Kornimate/medical-research-clean huggingface dataset:
assessment of diagnostic and therapeutic practices for cardiac implantable electronic devices suspected infections in nancy university hospital

Conditions: Cardiac Implantable Electronic Device Infections

Summary: the frequency of cardiac implantable electronic devices (cied) is constantly increasing. devices infections are one of the most serious complications in terms of morbidity and mortality. although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing. the infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. the diagnosis is based on clinical, biological and multimodal imagery data. early diagnosis and specific management are necessary to reduce mortality and morbidity. since the last european recommendations on infectious endocarditis in 2015, the heartrythm society of patient described an algorithm to treat cied infections and extraction indications. however, in practice, management of ceid infections remains center-dependent and data from robust international studies are missing. the main objective of our study is to evaluate the management of ceid suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the nancy university hospital and to compare the treatment with the latest recommendations in force


Eligibility criteria:
inclusion criteria: * all patients who have been hospitalized in nancy university hospital between january 2014 et july 2019 for suspected infection of cardiac implantable electronic device exclusion criteria: * minor patients * epicardial cied
study comparing appearance and function of three different dental implant designs when placed in front region of upper jaw

Conditions: Jaw, Edentulous, Partially

Summary: the primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. the changes from baseline to one year after will be compared. the null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.


Eligibility criteria:
inclusion criteria: * provision of informed consent * at least 18 years * in need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24 the following should be considered at inclusion but can not be fulfilled until at visit 2: * edentulous for at least 5 months at study site * a buccal-lingual bone width at study site of at least 5.5 mm * a mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm * a keratinized mid-buccal mucosal height of at least 2 mm at study site * teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (\>1 mm) and/or significant soft tissue loss * teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions * an opposing dentition with teeth, implants or prosthesis exclusion criteria: * insufficient interocclusal distance for implant placement and restoration at study site * tooth adjacent (mesial and/or distal) to study site is ankylosed * more than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth * site development (bone tissue) performed at less than 5 months before visit 2 at study site * untreated rampant caries and/or uncontrolled periodontal disease * class ii division 2 malocclusion (edward hartley angle) * use of tobacco within last 6 months * uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent diabetes mellitus) * current alcohol or drug abuse * systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * use of any substance that will influence bone metabolism * need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration * history of radiation in the head and neck region * known pregnancy, pregnancy tests will be performed as per local requirements. * unable or unwilling to return for follow-up visits for a period of 5 years * unlikely to be able to comply with study procedures according to investigators judgement * involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study center) * previous enrollment or randomization of treatment in the present study.
luteal phase support with progesterone versus estrogen and progesterone on pregnancy rates

Conditions: Unexplained Infertility; Mild Male Factor

Summary: this is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and iui cycles with recombinant fsh in patients with unexplained infertility and mild male factor. patients will be randomized into 3 groups: 1. luteal support with progesterone only (they will received vaginal p gel (crinone 8% vaginal gel; serono, israel) 2. luteal support with estrogen + progesterone \[(crinone 8% vaginal gel; serono, israel) and estrofem 4mg\]. 3. no luteal support

study design: single center, 3 arms, prospective randomized controlled open study objective: to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and iui cycles with recombinant fsh in patients with unexplained infertility and mild male factor. methods: all patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups: 1. luteal support with progesterone only (they will received vaginal p gel (crinone 8% vaginal gel; serono, israel) 2. luteal support with estrogen + progesterone \[(crinone 8% vaginal gel; serono, israel) and estrofem 4mg\]. 3. no luteal support luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. a pregnancy test will be performed 2 weeks after insemination (serum hcg) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. if no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.

Eligibility criteria:
inclusion criteria: 1. couples with diagnosis of unexplained infertility 2. in their treatment cycle with ovarian stimulation and iui using recombinant fsh in our institution. exclusion criteria: 1. female partners with one or more of the following: * previous ovarian surgery * one ovary * polycystic ovaries on ultrasound examination * other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism) * past ovarian hyperstimulation or hyperstimulation during the study period * diminished ovarian reserve (basal fsh level \>15 iu/ml) * age of \>40 years 2. sever male factor \< 5 million total motile sperm on the day of insemination.

Keywords: unexplained infertility insemination luteal phase support ovarian stimulation
study of diclofenac capsules to treat pain following bunionectomy

Conditions: Other Acute Postoperative Pain

Summary: the purpose of this study is to determine whether diclofenac \[test\] capsules are safe and effective for the treatment of bunionectomy pain.


Eligibility criteria:
inclusion criteria: * patient is male or female between 18 and 65 years of age * for women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures * patient must be willing to stay at the study site ≥ 72 hours exclusion criteria: * patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs * patient has a current disease or history of a disease that will impact the study or the patient's well-being * patient has used or intends to use any of the medications that are prohibited by the protocol * patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test * patient has taken another investigational drug within 30 days prior to screening
evaluating the effect of tranexamic acid on the clinical outcomes in patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. this could potentially lead to improved treatment protocols and better outcomes for this vulnerable population.


Eligibility criteria:
inclusion criteria: 1. age less than 18 years old 2. clinical diagnose of trauma to the head and gcs score less than or equal to 13 with associated intracranial haemorrhage on cranial ct scan 3. time of admission within 3 hour of injury. exclusion criteria: 1. patient known pregnancy. 2. patient had cardiac arrest prior to randomization 3. gcs score of 3 with bilateral unresponsive pupils 4. known bleeding/clotting disorders. 5. known seizure disorders. 6. known history of severe renal impairment 7. unknown time of injury 8. prior txa for current injury 9. known venous or arterial thrombosis
effect of different suture techniques on early healing of peri-implant soft tissue

Conditions: Dental Implants; Wound Healing; Sutures

Summary: the purposes of this study are to compare the blood perfusion and early healing of horizontal mattress suture with vertical mattress sutures following open-flap implant surgery. patients wanting single implant replacement in esthetic area will be recruited. this is a randomized, open-label, controlled clinical trial. noninvasive procedures will be used to assess the primary and secondary outcomes. inclusion criteria: with sufficient bone width (≥6mm), with mesial-distal distance over 8mm, age over 18, willing to participate exclusion criteria: patients want multiple adjacent implant replacements in esthetic area, untreated periodontitis, smokers, diabetes mellitus

the overall aim of this study is to compare the microcirculation changes of peri-implant soft tissues following open-flap implant surgery using different suture techniques. subjects fulfilling the inclusion and exclusion criteria will be invited to participate in the study and randomized to one of the two groups: vertical mattress suture (test group) and horizontal mattress suture (control group) on a 1:1 ratio. a laser doppler flowmetry machine (ldf) (lw1111, lea) will be used to measure the tissue perfusion. assessment will be performed at different time, including: baseline assessments (presurgical measurements) - t0; immediate after anesthesia - t1; immediate after suture - t2; 1 hour after surgery - t3; 2 hours after surgery - t4; 6 hours after surgery - t5; 24 hours after surgery - t6; 72 hours after surgery - t7; 7 days after surgery - t8; 14 days after surgery - t9; 30 days after surgery - t10. the primary outcome is blood perfusion volume (pu) change during the observation period. and secondary outcomes include blood flow velocity change during the observation period, hemoglobin count change during the observation period, blood oxygen saturation change during the observation period; three-dimensional soft-tissue volumetric changes during the observation period, changes in clinical wound healing score during the observation period, proms (vas).

Eligibility criteria:
inclusion criteria: 1. aged 18 and above 2. subjects want single implant treatment in esthetic area (premolar to premolar) in maxilla 3. with sufficient bone width (≥6mm) 4. with mesial-distal distance over 8mm 5. evidence of subject ability to achieve good oral hygiene and control periodontitis in the whole of the dentition (fmps\<20% and fmbs\<20%) 6. ability to understand study procedures and to comply with them for the entire length of the study. ability and willingness to give written informed consent. exclusion criteria: 1. subjects want multiple adjacent implant treatment 2. patients with inadequate bone volume where major bone augmentation would be required at implant location. 3. subjects with untreated periodontitis 4. current smokers 5. subjects with diabetes mellitus. 6. pregnant females 7. participation in another intervention trial 8. inability or unwillingness of individual to give written informed consent.
biomarkers in patients undergoing transrectal ultrasound prostate biopsy

Conditions: Prostate Cancer

Summary: rationale: collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.

objectives: primary * identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy). secondary * collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine. outline: this is a pilot study. patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. patients then undergo a transrectal ultrasonography prostatic biopsy. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer patient characteristics: * no prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin * no serious medical or psychiatric illness that would preclude informed consent * no concurrent acute illness prior concurrent therapy: * no participation in another clinical trial within the past 30 days * no more than one enrollment into this study

Keywords: prostate cancer
safety of apslxr in patients presenting vertigo of vestibular origin or meniere's disease

Conditions: Meniere Disease; Vertigo; Vertigo Vestibular

Summary: the purpose of this study is to evaluate the safety of apslxr in participants with meniere's disease or other verigo of vestibular origin. pharmacokinetics will also be evaluated in a small group.


Eligibility criteria:
inclusion criteria: * diagnosis of meniere's disease or vertigo of vestibular origin; * voluntarily consent to participate in the study; exclusion criteria: * female patients who are pregnant or breastfeeding; * participants presenting uncontroled systolic hipertension (\>140/90 mmhg); * participants presenting uncontroled diabetes (blood glucose \>200 mg/dl).
safety and efficacy of sofosbuvir/velpatasvir/voxilaprevir in adults with chronic hcv infection who have previously received treatment with direct-acting antiviral therapy

Conditions: Hepatitis C

Summary: the primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (sof/vel/vox) in adults with chronic hepatitis c virus (hcv) infection who have previously received treatment with direct-acting antiviral therapy. participants randomized to placebo may be eligible for deferred treatment with active sof/vel/vox.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml at screening * chronic hcv infection (≥ 6 months) * treatment experienced with a direct acting antiviral medication for hcv * use of protocol specified methods of contraception key exclusion criteria: * current or prior history of clinically significant illness that may interfere with participation in the study * screening ecg with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * pregnant or nursing female * chronic liver disease not caused by hcv * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: chronic hepatitis c infection
the analysis of skin temperature by long wave infrared imaging to determine its effectiveness as a predictor of tissue injury

Conditions: Pressure Ulcers; Tissue Injury

Summary: long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. we want to determine if the use of long wave infrared imaging is as effective as the braden score in predicting nosocomial pressure ulcers.

the trillennium medical imaging system will be used to gather skin temperature data on 100 subjects. the subjects will be enrolled from duke north floors 8100 or 8300 in a prospective controlled trial. all eligible patients who have signed a consent form will be assessed using the long wave infrared imaging. subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. the intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. the subjects who already have an ulcer will only be scanned on non ulcerated tissue. the areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. the device will be held approximately 36 inches from the area of interest in order to obtain an image. the subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. the subject's routinely recorded braden scores (by on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the imaging system. the nurse conducting the imaging will also record a braden score. all subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.

Eligibility criteria:
inclusion criteria: * to be admitted to 8100 or 8300 and be willing to participate in the study exclusion criteria: * unwillingness to participate

Keywords: pressure ulcers tissue injury
efficacy & tolerability of a specific plantain,thyme and honey cough syrup vs placebo in child cough due to common cold

Conditions: Cough

Summary: cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. the intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. cough is assessed with a validated parent questionnaire. the degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results. a parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has not been done so far, in very young children, especially in a time frame of 4 days. the intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. the degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days. assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.

Eligibility criteria:
inclusion criteria: * cough attributed to infection of the upper respiratory tract since less or equal than 7 days, * children aged 1 to 5 years * score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent, * score of at least three of all questions assessing daytime cough considering the day prior to study entry * written consent by a parent. exclusion criteria: * children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies, * children who received antihistamines or any cough medicine the day prior to study entry, * the administration of any steroid preparation by oral administration or inhalation on the day prior to study entry, * known sensitivity to any component of placebo or to plantago lanceolata or thymus vulgaris, honey or any other component of the cough syrup.