Kornimate/medical-research-clean huggingface dataset:
pgl4001 versus placebo in uterine myomas

Conditions: Uterine Myomas

Summary: this trial will assess the efficacy and safety of pgl4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Eligibility criteria:
inclusion criteria: * be a pre-menopausal woman between 18 and 50 years inclusive. * have excessive uterine bleeding due to myoma. * have a myoma-related anaemia. * have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size. * be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others. * if of childbearing potential the subject must be practicing a non-hormonal method of contraception. * have a body mass index (bmi) ≥ 18 and ≤ 40. exclusion criteria: * has a history of or current uterine, cervical, ovarian or breast cancer. * has a history of or current endometrium atypical hyperplasia. * has a known severe coagulation disorder. * has a history of or current treatment for myoma with a selective progesterone receptor modulator (sprm) or a gnrh-agonist. * has abnormal hepatic function at study entry. * has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study. * has a current (within twelve months) problem with alcohol or drug abuse. * is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
topical yr001 ointment in adult with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is to evaluate the safety, tolerability, and pharmacokinetics of yr001 topical ointment in adult patients with mild to moderate atopic dermatitis


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from the subject. 2. male or female subject is aged 18 or older. 3. subject has a weight of at least 50 kg and a body mass index (bmi) between 18.0 and 30.0 kg/m2, inclusive. 4. an investigator static global assessment (isga) score of 2 (mild) to 3 (moderate) at screening and baseline. exclusion criteria: 1. pregnant or lactating women. 2. any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive uv exposure, at the possible ip application sites. 3. patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet). 4. have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response. 5. participation in another interventional clinical trial (e.g. investigational drug, biological agent, or device) within 30 days or 5 half-lives of investigational agent (whichever is longer) before entering, or during the trial, or previous participation in this clinical trial.

Keywords: yr001 kv1.3
study of magnetic fields for treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine if low level magnetic fields may help to relieve symptoms of parkinson's disease.


Eligibility criteria:
inclusion criteria: * idiopathic pd with motor fluctuations of at least 3-4 hours daily., subject on levodopa, subject is ambulatory, maintain regular med schedule, willing and able to abstain from new pd treatments, able to demonstrate correct completion of pd diaries, non-demented, adequate contraceptive measures, capable of giving full written consent. exclusion criteria: * any factors that will prevent subject from completing full course of therapy with the resonator, any factors preventing subject from attending clinic in the "off" state, atypical parkinsonism, no active brain tumors, strokes, hydrocephalus, any other neurologic or non-neurologic disorder which might affect the symptomatic expression of pts. parkinsonism, suffers from chronic pain, no meds that may produce parkinsonism, no psychiatric disturbance, epilepsy, hiv, cancer, history of ect, diabetic neuropathy, uncontrolled htn, advanced pulmonary disease, known heart conditions such as cardiac arrythmias, previous pd surgical interventions, prosthetics comprised of ferrous metals, pacemakers, dbs, uncontrolled, unstable or untreated medical illnesses, consumption of more than 21 alcoholic drinks per week, pregnant, breast feeding, developmental disability
the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques

Conditions: Stroke, Ischemic; Atherosclerosis, Cerebral

Summary: intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in asia. many studies mainly from euro-american population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (lrnc) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. high resolution magnetic resonance imaging (hrmri) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.


Eligibility criteria:
inclusion criteria: 1. patient age between 18-80 years 2. time of onset: within 1 week 3. nihss score ≤12 4. acute ischemic stroke confirmed by head ct or mri 5. premorbid mrs ≤1 6. the degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side \<50% 7. the culprit plaque or possible culprit plaque with plaque burden of 40% or more found by hrmri in the proximal part of the middle cerebral artery m1 segment or basilar artery of ipsilateral lesion 8. signed informed consent exclusion criteria: 1. intracranial hemorrhage found by head ct 2. stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis) 3. severe hepatic or renal dysfunction 4. pregnant females 5. abnormal elevation of creatine phosphokinase 6. expected stent angioplasty 7. blood sugar is out of control 8. receiving statins within 1 month before onset 9. obstinate hypertension with more than 140/90 mmhg after medication 10. not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures 11. unsuitable for this clinical studies assessed by researcher
manual diaphragm release in cleaning laborer

Conditions: Respiratory System Abnormalities

Summary: this study intended to examine the effect of manual diaphragm release on pulmonary function, chest wall mobility, and functional ability in female occupational cleaners with respiratory hazards.

cleaning chores have been linked to exposure to various chemical agents that have the potential to cause harmful effects on both the respiratory system and cardiovascular markers, many cleaning products and disinfectants contain ingredients that can act as airway irritants. one of the physical therapy procedures that is used to manage chest disorders is manual diaphragm release which aims to lengthen the diaphragm musculature whereas encouraging better and more proficient contraction.

Eligibility criteria:
inclusion criteria: * female occupational cleaners. * age between 35 and 45. * had work-related respiratory hazards. * clinically stable. * no exacerbation in the previous 6 weeks. * working in an occupation with respiratory hazards for at least 2 years. * mild to moderate air way obstruction. * willingness to participate in this study and provide a consent form. exclusion criteria: * other cardiopulmonary diseases. * body mass index \> 30 kg/ m2. * previous thoracic or abdominal surgery. * smokers and users of tobacco in any form (chewing, snuffing or water pipe). * systemic conditions (e.g., diabetes mellitus, hypertension). * sever airway obstructions. * inability to perform the required exercises. * inability to attend the scheduled sessions.

Keywords: respiratory hazards pulmonary function chest wall mobility functional ability manual diaphragmatic release
evaluation of lung cancer ct screening performance among former and current smokers

Conditions: Smoking

Summary: diagnostic performance of low-dose chest ct scan combined with lung-rads classification (version 1.1) for lung cancer screening among former and current smokers.


Eligibility criteria:
inclusion criteria: * male or female 50-80 years old * active smoker (≥ 15 pa) or former smoker (≥ 15 pa) exclusion criteria: * recent history of chest ct scan (within 12 months) * person unable to climb 2 floors * weight \> 140kg * personal history of cancer \< 5 years (currently being monitored by thoracic imaging)
chronic pelvic pain and education skills training for women veterans

Conditions: Pelvic Pain; Depression, Anxiety

Summary: chronic pelvic pain (cpp) is a debilitating condition that disproportionately affects women veterans (25% vs. 16% of civilian women). predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. cpp is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures). multimodal, interdisciplinary approaches are emphasized in the treatment of cpp. psychological interventions are essential for optimizing pain self-management for cpp. psychosocial factors are known to affect pain intensity and recovery. women veterans report higher rates of depression and anxiety with cpp, that leads to greater disability and poorer quality of life. cognitive and behavioral therapies, such as acceptance and commitment therapy (act), are effective options for pain self-management. barriers to effective pain treatment are high attrition and non-adherence. additionally, women veterans prefer treatments that address their gender-specific needs. gender-specific services remain limited in the veterans health administration (vha). in line with vha's priorities to expand women's health care, this study implements act in a brief intervention format to address a highly prevalent reproductive health issue among women veterans. act is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. brief workshop formats increase treatment completion and patient engagement. this study seeks to adapt an existing 1-day act workshop for use in vha integrated primary care (pcmhi) and specialty medical settings with women veterans experiencing cpp. primary outcomes are feasibility and acceptability of the adapted intervention.


Eligibility criteria:
inclusion criteria: * being a veteran * being female * having a diagnosis of chronic pelvic pain * endorsing severe pain (score ≤ 7 on brief pain inventory \[bpi\]) or moderate to severe pain plus clinically significant psychological distress (score ≤ 3 on bpi and score ≤ 10 on patient health questionnaire-9 \[phq-9\] or generalized anxiety disorder-7 \[gad-7\]) exclusion criteria: * cognitive impairment * an uncontrolled bipolar or psychotic diagnosis * active suicidal ideation * receiving concurrent psychotherapy or who have received act within the past year

Keywords: acceptance and commitment therapy women veterans primary care
rd13-01 for patients with r/r cd7+ t-all/t-lbl

Conditions: T Acute Lymphoblastic Leukemia; T-lymphoblastic Lymphoma

Summary: this study is designed to explore the safety of rd13-01 for patients with cd7+ relapsed and/or refractory t cell acute lymphoblastic leukemia or lymphoblastic lymphoma. and to evaluate the efficacy and pharmacokinetics of rd13-01 in patients.


Eligibility criteria:
inclusion criteria: 1. aged 3 to 70 years. 2. diagnosis of r/r t-all/t-lbl. 3. ecog: 0-2. 4. life expectancy greater than 12 weeks. 5. cardiac left ventricle ejection fraction ≥50%. 6. informed consent explained to, understood by and signed by the patient/ guardian. patient/guardian is given a copy of informed consent. exclusion criteria: 1. pregnant or lactating. 2. hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) positive and peripheral blood hepatitis b virus (hbv) dna titer detection is not within the normal range; hepatitis c virus (hcv) antibody positive and peripheral blood hepatitis c viral (hcv) rna positive; human immunodeficiency virus (hiv) antibody positive; cytomegalovirus (cmv) dna positive; syphilis positive. 3. patients with graft-versus-host disease (gvhd) or who need to use immunosuppressive drugs. 4. participated in other clinical studies within 2 weeks prior to screening. 5. history of alcoholism, drug abuse or mental illness. 6. any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
evaluation of a photopneumatic system for the treatment of acne

Conditions: Mild to Moderate Acne

Summary: the purpose of the study is to evaluate the safety and efficacy of a photopneumatic therapy for the treatment of acne and concomitant symptoms associated with the disease, including erythema.

the primary aims of the study will be to demonstrate the safety and efficacy of using a photopneumatic system for treatment of mild to moderate acne on the face or body - including neck, chest, and back - of up to 24 subjects. to support this clinical assessment, the affected areas to be treated will be documented at baseline, at each subsequent treatment visit (up to 6 treatments), and at one (1) month and three (3) months following final treatment.

Eligibility criteria:
inclusion criteria: 1. fitzpatrick skin type i-vi. 2. male or female. 3. subjects must be between 18 and 55 years of age. 4. subjects must have mild to moderate acne (defined as 15 or more inflammatory or non-inflammatory lesions). 5. subjects must read, understand, and sign the informed consent form. 6. subjects must be willing and able to comply with all follow-up requirements. exclusion criteria: 1. subjects must not have active localized or systemic infections. 2. subjects must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid scar formation), atrophic dermatitis or immunologic abnormalities such as vitiligo. 3. subjects must not have received microdermabrasion within one (1) month prior to enrollment. 4. subjects must not have received immunosuppressive medication(s) one (1) month prior to enrollment. 5. subjects must not have received laser or light treatment within the last three (3) months. 6. subjects must not have received dermabrasion, tca peel greater than 20%, botulinum toxin type a, dermal fillers, photodynamic therapy (pdt), or cosmetic surgery within the last six (6) months . 7. subjects must not be currently taking or have used isotretinoin (e.g. accutane) within six (6) months prior to enrollment. 8. subjects must agree to refrain from using cosmeceutical agents or topical agents during the course of the study, except as directed by study investigators. 9. subjects must not have had previous ablative laser treatment. 10. subjects must refrain from excessive sun exposure during participation in this study. 11. subjects must not have any condition that results in photosensitivity or be taking any medication containing aminolevulinic acid (e.g. levulan). 12. subjects must not be a current or past smoker of cigarettes and/or cigars. 13. subjects must not be pregnant. 14. any condition or situation that would prevent the subject from safely completing all protocol requirements for participation.
preoperative prophylactic antibiotic duration in moderate to high risk ureteroscopy

Conditions: Infections, Urinary Tract; Nephrolithiasis

Summary: the goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. the main questions it aims to answer are: 1. determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days) 2. identify secondary predictors of post-operative infectious complications

post-operative infectious complications including urinary tract infection (uti), systemic inflammatory response syndrome (sirs), and sepsis are uncommon but potentially devastating complications after ureteroscopy. the clinical guidance from the american urologic association (aua) and the european association of urology (eau) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. as a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. this is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (mdr) organisms but are also more susceptible to deleterious outcomes due to their frailty. recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (pcnl) for stone removal. ureteroscopy is the most commonly performed stone surgery worldwide. establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. the goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms.

Eligibility criteria:
inclusion criteria: * age (greater than or equal to 18 years) * indwelling ureteral stent in place * nephrostomy tube in place * indwelling foley catheter, suprapubic catheter or clean intermittent catheterization * asymptomatic bacteriuria * bowel interposition (such as ileal conduit, neobladder) * immunosuppression (such as for transplant recipients, active chemotherapy use) exclusion criteria: * pregnancy * active infection * received antibiotics within 7 days preceding surgery that were not prescribed for the study
trial of erapa in prostate cancer patients

Conditions: Prostate Cancer

Summary: this study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. there will be four groups of patients, each receiving a different dose of rapamycin.

this is a phase ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. this new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than \[the other formulation\]. the encapsulated and targeted rapamycin (erapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mtor inhibition, making erapa an ideal immuno-oncologic and chemopreventative agent. low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.

Eligibility criteria:
inclusion criteria: - the patient must: * have pathologically (histologically) proven diagnosis of prostate cancer with a gleason score ≤7 (3+4) and already undergoing active surveillance * be able to give informed consent * be age 18 or older exclusion criteria: * prostate cancer with a gleason score \>7 * unable to give informed consent * age \< 18 * immunosuppressed state (e.g., hiv, use of chronic steroids) * active, uncontrolled infections * on medications with strong inhibitors or inducers of cyp3a4 and or p-gp. * on agents known to alter rapamycin metabolism significantly (appendix h) * have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) * individuals with a reported history of liver disease (e.g., cirrhosis) * individuals who are not a good candidate for active surveillance in their treating physician's opinion * have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic. * uncontrolled hypertension. * individuals that have abnormal screening vital organ function prior to enrollment * liver function test * bilirubin \>2.0 * alkaline phosphatase \>5x upper limit of normal (uln) * alt/ast \>2x uln * complete blood count: * wbc elevated above the normal standard per the testing laboratory * hgb/hct below the normal standards of the testing lab * platelets below the normal standards of the testing lab * total cholesterol \>240 mg/dl * triglycerides \> 200 mg/dl * serum creatinine \>2 and bun \>30 * urinary protein: proteinuria \>1+ on urinalysis or \>1 gm/24hr