Kornimate/medical-research-clean huggingface dataset:
long-term follow-up study for patients treated with clbr001 car-t

Conditions: Relapsed/Refractory B-cell Lymphomas; Diffuse Large B-Cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Chronic Lymphocytic Leukemia (CLL); Marginal Zone Lymphoma (MZL); Mantle Cell Lymphoma (MCL); Small Lymphocytic Lymphoma (SLL); Primary Mediastinal Large B Cell Lymphoma; Transformed Follicular Lymphoma; Waldenstrom Macroglobulinemia; Lymphoplasmacytic Lymphoma; Burkitt Lymphoma

Summary: this study is designed as a long-term follow-up study of participants who have receive genetically modified autologous clbr001 car-t cells

patients will be enrolled following either the completion or early termination/discontinuation from study nct04450069 or any protocol in which patients were administered clbr001. patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. patients will be followed for up to 15 years post clbr001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

Eligibility criteria:
inclusion criteria: * all patients who received at least one clbr001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable. * subject is willing and able to adhere to the study visit schedule and other protocol requirements. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol exclusion criteria: * there are no specific exclusion criteria for this study

Keywords: car-t cell therapy switchable car-t cell autologous cell therapy cd19 positive disease blood cancer hematological malignancy neoplasms cd19 car-t cell long term follow up (ltfu)
urinary incontinence and practice of physical exercises

Conditions: Urinary Incontinence

Summary: introduction: urinary incontinence is often seen as a problem that affects multipara and old-aged women, however, there is evidence that during high impact physical activity, mainly, or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is common, even among young women, physically active, and without known risk factors. objective: evaluate the prevalence of urinary incontinence in nulliparous and nulligest women who regularly practice physical activities. method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old) who exercise regularly. they were divided into 3 groups according to the regular practice of exercise forms, they are (g1) weight training, (g2) aerobic exercises, included jump, step and dancing classes, and (g3) swimming (crawl mode). all participants were questioned about the perception of leakage of urine during the practice of exercises. the established exclusion criterion included: surgeries of urinary tract, urinary infections, gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form of physical activity.

the assessment was carried out in academies of the city of franca. all participants were questioned about the perception of loss of urine during the practice of exercises.

Eligibility criteria:
inclusion criteria: * practice of exercises exclusion criteria: * surgeries of urinary tract * urinary infections * gestations * child-birth * advanced aged * obesity * sedentary and practice of only one form of physical activity

Keywords: urinary incontinence physical exercise
efficacy and safety of betamethasone microsphere in patients with diabetic macular edema (tsubasa)

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the efficacy and safety of betamethasone microsphere (de-102) for diabetic macular edema.


Eligibility criteria:
inclusion criteria: * provided signed, written informed consent * 20 years of age or older with diabetic macular edema exclusion criteria: * active proliferative diabetic retinopathies (pdr) in the study eye * uncontrolled diabetes mellitus and hypertension * known steroid-responder

Keywords: dme
multimodal analgesia for cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: it is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. we will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * patients aged 19 years old or older, with american society of anesthesiologists physical status 1-3, and scheduled for elective laparoscopic cholecystectomy exclusion criteria: 1. recent gastric ulcer disease 2. hepatic or renal insufficiency 3. opioid dependency 4. coagulopathy 5. pre-existing neurologic or anatomic deficits in the lower extremities 6. severe psychiatric illness 7. pregnancy

Keywords: postoperative pain
effect of different pranayama breathing techniques on quality of life in hypertensive patients

Conditions: Hypertension; Stress; Aging Problems

Summary: the purpose of the current study is to compare between the effect of bhramari pranayama versus sheetali pranayama on quality of life in hypertensive patients.

people with hypertension have poorer sleep quality, less physical activity and more psychological stress than those with normal blood pressure. it has been shown that sleep affects vitality and health status and that sleep problems affect daily functioning and qol, and so it can be assumed that in patients with hypertension, sleep problems will have a negative effect on qol (uchmanowicz et al., 2019). yogic breathing exercises are known as pranayamas and are considered a form of meditation in itself, as well as a preparation for deep meditation. they promote physical well-being and self-awareness, improve lung and cognitive capacities, reduce blood pressure, anxiety, and other psychosomatic patterns, probably by increasing the parasympathetic tone. pranayama alone has demonstrated numerous beneficial health effects, including stress relief, beneficial cardiovascular effect, improved respiratory function, and enhanced cognition (jayawardena et al.,2020 ). since there is no study examined effect of bhramari versus sheetali on quality of life, physical fitness and stress in hypertensive elderly, this study aimed to examine this comparison.

Eligibility criteria:
inclusion criteria: - sixty elderly are selected from both sexes. 2-their age ranges from 60-75 years old. 3-hypertensive patients (sbp is 140 -159 mmhg and/or dbp is 90-99 mmhg). 4-their body mass index (bmi) ranged from \< 30kg/m2. 5-all patients are medically stable. exclusion criteria: * - patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery. 2- patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications. 3-patients who have difficulty in rolling the tongue for sheetali practice as stroke or bell's palsy. 4- tongue swelling in case of acromegaly, amyloidosis, myxedema and tongue cancer. 5- tongue pain in case of diabetic neuropathy, mouth ulcers, oral cancer and burn in the mouth. 6- chronic smokers and alcoholics. 7- severe ear infections that interfere with bhramari breathing.

Keywords: pranayama quality of life blood pressure physical activity
chemotherapy plus reduced radiotherapy in intracranial germinoma

Conditions: Intracranial Germinoma

Summary: the purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.

treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. however, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. in this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.

Eligibility criteria:
inclusion criteria: * patients with pathologically proven intracranial germinoma exclusion criteria: * elevated serum/cerebrospinal fluid alpha-feto protein * patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test \> ctcae grade 2)
an open label phase ii trial of bibw 2992 in patients with her2-negative metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of bibw 2992, a dual, irreversible egfr- and her2-inhibitor, in two cohorts of patients with her2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.


Eligibility criteria:
inclusion criteria: inclusion criteria: * female patients age 18 years or older * histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage iv); * her2-negative patients (her2 1+ or negative, or her2 2+ and fish negative) * at least one measurable tumour lesion (recist); * availability of tumour samples * written informed consent that is consistent with ich-gcp guidelines and local law * eastern cooperative oncology group (ecog, r01-0787) performance score 0 - 2. exclusion criteria: exclusion criteria: * active infectious disease * gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea * serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol * active/symptomatic brain metastases * cardiac left ventricular function with resting ejection fraction \< 50% (below upper limit of normal) * anc less than 1500/mm3 platelet count less than 100 000/mm3 * bilirubin greater than 1.5 mg /dl (\>26 and#61549 mol /l, si unit equivalent) * ast and alt greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases * serum creatinine greater than 1.5 mg/dl (\>132 and#61549 mol/l, si unit equivalent) * patients who are sexually active and unwilling to use a medically acceptable method of contraception * pregnancy or breast-feeding * concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. concurrent treatment with biphosphonates is allowed * previous treatment with trastuzumab, egfr-, or egfr/her2-inhibitors patients unable to comply with the protocol * active alcohol or drug abuse * other malignancy within the past 5 years
eliminating breast surgery for breast cancer patients with clinical complete response to neoadjuvant systemic therapy

Conditions: Breast Cancer

Summary: phase ii multicenter prospective study on the safety of eliminating surgery for triple negative or her2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.

the main purpose: to explore the safety of eliminating surgery for triple negative or her2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy. secondary study objective: to explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctdna can predict pcr or survival outcome. primary endpoint: 5-year event-free survival (5-year efs). secondary end points: whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpcr: ypt0), overall survival (os), patient-reported outcomes (pros) and safety

Eligibility criteria:
inclusion criteria: * female initial treatment patients aged ≥ 18 years and ≤ 70 years old * ecog score 0-1 * clinical t1-2n0 her2 positive ( hr negative her2 ihc score of 3+, or 2+and ish test positive) or triple negative invasive breast cancer * left ventricular ejection fraction (lvef) ≥ 50% * 12 lead electrocardiogram: qt interval (qtcf) corrected by fridericia method for females\<470ms * the functional level of the main organs must meet the following requirements: blood routine: anc ≥ 1.5 × 109/l# plt≥90 × 109/l# hb≥90 g/l#blood biochemistry: tbil ≤ 2.5 × uln# alt and ast ≤ 2.5 × uln# bun and cr ≤ 1.5 × uln# * for female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment * agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up. exclusion criteria: * inflammatory breast cancer * metastatic tumor * previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol. * active infections that require systemic treatment * has used any medication in this study within 14 days prior to enrollment * major surgery (excluding biopsy) performed within 14 days before enrollment
the management of asymptomatic carotid stenosis

Conditions: Carotid Artery Diseases; Carotid Stenosis

Summary: carotid stenosis are asymptomatic if no hemispheric or retinal symptoms have appeared in the 6 months preceding the discovery of the stenosis. asymptomatic carotid stenosis (acs) accounts for about ¾ of all carotid lesions. the goal of treating carotid stenosis is to prevent a stroke. while carotid surgery is recommended in the elderly patients in cases of symptomatic carotid stenosis, that of acs in patients over 75 years old, even when tight, remains subject to many controversies. indeed, the debate, concerning the benefit to be expected from a surgical procedure or a possible angioplasty procedure, is not yet closed. the aim of our study, through a retrospective evaluation of the results of all consecutive carotid endarterectomy (cea) and stenting in the participating center.


Eligibility criteria:
inclusion criteria: * asymptomatic carotid stenosis * patient with degree of carotid stenosis greater than 80% measured by the maximum systolic velocity at the site of the stenosis which must have been greater than 250 cm/s * ultrasound characteristics of a possibly unstable plaque exclusion criteria: * symptomatic carotid artery stenosis
a safety study to investigate the skin irritancy potential of diclofenac-menthol gel

Conditions: Pain

Summary: this research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. the seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily. the subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed. during the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. the skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).

Eligibility criteria:
inclusion criteria: * male/female volunteer ≥18 years * no systemic/dermatologic disorder exclusion criteria: * visible skin disease at the site of application that might interfere with skin assessments * allergy or hypersensitivity to nsaids or menthol or any of the excipients in the test product * history of physical or psychiatric illness, or medical disorder * recent history of alcohol or drug abuse * pregnant or lactating females
mad trial: myopia atropine dose

Conditions: Progressive Myopia

Summary: the goal of this interventional study is to compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of axial length in european children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. subjects will use atropine eye drops for a period of 3 years, followed by a 2 year observational period.

with the current worldwide myopia boom the frequency of high myopia will also increase, and potentially blinding complications such as myopic macular degeneration, retinal detachment, and glaucoma will occur more often. in the netherlands high myopia will become the most important cause of low vision and blindness by 2050. as treatment options are limited once the eye is fully grown, prevention of a long axial length at childhood is the only way to counteract this prospect. pharmacological interventions have shown a high efficacy in stopping eye growth, in particular eye drops with high dose atropine (0.5%, 1%). nevertheless, the high frequency of side effects (photophobia, reading problems) of these atropine concentrations has favoured the use of low dose atropine. atropine 0.01% is the most commonly used and lowest dosage; it has shown stability of refractive error, but not of axial length. recent studies have shown that atropine 0.05% has low risk of side effects, but a higher efficacy than 0.01%. many ongoing trials are now comparing various low dose atropine to placebo, but none are comparing the highest low dose to the lowest high dose atropine.

Eligibility criteria:
inclusion criteria: * children aged 6 to ≤ 11 years with bilateral myopia * onset of myopia ≥ 4 years of age * history of progression * ser of at least -1.00d and no greater than -6.00d in each eye measured using cycloplegic auto refraction * intraocular pressure \< 21 mm hg in each eye * distance vision correctable to at least 0.1 log mar (logarithm of the minimum angle of resolution) in each eye exclusion criteria: * allergy to atropine or other excipients of the eye drops * history of amblyopia or strabismus * history of retinal dystrophy or systemic disorder * abnormal ocular biometry aside from axial length * history of glaucoma * chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year). * chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. the use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication. * the anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., \< 2 weeks) * prior myopia treatments. * employees of the study center and their family members.

Keywords: myopia atropine axial length child
bioequivalence study of montelukast 5 mg chewable

Conditions: Asthma

Summary: the objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. test product was montelukast (5 mg chewable tablets; glaxosmithkline) and reference product singulair (5 mg chewable tablets; merck sharp \& dohme). the single dosage was one tablet. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 32 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 50 years. body mass index between 19 and 27 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. positive pregnancy test. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study. breast-feeding. females on contraceptive hormonal treatment. -

Keywords: bioequivalence mexico asthma montelukast chewable