Kornimate/medical-research-clean huggingface dataset:
chidamide combined with zimberelimab in the treatment of metastatic triple-negative breast cancer patients

Conditions: Triple Negative Breast Cancer

Summary: the objective of this study is to evaluate the efficacy and safety of a new treatment regimen (chidamide combined with zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.

this is a phase ii, single center, prospective, single arm clinical trial. the objective of the study is to evaluate the efficacy and safety of a new treatment regimen (chidamide combined with zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. this study plans to recruit 47 subjects.

Eligibility criteria:
inclusion criteria: * histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis. * at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist) criteria. * fail first-line or above anti-tumor treatment. * adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve. * compliance with the study protocol. * have provided written and signed informed consent. * minimum life expectancy 16 weeks. exclusion criteria: * pregnant or breast feeding. * uncontrolled medical problems. * evidence of active acute or chronic infection. * hepatic, renal, cardiac, or bone marrow dysfunction. * concurrent malignancy or history of other malignancy within the last five years. * known severe hypersensitivity to chidamide or zimberelimab * patients were unable or unwilling to comply with program requirements.

Keywords: chidamide plus zimberelimab
an innovative treatment for cervical pre cancer

Conditions: Cervical Intraepithelial Neoplasia

Summary: the purpose of this study is to test two innovative devices, the cryopen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. tissue destruction with single freeze versus double freeze treatments with the cryopen and gas-based cryotherapy will also be compared.

the primary objectives of the study are to test the hypothesis that the cryopen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional co2-based cryotherapy and to test single versus double freeze applications. the secondary objectives of the study are to determine if the cryopen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.

Eligibility criteria:
inclusion criteria: * between 25 and 65 years old. * scheduled for a hysterectomy for reasons other than cervical precancer or cancer * diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted * histological evaluation of the cervix does not interfere with the woman's current diagnosis * woman consents to participate after being informed about the study * normal pap smear or hpv test in the past 3 years exclusion criteria: * pregnancy * history of cervical surgery in past 5 years * presence of cervical lesion pre-invasive or invasive on the cervix \* * current pelvic inflammatory disorder or severe acute cervicitis * cervix shape disfigured or hard to reach
a study of trpc5 channel inhibitor in patients with diabetic nephropathy, focal segmental glomerulosclerosis, and treatment-resistant minimal change disease

Conditions: Kidney Diseases; Diabetic Nephropathies; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Nephrosis

Summary: this is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of gfb-887 in patients with diabetic nephropathy (dn), focal segmental glomerulosclerosis (fsgs), and treatment-resistant minimal change disease (tr-mcd).

approximately 125 patients will be enrolled in this study across the united states. patients with dn and fsgs/tr-mcd will be randomized in 3 ascending dose cohorts to receive either gfb-887 or placebo.

Eligibility criteria:
inclusion criteria: * all patients: 1. male or female 18-75 years of age, of any race, at the time of signing informed consent. 2. estimated glomerular filtration rate (egfr) ≥ 30 ml/min/1.73 m2 at screening. 3. currently receiving an angiotensin-converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb). * for dn patients: 1. diagnosis of type 2 diabetes with glycated hemoglobin (hba1c) level ≤11% at screening. 2. uacr ≥ 150 mg/g. * for fsgs/tr-mcd patients: 1. diagnosis of fsgs based on either biopsy or genetic testing or tr-mcd based on biopsy. 2. upcr ≥ 1.0 g/g. exclusion criteria: * all patients: 1. evidence of another (non-dn, non-fsgs/tr-mcd, respectively) kidney disease. 2. history of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study. 3. history of any organ or bone marrow transplant, including kidney grafts. 4. history of alcoholism or drug/chemical abuse within 12 months prior to screening. * for dn patients: 1. renal disease that requires immunosuppressive therapy (currently, or in the past). 2. body mass index (bmi) \>45 kg/m2. * for fsgs/tr-mcd patients: 1. currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors. 2. body mass index (bmi) \>40 kg/m2. 3. known history of severe or chronic hepatobiliary disease.
lung irradiation for covid-19 pneumonia

Conditions: SARS-CoV 2

Summary: in this research study the investigators want to learn more about the potential benefit of radiation to the lung to improve the health of patients who are hospitalized with coronavirus-19 (covid-19) due to infection with a virus called sars-cov-2. this infection causes inflammation of the lung, which can make it difficult to breathe. as a result, patients may need supplemental oxygen or be placed on a ventilator. the investigators believe that low dose radiation therapy to the lung may reduce this inflammation and increase the likelihood that patients will need less oxygen support such as ventilation or supplemental oxygen, or be discharged from the hospital in fewer days, compared to without radiation therapy. the amount of radiation is much lower than what is typically used to treat other conditions such as cancer, although it is higher than the dose used for routine medical imaging.


Eligibility criteria:
inclusion criteria * diagnosis of sars-cov-2 infection by rt-pcr or another approved laboratory test ≤ 3 days before enrollment or ≤ 14 days before enrollment with progressive disease suggestive of ongoing sars-cov-2 infection; retesting allowed * current hospitalization for ≤ 14 days with sars-cov-2 infection at the time of enrollment * use of supplemental oxygen or oxygen saturation ≤ 94% on room air * age ≥ 40 * may receive antiviral medication (e.g., remdesivir, lopinavir/ritonavir, oseltamivir, favipiravir), antibiotics (e.g., azithromycin), chloroquine, hydroxychloroquine, corticosteroids, statins, anticoagulation, antiplatelet agents (e.g., aspirin) and/or convalescent plasma from recovered individuals off study and/or on study if permitted by the other protocol exclusion criteria * prior or planned treatment with interleukin inhibitors (e.g., tocilizumab, canakinumab, sarilumab) or tnf-α inhibitors within 14 days of enrollment * prior lobectomy or pneumonectomy * prior thoracic radiotherapy with cumulative lung v20 \> 15% to either lung within 1 year of enrollment, or any radiotherapy resulting in a maximum lung dose of 100 cgy or higher within 14 days of enrollment * prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radiosensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin or gemcitabine * prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment * severe pre-existing heart disease, e.g., new york heart association (nyha) functional class ≥ 3 congestive heart failure * history of bone marrow or solid organ transplantation * known history of autoimmune collagen vascular disease, e.g., scleroderma * known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or fanconi anemia * pregnancy * inability to be positioned supine and flat for radiation planning and delivery * inability to provide informed consent or lack of an authorized representative who can provide informed consent

Keywords: sars-cov-2 radiation therapy covid-19
the effect of sound stimulation on pure-tone hearing threshold

Conditions: Sensorineural Hearing Loss

Summary: the purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold. in the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function. in addition, prolonged exposure to an augmented acoustic environment could improve age-related auditory changes. these ameliorative effects were shown in several types of mouse strains, as long as the acoustic environment was provided prior to the occurrence of severe hearing loss. in addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing ability against damage by traumatic noise. in particular, a method called forward sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce noise-induced hearing impairment in a number of mammalian species, including humans. interestingly, recent report has suggested that low-level sound conditioning also reduces free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces cox-2 expression in cochlea, and can enhance cochlear sensitivity. specifically, increased cochlear sensitivity was observed when distortion product otoacoustic emissions (dpoaes) and compound action potentials (caps) were measured. in addition to forward sound conditioning, backward sound conditioning (i.e., the use of acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing ability against acoustic trauma and to prevent the cortical map reorganization induced by traumatic noise. based on the results of animal studies, the investigators conducted a human study in 2007 and observed that sound stimulation could improve hearing ability. on average, the pure-tone hearing threshold decreased by 8.91 db after sound stimulation for 2 weeks. in that study, however, the investigators observed only the hearing threshold changes by sound stimulation. to verify the previous ameliorative effect of sound stimulation, the investigators included a control period in this study.


Eligibility criteria:
inclusion criteria: * you are a male or female aged between 18 and 70 years * you have 25\~70 db hl hearing loss at any frequency above 1.5 khz * you are able to use an mp3 player * you are able to read english exclusion criteria: * under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen) * chronic disease that could affect hearing (such as diabetes or high blood pressure) * temporal hearing loss * hearing loss more than 75 db hl at any frequency * ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum * hearing aid user * pregnant females
brain stimulation and cognitive training - efficacy

Conditions: Schizophrenia; Schizo Affective Disorder; Bipolar Disorder

Summary: people with serious mental illness often experience difficulties with thinking skills like memory. these difficulties can make it harder to perform day-to-day activities. the purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is helpful in improving a specific type of memory skill in people who have mental health conditions. the study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. all participants will complete computerized cognitive exercises, also known as cognitive training. overall, participants will be in the study for 6-8 weeks. the study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder i or ii, schizoaffective disorder, or schizophrenia * willingness to participate in study procedures exclusion criteria: * history of neurological illness or injury (e.g., stroke) * history of loss of consciousness * diagnosed intellectual disability * current substance use disorder * current mania or moderate depression or severe psychosis * current serious suicidal ideation/behavior * pregnant or trying to become pregnant, or currently lactating
comparison of combined intravitreal bevacizumab and oral acetazolamide versus intravitreal bevacizumab alone for the treatment of macular edema secondary to retinal vein occlusions

Conditions: Macular Edema

Summary: in this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. after a thorough eye examination, people are randomly divided into two groups. the first group was treated with intravitreal injection of bevacizumab in three injections one month apart with receiving oral acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of bevacizumab for three loads are spaced one month apart. ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with spectral-domain optical coherence tomography (sd-oct) at the beginning of treatment and at the end of the first, second, and third months. at the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.


Eligibility criteria:
inclusion criteria: * 20 / 400≤ best corrected visual acuity ≤20 / 40 * central macular thickness \<300 μm * the onset of the disease is less than three years * no other eye diseases that affect the evaluation and process of this study. exclusion criteria: * it is not possible to provide informed consent. * patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies) * other eye diseases that affect the evaluation and process of this study. including diabetes retinopathy * history of retinal laser photocoagulation
effects of whole grain rye on metabolic risk markers and mood

Conditions: Metabolic Disorders and Cognitive Decline

Summary: the purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers


Eligibility criteria:
inclusion criteria: * healthy * bmi 19-28 * plasma glucose \< 6.1 mmol/l * non smooker exclusion criteria: * known metabolic diseases * known gastrointestinal disorders * known cognitive decline.
as-needed budesonide/formoterol turbuhaler in stepping down period

Conditions: Asthma

Summary: this study will evaluate the efficacy of as-needed budesonide/formoterol turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient comparing with standard maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled corticosteroid.

the study will measure the efficacy of as-needed low dose ics/ laba in well controlled asthmatic patient comparing with low dose ics in step down circumstance.

Eligibility criteria:
inclusion criteria: 1. patients who have been diagnosed as asthma at least 6 months. 2. patients who have well controlled asthma by act \> 23 and acq-7 \< 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily 3. patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid. 4. patients who able to do spirometry without contraindication. exclusion criteria: 1. history of using systemic steroid previous 12 week and respiratory infection history of pulmonary tuberculosis with residual lung lesion by chest radiograph recent serious medical condition such as myocardial infarction, stroke, pneumonia etc. 2. history smoking less than 10 pack-years or be smoking 3. history of asthma exacabation previous 12 week

Keywords: asthma allergy
a clinical trial to study the efficacy, safety, tolerability and pharmacokinetics of p2202 in patients of type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: it is a phase ii, randomized, double-blind, placebo-controlled study of p2202 in patients of type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or sulfonylurea or both.

it is a phase ii, prospective, randomized, double-blind, placebo-controlled, dose-ranging, multi-centre, two-staged, fixed-design study of p2202 in patients of type 2 diabetes mellitus, inadequately controlled with a stable dose of metformin or sulfonylurea or both. this study will consist of accrual in stage i (n=56/arm, which is 70% of the total sample size required), followed by an interim analysis on completion of the treatment period, to aid further decisions on accrual and dose selection in stage ii of the study, and completion of stage i.

Eligibility criteria:
inclusion criteria: * subjects who understand and are willing to give informed consent to participate in the trial. * adult male and female subjects between 18 years to 65 years of age with a bmi ≥ 27 kg/m2 ≤ 40 kg/m2, inclusively. * subjects with established type 2 diabetes mellitus of at least 3 months duration at the time of screening. * subjects with an inadequate glycemic control defined by an hba1c level of ≥ 7.5% and ≥10% at screening. * subjects who are on a stable dose of: * metformin (up to 2.55 gm/day or maximum tolerated dose of at least 1 gm/day) and/or * sulfonylurea (glimepiride ≤ 4 mg/day, gliclazide ≤ 160 mg, glibenclamide or glyburide ≤ 10 mg and glipizide ≤ 10 mg), for ≤ 2 months prior to the screening visit. * subjects with fasting plasma glucose of ≤14.4 mmol/l (260 mg/dl) and at least 5.5 mmol/l or 100 mg/dl. exclusion criteria: * subjects who have type 1 diabetes mellitus, maturity-onset diabetes of the young or any rare form of diabetes. subjects with hyperglycemia due to secondary causes. * subjects who have had more than 4 episodes of severe hypoglycemia in the 6 months prior to screening. * subjects with a history of acute diabetic complications * subjects who have been treated with insulin (except for use of insulin for short term management of acute conditions), thiazolidinediones, dual proliferator activated receptors agonists, glucagon-like peptide analogues, dipeptidyl peptidase inhibitors or 11bhsd-1 inhibitors in any form, in the 3 months prior to screening. * subjects who are receiving systemic glucocorticoids (≥14 days)

Keywords: diabetes mellitus
a study for pro of cml in real word

Conditions: CML (Chronic Myelogenous Leukemia)

Summary: successful outcomes in cml require both prolonged adherence to oral tki therapy by patients and careful monitoring of treatment responses by their physicians. patient reported outcomes(pro) assessment is important to facilitate decisions in the current treatment landscape of cml.

1. above 18 years of age. 2. patient with confirmed diagnosis of philadelphia chromosome positive and/or bcr-abl positive chronic myeloid leukemia (cml). 3. written informed consent. 4. patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Eligibility criteria:
experiences of healthcare for autistic tgd adults

Conditions: Autism Spectrum Disorder (ASD

Summary: to explore the experiences of autistic gender diverse adults that have attempted or are attempting to access, have accessed or are currently accessing gender identity healthcare in the united kingdom


Eligibility criteria:
inclusion criteria: * participants must be 18 years or older, they must have first-hand experiences of currently accessing, previously having accessed, or having attempted to access nhs gender identity clinics in the united kingdom. the participant must identify as tgd in some capacity (e.g. transgender, nonbinary) and have a formal diagnosis of autism. (proof of formal diagnosis will not be sought, but participants will be asked about information on this. diagnosis of autism be asked on the demographic questionnaire, along with question on the diagnosis procedure (e.g. service diagnosis, age of diagnosis). the participant must be able to communicate (verbal or written) in the english language and be able to provide informed consent. exclusion criteria: * people who do not meet the inclusion criteria will be excluded from the research.
bonebridge bone conduction implant in adults

Conditions: Hearing Loss, Conductive; Hearing Loss, Mixed

Summary: approximately thirty subjects with mixed or conductive hearing loss, meeting fda-cleared candidacy criteria for the bonebridge, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the bonebridge implant.


Eligibility criteria:
inclusion criteria: * adults, 18 years of age or older at the time of implantation * conductive or mixed hearing loss, defined as: * conductive hearing loss with pure-tone average (pta) for bone conduction thresholds better than or equal to 25 db at 500, 1000, 2000 and 3000 hz * mixed hearing loss with pta for bone conduction thresholds better than or equal to 45db at 500, 1000, 2000, and 3000 hz * air-bone gap greater than or equal to 30 db at 500, 1000, 2000, and 3000 hz * ability to benefit from amplification as defined by a monosyllabic (cnc) word score of 30% correct or better * bilateral bonebridge can be considered if the difference in pta for bone conduction thresholds is 10 db or less between the right and left ears * prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * able to complete testing materials in english * ct scan indicating the patient's anatomy is adequate to enable placement of the implant * ability to undergo general anesthesia * appropriate motivation and expectation levels * stated willingness to comply with all study procedures for the duration of the study exclusion criteria: * evidence that hearing loss is retrocochlear in origin * skin or scalp condition precluding use of external audio processor * suspected cognitive impairment or organic brain dysfunction