cyrilzakka/clinical-trials huggingface dataset:
Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting

Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.

Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.

The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring implant placement in the posterior maxilla.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor is 3-5 mm

Exclusion Criteria:

* Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
* Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
* Heavy smokers (smoke greater than or equal 25 cigarettes daily).
* Acute oral infections.
* Untreated periodontal disease (gingival index 2 and 3).
* Poor oral hygiene ( Silness-Löe index (score 2-3) ).
* A history of radiotherapy or chemotherapy of the head and neck region.
* Pregnancy.
Attention & Memory Impairments in Menopausal Women

The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in alleviating those cognitive disruptions when compared to a placebo.

Midlife decline in cognitive function, particularly attention and working memory, is a frequent complaint for which menopausal women seek clinical intervention. Many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with ADHD. These impairments are reported by many women who have no previous history of ADHD, and appear to be linked to reduced estrogen levels occurring in menopause.

This is a double-blind, placebo-controlled, cross-over study testing whether LDX, a stimulant medication, would be effective in alleviating midlife onset impairments of attention and working memory among menopausal women. There will be 3 days in which subjects will undergo a brief cognitive testing assessment; the first testing period will occur at baseline prior to beginning LDX or placebo treatment (PT) in trial A; the second testing period will occur following 4 weeks of double blind LDX or PT; and the final testing period will take place after another 4 weeks of double blind LDX or PT in Trial B. Each cognitive test period will involve 2 separate cognitive testing batteries that will take approximately 120 minutes total to complete.

Eligibility Criteria:
Inclusion Criteria:

Women ages 45 to 60 will be eligible for this study if they:

* Are within 5 years of their last menstrual period;
* Are able to give written informed consent;
* Must have clear urine toxicology screen upon recruitment;
* Are fluent in written and spoken English;
* Must have negative urine pregnancy test if still menstruating.

Exclusion Criteria:

* History of seizures;
* History of cardiac disease including known cardiac defect or conduction abnormality;
* Abnormal electrocardiogram during screening;
* Use of estrogen therapy within previous 6 months;
* Current pregnancy or planning to become pregnant.
* Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.
Craving and Lifestyle Management Through Mindfulness Pilot Study

The purpose of this study is to determine whether an innovative program that combines mindfulness-based stress reduction and mindful eating practices with diet and exercise guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat distribution than a conventional weight-loss program(Diet-Ex intervention).

Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal, Carroll et al. 2002). Psychological stress is widely cited anecdotally as a factor that causes people to engage in overeating, and studies provide strong evidence that stress can promote obesity. Stress induces selective preference of sweet, high-fat food and increases visceral fat depots. Chronic stress has also been shown to impair immune responses, including decreasing immune responses to vaccination. The proposed study will pilot test an innovative program that combines stress reduction and mindful eating practices with diet and exercise, Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the metabolic and psychological processes assessed in this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* healthy female
* aged 18-50
* BMI range 25-45
* negative urine glucose test
* must be able to provide informed consent

Exclusion Criteria:

* male
* age less than 18 or menopausal
* clinical diagnosis of eating disorder, diabetes, polycystic ovary syndrome, and coronary artery disease
* history of anginal chest pain without adequate evaluation
* substance abuse, mental health or medical condition that might interfere with study participation
* use of medications containing corticosteroids
* breastfeeding
* non- English speaker
* pregnant or planning to get pregnant in the next 6 months
* previous Mindfulness Based Stress Reduction training
* initiation of new class of psychiatric medications in past 2 months
* currently on a weight loss diet
Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery

Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.

Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.

The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (\~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old,
* Severely obese patient with a BMI ≥ 35 kg.m-2,
* Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy,
* Affiliated to social security,
* The patient is able to consent to clinical research and has received all information on the study design/protocol,
* Signed/written informed consent

Exclusion Criteria:

* Refuse to consent to the study or the patient is unable to consent,
* Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected,
* Pregnancy,
* Persons deprived of their liberty by judicial or administrative decision,
* Urgent or emergent surgery.
Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections

This study aims to evaluate an endodontic treatment protocol using adjunctive steps for disinfection of teeth with primary endodontic infections.

The success of endodontic treatment in teeth with necrotic pulp and apical periodontitis depends on the reduction of viable microorganisms of root canals by endodontic disinfection procedures. This study aims to evaluate by molecular methods the effect of different disinfection procedures on reduction, diversity and microbial metabolic activity. Patients with necrotic pulps and apical periodontitis in single-rooted teeth will be selected. Microbiological samples will be taken from root canals after access cavity (S1), after chemomechanical preparation with Reciproc System and 2.5% NaOCl (S2), after irrigant activation using the XP-Endo Finisher instrument (S3a) and ultrasonic activation (S3b); and after intracanal medication with calcium hydroxide for 14 days (S4), followed by 2nd-visit root canal preparation (S5). DNA and RNA will be extracted from root canal samples, and complementary DNA (cDNA) synthetized using reverse transcription reaction. The effect of treatment protocols on total microbiota levels will be determined by DNA-based quantitative polymerase chain reaction (qPCR) using universal primers for Bacteria domain. RNA of root canal samples will be used to determine the diversity of metabolically active microbiota by Reverse Transcriptase Reaction (RT), followed by amplification (PCR) and high throughput sequencing of the hypervariable region V4-V5 of 16S rRNA gene. The metabolic activity of the most prevalent species / taxa will be calculated by rRNA- and DNA-based molecular methods. Ratios between rRNA and DNA levels will be calculated to search for active bacteria (rRNA/DNA ≥ 1) in root canal samples. Data will be analyzed by statistical tests, with 5% significance level.

Eligibility Criteria:
Inclusion Criteria:

* Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion Criteria:

* patients who had received antibiotics during the previous 3 months or had any general disease,
* teeth that could not be properly isolated with rubber dam,
* non-restored teeth,
* periodontal pockets depths greater than 4 mm,
* previous endodontic treatment,
* open apex,
* crown/root fracture
* root resorption or calcifications.
W-SUDs for COVID-19

The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.

This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* All genders aged 18-65 years
* Access to a smartphone
* Available and committed to engage with app and complete assessments
* Be willing to provide email address (as this is how assessment incentives will be distributed),
* Literate in English (as W-SUDs conversational and video materials will be in English).

Exclusion Criteria:

* Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
* History of severe drug/alcohol use
* History of opioid misuse without medication-assisted treatment
* Suicide attempt within the past year
* Opioid overdose within the past year
Video-Assisted Laryngoscopy Education

This study is designed to evaluate the impact of a video recording review on the acquisition of a new technical skill (laryngoscopy and tracheal intubation).


Eligibility Criteria:
Inclusion Criteria:

* Medical students on elective rotation in anesthesiology.

Exclusion Criteria:

* None
Evaluation of the Safety and Performance of the HARMONI® Toric Lens

The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months).

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Eligibility Criteria:
Key Inclusion Criteria:

* Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
* Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
* Target dioptric lens power within the range of 16 - 26 D
* Willing to discontinue contact lens wear for the duration of the study
* BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)
* Stable cornea
* Dilated pupil size at least 7.0 millimeters (mm)
* Able to understand and provide informed consent.

Key Exclusion Criteria:

* History of any intraocular or corneal surgery in study eye (including refractive)
* Pregnant or lactating
* History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
* History of ocular conditions which could affect the stability of the IOL in study eye
* Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
* Any visually significant intraocular media opacity other than cataract in study eye
* Uncontrolled glaucoma in study eye
* Uncontrolled systemic disease
* Severe dry eye that would impair the ability to obtain reliable study measurements
* Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.
Neurovascular Reactions to AAT in Patients With DOC

There is practical evidence but no scientific investigations that persons with severe disorders of consciousness can profit from animal-assisted therapy regarding their level of awareness.

The aim of this study is to investigate the effect of animal-assisted therapy on brain activity of inpatients at REHAB Basel with severe disorders of consciousness.

To do so, the frontal brain activity of 20 the inpatients at REHAB Basel in a minimally conscious state is investigated via near-infrared spectroscopy (NIRS). Moreover, 20 healthy participants are included as control subjects.

Each participant will be measured in 6 sessions. Sessions take place three times a week for 2 weeks (leading up to a total of 3 experimental sessions and 3 control sessions), each lasting for about 15 minutes.

Each session consists of 5 phases, with an animal present in three of them. In the beginning, waiting (with no stimulus presented) serves as baseline measurement. Second, an animal is watched, then the animal is placed on the patient's lap and in the fourth condition, the patient can stroke the animal with the help of the present therapist. After, there is again a waiting condition.

Control sessions are comparable sessions but with a fur pet instead of a live animal as stimulus.

Measurements are: brain activity (near-infrared spectroscopy, NIRS), skin conductance (EDA), heart rate and heart rate variability assessed via photoplethysmography (PPG) during the sessions and the BAVESTA score after each session. For further behavior analysis all sessions are videotaped.

Eligibility Criteria:
Inclusion Criteria for patients:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Inpatients of REHAB Basel with severe disorder of consciousness: minimal conscious state defined via: Glasgow Coma Scale (GCS) / Coma Recovery Scale-Revised (Koma Remissions Skala, KRS/KRS-S) / BAVESTA Score
* Minimum Age of 18 years

Inclusion Criteria for healthy participants:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* History of acquired brain-injury
* Minimum age of 18 years

Exclusion Criteria:

* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* medical contraindications for contact with animals as allergy, phobia etc.
* If the patient's medication changes radically during the time of data collection (only eligible for clinical participants)
Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages

The aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in South Kivu, in the east of the Democratic Republic of Congo.


Eligibility Criteria:
Inclusion Criteria:

* Work in one of the selected maternity units
* Have two years' experience
* Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician.

Exclusion Criteria:

-
Influence of Medication on Functional Connectivity

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).

Eligibility Criteria:
Inclusion Criteria:

1. males or females, ages 18-30
2. for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
3. ability to provide written, informed consent
4. eligibility and willingness to participate in fMRI scanning and to receive oxycodone
5. normal weight, as indicated by a body mass index (BMI) between 18.5 to 25

Exclusion Criteria:

1. current DSM-5 Axis I disorder
2. any psychotropic medication or medication known to interfere with metabolism of opioids
3. medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
4. known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
5. not eligible for MRI scanning
6. positive drug screen
7. recent (past 6 months) medical or non-medical opioid-use
8. current or previous chronic pain disorder
9. significant lifetime use of prescription opioids (\>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of SAR symptoms
* A positive skin prick test at least one grass allergen
* Moderate - severe SAR symptoms at baseline
* Women of childbearing potential must use a medically acceptable form of contraception
* 80% compliance on run in study medication and 80% compliance on completing the diary

Exclusion Criteria:

* The presence of any clinically significant comorbid disease which may interfere with the study assessments
* The presence of renal disease
* Pregnant or breastfeeding
* Subject is currently participating in another clinical trial
* Known hypersensitivity to piperazines or any of the excipients
* Intake of medications prohibited before the start of the trial
* Subjects who started or changed the dose of immunotherapy
* Rhinitis medicamentosa
* Subjects with a recent history (within the last 2 years) of drug or alcohol abuse