cyrilzakka/clinical-trials huggingface dataset:
Porphyromonas Gingivalis and Alzheimer's Disease

With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* age 40-70
* caucasian origin
* dementia (Alzheimer's or other dementia)
* cognitive healthy (need for spinal anesthesia)

Exclusion Criteria:

* use of antibiotics within las 6 months
* pregnancy
* another illness explaining the symptoms in a better way
* smoking (\>10 cigarettes)
* patients who have a legal custodian
Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)

Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless telemetry vest in cardiac rehabilitation.

Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating the NimbleHeart chest harness system.

20 subjects will be consented to participate at an early cardiac rehabilitation exercise session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with existing telemetry system during exercise sessions, and thus not replace existing telemetry monitoring. Both staff and subjects will be queried for their (user) experiences during and after each session. Experiences will be documented on surveys after each session. De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions. Study participation will end after the 2nd session.

Eligibility Criteria:
Inclusion Criteria:

1. Participating in the Cardiac Rehabilitation Program.
2. Capable of giving, and willing to sign, informed consent.

Exclusion Criteria:

1. Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
2. Presence of Ventricular Assist Device (VAD).
Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris

The primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.


Eligibility Criteria:
Inclusion Criteria

Informed subject consent will be obtained from those patients meeting the following inclusion criteria:

* Male and female patients 18 years or older.
* Clinical and/or histopathological diagnosis of PRP
* Candidate for systemic therapy (PASI ≥ 10)
* Body surface area of involvement ≥ 10%
* Good general health as confirmed by medical history
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion Criteria

Patients are to be excluded based on the following criteria:

* Vulnerable study population
* Pregnant or nursing women
* Women planning a pregnancy within the study period
* Human immunodeficiency virus (HIV) positivity
* Known history of adverse reaction to Cosentyx
* Known history of hepatitis B, hepatitis C, or tuberculosis
* Personal or family history of inflammatory bowel disease
A Clinical Analysis of Bella Blankets® Protective Coverlets

This study will collect and compare clinical image quality measurements of randomly scheduled, asymptomatic, screening mammography patients, right breast mammogram performed with and without the use of Bella Blankets protective coverlets on the receptor plate.

The measurements will determine if the use of Bella Blankets protective coverlets increases the mammogram's clinical image quality and if Bella Blankets protective coverlets can be used as an aid for EQUIP compliance.

In addition, a patient satisfaction survey will be conducted with participants to determine if the use of Bella Blankets protective coverlets improves patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Subject is Female of any race and ethnicity
* Subject is 40-75 years old
* Subject is scheduled for a screening mammogram
* Subject is willing and able to understand and read the Informed consent form
* Subject has been a patient at Elizabeth Wende Breast Care for 2 years or more

Exclusion Criteria:

* Subject is Male
* Subject has been a patient at Elizabeth Wende Breast Care for less than 2 years
* Subject has had a breast biopsy within the last 2 years
* Subject has had breast surgery within the last 2 years
* Subject is scheduled for a Diagnostic mammogram
* Subject suspects or may be pregnant
* Subject is currently pregnant or breastfeeding
* Subject has breast implants
Cortical Effects of Peripheral Proprioceptive Stimulation on the Motor Evoked Potentials of the Limbs

Through motor muscle potentials, we will observe how a peripheral somatosensory mechanical stimulus on key limb musculature communicates signals via afferent sensory fibers that encode proprioceptive signals from muscle spindles (particularly type Ia fibers) to the somatosensory cortex at rest, confirming the integrative hypothesis of movement.

These results would support interventions aimed at addressing sensory deafferentation present in multiple health conditions related to movement disorders, where disuse or immobilization lead to changes in movement patterns and a decrease in neuronal activation in somatosensory cortex areas involved in constructing voluntary movement.

Objective: To evaluate whether a proprioceptive stimulus applied to the limb of healthy subjects activates the corticospinal pathway, compared to a condition without stimulation, through the analysis of motor evoked potentials (MEPs).

Methods: Experimental and crossover. Each participant will serve as their own control and will be assessed under both stimulation (experimental) and no-stimulation (control) conditions.The stimulus will consist of intermittent mechanical pressure on the skin located at the neuromuscular motor points (NMPs) of the upper limb (biceps muscle (B) and wrist extensors (WE)) and the lower limb (rectus femoris of the quadriceps (RFQ) and tibialis anterior (TA).Motor evoked potentials (MEPs) will be recorded from the B, WE, RFQ, and TA muscles using transcranial magnetic stimulation (TMS).The optimal stimulation point (hotspot-the area where TMS generates the highest MEP) will be identified individually for the B, WE, RFQ, and TA muscles.Participants will be recruited at the facilities of the Faculty of Physiotherapy and Nursing of Castilla-La Mancha University (UCLM), in collaboration with the Toledo Physiotherapy Research Group (GIFTO) and the Faculty of Health Sciences, Blanquerna - Ramon Llull University.

Eligibility Criteria:
Inclusion Criteria:

Good health status with no history of neuromuscular injuries, surgical interventions, or trauma affecting the central or peripheral nervous system.

Not currently taking drugs or medications known to affect the central nervous system, and not pregnant at the time of testing.

No metallic or electronic implants and no history of epilepsy.

(Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research)
Alcohol and the Social Brain: an Alcohol-Administration Hyperscanning Study

In this study, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

Objective: Alcohol's ability to boost mood in the face of stress is perhaps its most notoriously addictive property, long held by researchers to be of critical importance for understanding alcohol use disorder (AUD) etiology. Yet, while most real-world alcohol consumption occurs in social settings, in the context of laboratory studies, participants have almost always consumed alcohol alone. The discrepancy between real-world and laboratory contexts emerges as particularly stark in the neuroimaging literature, where no alcohol-administration study to date has incorporated in-vivo social context. In this first alcohol-administration study to leverage EEG hyperscanning methods, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

Specifically, this study aims to characterize the mechanisms driving social reward from alcohol in the context of stress and elucidate the role of social processes and novel social context in driving problem drinking.

Study Population: Participants will consist of 240 regular drinkers, aged 21-30, with no reported history of severe alcohol use disorder.

Design: In the laboratory arm of the study, individuals will be randomly assigned to consume either a moderate dose of alcohol or a control beverage in stranger dyads. Participants will engage in both structured and unstructured tasks aimed at assessing social engagement and threat sensitivity. EEG and ERP data will be collected from both participants simultaneously. In the ambulatory study arm, participants will wear transdermal sensors to assess BAC and will further provide information about their mood and their social contexts in response to random prompts.

Outcome Measures: Primary outcome measures include EEG measures of inter-brain entrainment as well as ERP metrics derived from task contexts (both players and observers). Additional outcomes include measures of positive mood, negative mood, and social bonding. Finally, drinking behaviors will be assessed via transdermal ambulatory alcohol sensors and longitudinal self-reports of drinking.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 21 and 30
* Regularly consumes alcohol

Exclusion Criteria:

* History of adverse reaction to the amount of beverage employed in the study
* Have a history of major problems associated with alcohol
* Take medications that could adversely interact with alcohol
* Have medical conditions that contraindicate alcohol administration
* Individuals with a history of skull fractures or who indicate discomfort with EEG procedures used
* Female participant is pregnant or trying to become pregnant
Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women

The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic reactions to the vaccine will also be assessed.

Schedule of Events

Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed

Local/ systematic reactions

Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed

Eligibility Criteria:
Inclusion Criteria:

(i) Documented to be HIV-1 infected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.

* Able to understand and comply with planned study procedures.
* Provides written informed consent prior to initiation of study.
* Not pregnant at time of enrolment (confirmed by urine testing). If pregnant in past year, participant must be at least 6 months post delivery at time of enrolment.
* Women age ≥ 18 years to \< 39 years.

Exclusion Criteria:

* Receipt of TIV, other than through the study, during the current and previous two influenza seasons, documented by medical history or record.
* Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
* Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained.
* Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
* Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
* Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
* Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products.
* Receipt of Interleukin 2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
* Uncontrolled major psychiatric disorder.
* History of a severe adverse reaction to previous TIV.
* Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Tanner stage 2-5 pubertal development at time of randomisation
* Body Mass Index (BMI) corresponding to 30 kg/m\^2 or above for adults by international cut-off points and 45 kg/m\^2 or below and equal to or above 95th percentile for age and gender
* Fasting plasma glucose below 7.0 mmol/L (126 mg/dL) (central laboratory analysis)

Exclusion Criteria:

* Subjects with clinically diagnosed secondary causes of childhood obesity such as chromosomal abnormalities (e.g. Turner syndrome), syndromic obesity (e.g. Prader Willi syndrome) or endocrinologic disorders (e.g. Cushing Syndrome)
* Subjects with confirmed diagnosis of bulimia
* Subjects with Tanner stage 1 development (prepubertal)
* Diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator
* Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 (dipeptidyl peptidase-4) inhibitors, orlistat or other weight lowering medication, any antipsychotic medication or systemic corticosteroids within the last 3 months
* Currently using or have used within 3 months before screening for this trial: any systemic treatment that in the opinion of the investigator interferes with PK (pharmacokinetic), PD (pharmacodynamic) and safety endpoints
* Surgical treatment for obesity
* Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), -triglycerides above 500 mg/dL, -calcium above UNR, -history of gallstones (not treated by cholecystectomy)
* Uncontrolled treated or untreated hypertension 99th percentile for age and gender in children
* History of major depressive disorder or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) that could in the opinion of the investigator interfere with trial compliance or subject safety
* Subjects with a history of suicide attempts or history of any suicidal behaviour within the past month before entry into the trial
Investigation of the Photobiomodulation Applications

Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor.

When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters.

The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days.

LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined.

The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done.

The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.


Eligibility Criteria:
Inclusion Criteria:

* adequate oral hygiene
* Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
* lack of congenital missing teeth in upper jaw
* no systemic disease

Exclusion Criteria:

* patients who wish to discontinue treatment
* patients who cannot provide oral hygiene
A Pilot Study of Renal Hypothermia During Partial Nephrectomy

Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
2. Bilateral renal function on radiographic imaging.
3. Willing to consent to randomization.
4. Willing to comply with study protocol.

Exclusion Criteria:

1. Anatomically or functionally solitary kidney
2. Multiple renal tumours
3. Bilateral renal tumours
4. Life expectancy \< 3 months as deemed by treating physician
5. Age less than 18 years old
6. Pregnancy
Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

The purpose of this study is to measure the rate of anti-palivizumab antibodies (also referred to as immune reactivity or immunogenicity) in subjects receiving either the liquid or lyophilized formulation of palivizumab. This study will compare the number and percentage of subjects with anti-palivizumab antibodies receiving either the liquid or lyophilized formulation of palivizumab.

The approved liquid formulation of palivizumab was developed to simplify preparation of the drug before injection. Both formulations of palivizumab have been shown to be bioequivalent in children 6 months of age or younger with a history of chronic lung disease. In previous studies of liquid palivizumab, immunogenicity was evaluated up to 2 months after dosing in adults, and 1 month after dosing in children. In this study, MI-CP116, immunogenicity will be evaluated between 4 and 6 months after the last dose of study drug, in order to provide data at a time point significantly distant from dosing when drug interference is minimal.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable child with chronic lung disease of prematurity who is ≤24 months of age at randomization OR child with premature birth (gestational age ≤35 weeks or less) and who is 6 months of age or younger at randomization
* Written informed consent obtained from the patient's parent(s) or legal guardian(s)
* The child must be able to complete the follow-up visit 4-6 months after the last dose of study drug

Exclusion Criteria:

* Hospitalization at the time of randomization (unless discharge is anticipated within 3 weeks)
* Be receiving mechanical ventilation at the time of study entry (including CPAP)
* Congenital heart disease (children with uncomplicated CHD \[e.g., PDA, small septal defect\] and children with complicated CHD who are currently anatomically and hemodynamically normal can be enrolled).
* Mother with HIV infection (unless the child has been proven to be not infected)
* Life expectancy \<6 months
* Known allergy to Ig products
* Acute respiratory or other acute infection or illness
* Previous reaction to IGIV, blood products, or other foreign proteins
* Receipt of lyophilized palivizumab, RSV-IG IV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
* Any previous receipt of MEDI-524
* Participation in other investigational drug product studies
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.

The subject devices are:

* plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures
* plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).

Eligibility Criteria:
Inclusion Criteria:

1. Males or females
2. A patient who underwent one or more of the following surgical procedures completed between January 1, 2015 and December 31, 2019, with plates, screws, and or meshes from the Biomet Microfixation Facial Plating System:

   * Repair of a facial fracture
   * Repair of a facial osteotomy
   * Reconstructive procedures of the facial skeleton
   * Revision procedures where other treatments or devices have failed
3. Available follow-up data at least at 30 days' post-operative

Exclusion Criteria:

1. Active or latent infection at the time of implantation
2. Documented foreign body sensitivity
3. Patients with limited blood supply, insufficient quantity or quality of bone (e.g., osteomalacia or a bone resorption condition such as Paget's disease, osteoporosis, bone metastasis)
4. Patients with documented mental or neurologic conditions who were unwilling or incapable of following postoperative care instructions