Kornimate/medical-research-clean huggingface dataset:
paclitaxel in treating patients with ovarian stromal cancer

Conditions: Adult Type Ovarian Granulosa Cell Tumor; Ovarian Gynandroblastoma; Ovarian Sertoli-Leydig Cell Tumor; Ovarian Sex Cord Tumor With Annular Tubules; Ovarian Steroid Cell Tumor

Summary: this phase ii trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

primary objectives: i. to estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma. ii. to evaluate the value of inhibin for predicting response. outline: patients receive paclitaxel intravenously (iv) over 3 hours on day 1. treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, sertoli-leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules) * patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen * patients must have measurable disease as defined by gynecological oncology group (gog) response evaluation criteria in solid tumors (recist) criteria * white blood count equal to or greater than 3000/mcl * granulocyte count equal to or greater than 1500/mcl * platelet count equal to or greater than 100,000/mcl * creatinine equal to or less than 2.0 mg% * bilirubin less than or equal to 1.5 times normal * serum glutamic oxaloacetic transaminase (sgot) less than or equal to 3 times normal * patients with a gog performance grade of 0, 1 or 2 * patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control * patients who have met the pre-entry requirements as specified * patients must have signed an approved informed consent and health insurance portability and accountability act (hipaa) authorization exclusion criteria: * patients with gog performance grade of 3 or 4 * patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy * patients having received more than one prior chemotherapy regimen * patients amenable to cure by surgery * patients with prior radiation except for those whose recurrent disease is outside the radiation port
effects of empagliflozin on cardiac microvasculature and insulin sensitivity in subjects with type 2 diabetes

Conditions: Type2 Diabetes; Insulin Sensitivity

Summary: the aim is to test in t2dm patients, whether, compared to placebo, 12 weeks of sglt-2 inhibitor improves post-absorptive, post-insulin infusion or postprandial insulin action to enhance cardiac muscle vascular function and whether changes correlate with improved gv or postprandial hyperglycemia

the investigators will study 32 t2dm subjects measuring cardiac muscle vascular function before and after a 4 hour insulin clamp ( protocol a) and before and after a mixed meal (protocol b). then subjects will be randomized into 2 groups: group 1 will undergo a 12 week intervention of empagliflozin, and group 2 will do 12 weeks of placebo. the intervention will be single blinded. at the end of the 12 week intervention subjects will repeat protocol a and b. the study's primary objective is to assess whether, compared to placebo, 12 weeks of empagliflozin improves post-absorptive or postprandial insulin action to enhance myocardial perfusion (mp) and whether changes of mp correlate with improved glucose variability or postprandial hyperglycemia

Eligibility criteria:
inclusion criteria: * a1c \> 6.5 and \<9% * never on sglt-2i (eg: jardiance, invokana, farxiga, steglatro) * on stable dose of oral hypoglycemic agents \>3 months * on stable dose of other medications for \>3 months * bmi-\<35 exclusion criteria: * • smoking presently or in the past 6 months * taking insulin * bp \>160/90 * bmi \>35 * history of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease. * any vascular disease such as myocardial infarction, stroke, peripheral vascular disease * history of cancer or psychiatric disease * presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by pi). * pregnant or breastfeeding. * known hypersensitivity to perflutren (contained in definity) * screening o2 saturation \<90% * history of recurrent uti/bladder/kidney infections-egfr is below 45 ml/min/1.73.
cervical nodal mets in squamous cell carcinoma of h&n - mri, fdg-pet, & histopathologic correlation

Conditions: Head and Neck Cancer; Carcinoma, Squamous Cell; Head and Neck Cancers

Summary: the purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.


Eligibility criteria:
inclusion criteria:- adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (scc) of the head and neck who will undergo neck dissection as part of primary surgical therapy. exclusion criteria:- a prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied. - pregnancy.
safety and performance evaluation of circulite synergy

Conditions: Heart Failure

Summary: the purpose of the study is to demonstrate the safety and functionality of the circulite synergy pocket circulatory assist device.

the circulite synergy pocket circulatory assist device is an implantable miniature, mixed-flow blood pump designed o provide partial left ventricular support in patients with advanced heart failure. treatment for this patient population currently include lifestyle changes, medicines, transcatheter interventions and surgery, including implantation of mechanical ventricular assist devices (vads); most of the currently available vads require highly invasive, high-risk surgical procedures to implant due to large device size, and are therefore generally limited to use in patients with terminal heart failure. the synergy pump is intended for treatment of patients with new york heart association (nyha) class iii and iv heart failure; it is expected that the pump will provide these patients with 2-3 l/min of additional blood flow, giving adequate cardiac support to increase exercise tolerance and improve patients' quality of life. the pump's small size will allow it to be implanted in a less surgically invasive procedure than used with previous vads, which should result in a reduction of perioperative morbidity. the device wil be implanted in a left atrial to subclavian artery bypass with the pump being located in the infraclavicular fossa like a pacemaker.

Eligibility criteria:
inclusion criteria: * maximum tolerable medical therapy including ace inhibitors and beta blockers * nyha class iii or iv despite maximal tolerable medical therapy * ambulatory (inpatient or outpatient) * patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant) * life expectancy of at least 6 months without full vad support exclusion criteria: * age \>75 years * exercise tolerance limited by factors other than heart failure * presence of intra-atrial thrombus * clinically significant right heart failure * serum creatinine \>/= 2.5 mg/dl or any dialysis in previous 3 months * evidence of intrinsic hepatic disease * previous episode of resuscitated sudden death without subsequent treatment with aicd * subclavian artery stenosis * low platelet count, inr that cannot be corrected prior to implant or contraindication to anticoagulation

Keywords: heart failure partial circulatory assist nyha class iiib nyha class iv ventricular assist device vad
zx008 expanded access protocol

Conditions: Dravet Syndrome

Summary: the treatment plan for this expanded access protocol is for patients with dravet syndrome who do not qualify for participation in one of the ongoing zx008 clinical trials.

the treatment plan consists of an up to 24-month treatment period. access is via application by your health care provider and available at one of the expanded access treatment centers. the dose of zx008 for the duration of the treatment period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day. the fenfluramine us expanded access program (us eap) is available to full-time us residents only. participation in the us eap is limited to patients currently residing in the us. residency in the us must be for the duration of participation in the us eap. drug may not be shipped outside the us.

Eligibility criteria:
inclusion criteria: * patient is male or female, age 2 years and older, inclusive as of study day 1. * patient is diagnosed with dravet syndrome. * patient is experiencing convulsive seizures which are not controlled by current aeds. * patient is receiving at least one aed and will remain on at least one aed for the duration of treatment. * patient has been approved for inclusion by zogenix. exclusion criteria: * patient requires or starts using an unacceptable or contraindicated concomitant medication. * patient has valvulopathy. * patient is at risk for pulmonary hypertension. * patient exclusion will be at the sole discretion of the sponsor.
neurologic physiology after removal of therapy (neupart)

Conditions: Determination of Death

Summary: the purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.

there are many canadians who need an organ transplant and who will never get one. in the past, people could only be organ donors after being declared brain dead. the dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. in canada, death determination occurs in one of two ways. in neurologic determination of death (ndd), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. in donation after circulatory determination of death (dcdd), death is declared 5 minutes after circulatory arrest. by confirming permanent loss of brain activity, the current ndd process protects donors from suffering and maintains stakeholder trust. in contrast, the current dcdd process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. while this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the dcdd process among healthcare and public stakeholders.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. plan for the withdrawal of life sustaining measures (wlsm) 3. attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures 4. patient has an indwelling arterial cannula for monitoring blood pressure exclusion criteria: 1. brain death or plan for neurologic determination of death (ndd) 2. injuries that anatomically preclude the use of neurologic monitoring
maintenance therapy with toripalimab combined with capecitabine/placebo for recurrent and metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma; Maintenance Therapy

Summary: the aim of this study is to investigate the efficacy and safety of the "capecitabine combined with toripalimab maintenance regimen" in improving the first-line treatment of recurrent and metastatic nasopharyngeal carcinoma after receiving remission through chemotherapy combined with anti pd-1 monoclonal antibody standard regimen.


Eligibility criteria:
inclusion criteria: 1. the age at the time of diagnosis is 18-75 years old, regardless of gender; 2. histologically confirmed nasopharyngeal carcinoma; 3. confirm the presence of distant metastasis in advanced nasopharyngeal carcinoma patients or recurrent nasopharyngeal carcinoma patients who cannot receive local treatment. ; 4. after receiving standard treatment for 4-6 cycles, the disease is control; 5. ecog score 0-1; 6. expected survival time of at least 12 weeks; 7. patients who have not received systemic chemotherapy within 6 months prior to diagnosis ; 8. according to recist 1.1 standard, at least 1 measurable lesion; 9. enough organ function; 10. sign an informed consent form; 11. female participants with fertility and male participants with fertility partners must agree to use reliable contraceptive measures within 6 months after screening and the last treatment. exclusion criteria: 1. patients who are known to be intolerant to capecitabine or allergic to any therapeutic drug, or who are participating in clinical studies of other new drugs; 2. diseases that may interfere with oral medication treatment, including but not limited to swallowing difficulties, chronic diarrhea, or intestinal obstruction; 3. previous or current history of other tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, and thyroid papillary carcinoma; 4. sever heart disease; 5. central nervous system metastasis with clinical symptoms; 6. serious infections ; 7. within 4 weeks of signing the informed consent form, receive systemic hormone or other immunosuppressive therapy with an equivalent dose greater than 10mg prednisone per day. subjects with a systemic hormone dose ≤ 10mg prednisone per day or inhaled/topical corticosteroids can be enrolled in the study; 8. patients with active chronic hepatitis b or active hepatitis c. 9. a history of interstitial pneumonia or other autoimmune diseases. 10. hiv infection; 11. individuals with significant organ dysfunction or uncontrollable comorbidities, including but not limited to uncontrollable hypertension, decompensated liver cirrhosis, active peptic ulcer, or hemorrhagic disease; 12. less than 6 weeks after major organ surgery; 13. pregnant or breast feeding; 14. patients with mental illness, those with a history of alcohol or drug abuse, or those who are unable to obtain informed consent; 15. other researchers have determined that it is not suitable to participate in this trial. 16. those who refuse or are unable to sign the informed consent form.
clinical trial of quantitative detection kit for hsp90α in hepatic cancer

Conditions: Liver Cancer

Summary: detect plasma hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases.

detect plasma hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases, validate accuracy, specificity and sensitivity of hsp90α kit.

Eligibility criteria:
inclusion criteria: * liver cancer patients * healthy volunteers, * benign liver diseases patients exclusion criteria: * patients who previously accepted radiotherapy
telerehabilitation for patients diagnosed with coronavirus

Conditions: Telerehabilitation; Coronavirus

Summary: in december 2019, new coronavirus pneumonia (covid-19) erupted in wuhan (hubei, china) and quickly spread from a single city to the entire country. it did not take long for this epidemic to spread to the world. after that, world health organization declared this epidemic disease as a pandemic. as of now, the number of coronavirus deaths increased to 108,281 worldwide. total number of cases approached 1,800,000 according to the latest information. while the number of healed patients was highest in china, 77,525 people with covid-19 recovered. covid-19 is a highly contagious respiratory infectious disease that can cause respiratory, physical and psychological dysfunction in patients. respiratory rehabilitation reduces the patient's symptoms of dyspnea, relieves anxiety and depression, reduces the patient's need to apply to the hospital, increases functional capacity and improves the patient's quality of life. respiratory rehabilitation, according to the feedback from china, is very important for patients in the clinical treatment and recovery process after treatment. rehabilitation of people with mild disease after discharge is mainly based on improving physical fitness and psychological adaptation. it is also aimed to gradually restore the individual's ability to the activity before the disease and return to the community as soon as possible. individuals with covid-19 who have respiratory and / or limb dysfunction and chronic disease after discharge should receive respiratory rehabilitation therapy. according to the current findings of the patients discharged from severe acute respiratory syndrome (sars-cov) and middle east respiratory syndrome (mers) and the clinical experience of patients with acute respiratory distress syndrome (ards) patients who recovered after discharge, covid-19 patients may have physical fitness, dyspnea after activity, and muscle atrophy. (including respiratory muscles and trunk muscles) it is recommended to use respiratory videos and booklets as the main method for respiratory rehabilitation in isolated patients at home. telerehabilitation method is also a different recommendation option for rehabilitation. the purpose of this study is to investigate the effects of exercises performed by telerehabilitation in patients diagnosed with covid-19 followed at home. it is aimed to use an innovative model based on the digitally supported, home-based exercise program.


Eligibility criteria:
inclusion criteria: * having been diagnosed with covid-19, * having been diagnosed in the last 1 week, * being between the ages of 18-70, * patients who continue to be followed at home exclusion criteria: * hospitalization patients * having a serious cognitive impairment * having serious hearing and vision problems

Keywords: exercise breathing exercise physiotherapy
effect of asea on energy expenditure and fat oxidation in humans

Conditions: Obesity

Summary: to test the effect of asea consumption on 24-hour resting energy expenditure. hypothesis: consumption of 8-oz of asea water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

the asea beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. a proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. data obtained thus far, suggests the possibility that consumption of the asea beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. to this end, we will measure the effects of asea consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the university of north carolina (unc) nutrition research institute. the primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to asea consumption. the secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of asea.

Eligibility criteria:
inclusion criteria: * woman * postmenopausal * healthy * age 50-65 * bmi 25-35 kg/m² * exercise less than 150 minutes per week * weight neutral for past 6 months exclusion criteria: * smoker * exercises more than 150 minutes per week * abuses drugs or alcohol * vegetarian * taking herbal supplements, attention deficit hyperactivity disorder (adhd) medication or thyroid medication * taking beta-blockers, steroidal anti-inflammatory medication * taking pseudoephedrine

Keywords: obesity overweight over nutrition nutrition disorders energy expenditure metabolic rate
evaluation of the efficacy of addition of progesterone to standard chemotherapy in adrenocortical carcinoma (acc)

Conditions: Adrenocortical Carcinoma

Summary: this is a prospective randomized, double blind, placebo controlled phase ii study planned in patients with advanced acc. the study will be conducted at asst spedali civili hospital and university of brescia in brescia.

as no effective second-line therapies are available for patients with disease progression to edpm, including modern molecular target therapies and immunotherapy, it is reasonable to expect that no newer drugs or combination regimens will be able to replace edpm in the next 5 years. since edp-m is destined to remain the standard first line therapy, research strategies aimed to improve the efficacy of this regimen are of relevance. in this study, investigators will address the hypotheses that progesterone has a synergistic and/or additive effect to edp-m in inducing cytotoxicity in acc cells in vitro and the antineoplastic activity of edp-m in locally advanced/metastatic acc patients could be improved by the addition of megestrol acetate.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of acc * locally advanced or metastatic disease not amenable to radical surgery resection * ecog performance status 0-2 * effective contraception * life expectancy \> 3 months * age \> 18 years * adequate bone marrow reserve (neutrophils \>1,000/mm3 and/or platelets \>80,000/mm3) and organ function (including renal, liver and cardiac function) * be able to comply with the protocol procedures and provide written informed consent. exclusion criteria: * history of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years * renal insufficiency (estimated glomerular filtration rate \[gfr\]\ 2 times the upper normal range and/or serum alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\]\>3 times the upper normal range). gfrs will be calculated according to the validated formula (mdrd) * pregnancy or breast feeding * congestive heart failure (ejection fraction\<45%) * preexisting grade 2 peripheral neuropathy * previous or current treatment with mitotane or other antineoplastic drugs for acc * previous radiotherapy for acc * any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.