Kornimate/medical-research-clean huggingface dataset:
comparative real world tumor response in pre-menopausal metastatic breast cancer patients treated with palbociclib + aromatase inhibitor or aromatase inhibitor alone

Conditions: Metastatic Breast Cancer

Summary: this study aims to assess real-world tumor response in pre/perimenopausal hr+/her2- metastatic breast cancer (mbc) patients initiating palbociclib + aromatase inhibitor (ai) or ai alone as first-line therapy during the period on or after 01 january 2010 to on or before 30 june 2020. data will be obtained from structured data fields within an electronic health record (ehr) database and will be supplemented by additional unstructured data collected through a targeted chart review.


Eligibility criteria:
inclusion criteria: 1. pre or perimenopausal at mbc diagnosis 2. diagnosis of mbc in patient history 3. confirmed hr+/her2- status as defined as: a. hr+: er+ or pr+ test; b. her2-: any her2 negative test and the absence of a positive test (ihc positive 3+, fluorescence in situ hybridization \[fish\] positive/amplified, positive not otherwise specified \[nos\]). 4. received one of the following regimens as first-line treatment for mbc during the period from 01 january 2010 through index period 30 june 2020 until the data cutoff date of 31 december 2020. 1. palbociclib + ai as first-line treatment for mbc or 2. monotherapy ai as first-line treatment for mbc 5. received care at a us oncology network (uson) site(s) utilizing the full ehr capacities of iknowmed (ikm) at the time of treatment. 6. ehr data available from the uson site(s) where the patient received treatment are accessible for research purposes. exclusion criteria: 1. evidence of prior treatment with cyclin-dependent kinase (cdk) 4/6 inhibitors (palbociclib, ribociclib or abemaciclib) in the early breast cancer (bc) or mbc setting. 2. first structured activity (clinical visit) greater than 120 days after mbc diagnostic date with chart review to confirm no initial mbc treatment outside uson. 3. receipt of treatment indicated for another primary cancer during the study observation period (after initiation of palbociclib + ai or ai monotherapy and before 31 december 2020) or history of another primary cancer within uson. 4. enrolled in any interventional clinical trial after initiation of palbociclib + ai or ai monotherapy and before 31 december 2020.

Keywords: pre-menopausal palbociclib aromatase inhibitor
perforating cutaneous nerve injection efficacy in chronic coccydynia: a randomized, double-blind study

Conditions: Coccyx Disorder; Coccyx Injury

Summary: interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. their effectiveness remains at the level of case presentations. according to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 50 years. 2. chronic coccyx pain (≥3 months). 3. pain visual analogue scale (vas) score ≥4. 4. pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion). exclusion criteria: 1. injection to the area in the last 3 months. 2. concurrent mechanical or inflammatory low back pain. 3. coccyx pain that started during pregnancy or postpartum. 4. history of myelomeningocele or spina bifida. 5. history of sacrococcygeal luxation or subluxation (confirmed by radiography). 6. history of coccyx fracture. 7. concurrent neurological deficit. 8. skin disease affecting the injection area. 9. history of malignancy. 10. pregnancy or breastfeeding. 11. severe coagulopathy. 12. infection at the injection site. 13. neurological or psychiatric diseases, including ongoing depression (beck depression inventory score \>14).
a structured school-based health intervention for the obesity prevention

Conditions: Child Obesity; Child Behavior; Obesity, Childhood

Summary: the proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. the intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. the goal of nutritional and physical education is to raise knowledge about the negative effects of obesity and encourage healthy eating habits in children and their caregivers. these educational campaigns will be delivered primarily through schools, guaranteeing a wide audience and consistent messaging.

the demographic profile of pakistan offers a unique background for researching the dynamics of childhood obesity because of its rapid urban growth and socioeconomic shifts. processed foods are displacing traditional diets, and children's physical activity is decreasing as a result of longer screen times and restricted access to leisure centers. the proposed research aims to assess how well a structured intervention is intended to reduce childhood obesity. the intervention addresses food and physical activity behaviors, important determinants of obesity, by concentrating on these elements. dietary education: teaches kids about eating the right portions of food and maintaining a balanced diet. better eating habits and an understanding of nutrition are among the results. information regarding physical activity: raises awareness and encourages regular exercise. improved comprehension and engagement in physical activities are among the results. extra physical activity time: offers extra opportunities for physical activity after school, such as fitness classes and sports, after hours. improved fitness, a decrease in sedentary time, and higher levels of physical activity are the results.

Eligibility criteria:
inclusion criteria: * children of age between 5 to 12 years. * enrollment at one of the selected schools. exclusion criteria: * children and their parents who did not give assent and consent to participate in the study.
improving maternal and child health in india: evaluating demand and supply side strategies (imatchine)

Conditions: Obstetric Labor Complications; Post-partum Hemorrhage; Sepsis; Pre-eclampsia; Neonatal Mortality

Summary: the study evaluates the impact of a new conditional cash transfer (cct) program (thayi bhagya yojana) to promote child birth in obstetric facilities in the state of karnataka, india in order to determine its policy value and to guide efforts to improve maternal and infant health outcomes nationally. in addition, the study includes a large randomized evaluation of performance-based incentive payments to providers to improve quality of medical care provided during delivery and actual health improvement in the providers' patient populations and their catchment areas.

the evaluation study will first provide new evidence on the effectiveness of demand-side strategies to increase institutional deliveries and improve childbirth outcomes. second, the study will analyze one of the first implementations of direct rewards to providers for health improvement in a developing country. third, the study will provide critical new insight into dynamics between demand and supply-side incentives in improving population health outcomes as either complements or substitutes. the study uses household survey to collect data from mothers on socio-economic, human capital, quality of life variables (including below poverty line \[bpl\] index components) and as well as information about deliveries, fertility histories, morbidity and mortality (for mothers, infants, and children), birth related complications, health service use and spending. additionally, provider surveys will collect data on infrastructure, staffing, provider qualifications, provider knowledge and process measures of provider performance.

Eligibility criteria:
inclusion criteria: * households with new mothers (one to three weeks after childbirth) * rural private sector maternity care providers who are listed on the karnataka government's legitimate provider list. exclusion criteria: * households without children * households where mothers gave birth \> 3 weeks ago * public sector maternity care providers * private sector maternity care providers serving in towns with large public providers such as community health centers (chcs)

Keywords: institutional deliveries maternal health infant health private medical providers provider incentives randomized control trial
study of safety and biomarker efficacy of ts23 in healthy volunteer

Conditions: Thrombosis; Cerebral Ischemia; Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction

Summary: this study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of ts23 in healthy adults.

this is a first-in-human, phase 1 study of the safety, pharmacokinetics and pharmacodynamics of ts23 in healthy male volunteers.ts23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * healthy males age 18 years to 60 years of age * body mass index ≥ 20 and ≤ 33 kg/m squared exclusion criteria: * known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of cho cells * current alcohol or drug abuse or history of alcohol or drug abuse * participation in any trial with an investigational drug within 90 days prior to dosing * blood donation of more than 500 ml of blood within 90 days prior to dosing * any history of a bleeding or thrombotic disorder * any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or immunologic disorder * over-the-counter medications, dietary supplements and herbal products (except a daily vitamin) within 14 days of drug administration or during the study * no prescription medication for at least 14 days or 5-half-lives, whichever is longer, prior to study drug administration. * use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and during the study * known hereditary fructosemia (due to sorbitol in the formulation) * any previous or current monoclonal antibody therapy * history of trauma or surgery within the past 60 days or planned surgery within 30 days * abnormal baseline laboratory values or any laboratory values deemed clinically significant by the investigator * recent history of head trauma in last 30 days prior to receiving ts23 * unwillingness or inability to avoid contact sports or other activities with more than a small risk of head or facial trauma within 30 days of receiving ts23 * history of or risk of falls (e.g., due to dementia, frailty, etc.) * sexually active subjects must agree to use a reliable method of birth control (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving ts23
small-volume tubes to reduce anemia and transfusion (stratus)

Conditions: Blood Loss Anemia

Summary: stratus will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. this is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

the stratus pilot study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (rbc transfusion, incidence and severity of anemia). identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.

Eligibility criteria:
investigative site eligibility: * intensive care unit with at least 15 beds with capacity for mechanical ventilation * current standard to use standard-draw blood collection tubes * availability of hospital administrative data and electronic patient information
ecco2r in the treatment of acute exacerbation of copd with severe hypercapnia

Conditions: Lung Diseases, Obstructive

Summary: patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to icu for monitoring and respiratory support treatment. noninvasive ventilation has become the first-line respiratory support for the treatment of aecopd with hypercapnia and respiratory failure. however, 26-54% of aecopd patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. for these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. in aecopd patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood co2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. as a new type of respiratory support technology, ecco2r is worthy of attention in monitoring and evaluation of support effect in aecopd patients with respiratory failure. it is urgent that ecco2r can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.


Eligibility criteria:
inclusion criteria: * aecopd patients. * the patients with hypercapnia respiratory failure were admitted to icu and needed noninvasive ventilation. * the results of blood gas analysis showed ph \ 50 mmhg. * there were high risk factors for failure of noninvasive ventilation: after receiving continuous 2 hours of noninvasive ventilation, the arterial blood pressure showed the ph value was ≤ 7.30, while paco2 was 20% higher than the baseline value, and any one or more of the following conditions were combined: respiratory rate ≥ 30 times / min, assisted respiratory muscle breathing; contradictory breathing. * informed consents were sighed. exclusion criteria: * the mean arterial pressure was less than 60 mmhg after volume and vasoactive drug treatment. * there were anticoagulant contraindications. * weight over 120kg. * patients with malignant tumor or other complications, the expected survival time was less than 30 days. * it could not cooperate with noninvasive ventilation or has contraindication of noninvasive ventilation.

Keywords: acute exacerbation of chronic obstructive pulmonary disease extracorporeal carbon dioxide removal hypercapnia respiratory failure
acute beetroot juice supplementation in amateur climbers

Conditions: Dietary Supplement; Sport Performance

Summary: whereas beetroot juice (bj) supplementation is shown to increase physical performance in endurance activities, its benefits in neuromuscular function and strength performance has been barely studied. in this cross-over randomized placebo-controlled study, we investigated the effects of bj acute supplementation in improving neuromuscular performance in amateur climbers


Eligibility criteria:
inclusion criteria: * more than 18 years * active climbing for, at least, last 6 months exclusion criteria: * smoking * contraindications to bj diet * physical limitations, health problems, or musculoskeletal injuries
a study of skin and systemic biomarkers in patients with active cutaneous lupus erythematosus and in healthy volunteers

Conditions: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Healthy

Summary: the purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.

this is a phase 0 multi-center and longitudinal study of biomarkers and clinical parameters in patients with lupus erythematosus (le). approximately 80 participants (20 healthy participants and 60 patients with le) will be enrolled. this will include 30 with discoid lupus erythematosus/subacute cutaneous lupus erythematosus (dle/scle) without systemic lupus erythematosus (sle), and 30 with dle/scle with sle. all patients with le will continue to be managed by their personal physicians per their standard-of-care. study participants will undergo interventional procedures that include collection of urine, blood samples and skin biopsy. there will be a single sample collection timepoint for healthy participants and two sample collection timepoints for le patients, separated by approximately 12 weeks. a blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. the data obtained in this study will be used in the evaluation of new therapies for lupus and may help in developing new treatments. safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examinations. the total duration of study participation will be approximately 11 days for healthy participants and 95 days for patients with le.

Eligibility criteria:
inclusion criteria: * have discoid lupus erythematosus (dle) or subacute cutaneous lupus erythematosus (scle) with or without a diagnosis of systemic lupus erythematosus (sle) * active dle or active scle confirmed by histological analysis (for participants with dle or scle without sle) * confirmed diagnosis of sle using american college of rheumatology criteria and has current or historical positive antinuclear antibodies (ana) or anti double-stranded deoxyribonucleic acid (anti-dsdna) (for participants with dle or scle with sle) * an active skin lesion that can be biopsied (for participants with lupus erythematosus) exclusion criteria: * known or thought to have a diagnosis of drug-induced lupus * an active skin disease that is not a manifestation of lupus erythematosus * has an acute cutaneous lupus erythematosus rash only * if taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before day 1 * participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to day 1 * positive serology for human immunodeficiency virus antibody, hepatitis b virus, or hepatitis c virus

Keywords: lupus erythematosus, cutaneous lupus erythematosus, systemic lupus erythematosus, discoid healthy active cutaneous lupus erythematosus longitudinal study biomarkers subacute cutaneous lupus erythematosus skin biopsy
acupuncture, dry needle and botox injection in management of patient with myofascial pain dysfunction syndrome

Conditions: Myofascial Trigger Point Pain; Myofascial Pain Syndrome

Summary: evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and botox injection using electromyography and visual analogue scale on two time intervals at 2 and 6 months after the intervention

all the patients will be selected and examine from the outpatient clinic of oral and maxillofacial surgery department. faculty of dentistry, cairo university, egypt. electromyography examination will be conducted in the department of neurophysiology department. faculty of medicine, cairo university, egypt. adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to tmj disorders all patients involved in this study will be divided into three groups, each group will receive a technique for one side of mpds, involving acupuncture, dry needle, and botox injection. for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 weeks

Eligibility criteria:
accepts healthy volunteers inclusion criteria: * healthy volunteers * mpds patient * adult patients of both sexes, aged from 15 to 60 years * signs and symptoms of pain or muscles spams * trigger points in masticatory muscles * patients had not received any other form of surgical treatment related to tmj disorders * cooperative patient exclusion criteria: * severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia * edentulous patients, and total dental prosthesis. * psychologically disturbed and mental disturbance patients * major systemic disorders (- valvular heart disease: avoid indwelling needles) * seizure patients * a confirmed or suspected diagnosis of an inflammatory disorder and autoimmune. * patient on medication (insulin- corticosteroids, nonsteroidal anti-inflammatory therapy or narcotics, muscle relaxants, herbal medicines.) * analgesic or anti-depressants over the last 2 weeks. * any anatomical abnormality in tmj. * pregnant women. * allergies to metals.

Keywords: botox injection dry needle myofascial trigger point pain acupuncture
manual therapy on the improvement of functional disability in patients with chronic non specific low back pain

Conditions: Back Pain Lower Back Chronic

Summary: background: models have tried to explain the driving mechanisms behind chronic non specific low back pain (cnslbp) in order to propose better appropriate conservative treatment. altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of cnslbp patients. recent clinical recommendations still propose active exercises (ae) for cnslbp. however, acceptance of exercises by patients may be limited by pain-related manifestations. current evidences suggest manual therapy (mt) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. the aim of this study was first, to assess whether mt has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of mt followed by ae to sham therapy (st) followed by ae. methods: forty-two cnslbp patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus ae (mt group; n = 22), or detuned ultrasound (first intervention) plus ae (st group; n = 20). eight therapeutic sessions were delivered over 4 to 8 weeks. instant analgesic effect was obtained by measuring pain intensity (visual analogue scale) before and immediately after the first intervention of each therapeutic session. pain intensity, disability (oswestry disability index) and fear-avoidance beliefs (fear-avoidance beliefs questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.


Eligibility criteria:
inclusion criteria: * suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks * can maintain the usual medication exclusion criteria: * spinal fracture or surgery within the previous 6 months * pregnancy * neoplasia * spinal infection * spinal inflammatory arthritis * low back pain of visceral origin * severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months * score of 3/5 or more on the waddell score * on sick leaves from work for 6 months or more * psychiatric disorders * opioid medication * patient unable to collaborate (linguistic barrier; cognitive impairments) * radiologic abnormalities other than degenerative disease * clinical neurogenic claudication.

Keywords: chronic non specific low back pain manual therapy active exercises pain disability