Kornimate/medical-research-clean huggingface dataset:
open-label study to evaluate the safety of various dosing regimens of musk-caart for musk myasthenia gravis

Conditions: MuSK Myasthenia Gravis

Summary: muscle-specific tyrosine kinase (musk) myasthenia gravis (mg) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the musk protein in the neuromuscular junction. this phase 1 study is being conducted to evaluate the safety of various dosing regimens of an investigational cell therapy, musk-caart, that can be given to patients with anti-musk antibody positive myasthenia gravis (musk mg), who have active disease. various dosing regimens of musk-caart alone, in combination with cyclophosphamide (cy), and in combination with cy and fludarabine (flu) will be evaluated. treatment with musk-caart may potentially lead to complete and durable remission of disease.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of musk-type mg with at least 1 prior positive anti-musk antibody test. * history of a negative anti-achr (acetylcholine receptor) antibody test. * positive anti-musk antibody test at screening * mg severity class i to iva on the mgfa (myasthenia gravis foundation of america) clinical classification exclusion criteria: * rituximab in the last 12 months. * prednisone \> 0.25mg/kg/day \[in part a\] * other autoimmune disorder requiring immunosuppressive therapies. * investigational treatment for mg in the past 12 weeks. * absolute lymphocyte count \< 500/µl at screening.

Keywords: caar-t (chimeric autoantibody receptor t cells) therapy car-t (chimeric antigen receptor t cells) therapy cell therapy autoimmune disease autoimmunity immunotherapy, adoptive immune system diseases myasthenia gravis (mg) muscle-specific tyrosine kinase (musk) muscle weakness neuromuscular diseases musculoskeletal diseases
soy estrogen alternative study (sea)

Conditions: Cardiovascular Diseases; Endometrial Hyperplasia; Heart Diseases; Menopausal Complaints; Uterine Diseases; Menopause

Summary: to conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation, and health related quality of life.

background: the results of many studies indicate that estrogen replacement therapy (ert) reduces the risk of coronary heart disease (chd) in postmenopausal women. however, less than 9 percent of these women choose to take ert because of unwanted side effects and concerns about increased risk of cancer associated with ert. therefore, alternative therapies are needed. the isoflavonoids found in soy protein (specifically genistein) have many properties that may reduce the risk of coronary heart disease. these include favorable effects on plasma lipids and coronary artery vasomotion. furthermore, genistein is a tyrosine kinase (tk) inhibitor with inhibitory effects on thrombin activity and tk receptor-linked mitogens that may be associated with atherogenesis and neointimal formation after angioplasty. design narrative: randomized, double-blind, placebo-controlled. the women were randomized into one of three groups: placebo, conjugated equine estrogens, or soy supplementation. primary endpoints were the impact on menopausal complaints such as hot flushes, mood lability, anxiety, sleep disturbances; effects on plasma lipids and lipoproteins, including lipoprotein (a); effects on vaginal bleeding and endometrial proliferation; changes in health-related quality of life. secondary endpoints included: assessment of the impact of these interventions on the progression of carotid artery intimal medial wall thickening as assessed by b-mode ultrasonography; bone density and bone turnover; additional measures to monitor the compliance and safety of the intervention such as mammography, anticipated or known side effects of hormone replacement therapy, blood levels of genistein, and clinical outcomes such as hospitalizations, physician visits, and symptoms. the study ended in december, 1998. the study was a subproject within a program project on coronary atherosclerosis in females, primarily monkeys. dr. thomas b. clarkson was the p.i. the subproject dollars were estimated based on the crisp dollars assigned to the study which were approximately 12 percent of the total program project dollars and were broken down as follows: fy 1996 - 219,254; fy 1997 - $217,000; fy 1998 - $221,000. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
perimenopausal/menopausal women, ages 45 to 55.
preoperative rehabilitation training and total knee arthroplasty outcomes

Conditions: Osteoarthritis of Knee

Summary: joint replacement surgery is an effective treatment for severe joint diseases, but the postoperative recovery process is complex and lengthy. preoperative rehabilitation training, as an important part of preoperative preparation, has been proven to significantly improve postoperative recovery outcomes. however, there is currently a lack of systematic research on the optimal protocols and duration of preoperative rehabilitation training and their specific impacts on postoperative recovery. this study aims to evaluate the effects of preoperative rehabilitation training on postoperative recovery after joint replacement through a randomized controlled trial, providing scientific evidence for clinical practice.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis is osteoarthritis and scheduled for joint replacement surgery. 2. age ≥18 years old and ≤90 years old, with no gender restrictions. 3. patients voluntarily participate in the study and sign the informed consent form. exclusion criteria: 1. severe cardiopulmonary insufficiency, unable to tolerate rehabilitation training. 2. neurological disorders leading to motor dysfunction. 3. mental illnesses that prevent cooperation with rehabilitation training. 4. severe joint deformities or muscle atrophy present before surgery, affecting the implementation of rehabilitation training.
breast mri screening in women treated with mediastinal irradiation for hodgkin's disease

Conditions: Breast Cancer; Hodgkin's Disease

Summary: the purpose of this study is to determine if the use of breast mri in detecting breast malignancies in survivors of hodgkin's disease is more successful than the traditional mammogram.

* the screening breast mri and mammography will be performed 6 months or longer after the last mammogram. for pre-menopausal women, the screening will be performed during the second week of the menstrual cycle to reduce cycle-related breast changes. as much as possible, the breast mri and mammogram are to be performed on the same day. * on the day of the breast imaging studies, the patient will also be asked to fill out a baseline breast health questionnaire, which includes questions on time since radiation therapy, prior screening history, history of prior benign breast biopsies, menopausal status, prior hormonal therapy use, etc. * in patients with suspicious findings or findings highly suggestive of malignancy, the abnormal findings will be reviewed with the patient and recommendations will be made for a biopsy.

Eligibility criteria:
inclusion criteria: * female patients treated with radiation therapy to the chest area for hodgkin's disease * age between 12 and 35 at initial treatment * eight years or longer after initial treatment * pre-approval from the participant's insurance company for the breast imaging studies exclusion criteria: * pregnant or lactating women * post bilateral mastectomy * currently undergoing breast cancer therapy * known metastatic cancer * patients with contraindications for undergoing an mri: cardiac pacemaker, known metallic objects in body e.g. metallic clips, bullets, shrapnel or buckshots.

Keywords: breast screening breast mri mammogram mammography
establishment of a database for long-term monitoring of patients with nephropathic cystinosis

Conditions: Cystinosis

Summary: objectives: i. establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine. ii. track and monitor all patients including renal transplant, dialysis and post renal transplants.

protocol outline: data are collected from patients and physicians. information includes disease, treatment, family history, demographic, and physical exam data. the dates of kidney transplantation and/or dialysis initiation are also recorded.

Eligibility criteria:
protocol entry criteria: nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms

Keywords: cystinosis rare disease renal and genitourinary disorders
a study to assess the safety and tolerability of gw642444 in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the compound gw642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. this study will assess the safety and tolerability of gw642444 in subjects with copd in order to obtain information to support dosing in a broader population of subjects with copd

a multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of gw642444h (100 administered once daily in the morning via diskus™ dry-powder inhaler) compared with serevent (salmeterol) (50mcg administered twice daily via diskus dry-powder inhaler) and placebo in subjects with moderate copd.

Eligibility criteria:
inclusion criteria: * females must be of non-childbearing potential * moderately severe copd exclusion criteria: * subjects with a main diagnosis of asthma * subjects with poorly controlled copd * subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.

Keywords: chronic obstructive pulmonary disease (copd) copd
ten-year outcomes of stents versus coronary-artery bypass grafting for left main coronary artery disease

Conditions: Coronary Arteries

Summary: the purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in korea.


Eligibility criteria:
inclusion criteria: * unprotected left main disease exclusion criteria : * no exclusion criteria

Keywords: left main unprotected percutaneous coronary intervention coronary-artery bypass graft
melatonin decreases eye pressure in normotensive patients

Conditions: Depressive Disorder

Summary: agomelatine is a melatonin drug used to treat depressive disorder. agomelatine may also some effects on ocular pressures. in this study, we aimed to demonstrate that melatonin decreases intraocular pressures when given depressive patients.

melatonin has been shown to be effective to decrease intraocular pressure in experimental animal researches. agomelatine is a melatonin derivative drug approved for the treatment of depression, which is also available in our country. depending on animal experiments, it can be assumed that agomelatine can decrease intraocular pressure. demonstrating that agomelatine is effective to reduce eye pressure may give a concurrent treatment of depressive patients with glaucoma. with this it may be possible to treat both diseases at the same time with single drug. in this study, the researchers intended to investigate the changes in ocular tension in normotensive depressive patients treated with agomelatine.

Eligibility criteria:
inclusion criteria: * depressive patients suitable for agomelatine therapy for the treatment of their primary disease. exclusion criteria: - any past history of ocular surgery, ocular trauma or existing ocular diseases

Keywords: agomelatine depression intraocular pressure
the effect of caffeine on ischemic preconditioning

Conditions: Caffeine; Ischemic Preconditioning; Ischemia-Reperfusion Injury

Summary: ischaemic preconditioning (ip) describes the phenomenon that brief periods of ischaemia render the (myocardial) muscle more resistant to a subsequent more prolonged period of ischaemia and reperfusion. animal studies have provided evidence that adenosine receptor stimulation is an important mediator of ip. as caffeine is an effective adenosine receptor antagonist already at concentrations reached after regular coffee consumption, we aimed to assess whether caffeine impairs ip in humans in vivo. we used a novel and well-validated model to study ip in humans: 99m-tc-annexin a5 scintigraphy in forearm skeletal muscle. 24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or saline before a protocol for ip.


Eligibility criteria:
inclusion criteria: * healthy male volunteers exclusion criteria: -
safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of qge031 in japanese atopic male subjects

Conditions: Allergy

Summary: this study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of qge031 in japanese atopic male subjects in order to determine the eligibility of japanese patients in subsequent clinical studies.


Eligibility criteria:
inclusion criteria: * male japanese subjects who are atopic as determined by an in vitro test (cap-rast or mast test) * serum ige level must be equal to or greater than 30 iu/ml at screening. exclusion criteria: * poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week * worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing * severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen * severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing * severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing * prior use of xolair® or other anti-ige antibodies * concomitant use of allergy vaccination therapy other protocol-defined inclusion/exclusion criteria may apply.

Keywords: allergy, asthma, atopic dermatitis, japanese, qge031, ige
a continuous, non-invasive, real-time method for estimating and predicting intracranial hypertension

Conditions: Intracranial Hypertension; Elevated ICP (Intracranial Pressure)

Summary: there is statistically significant correlation between invasive measures of intracranial pressure (icp) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict icp. furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived icp information. specific aims: 1. develop models to estimate icp and cerebral perfusion pressure (cpp) after traumatic brain injury in humans. 2. predict and anticipate changes in icp for preemptive management purposes. 3. analyze characteristics of changes in icp after treatment failure. 4. analyze data to predict/anticipate confounding physiologic factors that affect icp and its treatment. 5. test the resulting models in real time.


Eligibility criteria:
inclusion criteria: * patients with severe traumatic brain injury resulting in motor glasgow coma score (gcs) score \< 5 * age 18-89 years * health care provider indicating the need for hyperosmolar therapy for elevated icp exclusion criteria: * pregnancy * incarceration * brain death (gcs 3 with fixed, dilated pupils) * life-threatening systemic injuries (abbreviated injury scale (ais) \>4 in an organ system other than cns)

Keywords: intracranial hypertension elevated icp (intracranial pressure)
water iii: aquablation vs. transurethral laser enucleation of large prostates (80 - 180ml) in benign prostatic hyperplasia

Conditions: BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Summary: comparative analysis of efficacy and safety of aquablation (aquabeam robotic system®, procept biorobotics, redwood city, ca, usa) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).

prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of aquablation (aquabeam robotic system®, procept biorobotics, redwood city, ca, usa) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).

Eligibility criteria:
inclusion criteria: 1. age: 45 - 80 years 2. international prostate symptom score (ipss) ≥ 8 3. prostate size (measurement by transrectal ultrasound): 80 - 180 ml 4. subject has diagnosis of luts (lower urinary tract symptoms) due to bph (benign prostatic hyperplasia) 5. patient is mentally capable and willing to sign a study-specific consent form 6. subjects with the ability to follow study instructions and likely to attend and complete all required visits 7. written informed consent exclusion criteria: 1. body mass index ≥ 42 2. suspected or history of prostate cancer 3. suspected or history of bladder cancer 4. bladder stone 5. indwelling catheter for more than 3 months before baseline 6. active urinary tract infection 7. history of urethral stricture or bladder neck stenosis 8. damage of the external urethral sphincter 9. previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis) 10. use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ass 100mg/d). 11. contraindications for general and spinal anaesthesia 12. the investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations 13. subject is unwilling to accept a blood transfusion if required 14. subject is not able to give consent 15. subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial 16. simultaneously participation in another clinical trial in the field of urology 17. known or persistent abuse of medication, drugs or alcohol

Keywords: aquablation therapy laserenucleation holep thulep
functionality assessments in patients (adults and children) following treatment with debrase compared to standard of care

Conditions: Burns, Upper Extremity; Burns, Lower Extremity

Summary: once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function. thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products

this is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study mw2004-11-02 (previous phase 3 study). we had previously shown that by using the mvss scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in debrase vs. soc group were observed in sub-groups of highly functional body parts of the hands and feet. this study will include specific functionality evaluation using the "lower extremity functional scale" test for burns in the lower extremities and the "quickdash" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).

Eligibility criteria:
inclusion criteria: * adults and children who had participated and completed study mw2004-11-02. patients must be able to sign and dated written informed consent prior to study entry (by patient or by a guardian, when applicable). exclusion criteria: * none

Keywords: functionality extremities rom upper and lower extremity for burned patients
chemo-embolization for head and neck cancer

Conditions: SCCHN; Squamous Cell Carcinoma

Summary: the study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

this is a single site, single arm phase ii trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the u.s. chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. within uab, the investigators plan to recruit 48 patients to implement the intervention, within a two-year period. progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up head and neck imaging (ct or mri) interpreted by a radiologist not involved in the study, per standard of care. overall survival will be reported by the patients' oncology team on a monthly basis. the trial endpoints will form the basis of how pfs and os compare to historical outcomes in a similar cohort of patients.

Eligibility criteria:
inclusion criteria: * 1. provision of signed and dated informed consent form * 2.stated willingness to comply with all study procedures and availability for the duration of the study * 3.male or female, aged 18 or older * 4.diagnosed with squamous cell carcinoma of the head and neck * 5.ability to undergo chemo-embolization * 6.for females of reproductive potential: negative pregnancy test at time of chemo-embolization * 7.platinum-ineligible as determined by presence of cts grade i nephropathy, neuropathy or otopathy, and/or ecog 2+ performance status. * 8.plan to undergo standard of care radiation and chemo- and/or immunotherapy. exclusion criteria: * 1. medically unfit to undergo chemo-embolization * 2. treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.

Keywords: chemo-embolization chemoembolization squamous cell carcinoma of head and neck scchn platinum-ineligible