Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of transdermal therapeutic system (tts) fentanyl in participants with osteoarthritis knee pain

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate the efficacy and safety of transdermal therapeutic system (tts) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.

this is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective study (study following participants forward in time) of tts-fentanyl matrix form in knee osteoarthritis participants. the study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. the first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until day 30 will be provided to the participant with the instructions to apply the patch. the tts-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. this record will be used to support more detailed assessments at study visits on western ontario and mcmaster universities osteoarthritis index (womac) questionnaire. participants' safety will be monitored.

Eligibility criteria:
inclusion criteria: * chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with stage ii kellgen-lawrence, for more than 3 months with visual analogue scale (vas) more than 4 * good knee deformity, no limit range of motion * participant who has signed the informed consent form exclusion criteria: * skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability * history or suspicion of alcohol or drug abuse within the past 5 years * history of cardiac, nervous system or respiratory disease which in the investigator's judgment prevents participation in the study because of the potential for respiratory depression * confusion, reduced level of consciousness, or concomitant psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial * participants who do not understand or speak thai

Keywords: osteoarthritis, knee transdermal therapeutic system (tts) fentanyl durogesic
glucosamine as a novel adjunctive therapy in oral lichen planus

Conditions: Oral Lichen Planus

Summary: glucosamine (glcn) is an n-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and was administrated orally in osteoarthritis and atopic dermatitis therapy. given the oral lichen planus (olp) t-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. the investigators compared clinical effectiveness of glucosamine combined with two topical corticosteroid regimens to that of topical corticosteroid alone in symptomatic olp and investigated therapeutic mechanism by examining treatment effect on expression of inhibitor kappa kinase alpha (ikkα) and interleukin-8 (il-8) in olp lesions.

thirty patients with erosive or atrophic olp were randomly assigned into three equal groups to receive combination of topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks (group i), combination of topical steroid twice daily and glucosamine sulfate 500 mg orally three times per day for 8 weeks (group ii), or topical steroid alone four times per day for 8 weeks (group iii) all patients were followed up for another treatment free 4 weeks observational period. photographs of the most severe lesion were taken (marker lesion) in each patient and analyzed for total ulcerative area (tua), total atrophic area (taa), and total reticular area (tra), patients were also assessed using clinical scores (cs) and visual analogue scale (vas). pre-treatment and post-treatment specimens were immunohistochemically stained to detect expression of ikkα and il-8.

Eligibility criteria:
inclusion criteria: * clinically and histologically proven painful bullous/erosive or atrophic forms of olp exclusion criteria: * lichenoid lesions * presence of systemic conditions * smoking * known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation * pregnancy or breast-feeding * history of previous treatments potentially effective on olp in last 3 months * loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus

Keywords: oral lichen planus glucosamine il-8
expanding patient applicability with polymer sealing ovation alto stent graft investigational device exemption (ide) study

Conditions: Aortic Aneurysm, Abdominal

Summary: a prospective clinical evaluation of the effectiveness of the ovation alto abdominal stent graft system when used in the treatment of subjects with abdominal aortic aneurysm (aaa).

a prospective clinical evaluation of the effectiveness of the ovation alto abdominal stent graft system when used in the treatment of subjects with abdominal aortic aneurysm (aaa). the primary objective is to evaluate treatment success at 12 months with the ovation alto abdominal stent graft system. the study will have up to 16 sites, and up to 75 patients based on attrition rates. the follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

Eligibility criteria:
inclusion criteria include: 1. patient has adequate iliac/femoral access compatible with the required delivery systems. 2. patient has non-aneurysmal proximal aortic neck. 3. patient has non-aneurysmal distal iliac landing zone. exclusion criteria include: 1. patient has dissecting aneurysm. 2. patient has acutely ruptured aneurysm. 3. patient has need for emergent surgery.

Keywords: abdominal aortic aneurysm
psychiatry of transition in a world in transition

Conditions: Transitional Care; Mental Disorder in Adolescence; Mental Health

Summary: this clinical study evaluates risk and protective factor to develop psychopathology in transitional age youth. 300 patients will be recruited at the age of 17 years old and assessed at baseline and 2 years later.

emerging adults are a particularly at-risk population in mental health. transitional age youth have specific needs, not currently covered between child and adolescent mental health services (camhs) and adult mental health services (amhs), mainly because of existing barriers. movements from one to the other must be planned to achieve optimal patient care. our project aims to identify clinical dimensional characteristics contributing to the development of psychopathology during the transition period. continuities, discontinuities and resilience factors will be explored. the final purpose is to develop a non-stigmatizing approach to reduce rejection from youths in psychopathological suffering and increase social inclusion. the transversal and trans-diagnostic approach consists of a dimensional evaluation: 300 youth at the age of 17 will be included in a cohort of in-patients, out-patients and control group. participants will be assessed at baseline and 2 years later. the primary outcome is based on health of the nation outcome scale for children and adolescents, measuring mental health care need, and who quality of life assessment. the secondary outcomes include the assessment of dimensions representing risk or protective factors to develop psychopathology and evolution of mental health status during transition age. baseline evaluation consists in internalizing/externalizing symptoms, impulsivity/compulsivity, emotion regulation, cognitive functioning, social and family functioning, developmental, medical and trauma history. at follow-up, mental health pathways and transition results will be described.

Eligibility criteria:
inclusion criteria: * french-speaking and french-understanding * subjects who accepted to participated to the study (signature of informed consent/assent document from subjects and parents or legal holder of parental authority) * specific criteria for patients: inpatients and out-patients * specific criteria for control group: youth from general population or placed in residential centres exclusion criteria: * impossibility to answer to the assessment tools * medium intellectual disability (homogenous iq \< 75) * presence of a grave somatic disease (cancer, cardiac failure, renal failure, central nervous system disorder), that is progressive or that affects the vital prognosis in the short term * active participation to another study

Keywords: transitional age youth camhs amhs dimensional approach child and adolescent psychiatry services adult psychiatry services
study of loteprednol etabonate in adults undergoing bilateral cataract surgery

Conditions: Inflammation Following Ocular Surgery

Summary: this study will assess the bioequivalence of loteprednol etabonate and the reference listed drug (rld)


Eligibility criteria:
inclusion criteria: * subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes. * non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: intrauterine device in place for at least 90 days. barrier method (condom or diaphragm) with spermicide. stable hormonal contraceptive for at least 90 days prior to study and through study completion. abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control \[condom or diaphragm and spermicide\] for the duration of the study). * male subjects should use medically reliable contraception methods such as condom or vasectomy. * subjects are able to perform the activities required by the study protocol and have provided written informed consent. exclusion criteria: * subjects having an iop less than 5 mmhg or greater than 24 mmhg. * known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in iop after steroid instillation. * subjects unable to tolerate instillation of study product by the investigator or qualified staff. * use of other investigational drugs within 30 days prior to dosing and for the duration of the study. * subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to visit 1.

Keywords: loteprednol etabonate
safety and clinical performance of the protecta icd and crt-d

Conditions: Tachyarrhythmias; Heart Failure; Ventricular Dysfunction

Summary: the purpose of the study is two-fold. in phase i (protecta clinical study), system performance will be evaluated. in phase ii (painfree sst), the inappropriate shock-free rate at one year of subjects implanted with a medtronic protecta implantable cardioverter defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) will be evaluated.

the painfree sst study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. phase i assessed safety as determined by assessment of delays in ventricular fibrillation (vf) arrhythmia detection time using new algorithms. phase ii assessed the influence of new algorithms on inappropriate and unnecessary shocks at 1 year of follow-up. subjects enrolled in phase i continued in phase ii of the study and data from all enrolled subjects contributed to the analysis of phase ii objectives. a sub-study of phase ii randomized secondary prevention subjects to either 18/24 nid or 30/40 nid in order to assess the safety of prolonged detection in these patients.

Eligibility criteria:
inclusion criteria: * patients meeting one of the following criteria can be included in phase i of the study: * patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (dr-icd)/cardiac resynchronization therapy defibrillator (crt-d) * patients undergoing a device replacement or upgrade to dr-icd or crt-d and with the protocol required leads (patients must be enrolled prior to implant) * patients meeting one of the following criteria can be included in phase ii of the study: * patients indicated for a dr-icd/vr-icd/crt-d device and intended to receive a protecta device * patients undergoing a dr-icd/vr-icd/crt-d device replacement or an upgrade to a protecta dr-icd/vr-icd or crt-d * patients indicated for a dr-icd/vr-icd/crt-d already implanted with a protecta device and the protocol required leads, who have not yet been discharged after implant exclusion criteria: * patients with a mechanical tricuspid heart valve * patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by medtronic, during the course of this clinical study * patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients * patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc) * patients anticipated not being able to complete the study * patients unwilling to provide written informed consent
tese (testicular sperm extraction) in azoospermic patients: m-tese vs. l-tese

Conditions: Azoospermia, Nonobstructive

Summary: the aim of the study is to compare surgical outcomes (intra and post-operative complications) and sperm retrieval rates between conventional microsurgical-assisted testicular sperm extraction (m-tese - group a) and testicular sperm extraction performed with surgical loupes (l-tese - group b) in adult males with non-obstructive azoospermia.

objective: to compare surgical outcomes and sperm retrieval rates (srr) between conventional microsurgical-assisted testicular sperm extraction (m-tese - group a) and testicular sperm extraction performed with surgical loupes (l-tese - group b) in adult males with non-obstructive azoospermia (noa). a multicentric prospective randomized trial was conducted from march 2022. adult males with noa without genetic alterations who agreed to participate in the study and signed the required informed consent were enrolled. srr, intra and post-operative complications (according to clavien-dindo classification), hormonal profile tchanges were considered as outcomes during the follow up period.

Eligibility criteria:
inclusion criteria: * adult males * diagnosis of non obstructive azoospermia who required m-tese. exclusion criteria: * absence of signed written informed consent * age \< 18 years * obstructive azoospermia * genetic anomalies (e.g., klinefelter syndrome, kallmann syndrome, y chromosome microdeletions, cftr mutations) * previous testicular biopsies/surgical sperm retrieval * personal history of malignant testicular tumor * unilateral cryptorchidism * varicocele * previous chemotherapy/radiotherapy treatments * monorchidism
a placebo-controlled study of oral ozanimod as maintenance therapy for moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: this is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active crohn's disease.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit: www.bmsstudyconnect.com inclusion criteria: * fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study * in clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at week 12 of the induction study exclusion criteria: * partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula * had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis other protocol-defined inclusion/exclusion criteria apply

Keywords: crohn's disease crohn disease oral ozanimod moderately active severely active rpc01 rpc01-3203
clavipectoral fascia plane block versus interscalen brachial plexus block for clavicle surgery

Conditions: Clavicle Fracture; Clavicle Injury

Summary: the pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (cpb). cpb was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. cpb may be an alternative to interscalene brachial plexus block. the aim of this study is to compare the efficacy of the us-guided cpb and iscb for postoperative analgesia management after clavicle surgery. the primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (vas), adverse effects related with opioids (allergic reaction, nausea, vomiting).

clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. the pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block (iscb) and recently clavipectoral fascia plane block (cpb). cpb was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. the clavipectoral fascia covers the clavicular site of the pectoralis major muscle. it provides the potential interfascial space between the clavicle and the pectoralis major muscle. cpb provide effective analgesia after clavicle surgery. it is also easy to perform. with this advantage and its analgesic effectiveness for clavicle surgery, cpb may be an alternative to interscalene brachial plexus block. however, randomized clinical efficacy trials are needed to investigate the effectiveness of cpb for clavicle fractures. in the literature, data about cpb is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture. the aim of this study is to compare the efficacy of the us-guided cpb and iscb for postoperative analgesia management after clavicle surgery. the primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (vas), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i-ii * scheduled for clavicle surgery under general anesthesia exclusion criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who do not accept the procedure

Keywords: clavicle fracture clavipectoral fascia plane block postoperative analgesia interscalene block
the effect of virtual reality and kaleidoscope on pain and anxiety levels during venipuncture in children

Conditions: Acute Pain

Summary: aim: the study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection. methods: the population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in turkey between july and december 2018. a total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. information form, child anxiety scale, visual analogue scale and wong baker pain scale were used in the collection of data.


Eligibility criteria:
inclusion criteria: * being aged between 4 and 10 years for the child, * applying for health control purpose, * not having any chronic, mental or neurological illness, * not using any analgesic in the last 6 hours before the venipuncture procedure. exclusion criteria: -having a chronic, mental or neurological illness,

Keywords: acute pain blood collection nursing children distraction
optimal planning target volume with stereotactic radiosurgery

Conditions: Brain Neoplasms; Brain Cancer

Summary: the purpose of this study is to estimate the rate of local control at the treated site of the metastasis as a function of 1mm versus 3mm expansion about the gross tumor volume (gtv). each lesion, not each patient will be ranndomized to either the 1mm or 3mm margin with 40 lesions randomized to each arm.

stereotactic radiosurgery (srs) is used either as definitive treatment alone or as a "boost" in combination with whole-brain radiotherapy (wbrt) for the treatment of brain metastases. to establish a target for srs, the gross tumor volume (gtv) is typically defined as the contrast-enhancing volume on t1-weighted axial mri images. in turn, the volume chosen for treatment (the planning target volume or ptv) is generated by expanding the gtv to account for microscopic extension of tumor beyond the mri-visualized volume and deviations in patient positioning at the time of treatment., however, the optimal ptv in patients undergoing srs of brain metastases has not been established. this pilot randomized study of approximately 49 patients (representing a total of 80 brain lesions) should be sufficient to explore the effect of margin expansion around the gtv for brain metastases. the patients enrolled in this study will undergo radiosurgery to a planning treatment volume generated by expanding the gtv of each lesion by either a 1mm or 3mm margin. each lesion, not each patient, will be randomized to receive either the 1mm or 3mm margin with 40 lesions randomized to each arm (a patient with multiple lesions potentially could have a lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm). the primary outcome of 12-month local recurrence and the secondary outcome of the rate of radionecrosis at the srs treatment site will be lesion-specific outcomes. all other secondary outcomes will be patient-specific outcomes.

Eligibility criteria:
inclusion criteria: * age \>18 years * life expectancy of at least 6 months. * karnofsky performance score greater than 70 * graded prognostic assessment (gpa score 0.5 or greater * 1 to 3 brain metastases unresectable * maximum tumor diameter no larger than 4cm exclusion criteria: * primary lesion with radiosensitive histology (such as: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma. * metastases in the brain stem, pons or medulla or within 5 mm of optic apparatus * previous cranial radiation * pregnancy

Keywords: brain metastases