Kornimate/medical-research-clean huggingface dataset:
bioactive surfaces vs. conventional surfaces in implants placed in atrophic maxilla with simultaneous sinus lift

Conditions: Edentulous; Alveolar Process, Atrophy; Edentulous Alveolar Ridge Atrophy

Summary: in this controlled clinical study, a maxillary sinus lift (crestal approach) with ossix® bone will be performed, and then implants multineo cs (control group) and nina multineo nh (test group) will be inserted in edentulous posterior maxillae of study subjects. .+the clinical and radiographic results of the rehabilitation of posterior edentulous maxillary areas, obtained with traditional surface implants (multineo cs, control group), are compared with those obtained with bioactive surface implants (nina - multineo nh, test group ).

in this post- market controlled clinical study, the tested ce-marked dental implants are multineo cs 1930 and nina multineo nh 9330, both manufactured by alpha-bio tec. neo or multineo is defined as a system since it includes three types of connections: a conical narrow connection (chc), a conical standard conical connection (cs) and an internal hex connection (ih). the fixture has a straight coronal part, a slightly tapered body, and a conical apical part. we will use multineo cs to treat control group. one of the multineo cs biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3. multineo cs has an implant surface with a sub-micron scale roughness created by aluminum oxide blasting and double acid etching. nina multineo nh is used for tret group, it has got an innovative bioactive surface. nina multineo nh surface is a combination of the abovementioned roughening process and the creation of titanium oxide nano structure. its hydrophilic part is created by resorbable salt thus maintaining its hydrophilicity patient requiring sinus floor elevation with native bone crest height \> 4 mm will be enrolled.although a variety of implant surface are available for implant supported rehabilitation, the first hypothesis is that nina multineo nh alpha-bio tec will be present faster osteointegration time compared to multineo cs when adopted to rehabilitate of missing teeth in case of critical areas such as in the posterior mandible with critical bone defects. the second hypothesis is that nina multineo nh will promote a better apical bone regeneration in patients treated with sinus lift compared to multineo cs due to its bioactive surface.

Eligibility criteria:
inclusion criteria: * edentulous posterior maxillae * residual bone height \> 4mm * healthy periodontal conditions exclusion criteria: * smokers over 5 cigarettes/day * pregnancy (confirmed by verbal inquiry) * chronic systemic pathologies and neoplastic of the oro-facial district * bisphosphonates intake * any sites where an implant already failed sites * untreated periodontitis * sites with acute infections * chronic inflammatory diseases of the oral cavity * autoimmune diseases (cortisone intake) * allergy declared to one or more medicaments to be used during treatment * alcoholics patients and/or drug addicts * collagen hypersensitivity.

Keywords: dental implant implant surface sinus lift sinus floor elevation
duloxetine compared to escitalopram and placebo in the treatment of patients with depression

Conditions: Depression

Summary: the purposes of this study are to determine: * the safety of duloxetine and any side effects that might be associated with it. * how duloxetine compares to escitalopram and placebo (an inactive ingredient)

duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,

Eligibility criteria:
inclusion criteria: * must be at least 18 of age * must meet the criteria for major depressive disorder * you must be able to visit the doctor's office about once a week for 2 to 3 months. after that, you will need to visit the doctor's office once a month for about 6 months * you must be able to take the study drug as prescribed (6 capsules per day taken once-daily) exclusion criteria: * you are a woman and are pregnant or breastfeeding. * you have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. * you have a history of alcohol or drug dependence within the past 6 months
use of v care in abdominal hysterectomy

Conditions: Uterine Fibroid

Summary: the investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.


Eligibility criteria:
inclusion criteria: * benign causes for hysterectomy exclusion criteria: * malignant causes for hysterectomy
observational study of muscle invasive urothelial carcinoma participants treated with adjuvant nivolumab in france

Conditions: Urothelial Carcinoma

Summary: this study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (miuc) in france.


Eligibility criteria:
inclusion criteria: * participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (pd-l1) tumour cell expression ≥ 1%: * who received neoadjuvant chemotherapy or * who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy * at least 18 years of age at the time of treatment decision * decision to treat with adjuvant nivolumab therapy has already been taken * participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively) exclusion criteria: * participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (os) can be enrolled. patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities). * pregnant women * participants under guardianship
effect of oral n-acetyl cysteine in prevention of necrotizing enterocolitis in preterm neonates with feeding intolerance

Conditions: Preterm Neonates and Feeding Intolerance; Necrotizing Enterocolitis; Oral N-acetyl Cysteine

Summary: necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications. n-acetyl cysteine is an fda- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.


Eligibility criteria:
inclusion criteria: * preterm neonates (less than or = 36 weeks gestational age ) * feeding intolerance exclusion criteria: * active gastro-intestinal tract bleeding * gastro- intestinal tract surgical problem * congenital gastro-intestinal tract anomalies * evidence of allergy to nac * use of prebiotics or probiotics

Keywords: preterm neonates neonates feeding intolerance necrotizing enterocolitis prematurity n-acetyl cysteine oral n-acetyl cysteine
amnion chorion membrane and oroantral communication

Conditions: Oroantral Communication

Summary: an oroantral communication is a relatively common yet, serious complication following the extraction of posterior maxillary teeth because of their close relationship to the maxillary sinus. several surgical techniques exist for the repair of oroantral communication, including local and free flaps, tissue expansion, allogenic tissue, and biomaterials. the present study aims to evaluate the use of the bioxclude amnion chorion membrane in the repair of oroantral communication.

this study will be performed on ten patients who have oroantral communication after extracting posterior maxillary teeth. the oroantral communication will be repaired by using the bioxclude amnion chorion membrane.

Eligibility criteria:
inclusion criteria: * patients should be free of any relevant systemic diseases. * patients with recent oroantral communication (o.a.c) (24:72) hours . * good oral hygiene exclusion criteria: * an immune compromised state. * previous sinus disease. * history of sinus surgery. * presence of intra-antral foreign bodies and need for cold well-luc procedure. * presence of intra-sinus pathology
prospective cohort study of complications and outcomes in cirrhosis

Conditions: Decompensated Cirrhosis; CMV Reactivation; Overt Hepatic Encephalopathy

Summary: this is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on cytomegalovirus (cmv) reactivation, bacterial infections, hepatic encephalopathy, and hepatorenal syndrome. patients diagnosed with acutely decompensated cirrhosis were enrolled. upon enrollment, detailed baseline data were collected and samples were harvested. complications were assessed during hospitalization. post-discharge follow-up was conducted through telephonic interviews at day 30 and day 90.

this is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on cmv reactivation, bacterial infections, hepatic encephalopathy, and hepatorenal syndrome. patients diagnosed with acute decompensated cirrhosis were enrolled. upon enrollment, detailed baseline data were collected and samples including ascites, feces, plasma, urine and pbmc were harvested. following enrollment, patients were subjected to a rigorous follow-up regimen extending over a period of 90 days. complications were assessed every 3-4 days during hospitalization through a combination of laboratory and clinical evaluations. post-discharge follow-up was conducted through telephonic interviews at day 30 and day 90. upon the emergence of new complications, such as infections (viral, bacterial or fungal) or hepatic encephalopathy, a detailed, complication-specific protocol was activated (per complications protocols as follows). special complications protocols: hepatic encephalopathy: 1. the feces, plasma, and urine were collected at hepatic encephalopathy diagnosis before treatment and at day 4, 7, 14 since hepatic encephalopathy treatment. if patients were discharged before14 days post-hepatic encephalopathy, the sample at discharge were collocated; 2. the treatment strategy for he is recorded; 3. the he severity assessments were carried out daily. cmv reactivation: 1. the patients' plasma were collected twice a week for the assessment of cmv reactivation; the patients' peripheral blood mononuclear cells (pbmc) samples were collected at baseline and at the time of diagnosis of cmv reactivation; 2. the treatment strategy for cmv is recorded.

Eligibility criteria:
inclusion criteria: * informed written consent * age between 18 years and 80 years * cirrhosis based on liver histology or a combination of characteristic clinical, biochemical, and imaging features * complications of decompensated cirrhosis (ascites, gastrointestinal bleeding and hepatic encephalopathy) exclusion criteria: * malignancy * acquired immune deficiency syndrome * received immunosuppressive drugs for non-hepatic reasons * received organ transplantations
specimens from normal controls

Conditions: Viral Infections

Summary: the viral epidemiology branch (veb) of the national cancer institute (nci) conducts research on viral infections and their associations with various diseases including aids and cancer. for some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. this protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

the viral epidemiology branch (veb) of the national cancer institute (nci) conducts research on viral infections and their associations with various diseases including aids and cancer. for some research questions, specimens are available from "case" subjects as part of ongoing protocols but are not available from normal "control" subjects (i.e., those without the infection or disease under study) to whom the case subjects can be compared. this protocol is to obtain routine specimens (usually peripheral venous blood, occasionally other body fluid such as saliva, urine, or tears) from healthy volunteers.

Eligibility criteria:
* inclusion criteria: subjects can be friends of veb investigator or collaborator, hospital or office workers, repeat volunteer blood donors, etc. exclusion criteria: must not be minors, prisoners, pregnant women or incapable of providing informed consent.

Keywords: aids cancer epidemiology immunology virology
repair - transcatheter repair of mitral insufficiency with cardioband system

Conditions: Mitral Valve Insufficiency; Cardiac Valve Annuloplasty; Mitral Valve Annuloplasty; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Regurgitation

Summary: the cardioband transcatheter system (cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (fmr). the cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. the cardioband is deployed along the posterior annulus of the mitral valve (mv) and is adjusted under trans-esophageal guidance on the beating heart. a ce mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (mr) and improvement in 6- minute walk test in subjects with moderate to severe mr. study objectives are to test the efficacy of the cardioband in improving mr and heart failure symptoms in patients with symptomatic (new york heart association (nyha) class iii-iva), severe mr in the post-marketing setting, and to evaluate the safety of the cardioband system in the post-marketing setting.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. severe (3+ to 4+) secondary mitral regurgitation 3. symptomatic heart failure (nyha class iii-iva) despite guideline directed medical therapy including crt if indicated 4. the local site heart team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy. 5. transfemoral access and transseptal deployment of the cardioband is determined to be feasible 6. subject is willing and able to provide informed consent and follow protocol exclusion criteria: 1. ef \< 20% 2. lvedd ≥ 70 mm 3. heavily calcified annulus or leaflets 4. significant cad requiring revascularization 5. active bacterial endocarditis 6. any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months 7. renal insufficiency requiring dialysis 8. life expectancy of less than twelve months 9. subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint 10. pulmonary hypertension ≥ 70mmhg at rest 11. mitral valve anatomy which may preclude proper device treatment 12. right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation 13. severe liver disease 14. patient is pregnant or lactating 15. hypersensitivity to nickel or chromium 16. clinically significant bleeding diathesis or coagulopathy 17. history of mitral valve repair 18. tia or cva within 3 months

Keywords: valtech cardio cardioband mitral valve
management of women with brca1/2 mutation

Conditions: BRCA1 Mutation; BRCA2 Mutation

Summary: the aim of this study is to determine general practitionners' role in management of women with brca1/2 mutation. this study will be conduct between april 2017 and december 2017 at montpellier university hospital on women followed-up in the department of genetics and their general practitionners (gp). patients and their gp will be called by the investigators and questionnaire will be given to them. questionnaire includes questions for patients and their gp. the primary endpoint was to determine the rate of gp having sufficient knowledge of the adequate management of patients with brca1 / 2 mutation. adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. secondary endpoint was to determine women' opinion on their gp : whether or not well managed for their brca 1 / 2 mutation.

purpose: the aim of this study is to determine general practitionners' role in management of women with brca1/2 mutation. methods: this study will be conduct between april 2017 and december 2017 at montpellier university hospital on women followed-up in the department of genetics and their general practitionners (gp). patients and their gp will be called by the investigators and questionnaire will be given to them. questionnaire includes questions for patients and their gp. the primary endpoint was to determine the rate of gp having sufficient knowledge of the adequate management of patients with brca1 / 2 mutation. adequate knowledge includes : systematic search for a family history of cancer, knowing criteria required to refer women in oncogenetic department, and the ability to respond to patients' questions. secondary endpoint was to determine women' opinion on their gp : whether or not well managed for their brca 1 / 2 mutation.

Eligibility criteria:
inclusion criteria * aged over 18 * women * living in france * having a medical insurance exclusion criteria * men * dementia * non frenchspeaker * mental retardation * being the subject of a guardianship or tutelage measure

Keywords: brca1/2 mutation breast cancer general practitionner
study comparing fit of the itotal versus standard total knee implants

Conditions: Osteoarthritis

Summary: this study compares intraoperative fit of the patient-specific itotal knee replacement to other standard knee replacement implants

the study is designed as a single center, two arm analysis. the study will be completed in two phases, based on measurement type. all additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.

Eligibility criteria:
inclusion criteria: * patients who are scheduled for a standard total knee replacement * patient who are scheduled for patient-specific total knee replacement (itotal) * patient age \> 18 years exclusion criteria: * patients who do not receive a total knee replacement * unwilling or unable to comply with study requirements

Keywords: total knee replacement total knee arthroplasty patient-specific
mesalamine pellet to maintain remission of mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

this is a phase 3 study evaluating the effectiveness and safety of emg 1.5 g given once daily (qd) compared to placebo in subjects with demonstrated remission from uc. eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g emg (4 capsules total) or matching placebo capsules qd for 6 months. the study consists of a screening phase (completed within 7 days prior to randomization), a treatment phase (6 months), and a follow-up visit (2 weeks after end-of-study \[eos\] visit.) the treatment phase consists of 4 scheduled study visits: visit 1 (baseline/randomization (day 1), visit 2 (month 1), visit 3 (month 3), visit 4 (eos (month 6). primary objective: to compare the maintenance of remission from mild to moderate ulcerative colitis as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (emg) of 1.5 g qd, as compared with placebo. secondary objective: to compare the safety and tolerability of long-term dosing with emg at 1.5 g qd as compared to placebo in the maintenance of remission from mild to moderate uc.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis and in remission for at least 1 month * greater than 18 years of age exclusion criteria: * allergy/intolerance to aspirin, mesalamine, or other salicylates * prior bowel surgery other than appendectomy * pregnancy, at risk of pregnancy, or lactating * hiv or hepatitis b or c

Keywords: uc ulcerative colitis ibd inflammatory bowel disease
supportive care needs of caregivers of people with erdheim-chester disease and other histiocytic diseases

Conditions: Supportive Care Needs of Caregivers

Summary: this study is being done to answer the following question: what are the supportive care needs of informal caregivers of people with erdheim-chester disease and other histiocytic diseases?


Eligibility criteria:
inclusion criteria: * self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with erdheim-chester disease (or lch, rdd, or jxg for the exploratory aim). * proficiency to complete study assessments in english, evaluated at the time of consent. * age 18 or over. exclusion criteria: * participant unwilling to sign consent. * participant unable to complete web-based assessments.

Keywords: supportive care erdheim-chester disease other histiocytic diseases 19-213