Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of t1225 1.5% versus tobramycin 0.3 % in the treatment of purulent bacterial conjunctivitis

Conditions: Conjunctivitis, Bacterial

Summary: to demonstrate the efficacy of t1225 1.5% eye drops, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis, and to assess the safety

the aim of the present study was to compare the efficacy and safety of t1225 1.5% eye drops administered bid for 3 days in comparison to reference antibiotic eye drops, tobramycin, for the treatment of purulent bacterial conjunctivitis. the study was conducted as a phase iii, multicentre, international, investigator-masked, randomised, parallel-group, non-inferiority study in newborns, children, and adults.

Eligibility criteria:
inclusion criteria: * male or female \>= 1 day old (newborn, infant, child, adult); * written informed consent by patient or legally acceptable representative; * purulent bacterial conjunctivitis (unilateral or bilateral) defined as bulbar conjunctival injection (mild, moderate, or severe) and conjunctival purulent discharge (mild, moderate or severe). exclusion criteria: * bacterial conjunctivitis diagnosed \>= 7 days ago; * bacterial infection due to trauma or foreign body; * dacryocystitis; * corneal ulceration or keratitis; * viral ocular infection; closed angle glaucoma; * acute allergy conjunctivitis; * clinically significant ocular abnormality; * organic amblyopia, monophthalmia; * corrected visual acuity below 20/100; * contact lens wearer; * newborn (i.e. 0-2 months old) not born at term (\< 37 weeks of amenorrhea); * ocular surgery, laser in situ keratomileusis (lasik), laser epithelial keratomileusis (lasek), or photo-refractive keratectomy (prk) in last 12 months; * ocular laser treatment in last 3 months; * systemic macrolide antibiotics in last month; * systemic steroids in last 2 weeks or during the study; * topical ocular macrolide antibiotics and/or topical ocular steroids and/or non-steroidal anti-inflammatory drugs (nsaids) in last week; * topical (ocular, nasal, bronchial etc.) treatments and/or systemic nsaids in last day; * immunosuppressives and/or any systemic antibiotic on d0.
onsite buprenorphine treatment at syringe exchange programs

Conditions: Opiate Addiction

Summary: this trial will recruit syringe exchange participants with opioid use disorder in new york city and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.

in a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (oud) and hiv, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (o-bmt) or enhanced referral to buprenorphine treatment. over 2 weeks, participants in the o-bmt arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. in the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. opioid use disorder 3. interest in buprenorphine treatment 4. motivation for opioid use disorder treatment 5. willingness to accept community health center referral 6. syringe exchange participant exclusion criteria: 1. receiving opioid agonist treatment in the past 30 days (confirmed by new york prescription drug monitoring program); 2. inability to provide informed consent 3. unstable mental illness (e.g., suicidality, psychosis, etc.) 4. severe alcohol use disorder or benzodiazepine use disorder by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria 5. hypersensitivity to buprenorphine or naloxone. 6. pregnancy (confirmed via urine testing)

Keywords: opioid use disorder, syringe exchange, hiv risk reduction
eras protocol on the incidence of postoperative complications following intestinal surgery

Conditions: Postoperative Complications

Summary: enhanced recovery after surgery (eras) was first proposed by kehlet in copenhagen denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. the purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. the investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an eras program with traditional treatment program at a major teaching hospital in china.the investigators will apply eras plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. and data compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.

major colorectal surgery usually requires a hospital stay of more than 12 days. inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. this study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. this prospective study will be performed at a major hospital in china, involved 200 patients. all patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. the main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.

Eligibility criteria:
inclusion criteria: 1. elective laparotomy or laparoscopic intestinal surgery. 2. age ≥ 18 years old. 3. asa grade ii - iv. 4. general anesthesia. exclusion criteria: 1. patients with cognitive dysfunction and uncooperative subjects. 2. failure to obtain informed consent

Keywords: colorectal resection enhanced recovery after surgery postoperative complications length of hospital stay
s-frame ct immobilization masks for patients undergoing radiation therapy for head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. it is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). if these new thermoplastic masks such as medtec s-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment.


Eligibility criteria:
inclusion criteria: * histological confirmation of mucosal malignancy in the head and neck (h\&n) region * undergoing radiotherapy (rt) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a medtec s-frame mask
posterior capsule opafication of two different hydrophobic acrylic intraocular lenses

Conditions: Age Related Cataracts

Summary: on the day of surgery, the first eye to be operated is randomised to receive a vivinex , hoya surgical optics gmbh or an sn60wf, alcon, fort worth, texas. the second eye to be operated receives the other iol type. a complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for pco evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract for which phacoemulsification extraction and posterior iol implantation has planned * age 50 and older * visual potential in both eyes of 20/30 or better as determined by investigators estimation * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant exclusion criteria: * preceding intraocular surgery or ocular trauma * relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.) * laser treatment * uncontrolled systemic or ocular disease * infectious disease * pregnancy/nursing
evaluation of immunogenicity and safety of varivax® passage extension 34 (pe34) process in children (v210-a03)

Conditions: Varicella

Summary: this study will evaluate the immunogenicity, safety, and tolerability of varivax® (varicella virus vaccine live) manufactured with a new passage extension (pe34) process compared with the varivax® 2016 commercial process. the primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by varivax® pe34 process are non-inferior to those induced by varivax® 2016 commercial process, and that antibody response rate induced by varivax® pe34 process is acceptable.


Eligibility criteria:
inclusion criteria: * negative clinical history for varicella, herpes zoster, measles, mumps, and rubella exclusion criteria: * received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study * any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity * received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study * history of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of varivax® or m-m-r ii® * has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems * received salicylates within 14 days prior to study vaccination * exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination * received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination * history of seizure disorder, including febrile seizure * fever illness (\>=102.2 °f \[39.0 °c\] within 72 hours prior to study vaccination * history of thrombocytopenia * born to a human immunodeficiency virus (hiv)-infected mother * has a diagnosis of active untreated tuberculosis * participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
study of cs-3150 in patients with essential hypertension

Conditions: Essential Hypertension

Summary: to evaluate antihypertensive effect and safety of cs-3150 compared to eplerenone in patients with essential hypertension.

primary objective is to evaluate antihypertensive effect and safety of cs-3150 2.5 mg compared to eplerenone in patients with essential hypertension. secondary objective is to evaluate antihypertensive effect and safety of cs-3150 5.0 mg compared to 2.5 mg.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 years or older at informed consent * subjects with essential hypertension satisfying the following blood pressure criteria; * sitting sbp: ≥ 140 mmhg and \< 180 mmhg * sitting dbp: ≥ 90 mmhg and \< 110 mmhg * mean 24 hr bp: sbp ≥ 130 and dbp ≥ 80 mmhg exclusion criteria: * secondary hypertension or malignant hypertension * diabetic nephropathy or diabetes mellitus with albuminuria * serum potassium level \< 3.5 or ≥ 5.1 meq/l * reversed day-night life cycle including overnight workers * egfr \< 60 ml/min/1.73 m\^2

Keywords: essential hypertension mineralocorticoid receptor antagonist esaxerenone ambulatory blood pressure monitoring
high resolution micro oct imaging

Conditions: Cystic Fibrosis; COPD; PCD - Primary Ciliary Dyskinesia; Covid19; Sinusitis

Summary: the purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

lung disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (cf). a better understanding of the primary pathogenesis of cf is essential in order to reveal the features that may lead to the onset of progressive lung disease. discerning the nature of the cf defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µoct), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.

Eligibility criteria:
the inclusion criteria: * patients diagnosed with cf or healthy normal controls with no respiratory disease * patients must be over the age of 14 * patient must be able to give informed consent the exclusion criteria: * patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics) * patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares * any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room * female subjects who are pregnant
validation of endoscopic bimodal imager for the bladder cancer detection

Conditions: Bladder Cancer

Summary: this study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall. all participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the cypam2 project. the other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

an innovative medical device was developped by the cypam2 project's partners.this device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. the medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. the main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.

Eligibility criteria:
inclusion criteria: * age \>18 years * patient with suspicion of a bladder cancer or a suspected recurrence of a bladder cancer * cytological and bacteriological examination of urine culture negative * patient must be affiliated to a social security system * ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study exclusion criteria: * age \< 18 years * bladder infection in progress and untreated * hemorrhage * urethral stenosis * contraindication for a cystoscopy examination * contraindication to administration of hexvix (porphyria, hypersensitivity to hexylaminolévulinate or excipient of hexvix (disodium phosphate dihydrate, potassium dihydrogen phosphate) * pregnant or breast feeding females * patients deprived of liberty or under supervision

Keywords: bladder cancer hexvix bimodal endoscopic imager cystoscopy
efficacy and safety study of elagolix in women with endometriosis

Conditions: Endometriosis, Pain

Summary: the purpose of this study is to evaluate elagolix (nbi-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. following 8 weeks of dosing, participants continued in the study for an additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once daily. there was no pre-specified primary efficacy end point for this study as there is no single key efficacy outcome measure in this exploratory phase 2 study. however, the efficacy measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-diary.

Eligibility criteria:
inclusion criteria: * be female, aged 18 to 49 years, inclusive. * have moderate to severe pelvic pain due to endometriosis. * have a history of regular menstrual cycles. * have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening. * have a body mass index (bmi) of 18 to 36 kg/m², inclusive. * agree to use two forms of non-hormonal contraception during the study. exclusion criteria: * are currently receiving gonadotropin-releasing hormone (gnrh) agonist, a gnrh antagonist other than nbi-56418, or danazol or have received any of these agents within 6 months of the start of screening. * are currently receiving subcutaneous medroxyprogesterone acetate (dmpa-sc) or intramuscular medroxyprogesterone acetate (dmpa-im) or have received any of these agents within 3 months of the start of screening. * are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month. * have had surgery for endometriosis within the last month. * have had a hysterectomy or bilateral oophorectomy. * are using systemic steroids on a chronic or regular basis within 3 months. * have uterine fibroids ≥ 3 cm in diameter. * have pelvic pain that is not caused by endometriosis. * have unstable medical condition or chronic disease. * have been pregnant within the last six months. * currently breast feeding.

Keywords: pelvic pain,nbi-56418,endometriosis
virtual reality stimulation to enhance cognitive function of intensive care unit patients

Conditions: Cognitive Impairment, Mild; Quality of Life

Summary: an observational study will be conducted in the icu (intensive care unit) including patients with heart surgery (\ 5 days). patients will receive 5 min virtual reality stimulation per day. a modified version of the oculus rift vr glasses (facebook inc., usa) with stereoscopic vision and stereo sound will be used to present the virtual world to patients. an integrated eye tracker will measure oculomotor responses that will be synchronized with the physiological data recording. all participants will undergo neuropsychological testing after icu stay, and after a three-months follow-up. quality of life prior to the icu stay will be enquired from relatives. main outcome variable is the explorative behaviour (attention). secondary outcomes are the quality of life and cognitive functioning.


Eligibility criteria:
inclusion criteria: * age \> =18 * speak german or french * are able to participate the follow up measurements * written informed consent exclusion criteria: * visual impairments * cognitive impairments * cognitive impairments * craniocerebral injury before admitting the icu * already admitted the intensive care unit (last year) or at reentry * psychotic disorders
safety and immunogenicity of gsk's tdap vaccine (boostrix) in adults aged 19 to 64 years

Conditions: Acellular Pertussis; Diphtheria; Tetanus

Summary: gsk biologicals' dtpa vaccine has recently been approved by the us food and drug administration (fda) for booster vaccination of adolescents aged 10 to 18 years. the acip has recently issued provisional recommendations for universal adult tdap vaccination. the current study will provide pivotal data in support of extending the age range for boostrix vaccine to include adults 19-64 years of age.


Eligibility criteria:
inclusion criteria: * a healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study. * chronic administration of immunosuppressants or within six months prior to administration of study vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine). * administration of a diphtheria-tetanus (td) booster within previous five years. * administration of tdap vaccine at any time prior to study entry. history of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Keywords: prophylaxis for diphtheria, tetanus, pertussis immunogenicity, booster, dtpa