Kornimate/medical-research-clean huggingface dataset:
gemcitabine + carboplatin in breast cancer

Conditions: Breast Cancer

Summary: the rational for this trial is given by the knowledge that gemcitabine acts as a potent inhibitor of dna repair and therefore may prevent adequate repair of platin-induced dna damage. gemcitabine is an excellent choice for combination therapy by its unique mechanism of action and favourable toxicity profile. the combination of gemcitabine and cisplatin was shown to be effective in several trials, producing response rates of 30-52 % in patients with pretreated metastatic breast cancer. to improve on tolerability and handling of the regime carboplatin may be the more appropriate choice for treatment. the mechanism of action of carboplatin is very similar to that of cisplatin. the rational for combining gemcitabine and carboplatin is based on their single-agent activities in metastatic breast cancer, the activity of this combination in other malignancies and on the fact that carboplatin has demonstrated efficacy comparable with cisplatin in several tumor types.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast cancer * all patients were required to give written informed consent. * prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents). * patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port. * age ≥ 18 years * karnofsky performance status ≥ 70 % * minimal life expectancy of 12 weeks * adequate haematological, renal, cardiac and hepatic function: 1. leukocyte count ≥ 3.0 x 109/l 2. absolute neutrophil count ≥ 2.0 x 109/l 3. platelet count ≥ 100 x 109/l 4. haemoglobin ≥ 8 g/dl 5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln 6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln 7. alkaline phosphatase level ≤ 2.5 x uln 8. creatinine clearance was required to exceed 60 ml/min. exclusion criteria: * prior treatment with gemcitabine or platinum agents * inadequate creatinine clearance (\< 60 ml/min) * only bone metastases * symptomatic brain metastases * women who are pregnant, lactating or refuse effective contraception * secondary malignancy * history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer * active infection * any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.

Keywords: pretreated metastatic
measurement of sarcopenia at post-stroke rehabilitation outcome

Conditions: Sarcopenia

Summary: the purposes of this study are 1. to explore effect of sarcopenia on recovery of post stroke hemiplegia 2. to explore the effect of stroke on sarcopenia and relationship between the degree of sarcopenia and respiration and swallowing function 3. to quantify and qualify post stroke loss of muscle mass 4. to validity the use of echointensity and elastography in evaluation of sarcopenia. by reaching the above list purposes, sarcopenia can be viewed as one of serious post stroke complications that is closely related to worth functional outcome, thereby emphasizing the importance of evaluation of sarcopenia as well as its prevention.

sarcopenia occurs frequently among old population. the changes can rather occur earlier after trauma or generalized illness. however, the nature of these sarcopenia is different from that of geriatric population. post stroke sarcopenia is underestimated however reduction in the motor uni number begins within 4 hours post stroke and after 3 weeks, sarcopenia can be seen in both hemiplegia and normal side. this muscular weakness can hinder functional recovery process.

Eligibility criteria:
inclusion criteria for stroke patients * first ever subacute stroke patients whose lesions were confirmed in brain imaging (mri/ct) * patients who did not have difficulty in premorbid ambulation or activities of daily living. * patients who can follow 1 step obey * patients who can perform hand function test * patients whose laboratory tests, neurologic, cognitive, and dysphagia evaluations are completed within 1 month from the onset date. * patients who admitted/transferred into our department for at least 4 weeks, following conventional rehabilitation protocols. * patients with at least 2 of mrs(modified ranking score) and fac(functional ambulation category) scores. exclusion criteria: for stroke patients * patients who do not meet the above listed criteria * patients with double hemiplegia * patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, aids, malignancy, pregnancy, amputation, or operation. * patients with joint contracture who are difficult to perform sonographic evaluation. * traumatic brain injury patients. inclusion criteria for normal subjects * subjects who can walk independent without any difficult * subjects without history of cns or pns lesion * mrs(modified ranking scale) \<=2 * fac(functional ambulation category) \>=2 exclusion criteria for normal subjects * patients with other systemic diseases that can affect loss of muscle mass or causr malnutrition. (example : chronic inflammatory disease, autoimmune disease, chronic intestinalis, active tuberculosis, immunocompromised state, aids, malignancy, pregnancy, amputation, or operation.
radiological outcomes of modified extra-articular lcl

Conditions: Adult Acquired Flexible Flatfoot Deformity After Failure of Conservative Treatment

Summary: to assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity

measurement of 1. calcencal pitch : this angle is formed on a weight-bearing lateral foot radiograph between the calcaneal inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have been proposed(11) 2. meary's angle: it is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', meary's angle is 0°, with abnormal values considered angle \>4° convex upward: pes cavus , angle \<-4 convex downward: pes planus, it can be used to classify the severity of deformity 3. lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , the lateral talocalcaneal angle should normally measure between 25 and 40°, \>40° diagnoses flatfoot deformity(12) 4. talonavicular coverage angle: it is the medial angle between ( talar head articular surface and proximal navicular articular surface) ,interpreting the talonavicular coverage angle (13)normal: \ 7°

Eligibility criteria:
inclusion criteria: - 1) age : adult ( age above 16 years old and below 65 years old 2) symptomatic flexible flat foot after failure of conservative treatment exclusion criteria: * 1- age: (\&lt;16,\&gt;65) years old 2 -previous foot surgery 3- autoimmune disease * 4 uncontrolled blood sugar 5- osteoprotic patient 6- infection
effects of dietary nitrate from vegetable/fruit juice on cerebral blood flow parameters

Conditions: Cerebrovascular Circulation; Cognitive Impairment

Summary: nitrate provides the body with an alternative source of nitric oxide which plays a large role in promoting blood flow and reducing blood pressure. nitrate supplementation with vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy expenditure during low intensity exercise. such findings combined with the previously known biological effects of nitric oxide would suggest that nitrate supplementation would also impact on blood flow. the aim of this study is to examine the effects of dietary nitrate supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using near infrared spectroscopy).


Eligibility criteria:
inclusion criteria: * healthy young (18-35 years) male and female adults, not vulnerable. exclusion criteria: * smoke or consume any tobacco products (even occasionally) * not proficient in english * pregnant (or are seeking to become) * currently taking recreational, over the counter/prescription medication (excluding the contraceptive pill), and/or dietary/herbal supplements. * any food allergies or sensitivities that are relevant to the study * history of/current head trauma, learning difficulties, adhd, dyslexia, migraines or any gastric problems.
treatment of crohn's complex perianal fistulas with tissue transplantation by local injection of micro-fragmented autologous adipose tissue.

Conditions: Crohn Disease

Summary: multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.


Eligibility criteria:
inclusion criteria: * the patient's age is over 18 at the time of surgery. * the patient suffers from crohn's disease confirmed by instrumental and histological methods. * the patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-tnf-α for at least 1 year) * the patient received, understood and signed informed consent for active participation in the study. * the patient is able to understand the conditions of the study and to participate throughout the duration. exclusion criteria: * patients with more than 1 internal and 3 external openings. * patients with ileus / colo ostomy. * patients with anus / rectum-vaginal fistulas. * patients with active hiv infections, hepatitis c (hcv), hepatitis b (hbv), tuberculosis. * patients with abdominal localization of crohn's disease who may require general surgery during the study. * patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc). * patients with clinical conditions that may compromise the success of the surgery or the follow-up. * pregnant or breastfeeding women.
hypercapnia and its association with long-term respiratory morbidities in premature infants with chronic lung disease

Conditions: Bronchopulmonary Dysplasia

Summary: this is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pco2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes.

data collection will begin once an infant no longer requires mechanical ventilation, cpap, and hfnc, up to twice per week while in the nicu. investigators will obtain up to twenty minutes of end-tidal capnography data, using masimo isa modules with continuous co2 display. five minutes of good quality data, at approximately 30 breaths per minutes, should provide approximately 150 data points. after filtering for artifact, the mean and range of end tidal co2 will be recorded during this interval. these recordings will be started after a feed for infants receiving enteral feeds. the capnography cannula will be placed by the bedside nurse or respiratory therapist at the conclusion of a feed and removed no later than the next feed. if data is unable to be obtained, investigators will attempt to collect it at the next regularly scheduled interval. available blood gases with pco2 will also be recorded during the nicu hospitalization. after discharge, consented subjects who are followed in the bch outpatient pulmonary clinic will have capnography recorded at every clinic visit for a period of up to twenty minutes, and mean and range of end-tidal co2 will be recorded after filtering for artifact. available blood gases with pco2 during pulmonary visits will be recorded; blood gases during sick encounters (i.e. emergency room) will be excluded. from available electronic medical record (emr) and clinic note data, investigators will also record duration of time on respiratory support including positive pressure ventilation and nasal cannula oxygen.

Eligibility criteria:
inclusion criteria: * potential eligible patients will be identified in the first 3-14 days of life at beth israel deaconess hospital (bidmc) nicu who have a birth gestational age \<=32 0/7 weeks and current or previous requirement for positive pressure (ventilation or continuous positive airway pressure (cpap). exclusion criteria: 1. death prior to discharge from the nicu, 2. chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and 3. other underlying identified genetic syndromes.

Keywords: bronchopulmonary dysplasia chronic lung disease prematurity
dismantling mindfulness: contributions of attention vs. acceptance

Conditions: Mild-moderate Unipolar Depression; Persistent Negative Affect

Summary: this study addresses nccam's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices. the purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (fa) and open monitoring (om) in comparison to each other and to the standard package, mindfulness-based cognitive therapy (mbct).

meditation, particularly mindfulness meditation, is one of the most popular complementary and alternative medicine (cam) therapies for alleviating emotional stress, depression and anxiety. while standardized meditation-based treatment packages like mindfulness based stress reduction (mbsr) and mindfulness-based cognitive therapy (mbct) have reliably shown sustained improvements in emotional disturbances and wellbeing, they contain so many different components and practices that the active ingredient cannot be ascertained. what is commonly called "mindfulness" meditation is actually comprised of two separate practices: 1) focused awareness practice (fa), and 2) open-monitoring practice (om). this project aims to create separate 8 week programs for fa and om meditations, compare their clinical efficacy and investigate their separate mechanisms of action in individuals with clinically significant levels of persistent negative affect and depression. the clinical benefit and mechanism of action of focused awareness (fa) vs open-monitoring (om) vs mbct will be examined with a 3-armed randomized control trial of these 8 week interventions. outcome variables include negative affect (depression, anxiety, stress) and wellbeing. hypothesized mediating processes include objectively measured attention, emotion regulation and the basic wakefulness on which they depend.

Eligibility criteria:
inclusion criteria: * english-speaking * ages 18-65 * mild-severe levels of depression or high level of negative affect exclusion criteria: * current: * age \ 65 * inability to read and write in english * extremely severe levels of depression * active suicidal ideation * presence of axis i personality disorder * panic disorder * post-traumatic stress disorder * obsessive-compulsive disorder * eating disorder, or substance abuse/dependence * current psychotherapy * change in antidepressant medication type or dosage in the last 8 weeks. lifetime history exclusions: * bipolar disorder * psychotic disorders * persistent antisocial behavior or repeated self-harm, * borderline personality disorder, * organic brain damage * regular meditation practice
refractive transepithelial photo-keratectomy (t-pkr) in high myopia

Conditions: Ophthalmopathy; Myopia; Keratopathy

Summary: the aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (t-prk) without the addition of mitomycin-c for the treatment of high myopia of 6 diopters or more.

in this retrospective study, 69 high myopic eyes of 6 diopters or more were treated in 38 patients by trans-prk with the schwind amaris 500e® excimer laser platform without the use of mitomycin-c. several outcomes are measured in treated patients, such as postoperative uncorrected visual acuity (ucva), best spectacle corrected visual acuity (bscva), efficacy, safety and predictability of the procedure, as well as corneal haze measurement. the patients are followed-up for 3 months.

Eligibility criteria:
inclusion criteria: * age ≥18 years, * myopic sphere of -6 diopters or more, * astigmatism less than 3 diopters, * stable myopia not progressing for more than one year exclusion criteria: * age \<18 years, * myopic sphere less than -6 diopters, * astigmatism greater than 3 diopters, * progressive myopia (variation of more than 0.5 diopters over one year), * abnormal corneal topography or the presence of manifest keratoconus, * pre-existing eye pathology, * history of eye surgery, * active inflammatory or infectious eye disease, * dermatological disease or systemic connectivitis

Keywords: transepithelial photorefractive keratectomy high myopia mitomycin-c corneal haze efficacy predictibility
blood pressure self management for hypertension & prehypertension using an internet enabled, automated self management program

Conditions: Blood Pressure

Summary: the specific aim of the study is to assess the impact of an internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.

we propose to conduct a randomized controlled trial of an internet-enabled, automated self-management program. the study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites. subjects enrolled from the intervention sites will receive a blood pressure meter and access to an internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback. subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback. the trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure.

Eligibility criteria:
inclusion criteria: * full-time employees of emc * aged 30 to 65 years at time of enrollment * any of the following * a diagnosis of hypertension as defined by one of the following * taking an antihypertensive medication * being told at least twice by a physician or other health professional that the subject has high blood pressure† * a bp \> 140/90 detected at screening by the research team on 2 separate occasions. * a diagnosis of prehypertension as defined by a systolic bp between 120-139 or a diastolic bp between 80-89 detected at screening by the research team on 2 separate occasions * access to the internet at work and / or at home exclusion criteria: * inability to self-monitor blood pressure due to musculoskeletal or cognitive impairment * known secondary cause of hypertension e.g. renal artery stenosis, cushing's disease.
backward walking observation training in people with stroke and gait quality in stroke

Conditions: Stroke

Summary: walking impairment is one of the most common and concerning issues for individuals with stroke. previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. however, for people with chronic stroke, it may be more appropriate to prioritize improving gait symmetry and gait variability to enhance gait quality as a primary intervention goal. additionally, stroke can lead to an imbalance in interhemispheric brain activity, which evolves as motor function recovers. according to the literature review, backward walking may extend the support time of the lower limbs, thereby enhancing the weight-bearing capacity of the affected limb. this, in turn, could promote gait symmetry and reduce gait variability. changes in brain activity might also accompany such improvements in gait quality. therefore, this study aims to investigate the immediate, short-term and post carryover intervention effects of backward walking observation training on gait quality in individuals with chronic stroke as well as to explore its effects on interhemispheric activity balance in individuals with chronic stroke.


Eligibility criteria:
inclusion criteria: * ≥ 6 months after the diagnosis of stroke * independent walking over at least 7m with or without a walking aid * mini-mental state examination score ≥ 24 exclusion criteria: * had difficulty in backward walking * any neuromuscular disorders history * with visual or auditory disorders * unstable cardiac status or uncontrolled hypertension * any musculoskeletal disorders that would affect walking ability

Keywords: backward walking action observation training gait symmetry gait variability brain activity stroke
a phase i/ii study of intralesional recombinant tumor necrosis factor in patients with aids-related cutaneous kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (tnf) and to define a maximum tolerated dose (mtd) for single intralesional injections. in addition, to assess the effects of tnf injections on kaposi's sarcoma (ks) lesions as measured by p-32 magnetic resonance spectroscopy.


Eligibility criteria:
inclusion criteria patients must have: * biopsy-proven kaposi's sarcoma (ks) with multiple cutaneous lesions. * minimum life expectancy of 3 months. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * clinically significant cardiac disease. * known hemorrhagic diathesis or active bleeding disorder. * clinically apparent vascular disease. * known lipoprotein disorders. * history of seizure disorder or central nervous system (cns) metastasis. * additional malignancy. concurrent medication: excluded: * cardiac agents. * anticoagulants. * thrombolytic agents. * nonsteroidal anti-inflammatory drugs. * corticosteroids. * aspirin. * vasodilators. patients with the following are excluded: * additional malignancies or other conditions listed in patient exclusion co-existing conditions. prior treatment: excluded within 4 weeks of study entry: * chemotherapy. * radiotherapy. * immunotherapy.

Keywords: skin neoplasms tumor necrosis factor acquired immunodeficiency syndrome