Kornimate/medical-research-clean huggingface dataset:
erector spinae plane block for acute back pain in the emergency department

Conditions: Low Back Pain

Summary: the goal of this clinical trial is to learn if an erector spinae plane block (espb; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. it will also learn if the espb reduces pain, disability, and return to work at 7 days. the main questions it aims to answer are: 1. does the espb reduce short-term pain in participants with low back pain? 2. does the espb reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain? researchers will compare espb to a placebo (an injection that does not involve a nerve block) to see if espb works to treat low back pain. participants will: receive either the espb or a placebo injection in the emergency department report their pain scores for up to 120 minutes report their pain, disability, and return to work at 7 days


Eligibility criteria:
inclusion criteria: * adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks. exclusion criteria: * do not speak english or spanish as a primary language * are incarcerated * have a known pregnancy * are allergic to amide-type local anesthetics * are unable to tolerate positioning for the procedure * have a critical illness precluding the ability to perform the procedure.

Keywords: erector spinae plane block emergency department low back pain regional anesthesia nerve block
drug use survey of respimat in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to investigate safety and effectiveness information on the use of tiotropium respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.


Eligibility criteria:
inclusion criteria: patients with copd who is expected to be treatable with long term. all patients must have a diagnosis of copd and register after the start of treatment of tiotropium respimat. exclusion criteria: there is no special restriction, because this pms is an observational investigation under conditions of normal clinical practice. spiriva respimat is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in package labelling.
airway basal stem cell therapy in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this clinical trial aims to evaluate the safety and efficacy of regend001, an autologous bronchial basal cell therapy, for the treatment of chronic obstructive pulmonary disease (copd). copd is a chronic respiratory condition characterized by persistent airflow limitation and impaired lung function, leading to significant morbidity and mortality worldwide. current treatments primarily focus on symptom management and have limited impact on disease progression or survival. this study proposes a novel approach using autologous bronchial basal cells, which have demonstrated the potential to repair damaged lung tissue and improve lung function in preclinical studies. the therapy involves the collection of bronchial basal cells via bronchial brushing, followed by their expansion and reintroduction into the patient's lungs via bronchoscopic infusion. the primary objective is to assess the improvement in lung diffusion capacity (dlco), with secondary endpoints including changes in lung ventilation function (fev1, fvc) and quality of life (cat score). the study will also monitor safety, including the incidence of adverse events. eligible participants are copd patients aged 40-80 with moderate to severe disease. the trial includes a screening phase, cell collection, transplantation, and follow-up assessments at 4 and 24 weeks post-treatment. this study represents a promising advancement in regenerative medicine for copd, offering a potential therapeutic option that addresses the underlying structural damage in the lungs.


Eligibility criteria:
inclusion criteria: 1. diagnosed with copd according to the 2021 global initiative for chronic obstructive lung disease (gold); 2. post-bronchodilator fev1/fvc \<70%; 3. dlco ≥20% and \<80% of predicted value. exclusion criteria: 1. pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant); 2. positive for syphilis (tp-ab), hiv, hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibodies; 3. current or past history of malignancy.
efficacy of xiidra in dry eye disease after collagen cross linking

Conditions: Corneal Disease

Summary: dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.

first group of patients were treated with 0.5 % xiidra twice daily and artificial tears for 6 months.second group treated with artificial tears for 6 months. the treatment starts after corneal collagen cross linking in both groups ,baseline and post-treatment full ophthalmic examination was done.

Eligibility criteria:
inclusion criteria: * corneal collagen cross linking exclusion criteria: * systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers

Keywords: dry eye cross linking xiidra
safety and pharmacology study of sapacitabine to treat advanced leukemias or myelodysplastic syndromes

Conditions: Leukemias; Myelodysplastic Syndromes

Summary: the goal of this safety/pharmacology study is to determine mtd of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.

the goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

Eligibility criteria:
inclusion criteria: * adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; eastern cooperative oncology group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities. exclusion criteria: * patients with known cns involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be hiv positive
aruba aloë formula f-bc-096 in the treatment of split thickness donor sites after wound closure

Conditions: Hydration of Scars

Summary: comparison between use of aruba aloë formula f-bc-096 and control.

patients with two equal donor sites will be selected for inclusion. after wound healing one donor site will be treated with aruba aloë formula f-bc-096 while a control product will be applied to the second site. if pressure garments are applied they must be equal for both donor sites. during follow-ups objective methods will be used to evaluate elasticity and colour of the scar.

Eligibility criteria:
inclusion criteria: * patients must have two similar donor sites, identical in depth and wound treatment. * healing time of both donor sites may differ by 3 days maximum. * flux values determined by laser doppler imaging before commencement of the therapy must be approximately similar. * if possible, the donor sites to be compared must have the same location. * patient compliance with therapy in relation to the protocol is necessary. in case of pediatric patiënts this depends on collaboration of the parents. * for the two donor sites to be compared, the entire after-treatment concerning pressure garments or eventual silicone sheets must be equal for both donor sites. * patients must be available for regular and necessary follow-up. * possibility to finish all measurements during follow-up visits. * written authorisation of the patient, family or parents is required. exclusion criteria: * donor sites are not similar (not identical in: depth, wound treatment, healing time and flux values) * children requiring sedation for ldi of donor sites * not following the complete treatment schedule or missing some evaluations during the follow-up period * patient has any condition(s) that seriously compromises the patient's ability to complete this study. * patient has participated in another study utilizing an investigational drug or device within the previous 30 days * patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study * patients wish to terminate the study * no informed consent before start of the trial

Keywords: scars hydratation after treatment
sars cov-2 in conjunctival secretion in covid-19 patients

Conditions: Sars-CoV2; Tear

Summary: observational study to evaluate the presence of sars cov-2 in tears collected in covid-19 patients in lombardia region, northern italy, and to correlate virus presence to concomitant systemic clinical conditions.

since february 2020, coronavirurus disease 2019 associated to a severe acute respiratory syndrome started in china and rapidly spread all over the world and in particular in northern italy. there are many reasons to justify this rapid diffusion in italian lombardia region as the high population density with more possibilities of interpersonal contact, high prevalence of respiratory pathologies, in particular in elderly people, due to pollution, high number of contacts with chinese population for travelling and business reasons, and at last the non-windy temperate climate conditions, that increases the persistence of virus in the environment. at now, more than eighty thousand citizens from lombardia region have been officially affected by the disease with a high death toll, also considering that actual numbers are certainly much underestimated. the aim of the present study was to evaluate the prevalence of sars cov-2 virus in tears collected from covid-19 patients by rtpcr analysis directed to target sites of viral rna, and to correlate virus presence to concomitant systemic clinical conditions

Eligibility criteria:
inclusion criteria: * hospitalized covid 19 patients exclusion criteria: * patients with respiratory support that interferes with tears sampling

Keywords: covid 19 eye tears
risk adapted therapy optimization for patients with relapsed or refractory aggressive non-hodgkin-lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this study investigates toxicity and efficacy of 2 x r-dhap followed by high dose chemotherapy r-tec and autologous stem cell transplantation in patients with relapsed or refractory aggressive non- hodgkins's lymphoma.

initial cytoreduction is performed with dhap- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (tec) an autologous peripheral blood stem cell transplantation(apbsct). in case of only partial remission a second identical high dose chemotherapy and apbsct follows. patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. for patients with cd 20 positive b-cell lymphoma the chemotherapy regiments dhap and tec are combined with rituximab.

Eligibility criteria:
inclusion criteria: * first relapse or primary refractory disease of aggressive non-hodgkin's lymphoma stage i-iv * pretreatment with systemic therapy * 18-65 years of age * performance status:ecog 0-2 * granulocyte count \>1.5/µm3, platelet count \>100/µm3 * creatinine -clearance ≥ 1 ml/sec * gpt/got ≤ 1.5 x normal (except tumour related) * bilirubine \< 22 µmol/l * no participation in another study 3 month before and during this study * informed consent exclusion criteria: * second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia * cns- involvement by lymphoma * respiratory partial- or global insufficiency * cardiac insufficiency (nyha-stage 3-4, ef \< 30 %) * severe neurological or psychiatric disease * pregnancy * hiv positivity ,active virus hepatitis, bacterial infection * no follow up procedures ensured
efficacy and safety of insulin detemir in type 2 diabetes inadequately controlled on oha therapy alone

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current oha treatment.


Eligibility criteria:
inclusion criteria: * duration of type 2 diabetes mellitus for at least one year * insulin naive patients * oha treatment for at least 12 weeks * hba1c between 7.5-10.0% * body mass index (bmi) below 30.0 kg/m2 exclusion criteria: * impaired renal function * impaired hepatic function * pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
enhancing the anabolic effect of perioperative nutrition with insulin while maintaining normoglycemia

Conditions: Colorectal Cancer

Summary: the purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class\<3 * age\>18 years * colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection * ability to give informed consent exclusion criteria: * bmi\>30 kg/meter squared * confirmed diagnosis of diabetes mellitus or a hba1c\>6.0% * significant cardiorespiratory, hepatic, renal and neurological disease * musculoskeletal or neuromuscular disease * ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids) * severe anemia (hemoglobin\<10 g/dl * pregnancy * history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters

Keywords: colorectal cancer protein recovery perioperative nutrition hyperinsulinemia normoglycemia hyperinsulinemic-normoglycemic clamp anabolism
endoscopic transfer of flexor hallucis longus tendon for chronic achilles tendon rupture

Conditions: Achilles Tendon Rupture

Summary: the transfer of flexor hallucis longus (fhl) in the management of chronic achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. the arthroscopic fhl transfer may reduce the risk for soft tissue problems. functional outcome parameters are investigated, wound/soft tissue complications registered.

the transfer of fhl in the management of chronic achilles tendon ruptures has demonstrated good functional outcome with american orthopaedic foot ane ankle society (aofas) hindfoot scores at 80-89. the extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. the endoscopic fhl transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. several functional outcome measures and scores are evaluated a year after surgery. prospective study for evaluation of the surgical procedure.

Eligibility criteria:
inclusion criteria: * chronic achilles tendon rupture exclusion criteria: * pregnancy * bmi\ 39.9 * insufficient norwegian language proficiency lack of communication skills local skin conditions at site for planned surgery
systematic screening for primary immunodeficiencies in patients hospitalized for severe infections in intensive care.

Conditions: Primary Immunodeficiency

Summary: currently about 90 cases of infection in children are reported every year in pediatric intensive care, a disease considered to be the main cause of hospitalization of children. 16% of invasive pneumococcal infections are linked to a genetic abnormality in immunity. herpetic encephalitis has become a model of genetic infectious disease, with new mutations identified in the tlr3 pathway. severe infections are no longer the result of chance and can be the way to reveal a primary immune deficiency. in this context, the investigators propose to evaluate the incidence of hereditary immune deficiency after a systematic immunological screening in children admitted for a severe infection in pediatric intensive care unit (icu).

severe infection requiring admission in intensive care unit (icu) are not so rare. a retrospective pilot study conducted at montpellier university hospital center (uhc) between 2013 and 2015 showed that 19.7% of the pediatric icu admissions were related to a severe infection. an isolated severe infectious episode could be related to a hereditary immune deficiency (hid), even though there are no history of recurrent clinical signs and biological stigmata. for example, gaschignard and colleagues considered that 16% of the invasive pneumococcal infections are related to a genetic defect of immunity (doi: 10.1093/cid/ciu274). growing evidence has shown that severe infectious diseases occurring in childhood are attributed to inborn errors of immunity (doi: 10.1073/pnas.1521651112). while the nosology of severe infections has strong links to inherited immune deficiency that are rare diseases affecting less than 1 birth / 5000, there are no prospective studies that assessed the incidence of primary immune deficiencies in children who presented a severe infection.

Eligibility criteria:
inclusion criteria: * subject aged 1 month to 16 years. * admission in pediatric icu for more than 24h. * documented severe infection (bacterial, viral, fungal). * child benefiting from a social security scheme. * collection of parental consent / legal representatives. exclusion criteria: * prematurity (gestational age \<37 weeks of gestation) up to 6 months of age. * undocumented severe infections. * children entered for isolated rsv bronchiolitis, with no other infectious related complications. * previous comorbidity explaining the infection and/or the stay in intensive care / continuous care: known primary or secondary immunodeficiency; burned; risk factors for status epilepticus (encephalopathy, known epilepsy, head trauma), pneumonia or asthma (swallowing disorders, tracheotomy, chronic pulmonary pathology, asthma), meningitis (cochlear implants, breccia, neuromeningeal material), deep infection (implanted material, recent surgery), cardiovascular decompensation. * any other chronic pathology favoring an infection * impossibility to obtain the consent of parents / legal representatives.

Keywords: severe infection pediatric
ventricular tachycardia (vt) ablation or escalated drug therapy

Conditions: Recurrent Ventricular Tachycardia

Summary: this study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. the purpose of this study is to evaluate the optimal management of patients presenting with recurrent vt and receiving icd therapy in spite of first-line antiarrhythmic drug therapy. the hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent vt.

this is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent icd therapy despite at least one antiarrhythmic drug. the primary endpoint will be a composite of appropriate icd shocks or death.

Eligibility criteria:
inclusion criteria: * prior myocardial infarction * an implantable defibrillator * one of the following vt events (within the past 3 months): * greater than or equal to 3 episodes of symptomatic vt treated with atp * greater than or equal to 1 appropriate icd shock * greater than or equal to 3 vt episodes within 24 hours * sustained vt below detection rate of the icd documented by ecg * "failed" first-line antiarrhythmic drug therapy as defined by one of: * appropriate icd therapy or sustained vt occurred while patient was taking amiodarone (stable dose \>/= 2 weeks) * appropriate icd therapy or sustained vt occurred on another antiarrhythmic drug (stable dose \>/= 2 weeks) exclusion criteria: * active ischemia (acute thrombus, dynamic st elevation on ecg) or another reversible cause of vt (eg. electrolyte abnormalities, drug induced arrhythmia) * are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy) * are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves) * renal failure (creatinine clearance \< 15 ml/min) * current nyha functional class iv heart failure or ccs functional class iv angina * recent st elevation myocardial infarction (\< 1 month) * recent coronary bypass surgery (\< 3 mon) or recent pci (\< 1 mon) * pregnant * prior ablation for ventricular tachycardia * a systemic illness likely to limit survival to \< 1 year * unable or unwilling to provide informed consent

Keywords: ventricular tachycardia catheter ablation icd therapy antiarrhythmic drug therapy ischemic heart disease
evaluation of emotional status and coronary flow characteristics by timi frame count method

Conditions: Coronary Artery Disease; Coronary Artery Ectasia; Slow-Flow Phenomenon; Endothelial Dysfunction; Anxiety; Depression

Summary: this study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. patients whom undergoing elective coronary angiography will fulfill the beck anxiety inventory, beck depression inventory, state-trait anxiety inventory, hospital anxiety and depression scale. state anxiety inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. the other scales will be performed after 1 hour the patients learned their results. coronary flow will be assessed by timi (thrombolysis in myocardial infarction) frame count method.


Eligibility criteria:
inclusion criteria: * patients whom planned elective coronary angiography and accept to be included in the study as a participant exclusion criteria: * \< 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases