Kornimate/medical-research-clean huggingface dataset:
a pilot study of the mechanism of synergism between fp and salmeterol in preventing copd exacerbations

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the blood and airway of subjects with mild to moderate copd while undergoing standard treatment.

our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in: * preventing neutrophil adhesion to specific endothelial ligands, e.g. icam-1 and * undergoing activation as a consequence of this adhesion. we hypothesize that combination therapy with salmeterol + fluticasone (fp) will: * augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking giv-pla2 translocation to the nuclear membrane as for eosinophils; * augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease; * augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and * decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.

Eligibility criteria:
inclusion criteria: * males or females \> 50 years of age * physiologic evidence of copd defined per ats guidelines as: cigarette smoking history \>20 pack years, fev1/fvc \<70% * patients must have a post-bronchodilator fev1 \>50% of predicted value at enrollment * patient must have an o2 saturation measure by pulse oximetry \>90% on ra * must be able to participate in the study, willing to give informed consent, and comply with the study restrictions exclusion criteria: * women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy * observation of any solitary nodule in the lung requiring further medical intervention * patients on maintenance therapy with oral steroids * patients with giant bullous disease * significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests * presence of a coagulopathy as defined by a platelet count \ 1.2 x the upper limit of normal * concurrent enrollment or participation in any other clinical trials within the past 30 days * primary diagnosis of asthma * history of alpha 1 antitrypsin deficiency * any clinically significant and active pulmonary disease that could contribute to dyspnea * current systemic and inhaled steroids and theophylline

Keywords: copd chronic obstructive pulmonary disease inhaled corticosteroids airway inflammation bronchoscopy
a clinical study to assess next-day driving performance following administration of act-541468 in middle-aged and elderly subjects

Conditions: Healthy

Summary: a clinical study to assess next-day driving performance following evening administrations of act-541468 in middle-aged and elderly subjects


Eligibility criteria:
inclusion criteria general criteria: * signed informed consent prior to any study-mandated procedure. * male and female subjects aged between 50 and 80 years (inclusive) at screening. * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day 1 pre-dose of each treatment period. they must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner. * women of non-childbearing potential (i.e., postmenopausal, xy genotype, turner syndrome, uterine agenesis). study-specific criteria * subject has a valid driving license for more than 5 years, has driven at least 3000 km/year on average in the past 2 years. * normal visual acuity (corrected or uncorrected). exclusion criteria: general criteria: * pregnant or lactating women. * any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results. * history or presence of rhythm disorders * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. study-specific criteria: * current or previous diagnosis of insomnia-related disorder according to the diagnostic and statistical manual of mental disorders version 5 (dsm-5) criteria. * history of alcoholism, drug abuse, or regular use of sedative drugs or hypnotics within 3 years prior to screening. * history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). one unit is equivalent to a half-pint (approx. 250 ml) of beer or 1 measure (25 ml) of spirits or 1 glass (125 ml) of wine. * modified swiss narcolepsy scale total score \< 0 at screening or history of narcolepsy or cataplexy. * activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.
retroclavicular approach vs infraclavicular approach for brachial plexus block in obese patients

Conditions: Forearm Injuries; Hand Injuries

Summary: the retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. retroclavicular approach has already been proven effective and safe in the past. the general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. this study should represent the differences between the two techniques.

classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. the aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. a "u" shaped spread around the artery should ensure distribution around all three cords. ultrasound guidance is highly recommended and neurostimulation is optional. the retroclavicular approach is a variant to this classical technique. ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. the puncture site is just behind the clavicle at the most lateral point available. if initial entry point is optimal, needle direction is then parallel to ultrasound probe. the final aim and position of block needle is identical to classical approach. entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. this is turn optimizes safety, rapidity of technique, efficiency and efficacy. it is recognized that regional anesthesia is more difficult to perform in obese patients. anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. the complication rate of regional techniques is also reported to be higher in the obese patient population.

Eligibility criteria:
inclusion criteria: * 18-80 years * bmi\>30 * forearm- hand surgery exclusion criteria: * \<18 years * local infection * coagulopaty

Keywords: infraclavicular block retroclavicular block ultrasound
thrombectomy revascularization of intracranial vessel occlusion by originating from japan (tron1-japan)

Conditions: Acute Ischemic Stroke

Summary: to evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous administration of tissue plasminogen activator (t-pa) is not indicated or reperfusion cannot be achieved by intravenous t-pa administration.


Eligibility criteria:
inclusion criteria: 1. patients with neurological disorders caused by blood vessel occlusion associated with acute cerebral infarction 2. patients who can receive treatment within 8 hours after onset of symptoms of acute cerebral infarction 3. patients in whom intravenous administration of t-pa is not indicated or reperfusion cannot be achieved by intravenous t-pa administration 4. patients who have accessible occlusion of the middle cerebral artery (m1 or m2 to 3), basilar artery, vertebral artery, posterior cerebral artery (p1 or p2), anterior cerebral artery (a1 to 2), or intracranial internal carotid artery (pre-procedure tici score, 0 or 1) as determined by angiography 5. patients with an nihss score of 8 to 30 6. patients with an mrs score of 0 to 2 before onset 7. patients aged between 20 and 85 years (at the time of informed consent) 8. patients who are able to provide written consent (signature) or whose legally acceptable representative (a person with parental authority, spouse, guardian, and an individual legally responsible for his/her custody) can provide written consent (signature) exclusion criteria: 1. patients who manifest the following: * carotid artery dissection * vasculitis * an angulated vessel, making it difficult to guide an investigational device * significant (\>50%) stenosis, making it difficult to guide an investigational device * acute intracranial hemorrhage * mass lesion or intracranial tumor * widespread early ischemic changes revealed by ct or mri 2. patients who have two or more different major cerebrovascular occlusions requiring treatment 3. patients with an allergy to contrast agents or who cannot receive them or those who have a serious metal allergy 4. patients who received heparin within 48 hours and have partial thromboplastin time (ptt)/activated partial thromboplastin time (aptt) \> twice the upper limit of normal 5. patients with known bleeding tendencies or coagulation deficiency or who have received oral anticoagulants (such as warfarin), and who have (pt-) international normalized ratio (inr) \>3 6. patients with platelet count \<30,000 /mm3 7. patients with blood glucose levels \<50 mg/dl 8. patients with uncontrolled hypertension (systolic bp \>185 mmhg and diastolic bp \>110 mmhg) 9. patients with expected life expectancy \<90 days 10. female patients who are pregnant or breast feeding 11. patients who are participating in clinical trials of drugs or medical devices 12. patients disqualified from participation in the study by the investigator (sub-investigator) due to reasons other than the above
balloon assisted transarterial therapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: to prove the treatment concept of the use of balloon assistance in transarterial therapy for hcc.

transcatheter arterial chemoembolization (tace) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (hcc) not eligible for surgical resection, transplantation, or local ablative therapy. the use of balloon assisted tace has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.

Eligibility criteria:
inclusion criteria: 1. patients of age above 18 years 2. patients who are indicated for transarterial treatment for hcc 3. child-pugh a or b cirrhosis 4. eastern cooperative oncology group performance score 0 or 1 5. bclc a or b 6. no previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), 7. hcc diagnosed by typical enhancement patterns on cross sectional imaging or histology. 8. no extra-hepatic involvement on non-enhanced ct thorax and triphasic contrast enhanced ct abdomen. 9. no invasion of portal vein or hepatic vein 10. massive expansive tumor morphology with measurable lesion on ct (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) 11. total tumor mass \< 50% liver volume 12. size of any individual tumor \<= 7cm in largest dimension 13. serum creatinine \ 55 ml/min. exclusion criteria: 1. concurrent ischemic heart disease or heart failure 2. history of asthma, chronic obstructive airway disease or respiratory decompensation. 3. history of acute tumor rupture presenting with hemo-peritoneum 4. biliary obstruction not amenable to percutaneous or endoscopic drainage 5. child-pugh c cirrhosis 6. history of hepatic encephalopathy 7. intractable ascites not controllable by medical therapy 8. history of variceal bleeding within last 3 months 9. serum total bilirubin level \> 50 umol/l 10. serum albumin level \< 26 g/l 11. inr \> 1.3 12. infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) 13. arterio-portal venous shunt affecting \>1 hepatic segment on ct 14. arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on ct
extension study to assess the long-term safety of tegaserod in women with symptoms of dyspepsia

Conditions: Dyspepsia

Summary: this study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. tegaserod will be evaluated at 6 mg twice daily.


Eligibility criteria:
inclusion criteria: * female, 18 years and older * fulfilled eligibility criteria in chtf919 d2302 (double blind study) and successfully completed the double-blind study exclusion criteria: - early discontinuation from the double-blind study other protocol-defined inclusion/exclusion criteria may apply.

Keywords: dyspepsia, gastrointestinal, tegaserod
interventional study of bone and joint infections related gut dysbiosis

Conditions: Bone and Joint Infection

Summary: gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation. as part of its clinical development, maat (microbiota as a therapy) pharma is particularly interested in patients with bone and joint infections (bji). these patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea. maat pharma wishes to carry out a clinical study, osiris, in collaboration with prof. tristan ferry, member and coordinator of crioac (centre de référence des infections ostéo-articulaires complexes) lyon, center of reference of bone and joint infections (bji). the objective of this study is to follow patients with treated bji in order to characterize intestinal dysbiosis and the future relevance of an autologous fecal microbiota transplantation (afmt) intervention. to do this, patients will be monitored according to the current crioac recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution. thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.


Eligibility criteria:
inclusion criteria: * consenting subjects with bji (native or material related bji) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled * the subject is willing, able to understand and comply to the protocol requirement * more than 18-years-old * subject is suspected for implanted or native bji and is eligible for antibiotics treatment * subject signed inform consent form exclusion criteria: * pregnancy * severe disease with a life expectancy \< 3 months * antibiotherapy in the 14 days before inclusion in the study * patient non-affiliated to health care system * patient under the power of law * guardianship, curators patients
dry needling on myofascial trigger points in older adults with nonspecific shoulder pain

Conditions: Shoulder Pain

Summary: background: non-specific shoulder pain has a high prevalence in older adults and provokes functional alterations. besides, there are difficulties for its clinical diagnosis, lack of effectiveness in the treatment and not much evidence is found regarding invasive physical therapy techniques in this population. purpose: to determine the efficacy of a single physical therapy intervention with deep dry needling on latent and active myofascial trigger points in older adults with non-specific shoulder pain. methods: pilot study, single blind randomized controlled clinical trial on 60 subjects aged 65 and over, will be diagnosed with nonspecific shoulder pain. the study will be approved by the clinical research ethics committee of the area. sample will be recruited at their home and at a care center, and randomly will be distributed in experimental group (n=30), which will be received a session of deep dry needling on an active and a latent myofascial trigger points of the infraspinatus muscle; and control group (n=30), receiving a session of deep dry needling only on an active myofascial trigger point. a blind examiner will be evaluated pain intensity, pain pressure threshold (anterior deltoid; extensor carpi radialis brevis) and grip strength, before, immediately after intervention and after a week of treatment.


Eligibility criteria:
inclusion criteria: * people aged 65 or over with uni or bilateral non-specific shoulder pain and with at least one active and one latent mtrp in the infraspinatus homolateral to the painful shoulder exclusion criteria: * prior diagnosis of myopathy or neuropathy; cognitive deficit in the medical record; cervical spine, rotator cuff tendons or glenohumeral joint problems in the medical record; corticoid infiltration or local anaesthetic during the previous year or during follow-up; surgical procedure affecting the upper limb or preceding cervical; ingestion of antiaggregant, anti-coagulant, analgesic or anti-inflammatory medication or abusive substances in the week prior to treatment and during follow-up were excluded from the study

Keywords: myofascial pain syndromes trigger point shoulder pain aged
safety and efficacy of anti-sars-cov-2 equine antibody f(ab')2 fragments (inosars) for adult patients with mild covid-19

Conditions: COVID-19

Summary: this is a randomized, placebo-controlled, double-blind phase i clinical study of anti-sars-cov-2 equine immunoglobulin f(ab')2 fragments (inosars) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild covid-19 and low risk of disease progression.


Eligibility criteria:
key inclusion criteria * outpatient with a rt-qpcr confirmation of sars-cov-2 infection * body mass index (bmi) at screening of 18.0 - 34.9 kg/m\^2 * presence of at least one symptom consistent with covid-19 * mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met key exclusion criteria * presence of a risk factor for disease progression documented for covid-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, copd, asthma, active cancer, immunosuppression, hypercoagulable states, ckd currently under dialysis * documented allergy to equine serum proteins * previous hospitalization due to covid-19 * supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements * having received convalescent plasma or intravenous immunoglobulins for the treatment of covid-19 * previous vaccination or plans to get vaccinated for covid-19 * in the opinion of investigator, other health conditions that suppose an increased risk of progression of disease note: other inclusion/exclusion criteria apply

Keywords: covid-19 sars-cov-2 immunoglobulin fragments hyperimmune equine serum passive immunotherapy
subacromial methylprednisolone versus ketorolac for shoulder impingement

Conditions: Subacromial Impingement; Subacromial Impingement Syndrome

Summary: the investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.

because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. the investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ases (american shoulder and elbow surgeon) self-assessment score. the study will be performed at one institution, the university of texas medical branch.

Eligibility criteria:
inclusion criteria: * age \>18 years * severe or recalcitrant shoulder impingement syndrome * subacromial injection is a therapeutic option exclusion criteria: * allergy or intolerance to steroids within less than 1 month * allergy or intolerance to nsaids within less than 1 month * pregnancy * breastfeeding * pre-existing asthma * uncontrolled psychiatric illness * previous shoulder injection within the past 3 months * evidence of confounding shoulder pathology on imaging * history of a full-thickness rotator cuff tear * ipsilateral cervical radiculopathy * moderate to severe glenohumeral arthritis * systemic inflammatory conditions * kidney disease * liver disease * gastrointestinal ulcer * bleeding disorder * pending litigation or work-related claims related to the shoulder * previous shoulder surgery on the affected shoulder * evidence of local infection * evidence of adhesive capsulitis * evidence of shoulder instability

Keywords: ketorolac methylprednisolone subacromial impingement syndrome
study investigating patient-reported outcomes in lower-risk mds patients

Conditions: MDS; MDS/MPN

Summary: pro-red is a prospective, longitudinal, and multicenter observational study. enrolled patients will be followed for 6 months in at least monthly intervals in terms of their received red blood cell transfusions and routine myelodysplastic neoplasms (mds)-associated clinical parameters. in addition, the participating subjects will be provided with a digital/mobile application covering a smartphone app or paper-based questionnaires to answer a set of quality of life (qol) questions once a week. during routine visits in the clinical trials center performed by the treating physician (at least every month), patients will answer standardized questionnaires for the assessment of mds-related qol. also, included patients will take a photo of fingernails/eyelids with their smartphone camera with the aim to further analyze these pictures in a way to potentially deduct correlated hemoglobin (hb)-values. as a long term aim beyond the pro-red study, the data will serve as a training cohort for the development of an algorithm for image-based calculation of individual hb levels.


Eligibility criteria:
inclusion criteria: * written informed consent * confirmed diagnosis of lower-risk myelodysplastic neoplasms (mds; ipss-r very low, low, intermediate up to 3.5 points) or mds/mpn overlap including mds/mpn-rs-t, mds/mpnu, acml or non-proliferative chronic myelomonocytic leukemia (cmml) according to world health organization (who) criteria as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (cbc) * symptomatic transfusion dependent (td) anemia defined as having received ≥3 units of red blood cells (rbc) within the last 16 weeks prior to screening according to the international working group (iwg) criteria for mds (platzbecker et al. 2019) exclusion criteria: - suspected lack of compliance according to the investigator

Keywords: mds anemia transfusion dependence quality of life mds/mpn