Kornimate/medical-research-clean huggingface dataset:
a global study of volrustomig (medi5752) for participants with unresected locally advanced head and neck squamous cell carcinoma following definitive concurrent chemoradiotherapy

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary: the main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (la-hnscc) who have not progressed after receiving definitive concurrent chemoradiotherapy (ccrt).


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. m0). * confirmed unresected stage iii, stage iva or ivb according to the eighth edition of the american joint committee on cancer (ajcc) staging manual (tumor, node, metastasis (tnm) staging system). * participants will have completed definitive concurrent chemoradiotherapy (ccrt) with curative intent within 12 weeks prior to randomization. exclusion criteria: * histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). participants with \>1 primary tumors are not eligible for the study. * participants with any of the following: 1. residual disease that needs further treatment with curative intent after definitive ccrt administration; 2. la-hnscc that was resected before definitive ccrt 3. la-hnscc that was treated and is recurrent at the time of screening * participants who have received radiotherapy (rt) alone as definitive local therapy for la-hnscc. * receipt of the last dose of anticancer therapy (chemotherapy and/or rt) \> 12 weeks (84 days) prior to randomization.
quality of life validation in laryngitis

Conditions: Laryngopharyngeal Reflux (LPR)

Summary: the primary purpose of this study was to establish the psychometric properties of a new disease specific quality of life questionnaire, the lpr-hrql. the specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).


Eligibility criteria:
inclusion criteria: * new laryngopharyngeal reflux diagnosis less than 1 month or relapsed patients not under current treatment exclusion criteria: * unable to comply with study requirements.

Keywords: laryngopharyngeal reflux (lpr) omeprazole losec quality of life laryngitis
evaluation of ranibizumab in proliferative diabetic retinopathy (pdr) requiring vitrectomy

Conditions: Proliferative Diabetic Retinopathy

Summary: evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (pdr) requiring vitrectomy.

this is an open-label, phase i/ii study of multiple doses of intravitreally administered ranibizumab in patients with severe npdr and pdr prior to, during, and after vitrectomy therapy. 40 subjects will be enrolled and randomized 3:1 to ranibizumab or vitrectomy alone. 30 consented, enrolled subjects will receive 3 intravitreal injections of 0.5 mg ranibizumab administered 1-3 weeks pre-procedure, intraoperatively, and 1 month post-vitrectomy.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 20 years * best corrected visual acuity of 20/40 to 20/800 in the study eye * very servere nonproliferative diabetic retinopathy (etdrs level 53e) or moderate proliferative diabetic retinopathy (etdrs level 65) * visual reduction attributable to diabetic vitreous hemorrhage or diabetic macular edema * candidate for vitrectomy procedure exclusion criteria: * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an iud, or contraceptive hormone implant or patch. * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * participation in another simultaneous medical investigation or trial. * visual impairment attributable to causes other than diabetic macular edema or diabetic vitreous hemorrhage. * use of intraocular or periocular corticosteroids within 6 months. * history of panretinal photocoagulation * history of macular laser photocoagulation * history of pars plana vitrectomy * prior or concomitant treatment with ranibizumab, bevacizumab, or pegaptanib sodium, either as part of an investigational study or as an off-label medication. * current treatment of a systemic infection

Keywords: proliferative diabetic retinopathy vitrectomy ranibizumab
a clinical trial to evaluate the efficacy and safety of testosterone gel in adult hypogonadal males

Conditions: Adult Male Hypogonadism

Summary: this is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of fe 999303 (testosterone gel) in adult hypogonadal males.


Eligibility criteria:
inclusion criteria: * males between 18-75 years of age * two fasting serum testosterone levels \<300 ng/dl exclusion criteria: * previous use of the study drug * history of prostate or breast cancer * prostate-specific antigen (psa) ≥3 ng/ml * subject is sexually active and not willing to use adequate contraception
long-term follow-up of sanfilippo type a patients treated by intracerebral saf-301 gene therapy

Conditions: Mucopolysaccharidosis Type III A; Sanfilippo Disease Type A

Summary: p2-saf-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral saf-301 previously administered to 4 patients with sanfilippo type a syndrome. the primary objective is to collect additional safety and tolerability data on intracerebral saf-301 previously administered to 4 patients with sanfilippo type a syndrome. the secondary objective is to further collect data to assess the effects of saf-301 on neurological and psychological status, and potential biological markers.


Eligibility criteria:
inclusion criteria: * patients having completed the previous phase i/ii study (p1-saf-301), * family understanding the follow-up procedures and the informed consent, * patient's parents having signed the informed consent form. exclusion criteria: * participation in any other clinical trial.

Keywords: neurodegenerative diseases nervous systems diseases genetic diseases, inborn metabolic diseases gene therapy adeno associated virus (aav)
translation and psychometric testing of the norwegian foot functional index revised, short version.

Conditions: Foot Diseases; Plantar Fascitis

Summary: the aim of this study is to translate into norwegian and cross-culturally adapt the foot functional index- revised, short form (ffi-rs) according to international guidelines. furthermore, the reliability and the validity, responsiveness as well as floor and ceiling effect of the norwegian version of the ffi-rs will be determined.

foot functional index, revised short form is a foot specific patient reported outcome measurement (prom) which covers pain, stiffness, activity limitations, disability as well as psychosocial issues. the aim of this study is to translate into norwegian and cross-culturally adapt foot functional index revised, short form (nffi-rs). furthermore, the reliability, validity, interpretability and responsiveness will be determined. the department of physical medicine and rehabilitation at oslo university hospital has an ongoing double blind, randomized sham-controlled trial (rct) comparing the effect of radial extracorporeal shock wave therapy (reswt), sham reswt, standardized exercise program and usual care for patients with longstanding plantar fasciopathy (nct03472989). the testing of the psychometric properties of the nffi-rs will include totally hundred patients, both from the mentioned rct as well as patients with other foot diagnosis recruited from our department. the translation of the original ffi-rs into norwegian has been done following the official guidelines. in the test-retest study fifty patients will complete the nffi-rs at a one week interval. smallest detectable change, measurement error, floor and ceiling effects as well as internal consistency will be calculated by using the baseline data. to decide the construct validity we will test the various hypothesis at baseline. to calculate the responsiveness and the minimal clinically important change three months data will be assessed. patient global impression of change scale will be used to assess the minimal clinically important change and responsiveness of the nffi-rs with roc and auc analyses.

Eligibility criteria:
inclusion criteria: * patients with pain localized in the foot * patients understanding oral and written norwegian exclusion criteria: * patients without pain in the foot * patients not understanding oral and written norwegian

Keywords: foot functional index revised, translation and cultural adaption reliability validity responsiveness
efficacy of topical lidocaine/prilocaine in pain management in pleurocentesis

Conditions: Pleural Effusion

Summary: the research aims to compare the efficacy of topical pridocaine cream (lidocaine 2.5% and prilocaine 2.5%) and the standardized local lidocaine infiltration in pain management before pleurocentesis.

acute pain management is a core ethical concept in medical practice. during pleurocentesis, the standardized pain management is with 1% lidocaine with a 25 gauge needle for skin and a smaller gauge needle for deeper tissue. as the anesthetic injection is painful in and of itself, during these two procedures, pain management can sometimes fall short due to a lack of education and incorrect personal opinions. one example is "one needle insertion can cause less pain than two-needle insertions". therefore, it is essential to find an alternative method that is painless and reduces procedural pain, which does not require expertise to administer. this is particularly important in centers with a high volume of patients and a lack of expert medical staff. another option for administering a local anesthesia is using a topical anesthetic. generally, these are easily applied, tolerated better by patients, and have minimal systemic absorption resulting in fewer side effects6. a topical anesthetic can be a substitute for infiltrative lidocaine (il) if it can be effective in reducing pain. lidocaine-prilocaine cream (lpc) is an example of a topical anesthetic, which was introduced in 1980 for dermabrasion and minor surgery. previous research findings had noted the efficacy of lpc compared to il in trans-radial catheterization, perineal tears following vaginal delivery, and some pediatric procedures like lumbar punctures and venipunctures. additionally, lpc can be substituted for infiltrative prilocaine in pediatric femoral catheterization. hanieh halili et al, found a significant difference between the lpc and il groups in terms of patient pain or satisfaction levels, but their study was on a small sample size and they recommended further studies.

Eligibility criteria:
inclusion criteria: * all patients will be prepared for pleurocentesis. exclusion criteria: 1. patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product. 2. patients treated with class iii anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide).
intracoronary stenting and restenosis - randomized trial of drug-eluting stent implantation or drug-coated balloon angioplasty according to neointima morphology in drug-eluting stent restenosis 5

Conditions: Coronary Artery Disease; Restenoses, Coronary

Summary: the hypothesis of the study is, that there is a significant interaction in treatment effect between the oct pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.


Eligibility criteria:
inclusion criteria: 1. patients with ischemic symptoms and/or evidence of myocardial ischemia 2. presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels. 3. availability of an oct-pullback of the target lesion 4. written informed consent by the patient for participation in the study. 5. age ≥ 18 years exclusion criteria: 1. cardiogenic shock 2. acute st-elevation myocardial infarction within 48 hours from symptom onset. 3. target lesion located in left main trunk or bypass graft. 4. additional coronary intervention planned within 30 days of the procedure. 5. non-successful treatment of other lesion(s) during the same procedure 6. severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) 7. contraindications to any components of the investigational devices or dual antiplatelet therapy 8. pregnancy (present, suspected or planned) or positive pregnancy test. 9. previous enrollment in this trial or participation in any other study at the time of enrollment. 10. malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance. 11. patient's inability to fully comply with the study protocol
ablation of ventricular fibrillation by accurate targeting of arrhythmogenic regions (avatar)

Conditions: Ventricular Tachyarrhythmias

Summary: this study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

the investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias). during electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders. 1. the 'active' group will prospectively receive brief ablation at localized sources (focal impulse and rotor modulation, firm). 2. the control group will be a historical cohort who have received traditional ablation for this disorder. all patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Eligibility criteria:
inclusion criteria: 1. documented ventricular tachyarrhythmias. 2. undergoing clinically indicated ep study with ablation. exclusion criteria: 1. unwillingness or inability to provide informed consent.

Keywords: ventricular tachyarrhythmia ablation electrophysiology human mapping
effect of vitamin d repletion on insulin resistance and systemic inflammation

Conditions: Insulin Resistance

Summary: the purpose of this research is to study the effects of vitamin d supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.

over the last several years, studies have shown that low vitamin d levels may increase risk of developing type 2 diabetes. the investigators will administer vitamin d3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin d deficiency (total vitamin d levels \<20 ng/ml) to increase the level of vitamin d3. the investigators will study the effects of increased vitamin d on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue. investigators will study participants with a procedure called a "pancreatic clamp" study. during the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. adipose tissue inflammation will be measured using the following inflammatory markers: il-6, pai-1, tnf-alpha, and inos.

Eligibility criteria:
inclusion criteria: * serum 25(oh)d\<20ng/ml * insulin resistant based on homa-ir score of \>3 * able and willing to provide informed consent * bmi 20-35 exclusion criteria: * hiv/aids * history of any cancer * sarcoidosis * alcohol or substance abuse * cushing's syndrome * primary hyperparathyroidism * nephrolithiasis * pregnancy or breastfeeding * regular visits to a tanning salon * hypercalcemia or hypocalcemia * untreated or uncontrolled hypertension * any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia

Keywords: glucose metabolism disorders insulin resistance endocrine system vitamin d
effect of a tablet-administered educational video on patients´ knowledge on osteoporosis and treatment

Conditions: Osteoporosis

Summary: osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. in this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. the investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.


Eligibility criteria:
inclusion criteria: * scheduled for at dxa scan at the osteoporosis clinic * currently on once-weekly alendronate treatment * informed consent exclusion criteria: * patients that do not understand danish * patients having hearing impairments (unable to hear the video) * patients having visual impairments (unable to watch the video) * patients diagnosed with dementia * patients unable to give written informed consent.

Keywords: patient education video intervention
evaluating the effect of senna in uremic pruritus

Conditions: End Stage Renal Disease; Pruritus

Summary: uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. it affect up to 90 percent of patients with end stage renal disease. several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. the main goal of therapy remains to minimize severity of pruritus. in iranian traditional medicine cassia senna l. is used for healing uremic pruritus . in this study investigators considered to evaluate effect of cassia senna l. in uremic pruritus by a double blind placebo control clinical trial. it is hypothesized that oral cassia senna l. may attenuate uremic pruritus by decreasing serum il-2, ifn-γ and tnf-α.


Eligibility criteria:
inclusion criteria: * hemodialysis patients * suffering from pruritus for at least 6 weeks * have not responded to other drugs exclusion criteria: * dermatological disease * liver disease * metabolic disease

Keywords: end stage renal diseases hemodialysis uremic pruritus iranian traditional medicine cassia angustifolia
xeomin cosmetic in the management of masseter

Conditions: Masseter Muscle Hypertrophy

Summary: the goal of this study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using xeomin cosmetic.

background: xeomin cosmetic has been used previously in the management of masseteric hypertrophy. however, a standardized injection technique has not been established. the goal of the present study was to evaluate the efficacy and safety of two injection techniques in the management of masseteric hypertrophy using xeomin cosmetic. methods: thirty female patients with masseteric hypertrophy were recruited and evenly randomized to receive bilateral treatments of either 1) a single injection technique (sit), or 2) a multi-injection technique (mit). improvement of masseteric hypertrophy was assessed at week 16 using standardized measurements and photographs. patients completed a 5-point satisfaction questionnaire while physicians the global aesthetic improvement scale (gais) and 10-point photonumeric masseter prominence rating scale.

Eligibility criteria:
inclusion criteria: 1. at the time of consent, women over the age of 18 years old. 2. patients with established hypertrophy of the masseters, palpable and visible. 3. accepted the obligation not to receive any other facial procedures through the 6-month follow-up. 4. understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits. 5. no previous facial fillers for a period of 6 months prior to this study. 6. no previous facial fillers along the jawline for 18 months 7. capable of providing informed consent. 8. no previous botulinum toxin type a treatment for masseteric hypertrophy in the last 12 months. exclusion criteria: 1. current pregnancy or lactation 2. hypersensitivity to xeomin 3. generalized disorders of muscle activity (e.g. myasthenia gravis, lambert eaton syndrome) 4. presence of infection at the site of injection 5. inability to comply with follow-up and abstain from facial injections during the study period 6. patients with a score of 2 or greater on the merz aesthetics scale for the jawline

Keywords: xeomin cosmetic; masseteric hypertrophy
photomotor reflex to evaluate the role of the non-visual effects of light in neurological, psychiatric and ophthalmological pathologies

Conditions: Sleep Disorders; Neurological Pathologies; Psychiatric Pathologies; Ophthalmological Pathologies

Summary: the light has visual and non-visual effects on organism and can act on the behavior, the mood, the cognition and the sleep. these effects are mediated by "classical" retina photoreceptors which allow vision (rods, cones) but also melanopsin cells. the non-visual effects of light seems to be altered in many neurological, psychiatric or ophtalmological conditions but their exact role in the pathogenesis remains poorly understand. the purpose of the study is to increase our knowledge of the non-visual effects of light and establish new therapeutic applications


Eligibility criteria:
inclusion criteria: * man or woman * aged 18 years or older * subject having signed a free and informed consent * subject affiliated to a social protection scheme arm 1 :subjects with primary sleep-wake disorder arm 2 : subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep arm 3 : subject presenting a psychiatric pathology pathology with disorder of the controls of the wake and the sleep arm 4 : subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction arm 5 : subjects with photosensitivity with regulation disorder of sleep and wake arm 6 : healthy subject exclusion criteria: age-related macular degeneration (amd) and all maculopathies (retinopathies pigmentosa, macular involvement of diabetes) * cataract with significant vision loss \<5/10 * chorioretinal neovascularization * subject in exclusion period determined by previous or current study * impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...) * subject under the protection of justice * subject under guardianship or curatorship * pregnancy / breastfeeding