Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of vvz-149 injections in patients undergoing laparoscopic colectomy

Conditions: Pain, Postoperative; Acute Pain

Summary: the purpose of this phase 3 study is to evaluate the efficacy and safety of vvz-149 injections for the treatment of postoperative pain following laparoscopic colectomy.


Eligibility criteria:
inclusion criteria: * men and women who are at least 18 years of age * female subjects who are not pregnant or breastfeeding * subjects undergoing a planned first laparoscopic colectomy * subjects classified in american society of anesthesiologists (asa) risk class of i or ii * subjects who report the pain intensity ≥ 5 on the nrs measured after surgery * subjects who have the ability to understand study procedures and communicate clearly with the investigator and staff * subjects who provide written informed consent prior to participation in the study key exclusion criteria: * subjects undergoing emergency or unplanned surgery * subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure * subjects with pre-existing conditions causing preoperative pain at the site of surgery * female subjects who are pregnant or breastfeeding * diagnosis of chronic pain (e.g., persistent pain with the intensity of nrs ≥ 5 at baseline)
examining stress salivary biomarkers in pediatric patients undergoing dental procedures

Conditions: Dental Anxiety; Dental Fear; Stress; Pediatric Population

Summary: pediatric patients are susceptible to show signs of fear. one of the scenarios that have always been a source of fear is undergoing a dental procedure. fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene. fear stimulates multiple cerebral responses and can be often related to an increased stress level. stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. in contrast, salivary iga is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker. fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. however, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies. therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).


Eligibility criteria:
inclusion criteria: * children between the ages of 7 and 17 * ability to read and speak english language * patients seen for a first visit at the pediatric or orthodontic departments of the dental institute of the multispecialty clinic at midwestern university with a scheduled future appointment to start treatment in the pediatric or orthodontic department exclusion criteria: * older than 17 years of age or younger than 7 years of age * unable to read and speak english language * have any major health conditions or history of mental illness * being a returning patient in the pediatric or orthodontic department of the dental institute of the multispecialty clinic at midwestern university * taking any systemic medications that would cause a change in salivary flow (e.g., oxybutynin, protein pump inhibitors)

Keywords: dental anxiety pediatric patients salivary biomarkers salivary diagnostics dental fear stress salivary cortisol salivary alpha-amylase salivary iga
study of acetaminophen (acm) in post-operative dental pain

Conditions: Post Operative Dental Pain

Summary: this is a dental pain study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (ibu) 400 mg following third molar (wisdom tooth) extraction.

this is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. subjects will undergo dental extraction of three or four third molars.

Eligibility criteria:
inclusion criteria: 1. 17 years to 50 years old 2. weight 100 lbs or greater with a body mass index (bmi) 18-30 inclusive 3. dental extraction of three or four molars 4. experience moderate to severe pain after extraction of third molars 5. females of childbearing age must be willing to use acceptable method of birth control exclusion criteria: 1. currently pregnant or planning to be pregnant or nursing a baby 2. known allergy to acetaminophen (acm) or non-steroidal anti-inflammatory drugs (nsaids) 3. inability to swallow whole large tablets or capsules 4. have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
eye drops for early morning-associated corneal swelling of the cornea

Conditions: Fuchs' Endothelial Dystrophy

Summary: this study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with fuchs' endothelial corneal dystrophy (fecd). each participant will receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.

hyperosmolar eye drops are lubricating eye drops with 5% of sodium chloride. hyperosmolar eye drops are thought to temporarily deswell the cornea. during morning hours, patients with fuchs' endothelial corneal dystrophy (fecd) typically report poor vision and disturbing glare because of corneal edema. to improve vision in advanced stages of the disease, corneal endothelial transplantation has become the treatment of choice. many patients with fuchs' endothelial corneal dystrophy (fecd) use hyperosmolar eye drops before transplantation. at present, it is unclear, how much hyperosmolar eye drops help reducing corneal edema in fuchs' endothelial corneal dystrophy (fecd). based on our previous work that determined the amount of additional corneal edema in the morning in patients with fuchs' endothelial corneal dystrophy (fecd), the investigators will assess if hyperosmolar eye drops speed up the deswelling process.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced fuchs' endothelial corneal dystrophy (fecd) * indication for corneal endothelial transplantation (descemet membrane endothelial keratoplasty - dmek) * must be able to speak and understand german or english. exclusion criteria: * other corneal diseases (i.e. epithelial defects except for bullae caused by fuchs' endothelial corneal dystrophy (fecd), corneal scars, postoperative / bullous keratopathy, corneal degenerations / dystrophies, corneal inflammation / infection) * regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, constant use of antihistamines, use of contact lenses in past four weeks, anesthetic eye drops, corticosteroid eye drops, antibiotic eye drops in past four weeks, glaucoma drops, hyperosmolar eye drops within the past 24 hours) * systemic diseases that affect the cornea (e.g. connective tissue disease, complicated diabetes mellitus) * lack of fixation during corneal tomography

Keywords: corneal edema descemet membrane endothelial keratoplasty (dmek) hyperosmolar eye drops
a study to evaluate the efficacy and safety of otx-tic (travoprost) intracameral implant for patients with open-angle glaucoma (oag) or ocular hypertension (oht)

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: to assess efficacy, and safety of a single sustained release dose of the otx-tic drug product (2 travoprost dose strengths) in subjects with open angle glaucoma (oag) or ocular hypertension (oht)

this is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of otx-tic (travoprost) intracameral implant in subjects with open angle glaucoma (oag) or ocular hypertension (oht). approximately 105 subjects will be enrolled in this study at approximately 20 sites in the us. subjects will be a randomized to one of three treatment groups otx-tic drug product (2 travoprost dose strengths) compared to a single injection of durystatm. non study eyes will be treated with the pga, if not contraindicated.

Eligibility criteria:
inclusion criteria: * are 18 years of age or older at the time of screening * provide written informed consent and are able to comply with all study requirements * are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk * have a negative pregnancy test result for women of childbearing potential at baseline * have a documented diagnosis of oht, or oag in the study eye exclusion criteria: * have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes) * are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study * non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
effects of polyvinylpyrrolidone iodine on postoperative trismus and swelling during impacted third molar surgery

Conditions: Impacted Third Molar Tooth

Summary: the aim of the present study was to evaluate the effects of different concentrations of povidone iodine (pvp-i) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.


Eligibility criteria:
inclusion criteria: * totally impacted mandibular third molars of class c, 1, 2, and 3 according to the pell-gregory classification; * has no systemic disease exclusion criteria: * the use of medications that could interfere with the healing process; * smoking; * pregnancy or lactation; * presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth; * undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery; * history of hypersensitivity to iodine; * has any thyroid diseases.

Keywords: third molar surgery povidone iodine
self-management in patients with adrenal insufficiency.

Conditions: Adrenal Insufficiency

Summary: background: cortisol deficiency leads to a wide range of clinical consequences. substitution with glucocorticoids is necessary and demands knowledge and ability to self-management from the patient. methods: longitudinal questionnaire-based observational study including group education. research questions: to find out if education in group, enhances patients´ and relatives' knowledge about adequate dose adjustment of cortisone and increases the feeling of safety and qol in patients with adrenal insufficiency.


Eligibility criteria:
inclusion criteria: adrenal insufficiency or relative to a person with adrenal insufficiency exclusion criteria: -

Keywords: adrenal insufficiency self-management
clinical and radiological outcomes of medacta shoulder system fr

Conditions: Primary Osteoarthritis; Secondary Osteoarthritis; Rotator Cuff Tear Arthropathy; Rheumatoid Arthritis Shoulder; Avascular Necrosis; Fracture; Revision of Shoulder Arthroplasty

Summary: this is a post-marketing surveillance on medacta shoulder system


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patient with one of the following diagnosis: primary osteoarthritis secondary osteoarthritis cuff tear arthropathy; insufficient rotator cuff acute fracture (\<21d) rheumatoid or inflammatory arthritis avascular necrosis other posttraumatic condition revision of shoulder arthroplasty exclusion criteria: * patients with malignant diseases (at the time of surgery) * patients with proven or suspect infections (at the time of surgery) * patients with functional deficits other than dysfunction of the shoulder (at the time of surgery) * patients with known incompatibility or allergy to products materials (at the time of surgery)
study of efficacy and safety of ljm716 and cetuximab in head and neck squamous cell carcinoma patients

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: to establish whether ljm716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * most recent regimen contains both platinum and cetuximab (phase ii, group b). * ecog performance status (ps) ≤ 2. * recovery from all aes of previous anti-cancer therapies, to baseline or to ctcae grade ≤ 1, except for alopecia. * measurable disease as determined by recist v1.1. exclusion criteria: * previous anti-her3 antibody treatment. * symptomatic brain metastasis. * prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment. * prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations. * inadequate end organ function. * ongoing diarrhea ctcae grade ≥ 2. other protocol-defined inclusion/exclusion criteria may apply

Keywords: head and neck cancer
efficacy of oral ab1010 in adult patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to evaluate the activity of 2 oral doses of ab1010 in subjects suffering from active ra who have shown an inadequate response to one dmard including mtx or anti-tnf, after 3 months (12 weeks) of treatment. the safety and efficacy will be evaluated on: rate of patients achieving acr 20, 50, 70 and 90 das (disease activity score) after 3 months treatment acrn after 3 months treatment therapeutic maintenance of ab1010 at 3 months quality of life assessed by sf12 health assessment questionnaire (haq) clinical and biological safety pharmacokinetic profile of ab1010


Eligibility criteria:
inclusion criteria: 1. meet american college of rheumatology (acr) criteria for ra 2. have active ra 3. acr functional class i-iii 4. disease onset at \> 16 years of age 5. disease duration of at least 6 months 6. failure to one dmard including methotrexate and anti-tnf alpha exclusion criteria: 1. pregnant or breastfeeding women 2. inadequate bone marrow function 3. current use of a dmard within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out 4. any previous use of recombinant il1-ra 5. current use of more than 1 non steroidal anti-inflammatory drug (nsaid) or change of dose of the nsaid within 4 weeks of baseline or nsaid use greater than the maximum recommended dose 6. within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (\>20 mg prednisone or equivalent

Keywords: rheumatoid arthritis dmard failure acr
the effects of playing live music in music therapy/occupational therapy co-treatment on unilateral spatial neglect

Conditions: Unilateral Spatial Neglect (USN)

Summary: investigators hypothesize, based on anecdotal evidence to date, that active music making interventions conducted on a patient's neglected side will result in improved attention to that side and that this will be measurable within session.

an open, single group of ten patients selected will receive a 30 minute music therapy/occupational therapy co-treatment intervention. music interventions will be performed by a licensed, board-certified music therapist while a licensed occupational therapist will provide support, assistance, and measurements of behavioral attention/inattention. at the outset of the first session patients will be briefly, informally interviewed to ascertain their musical preferences, which will then be integrated into the music therapist's interventions whenever possible to maximize engagement and therapeutic rapport. live music will be provided on the patient's neglected side and patients will be encouraged to play music interactively with a focus towards that side whenever possible. an outcome measurement tool (star cancellation test) will be focused on measuring hemispheric neglect and administered at the beginning and end of each session to measure within session changes.

Eligibility criteria:
inclusion criteria: * patients experiencing unilateral left spatial neglect post brain injury (stroke, tbi, n-tbi). * patients able to follow two step commands and maintain attention to task for five minutes in a quiet environment. * the kf-nap, which is administered to all patients with suspected neglect on admission, will be used as a screening tool for the neglect syndrome. inclusion criteria will be participants with score of ≤ 5. * patients must be able to hold a pencil to complete the sct * patients must be able to discriminate between distractor items (words versus big and small stars) and see items in picture cards * patients communicate willingness to participate in music therapy interventions. * admission to acute inpatient rehabilitation unit at nyu/hjd. * patient will have the ability to provide informed consent. exclusion criteria: * visual impairment. * right side or dominant hand impairment. * any social or medical problem that precludes completion of the protocol. * patients who have sensory neglect or motor neglect , as the sct cannot be used with this population * severe language comprehension impairment

Keywords: music therapy sensorimotor cortex brain injury
conventional mri versus mr arthrography in evaluation of ankle impingement syndromes and intra articular pathologies.

Conditions: Ankle Impingement Syndrome

Summary: chronic ankle pain is a common clinical problem with a wide differential diagnosis. soft-tissue and osseous impingement syndromes are now increasingly recognized as a significant cause of chronic ankle pain. ankle impingement syndromes are defined as pathologic conditions resulting in chronic, painful restriction to movement at the tibiotalar articulation secondary to soft-tissue or osseous abnormalities. ankle impingement is classified according to its anatomic relationship to the tibiotalar joint as anterolateral, anterior, anteromedial, posteromedial, or posterior impingement.

the anterolateral impingement syndrome is caused by obstruction of the so-called anterolateral gutter (alg) or recess secondary to an inversion injury resulting in disruption of the syndesmotic and/or lateral collateral ligaments and capsule. in anterior impingement,arthroscopic evaluations suggest direct microtrauma to the talus and tibia as the aetiology. the natural course of this microtraumas to form osseous spurs. in anteromedial impingement,the mechanism is not well understood but is likely a rare complication of a supination (inversion) injury rather than a pronation (eversion) injury as initially hypothesized.during the acute injury, there is damage to the anterior tibiotalar ligament, which subsequently thickens. in addition toligament thickening, osteophytes, synovitis and fractures have been described as other possible causative factors. in posteromedial impingement, the common precipitating injury for posteromedial ankle impingement is a plantar flexion, inversion and internal rotation trauma. this can lead to damage to the pttl and associated synovitis. the majority of the posterior impingement syndromes are related to the posterior talus.the secondary ossification centre of the posterolateral talus forms around 8-13 years of age and then subsequently fuses within 1 year of that. occasionally (approximately 7%), there may be non-fusion with a resultant ostrigonum. conventional mr imaging can accurately detect and localize osteophytes and associated lesions. in addition, mr imaging provides an easy evaluation of any articular cartilage changes, ligamentous injury, and occult bony contusions. direct magnetic resonance (mr) arthrography extends the capabilities of conventional mr imaging and utilizes the natural advantages gained from joint effusion. contrast solution distends the joint capsule, outlines intra articular structures,and leaks into abnormalities.it can detect cartilage damage, intra articular loose bodies and osteochondral talar lesions.

Eligibility criteria:
inclusion criteria: * patients in different age groups and both sex referred from orthopedic outpatient clinic with chronic ankle pain and suspected clinically to have impingement syndrome. exclusion criteria: 1. inflammatory arthritis of ankle joint, infection in ankle joint, neoplasm around ankle joint. 2. patients with contraindications for mri, e.g. an implanted magnetic device, pacemakers or claustrophobia.
heals (healthy eating and lifestyle after stroke)

Conditions: Stroke

Summary: this lifestyle intervention plan will improve healthy lifestyle practices (diet, exercise, and smoking cessation) among stroke survivors and result in a reduction in measures of general and abdominal obesity.

study data collection will consist of a baseline and outcome study visit. each visit will consist of a survey and physical exam to collect height, weight and body measurements. outcome measures include: 1. physical activity: collected via survey using a version of the international physical activity questionnaire 2. diet: collected via survey using the brief dietary assessment tools for hispanics 3. body mass index (bmi): collected via physical exam following the alaska state department of health and social services bmi guidelines 4. abdominal obesity: collected via physical exam following the nih standard circumference methods.

Eligibility criteria:
inclusion criteria: * phase i: completed 12 month sustain trial (sustain criteria: age ≥ 40 years, acute tia or ischemic stroke within the prior one month and systolic blood pressure (sbp) \>120 mm hg). * phase ii: stroke or tia \> 3 months prior to screening date, age \> 20 years, blood pressure (sbp) \> 120 mm hg. exclusion criteria: * phase i and phase ii: same as sustain criteria: medical condition limiting participation in follow up assessments, severe cognitive impairment (mmse ≤24), and severe global disability (modified rankin ≥3).

Keywords: stroke, lifestyle habits