Kornimate/medical-research-clean huggingface dataset:
study of intramuscular injections of abbv-950 to assess adverse events and change in disease activity in adult participants with upper limb spasticity

Conditions: Upper Limb Spasticity

Summary: spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. common causes of spasticity include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. this study will assess how safe and effective abbv-950 is in treating upper limb spasticity in adult post-stroke participants. adverse events and change in symptoms will be assessed. abbv-950 in an investigational drug being developed for treating spasticity. this study is conducted in 2 parts. in part 1, participants are assigned to receive different doses of abbv-950 or placebo. there is 1 in 4 chance that participants will be assigned to receive placebo. in part 2, participants will be randomly assigned to receive botox, abbv-950, or placebo. there is 1 in 5 chance for participants to receive placebo. approximately 297 adult post-stroke participants with upper limb spasticity will be enrolled at approximately 50 sites in the united states. in part 1, participants will receive intramuscular (im) injections of abbv-950 or placebo on day 1. in part 2, participants will receive im injections of botox, abbv-950, or placebo on day 1. all participants will be followed for 24 weeks. there may be higher treatment burden for participants in this trial compared to the standard of care. participants will attend regular clinic visits during the study. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of upper limb spasticity due to stroke, with most recent stroke occurring at least 12 weeks prior to the screening visit. * modified ashworth scale-bohannon (mas-b) score of \>= 3 in the wrist flexors, and a score of \>= 1+ in the finger flexors and mas-b score of \>= 2 elbow flexors at both screening and visit 2 (baseline). exclusion criteria: * additional strokes in the 12 weeks preceding the most recent stroke and in the opinion of the investigator, is not at significant risk of experiencing another stroke during the study period. * spasticity in the contralateral upper limb that requires treatment. * presence of fixed contractures in muscles of wrist, elbow, fingers. * botulinum toxin treatment of any serotype in the 20 weeks prior to day for upper limb spasticity and in the 12 weeks prior to day 1 for any indication other than upper limb spasticity. * previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months. * injection of corticosteroids or anesthetics in the study limb within 12 weeks. * casting of the upper limbs within 12 weeks. * diagnosis of myasthenia gravis, eaton-lambert syndrome, and/or amyotrophic lateral sclerosis.

Keywords: spasticity upper limb spasticity stroke abbv-950 botulinum toxin type a
single dose gw685698x magnesium stearate study in asthmatic patients.

Conditions: Asthma

Summary: this is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder gw685698x (800?g) containing magnesium stearate. magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of gw685698x (800?g) with and without magnesium stearate. there will be a wash-out period of at least 5 days between doses.


Eligibility criteria:
inclusion criteria: * clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit, * screening pre-bronchodilator fev1 \>or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in fev1 of \>or= 12.0% over the max of the three screening measures and an absolute change of \>or= 200 ml within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria), * bmi 19-31 kg/m2, * non-smoker, * refrains from use of prohibited medication within the specified timeframes exclusion criteria: * pregnant or nursing females * history of life threatening asthma * subjects who are unable to stop taking protocol defined prohibited medication

Keywords: asthmatic patients
unstable distal radius fractures with dorsal dislocation in patients aged 18-64 years. volar locking plate (vlp) vs closed reduction and percutaenous pinning (crpp).

Conditions: Distal Radius Fractures; Wrist Fracture; Colles' Fracture

Summary: 120 patients age 18-64 years with dorsally displaced distal radius fractures ao-type a2, a3 and c1 are recruited from oslo casualty medical centre (oslo skadelegevakt). patients are randomized to surgery with closed reduction and pins (crpp) or open reduction and volar locking plate (vlp). the hypotheses is that crpp will give equal function and satisfaction to vlp. patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. these follow-ups will be performed by hand therapist. scores are also recorded from patient-reported wrist and hand evaluation (prwhe), quick-dash (q-d) and euroqol questionnaire (eq-5d) questionnaires. the main efficacy measure in the study is prwhe scores after 12 months. there will be x-ray initially, postoperatively and after 12 months. sub-objectives in the study are analyses of cost-effectiveness (measured by eq 5d, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.


Eligibility criteria:
inclusion criteria: * distal radius fractures of ao- a2, a3 and c1 which should be operated on in accordance with norwegian guidelines * \>18 years and \<65 years * address in oslo municipality exclusion criteria: * multitrauma * previous fracture same wrist * multiple injuries on the same side * not competent to consent * dementia / nursing home patient * substance abuse * foreign / tourists * median nerve compression requiring emergency surgery * pathological fracture * open fracture * congenital malformations that make it difficult to interpret data * patient does not want surgical treatment * not operable due to comorbidity (asa 4, some asa 3 after assessment by anesthesiologist) * more than 10 days after injury
studying warmed lidocaine for increased analgesic effect during intravitreal injections

Conditions: Pain Intensity Assessment; Pain Management

Summary: investigating whether warmed lidocaine increases analgesic effect for intravitreal injections


Eligibility criteria:
inclusion criteria: * receiving intravitreal injection for any indication exclusion criteria: * previous participant in study

Keywords: warmed lidocaine intravitreal injections
cost-effectiveness analysis on remote monitoring for cieds in japan by using systematic review methodology

Conditions: Cardiovascular Diseases; Heart Failure

Summary: 2018 revision of health reimbursement in japan recognized non face-to-face diagnostics, such as online treatment, as the standard of care. there was a significantly additional cost for cardiovascular implantable electronic devices (cieds) management fee as well. the adaption of remote monitoring for cieds patients is recommended by the societies based on the clinical evidences. however, how qalys earned by cieds remote monitoring are justified in japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. the evaluation about the impact on the health economics about the installation of cieds remote monitoring has not been enough due to the lack of the researches around this field. therefore this research is designed to examine the impact of the installation of cieds remote monitoring from the health economics perspective by considering the health insurance system and the clinical process in japan, through systematic review methodology.

2018 revision of health reimbursement in japan recognized non face-to-face diagnostics, such as online treatment, as the standard of care. there was a significantly additional cost for cardiovascular implantable electronic devices (cieds) management fee as well. the adaption of remote monitoring for cieds patients is recommended by the societies based on the clinical evidences. however, how qalys earned by cieds remote monitoring are justified in japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. the evaluation about the impact on the health economics about the installation of cieds remote monitoring has not been enough due to the lack of the researches around this field. therefore this research is designed to examine the impact of the installation of cieds remote monitoring from the health economics perspective by considering the health insurance system and the clinical process in japan, through systematic review methodology.

Eligibility criteria:
inclusion criteria: * studies that involves cieds remote monitoring, such as implantable cardioverter defibrillator, cardiac resynchronization therapy, and pacemaker * follow-up periods more than or equal to 12 months * prospective studies * qalys available to make icer analysis possible * published after year of 1971 exclusion criteria: * studies that are not related with cieds * follow-up periods less than 12 months * not prospective studies * qalys unavailable * published before year or 1971

Keywords: remote monitoring
topotecan plus apatinib versus topotecan alone as second-line therapy in small-cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

small-cell lung cancer (sclc) is an aggressive tumor and most patients experienced relapse or progression after standard chemotherapy. topotecan is active as second-line therapy for sclc patients. however, even in sensitive patients, only 20% response rate and a median time to progression of 12 weeks are observed. new therapeutic options in sclc are needed. apatinib is a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2. it has been approved in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. the efficacy of apatinib in sclc is unknown. the purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

Eligibility criteria:
inclusion criteria: * limited or extensive-stage sclc who had failed to first-line therapy * ≥18 years old * eastern cooperative oncology group performance status ≤2 * at least one measurable lesion as defined by recist (version 1.1) * at least one measurable lung tumor lesion * wbc count ≥3,500/μl, neutrophils ≥1,500μl, platelets ≥100,000μl, hemoglobin ≥ 9.0 g/dl * ast, and alt ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases. exclusion criteria: * symptomatic cns metastases * concomitant or previous malignancies within the last 5 years * severe comorbidities; prior topotecan therapy * hypersensitivity or other contraindication to the study drugs.
comparative study of circular stapling instruments

Conditions: Anastomotic Leak; Rectal Cancer

Summary: after removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. this anastomosis is most commonly created by the use of surgical circular stapling instruments. in a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in sweden as compared to the other brand in use. in the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.


Eligibility criteria:
inclusion criteria: * age over 18 * anterior resection for rectal cancer * informed consent exclusion criteria: * can not give informed consent * patient can not be followed

Keywords: circular stapling devices anastomotic leak anastomotic dehiscence rectal cancer
comparing of different biomarkers from vena rectalis superior and vena cubiti in patients undergoing low anterior resection for rectum cancer

Conditions: Rectal Cancer

Summary: the primary aim of the present study is to investigate different biomarkers like vegf, evgf and others ability to predict time to recidive and progressions free survival.

patients undergoing lar for rectum cancer is subjected. preoperative blood samples from vena rectalis superior and vena cubiti is collected, as well as biopsies from tumor. preoperative and after 3 month peripheral blood samples is collected. a total of 50 patients will be included in this study. the study is approved by the local scientific ethical committee no. s-20100006

Eligibility criteria:
inclusion criteria: * histological verified cancer * the cancer must be located in rectum maximum of 15 cm. * age above 18 exclusion criteria: * disseminated cancer * perioperative radio-chemotherapy * laparoscopy surgery
study comparing 0.5mg of ranibizumab and higher doses in the treatment of clinically significant diabetic macular edema

Conditions: Clinically Significant Diabetic Macular Edema

Summary: the purpose of this study is to evaluate the safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema (csdme). it will also compare treatment outcomes for patients receiving 0.5mg ranibizumab and higher doses of 1.0mg and 2.0mg ranibizumab.


Eligibility criteria:
inclusion criteria: * type i or type ii diabetic subjects * vision between 20/20 and 20/400 * presence of clinically significant diabetic macular edema exclusion criteria: * presence of any condition that would prevent clear visualization of the back of the eye * uncontrolled glaucoma * complications of glaucoma * inflammation inside the eye * certain prior eye surgeries, other than cataract surgery * other eye diseases that may compromise the vision in the study eye * certain prior eye treatments * pregnancy * uncontrolled health conditions * history of heart attack * history of stroke * current participation in another investigational trial
duloxetine versus placebo in the prevention of relapse of major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.


Eligibility criteria:
inclusion criteria: * signed the informed consent * meet criteria for major depressive disorder without psychotic features. * have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. * have had at least one other major depressive episode prior to the one being experienced at study entry. * you are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. exclusion criteria: * you have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. * any women who are pregnant or breast feeding. * if you have any serious medical illnesses other than major depressive disorder. * if you have previously participated in a clinical trial for duloxetine. * any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Keywords: major depressive disorder diagnostic and statistical manual of mental disorders fourth edition-defined major depressive disorder without psychotic features
interest of a tongue strength measurement in the screening for sarcopenia in hospitalized elderly patients

Conditions: Sarcopenia

Summary: sarcopenia is a syndrome characterized by a progressive and generalized loss of skeletal muscle mass, strength and function that increases the risk of physical dependence, impaired quality of life and mortality. this is a major public health problem. indeed, its prevalence has been estimated at 63.8% for elderly patients hospitalized in acute geriatric unit. several methods of sarcopenia screening exist at present. the european working group on sarcopenia in older people (ewgsop) proposes to carry out three examinations for the diagnosis of sarcopenia: the dual-energy x-ray absorptiometry (dexa) test and two motor tests (walking speed and hand test). these measurements have already been evaluated and validated. they are reliable, inexpensive and easily achievable in clinical routine. recent studies have shown that decreased muscle mass and / or strength could be associated with dysphagia. indeed, many muscles of the head and neck are simultaneously solicited for swallowing coordination. this suggests that a reduction in the mass or strength of these muscles could impact the swallowing function. the investigator's hypothesize that loss of lingual muscle strength may be associated with sarcopenia. the study will measure the tongue strength using the iowa oral performance instrument (iopi) in a geriatric population with or without sarcopenia. * determine the incidence of lingual hypotonia in hospitalized elderly sarcopenia patients. * to compare the sensitivity, the specificity of the measurement of the force of the tongue with the usual measures proposed by the ewgsop in the context of screening for sarcopenia.


Eligibility criteria:
inclusion criteria: patients hospitalized in an acute geriatric unit within the chu brugmann. exclusion criteria: none

Keywords: sarcopenia tongue strength
stress reduction and anxiety: effects on the function and structure of the brain

Conditions: Generalized Anxiety Disorder

Summary: the aim of the study is to test whether generalized anxiety disorder (gad) patients that participate in a stress reduction intervention show a brain activation pattern (assessed by mri) indicative of improved emotion regulation compared to an active control intervention.


Eligibility criteria:
inclusion criteria: * participation in the study 'stress reduction techniques and anxiety: therapeutic and neuroendocrine effects" by dr. elizabeth hoge exclusion criteria: * metallic implants * left handed * epileptic seizures * head trauma * weight over 350 pounds * claustrophobia
sentinel lymph node mapping and analysis in colon cancer using indocyanine green dye

Conditions: Colon Cancer

Summary: approximately 20-30 % of colon cancer patients who have no metastasis in lymph nodes after definitive colectomy have recurrence with distant metastasis. these recurrences could be due to missed occult tumor cells or micrometastasis. detailed examination of all lymph nodes is expensive and time consuming. sentinel lymph node mapping using indocyanine green dye helps in identifying the lymph nodes which are most likely to harbour metastasis. these sentinel lymph nodes can be subsequently subjected to detailed pathologic examination and immunohistochemistry which increases the likelihood of identifying micrometastasis and occult tumor cells. patients found to harbour such metastasis can be treated with additional chemotherapy after surgery. the aim of the study is to examine the feasibility of sentinel lymph node mapping using indocyanine green dye in colon cancer and evaluate the upstaging rate in post-operative colon cancer patients who don't have metastatic lymph nodes on routine histopathology.

all patients of colon cancer fulfilling the inclusion criteria and excluding the patients according to the exclusion criteria will undergo standard laparoscopic/open colectomy. indocyanine green dye is injected around the tumor in subserosal location for open surgeries and submucosally after on-table colonoscopy for laparoscopic surgeries and followed with near-infrared scope. patients will undergo intra-operative on-table colonoscopy after induction of anesthesia. all sentinel nodes will be marked with clips/sutures for identification by the pathologist post-operatively. any aberrant lymph nodes identified outside the planned resection margins will be excised, marked with the position of excision and sent separately from the gross specimen. after this the surgeon will proceed with the surgery including vascular ligation and resection of mesocolon. after surgery, all the lymph nodes identified in the specimen including the tagged sentinel lymph nodes will be examined using standard hematoxylin and eosin staining. if all the lymph nodes are negative for metastasis, the sentinel lymph nodes will undergo additional stepwise sections and immunohistochemistry for pancytokeratin.

Eligibility criteria:
inclusion criteria: age 18 years or older biopsy proven colon cancer scheduled for laparoscopic/open colectomy exclusion criteria: prior colorectal surgery gross lymph node invasion on pre-operative imaging or intraoperative staging advanced disease (t4 disease or metastasis) on preoperative imaging or intraoperative staging allergy to iodide containing compounds, human albumin or indocyanine green dye history of hyperthyroidism or thyroid adenoma palliative surgery advanced hepatic failure advanced renal failure

Keywords: sentinel lymph node indocyanine green
investigating the effects of lipid-therapy intensification with alirocumab on endothelial function, carotid arteries, lipoprotein particle subfractions, inflammation and post-prandial lipemia

Conditions: Atherosclerosis; Hypercholesterolemia; Post Prandial Lipemia; Cardiovascular Diseases

Summary: a prospective, open-label, pilot study with 24 cardiovascular high risk patients (n=24) having insufficient low density lipoprotein cholesterin (ldl-c) reduction despite standard of care lipid-modifying therapies (lmts), to evaluate the effects of potent lipid-therapy intensification via the recently approved monoclonal, human anti-pcsk9 antibody alirocumab on endothelial function, inflammation, lipoprotein particle subfractions, carotid arteries and post-prandial lipemia in clinical routine at the medical university of graz.


Eligibility criteria:
inclusion criteria: 1. patient scheduled for treatment with alirocumab in clinical routine (after approval of cost coverage by insurance company) 2. no previous treatment with pcsk9 antibodies 3. signed informed consent form exclusion criteria: 1. age of \< 18 years 2. pregnancy (pregnancy test at screening visit) 3. breast-feeding 4. impossibility to perform magnetic resonance imaging of the carotid artery (claustrophobia, carotid stent)