Kornimate/medical-research-clean huggingface dataset:
tolerability comparison between differin® cream 0.1% versus differin® lotion 0.1% in subjects with healthy skin

Conditions: Skin Manifestations

Summary: the purpose of this study is to compare the tolerability of differin® (adapalene) cream, 0.1% to differin® lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years and older * subjects with healthy skin as determined by the clinical grader. exclusion criteria: * subjects with a degree of skin pigmentation that interferes with the reading of skin reactions. * subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study * subjects with known allergy to one of the components of the study drugs (refer to the package insert for differin® cream 0.1% and the investigator's brochure for differin® lotion 0.1%) * subjects who have participated in another investigational drug or device research study within 30 days of enrollment. * subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids. * subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids. * subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated. * subjects who foresee unprotected and intense uv exposure during the study (mountain sports, uv radiation, sunbathing, etc.).
catheter evaluation for endocardial ablation in patients with typical atrial flutter

Conditions: Atrial Flutter

Summary: the primary objective is to provide additional corroborative safety and efficacy data for the navistar thermocool catheter for the treatment of subjects with typical atrial flutter (afl).

this study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. the device is currently fda approved for commercial distribution. subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. this study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.

Eligibility criteria:
inclusion criteria: * two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. this may include typical afl occurring while receiving anti-arrhythmic drug (aad) therapy for non-afl tachyarrhythmia, including atrial fibrillation. * at least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ecg), holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment. * 18 years of age or older * informed consent exclusion criteria: * intracardiac thrombus * uncontrolled heart failure, or new york heart association (nyha) class iii or iv heart failure * women who are pregnant * cardiac surgery (ventriculotomy or atriotomy) within the past two months * intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement * unstable angina or acute myocardial infarction within 3 months * awaiting cardiac transplantation * heart disease in which corrective surgery is anticipated within 6 months * presence of condition that precludes appropriate vascular access * enrolled in any investigational device exemption (ide) investigating study for a device or drug * high risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician) * radio frequency (rf) ablation for typical atrial flutter within the past 2 months

Keywords: heart disease atrial flutter typical atrial flutter
bilateral condylar fractures registry

Conditions: Bilateral Condylar Fracture of the Mandible

Summary: prospective data will be collected in approximately 250 patients sustaining bcfx with or without any additional fracture(s) of the symphysis. patients will be followed according to the standard (routine) at approximately 6 weeks and 3 months after the treatment. data collection will include fracture details (i.e. classification, mechanism of injury), treatment details, functional and patient-reported outcomes, and anticipated or procedure-related adverse events (i.e. complications).

fractures of the condyles occur in around one third of patients sustaining a mandibular fracture. bilateral fractures are reported in around one fifth to one third of all fractures of the mandibular condyles and are often combined with other fractures of the mandible or facial skeleton. the treatment of condylar fractures, and in particular of bilateral condylar fractures (bcfx), is complex due to many different fracture patterns, surgeon's preferences, local constraints of the health care system and patient characteristics. briefly, bcfx can be treated using either closed treatment (ctx) (e.g. intermaxillary fixation \[imf\] and/or functional therapy) or surgical treatment (i.e. open reduction and internal fixation \[orif\]) in both fractures, or a combination of closed treatment and orif. the relationship of these treatments with the final outcome remains elusive, since the available literature does not report specific data for patients sustaining bcfx and has ignored or inadequately reported patient-reported outcomes. consequently there is a lack of clinical evidence to assist the decision-making process. therefore, the purpose of this registry is to collect data in a standardized manner regarding the treatment, the clinical and the patient-oriented outcomes, and the complications of bcfx.

Eligibility criteria:
inclusion criteria: * age 18 to 90 years at the time of the fracture * diagnosis of bilateral condylar fracture of the mandible with or without a concomitant fracture of the symphysis * dentition: patients must have enough maxillary and mandibular teeth present to identify proper occlusion exclusion criteria: * unilateral condylar fracture * additional maxillary fracture(s) * polytrauma (i.e. life threatening condition) * patients being treated with antiresorptive drugs at the time of inclusion or during their participation in the registry * pregnancy * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

Keywords: mandibular condyle subcondylar mandible fracture
prospective randomized controlled trial comparing ecv success rates with and without full urinary bladder

Conditions: Breech Presentation; Before Labor

Summary: a comparison of external cephalic (ecv) success rates when ecv performed with full urinary bladder or not. the study is prospective and randomised. both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. written informed consent will be obtained prior to inclusion in the study.

a comparison of external cephalic (ecv) success rates when ecv performed with full urinary bladder or not. the study is prospective and randomised. both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. written informed consent will be obtained prior to inclusion in the study.

Eligibility criteria:
inclusion criteria: * non-cephalic presentation, * singleton pregnancy, * term gestation, * no previous attempt at ecv in this pregnancy, * signed informed consent. exclusion criteria: • any contraindication for vaginal delivery

Keywords: breech; ecv; version
long-term observation of ophthalmic changes in patients with obstructive sleep apnea

Conditions: Sleep Apnea; Glaucoma; Ocular Hypertension

Summary: the ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. the investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.


Eligibility criteria:
inclusion criteria: * newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, * ongoing treatment of sleep apnea with positive airway pressure therapy, * patients older than 18 years, * signed inform consent exclusion criteria: * pregnant and breastfeeding persons
an efficacy and safety study of ravulizumab in als participants

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: the purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with als.


Eligibility criteria:
key inclusion criteria: 1. a diagnosis of sporadic or familial als, defined by the el escorial criteria (possible, laboratory-supported probable, probable, or definite als). 2. als onset ≤ 36 months from screening. 3. documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment. 4. upright slow vital capacity ≥ 65% predicted at screening. 5. if on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles). 6. body weight ≥ 40 kilograms at screening. 7. contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. key exclusion criteria: 1. history of neisseria meningitidis infection. 2. human immunodeficiency virus (hiv) infection (evidenced by hiv 1 or hiv 2 antibody titer). 3. dependence on invasive or non-invasive mechanical ventilation. 4. previously or currently treated with a complement inhibitor. 5. exposure to an investigational drug or device within 30 days of screening or 5 half lives of the study drug, whichever is greater.

Keywords: ravulizumab alxn1210 ultomiris motor neuron disease amyotrophic lateral sclerosis als
high-intensity interval exercise in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. the investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis disease according to the american college of rheumatology (acr)/ the european alliance of associations for rheumatology (eular) 1987/2010 criteria * disease duration \>1 year * age (range 20-60 years) * stable medication on anti- rheumatic drugs for \>3 months * low-to-moderate disease activity (\<5.1) according to the disease activity score 28 (das28) exclusion criteria: * cerebrovascular diseases * diabetes * severe hypertension * chronic obstructive pulmonary disease or other severe pulmonary diseases * other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise * arthroplasty of large joints * inability to manage cardiopulmonary exercise testing (cpet) * pregnancy * already participating in regular aerobic or strength exercise at a high intensity level (\>1 hours/ week) during the last 6 months * inability to speak or read swedish.
combination chemotherapy in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

objectives: * determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. * determine the pharmacokinetic parameters of this regimen in these patients. * determine the antitumor response of these patients treated with this regimen. outline: this is a dose-escalation study of irinotecan and capecitabine. patients receive oxaliplatin iv over 2 hours followed 1 hour later by irinotecan iv over 30 minutes once weekly for 4 weeks. patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: approximately 9-15 patients will be accrued for this study within 9-15 months.

Eligibility criteria:
disease characteristics: * diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy * bidimensionally measurable or evaluable disease * no brain metastases or primary brain tumors patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * wbc at least 4,000/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin greater than 10.0 g/dl hepatic: * bilirubin no greater than 1.5 mg/dl * ast and alt less than 2 times normal renal: * creatinine no greater than 1.5 mg/dl * creatinine clearance greater than 60 ml/min cardiovascular: * no new york heart association class iii or iv heart disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study * no known hypersensitivity to fluorouracil prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and recovered endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior large-field radiotherapy and recovered surgery: * not specified

Keywords: unspecified adult solid tumor, protocol specific
a study of wd-890 in participants with moderate-to-severe plaque psoriasis

Conditions: Brief Description of Focus of Study

Summary: th purpose of the study is to evaluate the dose response of wd-890 in efficacy at week 16 in participants with moderate-to-severe plaque psoriasis.

the total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (\<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. aged 18 to 70 years (inclusive) were enrolled in this study. participants were randomized to receive wd-890 or placebo.

Eligibility criteria:
inclusion criteria: * male or female participant aged 18 to 70 years(inclusive)at the time of informed consent. * diagnosis of plaque psoriasis for at least 6 months prior to the screening visit. ≥10% of bsa involvement at screening visit and randomization; * psoriasis area and severity index (pasi) score ≥12 and static physician's global assessment (spga) ≥3 at screening visit and randomization exclusion criteria: * participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.) * has uncontrolled arterial hypertension characterized by a systolic blood pressure (bp) ≥160 mm hg or diastolic bp ≥100 mm hg note: determined by 2 consecutive elevated readings. if an initial bp reading exceeds this limit, the bp may be repeated once after the subject has rested sitting for ≥10 minutes. if the repeat value is less than the criterion limits, the second value may be accepted * class iii or iv congestive heart failure by new york heart association criteria * participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).
optical coherence tomography angiography and in fluorescein angiography in diabetic retinopathy

Conditions: OctA .FFA Findings in DR

Summary: diabetic retinopathy (dr) is the leading cause of decreased vision in working age people. patients with dr can develop macular edema and proliferative retinopathy which are major causes of visual impairment \[1\]. the potential of octa regarding diagnosis and follow up of dr has been shown in previous studies \[2-4\]. at present fluorescein angiography (fa) represents the gold standard in the diagnosis and staging of dr \[5\]. with fa vascular lesions like micro aneurysms (mas), the size of areas of non-perfusion and of the foveal avascular zone (faz) and retinal neovascularisations can be reliably identified \[6\]. al-though the capabilities of fa are well known, its use also contains some risks related to the intravenous injection of the dye, which can cause nausea, vomiting and allergic re actions and even anaphylactic shock \[7\]. besides that, it also requires time and trained personnel \[8\]. image acquisition by octa in contrast is not as time consuming and can be performed without taking any risks. additionally, it provides a 3 dimensional cross sectional view of the retinal and choroidal layers with micro meter depth resolution, providing depth selective information of the retinal vasculature. this facilitates accurate diagnosis and follow up of retinal vascular diseases since significant insights into both morphology and perfusion status can be obtained simultaneously. although various artifacts appear in octa images, a qualitative assessment is mostly possible \[9\].early changes to be seen in octa in patients with non-proliferative dr are vascular remodelling bordering the faz, vascular tortuosity, narrowing of capillary lumen and capillary dilatation. these changes cannot be seen in the same manner in fa \[10\].in this study we investigated the size of the faz and the count of mas in patients with dr.


Eligibility criteria:
inclusion criteria: * all pts with confirmed type 2 diabetes of at least 6 months. best corrected visual acuity of 6/60 or higher (using asnellen chart) in each eye exclusion criteria: * dense media opacities interfere with image ffa as dense cataract . previous ttt mainly retinal laser photocoagulation or intra vitreal injection. history of ocular disease as glaucoma and retinal vascular occlusion . previous ocular surgery.
pharmacokinetic and -dynamic of propofol during awake craniotomy

Conditions: Brain Tumor

Summary: certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. with respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. to do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. however, diverse pk/pd-parameter sets have been described in the literature. the aim of the study is to investigate whether the pk/pd model proposed by marsh et al. or by schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.


Eligibility criteria:
inclusion criteria: * patients scheduled for awake craniotomy exclusion criteria: * pregnancy

Keywords: propofol awake craniotomy patients requiring an awake craniotomy for brain tumor/lesion resection
dysport™ clinical & health economics outcomes registry in cervical dystonia

Conditions: Cervical Dystonia

Summary: the purpose of the protocol is to determine typical patient response to dysport in the treatment of adult cervical dystonia (cd).


Eligibility criteria:
inclusion criteria: * a diagnosis of idiopathic cd as determined by the enrolling investigator * if previously treated with a neurotoxin for cd, at least a 12-week interval must have elapsed between the last injection of botulinum toxin a (bont-a) or botulinum toxin b (bont-b) and the first dose of dysport injected in this study * patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews) * provision of written informed consent prior to enrollment exclusion criteria: * contraindications to treatment with any bont-a or bont-b preparations * based on investigator opinion, patients in whom previous bont-a or bont-b therapy has failed to produce a clinical response or produced an intolerable adverse reaction * anticipated concomitant treatment with bont for other than cervical dystonia * secondary cervical dystonia
evaluation of the intravenous tissue plasminogen activator treatment algorithm of nursing intern students

Conditions: Acute Stroke

Summary: intravenous (iv) tissue plasminogen activator (tpa) is one of the key elements of acute ischemic stroke. in this study, acute stroke patients maximum benefit from the treatment, intravenous tissue plasminogen activator (iv tpa) minimizing the errors related to the treatment of acute ischemic stroke patients of nursing students from clinical practice guides published on the treatment of it is aimed to be informed and to standardize nursing interventions.

time management in acute stroke patients is possible with a multidisciplinary approach and team members who have received specific training for acute stroke patients. studies have shown that the maximum result of treatment for acute stroke patients depends on nurses' ability to identify disease symptoms, plan and apply symptom-specific nursing care. there is evidence that the multidisciplinary presence of stroke teams in stroke units and the delivery of coordinated care during the acute phase improve patient outcomes . coordinated care by the stroke team improves patient outcomes, reduces hospital costs, reduces patient readmission, and improves patient care quality.

Eligibility criteria:
inclusion criteria: intern nursing student at dokuz eylül university exclusion criteria: those who did not agree to participate in the study those who were not be intern

Keywords: tissue plasminogen activator acute stroke intravenous tissue plasminogen activator nursing care neurology nursing acute stroke treatment