cyrilzakka/clinical-trials huggingface dataset:
Impact of Buccal Bone Thickness on Pathological Peri-implant Bone Loss: A 3-year Prospective Cohort Study

Implant placement may trigger bone trauma, which might result in 3-dimensional bone changes. While the process of peri-implant disease is not well understood, implant position within the bony structure might play a role. However, there is no data available on this regard.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 80 years old
* Patients requiring oral rehabilitation through supported prosthesis
* Patients with partial edentulism
* No antibiotic in the last 2 months
* No smoking or smoking \<10 cigarettes a day

Exclusion Criteria:

* Systemic diseases uncontrolled
* Implants that because prosthetic characteristics can not be registered probing depth or attachment level appropriately
* Smoking\> 10 cigarettes a day
* Pregnant Patients
* Implants that can not be followed in CICOM
* Patients who do not return to regular maintenance therapy every 3-6meses
* Patients who are not controlled periodontal disease
CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.

Eligibility Criteria:
Inclusion Criteria:

* With suspected or known disease of the arteries
* Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
* Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
* Patient is between 20 and 75 years of age
* Fully informed and has signed consent in advance

Exclusion Criteria:

* Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
* Patient with renal failure
* Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
* Lactating woman
* Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
* Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
* Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.
* Hypersensitivity to gadobutrol products
* Patient has previously entered this study
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)

This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen \[HBeAg\] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.

This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative subjects) will be randomised (1:1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms. The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \<400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study. The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV on safety and efficacy endpoints; dosing will be double-blind. This period will be followed by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240). Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12 weeks followed by every 12 weeks for a total of up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* HBeAg positive/negative CHB with blood HBVDNA≥10\^5 copies/mL and elevated ALT
* Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed in less than 10% of the total study population

Exclusion Criteria:

* subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease
* subjects with acute liver disease due to other causes
* subjects with medication history of immunosuppressive therapy, immunomodulatory therapy, systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e.g., lamivudine, hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to randomisation into this study
Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity

The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to drink and food with few or no additional calories. Sweeteners are widely used in commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a reasonable level of consumption (less than 20 cans per day). However little data is available on the metabolic effects of a regular consumption of beverages containing sweeteners. The objective of the study is to evaluate the effect of a regular consumption (twice a day for 12 weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Subject taking at least three main meals (breakfast, lunch, dinner)
* Subject able to understand and sign an informed consent
* Subject drinking and enjoying soft drinks
* Subject appreciating sweeteners taste
* 19 kg/m² \< BMI\< 30 kg/m²

Exclusion Criteria:

* Any severe or acute illness that may influence the results of the study or may be life-threatening
* Pregnant or breastfeeding subject
* Past or present metabolic or digestive diseases, with the exception of a possible appendectomy
* Diabetes or severe acute illness that may alter blood sugar
* Treatment that may interfere with glucose homeostasis
* Past or present kidney disease (renal failure, ... )
* Local or systemic medication that may change water status, metabolism and feeding behavior
* Antiplatelet treatment
* Alcohol consumption ≥ 3-4 glasses / day ( ≥ 21 drinks / week )
* Sustained physical exercise (more than 4 hours per week)
* Subject adding sweeteners (tablets or powder) in their diet
* Subject drinking more than two cans of drinks with sweeteners / day
* Subject dieting to lose weight
* Subject unable or unwilling to consume 2 liters of fluid / day
Study of Intravenous COVI-MSC for Treatment of COVID-19-Induced Acute Respiratory Distress

This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.

This is a Phase 2 randomized controlled study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for COVID-19 infection in hospitalized subjects with acute respiratory distress syndrome.

COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

Acceptable standard of care treatments for COVID-19 include all approved or emergency use authorized treatments for COVID-19, even if used off-label.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Hospitalized with COVID-19-induced ARD or ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
* Requires oxygen supplementation at Screening
* Willing to follow contraception guidelines

Exclusion Criteria:

* Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
* A previous stem cell infusion unrelated to this trial
* Certain medical conditions that pose a safety risk to the subject
* Pregnant or breast feeding or planning to during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* History of splenectomy, lung transplant, or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions
* Expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days
* Has an existing "Do Not Intubate" order
* Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) expect for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing
Mapping Functional Networks of Brain Activity (Brain Network Activation, BNA) Based on Analysis of Evoked Response Potential (ERP) Signals for Healthy Controls Evoked Response Potential (ERP) Signals for Healthy Controls and Patients With Parkinson Disease

A cornerstone in PD research is the investigation of neurophysiological changes as potential biomarkers that could help in tracking disease progression and response to therapies. Electroencephalography (EEG) could provide a non-invasive and relatively cheap tool for identification of such biomarkers. In this study we will use high-density electroencephalograph (EEG) recording, in order to develop a platform of biomarkers that could be more sensitive and reliable to disease progression and response to therapeutic intervention than standard clinical measures.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic PD patients (according to the UK PD Society brain bank clinical diagnostic criteria (bradykinesia plus at least one other cardinal feature of PD, no atypical features or secondary cause) and HC aged 40-80 years
2. PD patients Hoehn and Yahr stages I to IVStable PD therapy

Exclusion Criteria:

* In the investigator's opinion, any unstable or clinically significant condition that would impair the participants' ability to comply with study requirements.
* Patients or HC with significant psychiatric symptoms or history
* BDI score \<14
* MMSE \<25
* Treatment with neuroleptics.
* For PD patients: Hoehn and Yahr Stage 5
* PD Patients with severe dyskinesia or tremor
* PD Patients with atypical Parkinsonism or secondary Parkinsonism
* History or evidence of neurological problems: cerebrovascular disease, previous head injury or neurosurgical interventions.
* Currently with lice or open wounds on scalp.
* Significant sensory deficits, e.g., deafness or blindness
* Current drug abuse or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Participation in current clinical study or clinical study within 30 days prior to this study.
Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

To evaluate the product performance of a Bausch \& Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution


Eligibility Criteria:
Inclusion Criteria:

* Subjects are adapted wearers of silicone hydrogel contact lenses
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* wear a monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday).
* Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
* Participant is available for the duration of the study.
* Parent/legal acceptable representative is willing and able to provide informed consent.
* Parent/legal acceptable representative is willing and able to meet protocol requirements.
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.

Exclusion Criteria:

* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
* Documented history of influenza infection.
* An acute illness with or without fever (temperature ≥ 100.4 °F, rectal) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
* Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
* Participation in any other interventional clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital, or developmental disorder.
* Known Human immunodeficiency virus (HIV)-positive mother.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Energy Expenditure Methodology

This study is simply to test the repeatability of the indirect calorimetry instrument the investigators use for our clinical studies.

Participants will be required to attend two study visits at the Arkansas Children's Nutrition Center. During the first visit, informed consent will be obtained, participant will be measured and an indirect calorimetry assessment to measure resting energy expenditure will be performed. During the second visit, we will repeat the indirect calorimetry assessment to measure resting energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* pulmonary or respiratory disorders
Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology

The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

A multi-center study in which subjects that had completed or are completing a BNA test with the Auditory Oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. At each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's ePRO device. The study will include up to 10,000 subjects which had completed or will complete a standard BNA test. Authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. Procedure of consent will be performed by the PI or delegates.

Eligibility Criteria:
Inclusion Criteria:

* Completed or will complete a BNA test
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate

Exclusion Criteria:
Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice

Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.

See attached protocol documents.

Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible to participate if they were US residents, aged of 18 or above, fluent in English, had access to a computer with an internet connection and had no dietary restrictions

Exclusion Criteria:

* See above.

Stratification Criteria:

- We aimed to recruit a sample stratified by gender (approx. 50/50) and highest educational qualification (approx. 40% high school or less, 60% above high school) to be broadly representative of US adults.
Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors

This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' confidence for maintaining their physical activity and nutrition. Cancer survivors often experience problems with the musculoskeletal system (bones, joints, muscles, connective tissue), the cardiopulmonary system (heart, blood vessels and lungs) and the metabolic system (how the body's cells change food into energy) following treatment. There is substantial evidence that physical activity, diet, and weight management can improve quality of life (emotional and physical well-being) and physical fitness. Information gathered from this study may help researchers determine whether participating in a community-based exercise/nutrition training and education program may improve levels of fitness, cardiovascular health, and quality of life for cancer survivors.

PRIMARY OBJECTIVE:

I. To assess the feasibility and acceptability of a 12-week supervised community-based exercise/nutrition training and education program for cancer survivors.

SECONDARY OBJECTIVE:

I. To assess the effectiveness of a supervised exercise and nutrition training and education program by evaluating pre-post changes in exercise self-efficacy.

TERTIARY OBJECTIVE:

I. To assess changes in functional performance and quality of life (QoL).

OUTLINE:

Patients participate in a supervised, community-based exercise program consisting of aerobic and resistance exercise over 45-60 minutes twice a week (BIW) for 12 weeks. Beginning at week 2, patients also receive nutrition education and training once a week (QW) for 10 weeks. Patients also wear an activity tracker throughout the study.

After completion of study intervention, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Have had a previous cancer diagnosis and completed all therapy.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related interventions.

Exclusion Criteria:

* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia including atrial fibrillation (AFIB), multiple myeloma, or psychiatric illness/social situations that would limit compliance with study requirements.
* Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise.
* Are pregnant or nursing.
* History of a stem cell transplant.
* Currently on steroids.
* Unwilling or unable to follow protocol requirements.
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study.
Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED. The study should be reviewed and receive approval from the institutional review board. Principles of the Helsinki Declaration are considered All patients should provide their informed consent prior to enrollment.

Eligibility Criteria:
Inclusion Criteria;

* patients between 18 and 70 years of age
* a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature.

Exclusion Criteria: -Patients aged \> 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial,

* history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid,
* history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.
Canine Assisted Therapy to Reduce Emergency Care Provider Stress

The main study hypothesis is that emergency healthcare workers on shift who interact for 5 min with a therapy dog and handler will have lower perceived and manifested stress response compared with use of a time out that includes voluntary use of a coloring mandalas. The work will also address two exploratory hypotheses: The first is that salivary cortisol will correlate significantly with perceived stress and will increase from beginning to end of shift, and that exposure to a therapy dog will blunt this increase. The second exploratory hypothesis states that participants who interact with a therapy dog will display more empathic behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria require that participants work full time as either a nurse or physician in the Eskenazi emergency department and are willing to consent to participation.
* Participants will include residents, faculty and nurses who work in the emergency department

Exclusion Criteria:

* Exclusions include any reported prior fear or adverse reaction to dogs