Kornimate/medical-research-clean huggingface dataset:
efficacy of teeth whitening product offerings in adults

Conditions: Tooth Discoloration

Summary: this is a 30 day randomized, parallel comparative trial where participants with tooth shade of c2 or darker will be assigned to one of five groups. the participants will be evaluated for the difference in tooth shade, as determined by the digital vita easyshade v (provided by glo) before the respective whitening regimen (baseline), immediately following the treatment period, and at 30 days (\~4 weeks) from end of the treatment intervention.


Eligibility criteria:
inclusion criteria: * provide written informed consent to participate in the study. * be 18 to 65 years of age. * agree not to participate in any other oral/dental product studies during the trial. * agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed. * agree to refrain from the use of any other teeth whitening products once assigned to a treatment group. * agree to refrain from the use of any oral care products that may cause staining (chlorhexidine rinses, stannous fluoride toothpaste, etc.). * agree to return for all scheduled visits and follow study procedures. * be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study. * have at least 4 gradable maxillary anterior teeth ( canine to canine) with a vita shade average score of c2 or darker. * be willing to refrain from consuming stain-causing food and beverages (i.e., coffee, tea, red wine, berries, etc.) during the initial treatment duration (treatment period excluding the 4 week follow up). * be a current or recent non-smoker (no smoking for at least 3 months). exclusion criteria: * are undergoing treatment for gingivitis, periodontitis, or caries. * presence of self-reported tooth sensitivity. * present with fixed orthodontic appliances on the facial surfaces of the maxillary arch. * have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth ( canine to canine) or mandibular anterior teeth. * have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, exposed root surfaces (generalized recession), tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised. * present with any pre-existing oral or medical condition that the investigator/designee determines may place the subject at increased health risk from study participation. * have meaningful malocclusion that would impact treatment or ease of viewing/scoring maxillary anterior teeth. * have teeth with severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis or hypocalcification. * have any known allergies to over-the-counter oral hygiene/whitening products. * have any known allergies to the trial product ingredients. * are pregnant and/or breastfeeding. * are current smokers.

Keywords: teeth whitening teeth bleaching tooth discoloration
nexium response trial

Conditions: GERD

Summary: the primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.


Eligibility criteria:
inclusion criteria: * patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the gp would prescribe an acid-inhibiting agent exclusion criteria: * alarm symptoms * pregnancy * contraindications to nexium

Keywords: acid reflux nexium esomeprazole
blood donation could improve insulin sensitivity

Conditions: Ferritin; Insulin Sensitivity; Blood Donation

Summary: studies in the literature suggest that people with obesity have an excess of stored iron. there is possibly an inverse relationship between ferritin levels and the actions of insulin on glycemic control. the reduction of stored iron by simply donating blood could result in improvements in glycemic control in people with obesity and prediabetes. we propose, to reduce ferritin levels through a standard donation of a unit of whole blood, and to measure if it positively affects glycemic control.

individuals with pre-diabetes and abdominal obesity will be randomized to either a donation group (don) or a control group (cont) in a double-blind fashion (rct). insulin sensitivity during an oral glucose tolerance test (ogtt) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions. 1. two weeks prior to don/cont 2. two weeks after to don/cont indexes of the bodily iron stores will be measured after don/cont to evaluate if the primary treatment was effective.

Eligibility criteria:
inclusion criteria: * have not donated in the last 3 months * imc\>25 * fasting blood glucose 100-125 mg/dl * glycosylated hemoglobin levels between 5.7-6.4% exclusion criteria: * to not meet donor bank requirements * insulin treatment for diabetes * anemia * hereditary hemochromatosis * heart disease * familial hypertriglyceridemia or hypobetalipoproteinemia * any disease that requires medication that interferes with iron or glucose metabolism
the safety and efficacy of anidulafungin versus comparator in patients with candidemia and invasive candidiasis

Conditions: Candidiasis

Summary: anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. these infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.

anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility criteria:
* diagnosis of candidemia and/or other forms of invasive candidiasis. * should not have received greater than 48 hours of systemic antifungal therapy. * life expectancy should be greater than 72 hours. * should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment

Keywords: candida blood stream infections candida infections candidemia invasive candidiasis
external focus of attention posttraumatic osteoarthritis

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Osteo Arthritis Knee

Summary: knee injuries, especially those to the acl, are common among physically active people. these injuries are frequently treated with surgical reconstruction (acl reconstruction; aclr). while aclr restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. if you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. after this initial assessment, you will be randomly allocated to one of 2 treatment groups. each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.


Eligibility criteria:
inclusion criteria: * history of primary, unilateral acl reconstruction 6-24 months prior to enrollment * cleared to return to full activity by treating orthopedic surgeon exclusion criteria: * body mass index \>35 kg/m2 * history of musculoskeletal injury sustained 3 months prior to enrollment * current participation in formal post-operative rehabilitation
traditional dietary advice versus low fodmap diet in postprandial functional dyspepsia

Conditions: Dyspepsia; Functional Gastrointestinal Disorders

Summary: functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (pds) variant. however, studies evaluating dietary modifications in pds are sparse. the investigators will perform a randomised trial evaluating traditional dietary advice (tda) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low fodmap diet) in pds. 70 patients with pds will be randomly assigned tda or a low fodmap diet. the tda group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. the low fodmap diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners. questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated leuven postprandial distress scale (lpds), gastrointestinal symptom rating scale, and nepean dyspepsia quality of life index. the primary endpoint to define clinical response will be evaluated over weeks 4-6 as \>0.5-point reduction in the pds subscale of the lpds (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).


Eligibility criteria:
inclusion criteria: * fulfil rome iv symptoms criteria for postprandial functional dyspepsia * normal upper gastrointestinal endoscopy within last 3years * online access * english literate exclusion criteria: * organic gastrointestinal diseases (e.g. inflammatory bowel disease, gi cancer, coeliac disease) * major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy) * documented h.pylori in the last 3 months * history of eating disorders * body mass index \<20 * current dietary interventions * current use of opioids or anti-inflammatory drugs * severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations) * pregnant * diabetes mellitus * scleroderma * memory impairment
effect of global postural reeducation (gpr) program with hamstring stretch for patients with low back pain

Conditions: Back Pain

Summary: the purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.

low back pain (lbp) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. lbp is a complicated condition which affects the physiological and psychosocial aspects of the patient. the muscles of the low back provide the strength and mobility for all activities of daily living. the purpose of this study is to find out the additional effect of global re-education program with hamstring stretching in patients with low back pain.

Eligibility criteria:
inclusion criteria: * females * 18-35 years * low back pain \> 3 month * no exercise for last 6 months exclusion criteria: * any diagnosed pathology (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis) * any lower limb abnormality * congenital deformities * central or peripheral neurologic signs * systemic illness (tumor and rheumatologic diseases), * psychiatric and mental deficits * diabetic neuropathy

Keywords: low back pain oswestry disability index numeric pain rating scale stretch
anterolateral watson jones approach versus transgluteal approach for uncemented hemi- arthroplasty in displaced femoral neck fracture

Conditions: Femoral Neck Fracture

Summary: hemiarthroplasty is a well established treatment of femoral neck fractures in the elderly. during the last decade the use of minimal invasive surgical( mis) approaches have been increasing. our hypothesis is that patients with a femoral neck fracture may benefit from a mis approach.

the study's main objective: the purpose of the study is to test the following hypothesis. patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by proms than patients operated through the lateral approach. the study's subsidiary objectives. we aim to shed light on the following subsidiary hypotheses. 1. a hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by dexa around the stem, than a hemiarthroplasty inserted via a direct lateral approach. 2. a hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by ck, than a direct lateral approach

Eligibility criteria:
inclusion criteria: patients 70- 85 years of age - exclusion criteria: dementia, infection not suitable for hemiarthroplasty -

Keywords: femoral neck fracture anterolateral approach trans-gluteal approach watson jones approach hardinge approach
oral vancomycin vs placebo in the prevention of recurrence of clostridioides difficile's infection

Conditions: Clostridioides Difficile Infection

Summary: a phase iii randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. the main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of clostridioides difficile infection (cdi) in patients who suffered previous cdi and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first cdi.

as secondary objectives the investigators intend to: * evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent icd in patients with previous icd episodes stratified by the number of previous recurrences. * compare the severity of recurrences in both study groups. * compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed. * evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance. * evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of icd recurrences.

Eligibility criteria:
inclusion criteria: * age equal or superior to 18 years * previous history of clostridioides difficile infection in the 90 days before the study enrolment * need for hospitalization and need of antibiotic therapy * signature of informed consent exclusion criteria: * woman of childbearing age, pregnant woman, or breastfeeding woman * hypersensitivity to vancomycin * inability to comply with study protocol * critically ill condition or life expectancy less than 30 days * patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea * fulfilment of the criteria for diarrhea or diagnosis of cdi at the time of assessment for eligibility or in the previous 3 days * therapy with oral vancomycin or any other agent with activity against c. difficile for \>48 hours in the previous 3 days;. * prophylaxis with oral vancomycin or any other agent with activity against c. difficile within the 70 days before the assessment for eligibility * systemic antibiotic therapy for 72 hours or more before the recruitment * ongoing enrolment in another rct evaluating the effectiveness of other drugs * estimated use of systemic antibiotic therapy for more than 4 weeks

Keywords: vancomycin oral capsules
a gilead sequence registry of subjects who did not achieve sustained virologic response

Conditions: Hepatitis C, Chronic

Summary: this registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (svr) while receiving at least one gilead oral antiviral agent (oav) in a previous gilead-sponsored hepatitis c virus (hcv) study.


Eligibility criteria:
key inclusion criteria: * have previously participated in a gilead-sponsored hepatitis c study and received at least one gilead oav * have failed to achieve an svr in a previous gilead-sponsored study, as defined in the original treatment protocol * provide written, informed consent * be willing and able to comply with the visit schedule key exclusion criteria: * individuals planning to start a new course of hepatitis c therapy including any investigational drug or device during the course of the follow-up registry * history of clinically significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis c hcv sustained virologic response direct acting antiviral combination therapy tegobuvir registry hcv rna treatment experienced treatment naive gs 9451 gs 5885 sequence gs 5816 gs 7977 sofosbuvir sovaldi™ sof ledipasvir ldv
evolution of cochleovestibular schwannomas

Conditions: Schwannoma

Summary: investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 mris during a span of more than 2 years. they will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease. the secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.


Eligibility criteria:
inclusion criteria: * age over 18 years * having a typical vestibular schwannoma diagnosis during the first mri, having a minimum of 3 internal auditory canal mris on the same machine (signa hdxt, general electric, strasbourg, france) ) at the hôpitaux universitaires de strasbourg * patients consenting to participate exclusion criteria: * intra-labyrinthical extension * treatment before the 3 mris * no injection of gadolinium * atypical diagnosis

Keywords: schwannoma cochleovestibular schwannomas cochleovestibular intra labyrinthine schwannoma
effect of iron therapy as an adjunct to epoetin alfa in the anemia of cancer chemotherapy

Conditions: Anemia

Summary: this study evaluates the safety and efficacy of ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of nonmyeloid malignancy * moderate to severe anemia * adequate iron stores as measured by either tsat or ferritin * about to start cycle of chemotherapy * eligible for epoetin alfa therapy exclusion criteria: * highly elevated tsat or ferritin * recent transfusion, epoetin alfa, darbepoetin or intravenous iron * medical conditions that would confound the efficacy evaluation

Keywords: iron deficiency sodium ferric gluconate anemia cancer chemotherapy epoetin alfa anemia/drug therapy anemia, iron-deficiency/drug therapy/etiology hematinics/administration & dosage/pharmacology antineoplastic agents/adverse effects erythropoietin, recombinant/therapeutic use/adverse effects
effect of preemptive intramuscular diclofenac on minimal effective-dose bupivacaine saddle block for minor perianal surgeries

Conditions: Postoperative Pain

Summary: the research will be carried out in order to test the effect of intramuscular (im) diclofenac, administered as preemptive analgesic with minimal effective dose spinal anesthesia in perianal surgeries, on prolonging the time to first request for analgesic and lowering analgesic consumption. investigators hypothesized that using im diclofenac in this surgery will postpone the time to first analgesic request and will decrease the consumption of post-operative analgesics. our method includes dividing the patients into control and study groups and recording the first analgesic request and post-operative analgesic consumption after surgery and comparing the results.

effective control of post-operative pain is an issue that has been repeatedly emphasized and has received an increasing amount of attention in the past few years (1, 2). opioids, despite their side effects, are still the main cornerstone in managing acute postoperative pain (3). preemptive analgesia refers to the administration of effective analgesia prior to surgical trauma. the main mechanism of preemptive analgesia is desensitization of the central nervous system and prevention of pain before its onset. (3). non-opioid preemptive analgesics are commonly used to increase analgesic efficacy and patient satisfaction as well as to reduce opioid consumption and side effects. saddle anesthesia is a selective spinal anesthesia that is commonly used for perianal surgeries (4-7). investigators previously performed a prospective up-down sequential allocation study to evaluate the minimum effective dose of hyperbaric bupivacaine that is needed for inducing a satisfactory and reliable saddle block for perianal surgeries that was restricted to the most caudal spinal nerve roots (s4-coccygeal) that supply the perianal region (8). although the block produced no motor block in the lower limbs (thus allowing early ambulation), rapid sensory recovery resulted in early request of analgesia and increased opioid consumption. in this prospective, randomized, double blinded, placebo controlled clinical trial, investigators hypothesize that a single dose of im diclofenac administered before spinal anesthesia, will decrease postoperative pain, and delay and reduce postoperative analgesic requirement in patients undergoing minor perianal surgeries under minimal effective-dose bupivacaine saddle block

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i and ii scheduled for elective outpatient perianal surgery in the lithotomy position (hemorrhoidectomy, fistulectomy) exclusion criteria: * contraindications to regional anesthesia, bleeding disorders, are morbidly obese, suffer from mental health problems, are on analgesic medication or psychotropic drugs, have a known history of allergy to amide local anesthetic drugs, if there is a language barrier, or if they are unwilling to participate
tfl driven urinary system treatment study

Conditions: Urologic Diseases

Summary: the goal of this observational study is: to assess the use of coloplast tfl drive in daily practice to confirm: * the safety and efficacy of the coloplast tfl drive and its gui (graphical user interface) with pre-embedded settings in laser lithotripsy * the safety and efficacy of the coloplast tfl drive and its gui with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia * the safety and efficacy of the coloplast tfl drive and its gui with pre-embedded settings for ablation of urological tumors


Eligibility criteria:
inclusion criteria: * any adult patient, for which tfl laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, bph (benign prostate hypertrophy...) exclusion criteria: * any condition when tfl laser should not be indicated as per the tfl user manual (untrained surgeon on laser use, patient's conditions) * patients with no signed consent form * patients \<18 years old * patients under tutorship or guardianship * patients who already took part in the study * pregnant or breastfeeding women * patient undergoing 2nd step laser procedure at inclusion * subject already included in another study