Kornimate/medical-research-clean huggingface dataset:
investigating the effect of at home thermal therapy on dry eye patients with meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction; Dry Eye Disease

Summary: the purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of meibomian gland dysfunction. this will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

this study will be a non-randomized, open label study of subjects with documented mgd. all subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. after treatment subjects will be re-examined and measured for clinical and symptomatic change in their mgd as well as changes to their sleep quality and anxiety index. subjects will also be followed after treatment has been completed.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mgd * minimum age 18 years exclusion criteria: * history of ocular disease, trauma, surgery (other than refractive), orbital cancer * 3 month history of ocular infection and/or ocular inflammation not associated with dry eye * 3 month history of any active physician administered or prescription dry eye treatment * pregnant, potentially pregnant or nursing

Keywords: dry eye thermal therapy meibomian gland dysfunction
pulmonary hypertension and arrhythmia

Conditions: Pulmonary Hypertension

Summary: patients with pulmonary hypertension underwent (routine) holter ecg and were screened for (malignant) arrhyhtmias. results of holter ecgs were correlated with clinicial and technical data (echocardiography and right heart catheterization).


Eligibility criteria:
inclusion criteria: holter ecg - exclusion criteria: none -

Keywords: pulmonary hypertension ph arrhythmias survival
us-non contrast computed tomography real-time fusion for urinary stones follow up

Conditions: Urolithiasis; Ureterolithiasis

Summary: urolithiasis is a universal problem, a large part of patients will be affected by multiple stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. the high recurrence rate requires an increasing amount of imaging follow-up. us-ncct real-time fusion (fusion) enables lesion assessment and follow up using both modalities as reference for each other. our study proposes a novel approach for short term follow up of patients using fusion instead of repeat ncct exams. the goal of the study is to create an initial proof of concept that fusion is effective for follow up of known urinary stones. the study is a prospective study on patients with an obstructing ureteral stone found on a ncct. patients will undergo fusion (using general electric logiq e9) after ncct. the primary endpoint was the ability to locate the ureteral stone using us with guidance of the ncct as a "road map".


Eligibility criteria:
inclusion criteria: * ncct within 3 months prior to the us study with proved urolithiasis exclusion criteria: * inability to perform a us study. * pacemaker

Keywords: kidney stones ureteral stones
arsenic trioxide in combination with cytarabine in patients with high-risk mds and poor-prognosis aml

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-c.

this is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide. patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-c administered at 5, 7.5, or 10 mg/m2 sc bid days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).

Eligibility criteria:
inclusion criteria: * histologic diagnosis of high-risk mds (ipss int-2). * no prior cytotoxic therapy for mds or aml (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine). exclusion criteria: * pregnant or lactating women. * absolute qt interval \>460 msec in the presence of serum potassium and magnesium values within the normal range. * concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. * uncontrolled or severe cardiovascular or pulmonary disease.

Keywords: myelodysplastic syndrome
single patient use of selinexor and dexamethasone for a patient with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is an individual patient, expanded access protocol using selinexor and dexamethasone ("sd") for the treatment of relapsed, refractory multiple myeloma in a 64 year old male, "19023-umn-01" weighing 105.7 kg. 19023-umn-01 has igg kappa myeloma that has relapsed after numerous treatments.

selinexor is an oral, first in class, slowly reversible, potent and selective inhibitor of nuclear export (sine) compound that specifically blocks exportin 1 (xpo1). it is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Eligibility criteria:
inclusion criteria: * patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib) * aged 18 years and older * patient able to provide written, informed consent to participate in and follow the keap treatment plan exclusion criteria: * known hypersensitivity to selinexor or any excipients. * patient receiving any other investigational agent. * any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.). * known intolerance, hypersensitivity, or contraindication to glucocorticoids. * active graft versus host disease (after allogeneic stem cell transplantation). * active, unstable cardiovascular function: * symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics) * congestive heart failure of new york heart association class ≥ 3 or known leftventricular ejection fraction \< 40%, or * myocardial infarction within 3 months prior to c1d1. * significant renal impairment with ongoing dialysis treatment * active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment. * any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Keywords: mm
combination of anti-pd-1 and nk immunotherapy for recurrent solid tumors

Conditions: Malignant Solid Tumour

Summary: the aim of this study is the safety and efficacy of anti-pd-1 plus nk immunotherapy to multiple solid tumors.

by enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-pd-1 and natural killer (nk) cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * progression after chemotherapy or appropriate tki treatment for those patients with an egfr-sensitizing mutation or alk rearrangement * kps ≥ 70, lifespan \> 3 months, pd-l1 tps of 1% or greater * platelet count ≥ 80×10\^9/l，white blood cell count ≥ 3×10\^9/l, neutrophil count ≥ 2×10\^9/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis * previous treatment with a therapeutic antibody against ctla4, pd-l1, or pd-1, or pd-l1/pd-1 pathway-targeting agents.

Keywords: solid tumor anti-pd-1 nk immunotherapy
feasibility of the sinex program for shoulder instability

Conditions: Anterior Shoulder Dislocation

Summary: an optimal treatment for traumatic anterior shoulder instability (tasi) remains to be identified. a shoulder instability neuromuscular exercise (sinex) program has been designed for patients with tasi, but has not yet been tested in patients eligible for surgery. the purpose of this study was to investigate and evaluate the feasibility and safety of the sinex program for patients diagnosed with tasi and eligible for surgery. a feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. participants undergo the sinex program, a twelve week exercise program including physiotherapist supervised sessions. feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. clinical assessments included apprehension and relocation tests, shoulder joint position sense (sjps), shoulder sensorimotor control measured by center of pressure path length (copl) on a force platform, isometric strength measured by constant score - isometric maximal voluntary contraction (cs-imvc), self-report questionnaires included western ontario shoulder instability index (wosi), tampa scale of kinesiophobia (tsk) and global perceived effect questionnaire (gpe).


Eligibility criteria:
inclusion criteria: * men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with tasi, eligible for stabilizing bankart surgery exclusion criteria: * complex shoulder injuries not suitable for a bankart procedure as determined by an orthopedic surgeon, insufficient norwegian language skills, and/or not being able to participate in a supervised exercise program

Keywords: shoulder instability feasibility studies neuromuscular exercise
antibiotic concentration in internal mammary graft preparation

Conditions: Coronary Heart Disease; Surgical Wound Infection

Summary: the negative effect of internal mammary harvesting on sternal perfusion is well known, especially in diabetic subjects. microdialysis previously showed increased lactate tissue concentration after mammary artery preparation. although high antibiotic concentration is of utmost importance in this region, no study previously measured the effect of internal mammary artery harvesting on target tissue antibiotic concentration. study hypothesis: internal mammary artery harvesting imposes an additional risk for deep sternal wound infection by impairing antibiotic tissue penetration. this effect is mediated by altered perfusion patterns and may be seen in cephalosporin and/or teicoplanin treatment. study objective: to evaluate the impact of left internal mammary artery preparation on target tissue antibiotic concentration of cefazolin and teicoplanin during cardiac surgery design: this study is designed as an observational pharmacokinetic trial. patients are their own controls by measuring antibiotic concentration in different subcutaneous tissues. study population: patients referred for coronary artery bypass grafting to the department of cardiothoracic surgery with planned unilateral left internal mammary artery preparation and a high risk profile for deep sternal wound infections will be asked to participate in this trial.


Eligibility criteria:
inclusion criteria: * written informed consent * planned coronary artery bypass grafting with unilateral internal mammary artery bypass * planned used of cardiopulmonary bypass exclusion criteria: * inability to give informed consent * know allergy to cephalosporins, penicillin or teicoplanin * re-operation * additional planned valve surgery * dialysis * bmi \> 30 * long standing diabetes mellitus (\> 7 years) * ejection fraction below 20% measured with transthoracic echocardiography * chronic severe renal insufficiency * childbearing potential

Keywords: postoperative wound healing
cultural adaptation of a ssi for youth anxiety

Conditions: Anxiety Disorders

Summary: the overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (ssi) to better reflect the cultural and linguistic diversity of latin, haitian, and haitian-american individuals via a fully online platform.


Eligibility criteria:
inclusion criteria: 1. be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10. 2. affirm that they have read the consent language and study overview on redcap by checking a box. exclusion criteria: - not meet all of the inclusion criteria.
the shine-mdt randomized controlled trial

Conditions: Head and Neck Carcinoma; Radiotherapy Side Effects

Summary: radiotherapy is one of the main treatments for head and neck carcinoma. the incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy. the management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. we aimed to evaluate the efficacy of the shine-mdt (supportive holistic interventions by nurses and experts via multidisciplinary team) in reducing radiotherapy interruptions and improving patients' quality of life (qol) compared with usual care.


Eligibility criteria:
inclusion criteria: 1. patients had pathologically confirmed malignant head and neck tumors without distant metastasis. 2. patient age ≥18 years; 3. patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy. 4. baseline ecog (eastern cooperative oncology group) score 0-2; 5. good cognitive and reading skills, able to complete the questionnaire survey. exclusion criteria: 1. presence of other malignant tumors aside from head and neck malignancies; 2. a history of prior head and neck radiotherapy; 3. mental illness or cognitive impairments; 4. uncontrolled systemic diseases that could significantly affect their qol

Keywords: head and neck carcinoma multidisciplinary team radiotherapy interruption supportive care
pathogenesis of primary spontaneous pneumothorax

Conditions: Pneumothorax

Summary: primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. the estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. the pathogenesis of this benign disease remains unclear. generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. the main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.

primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. the estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. the pathogenesis of this benign disease remains unclear. generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. the main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients. the blebs resected from the pneumothorax patients will be used for rna and protein levels analyses. the adjacent normal lung tissue will be used as a control for comparison.

Eligibility criteria:
inclusion criteria: * age between 14 and 40 years * spontaneous pneumothorax * underwent bullectomy of the lung exclusion criteria: * with underlying lung disease

Keywords: pneumothorax thoracoscopy pathogenesis blebs surgery
somatocognitive therapy in treatment of provoked vestibulodynia - a feasibility study

Conditions: Provoked Vestibulodynia

Summary: this study examines feasibility of r\&d activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.

provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young women. it represents the most common cause of pain during sexual intercourse. existing treatment approaches are predominantly based on clinical experience, observational studies, or reports of expert committees. although, physiotherapy is one of the most commonly recommended treatments, high quality randomized controlled trials are needed to assess its effectiveness. this is a phase i, feasibility study with the purpose of testing r\&d activities for a planned full size rct. additionally, patients experiences with the somatocognitive therapy intervention, assessment measures and condition itself will be collected using qualitative interviews. the results will be applied to adjust time-line of the treatment, outcome measures and therapeutic approach before commencing full scale rct.

Eligibility criteria:
inclusion criteria: * confirmed provoked vestibulodynia diagnosis exclusion criteria: * vulvar pain is not clearly linked to intercourse or pressure applied to vestibule or usage of tampon * active infection or dermatologic lesion in the vulvar region

Keywords: provoked localized vulvodynia provoked vestibulodynia vestibulitt physiotherapy
low flow low gradient aortic stenosis relevance of the (re)search for a contractile reserve

Conditions: Aortic Valve Stenosis

Summary: investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.


Eligibility criteria:
inclusion criteria: * patient from 45 to 90 years old * patient agreeing freely to participate in the study * aortic surface area suspected to be \< 1 cm² or \< 0.6 cms²/m² * low aortic gradient defined by a mean pressure gradient \< 40 mmhg * aortic low flow defined by: a stroke volume indexed \< 35 ml/m2 * any contra-indication for the realization of the mri exclusion criteria: * heart rhythm disorders * presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (gfr 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (vems 1 l) * presence of a concomitant valvular heart disease with stenosis or regurgitation \> moderated * persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Keywords: aortic valve stenosis low flow dobutamine stress echocardiography
flaxseed for the treatment of hot flashes

Conditions: Hot Flashes

Summary: flaxseed, a phytoestrogen, is a natural food supplement rich in plant ligands, which have a very weak estrogen effect. in this study, flaxseed is being evaluated in regard to its capacity to safely and effectively treat hot flashes. specifically, this study seeks to determine if flaxseed will lower the number and severity of hot flashes and if women experience any side effects from taking flaxseed for this purpose.


Eligibility criteria:
inclusionary criteria: * age greater than or equal to 18 years * women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer. * bothersome hot flashes (defined by occurenece of greater than or equal to 14 times per week and of sufficient severity to make the patient desire therapeutic intervention). * presence of hot flashes for greater than or equal to 1 month prior to study entry. * life expectancy greater than or equal to 6 months. * ecog performance status (ps) 0 or 1 (see appendix viii) exclusionary criteria/contraindications * any of the following current (less than or equal to 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but patient must have been on a constant dose for greater than or equal to 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a grocery store are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency) * history of allergic or other adverse reaction to flaxseed, wheat, nuts, lactose, and/or certain spices * current or planned use of other agents for treating hot flashes (except stable dose of vitamine e or antidepressants are allowed as long as they wre started \>30 days prior to study initiation and are to be continued through the study period). * diabetes (as flaxseed can lower blood glucose levels and might have additive effects when used with antidiabetic drugs). * diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture. * any of the following: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception * current use of anticoagulants including aspirin, clopidogrel (plavix), ticlopidine (ticlic), and coumadin (1 mg of dialy coumadin is allowed for central line patency). * diagnosis of/problems with von willebrand's disease or other bleeding disorders.