Kornimate/medical-research-clean huggingface dataset:
bacillus calmette-guérin (bcg) and gemcitabine in people with high-grade non-muscle invasive bladder cancer that came back after bcg treatment

Conditions: Non-Muscle Invasive Bladder Cancer (NMIBC)

Summary: this study will test the safety of bcg and gemcitabine in people who have bcg-relapsing non-muscle invasive bladder cancer (nmibc). the researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with bcg. the study will also look at whether this combination of drugs is effective in treating bcg-relapsing nmibc.


Eligibility criteria:
inclusion criteria: * recurrent for persistent high-grade nmibc ta/t1/tis (ta/t1 with cis is preferred, but not required) within 24 months of the last treatment with bcg (with or without ifn) o up to 26 months from the last bcg treatment is allowed for the treating physician to perform a transurethral resection of bladder tumor (turbt) so long as there is evidence of recurrent disease (by positive cytology, imaging, or office cystoscopy) within 24 months of last bcg transurethral resection of bladder tumor (turbt) * pathologic confirmation of stage, grade, and urothelial histology by the department of pathology at msk * all visible papillary lesions macroscopically resected within 60 days of treatment initiation * absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment * receipt of restaging transurethral resection (tur) for any tumor with invasion into the lamina propria (hgt1) as part of standard care * age ≥18 years * karnofsky performance status ≥60% * informed consent exclusion criteria: * positive pregnancy test * known contraindications to bcg * history of systemic hypersensitivity reaction or history of febrile systemic bcg reaction * febrile illness or persistent gross hematuria * active tuberculosis * immunosuppression due to congenital or acquired immune deficiency, concurrent immune suppressive disease, systemic cancer therapy, or chronic immunosuppressive therapy other than topical or inhaled corticosteroids * history of or currently being treated for muscle-invasive (i.e., stage t2 or higher) or metastatic urothelial cell carcinoma * evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma * bcg-unresponsive nmibc as defined by the fda: * hgt1 within 3 months after an induction bcg course (received ≥5 of 6 doses) * persistent or recurrent high-grade nmibc (tis, ta, t1) within 6 months of ≥5 of 6 doses of induction bcg therapy and ≥2 of 3 doses of maintenance bcg therapy

Keywords: bacillus calmette-guérin (bcg) gemcitabine 19-374
comparison of outcomes with multifocal intraocular lenses

Conditions: Cataract

Summary: the purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of multifocal intraocular lenses: sn6ad1, sbl-3, ls-313 mf30, at lisa tri 839 mp, art, ls-313 mf30t.

this study is a prospective randomized controlled trial to compare and evaluate the clinical outcomes of 6 kinds of multifocal intraocular lenses, the outcome measurements include postoperative visual acuity, visual quality and complications. patients enrolled in the study will be randomized to receive one of the multifocal intraocular lenses mentioned above, and the clinical outcomes of each multifocal intraocular lens will be assessed at several visits: 1 day, 1 week, 1 month, 3 months and months post-operatively.

Eligibility criteria:
inclusion criteria: * age from 40 to 80 years old, either gender; * patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined intraocular lens implantation; * willing to undergo second eye surgery within 7 days after first eye surgery; * the potential postoperative visual acuity of 20/40 or better in both eyes; * preoperative measurement of corneal astigmatism indicate the subjects are suitable for multifocal intraocular lenses implantation; * capability to understand the informed consent and willing and able to attend study exclusion criteria: * preexisting ocular diseases or conditions other than age related cataracts, have contraindications for cataract surgery; * preexisting systemic diseases or conditions that may confound the results of the study; * previous ocular surgery history or ocular trauma that may confound the results of the study; * require combined surgery that may confound the results of the study; * previous participation in other clinical trial within 30 days of this study start; * systemic or ocular medications that may confound the outcome of the intervention * pregnant, lactating, or planning to become pregnant during the course of the trial;

Keywords: multifocal intraocular lenses bilateral implantation
efficacy emollient on xerosis in children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. a lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (european academy of dermatology and venereology task force 2009 position paper). improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy. the primary objective of this study is to demonstrate the efficacy of the tested product (v0034cr01b) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.


Eligibility criteria:
inclusion criteria: * presenting with atopic dermatitis, dry skin, objective scorad \< 15, * with xerosis on the body and a xerosis score \> = 2 (scorad sub-score) on the anterior part of lower limbs, exclusion criteria: * acute phase of atopic dermatitis * severe form of atopic dermatitis

Keywords: xerosis dry skin dermatitis pruritus eczema emollient corticosteroid
small doses muscle relaxant in general anesthesia

Conditions: Muscle Relaxant

Summary: this study will be held to assess the effect of minimal dose muscle relaxant on postoperative pulmonary function. the time to extubation in minutes will be the primary outcome as a clinical indicator of the return of muscle power. the extubation time will be defined as the time from injecting the muscle relaxant reversing agent given when regain the train of four (tof) ratio to 0.9 till removal of endotracheal tube. intraoperative surgical conditions will be assessed in the form of surgeon satisfaction and the need for more muscle relaxant boluses. postoperative complications as desaturation (peripheral oxygen saturation (spo2) less than 90%), the need for re-intubation or ventilation support will be recorded. patient lung will be assessed using ultrasound-based lung aeration score. also, the diaphragmatic and intercostal muscle function will be assessed in the early postoperative period. immediate postoperative pulmonary function tests will be evaluated using simple spirometer. patients will be followed up for 28 days for detection of pulmonary complications.

after arrival to the operating theater, a thoracic us examination will be done using lus dynamic re-aeration score. patients will be randomly allocated via sealed opaque envelopes into 2 groups of 30 patients each; control (c) group and minimal dose (min) group. for general anesthesia; intubating dose of muscle relaxant will be injected according to the study group; in c group; atracurium 0.5 mg/kg while in min group 0.2 mg/kg will be injected. the trial for intubation will be assessed and recorded. train-of-four (tof) stimulation will be maintained less than 2 throughout the intraoperative period in the control group. while, in the min group, boluses of muscle relaxant will be given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. when required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal.

Eligibility criteria:
inclusion criteria: * adult patients * aged from 20 to 50 years old * scheduled for non-cardiothoracic surgery * under general anesthesia * in supine position * after informed consent exclusion criteria: * american society of anesthesiologists (asa) score more than 3 * suspected full stomach or who will undergo intervention expected to necessitate profound muscle relaxation or dressing interferes with ultrasound (us) probe positioning * lung parenchymatous disease * renal disease * hepatic disease * neuromuscular disease * electrolytes imbalanc * on medication interfere with muscle contraction * with known allergy to any drug used in the study
complex post-traumatic stress disorder: what symptomatological specificities

Conditions: Psychiatric Health

Summary: a better understanding of the complex post-traumatic stress disorder would allow a management as close as possible to the specificities of this one, but also a better training of professionals and adapted therapeutic indications.

post-traumatic stress disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .in addition, dissociation, the origin and the resulting disorders also have some similarities to complex post-traumatic stress disorder. indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in complex post-traumatic stress disorder. we can then ask ourselves the following questions: is complex post-traumatic stress disorder a dissociative disorder in its own right causing difficulties with self-regulation? what is the share of dissociation in complex post-traumatic stress disorder?

Eligibility criteria:
inclusion criteria: for clinical population; * age between 18 and 65 years old; * having experienced repeated and prolonged traumatic exposure; * able to understand and answer self-questionnaires; * having expressed their free and informed consent * affiliated with a social security scheme for general population: * student volunteers from the university of lille; * aged between 18 and 65 years old; * able to understand and answer self-questionnaires; * having expressed their free and informed consent. exclusion criteria: for clinical population; * people with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties); * persons under tutorship or curatorship; * persons deprived of their liberty. for general population: * people with difficulties in answering the self-questionnaires (e.g. incomprehension of items, emotional difficulties); * persons under tutorship or curatorship; * persons deprived of their liberty; * persons having a link of subordination with the investigative team.

Keywords: disorder, complex post-traumatic stress disorder personality disorders
pathogenic species and genotypes of bacterial diversity in relation to the severity of dental caries

Conditions: Dental Cavity

Summary: the primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages icdas (international caries detection and assessment system) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the dentistry departments of the nîmes university hospital and the montpellier university hospital.

secondary objectives include: * compare the distribution of bacterial species in relation to stages of severity of caries * compare the results from plaque with those of saliva samples.

Eligibility criteria:
inclusion criteria: * volunteers aged 3 to 45 who come in to the hospital for a dental consultation * minors must have parental permission * the patient must have given his/her informed and signed consent exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is pregnant, or breastfeeding * the patient has been on antibiotics within the past two months * smokers * teeth under current care * parodontopathy * use of a mouthwash within the last week * insufficient numbers of healthy and/or teeth with carious lesions for carrying out the study

Keywords: bacteria microbial community hygiene
cardio pulmonary exercise testing in patients post the fontan palliation in comparison with patients with repaired congenital heart disease and healthy volunteers.

Conditions: Fontan Palliation; Congenital Heart Disease

Summary: prospective cardio respiratory evaluation for patients post the fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.


Eligibility criteria:
inclusion criteria: * children at age of 8-25 post fontan palliation * patients with repaired congenital heart disease without chronic lung disease * healthy patients ate age of 8-25 exclusion criteria: * patients with chronic lung disease * pregnant women * patients with acute active disease or chronic disease that may affect the exercise function

Keywords: repaired congenital heart disease cardio pulmonary exercise testing fontan fontan palliation functional capacity
postoperative pain endodontic retreatment

Conditions: Endodontically Treated Teeth

Summary: to compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.

post treatment failure could be treated by two options including orthograde retreatment and apical surgery . in a previous study, orthograde retreatments presented a success rate of 81 % classified as healed and 93 % as no symptoms and fully functional. in a systematic review, it has also been concluded that endodontic surgery offers more favorable initial success but orthograde retreatment yields to a better long-term outcome . although early results of single-visit treatments are contradictory ; completing the treatment in a single appointment reduces the treatment time and cost, decreases micro leakage risk and avoids recontamination of root canals between appointments in multiple-visit treatments . again, reviewing the literature concerning primary treatment showed that, no significant differences were observed in healing of periapical radiolucency between teeth treated in single-visit and those treated in two-visits. even, after using calcium hydroxide for four weeks . the presence of a positive bacterial culture at the time of filling did not influence the outcome of treatment . thorough online search revealed that, few studies are found concerning post- operative pain after single visit retreatment . the present study is designed to compare the effects of single-visit and two-visit root canal treatments on postoperative pain in retreatment cases. the primary outcome measure of this study is proposed to be whether single-visit root canal retreatment influenced the occurrence of postoperative pain as compared to two-visit treatment.

Eligibility criteria:
inclusion criteria: * clinically asymptomatic. * previously treated teeth in need of retreatment due to leakage and/or improper filling. * no periapical radiolucency. * no percussion pains. * age 20 - 45. * premolar teeth. * male \& female. exclusion criteria: * complicating compromised patient. * tenderness to percussion and acute apical abscess. * presence of an associated sinus tract. * presence of swelling in adjacent soft tissue. * teeth with periodontal pathologies or mobility. * teeth representing root fracture. * pregnant women. * if analgesics or antibiotics have been administrated by the patient during the past 24 hours.
safety, tolerability and pharmacokinetics of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism

Conditions: Hyperparathyroidism, Secondary

Summary: the purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.


Eligibility criteria:
inclusion criteria: * subjects provides written informed consent. * intact parathyroid hormone (ipth) ≥ 400 pg/ml (≥ 300 and \< 1200 pg/ml for cohorts 1-3). * serum corrected calcium ≥ 9.0 mg/dl * receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered kt/v (dialyzer clearance of urea \* dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (urr) ≥ 65%. * excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests exclusion criteria: * history or symptomatic ventricular dysrhythmias * history of angina pectoris or congestive heart failure * history of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months * history of or treatment for seizure disorder * recent (3 months) parathyroidectomy

Keywords: clinical trial, phase 1 renal dialysis secondary hyperparathyroidism parathyroid hormone
wound architecture and functional outcome after cataract surgery with manual vs.femtosecond laser assisted procedures

Conditions: Cataract

Summary: this study is the long term analysis of two types of fsl 3-plane corneal wound profiles, namely ct1 and ct2 obtained after a fsl cataract surgery.

femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. the aim of this study is the long term analysis of two types of fsl 3-plane corneal wound profiles, namely ct1 and ct2, ct2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. the traditional manual wound performed with a standard keratome will be used as a reference. as fsl cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and oct wound parameters are associated with a higher likelihood of wound leaks.

Eligibility criteria:
inclusion criteria: * consecutive cases of cataract surgery performed between january 2015 and june 2015 by a single surgeon (ph) at the clinique d'ophtalmologie bellevue, using either the catalys or a manual technique. * one eye per patient, the first eye * uneventful cataract only exclusion criteria: * combined glaucoma filtering surgery * any previous corneal surgery in this eye * any pathology of the interior segment * inflammatory eye disease of the interior segment

Keywords: cataract femtosecond laser cornea anatomy fsl surgery
therapeutic exposures and risk factors in mronj

Conditions: Medication-Related Osteonecrosis of Jaw

Summary: this study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (mronj), which can occur after using certain medications. the purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. by doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life.


Eligibility criteria:
inclusion criteria: * individuals aged 18 and over * male or female individuals * individuals who apply to the marmara university faculty of dentistry, department of oral and maxillofacial surgery due to medication-related osteonecrosis of jaw during the study period * individuals or their legal representatives who have given written consent to participate in the study exclusion criteria: * non-drug-related osteonecrosis/osteomyelitis * osteoradionecrosis * metastasis to the oral region * individuals who have not given written consent to participate in the study * individuals under the age of 18
sedentary intervention trial in cardiac rehabilitation

Conditions: Coronary Artery Disease

Summary: exercise-based cardiac rehabilitation (cr) has been shown to consistently reduce the rates of total and cardiovascular-related mortality and morbidity. sedentary behaviours have been shown to be high in patients with cardiovascular disease, but it is not yet known if current cr programming results in significant reductions in these behaviours, or whether a targeted component is warranted. it is also unclear if self-reported sedentary time measures can provide valid and reliable information for monitoring these behaviours in a cr setting, or whether more objective measures are needed. the purpose of this study is to assess the feasibility and usability of the activpal3 devices for measuring sedentary time in a cr setting, describe changes in sedentary time that occur with standard cr and assess whether the addition of prompting cues from a device can result in further declines in sedentary behaviour and improvements in clinical outcomes, health related quality of life, symptoms of anxiety and depression, aortic stiffness, and aerobic capacity.


Eligibility criteria:
inclusion criteria: * patient is attending on-site (2 times weekly for 8 weeks) cardiac rehabilitation at the minto prevention and rehabilitation centre at the university of ottawa heart institute * patient is 18 years of age or older * patient has confirmed diagnosis of coronary artery disease (cad) * patient understands english or french * patient is willing and able to provide informed consent exclusion criteria: * patient is unwilling to wear activity monitors * patient is already using a commercial activity monitor with sedentary prompts (e.g. jump up, garmin) * patient is unable to attend follow-up visits * patient not participating in a cardiac rehabilitation program at the university of ottawa heart institute * patient has cognitive impairment (unable to comprehend or participate in the intervention) * patient has a history of postural hypotension * patient is unable, in the opinion of the medical director, to participate in the study.

Keywords: sedentary behaviour
prevention of weight gain in university students

Conditions: Prevention; Weight Gain

Summary: this study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.


Eligibility criteria:
inclusion criteria: * first year students at the université de sherbrooke. exclusion criteria: * presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.). * pregnancy or planning a pregnancy in the next two years. * unable to give an informed consent.