cyrilzakka/clinical-trials huggingface dataset:
Use of Leucocyte- and Platelet-rich Fibrin Membranes in Single Implant

The objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of Leucocyte-Platelet rich Fibrin (L-PRF) membranes. The sample is of 42 individuals, where the control group (n = 21) will receive single implant placement only, while the test group will receive single implant placement with L-PRF membranes.

The greatest challenge in implantology is to achieve a satisfactory esthetic result. A new platelet concentrate protocol, named Leucocyte and platelet-rich Fibrin (L-PRF), has been developed in France. Research has shown positive results using L-PRF during implant placement, as improving soft tissue healing and bone formation, leading to higher esthetic level and greater implant stability. The aim of this study is to evaluate if the use of PRF associated to implant placement in esthetic area presents superior aesthetic result and soft tissue thickness increase when compared to implant placement without graft. Forty-two patients requiring single implant placement in the esthetic area of the maxilla will be randomly divided into test group (implant + L-PRF) and control group (implant without graft). Surgical procedures will be performed by a single operator. The rates of soft tissue thickness, esthetic and comfort will be evaluated at baseline and 3 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 20 years of age, systemically healthy, with satisfactory oral hygiene assessed by plaque index and gingival index of less than 25% (O'Leay et al. 1972).
* Patients requiring single implant placement in anterior maxilla (premolar to premolar)
* Buccal soft tissue thickness of at least 2mm
* Patients who agreed to participate in the study and signed a written consent (Resolution nº196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)

Exclusion Criteria:

* Smokers
* Patients with parafunctional habits, such as bruxism
* Patients who need other types of rehabilitation, such as removable prostheses
* Pregnant or lactating
* Patients with uncontrolled systemic diseases (cardiovascular alterations, blood disorders, diseases that affect bone metabolism, immunodeficiencies, diabetes)
* Patients who use drugs that interfere with wound healing or contraindicate the surgical procedure, such as gingival growth related drugs
* Implants in adjacent regions
* Sites requiring bone augmentation procedure
* Patients in orthodontic treatment
Cognitive Training to Improve Mobility in Middle-aged and Older Adults

The proposed study is designed to evaluate the effect of at-home executive function training on cognition and mobility in older adults with age-related hearing loss (ARHL), older adults with normal hearing, and middle-aged adults.


Eligibility Criteria:
Inclusion Criteria:

* Proficient in English (learned before age 5), can ambulate ≥ 10 meters independently, absence of cognitive impairment (neuropsychological test results in the average range compared to age norms), normal or corrected-to-normal visual acuity (ETDRS), availability of a home computer or tablet with internet connection.

Exclusion Criteria:

* Reported major depression, substance abuse or significant psychiatric disorder, uncorrected visual impairment, vestibular impairment, Parkinson's disease or other neurological disorder or sequelae, clinically significant musculoskeletal disorders, diseases affecting the ear, or damage to the ear (e.g., occupational noise), onset of hearing loss prior to adulthood.
Clinical Validation of DACP Digital Design

The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign an IRB/IEC approved Informed Consent form;
* Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
* Experiencing symptoms of eye strain from using technology;
* Willing to wear study lenses each day;
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
* Willing to NOT use rewetting/lubricating drops at any time during the study;
* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
* Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria:

* Conditions, use of medications, injury, or surgery, as specified in the protocol;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monocular (only one eye with functional vision);
* Pregnant.
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts \<350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).

This single-center, open-label non-randomized clinical trial was conducted at Korea University Guro Hospital from April 2015 to January 2017. Based on the CD4 T-cell counts at the time of study enrollment, HIV-infected subjects aged ≥ 18 years were divided into two groups, group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts \<350 cells/µL).

The primary objective of the study was to demonstrate that the immune responses to PCV13 serotypes in Group 2 (CD4 T-cell counts \<350 cells/µL) were not inferior to those in Group 1 (CD4 T-cell counts ≥350 cells/µL) at one month after vaccination. In addition, the safety profiles of PCV13 were compared between two study groups.

HIV-infected subjects aged ≥ 18 years with stable underlying diseases (≥ 4 weeks on HAART) were eligible for this study. All available subjects with low CD4 T-cell counts (\<350 cells/µL, group 2) were recruited, and age/visit day-matched controls with high CD4 T-cell counts (≥350 cells/µL, group 1) were enrolled. The exclusion criteria were as follows: 1) a history of pneumococcal infection within the recent five years, 2) previous pneumococcal vaccination, 3) current opportunistic infections, 4) known immunodeficiency other than HIV infection and 5) coagulation disorders.

The study was approved by the ethics committee of Korea University Guro Hospital (IRB No. 2014GR0014) and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Informed consent was taken for all participants before enrollment. Venous blood samples of 10 mL were collected on day 0 and post-vaccination day 28 ± 7.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infeted subjects who received antiretroviral therapy for ≥ 4 weeks

Exclusion Criteria:

* a history of pneumococcal infection within the recent five years
* previous pneumococcal vaccination
* current opportunistic infections
* known immunodeficiency other than HIV infection
* coagulation disorders
Assessment of Macrophage Activation syndromE in STill's Disease

Assessment of Macrophage activation syndrome in STill's disease: retrospective chart analysis of patient History, Symptom resolution and Treatment characteristics

This is an observational, retrospective cohort study on the treatment utilization and outcomes of Macrophage Activation Syndrome (MAS) refractory to glucocorticoids (GC) in patients with Still's disease. The study will be conducted entirely through medical chart abstraction; all data will be taken from the patient's medical record, with no additional assessments.

Eligibility Criteria:
Inclusion Criteria:

* Age \>6 months and ≤80 years at the beginning of the index MAS episode.
* Diagnosis of Still's disease (sJIA (systemic Juvenile Idiopathic Arthritis) or AOSD (Adult Onset Stills Disease) diagnosis).
* Diagnosis of MAS according to treating physician in the medical record.
* Patients who have received at least 3 consecutive days of GC after diagnosis of MAS and/or are judged by the Investigator to be refractory to GC due to clinical worsening of patient's condition .
* The onset of the index MAS episode occurred between 01 January 2012 and 30 September 2022.

Exclusion Criteria:

* A diagnosis of primary Hemophagocytic Lymphohistiocytosis (HLH) prior to the beginning of the index MAS episode.
* Confirmed malignancy prior to the beginning of the index MAS episode.
* Patient treated with any investigational product as a part of clinical trial during the index MAS episode.
Association of Bone and Metabolic Parameters With Overall Survival in Patients With Bone Metastases From Adenocarcinoma Lung Cancer (POUMOS)

Mortality due to non small cell lung cancers is the first cause of cancer death in men around the world. Lung adenocarcinoma regularly induces bone metastases responsible for high morbidity and impaired life quality. Overall survival of these patients is poor. Thus the investigators aimed to identify if some bone and metabolic parameters were associated with overall survival.

Patients and Methods POUMOS is a prospective cohort of patients suffering from adenocarcinoma lung cancers with a first bone metastasis (stage IV). All patients have a bone biopsy with molecular status characterization of the tumor for EGFR, KRAS, BRAF and ALK. Bone metastasis localizations are obtained by bone scintigraphy or FDG-PET/CT. Whole body composition is obtained by DEXA scan (Hologic®). The investigators assessed also fasting blood levels of bone and metabolic biomarkers.

Survival analyses will be performed using a proportional hazard regression model.


Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years
* both gender
* covered by the French National Insurance
* first bone metastases of adenocarcinoma lung cancer (synchronous or metachrone)

Exclusion Criteria:

- adenocarcinoma previously treated by systemic oncologic treatment (chemotherapy, targeted therapy, immunotherapy)
Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI

This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.

In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution

Exclusion Criteria:

* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.736m2)
* History of kidney transplant within the previous 90 days
* Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
* Acute DNR order or clinical team is not committed to escalating medical care
* Anticipated to require intensive care for less than 48 hours
Improving Sleep Quality in Heart Failure

Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-79 years old
* HFrEF, EF ≤ 45% (by echocardiography)
* NYHA functional class I to III
* Able to give written consent
* On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment
* No hospitalizations for HF within the past month
* Positive response to experiencing any of the following sleep-related symptoms at least once a week:
* Difficulty falling asleep
* Waking up during the night and having difficulty getting back to sleep
* Waking up too early in the morning and being unable to get back to sleep.

Exclusion Criteria:

* Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
* Current treatment with other sedating medications such as opioids
* On therapy for pharmacological therapy for depression
* History of alcohol/drug dependence
* History of liver disease, HIV, or severe COPD
* On Thorazine
* Current use of ketoconazole
* Current use of tricyclic antidepressants
* Current use of macrolide antibiotics
* Current use of anticonvulsant medications
* Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.
Pilot for the Analysis of Usability in the Use of the Diacare Platform for People With Type 2 DM and Their Professionals

The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.

Type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. In order to achieve an optimum level of independence in their self care, it is essential that type 2 DM patients take responsibility for the situation and be actively involved in the control of their health. Technology can solve some of the current challenges of chronic diseases such as type 2 DM, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mHealth. In this context, the Diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 DM in a more personalized and individual way. The Diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. This research project wants to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. For this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the DIACARE platform for 3 months. The results of this pilot will be collected through qualitative and quantitative data through the DIACARE platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with type 2 DM based on clinical criteria
* People who own a Smartphone and have competences in the use of technology

Exclusion Criteria:

* People that cannot go to the primary care center
* People with cognitive deterioration
* People with limitations in the practice of physical exercise
* People with a life expectancy lower than 6 months
Electrical Stimulation in Diabetic Peripheral Neuropathy

To assess the effect of the device on the progression of diabetic peripheral neuropathy

Diabetes is a metabolic disease that affects the body's ability to control blood sugar levels. This affects the tissues of the body, particularly the walls of blood vessels. People with diabetes are more likely to suffer from ischaemic heart disease, stroke, kidney problems, blindness, foot ulcers, and peripheral nerve problems. Diabetes affects approximately 347 million people worldwide, and by 2030 the WHO projects that complications of diabetes will be the 7th leading cause of death.

Peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. Diabetes is the leading cause of neuropathy in the Western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. The American Diabetes Association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. As regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. Diabetic neuropathy is implicated in 50-75% of non-traumatic amputations.

The device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. We have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. It is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. The device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy.

We wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.

Eligibility Criteria:
Inclusion criteria

* 18+ years old
* Diabetes as defined by WHO diagnostic criteria on best medical therapy
* Diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing

Exclusion criteria

* Pregnancy
* Pacemaker
* Metal implants in the legs (below knee)
Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

This study aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia

Exclusion Criteria:

* BMI \>25 or \< 20 kg/m2
* Patients taking intercurrent medication
* Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase \> 40 IU/L, Cr \> 1.4 mg/dl
Usefulness of Rehabilitation in Patients With Cervical Imbalance

Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any.

Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any. The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors. Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one. 3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors. With the data obtained in said field work, carried out in 2019, the present study aims to analyze the usefulness of rehabilitation treatment in vertigo.

Eligibility Criteria:
Inclusion Criteria:

* Present vertigo of vestibular, neurological or cervical cause.
* The last episode of vertigo occurred less than a year ago.

Exclusion Criteria:

* Present acute musculoskeletal pathology in the lower limbs or lumbar spine.
* Present some lower limb amputation.
* Present unresolved visual pathology.
* Being active with anticancer treatment.