Kornimate/medical-research-clean huggingface dataset:
effect of probiotics on the periodontal status of orthodontic patients

Conditions: Periodontal Health; Gingivitis

Summary: gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (fod). indeed, fods promote the accumulation of plaque and interfere with the efficacy of tooth brushing. according to in vitro and in vivo studies, the administration of oral probiotic bacteria including lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. a recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. however, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. the aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances


Eligibility criteria:
inclusion criteria: * adolescents aged 12 to 16 benefiting from social security coverage * in good general health in brushing and taking treatments * have fods * who consent to the study and whose parents have given their consent * suitable for orthodontic treatment in view of his oral state exclusion criteria: * inability to obtain informed consent * use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month before inclusion * allergy or hypersensibiliity to the active substance or to any of the excipients listed in the gum® periobalance® user guide) * no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion * medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care) * physiological, pathological condition, medication or behavior that may have repercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco) * oral state requiring other priority care (untreated cavities, untreated active periodontitis, progressive recession)

Keywords: gingivitis oral microbiota salivary biomarkers probiotics
assessment of pfm strength and function after radiotherapy treatment in women with pelvic cancers

Conditions: Pelvic Muscle Strength and Function

Summary: assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers

evaluate the impact of radiotherapy treament on pelvic floor muscles strength and function in women with cervical and rectal cancers

Eligibility criteria:
inclusion criteria: * women between 30 -50 years old * diagnosed with cervix or rectal cancers * married * will be treated with preoperative radiotherapy for at least 5 weeks * had not any pelvic operations in the past exclusion criteria: * un married women * age below 30 or above 50 years old * has another type of pelvic tumors * has any metastasis * had any pelvic surgeries * will be treated with short course radiotherapy

Keywords: pelvic floor muscles - radiotherapy - pelvic cancers
uterocervical angle: a screening tool that estimates the latent phase duration in post term pregnancies

Conditions: Post Term Pregnancy

Summary: to evaluate the performance of uterocervical angle (uca) in the prediction of latent phase duration in post term pregnancies


Eligibility criteria:
inclusion criteria: * patients with singleton pregnancies * post term pregnancies * patients with vertex presentation, * patients with intact membranes * patients with no uterine contractions exclusion criteria: * women with bmi \>30, * multiparity and multiple pregnancies, * patients with macrosomia (\>4500 gr), * patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes), * patients with abnormal pap smears, * patients with a history of previous cesarean section, myomectomy, hysteroscopic surgeries, dilatation and curettages, loop electrosurgical excision procedures, and cervical conization.
evaluation of efficacy and safety of combined omacor (omega-3-acid ethyl esters) and simvastatin therapy in hypertriglyceridemic subjects

Conditions: Hypertriglyceridemia

Summary: the purpose of om6 is to evaluate efficacy and safety of lovaza (omega-3-acid ethyl esters) \[formerly known as omacor\] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-hdl-c) in subjects with persistent high triglycerides despite statin therapy. additionally, a two-year extension trial (lov111818/om6x) is posted on nct00903409.

two studies comprise this om6 program. study om6 / lov111858 (double-blind study) and is not required to post results based on fdaaa. study om6x / lov111818 (open-label extension) is posted on nct00903409.

Eligibility criteria:
inclusion criteria: * men and women ages 18-79 years, inclusive * current therapy with a statin drug * triglyceride levels between 200 and 499 mg/dl * normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * sensitivity to statin drugs or omega-3 fatty acids * lipoprotein lipase impairment or apo c-2 deficiency or type iii hyperlipidemia * unexplained muscle pain or weakness * history of pancreatitis * recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer) * poorly controlled diabetes, or receiving insulin therapy * pregnant or lactating females. women of childbearing potential who are not using a medically approved method of contraception. * use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs * use of warfarin (coumadin)

Keywords: omega-3-acid ethyl esters simvastatin lovaza high triglycerides
an observational study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis treated with glucocorticoids

Conditions: Rheumatoid Arthritis

Summary: this prospective, observational, multicenter study will assess the efficacy and safety of roactemra/actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-tnf. data will be collected for 36 weeks.


Eligibility criteria:
inclusion criteria: * adults patients, over 18 years of age * patients with moderate to severe rheumatoid arthritis (ra) * patients on a stable dose of prednisone or equivalent (\>/=7.5 mg/day) for at least 4 weeks before study inclusion exclusion criteria: * patients previously treated with roactemra/actemra * any contraindication to roactemra/actemra
xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation

Conditions: Gingival Diseases

Summary: a split-mouth study comparing soft tissue augmentation results using free gingival graft (fgg) versus xenogeneic collagen matrix (cm) for the generation of keratinized tissue (kt) around teeth with insufficient (\< 2mm) kt.

a single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of kt (\< 2mm). the study utilized a within subject treatment comparison design to establish non-inferiority of the test (cm) versus control (fgg) therapy. the primary efficacy endpoint was kt width at 6-months. secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. patient reported pain, discomfort and esthetic satisfaction were also recorded. biopsies were obtained at 6-months.

Eligibility criteria:
inclusion criteria: * at least two non-adjacent teeth in contralateral quadrants of the same jaw with \< 2mm of kt that requires soft tissue grafting (1-4 teeth may be treated). in case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). the number of teeth treated must be the same on the test and control sites. * root coverage is not desired at the time of grafting. * females of childbearing potential must have a documented negative urine pregnancy test. * read, understood and signed an institutional review board (irb) approved informed consent form (icf). * able and willing to follow study procedures and instructions. * multi-rooted teeth may be treated but will not be included as study teeth exclusion criteria: * vestibule depth of less than 7mm from base of recession, and/or teeth with miller grade 2 or higher mobility. * any systemic conditions (i.e., diabetes mellitus, cancer, hiv, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. * presence of acute infectious lesions in the areas intended for surgery. * history of any tobacco use within the last six months. * taking intramuscular or intravenous bisphosphonates. * known hypersensitivity to collagen products, and/or allergy to iodine or shellfish. * participating in other clinical studies involving therapeutic intervention (either medical or dental). * previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site. * female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study. * subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Keywords: autologous; collagen matrix; keratinized tissue
the vidya study-designed to determine if patients with a history of basal cell carcinoma are more inclined to return for follow-up if their risk of a subsequent basal cell carcinoma is quantitated.

Conditions: Basal Cell Carcinoma

Summary: while current guidelines call for annual follow-up for patients with a history of basal cell carcinoma, compliance with these guidelines is imperfect. it is hypothesized that if patients are informed of the quantitative risk of a subsequent basal cell carcinoma based on individualized risk factors, the compliance rate for follow-up will improve. the primary objective of this study is to assess one-year compliance with requested follow-up for patients with recent history of basal cell carcinoma, among those who receive standard sun avoidance counseling and request for follow-up compared to those who receive, in addition, an estimate of their mathematical risk of a subsequent basal cell carcinoma based on individualized risk factors.

this is an open-label, single-blind study to evaluate the effect of informing subjects of their individualized risk of a subsequent basal cell carcinoma on proportion of subjects who achieve compliance with requested follow-up with a dermatology healthcare provider, defined as in-person follow-up within 365 days following diagnosis of initial basal cell carcinoma. subjects will be randomized 1:1 to "intervention" (knowledge of individualized risk) or "control" (lack of awareness of individualized risk). investigators will be aware of the modelled risk of a subsequent basal cell carcinoma for all subjects, but only subjects randomized to the "intervention" arm will be informed of their modelled risk. all subjects will receive standard sun avoidance counseling and will be requested to follow-up no later than 365 days from initial basal cell carcinoma diagnosis.

Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosed with at least one basal cell carcinoma within 30 days prior to enrollment * able and willing to answer all questions accurately in the individualized risk assessment exclusion criteria: * history of basal cell carcinoma 31 or more days prior to enrollment * solid organ transplant recipient * history of immunodeficiency (e.g., hiv infection, aids, genetic immunodeficiency * prisoner * psychiatric inpatients or people who are institutionalized
clinical evaluation of implant-secured removable partial denture

Conditions: Tooth Loss

Summary: this study aims to compare the therapeutic efficiency of implant-secured removable partial denture (pasi) with the therapeutic efficiency of the metalic standard removable partial denture (pac) in the treatment of intermediate extended-gap (4 adjacent teeth). the therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.


Eligibility criteria:
inclusion criteria: * patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw. * patients with at least 4 conservable teeth by dental arch, without major occlusal trouble. * patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm * patients with a sufficient bone volume for implant placement, without prior bone supply. exclusion criteria: * patients with general counter-indications for implant placement. * patients suffering from a titanium allergy. * patients with an insufficient oral and dental hygiene - patients smoking ten or more cigarettes per day. * patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture. * patient with an insufficient available bite level to deliver an attachment system (\< 7mm). * patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment. * women who have reported to be pregnant. * patients deprived of liberty
post market surveillance study evaluating biofoam surgical matrix in cardiovascular surgery

Conditions: Cardiovascular Procedures; Thoracic Aortic Aneurysm; Aortic Valve Replacement; Type A Aortic Dissection

Summary: this is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of biofoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. the overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of biofoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. this study is intended as a post-market surveillance (follow-up) study.


Eligibility criteria:
inclusion criteria: * subject is undergoing an elective cardiac or cardiovascular procedure; * subject is willing and able to give prior written informed consent for investigation participation; and * subject is \> 18 years of age. intraoperative inclusion criteria include: • subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples). exclusion criteria: * • subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde; * subject with active infection (either systemic or in the repair region); * subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the investigator; * subject diagnosed with a coagulation disorder; * subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism); * subject whose life expectancy is less than that required for the prescribed follow-up duration; * subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or * subject who is immunocompromised. intraoperative exclusion criteria include: • any major intraoperative bleeding incidences (i.e., american college of surgeons advanced trauma life support class ii, iii, or iv hemorrhage).

Keywords: type a aortic dissection (where the use of biofoam is limited to the anastomotic site)
evaluation of topical encapsulated benzoyl peroxide on the skin microbiome and skin biophysical properties

Conditions: Papulopustular Rosacea

Summary: the overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. specifically, the study objectives were to assess the following: * how the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea. * how the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.


Eligibility criteria:
inclusion criteria: * participants must sign an institutional review board (irb) approved written informed consent for this study. * male and female 18 years of age and older. * participants must have clinical diagnosis of moderate to severe rosacea. * have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose. * have 2 nodules or less. exclusion criteria: * females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at baseline or screening visits. * presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm). * current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
an open-label study of trofinetide for the treatment of girls two to five years of age who have rett syndrome

Conditions: Rett Syndrome

Summary: to investigate the safety and tolerability of long-term treatment with oral trofinetide in girls with rett syndrome


Eligibility criteria:
inclusion criteria: * female subject 1. 2 to 4 years of age and body weight ≥9 kg and \<20 kg at screening or 2. 5 years of age and body weight ≥9 kg and \<12 kg at screening * can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube * the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments * has classic/typical rett syndrome (rtt) or possible rtt according to the rett syndrome diagnostic criteria * has a documented disease-causing mutation in the mecp2 gene * has a stable pattern of seizures, or has had no seizures, within 8 weeks prior to screening * subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 4 weeks prior to screening exclusion criteria: * has been treated with insulin within 12 weeks of baseline * has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study * has a history of, or current, cerebrovascular disease or brain trauma * has significant, uncorrected visual or uncorrected hearing impairment * has a history of, or current, malignancy * has any of the following: 1. qtcf interval of \>450 ms at screening or baseline 2. history of a risk factor for torsades de pointes (e.g., heart failure or family history of long qt syndrome) 3. history of clinically significant qt prolongation that is deemed to put the subject at increased risk of clinically significant qt prolongation 4. other clinically significant finding on ecg at screening or baseline additional inclusion/exclusion criteria apply. patients will be evaluated at baseline to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).
mastectomy with retention of the nipple-areola complex, robot-assisted or not, and / or immediate or seconday reconstruction by latissimus dorsi flap, robot-assisted or not.

Conditions: Mastectomy; Breast Reconstruction

Summary: phase iii, non-randomized, monocentric, observational, prospective trial. it is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

phase iii, non-randomized, monocentric, observational, prospective trial. it is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, 2. signed consent to participate, 3. women with breast cancer over 18 or at high risk of breast cancer (brca 1-2 mutations, palb2, extensive border lesions) 4. mastectomy with conservation of the areolo-mammary plaque, or mastectomy without conservation of the areolo-mammary plaque and conservation of the skin case 5. mastectomy without conservation of the areolo-mammary plate, immediate breast reconstruction by prosthesis, 6. immediate breast reconstruction by autologous latissimus dorsi flap 7. immediate breast reconstruction by latissimus dorsi flap and prosthesis, 8. secondary breast reconstruction by latissimus dorsi flap 9. affiliation to, or beneficiary of, a social security scheme. exclusion criteria: 1. patient under 18, 2. pregnant woman or likely to be (without effective contraception) or breastfeeding, 3. person in emergency situation, adult person subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or out of state to express his consent, 4. inability to submit to medical follow-up for the trial for geographic, social or psychological reasons.

Keywords: robot-assisted mini-invasive surgery
correlation between epistaxis and cardiovascular disease

Conditions: Cardiovascular Disease; Epistaxis

Summary: investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. as a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder.

this study is prospective observational single blinded study. a participant is visit in the er who patient with epistaxis. investigators will enroll 50 patients with epistaxis. exclusion criteria is that patient needs immediately treatment for hypertensive urgency or patient with nasal trauma. investigators examine blood-pressure (bp) at five times in emergency department (ed) and out-patient department (opd) of otorhinolaryngology (ol) . investigators explain this study and ask to write consent for participant. after proper management of epistaxis, investigators get blood sampling of the participant and, the participant has a reservation to "opd of cardiovascular division of internal medicine" (cv opd) in the hospital. when the participant visit cv opd, the participant undergo 24-hours-bp-monitoring and pulse wave velocity (pwv). after that, the participant will be follow-up for 3 months. investigators collect 50 data from 50 participants as a registry and analyze the data.

Eligibility criteria:
group a inclusion criteria: * age is over 18 with spontaneous epistaxis exclusion criteria: * they needs immediately treatment for hypertensive urgency. * they don't want to participate in this investigation. group b inclusion criteria: * age is over 18 with bleeding of wound exclusion criteria: * their wounds' condition is serious or their pain is much severe. * they don't want to participate in this investigation.