords: perioperative fluid optimization goal-directed therapy elderly high-risk surgery