Kornimate/medical-research-clean huggingface dataset:
clinical study of venetoclax combined with cacag regimen in the treatment of relapsed/refractory acute myeloid leukemia

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Summary: the purpose of this study is to compare the efficacy and safety of venetoclax combined with cacag regimen with bat regimen in the treatment of relapsed/refractory acute myeloid leukemia.

despite advances in therapies for acute myeloid leukemia (aml) in the past decades, some patients still suffer from relapsed/refractory (r/r) disease, resulting in poor outcomes. with a median overall survival (os) of 4-7 months under classic chemotherapy approaches, it is imperative to explore new treatment options.accumulating research has demonstrated the importance of epigenetic modification in the pathogenesis of chemoresistance. recent studies have shown that combining venetoclax with hypomethylating agents (hmas) such as azacitidine, or low-dose cytarabine (ldac) improves the response and survival rates in r/r aml patients. to enhance the response rate, we designed a regimen that combines chidamide, azacitidine, cytarabine, aclarubicin, and g-csf with venetoclax (cacag+ven regimen) for the treatment of patients with r/r aml. in this study, we intend to compare the efficacy and safety of venetoclax combined with the cacag regimen with best-available therapy(bat) regimen in the treatment of relapsed/refractory acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * patients who are able to understand and willing to sign the informed consent form (icf). * all patients should aged 14 to 75 years,no gender limitation. * patients with r/r aml, diagnosed in accordance with the 2021 edition of the cma criteria * liver function: alt and ast≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * renal function: creatinine ≤the upper limit of normal; * patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * the score of eastern cooperative oncology group (ecog) is 0-3,and the predicted survival ≥ 4 months. * patients without severe allergic constitution. exclusion criteria: * patients with allergy or contraindication to the study drug; * female patients who are pregnant or breast-feeding. * patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * patients with mental illness or other states unable to comply with the protocol; * less than 6 weeks after surgical operation of important organs. * liver function: alt and ast\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;renal function: creatinine \>the upper limit of normal; * the patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Keywords: relapsed/refractory acute myeloid leukemia
a phase i/ii trial of aezs-108 in urothelial cancer patients who failed platinum-chemotherapy

Conditions: Urothelial Carcinoma

Summary: the purpose of this study is to determine the appropriate dose of aezs-108 to treat patients with a tumor of the urinary system.

aezs-108 is an investigational drug, combining luteinizing hormone-releasing hormone (lhrh), an hormone and doxorubicin (a drug approved to treat different types of cancer). some tumors, such as those found in the urinary system (also called urothelial carcinomas), have lhrh hormone receptors to which the lhrh hormone part of aezs-108 is attracted. aezs-108 is expected to work by accumulating mostly on the surface of cancer cells that have lhrh hormone receptors and by delivering doxorubicin more directly into the cells to kill them. this would allow the use doxorubicin at lower doses and thus would cause less toxicity. in the first part of the study, the appropriate dose of aezs-108 will be determined based on its side effects. the best dose will be the highest one without severe side effects. in the second part of the study, this best dose of aezs-108 will be given to determine its efficacy to stop the tumor from progressing.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma * expression of lhrh receptors confirmed by immunohistochemistry on archival cancer tissue * measurable disease on radiological studies * patients with locally advanced unresectable or metastatic urothelial carcinoma * documented progression on at least one prior chemotherapy regimen which must have incorporated platinum based therapy * left ventricular ejection fraction (ef) \> 50% * eastern cooperative oncology group (ecog) status of 0, 1 or 2 * adequate bone marrow, renal and hepatic function exclusion criteria: * prior treatment with or allergy to any components of aezs-108 * active second malignancies other than non-melanoma skin cancers * ongoing use of an lhrh agonist (or antagonist) * presence of an active infection or fever \> 38.5 c, parenchymal brain metastases or uncontrolled intercurrent illness * prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone * patients who received radiotherapy within 4 weeks of entry * major surgery within the last 4 weeks and minor surgery in last 7 days

Keywords: ureter cancer renal pelvis cancer bladder cancer urethra
daily low-level red light and 0.01% low-dose atropine for myopia prevention

Conditions: Myopia

Summary: to compare the preventive effects of daily low-level red-light and 0.01% low-dose atropine eye drops on myopia.


Eligibility criteria:
inclusion criteria: * 1. aged at least 7 years old. 2. the spherical equivalent error (ser) after pupil dilation was between -0.5 d and +0.75d. 3. had a record of cycloplegia ser at least 6 months before this study, and ser changed -0.5d compared with the last measurement or had a family history of high myopia. 4. corneal astigmatism ≤ 1.25d. 5. interocular refraction discrepancy ≤ 1.5d. 6. no allergy history of cycloplegia drugs. 7. willingness to participate in the study and signed informed consent. exclusion criteria: - 1. intraocular pressure was below 10 mm hg or higher than 22 mm hg. 2. presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders. 3. children currently using other myopia interventions other than lda or llrl. 4. children with systemic and immune disorders, such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, and diabetes 5. individuals with conditions like tourette's syndrome or epilepsy.
placebo-controlled study in patients with parkinson's disease to evaluate the effect of rotigotine on non-motor symptoms

Conditions: Idiopathic Parkinson's Disease

Summary: the primary objective of this study was to demonstrate that rotigotine improves non-motor symptoms compared to placebo in subjects with parkinson's disease.


Eligibility criteria:
inclusion criteria: * subject is male or female, ≥18 years of age * subject has idiopathic parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of parkinsonism * subject has a hoehn and yahr stage score ≤4 * subject has a total non-motor symptoms scale (nmss) score ≥40 * if the subject is taking levodopa (l-dopa), he/she must be on a stable dose of l-dopa (in combination with benserazide or carbidopa) for at least 28 days prior to the baseline visit * if the subject is receiving anticholinergics, monoamine oxidase (mao) b inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the baseline visit and must be maintained on that dose for the duration of the study exclusion criteria: * subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator * subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-a (mao-a) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (das) * subject is receiving central nervous system (cns) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors \[ssris\], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the baseline visit and is likely to remain stable for the duration of the study * subject has evidence of an impulse control disorder according to the modified minnesota impulsive disorders interview at the screening visit (visit 1), confirmed by a positive structured clinical interview

Keywords: rotigotine neupro® non-motor symptoms
a clinical trial to compare the pharmacokinetics of imatinib mesylate tablet 400mg (1 tablet) and glivec film-coated tablet 100mg (4 tablets)(phase i)

Conditions: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor

Summary: 1. investigational product 1. imatinib mesylate tablet 400 mg 2. glivec film-coated tablet 100 mg (comparator) 2. expected target disease 1. chronic myeloid leukemia 2. gastrointestinal stromal tumors 3. study design : randomized, open-label, single dose, two-period, two-way, crossover study 1. 36 healthy subjects, 2 groups (18 subjects/group) 2. 2 period (either 1-a(1 tablet) or 1-b(4 tablet)) 3. wash-out period : 14 days 4. evaluation on pharmacokinetics(pks) and safety 1. pks : cmax, auclast, tmax, aucinf, t1/2 2. safety : adverse events, physical examination, vital sign, ecg, laboratory test 5. statistical method 1. demography characteristics 2. pharmacokinetic parameters 3. safety data


Eligibility criteria:
inclusion criteria: * healthy male volunteers between the ages of 20 to 50 years old * weight more than 55kg and within the range of ±20% of ideal body weight (ibw) * having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination * doctor determines to be suitable as subjects within 3 weeks ago before administration exclusion criteria: * hypersensitivity(or history of hypersensitivity) to medicines including imatinib mesylate * active liver diseases or exceed 1.5 times the normal range of ast, alt, total bilirubin * creatinine clearance \< 80 ml/min * gastrointestinal diseases or surgeries that affect absorption of drug * excessive drinking(exceed 21units/week) * smoking over 10 cigarettes per day

Keywords: cml gist
lme636 in the relief of persistent ocular discomfort in subjects with severe dry eye disease

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the efficacy of lme636 compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of lme636, when administered topically for up to 42 days, in subjects with severe dry eye disease.

this study is organized into 2 phases. following a 2-week identification phase, eligible subjects with severe dry eye disease (ded) will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks.

Eligibility criteria:
inclusion criteria: * must sign written informed consent. * physician diagnosis of ded of at least 6 months prior to visit 1. * must use artificial tears, gels, lubricants or re-wetting drops on a regular basis. * respond as "often" or "constantly" to the question "how often do your eyes feel uncomfortable?". * best corrected visual acuity (bcva) of 55 or greater in each eye as measured by etdrs at visit 1. * other protocol-specified inclusion criteria may apply. exclusion criteria: * presence of any acute infection or non-infectious ocular condition in either eye within 1 month of visit 1. * contact lens wearers, defined as individuals who cannot be without their contact lenses for the entire duration of the study. * any chronic ocular degenerative condition that in the opinion of the investigator could possibly advance during the time course of the study. * use of biologics treatments, such as systemic biologic anti-cytokines, including anti-tnfα drugs, or immunosuppressive therapy for the treatment of severe systemic autoimmune disorders. * diseases or conditions affecting the ocular surface that are associated with clinically significant scarring and or destruction of conjunctiva and/or cornea. * unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc. after visit 2. * use of nasal, inhaled, systemic (including injections), or topical corticosteroids within 30 days of visit 1. * women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol. * other protocol-specified exclusion criteria may apply.

Keywords: lme636 dry eye disease efficacy ocular discomfort
efficacy of virtual warrior renew therapy for veterans who experienced military sexual trauma

Conditions: Military Sexual Trauma (MST); Post Traumatic Stress Disorder

Summary: group treatments may be helpful for veterans who have experienced military sexual trauma (mst). by doing this study, the investigators hope to learn if two different groups: warrior renew and health \& wellness are effective in reducing mental health symptoms in veterans who have experienced mst and if either is more effective than the other. participation in this research will last about 16 weeks.

this project will examine mental health treatment in a group setting for veterans who have experienced military sexual trauma. military sexual trauma or mst is defined as any experience of sexual assault or sexual harassment experienced during military service. survivors of mst may develop mental health symptoms. group treatment for survivors of mst may be helpful. this study will compare two different group treatments: 1) warrior renew; and 2) health \& wellness. by doing this study, the investigators hope to learn: 1) if one or both of the group treatments are safe and effective in reducing mental health symptoms in veterans who have experienced mst; and 2) if there are differences based on gender that should be addressed differently in developing treatments for survivors of mst.

Eligibility criteria:
inclusion criteria: 1. has established care with va medical or mental health provider. 2. reports having experienced military sexual trauma. 3. between the ages of 18 and 75. 4. is an outpatient and is able to comply with all study procedures, including the eight weeks of group treatment and the assessment measures. 5. positive screen on the primary care ptsd screen for dsm-5 (pc-ptsd-5). 6. able to participate in virtual group therapy via telehealth. exclusion criteria: 1. impaired decision-making capacity that in the clinical judgment of their provider would affect their ability to provide informed consent. 2. current/active suicidal ideation as evidenced by a positive screen on the columbia suicide severity rating scale (c-ssrs), or a suicide attempt or psychiatric hospitalization within the past year 3. current or past diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, psychotic or dissociative disorders. 4. current/active diagnosis of a substance use disorder or an alcohol use disorder as measured by the alcohol use disorders identification test-concise (audit-c).66 5. unable to read english. 6. currently receiving trauma-focused group or individual psychotherapy treatment. (previous psychotherapy or current pharmacotherapy is acceptable). 7. concurrently enrolled in another research protocol involving a mental health intervention during this study 8. has had previous warrior renew treatment.

Keywords: group therapy military sexual trauma randomized clinical trial ptsd mst
local non-salvage radiotherapy for synchronous oligometastatic non-small-cell lung cancer.

Conditions: Stage IV Non-small Cell Lung Cancer

Summary: aggressive therapy may improve survival in synchronous oligometastatic nsclc and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.

for nsclc patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 70 years old; 2. histologically or cytologically confirmed non-small cell lung cancer; 3. stage iv patients with measurable primary tumor and distant metastases number ≤5； 4. ps score 0-2； 5. have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy; 6. life expectancy of \>3 months; 7. organ function levels must meet the following requirements: (1)bone marrow: white blood cell (wbc)≥4.0g/l；neutrophile granulocyte (neu)≥1.5g/l；platelets (plt)≥100g/l; hemoglobin (hgb)≥9g/l； (2)liver and kidney: total bilirubin (tbil), aspartate aminotransferase (ast), alanine aminotransferase (alt)≤2.0 × the upper limit of normal (uln)；creatinine≤1.5×uln; 8.patient must be willing and able to provide written informed consent. exclusion criteria: 1. the amount of metastatic focus \>5; 2. patient can't tolerate chemotherapy or targeted therapy; 3. local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy; 4. previous or concurrent suffered from other malignancies; 5. concurrent with other serious disease that can not be controlled; 6. women who are breast-feeding or pregnant; 7. have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent; 8. patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.

Keywords: nsclc oligometastases radiotherapy
intervention on caregivers caring for patients poststroke with upper limb apraxia

Conditions: Performance Anxiety; Emotional Stress

Summary: the purpose of this study is to analyze the effects of a intervention on a specific health prevention/intervention program aimed at caregivers of mild and moderate patients post stroke with upper limb apraxia in comparison to a control group with a no specific formation in that kind of patients.

patients with upper limb apraxia after stroke have severe problems to adapt their daily life. the upper limb apraxia syndrome affects the performance of skilled movements carried out by the upper limbs and provoke that many patients´activities have to be made by their main caregiver or carers. caregivers usually have to occupy much time and efforts for caring their familiar or client, and it can result in a overload in different areas of the caregiver health. few data are available on the effectiveness of interventions in caregivers that informally works with that kind of patients. the specific prevention health program is based on improving the awareness of the assistance that the caregivers provide, and knowing the process of the information that carer has to give to the patient while the patients have their activities made.

Eligibility criteria:
inclusion criteria: * having an habitual role of carer (informal or formal). * being caring a mild-moderate poststroke patient with upper limb apraxia. * subjective manifestations of overload in the role as carer. * more than two month as carer. exclusion criteria: * uncooperativeness * being formed in the care of that kind of patients

Keywords: caregivers apraxias stroke cerebral stroke rehabilitation pragmatic clinical trials as topic
natural matrix protein™ (nmp™) fibers in cervical and lumbar interbody fusion

Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis

Summary: the aim of this study is to evaluate the effectiveness and safety of natural matrix protein™ (nmp™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (ddd), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

the study involves a retrospective review of patients' medical records and prospective collection of x-rays, and patient outcome questionnaires. the study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria. there will be 4 prospective study visits following consent. follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Eligibility criteria:
inclusion criteria: 1. subject was diagnosed with ddd, spinal stenosis, or spondylolisthesis; 2. subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between c2 and t1 or between l1 and s1; 3. subject has undergone cervical or lumbar interbody spine fusion using nmp fibers; 4. subject must be 18 years of age or older at the time of consent; 5. subject must be willing and able to sign an informed consent document; 6. subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations. exclusion criteria: 1. subject is under 18 years of age at the time of consent; 2. subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin; 3. subject is currently imprisoned.
association between embryo implantation rate and maternal age

Conditions: Infertility, Female

Summary: to explore the relationship between maternal age and embryo implantation rate in patients undergoing assisted reproductive technology.

the investigators designed a retrospective clinical trial conducted from january 2015 to december 2020 at the reproductive medicine center of the affiliated drum tower hospital of nanjing university medical school. infertility was defined as the failure of a clinical pregnancy after 12 months or more of regular unprotected intercourse with the same marriage partner. patients experiencing infertility no younger than the age of 20 who attended the reproductive medicine center of the affiliated drum tower hospital of nanjing university medical school for the first time and had experienced no less than one embryo transplantation between january 2015 and december 2019 were recruited. patients who had experienced or canceled embryo transplantation cycles for any reason were excluded from this study. the gap year from december 2019 to december 2020 allowed researchers to follow up on the outcomes of pregnancies before 2020. frozen cycles were performed when high-quality embryos existed to avoid unnecessary ovarian stimulation and oocyte retrieval processes. investigators were blinded to the outcome of embryo transplantation, and information on pregnancy was gathered through telephone follow-up one year after transplantation.

Eligibility criteria:
inclusion criteria: 1. infertile patients 2. attended the reproductive medicine center of the affiliated drum tower hospital of nanjing university medical school for the first time 3. had experienced no less than one embryo transplantation between january 2015 and december 2019 exclusion criteria: canceled embryo transplantation cycles for any reason