cyrilzakka/clinical-trials huggingface dataset:
A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants

1. To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations.
2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
3. To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.

* Screening (Inclusion/ Exclusion Criteria)
* Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
* Implant Restoration Day: Post-restoration periapical radiograph/ clinical picture/ clinical examination (probing depth, BOP, gingival recession).
* 6 month, 1 Year and 2 Year Post Restoration: periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).

Eligibility Criteria:
Inclusion Criteria:1. Male or female, between 20-70 years of age, who request dental implant treatment options for rehabilitation.

2. Subjects who are willing to sign an informed consent, participate and return for follow-up visits.

3. Subjects without significant medical history and currently not on medications that might complicate the results.

4. Subjects presenting with an edentulous area requiring a tooth-replacement option.

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Exclusion Criteria:1. Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.

2. Subjects who received and failed a previously placed dental implant. 3. Subjects who require an onlay ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.

4. Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.

5. Subjects who have used nicotine-containing products within 3 weeks prior to surgery.

6. Subjects who are insulin-dependent diabetic or if their Hgb1c levels \> 6.5%. 7. Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).

8. Subjects who are nursing or pregnant. 9. Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.

10. Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).

11. Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.

12. Acutely infected defect site. 13. Immediate implant site.

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Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age

The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.

The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. Real-time Polymerase Chain Reaction (rtPCR) will be used to confirm influenza infection and to type the strains involved, as molecular methodologies have been demonstrated to be more sensitive than other more traditional methodologies, e.g. culture. For rtPCR-positive clinical samples, reserved aliquots will be processed for culture, so that antigenic similarity to the HA present in study vaccines can be tested.

In various clinical studies the investigators demonstrated that the immune response against the influenza A viruses is improved as a result of the higher hemagglutinin content. Furthermore, influenza virus disease and hospitalization associated with influenza-related illness in older adults (\> 50 years) was considerably reduced (90%) following vaccination with TIV, even though the circulating influenza A strain was antigenically dissimilar to that in the vaccine. However, more recently Skowronski et al. reported that the low influenza vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead related to mutations in the egg-adapted H3N2 vaccine strain. Flublok manufactured using recombinant technology does not contain the mutations responsible for the reported lower effectiveness and may thus offer improved protection when mutations such as those described are induced in the process of adapting the influenza virus to growth in eggs.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory adults aged 50 and older.
2. Medically stable, as determined by medical history and targeted physical examination. "Medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study.
3. Absence of underlying conditions that make participation in the study contrary to the subject's best interest.
4. Able to understand and comply with planned study procedures.
5. Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

1. Known contraindication to either study vaccine (see product package inserts)
2. Receipt of any other influenza vaccine within 180 days prior to enrollment in this study.
3. Underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.
RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A

The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).


Eligibility Criteria:
Inclusion Criteria:

* Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
* Patents able to understand and sign an informed consent.
* Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
* Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.

Exclusion Criteria:

* General contraindications to implant surgery.
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients.
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients with untreated periodontitis.
* Patients with poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnancy or nursing.
* Substance abuser.
* Heavy smokers (smoking more than 11 cigarettes/day).
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for implant placement.
* Immediate implants (extractive sites will have to be healed from 6-8 weeks).
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients referred only for implant placement and cannot be followed ant the treating centre.
* Patients unable to be followed for 5 years
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Eligibility Criteria:
Inclusion Criteria:

* Hearing loss
* candidate for hearing aid amplification
* Bothersome chronic tinnitus (3 months+)

Exclusion Criteria:

* age less than 18 years
* normal hearing
* tinnitus presence for less than 3 months
* tinnitus not bothersome enough to warrant intervention
* non hearing aid candidates
Anxiety and Burnout in Anesthetists and Intensive Care Unit Nurses During Covid-19 Pandemic

The aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during COVID-19 pandemic.

The study protocol had consisted of three parts. The first part was related to demographic details including age, sex, marital status, working position, past medical history.

The second part of the survey was validated Turkish form of Beck anxiety inventory (BAI) It has 21 questions. Every question is a somatic symptom of anxiety. Participants scored them regarding how this symptom bothered them past week. Items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). Total anxiety score can be between 0 and 63. Participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 The last part of the survey was validated Turkish form of Maslach Burnout Inventory (MBI) to evaluate components of BOS

Our institution's ICU has served 31 beds for COVID-19 and 21 beds for other patients during pandemic with 27 attending physicians and 35 residents. Number of night shifts for attending physicians and residents were 3 and 8 per month, respectively. The aim of the study was to evaluate the by measuring anxiety level and burnout frequency of HCWs including attending physicians, residents and nurses in our institution's ICU.

Eligibility Criteria:
Inclusion Criteria:

Healthcare workers in our institute's intensive care units

Exclusion Criteria:

None
Cord Milking in Elective Cesarean Section

The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.


Eligibility Criteria:
Inclusion Criteria: singleton low risk pregnancy, gestational age of 39 to 40/0 weeks confirmed by a first trimester ultrasound, no evidence of active labor, 18 years of age, and (5) a written consent given by the woman.

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Exclusion Criteria:maternal medical and obstetric complications, severe anemia, clotting disorders and suspected intrauterine growth restriction

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Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

The study is designed to evaluate the use of electromagnetic tracking in transversal plane femoral derotation osteotomies. The goal is to raise the precision of the surgical procedure in order to improve the outcome in short- and long term. All patients are examined with an instrumented 3D gait analysis pre- and one year postoperatively. The electromagnetic tracking system is evaluated against a base line CT or MRI scan serving as reference standard pre- and postoperatively.

Internal rotation gait is a common deformity in children, especially in those with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral derotation osteotomies have proven to be effective both in short term and long term evaluation. Nonetheless there is still a relevant number of patients that suffer from over- or under-correction and recurrence over time. The reasons are diverse and include false measurement of the derotation in OR.

The study now evaluates electromagnetic tracking for femoral derotation to improve these results.

The patients are recruited from the outpatients department and included if they meet the criteria.

A baseline rotational CT or MRI scan and a 3D gait analysis are performed preoperatively. The patients are randomized into a electromagnetic tracking group or a classical goniometer group. The derotation is measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amount of derotation more accurately.

The surgical procedure follows standard rules and does not need alterations because of the study.

After the operation a second rotational CT or MRI scan is performed and the derotation precisely evaluated by two raters and later compared to the results of the intraoperative electromagnetic tracking system. One year postoperative a second 3D gait analysis is performed to measure and compare the functional and dynamic outcome.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* GMFCS level I-III
* Functionally disturbing internal rotation gait
* Indication for femoral derotation osteotomy

Exclusion Criteria:

* No capacity of consent
* Inability to perform all needed types examinations
* Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)
Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.

Considerable evidence suggests that inflammation may play a role in the neurodegenerative process of Alzheimer's disease (AD), and the use of non-steroidal anti-inflammatory drugs may be associated with reduced occurrence of AD. ADAPT is a randomized trial that will test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline. This long-term trial will run for 5 to 7 years.

The study is sponsored by the National Institute on Aging and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System with the University of Washington, in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY. At each of these six sites, the goal is the enroll approximately 700 men and women, totalling 2,625 participants. Participants must be 70 years of age or older, have a parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.

Participants will be asked to take an anti-inflammatory medication or placebo (inactive pill) twice daily. Before enrolling in the trial, participants will be asked to go to a study site for two medical evaluations. Once enrolled, they will need to go to a study site for a medical evaluation every six months and to participate in a telephone interview twice a year for an average of up to seven years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or older.
* Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.
* Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.
* Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.
* Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts
* Ability and intention to participate in regular study visits, in the opinion of the study physician.
* Provision of informed consent.

Exclusion Criteria:

* History of peptic ulcer disease with bleeding or obstruction.
* Clinically significant liver or kidney disease.
* History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.
* Use of anti-coagulant medication.
* Cognitive impairment or dementia.
* Current alcohol abuse or dependence
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fed Conditions

Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a 1 x 800 mg tablet, under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women, 18 years of age or older
* body mass index between 19 and 30
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* history of allergy or hypersensitivity to ibuprofen
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* use of tobacco products during the past 3 months
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes

The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects between 30-65 years of age
2. BMI 25-40kg/m2
3. HbA1c 5.7%-6.4%
4. Willing to comply with study requirements
5. Provide written informed consent

Exclusion Criteria:

1. Known diagnosis of diabetes / taking any medication for treatment of diabetes
2. History of previous bariatric surgery
3. History of chronic liver or renal disease
4. Current treatment with systemic corticosteroids
5. Pregnant women
6. History of allergy to any component of the test meal
Corail Stability at 5-Years Post-Total Hip Arthroplasty

Total hip arthroplasty (THA) is the mainstay, definitive management for end-stage hip osteoarthritis. Despite improvements of surgical and patient factors, prosthesis-related complications continue to increase in number. This is contributed to by the greater number of such surgeries being completed, larger proportion of elderly individuals among the population, and younger patient age being offered surgical intervention. Specifically, implant loosening and associated migration, is the pathology most commonly yielding revision surgery. A previous study assessing migration of total hip prostheses found that the greatest degree of migration occurred in the first 2 weeks postoperatively, although implants were considered overall stable 2 year following surgery. Continued evaluation of implant migration at time points further from surgery, specifically at 5 years postoperatively, offers insight into long term complications rates. Assessing implant migration will be completed using various imaging modalities, radiostereometric analysis (RSA) and computed tomography (CT). Comparisons between RSA and CT imaging will allow for greater analysis with regards to characterization of implant migration and associated bony changes. Additionally, an individual's gut microbiome has been shown to correspond to their inflammatory and immune profile. Association between gut microbiome profile and implant migration will be assessed to determine if underlying relationship does exist.


Eligibility Criteria:
Inclusion Criteria:

* Participated in the originally investigated cohort.
* Minimum of 4-5 years post-operation

Exclusion Criteria:

* Pregnancy
* Unable to attend follow-up
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis

The purpose of this study is to determine whether shortwave diathermy is effective in reducing knee pain and increasing function of the patients with knee osteoarthritis.

Osteoarthritis (OA) is the most common degenerative joint disease, resulting in significant morbidity and health care expense. It affects more than 60% of Western World adults over the age of 65 years. It causes pain and dysfunction in 20% of elderly persons. It can affect any joint containing hyaline cartilage; knee is the most commonly affected joint. There are many strategies for the treatment of knee OA but a curative method has not been found. Treatment is therefore aimed to relief symptoms and to prevent further functional deterioration. It is unclear whether any of the treatment modalities is efficacious. Shortwave diathermy (SWD) is one of deep heat widely applied to alleviate the symptoms associated with OA. The efficacy of SWD for the treatment of OA knee is still inconclusive. The outcome of treatment in previous reports varies from null to positive effect. This discrepancy is largely due to the different research methodology, the inadequate sample size, the methods used in outcome assessment, and the treatment protocols.

Comparison(s): Peri- or postmenopausal women with OA knee are randomized into two groups, receiving a course of either therapeutic SWD or sham SWD. The main outcome measured is the change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index.

Eligibility Criteria:
Inclusion Criteria:

* peri- or postmenopausal women aged \>50 years
* primary knee osteoarthritis

Exclusion Criteria:

* inability to walk
* severe joint instability
* history of previous shortwave diathermy
* intra-articular injection within 3 months
* metallic implant around knee joint
* suspicious of malignancy around knee joint
* significant cardiovascular disease
* inability to understand how to score the symptoms