Kornimate/medical-research-clean huggingface dataset:
treatment of tooth sensitivity with the use of biorepair toothpaste

Conditions: Dentinal Hypersensitivity

Summary: the purpose of this clinical study is to evaluate the effect of desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling dh after 8 weeks of treatment

this clinical study design is an 8-week single center, before and after use of desensitize dentifrice. this study will conducted in the college of dentistry qassim university. 72 patients surfing from dh, include in the study fulfill the inclusion criteria. all subjects 20 to 70 years of age in good health, and must have 2 teeth with dh, will be included in this study. screening will be performed for the selection of patients, which fulfill the inclusion criteria. baseline data will be recorded and sensitivity was assessed by air-blast sensitivity, using schiff sensitivity scale (sss). sensitivity was assessed by air-blast sensitivity, using schiff sensitivity scale (sss) described as follows. 0 = subject does not respond to air stimulus 1. = subject responds to air stimulus but does not request discontinuation of stimulus 2. = subject responds to air stimulus and requests discontinuation or moves from stimulus 3. = subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus

Eligibility criteria:
inclusion criteria: * all male and female subjects 20 to 70 years of age * all subjects in good health * all subjects must have 2 teeth with dh, only incisors, canine and premolars were included with the exposed cervical dentin (facial surfaces). all participants of the study having schiff sensitivity scale score of 2 \& 3 exclusion criteria: * subjects with deep carious teeth, defective restorations * any pathological lesion * periodontal disease, mobile teeth, cracked enamel, orthodontic appliances, * periodontal pockets \>4mm * subjects using pain control medicines, sensitive toothpaste * pregnant or lactating women

Keywords: biorepair sensitive toothpaste clinical trial dentinal hypersensitivity schiff sensitivity scale zinc-carbonate hydroxyapatite nanocrystals
study to evaluate monotherapy and combination immunotherapies in participants with pd-l1 positive non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer; Nonsquamous Non Small Cell Lung Cancer; Squamous Non Small Cell Lung Cancer; Lung Cancer

Summary: this randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (ab122) monotherapy, domvanalimab (ab154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (ab928) in front-line, pd-l1 positive, metastatic non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * male or female participants; age ≥ 18 years * histologically confirmed, treatment naive, metastatic squamous or non-squamous nsclc with documented high pd-l1 expression, with no epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) genomic tumor aberrations. * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * must have at least 1 measurable lesion per recist v1.1 * adequate organ and marrow function exclusion criteria: * use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (imps) * any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption) * history of trauma or major surgery within 28 days prior to the first dose of imp * concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications * positive test results for hepatitis b surface antigen, hepatitis c virus antibody with presence of hepatitis c qualitative rna or human immunodeficiency virus (hiv-1 and/or hiv-2) antibody at screening * any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. * prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

Keywords: non small cell lung cancer lung cancer nsclc
counseling on the interaction of hormonal contraceptives and antiepileptics

Conditions: Epilepsy

Summary: previous studies have shown that women on anti-seizure medications are not informed about the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, aeds) and certain hormonal contraceptive. the goal of this proposed study is to develop and assess the efficacy of an educational handout for participants on the ways aeds and certain hormonal contraceptives can interact to alter effectiveness of the medications. reproductive age women (18-45 years old) will be recruited from ucsd health system epilepsy clinics. if a patient agrees to participate, she will be given a knowledge exam prior to the clinic appointment to establish baseline understanding of hormonal contraceptive and aed interactions and then the participant will be randomized to receive the intervention (educational handout) or the standard of care (no educational handout). those in participants in the intervention group will read an educational handout on hormonal contraceptives/aed interactions. those in the standard care group will not receive this handout and the same knowledge exam will be re-administered to all of the participants after they have completed their appointments to check for knowledge comprehension and short-term knowledge retention. a same-day post-test questionnaire will evaluate participant's intention to discuss hormonal contraceptives/aed interactions with their gynecologist, neurologist or primary care physician.


Eligibility criteria:
inclusion criteria: * age of participants: 18-45 years old * gender of participants: female * ethnic background: no limitation, will include minorities * health status: on at least one antiepileptic medication * sexually active with men * english speaking exclusion criteria: * currently pregnant * history of hysterectomy or sterilization procedure * removal of both ovaries * cannot read or comprehend english language * unable to provide informed consent * attempting to become pregnant * not sexually active with men * no active telephone number for follow-up contact

Keywords: drug interactions
cu-64-psma-i&t positron emission tomography (pet) imaging of metastatic psma positive lesions in men with prostate cancer

Conditions: Metastasis From Malignant Tumor of Prostate (Disorder)

Summary: this is a prospective, open-label phase 2 study to evaluate copper cu 64 psma i\&t injection for pet/ct imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

the study will include a group of 26 patients with metastatic prostate cancer. each patient will be administered a 7-9 mci intravenous dose of copper cu 64 psma i\&t injection. pet/ct images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 minutes post copper cu 64 psma i\&t injection. the pet/ct images will be interpreted independently by three readers blinded to all patient information. each patient study will be assessed and scored for the detection of prostate cancer. specifically, each reader will categorize images as "disease" or "no disease" based only on tumor uptake of copper cu 64 psma-i\&t in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. analysis of the reads will be used for determination of the clr and cdr for 1 hour and 4-hour post-injection imaging of copper cu 64 psma i\&t pet/ct by comparison to the composite reference standard.

Eligibility criteria:
inclusion criteria: 1. patients with histologically proven prostate adenocarcinoma. 2. prior radical prostatectomy or radiation therapy with curative intent. 3. recurrence of disease defined as: 1. prior radical prostatectomy: psa \> 0.2 ng/ml, or 2. prior radiation therapy: 2 ng/ml rise in psa over post-treatment nadir 4. patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy. 5. age greater than or equal to 18 years. 6. able to understand and provide signed written informed consent. exclusion criteria: 1. androgen deprivation therapy (adt) or other therapies targeting the androgen pathway, unless subject has a rising psa level. 2. body weight greater than 350 lb (158 kg). 3. investigational therapy within the past 30 days. 4. creatinine clearance (clcr) less than 30 ml/min. 5. participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

Keywords: psma prostate cancer pet solar cu-64 psma
automated breast ultrasound and digital breast tomosynthesis screening compared to full field digital mammography in women with dense breasts

Conditions: Breast Cancer

Summary: this study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis


Eligibility criteria:
inclusion criteria: * able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; * women aged ≥18 years at the time of enrollment;\* * women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense; * at moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the acs criteria 1: and referred for screening mammography exclusion criteria: * have been screened using any breast imaging technology in \<12 months immediately prior to enrollment; * exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment; * diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment; * are currently pregnant as determined per standard clinical practice at the investigational site; * present with contraindications to any imaging examination required in the study protocol; * have breast implants; or * are lactating.

Keywords: breast cancer dense breasts mammography screening screening techniques women
clinical results of asqelio™ edof toric soft hydrophobic intraocular lens after cataract surgery

Conditions: Cataract

Summary: the goal of this observational study is to assess the clinical outcomes of binocular implantation of asqelio edof toric iols in healthy cataract patients. the main questions it aims to answer are: * what is the visual performance at different distances 3 months after implantation of asqelio edof toric in both eyes? * what is the amount of residual refractive error following the implantation? * what is the contrast sensitivity of patients 3 months after implantation of asqelio edof toric in both eyes? * what is the optical quality of the eye implanted with asqelio edof toric iol? * what is the incidence and severity of visual symptoms after implantation of asqelio edof toric? * what is the level of patient satisfaction after implantation of asqelio edof toric? for this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of asqelio edof toric iols, and asked to complete visual symptoms and patient satisfaction questionnaires.


Eligibility criteria:
inclusion criteria: * patients 50 years old or more submitted to bilateral cataract surgery and implanted with asqelio edof toric iol, with cylinder value of 0.0 d. * patients signing informed consent * transparent media except for the cataracts * potential postoperatoria visual acuity of 20/25 or better exclusion criteria: * preoperative corneal astigmatism greater than 1.00d * patients who do not provide informed consent * patients who do not understand the study procedure * previous corneal surgery or trauma * irregular cornea (e.g. keratoconus) * choroidal hemorrhage * microphtalmos * severe corneal dystrophy * uncontrolled or medically controlled glaucoma * clinically significant macular changes * concomitant severe eye disease * non-age-related cataract * severe optic nerve atrophy * diabetic retinopathy * proliferative diabetic retinopathy * amblyopia * extremely shallow anterior camera * severe chronic uveítis * pregnant or nursing * rubella * mature/dense cataract that makes it difficult to examine the fundus preoperatively. * previous retinal detachment * concurrent participation in other research with drugs or clinical devices * expect to require another eye surgery during the study period
microparticles's role in the pathophysiology of systemic lupus erythematosus and systemic sclerosis

Conditions: Systemic Lupus Erythematosus; Systemic Scleroderma

Summary: our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (sle) and systemic scleroderma (ssc). microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

systemic lupus erythematosus (sle) and systemic scleroderma (ssc) are two rare and potentially life-threatening auto-immune systemic diseases. there is an urgent need to describe prognostic factors and to discover new therapeutic pathways. microparticles (mps) are small extracellular vesicles formed from activated cells including endothelial cells and platelets. preliminary data from our lab indicate that these mps might play a key role in sle and ssc physiopathology. in fact, mps from patients with sle aggregates with t regulator lymphocytes (ltregs) and decrease their activity, thereby promoting auto-immunity. some works also indicate that mps might cargo dna to the immune system, also promoting auto-immunity. the investigators hypothesized that mps levels might be a prognostic factor in sle and ssc and that studying the molecular mechanisms involved could provide new therapeutic targets. our study will recruit 100 patients with sle or ssc followed in bordeaux university hospital. among classical disease activity information, blood and urine samples will be collected at each visit to study circulating microparticles. fundamental research will be realized on patients' sample to study molecular mechanisms involved. clinical and biological disease activity, treatment and outcomes will be studied in correlation with mps to describe their potential prognostic role. patients will be followed at regular intervals as their usual follow-up would request. no extra visit will be needed and blood samples will be drawn at the same times as those drawn for clinical purposes.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus or systemic sclerosis; * age ≥ 18 years; * being affiliated to health insurance, willing to participate and to sign informed consent. exclusion criteria: * pregnant or breastfeeding women; * patient concerned by articles l 1121-5 to l 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Keywords: systemic lupus erythematosus systemic scleroderma autoimmunity microparticles platelets
insulin by jet-injection for hyperglycemia in diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

recently, we showed in both healthy, non-diabetic volunteers and in patients with type 1 (t1dm) and insulin-treated type 2 diabetes (t2dm) a 40-50% faster absorption of rapid-acting insulin analogues when administered by jet injection technology rather than by conventional insulin pen. the faster insulin action of insulin administration by jet injection may be especially advantageous for correction of hyperglycemia. to investigate this, a open-label randomised controlled cross-over study will be performed in 20 adult patients (18-75 years) with t1dm or t2dm on basal-bolus insulin treatment. the pharmacokinetic and pharmacodynamic profile of insulin aspart will be derived from the time-action profiles of insulin and glucose, respectively, in response to insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) after reaching hyperglycemia (18-23 mmol/l). all patients will be investigated twice, where on one occasion the jet-injector device will be used to inject insulin, and on the other occasion insulin will be injected with a conventional insulin pen. the order of these occasions will be randomised. both devices will be operated by the patient after sufficient training. ease of use will be evaluated.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 or 2 * age 18-75 years * body-mass index ≥25 kg/m2 and ≤40 kg/m2 * stable glycaemic control with hba1c ≥48 (6.5%) and ≤86 mmol/mol (10%) * insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed exclusion criteria: * inability to provide informed consent * insulin requirement of \ 200 units per day * treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs * known allergy to aspart insulin * use of oral antidiabetic drugs other than metformin * symptomatic diabetic neuropathy * history of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months * pregnancy or the intention to become pregnant * renal disease (creatinine \>150 μmol/l or mdrd-gfr \<30 ml/min/1.73m2) * liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range) * presence of any other medical condition that might interfere with the study protocol * anemia

Keywords: diabetes insulin administration hyperglycaemia insulin aspart
non-interventional study on osilodrostat in patients with endogenous cushing's syndrome

Conditions: Endogenous Cushing's Syndrome

Summary: this is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous cushing's syndrome

this is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous cushing's syndrome. this study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. patients with endogenous cushing's syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. each patient enrolled in the study will be followed up for 3 years from study entry. patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis. the total number of patients enrolled in this study will be approximately 201. assuming a recruitment period of 3 years, the total study duration from first patient first visit (fpfv) to last patient last visit (lplv) will be 6 years. the maximum duration for the individual patient is 3 years.

Eligibility criteria:
inclusion criteria: * written informed consent obtained prior to registration of any patient data * male or female patients aged 18 years or older with endogenous cs treated with osilodrostat. treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening. exclusion criteria: * patients with exogenous cs * patients with pseudo cs * patients participating in an interventional clinical trial with an investigational drug.

Keywords: cushing's syndrome osilodrostat
energy drinks and vascular function

Conditions: Vascular Function

Summary: the purpose of this study will be to examine the acute effect of commercially available energy products on endothelial function, arterial stiffness and thrombosis in healthy young males.

the use of energy products has significantly increased in the last few years and is especially high among young men. the present study will compare the acute effect of a commercially available energy drink, energy gum, coffee and control beverage on endothelial function, arterial stiffness and circulating markers of thrombosis, inflammation and oxidative stress.

Eligibility criteria:
inclusion criteria: * being male * 18-30 years of age * no indication of major clinical disease (e.g. diabetes, hypertension, significant arrhythmias, syncope and cardiovascular disease) * bmi ≤ 30 kg/m\^2 and blood pressure ≤ 140/90 mmhg * consumption of \<400mg of caffeine/day * prior history of consumption of energy drinks exclusion criteria: * being female * age \ 30 years * bmi\> 30 kg/m\^2 and blood pressure \> 140/90 mmhg * use of medication that may affect vascular measures * use of tobacco products including smoking * vegan or vegetarian diet * being energy drink or caffeine naïve or consumption of \>400 mg of caffeine/day * consumption of \>1 energy drinks per month * being a shift worker

Keywords: energy drink consumption
efficacy and safety study of ataciguat versus placebo in patients with neuropathic pain

Conditions: Pain

Summary: the primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain. the secondary objective is to assess the safety and tolerability of ataciguat versus placebo.

this study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.

Eligibility criteria:
inclusion criteria: * patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. the pain must be present for more than 3 months. exclusion criteria: * presence or history of cancer within the past five years * patients with a history of hiv infection * patients with active hepatitis b or c * patients with any pain other than the neuropathic pain of greater or equal severity * patients with a diabetes mellitus for less than 6 months the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: diabetic neuropathy painful pain postoperative