Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of nva237 in patients with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is a post-authorization commitment to the european medicines agency (ema). the study serves to determine whether the treatment of patients with stable, symptomatic chronic obstructive pulmonary disease (copd) with the investigational drug nva237 is efficient and safe. the efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed * male and female adults aged ≥40 years * patients with stable copd according to the current gold strategy (gold 2014) * current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening * mmrc grade of at least 2 at visit 101 * patients with airflow limitation indicated by a post-bronchodilator fev1 ≥ 30 % and \< 80 % of the predicted normal, and a post-bronchodilator fev1/fvc \< 0.70 at visit 101. exclusion criteria: * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment * patients with type i or uncontrolled type ii diabetes; patients with a history of long qt syndrome or whose qtc measured at run-in (fridericia method) is prolonged (\>450 ms for males and \>460 for females) and confirmed by a central assessor * patients requiring long term oxygen therapy prescribed for \>12 h per day; patients with any history of asthma.

Keywords: anticholinergic antimuscarinic chronic obstructive airway disease chronic obstructive lung disease chronic obstructive pulmonary disease copd lama lung disease lung diseases, obstructive lung function muscarinic receptor antagonist pulmonary disease, chronic obstructive respiratory tract diseases
multidisciplinary perioperative care pathway in adolescents undergoing posterior spinal fusion surgery

Conditions: Analgesia; Scoliosis Idiopathic; Surgery; Postoperative Pain

Summary: posterior spinal fusion (psf) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. in addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. the consequences of untreated acute pain are known and can also contribute to chronification in pain.

surgical correction of adolescent idiopathic scoliosis (ais) is indicated for severe deformity. posterior spinal fusion (psf) for ais is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by a large surgical incision, extensive tissue trauma, risk of blood loss, longer operating times and severe postoperative pain. in addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. all of this can, along with under-treatment of postoperative pain, be an important delaying factor in postoperative recovery and rehabilitation with a late hospital discharge and increased patient dissatisfaction. various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. the consequences of untreated pain are known and can also contribute to chronification in pain. the incidence of chronic post-surgical pain after scoliosis fusion is 22% at 6 months and 11-15% at 1 to 5 years postoperatively. it is therefore important to minimize the pain during the first postoperative days. untreated pain in patients is far from benign with significant negative short and long term consequences with accompanying reduction in rehabilitation duration, sleep quality of life. to date, there is no scientific evidence that some analgesic policy is superior, making adequate and safe pain relief and associated anti-emetic therapy after psf a challenge makes for all healthcare providers involved.

Eligibility criteria:
inclusion criteria: * approved written informed consent by parent or legal representative * idiopathic adolescent scoliosis * planned for elective surgery: posterior spinal fusion exclusion criteria: * other types of scoliosis * chronic opioid usage (more than 3 months) * known unstable psychiatric medical condition

Keywords: enhanced recovery pathway analgesia tele-monitoring biopsychosocial evaluation
digital 3d breast tomosynthesis versus 2d in clinical evaluation of high risk women

Conditions: Breast Cancer

Summary: patients with a higher breast cancer risk (higher than 17% according to the ibis calculation) will receive a 2d digital mammography together with a 3d tomosynthesis (so called combo tomo) of both breasts in two views in order to investigate the additional value of tomosynthesis in the diagnosis of breast cancer.


Eligibility criteria:
inclusion criteria: * women * more than 17% risk for breast cancer (ibis calculation) * \> 40y old exclusion criteria: * \< 40y old

Keywords: digital breast tomosynthesis
effect of photobiostimulation versus pulsed electromagnetic field on quality of life in adults with chronic rhinosinusitis

Conditions: Photobiostimulation; Pulsed Electromagnetic Filed; Low Level Laser Therapy; Chronic Rhinosinusitis (Diagnosis); Quality of Life

Summary: this study was done to find out the effect of photobiostimulation and pulsed electromagnetic field in patients with chronic rhinosinusitis on: * quality of life. * pulmonary function. * mean platelet volume. * headache . * total nasal symptoms.

chronic rhinosinusitis is a severe disease that significantly impacts a patient's quality of life, leading to significant economic impacts on healthcare resources and absenteeism. symptoms interfere with daily activities and can lead to medication resistance. treatment options like steroids, oral antibiotics, and sinus surgery are less effective, and disease recurrence remains high even after surgery. alternative therapies like low-level laser therapy and pulsed electromagnetic filed have shown promise in improving symptoms and potentially making low-level laser therapy a non-invasive treatment for chronic rhinosinusitis

Eligibility criteria:
inclusion criteria: 1. participants suffering from mild to moderate symptoms (baseline total nasal symptoms score ≤ 9). 2. subjects age range from 20 to 40 years old. 3. patients of both sexes. 4. proven positive allergy test (skin prick test or multiple allergen simultaneous test) to any of the common perennial allergens such as dust mites, molds, insects, and animal dander within the last 12 months exclusion criteria: * pregnant or breastfeeding women. * patients with a definite deviated nasal septum, or history of operation within the last 6 months. * hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, active respiratory disease like asthma, or other systemic diseases. * long-term use of corticosteroids or immunosuppressive agents. * participation in another clinical study within 30 days. * hyperthyroidism * patients who had used antihistamines within 1 week, topical corticosteroids within 2 weeks, systemic corticosteroids within 4 weeks, anticholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, nonsteroidal analgesics within 2 weeks, and other drugs that the researchers believed were inappropriate. * patients with tattoos, moles and dark skin
multi-modality imaging for head & neck cancer free flap design assessment

Conditions: Head and Neck Neoplasms

Summary: surgical reconstruction of anatomical structures after head and neck cancer resection has made enormous strides in the past 20 years with advancing flap techniques and the usage of perforating vessels, but accurate and consistent identification of these perforators has remained a challenge due to the varying anatomy of vasculature in the donor region. computed tomography angiography (cta) has been used increasingly in preoperative free flap perforator mapping for breast reconstruction but has been limited in head and neck applications. in addition, indocyanine green (icg) assisted nir fluorescence angiography has been developed for intra-operative flap assessment. in this study, the investigators propose to assess a previously undocumented, multi-modal imaging technique with preoperative dual energy cta to design and intraoperative icg assisted nir angiography to assess free flap in head and neck reconstruction.

cta and nir-assisted icg angiography will be used in the mapping of the free flaps. cta provides surgeons with preoperative information on the vascular anatomy and facilitates surgical planning for flap harvesting. the advantages of cta are that it is noninvasive, rapid, and easy to read by the surgeon. moreover, it provides information to help the surgeon decide which site to explore in the operation and reduces the rate of injuring or missing an optimal perforator. this technique can help reduce the size of the incision needed for perforator exploration, which helps reduce the patient's postoperative discomfort. the operation time can be reduced by choosing suitable perforators in the preoperative stage, which can also help reduce the cost of hospitalization. nir-assisted angiography gives live localization of the flap's dominant perforator perfusion zones while quantifying the relative tissue perfusion for immediate skin paddle design.

Eligibility criteria:
inclusion criteria: * the study will include patients planned for free anterolateral thigh/fibula or scapula flap for head\&neck cancer reconstruction. * the patients should have a complete and detailed medical record. * subjects must be at least 18 years of age. * subjects must sign and be given a copy of the written informed consent form. exclusion criteria: * patients who are not able to consent by themselves or grasp the implication of the study. * subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation. * pregnant or potentially pregnant woman * lactation. * iodine, shellfish, cough mixture, betadine or icg allergy * the exclusion criteria for the iv contrast detailed in appendix 2.
clinical evaluation of the miradry system in subjects with hyperhidrosis

Conditions: Axillary Hyperhidrosis

Summary: the purpose of this study is to determine whether treatment by the miradry system can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).


Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older at the time of consent. * subject reports a quality-of-life rating of 3 or 4 on the hyperhidrosis disease severity scale. * subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla. * subject has primary focal axillary hyperhidrosis evidenced by at least two of the following: * bilateral and relatively symmetric * impairs daily activities * frequency of at least one episode per week * age of onset less than 25 years old * positive family history * cessation of focal sweating during sleep. * in the opinion of the physician, treatment with the miradry system is technically feasible and clinically indicated. * subject has provided written informed consent using a form that has been approved by the reviewing irb/ethics committee. * subject is willing and able to comply with protocol requirements and all study visits. * female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study. exclusion criteria: * subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy. * subject has hyperhidrosis on the trunk or chest. * subject has evidence of active infection. * prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis. * axillary injection of botulinum toxin within one year preceding the miradry treatment. * oral anticholinergic medication use (e.g., robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase. * subject is a prisoner or under incarceration. * currently participating in or recently participated in another clinical trial (within the last 30 days). * history of or current neurologic deficit in the treatment limb. * known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine). * history of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years. * injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for dts treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy). * subject has a pacemaker, defibrillator or other electronic implant * subject requires supplemental oxygen.

Keywords: hyperhidrosis
special drug use observational study with beovu kit for intravitreal injection

Conditions: Diabetic Macular Edema

Summary: this was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the good post-marketing study practice (gpsp) ordinance.

this study aimed to evaluate the safety of beovu kit for intravitreal injection in clinical use in diabetic macular edema (dme) patients. the observation period was 1 year (52 weeks) from the first beovu administration in the primary treated eye. in patients discontinuing treatment with beovu in the primary treated eye before week 52, the following observation periods applied. * date of last beovu dose + 90 days\* in primary treated eye \> week 52: up to week 52 * date of last beovu dose + 90 days\* in primary treated eye ≤ week 52: up to last dosing date in the primary treated eye + 90 days \*90 days: to collect as much data as possible considering clinical effects

Eligibility criteria:
inclusion criteria: 1. patients must provide written consent to cooperate in this study before the start of treatment with beovu 2. patients using beovu for the first time for the following indication • indication: diabetic macular edema exclusion criteria: 1. patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as beovu

Keywords: diabetic macular edema dme nis japan pms beovu
predicting responsiveness in oncology patients based on host response evaluation during anti cancer treatments, using multiomics

Conditions: Non Small Cell Lung Cancer; Healthy

Summary: the goal of this exploratory study is understand the mechanisms of response to immunotherapy in non-small cell lung cancer patients. the investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment. patients will provide biological samples before and during their treatment, and clinical data will be collected.

the goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of nsclc patients, and their: * response to treatment * clinical benefit parameters such as pfs and os. * adverse events to immune check inhibitor therapy * biological mechanisms involved in response or resistance to immune check inhibitor therapy. patients will provide plasma, pbmcs, stool and tissue samples (where applicable) before and during treatment. clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded. samples will be analysed as follows - * proteomic features (plasma proteomics) * epigenetic patterns (cell free dna) * ctdna mutation analysis * pbmc subpopulations * microbiome profiling (stool)

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures. * male or female aged at least 18 years. * ecog ps - 0/1-2. exclusion criteria: * any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment. * generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
evaluation of kidney disease in liver transplant recipients

Conditions: Kidney Disease; Liver Transplantation

Summary: a non-invasive urinary test that detects kidney injuries in liver transplant (lt) candidates would be useful for monitoring of kidney damage. particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in lt candidates would be of importance to determine the need for dual kidney-liver transplantation (klt) versus lt alone. we will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.


Eligibility criteria:
inclusion criteria: * subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes. exclusion criteria: * contraindication to kidney biopsy * inability to give informed consent
hematoma block for distal radius fracture

Conditions: Distal Radius Fracture

Summary: the purpose of this study is to determine the efficacy of ultrasound guided hematoma block versus traditional "blind" hematoma block for analgesia in distal radius fracture reduction.

hematoma blocks are safe and effective in providing analgesia for fracture reduction1-4. they involve injecting lidocaine directly into the fracture line for analgesia. the physician aspirates blood prior to injection to confirm placement in the hematoma created by the fracture. however, the procedure can be technically difficult if the fracture line is difficult to palpate, for example, due to significant swelling or body habitus. ultrasound has been shown to improve efficacy in other analgesic procedures such as peripheral nerve blocks5 and also in identifying fracture lines6. there have been case reports and case series which have shown the feasibility and effectiveness of ultrasound guided hematoma blocks for analgesia in patients undergoing reduction for distal radius fractures7,8. to our knowledge there are no randomized controlled trials comparing the use of ultrasound guided hematoma blocks versus traditional hematoma blocks in achieving analgesia for distal radius fracture reduction. in this study, we will determine if ultrasound improves the efficacy of analgesia when performing hematoma blocks for reduction of distal radius fractures.

Eligibility criteria:
inclusion criteria: * adult patient ≥ 18 years old presenting to the emergency department with complaint of distal radius fracture exclusion criteria: * high acuity/distress per the attending ed physician * altered mental status or intoxication * aphasia, mental retardation, dementia, or insurmountable communication barrier * acute psychiatric illness

Keywords: hematoma block distal radius fracture reduction ultrasound ultrasound guided hematoma block traditional hematoma block for analgesia bupivacaine pain reduction wrist fracture
solaris endoprosthesis in iliac occlusive disease

Conditions: Peripheral Arterial Disease

Summary: fifty patients will be treated with solaris endoprosthesis and followed up to 2 years with walking impairment questionnaire and doppler ultrasound evaluation in 30 days, 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * rutherford class 2 to 5; * tasc ii class a, b, c or d; * unilateral or bilateral lesion, de novo or restenotic but not in-stent; * target lesion of 3 to 10 cm length; * ≥ 50% stenosis or common iliac or external iliac artery; * reference vessel diameter ≥ 5 and ≤ 9 mm; * deep femoral artery patent and at least one infrapopliteal artery patent; * informed consent provided. exclusion criteria: * thrombocytopenia induced by heparina or tpa intravenous, clopidogrel, ticlopidine or aspirin sensitivity; * target lesion near to aneurysm, highly calcified or excessively tortuous; * previous stent on target vessel; * presence of other lesions that need treatment within 30 days; * rutherford class 6; * acute thrombotic occlusion; * history on amputation on the target limb.
preventative study against urate-lowering drug-induced gout exacerbations 1

Conditions: Intercritical Gout

Summary: the purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. subjects will participate in this study for approximately 22 weeks. rilonacept is being studied for use in preventing allopurinol-induced gout flares.


Eligibility criteria:
inclusion criteria: * male or female 18 to 80 years of age; * previously met the preliminary criteria of the american rheumatism association (ara) for the classification; of the acute arthritis of primary gout; * at least 2 gout flares in the year prior to the screening visit; * serum uric acid greater than or equal to 7.5 mg/dl at the screening visit; exclusion criteria: * acute gout flare within 2 weeks of the screening visit or during screening; * persistent chronic or active infections; * history of an allergic reaction to allopurinol; * history or presence of cancer within 5 years of the screening visit; * previous exposure to rilonacept; * use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.

Keywords: metabolism, inborn errors allopurinol metabolic diseases genetic diseases, inborn musculoskeletal diseases joint diseases arthritis rheumatic diseases metabolic disorder purine-pyrimidine metabolism, inborn errors gout
nadph oxidase polymorphisms in obstructive sleep apnea syndrome (osas)

Conditions: Sleep Apnea Syndrome; Oxidative Stress; Single Nucleotide Polymorphism

Summary: obstructive sleep apnea (osa) is associated with increased oxidative stress. the major sources of reactive oxygen species (ros) in the vasculature are the nadph oxidases. several polymorphisms related to nadph oxidase expression or nadph oxidase activity has been identified. the investigators are going to compare the distribution of the allelic frequencies of a-930g and c242t polymorphisms and their possible relationship with the levels of 8-isoprostanes as a marker of oxidative stress in patients with osa and in a control group without osa.

design: case-control study methods: we are going to determine the a-930g and c242t p22phox genotypes in patients with osa and healthy subjects recruited from sleep unit of son dureta university hospital, (palma de mallorca, spain). 8-isoprostane is going to be measured as an oxidative stress marker with an 8-isoprostane eia kit (cayman chemicals company, usa) in plasma samples.

Eligibility criteria:
inclusion criteria:polyysomnografic study with apnoea/hypoapnoea index higher to 10 in patients and lower in controls. exclusion criteria: * chronic obstructive pulmonary disease, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure and/or psychiatric disorders.

Keywords: nadph oxidase